CONCERN
(D)
Potential for Harm - no one hurt, but risky conditions existed
Medication Errors
(Tag F0758)
Could have caused harm · This affected 1 resident
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview, observation and record review the facility failed to identify an indication and appropriate duration of use ...
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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview, observation and record review the facility failed to identify an indication and appropriate duration of use for psychotropic (mind altering) medications on two (Resident 84 and Resident 44) out of 22 sampled residents as evidenced by:
1. When Resident 84 (Res 84) was admitted with a medication called quetiapine (or Seroquel- used to treat mental health problem or nerve pill) with conflicting indications in the medical chart affecting the care planning and behavior monitoring by nursing staff.
2. When Resident 44 (Res 44) was initiated and continued on a medication called diazepam (or Valium used to treat anxiety) without documentation for clinical justification (the process for determining reasons for medication use), informed consent (a signed resident's authorization and communication between a clinician and the resident in use of mind altering medication when all risks and benefits explained), side effect (means adverse drug effects) monitoring by nursing staff and care planning (the process by which healthcare professionals and resident discuss, agree, and review on a plan to achieve the health goals) documentation.
These failures had the potential for unsafe use of psychotropic or mind-altering medications in the facility.
Findings:
1. During a review of Res-84's medical record, titled History and Physical, dated 3/2/21, the Medical Doctor (MD 1), indicated a diagnosis of Advance Dementia (means profound memory loss and inability to care for self or perform activities) and listed the quetiapine (nerve pill) as home medication.
During a review of Res-84's medical record, titled Order (doctor's order) Summary Report, dated 4/23/21, the MD 1's order indicated to give Quetiapine 50mg (mg is a unit of measure) give 1.5 tablet by mouth in the evening for depression manifested by tearfulness causing distress to resident.
During review of the Res-84's medical records, titled Progress Notes, dated 4/3/21, written by the Family Nurse Practitioner 1 (PNP 1), the Progress Notes indicated, a diagnosis of advance dementia (means profound memory loss and inability to care for self or perform activities) and an assessment to continue the quetiapine. Further review of the subsequent progress notes, written by Medical Doctor 2 (MD 2), Medical Doctor 3 (MD 3) and PNP 1, dated 4/2/21, 4/6/21, 4/8/21, 4/10/21, 4/13/21, 4/16/21, 4/16/21, 4/19/21, and 4/21/21, all documented advance dementia as diagnosis without any update on resident's monitoring parameters.
During review of the Res-84's medical records titled skilled evaluation, dated 4/19/21 and 4/22/21, the Registered Nurse 1's (RN-1) note indicated, Mood is pleasant, no unwanted behavior witnessed, resident does not wander at night. Resident sleeps through the night.
During a concurrent observation and interview on 4/26/21 at 8:30 AM, with Licensed Nurse 3 (LVN 3) inside the Resident 84's (Res 84) room, LVN-3 administered the morning medications to the Res-84 without any refusal. Resident 84 was smiling and pleasant. LVN 3 stated she found no issues and complaints caring for the resident.
During an interview on 4/ 26/21 at 5:01 PM, with the Director of Nursing (DON), the DON stated the psychotropic medications (mind alerting medication) were care planned based on doctor's order with same behaviors monitored in the Medication Administration Record (or MAR-the place in the resident's medical record where all medications use and information were recorded). The DON added the care plan should have been updated based on patient's progress.
During review of the Res-84's medical records titled Medication Administration Record (or MAR where the nursing staff recorded the medication use and monitoring) for April of 2021, the MAR indicated the nursing staff monitored tearfulness due to depression every shift. The nursing staff recorded no episodes of tearfulness.
During an interview on 4/26/21 at 5:41 PM, over the telephone regarding Res-84, with Medical Doctor 1 (MD 1), the MD 1 stated that he preferred not to touch the psychotropic (mind altering) medications for short stay residents. He would not seek expert consult with a psychiatrist (A doctor specialized in mental health) if no behavioral issues communicated to him. MD 1 stated that the health records from hospital to the facility could at times be incomplete in regards to mental health issues. Additionally, he acknowledged the discrepancy and lack of clarification between what nursing were monitoring (depression) and what the medical providers were documenting (advanced dementia) in their progress notes for Res 84 since admission on [DATE].
During an interview on 4/27/21 at 3:04 PM, over the telephone with Consultant Pharmacist (CP- a pharmacist who guided the medication use and monitoring for the facility), the CP stated psychotropic medications should have had the same indication on the doctor's order and progress notes. She added, in her opinion, quetiapine was not a first choice to treat depression in elderly. CP acknowledged that she did not fully reviewed Res-84's medical record to address the discrepancy.
A review of Beers Criteria list (a set of criteria published by American Geriatric Society to improve the effectiveness and safety of prescription drugs for elderly), updated on 2019, last accessed on 5/4/21 via https://www.americangeriatrics.org/media-center/news/older-people-medications-are-common-updated-ags-beers-criteriar-aims-make-sure, indicated to avoid use of quetiapine in elderly. The criteria added, Avoid antipsychotics in older adults due to an increased risk of cerebrovascular accidents (stroke) and a greater rate of cognitive decline and mortality in patients with dementia. Antipsychotics . should be given in the lowest effective dose for the shortest duration possible.
2. Review of Resident 44's (Res 44) medical record, titled History and Physical, written by medical Doctor 1 (MD 1) on 2/24/21 when resident first admitted to the facility, indicated among medication list, olanzapine (mood altering medication) 5mg (mg is unit of measure) daily at bed time. The medication list from the hospital did not include diazepam (medication used for anxiety).
During a review of the medical records for Res 44, titled Doctor Progress Notes, dated 3/30/21, MD 3 indicated patient was anxious due to lack of sleep and complained of inability to sleep due to noise from loud TV and roommate.
During a review of Resident 44's (Res 44) medical record, titled Order (doctor's order) Summary Report, dated 4/23/21, the MD 1s order indicated to give diazepam 10mg ('mg is a unit of measure) every 12 hours as needed for anxiety. Further review of order history, indicated that diazepam initiated on 2/25/21 one day after admission to the facility from the hospital.
Review of medical record for Res 44, titled Progress Notes, dated 4/8/21, written by MD 3, indicated Res 44 will benefit from Cognitive Behavior Therapy (or CBT- or talk therapy with a skilled therapist) and will need to see a specialized therapist. The progress noted did not give clinical justification for continued use and dose increase on diazepam.
Review of medical record for Res 44, titled Medication Administration Record (or MAR where the nursing staff recorded the medication use and monitoring), for the months of February 2021, March 2021 and April 2021, the MAR did not show any side effect monitoring for diazepam from 2/25/21 to 4/8/21 by nursing staff.
Review of medical record for Res 44, titled Medication Administration Record, dated 4/23/21, the MAR indicated on 4/15/21 and 4/18/21, Res 44 received diazepam and an opioid pain medication called oxycodone at the same time at 11:42 and 14:42 respectively.
Review of medical record for Res 44, titled Verification of Informed Consent for Psychotropic Medications, dated 2/24/21, indicated an informed consent (a signed resident's authorization and communication between a doctor and the resident in use of mind altering medication when all risks and benefits explained) for a drug called olanzapine (a type of nerve pill) that was not ordered by the doctor. The medical records did not show any signed informed consent for use of diazepam.
Review of the electronic medical record for Res 44, titled Care Plan, dated 4/23/21, the Care Plan did not show any plan of care for use of diazepam for anxiety.
During a concurrent observation and interview on 4/26/21 at 10:18 AM, with Res 44, Res 44 stated sleep was not very good because of noises from other resident's yelling and crying. She added the talk therapy helped her thought process to get through difficulties of her illness. Res 44 stated she did not take any nerve or anxiety pills prior to hospitalization.
During an interview on 4/ 26/21 at 5:01 PM, with the Director of Nursing (DON), the DON stated the psychotropic medications (mind alerting medication) were care planned based on doctor's order with same behaviors monitored in the Medication Administration Record. DON added, the new care plan should have been initiated within 48 hours and customized based on resident's needs. The DON, additionally, stated that nursing staff should regularly check the doctor's progress notes to update the resident's care plan.
During an interview on 4/ 26/21 at 5:31 PM, with the DON, the DON stated concurrent use of powerful opioid pain medication and diazepam should have been addressed by facility's consultant pharmacist if there was no direction from the doctor's order. The DON acknowledged the risks of administering these two drugs at the same time.
During an interview on 4/26/21 at 5:41 PM, over the telephone regarding Res 44, with Medical Doctor 1 (MD 1), MD 1 stated diazepam was prescribed due to resident past use and preference. MD 1 acknowledged that diazepam was not the best choice to use in elderly residents. MD 1, additionally, acknowledged he was aware of warnings by US Food and Drug Administration (or FDA is a government agency responsible for protecting the public health by ensuring the safety of drug use) on avoiding concurrent of diazepam with opioid medications.
In an interview on 4/27/21 at 3:04 PM, over the telephone with the Consultant Pharmacist (CP), the CP stated diazepam use was on her monitoring list. The CP, however, did not question the indication for use, concurrent use with opioid pain medication and did not offer an alternative recommendation to the doctor.
Review of U.S. FDA drug safety warning to health care professionals, dated 9/20 /2017, titled FDA warns about serious risks and death when combining opioid pain medication with benzodiazepines; requires its strongest warning, last accessed on 5/5/2021 via https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-serious-risks-and-death-when-combining-opioid-pain-or, indicated Health care professionals should limit prescribing opioid pain medicines with benzodiazepines (drugs like diazepam-used for anxiety) or other CNS depressants ( drugs that affect thought process) only to patients for whom alternative treatment options are inadequate.
Review of Beers Criteria list (a set of criteria published by American Geriatric Society to improve the effectiveness and safety of prescription drugs for elderly), updated on 2019, last accessed on 5/4/21 via https://www.americangeriatrics.org/media-center/news/older-people-medications-are-common-updated-ags-beers-criteriar-aims-make-sure, indicated Avoid use of (diazepam) due to increased risk of impaired cognition, delirium (means restless and confused), falls, fractures, and motor vehicle accidents with benzodiazepine use. Older adults also have slower metabolism of long acting (stays in body for a long time) benzodiazepines (e.g., diazepam).
CONCERN
(E)
Potential for Harm - no one hurt, but risky conditions existed
Deficiency F0658
(Tag F0658)
Could have caused harm · This affected multiple residents
Definitions:
Central Line - also known as Central Venous Catheter (CVC), is a flexible tube inserted through the patient's skin and into their body through a peripheral vein or proximal central vein s...
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Definitions:
Central Line - also known as Central Venous Catheter (CVC), is a flexible tube inserted through the patient's skin and into their body through a peripheral vein or proximal central vein such as the internal jugular (neck), femoral vein (groin) or subclavian vein (upper chest) and used to give fluids, blood or medications.
Intravenous (IV) - defined as within a vein or commonly, it refers to giving medicines or fluids through a needle or tube inserted into a vein.
Peripherally Inserted Central Catheter (PICC) - a thin tube that is inserted through a vein in the arm and passed through to the larger veins near the heart used to administer medications, liquid nutrition or other intravenous (IV) treatments.
Based on observation, interview, and record review, the facility did not ensure services provided by the facility adhered to professional standards of quality, when:
1. Central line dressing was not changed as ordered by the physician for one of 22 sampled residents (Resident 87).
2. Central line site was not checked as ordered by the physician for one of 22 sampled residents (Resident 87).
These deficient practices had the potential to put the resident at risk for infection.
Findings:
1. During a review of the clinical record for Resident 87, the nurse's Progress Notes dated 3/31/21, indicated . Special Care: IV (Intravenous) Device: Central venous line (CVC) . CVC [Central Venous Catheter] location: left subclavian CVC line .
During an observation and concurrent interview with Registered Nurse (RN) 5 on 4/23/21 at 4:10 PM in Resident 87's room, RN 5 inspected Resident 87's central line site and dressing on the left upper chest area. The central line was covered with a clear, transparent dressing with handwritten label on the dressing that indicated, 4/23 IV 1325 IN. RN 5 confirmed the label indicated the date and time the dressing was changed, and the initials of the nurse who performed the dressing change. The dressing was clean, dry and intact. Resident 87's central line site did not appear to be infected.
During a review of the clinical record for Resident 87, the physician's Order Summary Report, dated 4/22/21, indicated, .IV (intravenous) site dressings will be changed every 7 days and PRN (as needed) if saturated. One time a day every 7 day(s) . Order Date 03/30/2021, Start Date 03/31/2021 .
During a review of the clinical record for Resident 87, the Treatment Administration Record (TAR), printed on 4/22/21 for the month 4/1/2021 - 4/30/2021, indicated that the line item for the central line IV dressing change had blank boxes on the following dates: 4/7, 4/14, and 4/21; and the rest of the other dates were marked X. The TAR did not have documentation on Resident 87's central line dressing change/s.
The facility policy and procedure (P&P) titled Documentation of Treatment Administration revision dated 4/2007, indicated .The facility shall maintain a treatment administration record to document all treatments administered . 1. A Nurse or Certified Medication Aide (where applicable) shall document all treatments administered to each resident on the resident's treatment administration record (TAR). 2. Administration of treatment must be documented after it is rendered. 3. Documentation must include, as a minimum . Method of administration . Date and time of administration . Reason(s) why a treatment was withheld, not administered, or refused (as applicable) . Signature and title of the person administering the treatment .Resident response to the treatment, if applicable .
During an interview with RN 4 on 4/26/21 at 2:35 PM, RN 4 stated that central line dressing changes for Resident 87 were documented in the resident's progress notes or Medication Administration Record (MAR). RN 4 acknowledged that if corresponding dates for the order showed a blank box on the MAR, it was possible that the order was not carried out because there was no documentation. RN 4 stated dressing changes should be documented so that the staff knew when the dressing was changed for the resident. RN 4 stated documentation for the dressing change served as a reference should an issue come up at some point.
During a review of the clinical record for Resident 87, the nurse's Progress Notes, printed on 4/22/21 from 3/30/21 through 4/22/21 did not have documentation on central line dressing change/s.
During a review of the clinical record for Resident 87, the Medication Administration Record (MAR), printed on 4/22/21 for the month 4/1/2021 - 4/30/2021, did not have documentation on central line dressing change/s.
The facility policy and procedure (P&P) titled Documentation of Medication Administration revision dated 4/2007, indicated .The facility shall maintain a medication administration record to document all medications administered . 1. A Nurse or Certified Medication Aide (where applicable) shall document all medications administered to each resident on the resident's medication administration record (MAR). 2. Administration of medication must be documented immediately after (never before) it is given . 3. Documentation must include, as a minimum . Method of administration . Date and time of administration . Reason(s) why a medication was withheld, not administered, or refused (as applicable) . Signature and title of the person administering the medication . Resident response to the medication, if applicable .
The facility policy and procedure (P&P) titled PICC [Peripherally Inserted Central Line] Dressing Change dated 6/2018, indicated .I. To Be Performed By: RN's (Registered Nurses) and IV (Intravenous) Certified LVN's (Licensed Vocational Nurses) according to state law and facility policy. II. Policy . B. Dressing changes using transparent dressings are performed: 1. Upon admission . 2. At least weekly 3. If the integrity of the dressing has been compromised .
During a review of the clinical record for Resident 87, the care plan printed on 4/26/21 indicated, Focus - High risk for signs and symptoms of infection, redness, swelling, pain and drainage on IV [intravenous] peripheral line site. Goal - IV peripheral line site will be free from signs and symptoms of infection, redness, swelling, pain and drainage through the next review date. Interventions/Tasks . Dressing change PICC [peripherally inserted central catheter] line site every 7 days and PRN [as needed] .
2. During an observation and concurrent interview with Registered Nurse (RN) 5 on 4/23/21 at 4:10 PM in Resident 87's room, RN 5 inspected Resident 87's central line site and dressing on the left upper chest area. The central line was covered with a clear, transparent dressing with handwritten label on the dressing that indicated, 4/23 IV 1325 IN. RN 5 confirmed the label indicated the date and time the dressing was changed, and the initials of the nurse who performed the dressing change. The dressing was clean, dry and intact. Resident 87's central line site did not appear to be infected.
During a review of the clinical record for Resident 87, the physician's Order Summary Report, dated 4/22/21, indicated, .Check IV [intravenous] site (L [left] Subclavian Double Lumen [channel]) Q [every] shift. Every shift, Record any changes: None (0). Redness (1). Swelling (2), Bleeding (3) . Order Date 03/30/2021, Start Date 03/30/2021 .
During a review of the clinical record for Resident 87, the Treatment Administration Record (TAR), printed on 4/22/21 for the month 4/1/2021 - 4/30/2021, indicated that the line item for checking the central line IV site had blank boxes on the following dates and work shifts: From 4/1/21 through 4/21/21 on the day shift; From 4/1/21 through 4/9/21, 4/11/21 through 4/17/21, and 4/19/21 through 4/22/21 for the evening shift; and From 4/4/21 through 4/7/21, 4/11/21 through 4/14/21, and 4/19/21 through 4/22/21 for the night shift.
During a concurrent interview with Director of Nursing (DON) on 4/27/21 at 3:56 PM and record review of Resident 87's TAR report printed on 4/22/21, the DON acknowledged that there was no consistent documentation on the resident's central line dressing change and IV site assessment. The DON stated the TAR should be filled out. The DON stated that if there was no documentation, it meant that the physician's order was carried out by the staff.
The facility policy and procedure (P&P) titled Documentation of Treatment Administration revision dated 4/2007, indicated .The facility shall maintain a treatment administration record to document all treatments administered . 1. A Nurse or Certified Medication Aide (where applicable) shall document all treatments administered to each resident on the resident's treatment administration record (TAR). 2. Administration of treatment must be documented after it is rendered. 3. Documentation must include, as a minimum . Method of administration . Date and time of administration . Reason(s) why a treatment was withheld, not administered, or refused (as applicable) . Signature and title of the person administering the treatment .Resident response to the treatment, if applicable .
The facility policy and procedure (P&P) titled PICC [Peripherally Inserted Central Line] Dressing Change dated 6/2018, indicated .I. To Be Performed By: RN's (Registered Nurses) and IV (Intravenous) Certified LVN's (Licensed Vocational Nurses) according to state law and facility policy. II. Policy . H. Assessment of venous access site is performed . 4. At least once every shift when not in use. I. Assessment is to include, but is not limited to, the absence or presence of: 1. Redness 2. Drainage 3. Swelling or induration 4. Change in skin temperature 5. Tenderness at the site or along vein tract . IV. Procedure . V. Documentation in the medical record includes, but is not limited to: 1. Date and time 2. Site assessment .
During a review of the clinical record for Resident 87, the care plan printed on 4/26/21 indicated, Focus - High risk for signs and symptoms of infection, redness, swelling, pain and drainage on IV [intravenous] peripheral line site. Goal - IV peripheral line site will be free from signs and symptoms of infection, redness, swelling, pain and drainage through the next review date. Interventions/Tasks - Observe for signs and symptoms of infection, redness, swelling, infiltration, pain and drainage on IV peripheral line site . Check IV site Q [every] shift (left subclavian double lumen) .
CONCERN
(E)
Potential for Harm - no one hurt, but risky conditions existed
Drug Regimen Review
(Tag F0756)
Could have caused harm · This affected multiple residents
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 2A. During review of Resident 44 (Res 44) medical document titled Medication Administration Record (or MAR, a document in medica...
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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 2A. During review of Resident 44 (Res 44) medical document titled Medication Administration Record (or MAR, a document in medical records that capture medication list and use), dated for April 2021, indicated Res 44 was prescribed an opioid medication on 3/22/21 as follow:
Oxycodone (opioid pain medication) 5 mg tablet (mg is unit of measure), give two tablets by mouth every 4 hours as needed for severe pain .
The MAR record did not show oxycodone administration on 4/22/21 at 13:40 PM.
A 4/23/21 review of Res 44 medical record document (undated), titled Antibiotic or Controlled Drug Record ( also known as CDR- a log used to assure accountability and security of the medication use), the document indicated a Licensed Nurse removed and signed for 2 tablets of oxycodone for administration on 4/22 at 13:40 PM. Further review of Res 44s Medication Administration Record, where medication administration were recorded for April 2021, did not show any corresponding documentation to reflect CDR removal of opioid oxycodone on 4/22 at 13:40 PM.
2B. During review of Resident 45 (Res 45) medical document titled Medication Administration Record (or MAR, a document in medical records that capture medication list and use), dated for April 2021, indicated Res 45 was prescribed an opioid medication on 4/6/21 as follow:
Oxycodone (opioid pain medication) 5 mg tablet (mg is unit of measure), give two tablets by mouth every 4 hours as needed for severe pain .
The MAR record did not show oxycodone administration on 4/10/21 at 2000 PM and 4/20/21 at 0100 AM.
A 4/23/21 review of Res 45 medical record document (undated), titled Antibiotic or Controlled Drug Record (known as CDR- a log used to assure accountability and security of the medication use), the document indicated nursing staff removed and signed for 2 tablets of oxycodone for administration on 4/10 at 20:00 PM and on 4/20/21 at 01:00 AM. Further review of Res 45s Medication Administration Record, where medication administration were recorded for April 2021, did not show any corresponding documentation to reflect CDR removal of opioid oxycodone on 4/10/21 at 20:00 PM and 4/20/21 at 01:00 AM.
2C. During review of Resident 88 (Res 88) medical document titled Medication Administration Record (or MAR, a document in medical records that capture medication list and use), dated for April 2021, indicated Res 88 was prescribed an opioid medication on 3/1/21 as follow:
Oxycodone (opioid pain medication) 5 mg= 5mL (mg and ml were unit of measure), give 5mL by mouth every 4 hours as needed for moderate pain .Oxycodone 7.5mg= 7.5mL, Give 7.5mL every 4 hours as needed for severe pain .
The MAR record did not show oxycodone administration on the following days and times:
4/3/21 at 1900 PM
4/5/21 at 2100 PM
4/10/21 at 1900 PM
4/12/21 at 11 AM
4/18 at 2000 PM
4/19 at 3 PM
A 4/23/21 review of Res 88 medical record document (undated), titled Antibiotic or Controlled Drug Record (known as CDR- a log used to assure accountability and security of the medication use), the document indicated a Licensed Nurse removed and signed for oxycodone for administration on the following days and times:
4/3/21 at 1900 PM (5mg=mL)
4/5/21 at 2100 PM (5mg=mL)
4/10/21 at 1900 PM (7.5 mg= 7.5mL)
4/12/21 at 11 AM (5mg=mL)
4/18 at 2000 PM (5mg=mL)
4/19 at 3 PM (5mg=mL)
Further review of Res 88s Medication Administration Record, where medication administration were recorded for April 2021, did not show any corresponding documentation to reflect CDR removal of opioid oxycodone in the following days and times:
4/3/21 at 1900 PM (5mg=mL)
4/5/21 at 2100 PM (5mg=mL)
4/10/21 at 1900 PM (7.5 mg= 7.5mL)
4/12/21 at 11 AM (5mg=mL)
4/18 at 2000 PM (5mg=mL)
4/19 at 3 PM (5mg=mL)
2D. During review of Resident 51 (Res 51) medical document titled Medication Administration Record (or MAR, a document in medical records that capture medication list and use), dated for April 2021, indicated Res 51 was prescribed an opioid medication on 3/17/21 as follow:
Oxycodone (opioid pain medication) 5 mg tablet (mg is unit of measure), give half a tablet or 2.5 mg by mouth every 4 hours as needed for moderate pain .Oxycodone 5mg tablet, give 2 tablet every 4 hours as needed for severe pain .
The MAR record did not show oxycodone administration on 4/9/21 at 0500 AM and 4/14/21 at 1700 PM. The MAR record, however recorded administration of oxycodone 5mg on 4/13/21 at 17:28 PM.
A 4/23/21 review of Res 51s medical record document (undated), titled Antibiotic or Controlled Drug Record (known as CDR- a log used to assure accountability and security of the medication use), the document indicated nursing staff removed and signed for oxycodone 5mg for administration on 4/9/21 at 5:00 AM and on 4/14/21 at 17:00 PM. Further review of Res 51s Medication Administration Record, where medication administration were recorded for April 2021, did not show any corresponding documentation to reflect CDR removal of oxycodone on 4/09/21 at 5:00 AM, 4/13/21 at 12:08 PM and 4/14/21 at 17:00 PM
In an interview with Licensed Nurse 3 (LVN 3) on 4/23/21 at 2:23 PM, LVN 3 stated once a pain medication removed from CDR, the nurse should document it in the MAR along with pain level before and after use.
In an interview with Director of Nursing (DON) on 4/26/21 at 3:12 PM, DON stated removal from the CDR sheets should corresponds to the MAR documentation because nursing staff were responsible for what they administer. DON added nursing staff could document medication administration in the progress notes for the outcome or result of the medication use by residents. DON was not aware of any audit of the CDR and MAR for opioid accountability by either her facility or the Consultant Pharmacist (or CP, pharmacist who reviewed medication use practices for the facility on monthly basis). DON stated that the facility had no problem with narcotic (or opioid, drugs at risk for abuse) medication loss and errors. DON, furthermore, acknowledged discrepancy and lack of documentation might happen, because most resident wanted narcotic and nurses knew their residents very well.
In an interview with Consultant Pharmacist (CP), on 4/27/21 at 3:44 PM, CP stated that she did not perform any audit of narcotic medication use by comparing the CDR and MAR. CP added this was not part of her work servicing the facility.
Record review of the facility's policy titled Preparation and General Guidelines on medication administration, dated October 2017, indicated The individual who administers the medication dose records the administration on the resident's MAR directly after the medication is given . In no case should the individual who administered the medication report off duty without first recording the administration of any medication.
3. During review of facility documents titled Consolidated Delivery Sheets (or CDS, or delivery sheet, a document that lists the medication names and quantities delivered to the facility by the provider pharmacy), dated 4/10/21, the CDS document did not have a signature and date from the receiving nurse. The document listed an opioid medication called oxycodone 5 mg (mg is unit of measure) for Resident 96 with prescription number 20072073-N. The bottom section of the document noted as Checked By . and Received By . were not signed. The document further noted Authorized Signatures Only (Stamped signature and dates are not acceptable).
During review of facility documents titled Consolidated Delivery Sheets (or CDS, or delivery sheet, a document that lists the medication names and quantities delivered to the facility by the provider pharmacy), dated 4/21/21, on fifth floor of the facility, the CDS document did not have a signature or date from the receiving nurse. The document listed an opioid medication called oxycodone 5 mg (mg is unit of measure) for Resident 999 with prescription number 20076213-N. The bottom section of the document was not signed when medication was received. The document further noted Authorized Signatures Only (Stamped signature and dates are not acceptable).
In an interview with Nurse Manager 1 (NM 1) on 4/20/21 at 10:50 AM, NM 1 stated that nursing staff upon receipt of the drugs should sign delivery sheets. NM 1 added that medical records collected and removed the delivery sheets every day from the units.
During an inspection on 4/20/21 at 11:56 AM, on fourth and fifth floor units, it was observed, the Consolidated Delivery Sheets (or CDS) were not signed upon receipt from the provider pharmacy as follow:
a. Date 4/10/21; Batch number 0123 (specific number by provider pharmacy); Prescription numbers: 61132997-R, 61233977-R, 61220130-R, 61272952-N, 61230330-R, 61095471-R, and 61219213-R (these are prescription numbers for residents)
b. Date 4/10/21; Batch number 0123; Prescription number: 61233974-R
c. Date 4/11/21; Batch number 2314 Prescription number: 61204887-R
d. Date 4/11/21; Batch number 2314; Prescription number: 60918437-R and 61280980-N
e. Date 4/11/21; Batch number 2314; Prescription number 61117715-R
f. Date 4/13/21; Batch number 1138; Rx numbers: 60924722-R, 61161275-R, and 61167057-R
g. Date 4/13/21; Batch number 0330; Prescription number: 6126710-R
h. Date 4/20/21; Batch Number: APHT; Prescription number: 60744073-R
i. Date 4/22/21; Batch number 0121; Prescription numbers: 61265856-R, 61320393-R
During an interview with LVN 2, on 4/20/21 at 12:14 PM, LVN 2 stated medications were delivered in the afternoon shift and the front lobby receptionist would notified the floors to pick up medications for their units. The delivery sheet should have been signed and dated when received by a licensed nurse.
In an interview with Director of Nursing (DON) on 4/226/21 at 3:06 PM, DON stated the medications were delivered to the lobby of the facility and each charge nurse retrieved their unit's medication. DON acknowledged the nursing staff should sign the CDS sheet because it was the facility's record of receiving prescription and narcotic medication. DON stated that she was not monitoring compliance for accountability of received medications.
In an interview with Consultant Pharmacist (CP) on 4/27/21 at 3:26 PM, CP states that medication delivery sheets should have been signed by nursing staff at the facility upon receipt. CP acknowledged that she did not review of Consolidated Delivery Sheets (or delivery sheet) for compliance. She added there was an electronic signature when facility received the medications from the delivery person. The medication, however, went to different units and each unit has to sign the delivery sheet belong to their unit or floor. CP added checking the delivery sheets was part of her workflow and it's a lesson learned opportunity.
4A. During an inspection of the medication refrigerator in the medication storage room located on the second (2ND) floor and concurrent interview with Registered Nurse (RN) 1, on 4/20/21 at 9:25 AM, RN 1 acknowledged the following drugs and biologicals were stored beyond the expiration date:
a. One multi-dose vial of influenza vaccine (known as flu shots) afluria Quadrivalent, labeled Date Vial Opened 11/1/20, Date Vial Expires 11/29/20, Discard After 28 days was stored beyond the expiration date;
b. One Refrigerated Emergency Kit [New] #3051 (E-kit, a kit/box containing small quantity of medications that can be dispensed when pharmacy services are not available) sealed with red plastic lock, indicated an expiration date of 3/31/21; the E-kit contains medications including Lorazepam (a medication used to manage anxiety disorders) injection vial, insulin (a medication used to treat high blood sugar levels), Prochlorperazine suppository (medication used to manage severe nausea and vomiting), and Promethazine suppository (medication used for prevention and control of nausea and/or vomiting). RN 1 stated, I don't know when asked regarding the expired E-kit in the medication refrigerator.
During an interview with NM 1, on 4/26/21 at 2:35 PM, NM 1 stated each E-kit are checked every shift during endorsement; the nurses communicates if it was reordered or not; E-kits need to be replaced by the pharmacy within 72 hours.
4B.During an inspection of the treatment cart located on the second (2ND) floor and concurrent interview with NM 1, on 4/20/21 at 9:42 AM, opened and undated biologicals were stored in the treatment cart as follow:
a. Two tubes of MediHoney (a medical-grade honey-based product line for the management of wounds and burns) Wound & Burn Dressing 44 ml (ml is unit of measure) did not have a cap/cover;
b. Two bottles of sterile saline (a solution used for wound cleansing, irrigation, and flushing) 100 ml (ml is unit of measure) for irrigation;
c. One bottle of Betadine solution (povidone-iodine 10%, used to treat or prevent bacterial infections).
NM 1 stated any medication container should be dated once opened; containers with no cap/cover are not acceptable and should be discarded; the opened bottle of sterile water is a one time use only and should be discarded after use. NM 1 stated that MediHoney and Betadine solution were used for residents during wound care.
During an inspection of the medication storage cart located on the second (2ND) floor and concurrent interview with RN 1, on 4/20/21 at 10 AM, opened and undated drugs were stored in the medication cart as follow:
a. One bottle of Regular Strength Acetaminophen (a medication used to relieve pain and reduce fever) 1000 tablets 325 milligrams (or mg is unit of measure) each;
b. One bottle of Extra Strength Acetaminophen 1000 tablets 500 mg (mg is a unit of measure) each;
c. One box/foil tray containing the BREO Ellipta 200/25 (fluticasone furoate 200 mcg and vilanterol 25 mcg inhalation powder (a combination inhaler used to treat blocked airflow in the lungs, mcg is a unit of measure) labeled with Resident 61's name.
RN 1 acknowledged the two bottles of Acetaminophen and inhaler did not have an open date. RN 1 stated, there were 2 puffs left as indicated on the inhaler device.
4C. During an observation of the medication storage room and concurrent interview with Licensed Vocational Nurse (LVN) 2, on 4/20/21 at 12:18 PM, on the fourth (4TH) floor, there were two bottles of Sterile Water for Inhalation (water intended for use with inhalators and in preparation of inhalation solutions), USP, 500 ml(ml is unit of measure) were stored beyond the expiration date; the manufacturer's label indicated an expiration date of 2020-11-12. LVN 2 acknowledged the two expired sterile water. LVN 2 stated it should be discarded, the central supply person was responsible for checking and replacing the house supplies.
4D. During an inspection of the medication refrigerator and concurrent interview with LVN 2, on 4/20/21 at 12:50 PM, on the fourth (4TH) floor, one multi-dose vial of influenza vaccine (known as flu shot) was opened and undated; nine bags of total parenteral nutrition solution formula (TPN - a nutritional supplement infused through a vein) were stored in the medication refrigerator, the pharmacy label indicated, Discard after: 03/14/21 for one bag and Discard after: 3/20/21 for eight bags. LVN 2 stated I don't know who opened the flu vaccine; it should be dated after opening and discarded after 28 days. LVN2 acknowledged the expired TPN stored in the refrigerator. LVN 2 further stated the TPN belongs to a resident on the fifth (5th) floor; the TPN bags did not fit in the medication refrigerator on the fifth floor (another unit in the facility) so it was stored on the fourth floor.
4E. During an inspection of the medication cart and concurrent interview with LVN 1, on 4/21/21 at 10:33 AM, on the fourth (4TH) floor, the following opened and undated drugs and biologicals were stored in the medication cart:
a. One bottle of Regular Strength Acetaminophen (a medication used to relieve pain and reduce fever) 1000 tablets 325 milligrams (mg is a unit of measure) each;
b. One bottle of Extra Strength Acetaminophen 1000 tablets 500 mg each;
c. One bottle of Fish Oil 500 mg Gluten Free Dietary Supplement 130 soft gels;
d. One bottle of PreserVision Eye Vitamin and Mineral Supplement 60 soft gels;
e. One bottle of Vitamin C 500 mg Gluten Free Dietary Supplement 200 tablets;
f. One bottle of Geri-lanta Regular Strength Antacid & Antigas 355 ml (ml is unit of measure);
g. Two bottles of Assure Platinum Blood Glucose Test Strips (a piece of plastic strip used to read the blood sugar levels).
LVN 1 acknowledged bottles were not dated. LVN 1 stated it should be dated once opened.
During a telephone interview with the CP, on 4/27/21 beginning at 3:05 PM, the CP stated she only did spot check/audit only on the medication storage room during her visit but the pharmacy nurse consultant is responsible for checking the medication storage room. The CP stated once the E-Kit is opened, the pharmacy will replace the E-Kit within 72 hours upon receipt from facility.
Review of the Medication Regimen Review (MRR) Report, dated March 2021, indicated, .General . Medication rooms are free from clutter and staff personal belongings . Ekits .2nd Floor .Fridge E-kit-3/31/21 . Consultant services provided . Pharmacist's monthly MRR provided on 3/16/21 (5 hours) & 3/17/21 (5 hours). Kindly note that March MRR was performed remotely therefore information for med cart and med room is carried over from the month of February .
Review of the facility's policy and procedure titled, Emergency Pharmacy Service and Emergency Kits, dated August 2014, indicated, .Procedures . L. Before reporting off duty, the charge nurse indicates the opened status of the emergency kit at the shift change report . N. If exchanging kits, the used sealed kits are replaced with the new sealed kits within 72 hours of opening. O. The kits are checked by a pharmacist at least monthly .
Review of the facility's policy and procedure titled, Medication Regimen Review (Monthly Report) , dated December 2016, indicated, .Procedures . A. The facility assures that the consultant pharmacist has access to residents and the resident's medical records; . medication storage areas; and controlled substances records and supplies . D. Resident-specific irregularities and/or clinically significant risks resulting from or associated with medications are documented and reported to the Director of Nursing, and/or prescriber as appropriate .
5A. Review of Resident 44's medical record, titled History and Physical, dated 2/24/21, indicated, olanzapine (mood altering medication) 5 milligrams (mg is unit of measure) daily at bed time under the medication list. The medication list from the hospital did not include diazepam (medication used for anxiety).
Review of the medical record for Resident 44, titled Doctor Progress Notes, dated 3/30/21, indicated, patient was anxious due to lack of sleep and complained of inability to sleep due to noise from loud TV and roommate.
Review of the medical record Resident 44's, titled Order (doctor's order) Summary Report, dated 4/23/21, indicated, to give diazepam 10mg ('mg is a unit of measure) every 12 hours as needed for anxiety. Further review of order history, indicated that diazepam initiated on 2/25/21 one day after admission to the facility from the hospital.
Review of the medical record for Resident 44, titled Progress Notes, dated 4/8/21, written by MD 2, indicated Resident 44 will benefit from Cognitive Behavior Therapy (CBT, is a psycho-social intervention that aims to improve mental health) and will need to see a specialized therapist. The progress noted did not give clinical justification for continued use and dose increase on diazepam.
Review of the medical record for Resident 44, titled Medication Administration Record (MAR - where the nursing staff recorded the medication use and monitoring), for the months of February 2021, March 2021 and April 2021, the MAR did not show any side effect monitoring for diazepam from 2/25/21 to 4/8/21 by nursing staff.
Review of the medical record for Resident 44, titled Medication Administration Record, dated 4/23/21, the MAR indicated, Resident 44 received diazepam and oxycodone (an opioid pain medication) at the same time on 4/15/21 at 11:42 AM and on 4/18/21 at 14:42 PM respectively.
Review of the medical record for Resident 44, titled Verification of Informed Consent for Psychotropic Medications, dated 2/24/21, indicated an informed consent (a signed resident's authorization and communication between a doctor and the resident in use of mind altering medication when all risks and benefits explained) for a drug called olanzapine (a type of nerve pill) that was not ordered by the doctor. The medical records did not show any signed informed consent for use of diazepam.
Review of the electronic medical record for Resident 44, titled Care Plan, dated 4/23/21, did not show any plan of care for use of diazepam for anxiety.
During a concurrent observation and interview with Resident 44 on 4/26/21 at 10:18 AM, Resident 44 stated, her sleep was not very good because of noises from other resident's yelling and crying. She added the talk therapy helped her thought process to get through difficulties of her illness. Resident 44 stated she did not take any nerve or anxiety pills prior to hospitalization.
During an interview with the Director of Nursing (DON), on 4/ 26/21 at 5:01 PM, the DON stated the psychotropic medications (mind alerting medication) were care planned based on doctor's order with same behaviors monitored in the Medication Administration Record (or MAR-the place in the resident's medical record where all medications use and information were recorded). DON added, the new care plan should have been initiated within 48 hours and customized based on resident's needs. DON, additionally, stated that nursing staff should regularly cheek the doctor's progress notes to update the resident's care plan.
During an interview on 4/ 26/21 at 5:31 PM, with Director of Nursing (DON), the DON stated concurrent use of powerful opioid pain medication and diazepam should have been addressed by facility's consultant pharmacist if there was no direction from the doctor's order. DON acknowledged the risks of administering these two drugs at the same time.
During an interview on 4/26/21 at 5:41 PM, over the telephone regarding Res-44, with Medical Doctor 1 (MD 1), the MD 1 stated diazepam was prescribed due to resident past use and preference. MD-1 acknowledged that diazepam was not the best choice to use in elderly residents. MD 1, additionally, acknowledged he was aware of warnings by US Food and Drug Administration (FDA, is a government agency responsible for protecting the public health by ensuring the safety of drug use) on avoiding concurrent of diazepam with opioid medications.
In an interview on 4/27/21 at 3:04 PM, over the telephone with Consultant Pharmacist (CP), the CP stated diazepam use was on her monitoring list. CP, however, did not question the indication for use, concurrent use with opioid pain medication and did not offer an alternative recommendation to the doctor.
5B. Review of Resident 84's medical record titled, History and Physical, dated 3/2/21, MD 1 indicated a diagnosis of Advance Dementia (means profound memory loss and inability to care for self or perform activities) and listed the quetiapine (nerve pill) as home medication.
Review of Resident 84's medical record titled, Order (doctor's order) Summary Report, dated 4/23/21, the MD 1's order indicated to give Quetiapine 50mg (mg is a unit of measure) give 1.5 tablet by mouth in the evening for depression manifested by tearfulness causing distress to resident.
Review of Resident 84's medical record titled, Progress Notes, dated 4/3/21, written by the Family Nurse Practitioner (FNP) 1, FNP 1 indicated a diagnosis of advance dementia (means profound memory loss and inability to care for self or perform activities) and an assessment to continue the quetiapine. Further review of the subsequent progress notes, written by MD 2, MD 3 and FNP 1, dated 4/2/21, 4/6/21, 4/8/21, 4/10/21, 4/13/21, 4/16/21, 4/16/21, 4/19/21, and 4/21/21, all documented advance dementia as diagnosis without any update on resident's monitoring parameters.
During review of Resident 84's medical record titled, Skilled Evaluation, dated 4/19/21 and 4/22/21, it indicated, Mood is pleasant, no unwanted behavior witnessed, resident does not wander at night. Resident sleeps through the night.
During a concurrent observation and interview on 4/26/21 at 8:30 AM, with Licensed Vocational Nurse (LVN) 3, in resident's room, LVN 3 administered the morning medications to the Resident 84 without any refusal. Resident 84 was smiling and pleasant. LVN 3 stated she found no issues and complaints caring for the resident.
During an interview with the DON, on 4/ 26/21 at 5:01 PM, the DON stated the psychotropic medications (mind altering medication) were care planned based on doctor's order with same behaviors monitored in the MAR. The DON added the care plan should have been updated based on patient's progress.
During review of the Resident 84's medical records titled, Medication Administration Record for April of 2021, the MAR indicated the nursing staff monitored tearfulness due to depression every shift. The nursing staff recorded no episodes of tearfulness.
During a telephone interview with MD 1 regarding Resident 84 , on 4/26/21 at 5:41 PM, MD 1 stated that he preferred not to touch the psychotropic medications for short stay residents. He would not seek expert consult with a psychiatrist (a doctor specialized in mental health) if no behavioral issues communicated to him. MD 1 stated that the health records from hospital to the facility could at times be incomplete in regards to mental health issues. Additionally, he acknowledged the discrepancy and lack of clarification between what nursing were monitoring (for depression) and what the medical providers were documenting (advanced dementia) in the progress notes since admission on [DATE].
During a telephone interview with the CP on 4/27/21 at 3:04 PM, the CP stated psychotropic medications should have had the same indication on the doctor's order and progress notes. She added, quetiapine was not a first choice to treat depression in elderly. CP acknowledged that she did not fully reviewed Resident 84's medical record to address the discrepancy.
Review of the facility's policy and procedure titled, Medication Regimen Review (Monthly Report) , dated December 2016, indicated, The consultant pharmacist performs a comprehensive medication regimen review (MRR) at least monthly . includes evaluation the resident's response to medication therapy to determine that the resident maintains the highest practicable level of functioning and prevents or minimizes adverse consequences related to medication therapy . Procedures . D. Resident-specific irregularities and/or clinically significant risks resulting from or associated with medications are documented and reported to the Director of Nursing, and/or prescriber as appropriate . 1) If no irregularities are found, the consultant pharmacist will provide documentation .
Based on observation, interview, and record review, the facility's Consultant Pharmacist (CP- a pharmacist who oversee the pharmaceutical services in the facility) failed to:
1. Ensure review safe blood sugar monitoring practices and act on missing blood glucose (or sugar) test results for two of 22 sampled residents (Resident 42 and 64).
2. Ensure opioid (or narcotics, drug of concern for possible abuse) medication accountability log sheet (also called Controlled Drug Accountability or CDR where every use of narcotic medication documented) were matched with the Medication Administration Record (or MAR, a document in medical records that listed medication use) on four (Resident 44, Resident 45, Resident 88 and Resident 51) out of 22 sampled residents.
3. Ensure the medication delivery documents known as Consolidated Delivery Sheets (or CDS, or delivery sheet, a document that lists the medication names and quantities when delivered to the facility), from the provider pharmacy ( a type of drug store that deliver medication to facility) were signed and acknowledged by licensed staff on a consistent basis with census of 110.
4. Ensure safe drug storage and labeling in the facility with census of 110.
5. Ensure irregularities related to the resident's drug regimen reviewed for two of 22 sampled residents (Resident 44 and Resident 84).
These failures had the potential to result in serious harm to the residents, risk of drug diversion (means when prescription medicines obtained or used illegally) and safe storage and labeling of the medications.
Findings:
1. Resident 64 was admitted on [DATE] with diagnoses including Type 2 diabetes mellitus (adult acquired excessive sugar in the blood) and altered mental status.
During observation on 04/20/21 at 8:30 AM, Resident 64 was on lying on the back in bed.
During an interview on 04/20/21 at 8:40 AM, Resident 64 stated good nursing services and no complaint.
During an interview on 04/26/21 at 1:20 PM, Case Manager __ stated when Resident 64 refused Blood Sugar (BS) test, the facility would notified the family member.
During an interview on 04/27/21 at 2:26 PM, Family Member __ stated there was no notification on BS test refusal until 04/25/21, no facility's interdisciplinary team (a team composed of individuals who have knowledge of the resident and his/her needs) had discussed how to resolve and care planning for the missing BS test, including having a continuous BS monitoring device, and not to have three finger stick for BS test every day.
Record review of 03/09/21 Minimum Data Set (MDS) indicated memory problem, decisions poor; cues/supervision required, two plus persons physical assist for moving to and from lying position while in bed, put on clothing, toilet use, and personal hygiene, including combing hair, brushing teeth, and washing face and hands. MDS indicated three insulin injections in the last seven days.
Record review of Order Summary Report, printed on 04/26/21, indicated an order date, 09/13/2020, to inject insulin (Glargine Solution 100 UNIT/ML) (unit/milliliter) inject 20 unit subcutaneously (under the skin) at bedtime for DM (diabetes).
Record review of Medication Administration Record (MAR) for 04/01/21 to 04/25/21 indicated Resident 64 had refused the order of 20 UNIT/ML insulin on 04/01, 02, 03, 04, 05, 07, 08, 11, 12, 13, 14, 15, 17, 19, 20, 21, and 23. Total of 17 out of 25 days (total of 68%) (percent) refusal for bedtime insulin injection.
Record review of Order Summary Report indicated an order date, 09/14/2020, to inject insulin on a sliding scale before meals (three meals a day) and If Blood Sugar is above 600 mg/DL (milligram/deciliter), Resident will be sent
CONCERN
(E)
Potential for Harm - no one hurt, but risky conditions existed
Unnecessary Medications
(Tag F0759)
Could have caused harm · This affected multiple residents
Based on observation, interview, and record review, the facility had a 21.43% error rate when nine medication errors out of 42 opportunities were observed during a medication pass for Resident 61, Res...
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Based on observation, interview, and record review, the facility had a 21.43% error rate when nine medication errors out of 42 opportunities were observed during a medication pass for Resident 61, Resident 45, Resident 51, and Resident 80.
This deficient practice resulted in medications not given in accordance to the prescriber's orders and/or manufacturer's specifications which may result in residents not receiving the full therapeutic effect of the medications.
Findings:
During a medication pass on 4/21/21 at 8:13 AM, Registered Nurse (RN) 1 was observed preparing six medications for Resident 61 including: a) Methimazole (a medication used to treat overactive thyroid gland - a butterfly shaped gland in the neck) 5 mg, half tablet; b) Theo-24 (a medication used to treat lung disease) extended release (ER, a mechanism that delivers the medication for a prolonged period of time) capsule (cap) 200 milligrams (mg); c) Metoprolol succinate (a medication used to treat high blood pressure, chest pain, and heart failure) ER tablet (tab) 25 mg. RN 1 crushed the three medications mentioned above together with the other medications with no gloves and mixed in applesauce before administering it to Resident 61.
During a review of the clinical record for Resident 61, the physician order dated 6/16/20, indicated,
a. methiMazole Tablet 5 MG Give 2.5 mg by mouth one time a day for hyperthyroidism with food.
b. Theophylline ER Capsule Extended Release 24 Hour 200 MG Give 200 mg by mouth in the morning for COPD.
c. Metoprolol Succinate ER Tablet Extended Release 24 Hour 25 MG Give 25 mg by mouth in the morning for HTN. Hold if SBP <100 or HR <60.
During a concurrent observation and interview on 4/21/21 at 1:48 PM, with RN 1 in the second floor, the pharmacy label on the Methimazole punch card indicated, Black Box Warning: N; there was no instruction and/or alert on the label regarding handling of the drug. RN 1 stated she was not aware that Methimazole is a hazardous drug (drugs that are known to cause harm) and that personal protective equipment is needed in handling the drug. RN 1 confirmed there was no Warning or instruction on the punch card and in the electronic medication administration record (E-MAR) regarding handling of the drug.
During an interview on 4/21/21 at 1:54 PM, with RN 1, RN1 stated Resident 61 has difficulty of swallowing, so she crushed the medications and mixed with apple sauce. RN 1 acknowledged that extended release medications should not be crushed but stated she would rather crush it than not give it.
During a review of the clinical records for Resident 61, the physician order dated 6/17/20 indicated, May crush medications (or open capsule) as indicated per pharmacy protocol. There was no physician order for Resident 61 to allow crushing of Theophylline ER capsule and Metoprolol Succinate ER tablet; there was no order and/or instruction regarding handling of Methimazole.
During an interview on 4/26/21 at 4:55 PM, with the Director of Nursing (DON), the DON stated, medications that are not crushable will have alert label Do Not Crush on the medication punch card; the pharmacy will also alert or notify the facility via a phone call or fax if an ordered medication can be crushed or not; a Do Not Crush List are also available at each nursing station for reference; the physician's order and the medication administration record (MAR) will also indicate if the medication can be crushed or not; if the medications on hand are not crushable, the physician will be notified and asked for an alternative.
According to Lexicomp, a nationally recognized drug reference, Methimazole . Hazardous Drugs Handling Considerations . Hazardous agent . Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage . NIOSH (National Institute for Occupational Safety and Health - a federal agency responsible for conducting research and making recommendations for the prevention of work-related injury and illness) recommends single gloving for administration of intact tablets or capsules . double gloving, a protective gown, and preparation in a controlled device . for compounding; if not prepared in a controlled device, respiratory and eye/face protection are recommended .
According to Lexicomp, do not chew or crush Theophylline ER capsule and Metoprolol Succinate ER tablet for oral administration.
During a review of the facility's policy and procedure titled, MEDICATION ADMINISTRATION - GENERAL GUIDELINES, dated October 2017, the Medication Administration - General Guidelines indicated, .A. Preparation . 5) . a. Long-acting or enteric-coated dosage forms should generally not be crushed; an alternative should be sought . i. crushed medications should not be combined and given all at once, either orally (e.g., in pudding or other similar food) or via feeding tube .
2. During a medication pass on 4/21/21 at 8:41 AM, RN 1 was observed preparing nine medications for Resident 51 including Iron (ferrous sulfate, a medication used to treat or prevent low blood levels of iron-an essential mineral) 65 mg and Calcium Acetate (a medication used to control high blood levels of phosphorus in people with kidney disease) 667 mg. RN 1 was observed administering the Iron and Calcium Acetate at the same time.
During a review of the clinical record for Resident 51, the physician's order dated 3/9/21, indicated,
a. Calcium Acetate Tablet 667 MG (Calcium Acetate (Phos Binder)) Give 2 tablets by mouth with meals for supplement; with meals.
b. Ferrous Sulfate Tablet 325 (65 Fe) MG Give 1 tablet by mouth three times a day for supplement.
During an interview on 4/21/21 at 2:45 PM with RN 1, RN1 acknowledged administering the iron and calcium acetate at the same time for Resident 51. RN 1 stated she knew she's not supposed to administer the iron and calcium acetate together since calcium decreases the absorption of iron.
According to Lexicomp, .Drug Interactions . Phosphate Supplements: Iron Preparations may decrease the absorption of Phosphate Supplements. Management: Administer oral phosphate supplements as far apart from the administration of an oral iron preparation as possible to minimize the significance of this interaction .
3. During a medication pass on 4/21/21 at 8:50 AM, RN 1 was observed preparing three prescription (a medicine ordered by a doctor for remedy) eye drops for Resident 45. RN 1 was observed administering the following prescription eye drops in a span of less than 3 minutes:
a. Brimonidine Tartrate (an eye medication used to treat open-angle glaucoma or high fluid pressure in the eye) 0.2% ophthalmic solution; RN 1 administered one drop to both eyes at 9:03 AM.
b. Timolol Maleate (an eye medication used in lowering high pressure inside the eye) 0.25% ophthalmic solution; RN 1 administered one drop to both eyes at 9:04 AM.
c. Dorzolamide Hydrochloride (HCl) (an eye medication used to treat increased eye pressure) 2% ophthalmic solution; RN 1 administered one drop to both eyes at 9:05 AM.
During an interview on 4/21/21 at 2:45 PM with RN1, RN 1 stated, you need to wait 2-3 minutes before the administration of the other eye drops. RN 1 acknowledged administering three prescription eye drops with 1 minute interval between each eye drop for Resident 45.
During a review of the clinical record for Resident 45, the physician order dated 4/6/21 indicated,
a. Brimonidine Tartrate Solution 0.2% Instill 1 drop in right eye three times a day for glaucoma.
b. Timoptic Solution 0.25% (Timolol Maleate) Instill 1 drop in right eye two times a day for glaucoma.
c. Dorzolamide Hcl Solution 2% Instill 2 drop in both eyes three times a day for glaucoma.
During an interview on 4/21/21 at 2:35 PM with RN1, RN 1 acknowledged administering the Brimonidine Tartrate 0.2% and Timolol Maleate 0.25% to both eyes for Resident 45 when the physician's order indicated to instill 1 drop in right eye.
According to Lexicomp, Separate administration of other ophthalmic agents by > 5 minutes for Brimonidine and Timolol ophthalmic administration.
During a review of the facility's policy and procedure titled, Medication Administration - Genral Guidelines, dated October 2017, the The Medication Administration - General Guideline indicated, .B. Administration . 2) Medication are administered in accordance with written orders of the attending physician .
4. During a medication pass on 4/21/21 at 9:29 AM, Licensed Vocational Nurse 1 (LVN 1) was observed preparing and administering one medication, Tylenol (an over the counter medication used for temporary relief of minor aches, pains, and headache) 325 mg 2 tablets, to be administered via G-tube (gastrostomy tube, a tube surgically inserted through the abdomen into the stomach to administer nutrition and medications) for Resident 80. LVN 1 crushed the Tylenol tablet into a fine powder and mixed it with 10 ml of water. LVN 1 checked for tube placement; LVN 1 flushed 20 milliliters (ml) of water before and after the Tylenol was administered.
During a review of the clinical record for Resident 45, the physician order dated 10/18/19 indicated, Enteral Feed Order every shift Flush G-tube with 30 ml of water before and after medication administration.
During an interview on 4/21/21 at 2:45 PM with LVN 1, LVN1 stated, 20 ml of water is okay for flushing the G-tube before and after medication administration.
During an interview on 4/26/21 at 4:55 PM, with DON, DON stated flushing of the G-tube is according to the physician's order; the facility's policy is to flush 30 ml of water before and after medication administration and 5 ml of water in between medications.
Review of the facility's policy and procedure titled, Medication Administration - General Guidelines, dated October 2017, indicated, the Medication Administration - General Guidelines indicated, .B. Administration . 2) Medication are administered in accordance with written orders of the attending physician .
Review of the facility's policy and procedure titled, Enteral Tube Medication Administration, dated October 2017, the Enteral Tube Medication Administration indicated, .Procedures . E. Prepare medications for administration. 1) Follow specific physician orders regarding liquid amounts and medication administration if different from the procedures outline below .
CONCERN
(E)
Potential for Harm - no one hurt, but risky conditions existed
Deficiency F0761
(Tag F0761)
Could have caused harm · This affected multiple residents
Based on observation, interview, and record review, the facility failed to:
1. Ensure discontinued and expired medications were removed from the active storage area and the medications were labeled wi...
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Based on observation, interview, and record review, the facility failed to:
1. Ensure discontinued and expired medications were removed from the active storage area and the medications were labeled with Beyond Use Date (or BUD, a date that no longer safe to use the medication) according to standards of practice or manufacturing information in two (Second and Fourth floor units) out of four medication storage units.
2. Ensure drugs were stored at required temperature according to manufacturer's instruction and facility's policy and procedure in one (second floor) out four medication rooms.
3. Ensure security of prescription medications in the medication storage room and not preventing storage of staff's personal items in one out of four medication rooms in the second floor.
4. Ensure security of treatment cart when it was left open and unattended in one (second floor unit) out of four units.
These deficient practices had potential to compromise the integrity and effectiveness of the medications, drug misuse, medication error, and/or drug diversion (when drug used in an unlawful manner.)
Findings:
1A. During a concurrent inspection and interview with Registered Nurse (RN) 1, on 4/20/21 at 9:25 AM, in the second floor medication storage room , RN 1 acknowledged the following drugs and biologicals stored in the medication room refrigerator were beyond the expiration date:
a. One multi-dose vial of influenza vaccine (known as flu shots) afluria Quadrivalent, labeled Date Vial Opened 11/1/20, Date Vial Expires 11/29/20, Discard After 28 days, stored beyond the expiration date.
b. One Refrigerated Emergency Kit [New] #3051 (E-kit, a kit/box containing small quantity of medications that can be dispensed when pharmacy services are not available) sealed with red plastic lock, indicated an expiration date of 3/31/21. The E-kit contained medications including Lorazepam (a medication used to manage anxiety disorders) injection vial, insulin (a medication used to treat high blood sugar levels), Prochlorperazine suppository (medication used to manage severe nausea and vomiting), and Promethazine suppository (medication used for prevention and control of nausea and/or vomiting). RN 1 stated, I don't know when asked regarding the expired E-kit in the medication refrigerator.
During an interview on 4/26/21 at 2:35 PM, with NM 1, NM 1 stated, each E-kit are checked every shift during endorsement. The nurses will communicate if it was reordered. E-kits need to be replaced by the pharmacy within 72 hours.
During a review of the facility's policy and procedure titled, Storage of Medications, dated April 2008, the Storage of Medicationsindicated, .Procedures .(M). Outdated, contaminated or deteriorated medications and those in containers that are cracked, soiled, or without secure closures are immediately removed from stock, disposed of according to procedures for medication disposal, and reordered from the pharmacy if a current order exists .
During a review of the facility's policy and procedure titled, Emergency Pharmacy Service and Emergency Kits, dated August 2014, the Emergency Pharmacy Service and Emergency Kits indicated, .Procedures .( L). Before reporting off duty, the charge nurse indicates the opened status of the emergency kit at the shift change report .( N). If exchanging kits, the used sealed kits are replaced with the new sealed kits within 72 hours of opening. (O). The kits are checked by a pharmacist at least monthly .
According to the Food and Drug Administration (FDA, is a federal agency responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices) regarding expired medications, retrieved from https://www.fda.gov/drugs/special-features/dont-be-tempted-use-expired-medicines, dated 2/8/21, indicated, .Using expired medical products is risky and possibly harmful to your health . Expired medical products can be less effective or risky due to a change in chemical composition or a decrease in strength. Certain expired medications are at risk of bacterial growth . Once the expiration date has passed there is no guarantee that the medicine will be safe and effective .
1B. During a concurrent inspection and interview on 4/20/21 at 9:42 AM, with NM 1, NM1 acknowledged the treatment cart located in the second floor, contained the following opened and undated biologicals:
a.
Two tubes of MediHoney (a medical-grade honey-based product line for the management of wounds and burns)
Wound & Burn Dressing 44 ml (ml is unit of measure) did not have a cap/cover.
b.
Two bottles of sterile saline (a solution used for wound cleansing, irrigation, and flushing) 100 ml (ml is unit of
measure) for irrigation.
c.
One bottle of Betadine solution (povidone-iodine 10%, used to treat or prevent bacterial infections).
NM 1 stated, any medication container should be dated once opened, containers with no cap/cover are not acceptable
and should be discarded. The opened bottle of sterile water is a one time use only and should be discarded after use.
NM 1 further stated that MediHoney and Betadine solution were used for residents during wound care.
During an inspection and concurrent interview on 4/20/21 at 10 AM, with RN 1 , RN1 acknowledged the medication storage cart located in the second floor, opened and undated drugs were stored as follow:
a. One bottle of Regular Strength Acetaminophen (a medication used to relieve pain and reduce fever) 1000 tablets 325
milligrams (or mg is unit of measure) each.
b. One bottle of Extra Strength Acetaminophen 1000 tablets 500 mg (mg is a unit of measure) each.
c. One box/foil tray containing the BREO Ellipta 200/25 (fluticasone furoate 200 mcg and vilanterol 25 mcg inhalation
powder (a combination inhaler used to treat blocked airflow in the lungs, mcg is a unit of measure) labeled with Resident
61's name.
RN 1 acknowledged the two bottles of Acetaminophen and inhaler did not have an open date. RN 1 stated, there were 2
puffs left as indicated on the inhaler device.
During a review the undated manufacturer's information sheet for MediHoney, on 4/20/21, the manufacturer's information sheet indicated, .Label with client's name and date the tube was opened . Product is single-client use. Discard product when wound has healed/closed or is no longer indicated. Use within 4 months of opening .
During a review the undated manufacturer (Aqua Care) information for Sterile Sodium Chloride on 4/20/21, the manufacturer information indicated each bottle is for single use and unused portions of sterile saline solution should be discarded and a separate container should be used for each patient and each start-up procedure .
During a review the undated manufacturer's label information for BREO Ellipta, on 4/20/21, the manufacturer's label information indicated .Store BREO in the unopened foil tray and only open when ready for use. Safely throw away BREO in the trash 6 weeks after you open the foil tray . Write the date you open the tray on the label on the inhaler .
1C. During an observation and concurrent interview on 4/20/21 at 12:18 PM, with Licensed Vocational Nurse (LVN) 2, in the fourth floor medication storage room, there were two bottles of Sterile Water for Inhalation (water intended for use with inhalators and in preparation of inhalation solutions), USP, 500 ml(ml is unit of measure) were stored beyond the expiration date. The manufacturer's label indicated an expiration date of 2020-11-12. LVN 2 acknowledged the two expired sterile water. LVN2 stated they should be discarded and the central supply person was responsible for checking and replacing the house supplies.
1D. During an inspection and concurrent interview on 4/20/21 at 12:50 PM, with LVN 2, in the fourth floor medication refrigerator, a multi-dose vial of influenza vaccine (known as flu shot) was opened and undated; nine bags of total parenteral nutrition solution formula (TPN - a nutritional supplement infused through a vein) were stored in the medication refrigerator, the pharmacy label indicated, Discard after: 03/14/21 for one bag and Discard after: 3/20/21 for eight bags. LVN 2 stated I don't know who opened the flu vaccine; it should be dated after opening and discarded after 28 days. LVN2 acknowledged the expired TPN stored in the refrigerator. LVN 2 further stated the TPN belongs to a resident on the fifth (5th) floor; the TPN bags did not fit in the medication refrigerator on the fifth floor (another unit in the facility) so it was stored on the fourth floor.
During a review of the facility's policy and procedure titled, Storage of Medications, dated April 2008, the Storage of Medications indicated, .Procedures . (M). Outdated, contaminated or deteriorated medications and those in containers that are cracked, soiled, or without secure closures are immediately removed from stock, disposed of according to procedures for medication disposal, and reordered from the pharmacy if a current order exists .
According to the FDA regarding expired medications, retrieved from https://www.fda.gov/drugs/special-features/dont-be-tempted-use-expired-medicines, dated 2/8/21, indicated, .Using expired medical products is risky and possibly harmful to your health . Expired medical products can be less effective or risky due to a change in chemical composition or a decrease in strength. Certain expired medications are at risk of bacterial growth . Once the expiration date has passed there is no guarantee that the medicine will be safe and effective .
1E. During an inspection of the medication cart and concurrent interview on 4/21/21 at 10:33 AM, with LVN 1, on in the fourth floor, the following opened and undated drugs and biologicals were stored in the medication cart:
a. One bottle of Regular Strength Acetaminophen (a medication used to relieve pain and reduce fever) 1000 tablets 325 milligrams (mg is a unit of measure) each;
b. One bottle of Extra Strength Acetaminophen 1000 tablets 500 mg each;
c. One bottle of Fish Oil 500 mg Gluten Free Dietary Supplement 130 soft gels;
d. One bottle of PreserVision Eye Vitamin and Mineral Supplement 60 soft gels;
e. One bottle of Vitamin C 500 mg Gluten Free Dietary Supplement 200 tablets;
f. One bottle of Geri-lanta Regular Strength Antacid & Antigas 355 ml (ml is unit of measure);
g. Two bottles of Assure Platinum Blood Glucose Test Strips (a piece of plastic strip used to read the blood sugar levels).
LVN 1 acknowledged bottles were not dated. LVN 1 stated it should be dated once opened.
According to an article regarding Drug Expiration Dates - Are Expired Drugs Still Safe to Take, retrieved from https://www.drugs.com/article/drug-expiration-dates.html, dated 7/22/20, indicated, .Drug expiration dates exist on most medication labels, including prescription, over-the-counter (OTC) and dietary (herbal) supplements . Once the container of medication is opened after production that expiration date is no longer guaranteed . The expiration date of a drug is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration (FDA) . 'beyond-use' dates are often put on the prescription bottle label. These dates often say 'do not use after .' or 'discard after .' . According to the manufacturer, the stability of a drug cannot be guaranteed once the original bottle is opened. Heat, humidity, light, and other storage factors can affect stability .
2. During an observation on 4/20/21 at 9:12 AM, the medication storage room located in the second floor (2nd floor), the digital thermometer (a device that measures the temperature) for room temperature attached to the wall, was switched off.
During a concurrent interview and record review , on 4/20/21 at 9:35 AM ,with NM 1 in the 2nd floor, the facility's document titled Medication Room Temperature Check log, dated March 2021 and April 2021, the Medication Room Temperature Check log indicated, no temperature was recorded for 3/30/21, 3/31/21, and 4/1/21 to 4/20/21; further review of the room temperature log sheet, indicated, The Medication Room Temperature must be maintained between 68 to 77 degrees Fahrenheit ( it's a scale of temperature); check daily. NM 1 acknowledged there was no temperature recorded. NM 1 stated the digital thermometer was not working, it's broken and the medication room temperature should be checked daily.
During a concurrent record review and interview with NM 1, on 4/20/21 at 9:35 AM, in the 2nd floor, facility's document titled Temperature Log for Refrigerator, dated April 2021, the Temperature Log for Refrigerator indicated, the temperature was recorded for 3 days in the span of April 1st to April 20th 2021 as follow: April 7th at 3 PM, April 14ht at 3 PM, and April 15th at 3 PM. NM 1 stated that the refrigerator temperature should have been checked and documented twice a day. NM 1 was not sure why the log sheet was missing 17 days or 34 opportunity to document the refrigerator temperature.
During an interview on 4/23/21 at 2:57 PM with Environmental Services Manager (EVM) , EVM stated, that the thermometer in the second floor medication room was replaced when he was notified on 4/20/21.
During a review of an undated facility's document titled Plant Review Maintenance Request Log Sheet, the Plant Review Maintenance Request Log Sheet indicated, request for thermometer service on 4/20/21. The document did not show any other request for thermometer service.
During a review of the facility's policy and procedure titled, Storage of Medications, dated April 2008, the Storage of Medication indicated, Medications and biologicals are stored safely, securely, and properly . Procedures .(J). Medications at 'room temperature' are kept at temperatures ranging from 150C (590 F) to 300C (860 F) . (N). Medication storage areas are kept clean, well-lit, and free of clutter and extreme temperatures. (O). Medication storage conditions are monitored on a routine basis and corrective action taken if problems identified.
During a review of the facility's document titled Temperature Log for the Refrigerator, dated April 2021, the Temperature Log for the Refrigarator indicated, Take action if temp (Temperature) is out of range- too warm (above 46 degree Fahrenheit) or too cold (below 36 degree Fahrenheit). Label exposed vaccine do not use and store it under proper condition as quickly as possible .
3. During an observation on 4/20/21 at 9:12 AM, a lavender backpack and a black jacket was found on the counter in the 2nd floor medication room next to unlocked refrigerator and medication storage cabinets.
During an interview on 4/20/21 at 9:35 AM, with Nurse Manager (NM) 1, NM 1 stated the backpack and jacket belongs to a staff and should not be in the medication room. NM 1 added, personal belongings should be in the employee storage.
4. During an inspection and concurrent interview on 4/20/21 at 9:42 AM, with NM 1, the 2nd floor treatment cart was in the hallway by the resident's room, unlocked and unattended. NM 1 went to check the treatment cart and stated that it should be locked at all times.
During an interview on 4/26/21 at 4:09 PM, with the DON, the DON stated the medication cart, treatment cart, and medication room should not have been be left unlocked and unattended.
During a review of the facility's policy and procedure titled, Storage of Medications, dated April 2008, the Storage of Medications indicated, .Procedures . (B). Only licensed nurses, pharmacy personnel, and those lawfully authorized are allowed access to medications. Medication rooms, carts, and medication supplies are locked or attended by persons with authorized access .
CONCERN
(E)
Potential for Harm - no one hurt, but risky conditions existed
Food Safety
(Tag F0812)
Could have caused harm · This affected multiple residents
Based on observation, interview and record review, the facility failed to ensure boxed frozen waffles were stored on a shelf above two boxes of frozen uncooked Italian sausages. This deficient practic...
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Based on observation, interview and record review, the facility failed to ensure boxed frozen waffles were stored on a shelf above two boxes of frozen uncooked Italian sausages. This deficient practice had a potential result for foodborne illness to medically compromised residents.
Findings:
During concurrent observation and interview on 4/20/21 at 8:49 AM, inside the walk-in freezer was a wire storage unit with four shelves. The top shelf (Shelf Number 1-one) was empty. Stored on the bottom shelf (Shelf Number 4-four) were boxed frozen waffles, ground beef and various frozen uncooked raw meat. And, stored on the shelf above (Shelf Number 3-three) were two boxes of uncooked Italian sausages and boxes of precooked food items. The Dietary Supervisor stated they did not want anything stored on the top shelf for safety reasons. In addition, as the Dietary Supervisor rearranged the various uncooked meat and removed the boxed frozen waffles stored on Shelf Number 4 and removed the boxed uncooked Italian sausages from Shelf 3 and placed them on Shelf Number 4 (bottom shelf), she stated the uncooked Italian sausages should not have been stored on Shelf 3, above the frozen waffles.
During review of facility undated document titled, Freezer, placement of uncooked and precooked items on storage shelves inside walk-in freezer were not indicated.
CONCERN
(E)
Potential for Harm - no one hurt, but risky conditions existed
Infection Control
(Tag F0880)
Could have caused harm · This affected multiple residents
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Definitions:
Transmission-Based Precautions (TBP) - infection control measures used to help stop the spread of infection.
Yellow...
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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Definitions:
Transmission-Based Precautions (TBP) - infection control measures used to help stop the spread of infection.
Yellow Zone - a designated area in the facility for symptomatic, suspected COVID-19, and residents awaiting test results; COVID-19 exposed residents; and newly-admitted or re-admitted residents under observation for COVID-19.
N95 Respirator - a respiratory protective device designed to filter at least 95% of airborne particles.
N95 Respirator, Extended Use - According to the Centers for Disease Control and Prevention (CDC), dated 3/27/20, retrieved on 5/4/21 from https://www.cdc.gov/niosh/topics/hcwcontrols/recommendedguidanceextuse.html, Extended use refers to the practice of wearing the same N95 respirator for repeated close contact encounters with several patients, without removing the respirator between patient encounters . Extended use has been recommended as an option for conserving respirators during previous respiratory pathogen outbreaks and pandemics .
Personal Protective Equipment (PPE) - refers to special coverings such as gloves, face masks and/or respirators, goggles, face shields, protective clothing and other equipment designed to protect the wearer from exposure to or contact with infectious agents.
Eye Protection, Extended Use - According to the CDC's Strategies for Optimizing the Supply of Eye Protection, dated 12/22/20, retrieved on 5/6/21, from https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/eye-protection.html, .The use of use of eye protection is the practice of wearing the same eye protection for repeated close contact encounters with several different patients, without removing eye protection between patient encounters. Extended use of eye protection can be applied to disposable and reusable devices .
Green Zone - a designated area in the facility for COVID-19 negative residents with no known exposure within the last 14 days and recovered residents who have completed their isolation period.
Nasal Cannula - a lightweight tube with one end connected to oxygen concentrator and the other end splits into two prongs which are placed in the nostrils.
COVID-19 - an infectious disease caused by a new coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Oxygen Concentrator - a medical device that supplies oxygen through the nose via a tube.
Cohort - a group of individuals (residents)
Based on observation, interview and record review, the facility did not ensure staff implemented infection control and prevention, when:
1. Certified Nursing Assistant (CNA) 5, Registered Nurse (RN) 4 and Licensed Vocational Nurse (LVN) 1 did not follow transmission-based precautions (TBP) in the yellow zone.
2. Certified Nursing Assistant (CNA) 6, CNA 7 and CNA 8 were not properly trained in storage of extended use of N95 respirators.
3. Certified Nursing Assistant (CNA) 6 and CNA 5 were not properly trained in disinfection and storage of extended use Personal Protective Equipment (PPE) for eye protection.
4. COVID-19 guidelines for cohorting residents in the yellow zone was not followed.
5. Minimal Data Set (An assessment Tool) Nurse (MDS) 1 did not wear PPE for eye protection in the green zone.
6. The nasal cannula for one of 22 sampled residents (Resident 305) was outdated and not replaced per physician's order.
7. Reusable resident care supplies were not labeled and found on the window ledge of the room occupied by Resident 60 and Resident 310 in the yellow zone.
8. Registered Nurse (RN) 1 and RN 3 did not wear eye protection during wound care, and paper tape used during wound care was put back in treatment cart's supplies shelf.
2. Registered Nurse (RN) 1 & 3 did not wear eye protection during wound care, and paper tape used during wound care was put back in treatment cart's supplies shelf.
These deficient practices had the potential to promote development of infection and proliferation of infectious diseases in the facility.
Findings:
1. During the initial tour observation in the yellow zone on 4/20/21 at 10:25 AM in Resident 60's room, Resident 60 was awake and talking. During an ongoing interview with Resident 60 about his care, the surveyor observed Certified Nursing Assistant (CNA) 5 entered the room without gown and gloves worn.
During an interview with CNA 5 on 4/20/21 at 10:28 AM, CNA 5 stated he forgot to wear gown and gloves. CNA 5 stated the practice was to wear a full personal protective equipment (PPE) such as gown, gloves, N95 respirator and eye protection before entering a resident's room in the yellow zone.
During an observation in the yellow zone on 4/20/21, at 11:30 AM, in the hallway outside Resident 108's room, Registered Nurse (RN) 4 poured fruit juice from a pitcher into a plastic cup, and placed it in a white plastic tray lined with brown paper towels on top of her mobile medication cart. RN 4 carried the plastic tray with the beverage and entered Resident 108's room with no gown worn.
During an interview with RN 4 on 4/20/21, at 11:36 AM, RN 4 confirmed the observation, and stated that she forgot to wear a gown before she entered the resident's room.
During an observation in the yellow zone on 4/22/21, at 2:26 PM, in the hallway of the unit, Licensed Vocational Nurse (LVN) 1 came off from the elevator. LVN 1 proceeded and walked in the hallway, spoke with a staff member, and got a clean patient gown and handed it over to a staff member.
During an interview with LVN 1 on 4/22/21, at 2:28 PM, LVN 1 acknowledged she did not wear eye protection in yellow zone. LVN 1 stated that she was supposed to wear appropriate PPE when in the yellow zone which included an N95 respirator and eye protection.
During an interview with the part-time Infection Preventionist (IP) 2 on 4/21/21 at 10:00 AM, IP 2 stated that the facility followed the Centers for Disease Control and Prevention (CDC), county guidelines and their policy and procedure on PPE use in the yellow zone. IP 2 stated staff had to wear an N95 respirator and eye protection when in the yellow zone. IP 2 stated staff were required to wear gown, gloves, N95 respirator and eye protection before entering a resident's room. IP 2 stated the facility followed droplet and contact precautions in the yellow zone.
During a review of the CDC's transmission-based precaution signages posted on resident room doors in the yellow zones, received on 4/27/21, the Droplet Precautions and Contact Precautions signages indicated, STOP - Droplet Precautions - Everyone Must: . Make sure their eyes, nose and mouth are fully covered before room entry. Or, Remove face protection before room exit ., STOP - Contact Precautions - Everyone Must: . Providers and Staff must also: Put on gloves before room entry. Discard gloves before room exit. Put on gown before room entry. Discard gown before room exit. Do not wear the same gown and gloves for the care of more than one person .
The facility policy and procedure (P&P) titled, INFECTION PREVENTION AND CONTROL: NOVEL CORONAVIRUS (COVID-19), dated 10/12/2020, indicated . 2. Yellow Cohort . Residents in yellow zone will be treated with standard, contact and droplet precautions (N95 or higher) until the resident meets the time criteria or symptom-based criteria to return to the green section based on current CDC guidance for the removal of transmission-based precautions . IV. Personal Protective Equipment (PPE) . PPE in each Cohort Zones . Yellow Cohort (Mixed) - Transmission Based Precautions . Contact/Droplet + Eye Protection, N95 respirators will be worn for duration of shift and doffed when contaminated, Goggles/Face Shields should be worn when providing care within 6 ft (feet) of a resident, Gowns should be worn with only single patient .
2. During an interview with Certified Nursing Assistant (CNA) 6 on 4/20/21, at 12:06 PM, CNA 6 confirmed he was assigned residents in the yellow zone. CNA 6 stated he practiced extended use of the N95 respirator in the yellow zone. CNA 6 explained that when he left the yellow zone during staff break, he would remove his N95 respirator and place it in his pocket. CNA 6 stated his N95 respirator was acceptable to re-use for up to 8 hours on his shift.
During an interview with CNA 7 on 4/21/21, at 11:20 AM, CNA 7 confirmed she was assigned to work on the yellow zone that day. CNA 7 stated she followed extended use of N95 respirator in the yellow zone. CNA 7 stated before she took a lunch break, she would remove her N95, place it in a plastic or Ziploc bag and then keep it inside her purse. CNA 7 stated she stored her purse in the staff storage closet located in the unit.
During an observation on 4/21/21, at 12:35 PM, there were two staff members inside the employee break room located on first floor of the building. CNA 8 wore an N95 respirator. The other staff member in the room had no face covering worn and was observed eating. There were no brown paper bags seen inside the employee break room.
During an interview with CNA 8 on 4/21/21, at 12:37 PM, outside of the employee break room, CNA 8 stated that she wore the same N95 respirator she had on in the yellow zone. CNA 8 explained that during her break, she would fold the N95 respirator, wrap it in a paper towel and keep it inside her bag. CNA 8 stated she did not remember any training on storage of extended use N95 respirator.
During an interview with the Director of Staff Development and Infection Preventionist (DSD/IP) on 4/27/21, at 11:33 AM, the DSD/IP stated she was one of two designated Infection Preventionists in the facility. The DSD/IP stated staff members were expected to place extended use N95 respirators in a brown bag [when not in use] and stored in designated areas of the employee break room, and in drawers below the resident charts located in the nursing station of the yellow zone. The DSD/IP stated the facility followed CDC, County, and State Guidelines on transmission-based precautions for COVID-19.
During a review of the California Department of Public Health's All Facilities Letter to the Skilled Nursing Facilities with subject titled, Coronavirus Disease 2019 (COVID-19) Recommendations for Personal Protective Equipment (PPE), Resident Placement/Movement, and Staffing In Skilled Nursing Facilities, dated 9/22/20, the letter indicated, .Refer to the COVID-19 PPE . (PDF) for a chart of the COVID-19 Recommendations . Extended use may be implemented for facemask (source control), N95 respirator, and eye protection (goggles or faceshield) during supply shortage . Respirators should be removed and carefully stored in a clean paper bag before activities such as meals, restroom breaks, and other breaks and then re-donned and worn through the remainder of the shift. The respirator must be discarded at any time it becomes contaminated or does not fit or function correctly .
During a review of the Division of Occupational Safety and Health ([NAME]) also known as Cal/OSHA's Interim Guidance on COVID-19 for Health Care Facilities: Severe Respiratory Supply Shortages, dated 8/6/20, the guidance indicated, .6.1 Extended use of respirators . Respirators should be removed and carefully stored in a clean paper bag before activities such as meals, restroom breaks, and other breaks and then re-donned and work through the remainder of the shift. The respirator must be discarded if at any time it becomes contaminated or does not fit or function correctly .
During a review of the CDC's Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings, dated 3/20/20, retrieved on 5/4/21 from https://www.cdc.gov/niosh/topics/hcwcontrols/recommendedguidanceextuse.html#risksextended, the guidance indicated, . Respirator Extended Use Recommendations . Healthcare facilities should develop clear written procedures to advise staff to take the following steps to reduce contact transmission: . Hang used respirators in a designated storage area or keep them in a clean, breathable container such as a paper bag between uses. To minimize potential cross-contamination, store respirators so that they do not touch each other and the person using the respirator is clearly identified. Storage containers should be disposed of or cleaned regularly . Healthcare facilities should provide staff clearly written procedures to: . Pack or store respirators between uses so that they do not become damaged or deformed .
The facility policy and procedure (P&P) titled, INFECTION PREVENTION AND CONTROL: NOVEL CORONAVIRUS (COVID-19), dated 10/12/2020, indicated . IV . Personal Protective Equipment (PPE) . PPE in each Cohort Zones . Yellow Cohort (Mixed) . Transmission Based Precautions . N95 respirators will be worn for duration of shift and doffed when contaminated . Extended Use of PPE . 4. N95 Respirators - When practicing extended use of N95 respirators, the maximum recommended extended use period is 8-12 hours. Respirators shall not be worn for multiple work shifts and not reused after extended use .
3. During a concurrent observation and interview with Certified Nursing Assistant (CNA) 6 on 4/27/21, at 10:34 AM, in the hallway of the yellow zone, CNA 6 wore a clear, reusable safety glasses with side shields for eye protection. CNA 6 stated that when he left the yellow zone, he would remove the safety glasses and wipe them clean with a bleach or alcohol wipe for 1 minute and let it air dry. CNA 6 stated he would then place the safety glasses in a plastic bag and keep them in his pocket.
During a concurrent observation and interview with CNA 5 on 4/27/21, at 10:40 AM, in the nursing station of the yellow zone, CNA 5 wore a clear, disposable face shield labeled with his name. CNA 5 stated that before he left the yellow zone for breaks, he would wash the disposable face shield with soap and water, wipe clean all surface area with disinfectant wipe, and air dry for about 2 minutes. CNA 5 stated he would then put the disposable face shield in a plastic bag and leave it in the unit until he returned for work in the yellow zone. CNA 5 stated he had re-used the disposable face shield for days and that no one had talked to him about when the face shield had to be replaced or discarded.
During an interview with the Director of Staff Development and Infection Preventionist (DSD/IP) on 4/27/21 at 11:45 AM, the DSD/IP stated staff were expected to follow the disinfectant wipe manufacturer's instruction for use to clean reusable and disposable PPE for eye protection. The DSD/IP stated extended use of disposable face shields were allowed for an entire shift. The DSD/IP stated that reusable and disposable PPEs for eye protection had to be kept in separate brown bags after cleaning and stored in dedicated cabinets located in the yellow zone until ready for use by the user.
The facility policy and procedure (P&P) titled, INFECTION PREVENTION AND CONTROL: NOVEL CORONAVIRUS (COVID-19), dated 10/12/2020, indicated . Policy . This policy is based on guidelines recommended by the Centers for Disease Control and Prevention (CDC) .V . Extended Use of PPE . 3. Eye Protection - Remove and reprocess if eye protection becomes visibly soiled or difficult to see through. Reprocessing of eye protection will be performed according to manufacturer instructions for cleaning and disinfection. When manufacturer instructions are unavailable, consider the following: a. While wearing gloves, carefully wipe the inside, followed by the outside of the face shield or goggles using a clean cloth saturated with a neutral detergent solution or cleaner wipe. b. Carefully wipe the outside of the face shield or goggles using a wipe or clean cloth saturated with EPA-registered hospital disinfectant solution. c. Wipe the outside of the face shield or goggles with clean water or alcohol to remove residue. D. Air dry or use clean absorbent towels to dry fully. E. Remove gloves and perform hand hygiene .
During a review of the CDC's Strategies for Optimizing the Supply of Eye Protection, dated 12/22/20, retrieved on 5/6/21 from https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/eye-protection.html,
the document indicated, .Contingency Capacity Strategies . Extended use of eye protection can be applied to disposable and reusable devices. Eye protection should be removed, cleaned, and disinfected if it becomes visibly soiled or difficult to see through. If a disposable face shield or goggles is cleaned and disinfected, it should be dedicated to one HCP (health care personnel) and cleaned and disinfected whenever it is visibly soiled or removed (e.g., when leaving the isolation area) prior to putting it back on . Eye protection should be discarded if damaged (e.g., face shield or goggles can no longer fasten securely to the provider, if visibility is obscured and cleaning and disinfecting does not restore visibility) . Adhere to recommended manufacturer instructions for cleaning and disinfection . When manufacturer instructions for cleaning and disinfection are unavailable, such as for single use disposable face shields or goggles, consider: While wearing a clean pair of gloves, carefully wipe the inside, followed by the outside of the face shield or goggles using a clean cloth saturated with neutral detergent solution or cleaner wipe. Carefully wipe the outside of the face shield or goggles using a wipe or clean cloth saturated with EPA-registered external icon hospital disinfectant solution. Wipe the outside of face shield or goggles with clean water or alcohol to remove residue. Fully dry (air dry or use clean absorbent towels). Remove gloves and perform hand hygiene. Cleaned and disinfected eye protection can be stored onsite, in a designated clean area within the facility .
4. During an observation in the yellow zone on 4/20/21 at 10:57 AM, Resident 308 and Resident 94 shared the same room. Resident 308 occupied bed A and Resident 94 occupied bed B. Bed C was empty.
During a review of the Resident List Report, dated 4/20/21, the report indicated, Resident 308 was admitted on [DATE], and had been in the facility for over eight weeks. Resident 94 was admitted on [DATE] and had been in the facility for three weeks. Resident 308 and Resident 94 shared a room in the yellow zone.
During a review of the Census Report, dated 4/21/21, the report indicated, a newly admitted resident (Resident A) joined Resident 308 and Resident 94 in the same room in the yellow zone. Resident A occupied Bed C.
During an interview with the Infection Preventionist (IP) 2 on 4/21/21 at 10:05 AM, IP 2 stated newly admitted residents were observed in the yellow zone for 14 days for any signs and symptoms of COVID-19. IPO 2 stated newly admitted residents were cohorted together.
During a concurrent record review of the Census Report, dated 4/21/21, and interview with the Nurse Manager (NM) 3 on 4/21/21 at 10:20 AM, NM 3 stated she cohorted and assigned resident rooms in the yellow zone based on the resident's status, condition, and transmission-based precaution for COVID-19. NM confirmed there was a vacant room [room [ROOM NUMBER]] available in the yellow zone on 4/20/21. NM 3 acknowledged the newly admitted resident (Resident A) who was under observation for COVID-19 in the yellow zone, was cohorted with Resident 308 and Resident 94.
During a review of the California Department of Public Health's All Facilities Letter to the Skilled Nursing Facilities with subject titled, Coronavirus Disease 2019 (COVID-19) Recommendations for . Resident Placement/Movement . In Skilled Nursing Facilities, dated 9/22/20, the letter indicated, .Refer to the COVID-19 Resident Placement/Movement .for a chart of the COVID-19 Recommendations . Newly admitted Residents Under Observation (Yellow-Observation) . Resident placement and movement considerations . Do not mix new admissions with any other resident groups . Although residents that are symptomatic with suspected COVID pending test results, COVID exposed residents, and newly admitted residents under observation would be placed in the yellow status, these residents should be cohorted based on their designation and not placed with residents on yellow status for different reasons .
During a review of the CDC's Interim Infection Prevention and Control Recommendations to Prevent SARS-CoV-2 Spread in Nursing Homes, dated 3/29/21, retrieved on 5/12/21 from https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html, the document indicated, .New Admissions and Residents who Leave the Facility - Create a Plan for Managing New Admissions and Readmissions . In general, all other new admissions and readmissions should be placed in a 14-day quarantine, even if they have a negative test upon admission . Facilities located in areas with minimal to no community transmission might elect to use a risk-based approach for determining which residents require quarantine upon admission .
The facility policy and procedure (P&P) titled, INFECTION PREVENTION AND CONTROL: NOVEL CORONAVIRUS (COVID-19), dated 10/12/2020, indicated . Policy . This policy is based on guidelines recommended by the Centers for Disease Control and Prevention (CDC) . III. COHORTING . 2. Yellow Cohort (Mixed-Quarantine & Symptomatic). This area is for the following residents . Newly admitted or re-admitted residents (Yellow-Observed) area of the Yellow Zone; Newly admitted or readmitted residents (Yellow-Observed) will not be cohorted with the PUIs (Yellow-Exposed) in the same room . Newly admitted and readmitted residents must stay in quarantine in the Yellow Cohort for 14 days of observation .
5. During an observation on 4/21/21, at 1 PM, MDS 1 exited a resident room located in the green zone. MDS 1 wore a surgical face mask and had no PPE worn for eye protection.
During an interview with MDS 1 on 4/21/21, at 1:02 PM, in the nurse's station of the green zone, MDS 1 confirmed she did not wear a face shield. MDS 1 stated she was told by the facility administration that she did not have to wear a face shield unless doing patient care where there was the possibility of a splash.
During an interview with the Director of Staff Development and Infection Preventionist (DSD/IP) on 4/27/21 at 12 PM, the DSD/IP stated that resident care staff were required to wear a surgical face mask when assigned to work in the green zone. The DSD/IP stated the facility followed county, state, CDC guidelines and their own policy and procedures on COVID-19 infection prevention and control.
During the time of the facility's re-certification survey from 4/20/21 through 4/28/21, the county where the facility was located was on moderate to substantial community transmission status for COVID-19.
The facility policy and procedure (P&P) titled, INFECTION PREVENTION AND CONTROL: NOVEL CORONAVIRUS (COVID-19), dated 10/12/2020, indicated . Policy . This policy is based on guidelines recommended by the Centers for Disease Control and Prevention (CDC) .PPE in each Cohort Zones . Transmission Based Precautions - [NAME] Cohort (Non-COVID Area) - Standard + mask + eye protection .
During a review of the California Department of Public Health's All Facilities Letter to the Skilled Nursing Facilities with subject titled, Coronavirus Disease 2019 (COVID-19) Recommendations for Personal Protective Equipment (PPE) . In Skilled Nursing Facilities, dated 9/22/20, the letter indicated, .Refer to the COVID-19 PPE .for a chart of the COVID-19 Recommendations . Residents with No Known Exposure, or COVID Recovered (Green Area) . Facemask - Yes . Eye Protection - Yes .
During a review of the CDC's Infection Control Guidance for Healthcare Professionals about Coronavirus (COVID-19), dated 6/3/20, retrieved on 5/6/21 from https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control.html, the guidance indicated, .Use of eye protection is recommended in areas with moderate to substantial community transmission. For areas with minimal to no community transmission, eye protection is considered optional, unless otherwise indicated as part of standard precautions .
During a review of the CDC's Interim Infection Prevention and Control Recommendations for Healthcare Personnel (HCP) During the Coronavirus Disease 2019 (COVID-19) Pandemic, the document indicated, . HCP working in facilities located in areas with moderate to substantial community transmission are more likely to encounter asymptomatic or pre-symptomatic patients with SARS-CoV-2 infection . One of the following should be worn by HCP for source control while in the facility and for protection during patient care encounters: An N95 respirator . A well-fitting facemask . Eye protection should be worn during patient care encounters to ensure the eyes are also protected from exposure to respiratory secretions .
6. During an observation in the yellow zone on 4/20/21 at 9:56 AM in Resident 305's room, Resident 305 had on a nasal cannula that was connected to an oxygen concentrator. The nasal cannula had a label dated 4/12.
During an interview with Nurse Manager (NM) 3 on 4/20/21 at 10:07 AM, NM 3 stated the nasal cannulas were replaced as needed and after 7 days of use. NM 3 stated the nurses should have replaced Resident 305's nasal cannula last night. NM 3 stated it was important to ensure the nasal cannula was intact, clean, and replaced to prevent infection.
During a review of the clinical record for Resident 305, the physician's order summary report, indicated, .Change oxygen cannula tubing Q (every) week, every 7 (days) and PRN (as needed) for soilage .
During a review of the manufacturer's label for the oxygen nasal cannula used by the facility, the label indicated, .For Single Patient Use . Warning: Re-use of single use only products may result in exposure to viral, fungal, or prionic pathogens. Validated cleaning and sterilization methods and instructions for reprocessing to original specifications are not available for these products . This product is not designed to be cleaned, disinfected or re-sterilized . Do not Re-use .
7. During an observation in the yellow zone on 4/20/21 at 10:25 AM, a yellow-colored plastic basin containing an unlabeled, empty plastic urinal and a white-colored washcloth were found on the window ledge occupied by Resident 60 and Resident 310.
During an interview with Resident 60 on 4/20/21 at 10:26 AM, Resident 60 stated the items identified were not his.
During an interview with Certified Nursing Assistant (CNA) 5, on 4/20/21 at 10:34 AM, CNA 5 stated he did not know which resident owned the basin, urinal and washcloth, and said, looks like it's dirty.
During an interview with Nurse Manager (NM) 3, on 4/20/21 at 10:40 AM, NM 3 stated the items found on the window ledge should be labeled with the resident's room number. NM 3 said, We're going to take that out, I don't like it in there .
During an interview with the Director of Staff Development and Infection Preventionist (DSD/IP) who was also designated as one of two Infection Preventionists in the facility, on 4/27/21, at 11:10 AM, the DSD/IP stated reusable equipment such as basin and urinal should be labeled with the resident's room number. The DSD/IP stated after cleaning and disinfection with each use, these items should be placed in a plastic bag and kept in the resident's bedside drawers.
8. During an observation on 4/27/21 at 10:17 AM, RN 3 sanitized hands, put gloves on and sanitized overbed tray table. Thereafter she took gloves off sanitized hands, put gloves on, then covered the overbed tray table with plastic.
During an observation on 4/27/21 at 10:19 AM, RN 3 put a box of gloves on the overbed tray table, cleaned scissors with sanitized wipes, 100 ml (milliliters) bottle normal saline, bottle of packing gauze and 4 x (by) 4 gauze.
During an observation on 4/27/21 at 10:30 AM, RN 3 sanitized hands, put gloves on, put the wound supplies back on the plastic covered overbed tray table, rolled the overbed tray table in to Resident 44's room, confirmed Resident 44's identity, informed Resident 44 of wound care, then proceeded with wound care.
During an observation on 4/27/21 at 10:31 AM, RN 3 removed the dressings from Resident 44's abdominal wound, cleaned the wound with saline solution soaked Q-tips, removed her gloves, washed hands, put on another pair of gloves, applied packing gauze into the abdominal wound, and covered it with 4X4 gauze secured with paper tape. RN 3 did not have eye protection on during wound care.
During a concurrent interview on 4/27/21 at 10:31 AM, RN 3 stated the wound dressing had serosanguineous (clear liquid swirled with blood) drainage.
During an observation on 4/27/21 at 10:35 AM, RN 3 took off soiled gloves, washed her hands, put on a new pair of gloves, put paper tape back on the shelf inside the treatment cart, sanitized scissors, put away the wound care trash, took off soiled gloves and washed her hands.
During an observation on 4/27/21 at 10:41 AM, RN 3 sanitized her hands, put on gloves, covered the overbed tray table with plastic and put wound supplies on overbed tray table for Resident 77's wound care.
During a concurrent observation and interview on 4/27/21 at 10:43 AM, after RN 3 finished preparing supplies for Resident 77's wound care, RN 3 stated she forgot to have Resident 77 premedicated for wound care. RN 3 informed RN 1 to administer medication for Resident 77. RN 1 administered Resident 77's medication. Thereafter, RN 3 secured Resident 77's wound care supplies in a plastic bag inside the locked treatment cart until wound care was resumed.
During an observation on 4/27/21 at 11:26 AM, RN 3 sanitized her hands, put gloves on, put the wound supplies back on the plastic covered overbed tray table and rolled it to Resident 77's bedside. RN 1 assisted with positioning Resident 77 to her side as RN 3 provided Resident 77's wound care. Both RN's did not wear eye protection during wound care.
During a concurrent observation and interview on 4/27/21 at 11:47 AM, inside the treatment cart were treatment wound care supplies including ointments and gels, saline solution, gauze dressings. In addition, there were rolls of silk and paper tapes that were new and in various lengths (remnants). RN 3 stated tapes were used until the whole roll was consumed, and she cleaned the paper tape before she put it back inside the treatment cart, and she did not need to wear eye protection during Resident 44 and 77's wound care.
Review of document titled, wound Care, dated 10/2010, indicated, Equipment and Supplies . 4. Personal protective equipment . as needed . 21. Take only the disposable supplies that are necessary for the treatment into the room. Disposable supplies cannot be returned to the cart .
CONCERN
(F)
Potential for Harm - no one hurt, but risky conditions existed
Pharmacy Services
(Tag F0755)
Could have caused harm · This affected most or all residents
Based on observations, interviews, and record reviews, the facility failed to:
1. Ensure a device called glucometer (glucometer, measured the amount of sugar in the blood) and the supplies used to tes...
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Based on observations, interviews, and record reviews, the facility failed to:
1. Ensure a device called glucometer (glucometer, measured the amount of sugar in the blood) and the supplies used to test blood glucose (sugar) were used properly by performing calibration (the process of configuring a device to provide accurate test results within an acceptable range) checks as instructed by the manufacturer and the United States Food and Drug Administration (or FDA is government agency responsible for protecting the public health by ensuring the safety and efficacy of drugs and medical devices) advisory in two out of four units (second and fourth floor units).
2. Ensure discontinued and expired medications were removed from the active storage area and the medications were labeled with Beyond Use Date (or BUD, a date that no longer safe to use the medication) according to standards of practice or manufacturing information in two (Second and Fourth floor units) out of four medication storage units.
3. Ensure drugs were stored at required temperature according to manufacturer's instruction and facility's policy and procedure in one (second floor) out four medication rooms.
4. Ensure security of prescription medications in the medication storage room by preventing storage of staff's personal items in one (second floor) out of four medication rooms.
5. Ensure security of treatment cart when it was left open and unattended in one (second floor unit) out of four units.
6. Ensure opioid (or narcotics, drug of concern for possible abuse) medication accountability log sheet (also called Controlled Drug Accountability or CDR where every use of narcotic medication documented) were matched with the Medication Administration Record (or MAR, a document in medical records that listed medication use) on four (Resident 44, Resident 45, Resident 88 and Resident 51) out of 22 sampled residents.
7. Ensure the medication delivery documents known as Consolidated Delivery Sheets (or CDS, or delivery sheet, a document that lists the medication names and quantities when delivered to the facility), from the provider pharmacy ( a type of drug store that deliver medication to facility) were signed and acknowledged by licensed staff on a consistent basis with census of 110.
These deficient practices had potential for serious harm through inaccurate blood sugar test results, compromise the integrity and effectiveness of the medications, drug misuse, medication error, and/or drug diversion (when drug used in an unlawful manner.)
Findings:
1. During an observation on 4/20/21, at 8:40 AM, in the facility's second floor unit, the two bottles of control solutions for the glucometer device were marked with open dates of 9/26/20 and 12/22/20. The outer label of control solution indicated to use within 90 days of first opening.
During an observation and inspection medication cart (a cart that holds medication and can be moved around) on 4/20/21, at 10:47 AM, in the facility's second floor unit, three bottles of test strips for glucometer device were not marked with an open date. The outer label of the test strip bottle indicated to use within 90 days (3 months) of first opening.
During an interview on 4/20/21 at 10:47 AM, with Registered Nurse (RN) 1 , RN 1 stated she was not sure when the control solution and test strips for second floor unit were first opened.
During an observation on 4/21/21, at 10:50 AM, in the facility's fourth floor unit, the two bottles of control solutions for the glucometer device were not marked with open date. The outer label of control solution indicated to use within 90 days of first opening.
During an observation of 4/21/21, at 10:50 AM, in the facility's fourth floor unit, one bottle of test strips for glucometer device was not marked with an open date. The outer label of the test strip bottle indicated to use within 90 days (3 months) of first opening.
During an interview on 4/21/21 at 3 PM, with Licensed Vocational Nurse (LVN) 1, LVN 1 stated that night shift managed the glucometer control solution use. She added the test strips should have been dated when they first opened it.
During a review of a document titled Quality Control Record .Blood Glucose Monitoring System, dated March through April of 2021, located on the third floor unit, the document indicated the use of the same lot number (lot number is a number given to a product or medication by its manufacturer when produced) for control solution on both the normal and high testing levels (normal and high were two different types of control solutions used to calibrate blood sugar device.) The lot number documented on Quality Control Record sheet (a record that documented dates of calibration and products used) from 3/22/21 to 4/21/21 for both normal and high testing levels were recorded as 092519A ( this is a number on each bottle of control solution by the manufacturer). Further review of Quality Control Record indicated multiple days of missing calibrations on 3/19/21, 3/23/21, 3/24/21, 3/29/21, 4/16/21, 4/18/21 and 4/19/21.
During a review of the facility document titled Quality Control Record . Blood Glucose Monitoring System, dated March 2021, located on second floor unit, the document indicated multiple days of missing calibration tests on 3/1/21, 3/2/21, 3/3/21, 3/4/21, 3/6/21, 3/7/21, 3/9/21, 3/11/21, 3/14/21, 3/15/21, 3/16/21, 3/17/21, 3/20/21, 3/21/21, 3/22/21, 3/23/21, 3/24/21, 3/25/21, 3/29/21 and 3/30/21.
During a review of the facility document titled Quality Control Record . Blood Glucose Monitoring System, dated April 2021, located on second floor unit, the document indicated multiple days of missing calibration tests on 4/1/21, 4/2/21, 4/3/21, 4/5/21, 4/6/21, 4/7/21, 4/8/21, 4/10/21, 4/13/21, 4/15/21, 4/17/21, and 4/19/21.
During an interview on 4/21/21 at 4:58 PM, with Registered Nurse (RN) 2, RN 2 stated he worked the night shift previously and was required to perform calibration for glucometers in use. He added they had to document the products used and results of calibration in a log sheet. RN 2 was not sure why the calibration log were not consistently documented and the test stripes or control solutions were not dated when first opened.
During an interview on 4/22/2021 at 11:17 AM, with the Director of Staff Development (DSD), the DSD stated orientation and training of the new nurses included 2 days of computer learning and then they go to the unit and observe another nurses for practical training. The director of nursing and nurse managers were responsible to make sure they were signed off all required training before they worked on their own. The DSD had no specific knowledge of training documents for glucometer use and maintenance.
During a concurrent observation and interview on 4/22/21 at 11:47 AM, with Nurse Manager 1 (NM 1), on the second floor of the facility, the two expired bottles of control solutions for the glucometer were once again observed in the black container; the high control solution with the green cap was marked 9/26/20 and the normal control solution with the blue cap was marked 12/22/20. NM 1 acknowledged the two bottles of control solutions were expired. NM 1 stated it should be discarded after 90 days of opening as it may alter the reading of the glucometer. NM 1 could not provide a written policy on blood sugar quality control, except the manufacturer catalogue booklet.
During an interview on 4/26/21 at 3:23 PM, with the DON, the DON stated facility performed the glucometer calibration and quality control using the manufacturer's instructions. She added, a short step-by-step instructions using the manufacturer guidelines would have been helpful to teach and guide the nursing staff.
During an interview on 4/27/21 at 3:10 PM, with Consultant Pharmacist (CP, a pharmacist that guided the facility on safe use of any medication related issues), the CP indicated that she did not check the glucometer control solution or the test strips for expiration. She added that the glucometer supply check was not part of her workflow during medication storage inspection of the facility.
Review of the glucometer's manufacturer (brand name used by facility was Assure Platinum by Arkray) instruction page titled Regulatory Review and Guidelines for QA/QC Protocols, [undated], the document listed a competency checklist for personnel training, Quality Assurance (or QA the maintenance on preventing mistakes and defects in products) and Quality Control (or QC involved testing of units and determining if they are within the specifications for use). The document indicated a requirement for formal training and written examination for personnel training. The QA indicated to follow manufacturer instruction for calibration along with a written procedure. The QC section of the document indicated, On each day of use, two controls . should be performed per instrument. Each operator to perform a quality control prior to the first patient test of the day. Additional checks should be performed when a new bottle of strips is opened, each time a reagent lot is changed and to ensure the strips and meter are functioning properly.
Review of the United States Food and Drug Administration (or FDA is government agency responsible for protecting the public health by ensuring the safety and efficacy of drugs and medical devices) advisory document dated 4/10/2019, titled how to safely use Glucose Meters and Test Strips for Diabetes last accessed on 5/4/2021, indicated Test strips should be properly stored to give accurate results . A lack of proper storage or using expired strips could put you at risk for getting incorrect results from your glucose meter. And incorrect results can put you at risk for serious health complications - and even death. Do quality control checks of your device. Regularly test your meter using a control solution to make sure the test strips and meter are working properly together. Read the meter's instructions for use to see how often you should test it.
2. During an inspection of the medication refrigerator in the medication storage room located on the second (2ND) floor and concurrent interview with Registered Nurse (RN) 1, on 4/20/21 at 9:25 AM, RN 1 acknowledged the following drugs and biologicals were stored beyond the expiration date:
a. One multi-dose vial of influenza vaccine (known as flu shots) afluria Quadrivalent, labeled Date Vial Opened 11/1/20, Date Vial Expires 11/29/20, Discard After 28 days was stored beyond the expiration date;
b. One Refrigerated Emergency Kit [New] #3051 (E-kit, a kit/box containing small quantity of medications that can be dispensed when pharmacy services are not available) sealed with red plastic lock, indicated an expiration date of 3/31/21; the E-kit contains medications including Lorazepam (a medication used to manage anxiety disorders) injection vial, insulin (a medication used to treat high blood sugar levels), Prochlorperazine suppository (medication used to manage severe nausea and vomiting), and Promethazine suppository (medication used for prevention and control of nausea and/or vomiting). RN 1 stated, I don't know when asked regarding the expired E-kit in the medication refrigerator.
During an interview with NM 1, on 4/26/21 at 2:35 PM, NM 1 stated each E-kit are checked every shift during endorsement; the nurses communicates if it was reordered or not; E-kits need to be replaced by the pharmacy within 72 hours.
Review of the facility's policy and procedure titled, Storage of Medications, dated April 2008, indicated, .Procedures . M. Outdated, contaminated or deteriorated medications and those in containers that are cracked, soiled, or without secure closures are immediately removed from stock, disposed of according to procedures for medication disposal, and reordered from the pharmacy if a current order exists .
Review of the facility's policy and procedure titled, Emergency Pharmacy Service and Emergency Kits, dated August 2014, indicated, .Procedures . L. Before reporting off duty, the charge nurse indicates the opened status of the emergency kit at the shift change report . N. If exchanging kits, the used sealed kits are replaced with the new sealed kits within 72 hours of opening. O. The kits are checked by a pharmacist at least monthly .
According to the Food and Drug Administration (FDA, is a federal agency responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices) regarding expired medications, retrieved from https://www.fda.gov/drugs/special-features/dont-be-tempted-use-expired-medicines, dated 2/8/21, .Using expired medical products is risky and possibly harmful to your health . Expired medical products can be less effective or risky due to a change in chemical composition or a decrease in strength. Certain expired medications are at risk of bacterial growth . Once the expiration date has passed there is no guarantee that the medicine will be safe and effective .
During an inspection of the treatment cart located on the second (2ND) floor and concurrent interview with NM 1, on 4/20/21 at 9:42 AM, opened and undated biologicals were stored in the treatment cart as follow:
a. Two tubes of MediHoney (a medical-grade honey-based product line for the management of wounds and burns) Wound & Burn Dressing 44 ml (ml is unit of measure) did not have a cap/cover;
b. Two bottles of sterile saline (a solution used for wound cleansing, irrigation, and flushing) 100 ml (ml is unit of measure) for irrigation;
c. One bottle of Betadine solution (povidone-iodine 10%, used to treat or prevent bacterial infections).
NM 1 stated any medication container should be dated once opened; containers with no cap/cover are not acceptable and should be discarded; the opened bottle of sterile water is a one time use only and should be discarded after use. NM 1 stated that MediHoney and Betadine solution were used for residents during wound care.
During an inspection of the medication storage cart located on the second (2ND) floor and concurrent interview with RN 1, on 4/20/21 at 10 AM, opened and undated drugs were stored in the medication cart as follow:
a. One bottle of Regular Strength Acetaminophen (a medication used to relieve pain and reduce fever) 1000 tablets 325 milligrams (or mg is unit of measure) each;
b. One bottle of Extra Strength Acetaminophen 1000 tablets 500 mg (mg is a unit of measure) each;
c. One box/foil tray containing the BREO Ellipta 200/25 (fluticasone furoate 200 mcg and vilanterol 25 mcg inhalation powder (a combination inhaler used to treat blocked airflow in the lungs, mcg is a unit of measure) labeled with Resident 61's name.
RN 1 acknowledged the two bottles of Acetaminophen and inhaler did not have an open date. RN 1 stated, there were 2 puffs left as indicated on the inhaler device.
A review of the undated manufacturer's information sheet for MediHoney, on 4/20/21, indicated, .Label with client's name and date the tube was opened . Product is single-client use. Discard product when wound has healed/closed or is no longer indicated. Use within 4 months of opening .
A review of the undated manufacturer (Aqua Care) information for Sterile Sodium Chloride on 4/20/21, indicated each bottle is for single use and unused portions of sterile saline solution should be discarded and a separate container should be used for each patient and each start-up procedure.
A review of the undated manufacturer's label information for BREO Ellipta, on 4/20/21, indicated .Store BREO in the unopened foil tray and only open when ready for use. Safely throw away BREO in the trash 6 weeks after you open the foil tray . Write the date you open the tray on the label on the inhaler .
During an observation of the medication storage room and concurrent interview with Licensed Vocational Nurse (LVN) 2, on 4/20/21 at 12:18 PM, on the fourth (4TH) floor, there were two bottles of Sterile Water for Inhalation (water intended for use with inhalators and in preparation of inhalation solutions), USP, 500 ml (ml is unit of measure) were stored beyond the expiration date; the manufacturer's label indicated an expiration date of 2020-11-12. LVN 2 acknowledged the two expired sterile water. LVN 2 stated it should be discarded, the central supply person was responsible for checking and replacing the house supplies.
During an inspection of the medication refrigerator and concurrent interview with LVN 2, on 4/20/21 at 12:50 PM, on the fourth (4TH) floor, one multi-dose vial of influenza vaccine (known as flu shot) was opened and undated; nine bags of total parenteral nutrition solution formula (TPN - a nutritional supplement infused through a vein) were stored in the medication refrigerator, the pharmacy label indicated, Discard after: 03/14/21 for one bag and Discard after: 3/20/21 for eight bags. LVN 2 stated I don't know who opened the flu vaccine; it should be dated after opening and discarded after 28 days. LVN 2 acknowledged the expired TPN stored in the refrigerator. LVN 2 further stated the TPN belongs to a resident on the fifth (5th) floor; the TPN bags did not fit in the medication refrigerator on the fifth floor (another unit in the facility) so it was stored on the fourth floor.
Review of the facility's policy and procedure titled, Storage of Medications, dated April 2008, indicated, .Procedures . M. Outdated, contaminated or deteriorated medications and those in containers that are cracked, soiled, or without secure closures are immediately removed from stock, disposed of according to procedures for medication disposal, and reordered from the pharmacy if a current order exists .
According to the FDA regarding expired medications, retrieved from https://www.fda.gov/drugs/special-features/dont-be-tempted-use-expired-medicines, dated 2/8/21, indicated, .Using expired medical products is risky and possibly harmful to your health . Expired medical products can be less effective or risky due to a change in chemical composition or a decrease in strength. Certain expired medications are at risk of bacterial growth . Once the expiration date has passed there is no guarantee that the medicine will be safe and effective .
During an inspection of the medication cart and concurrent interview with LVN 1, on 4/21/21 at 10:33 AM, on the fourth (4TH) floor, the following opened and undated drugs and biologicals were stored in the medication cart:
a. One bottle of Regular Strength Acetaminophen (a medication used to relieve pain and reduce fever) 1000 tablets 325 milligrams (mg is a unit of measure) each;
b. One bottle of Extra Strength Acetaminophen 1000 tablets 500 mg each;
c. One bottle of Fish Oil 500 mg Gluten Free Dietary Supplement 130 soft gels;
d. One bottle of PreserVision Eye Vitamin and Mineral Supplement 60 soft gels;
e. One bottle of Vitamin C 500 mg Gluten Free Dietary Supplement 200 tablets;
f. One bottle of Geri-lanta Regular Strength Antacid & Antigas 355 ml (ml is unit of measure);
g. Two bottles of Assure Platinum Blood Glucose Test Strips (a piece of plastic strip used to read the blood sugar levels).
LVN 1 acknowledged bottles were not dated. LVN 1 stated it should be dated once opened.
According to an article regarding Drug Expiration Dates - Are Expired Drugs Still Safe to Take?, retrieved from https://www.drugs.com/article/drug-expiration-dates.html, dated 7/22/20, indicated, .Drug expiration dates exist on most medication labels, including prescription, over-the-counter (OTC) and dietary (herbal) supplements . Once the container of medication is opened after production that expiration date is no longer guaranteed . The expiration date of a drug is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration (FDA) . 'beyond-use' dates are often put on the prescription bottle label. These dates often say 'do not use after .' or 'discard after .' . According to the manufacturer, the stability of a drug cannot be guaranteed once the original bottle is opened. Heat, humidity, light, and other storage factors can affect stability .
3. During an inspection and observation of the medication storage room located on the second (2ND) floor, on 4/20/21 at 9:12 AM, the digital thermometer (a device that measures the temperature) for room temperature attached to the wall, was switched off.
During a concurrent interview and record review with NM 1, on 4/20/21 at 9:35 AM, on the 2nd floor, facility's document titled Medication Room Temperature Check log, dated March 2021 and April 2021, indicated no temperature was recorded for 3/30/21, 3/31/21, and 4/1/21 to 4/20/21; further review of the room temperature log sheet, indicated The Medication Room Temperature must be maintained between 68 to 77 degrees Fahrenheit ( it's a scale of temperature); check daily. NM 1 acknowledged there was no temperature recorded. NM 1 stated the digital thermometer was not working, it's broken and the medication room temperature should be checked daily.
During a concurrent record review and interview with NM 1, on 4/20/21 at 9:35 AM, on the 2nd floor, facility's document titled Temperature Log for Refrigerator, dated April 2021, indicated the temperature was recorded for 3 days in the span of April 1st to April 20th 2021 as follow: April 7th at 3 PM, April 14th at 3 PM, and April 15th at 3 PM. NM 1 stated that the refrigerator temperature should have been checked and documented twice a day. NM 1 was not sure why the log sheet was missing 17 days or 34 opportunity to document the refrigerator temperature.
During an interview with Environmental Services Manager (EVM) on 4/23/21 at 2:57 PM, EVM stated that the thermometer in the second floor medication room was replaced when he was notified on 4/20/21.
Review of the facility's document titled Plant Review Maintenance Request Log Sheet, [undated], indicated a maintenance request for thermometer on 4/20/21. The document did not show any other request for thermometer service previously.
Review of the facility's policy and procedure titled, Storage of Medications, dated April 2008, indicated, Medications and biologicals are stored safely, securely, and properly . Procedures . J. Medications at 'room temperature' are kept at temperatures ranging from 15 degree Celsius or C a temperature scale (59 F or Fahrenheit F temperature scale) to 30 C (86 F) . N. Medication storage areas are kept clean, well-lit, and free of clutter and extreme temperatures. O. Medication storage conditions are monitored on a routine basis and corrective action taken if problems identified.
Review of the facility's document titled Temperature Log for the Refrigerator, dated April 2021, indicated, Take action if temp (Temperature) is out of range- too warm (above 46 degrees Fahrenheit) or too cold (below 36 degrees Fahrenheit). Label exposed vaccine do not use and store it under proper condition as quickly as possible .
4. During an inspection and observation of the medication storage room located on the second (2ND) floor, on 4/20/21 at 9:12 AM, a lavender backpack and a black jacket was found on the counter in the medication room next to unlocked refrigerator and medication storage cabinets.
During an interview on 4/20/21 at 9:35 AM, with Nurse Manager (NM) 1, NM 1 stated the backpack and jacket belongs to a staff and should not be in the medication room. NM 1 added, personal belongings should be in the employee storage.
5. During an inspection of the treatment cart located on the second (2ND) floor and concurrent interview with NM 1, on 4/20/21 at 9:42 AM, the treatment cart parked in the hallway by the resident's room was left unlocked and unattended. NM 1 went to check on the treatment cart and stated that it should be locked at all times.
During an interview on 4/26/21 at 4:09 PM, with the DON, the DON stated the medication cart, treatment cart, and medication room should not have been be left unlocked and unattended.
Review of the facility's policy and procedure titled, Storage of Medications, dated April 2008, indicated, .Procedures . B. Only licensed nurses, pharmacy personnel, and those lawfully authorized are allowed access to medications. Medication rooms, carts, and medication supplies are locked or attended by persons with authorized access .
6A. Review of Resident 44's clinical record titled Medication Administration Record (or MAR, a document in medical records that capture medication list and use), dated for April 2021, indicated Res 44 was prescribed an opioid medication on 3/22/21 as follow:
Oxycodone (opioid pain medication) 5 mg tablet (mg is unit of measure), give two tablets by mouth every 4 hours as needed for severe pain .
The MAR record did not show oxycodone administration on 4/22/21 at 13:40 PM.
Review of Resident 44's clinical record titled Antibiotic or Controlled Drug Record (also known as CDR- a log used to assure accountability and security of the medication use), [undated], indicated, a Licensed Nurse removed and signed for 2 tablets of oxycodone for administration on 4/22 at 13:40 PM. Further review of Resident 44's Medication Administration Record, where medication administration were recorded for April 2021, did not show any corresponding documentation to reflect CDR removal of opioid oxycodone on 4/22 at 13:40 PM.
6B. Review of Resident 45's clinical record titled Medication Administration Record, dated for April 2021, indicated Resident 45 was prescribed an opioid medication on 4/6/21 as follow:
Oxycodone (opioid pain medication) 5 mg tablet (mg is unit of measure), give two tablets by mouth every 4 hours as needed for severe pain .
The MAR record did not show oxycodone administration on 4/10/21 at 2000 PM and 4/20/21 at 0100 AM.
Review of Resident 45's clinical record titled Antibiotic or Controlled Drug Record (known as CDR- a log used to assure accountability and security of the medication use), [undated], the document indicated nursing staff removed and signed for 2 tablets of oxycodone for administration on 4/10 at 20:00 PM and on 4/20/21 at 01:00 AM. Further review of Resident 45's Medication Administration Record, where medication administration were recorded for April 2021, did not show any corresponding documentation to reflect CDR removal of opioid oxycodone on 4/10/21 at 20:00 PM and 4/20/21 at 01:00 AM.
6C. Review of Resident 88's clinical record titled Medication Administration Record, dated for April 2021, indicated, Resident 88 was prescribed an opioid medication on 3/1/21 as follow:
Oxycodone (opioid pain medication) 5 mg= 5 mL (mg and ml were unit of measure), give 5 mL by mouth every 4 hours as needed for moderate pain .Oxycodone 7.5 mg= 7.5 mL, Give 7.5 mL every 4 hours as needed for severe pain .
The MAR record did not show oxycodone administration on the following days and times:
4/3/21 at 1900 PM
4/5/21 at 2100 PM
4/10/21 at 1900 PM
4/12/21 at 11 AM
4/18 at 2000 PM
4/19 at 3 PM
Review of Resident 88's clinical record titled Antibiotic or Controlled Drug Record (known as CDR- a log used to assure accountability and security of the medication use), [undated], the document indicated a Licensed Nurse removed and signed for oxycodone for administration on the following days and times:
4/3/21 at 1900 PM (5 mg=mL)
4/5/21 at 2100 PM (5 mg=mL)
4/10/21 at 1900 PM (7.5 mg= 7.5 mL)
4/12/21 at 11 AM (5 mg=mL)
4/18 at 2000 PM (5 mg=mL)
4/19 at 3 PM (5 mg=mL)
Further review of Resident 88's Medication Administration Record, where medication administration were recorded for April 2021, did not show any corresponding documentation to reflect CDR removal of opioid oxycodone in the following days and times:
4/3/21 at 1900 PM (5mg=mL)
4/5/21 at 2100 PM (5 mg=mL)
4/10/21 at 1900 PM (7.5 mg= 7.5 mL)
4/12/21 at 11 AM (5 mg=mL)
4/18 at 2000 PM (5 mg=mL)
4/19 at 3 PM (5 mg=mL)
6D. Review of Resident 51's clinical record titled Medication Administration Record, dated for April 2021, indicated Resident 51 was prescribed an opioid medication on 3/17/21 as follow:
Oxycodone (opioid pain medication) 5 mg tablet (mg is unit of measure), give half a tablet or 2.5 mg by mouth every 4 hours as needed for moderate pain .Oxycodone 5 mg tablet, give 2 tablet every 4 hours as needed for severe pain .
The MAR record did not show oxycodone administration on 4/9/21 at 0500 AM and 4/14/21 at 1700 PM. The MAR record, however recorded administration of oxycodone 5 mg on 4/13/21 at 17:28 PM.
Review of Resident 51's clinical record titled Antibiotic or Controlled Drug Record (known as CDR- a log used to assure accountability and security of the medication use), [undated], the document indicated nursing staff removed and signed for oxycodone 5 mg for administration on 4/9/21 at 5:00 AM and on 4/14/21 at 17:00 PM. Further review of Resident 51's Medication Administration Record, where medication administration were recorded for April 2021, did not show any corresponding documentation to reflect CDR removal of oxycodone on 4/09/21 at 5:00 AM, 4/13/21 at 12:08 PM and 4/14/21 at 17:00 PM.
During an interview with Licensed Vocational Nurse (LVN) 3 on 4/23/21 at 2:23 PM, LVN 3 stated once a pain medication removed from CDR, the nurse should document it in the MAR along with pain level before and after use.
During an interview with the DON, on 4/26/21 at 3:12 PM, the DON stated removal from the CDR sheets should corresponds to the MAR documentation because nursing staff were responsible for what they administer. The DON added nursing staff could document medication administration in the progress notes for the outcome or result of the medication use by residents. The DON was not aware of any audit of the CDR and MAR for opioid accountability by either her facility or the Consultant Pharmacist (or CP, pharmacist who reviewed medication use practices for the facility on monthly basis). The DON stated that the facility had no problem with narcotic (or opioid, drugs at risk for abuse) medication loss and errors. The DON, furthermore, acknowledged discrepancy and lack of documentation might happen, because most resident wanted narcotic and nurses knew their residents very well.
During an interview with the Consultant Pharmacist (CP), on 4/27/21 at 3:44 PM, the CP stated that she did not perform any audit of narcotic medication use by comparing the CDR and MAR. The CP added this was not part of her work servicing the facility.
Review of the facility's policy and procedure titled Preparation and General Guidelines on medication administration, dated October 2017, indicated, The individual who administers the medication dose records the administration on the resident's MAR directly after the medicati[TRUNCATED]