CONCERN
(D)
Potential for Harm - no one hurt, but risky conditions existed
Deficiency F0658
(Tag F0658)
Could have caused harm · This affected 1 resident
Based on observation, interview and record review, the facility failed to follow professional standards of practice for one Resident (Resident 41) when: 1) there was no formalized process for nursing ...
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Based on observation, interview and record review, the facility failed to follow professional standards of practice for one Resident (Resident 41) when: 1) there was no formalized process for nursing to communicate with the RD to provide assessments for residents who had pressure or diabetic ulcers; and, 2) there was lack of inclusion of the RD in relevant patient care committees, in accordance with the approved job description.
Resident 41 had a diagnosis of Diabetes Mellitus (Diabetes mellitus refers to a group of diseases that affect how the body uses blood sugar--glucose) and a Pressure ulcer. This failure resulted in a nutritional assessment not being completed, which had the potential to contribute to the wound not healing.
Findings:
It is estimated that up to 50% of hospitalized patients are malnourished. Malnutrition can lead to longer hospital stays, altered immune function, and impaired skin integrity and wound healing. Malnutrition has been found to be a significant factor influencing pressure injury (PI) risk and wound healing. While PI prevention requires multidimensional complex care using a variety of evidence-based strategies, hospitalized patients benefit from interventions that focus on improving oral nutrition to reduce PI risk and enhance wound healing. Unfortunately, malnutrition is often under-recognized and inadequately managed in hospitalized patients and this can lead to higher rates of complications such as PI.
Recent Advances: Recent studies suggest that nutritional care has a major impact in PI prevention and management. Strategies, including early identification and management of malnutrition and provision of specially-formulated oral nutritional interventions to at-risk patients, optimization of electronic health record systems to allow for enhanced administration, monitoring, and evaluation of nutritional therapies, and implementation of protocol-based computerized decision support systems, have been reported to improve outcomes. Optimizing Nutrition Care for Pressure Injuries in hospitalized Patients. (2019) Advances in wound care, 8(7), 309-322.https://doi.org/10.1089/wound.2018.0925
During a review of Resident 41's clinical record, indicated Resident 41 had an acute care hospital office visit and saw a Doctor of Podiatry Medicine (DPM) on 3/1/22. The following issues were addressed: Diabetes Type 2 with peripheral neuropathy, Diabetes Type 2 with Diabetic Ulcer of right heel, and pressure ulcer of the right heel Stage 3.
During a further review of the clinical record, it indicated Resident 41 had a diet order of CCHO (Consistent Carbohydrate Controlled) diet for diabetics. Resident 41 needed 75g protein for wound healing. Review of Documentation of Survey Report v2, dated 10/19/22, indicated Resident 41's average meal intake for August, September and October 2022, Resident 41's average intake was 56% of her meals. Her caloric needs were 1678-1845 Kcals. If she was only eating 939.68 kcals and 42g protein, she was not meeting her caloric needs.
During an interview with the RD on 10/19/22 at 11:28 AM, she stated she started in 2019. Apparently, it was missed by me. I wasn't notified of that change. I don't attend the meetings. The Interdisciplinary Team is nursing, DFS (Director of Food Services) The Care planning and weight committee is limited to DFS and nursing.
During an interview and concurrent record review with the RD on 10/20/22 at 10:30 AM, showed the baseline care plan, dated 9/25/17, which documented a recommended intervention for the RD to do an assessment. The RD stated she did not know why she was not notified.
During an interview with DFS on 10/21/22 at 1:38 p.m., when asked how the RD was notified of residents, she stated change of condition, onsite, weekly weights, staff can reach out, all new admissions.
During a review of the job description for the Registered Dietitian, not dated, it indicated the RD was hired on 3/13/20. The primary purpose of the job position was to, .plan, organize, develop, and direct the overall operation of the Dietary Department . to assure that quality nutritional services are provided on a daily basis and that the dietary department is maintained in a clean, safe, and sanitary manner.
It further indicated the RD assist the Quality Assessment and Assurance committee in developing and implementing appropriate plans of actions to correct dietary deficiencies. The RD serves on, participates in, and attends the various committees of the facility (i.e. Infection Control, Policy Advisory, Pharmaceutical, Budget, Quality Assessment and Assurance, etc.) as required, and as appointed by the Administrator.
The facility policy and procedure titled, Quality of Care - Skin Management System, dated 5/2019, indicated, It is the policy of this facility that any resident who enters the facility without pressure ulcers will have appropriate preventative measures taken to ensure that the resident does not develop pressure ulcers. It further indicated the Registered Dietitian would provide nutritional support when appropriate.
The facility policy and procedure titled Pressure Ulcers/Skin Breakdown-Clinical Protocol, not dated, indicated under, Treatment and Management: a. Although poor nutritional status is associated with increased risk of pressure ulcer development, no specific nutritional interventions clearly prevent or heal pressure ulcers. b. Beyond trying to maintain a stable weight and providing approximately 1.2-1.5 gm/kg protein daily, there are no routine pressure ulcer-specific nutritional measures for those with or at risk for developing a pressure ulcer. The facility policy was not reflective of accepted standards of professional practice. It was also noted that the policy did not indicate a professional reference for the practice statement discounting the benefit of nutritional interventions in wound healing.
CONCERN
(D)
Potential for Harm - no one hurt, but risky conditions existed
Accident Prevention
(Tag F0689)
Could have caused harm · This affected 1 resident
Based on observation, interview and record review, the facility failed to ensure the environment was safe for residents and visitors, when a known tripping hazard, located in the parking lot, was not ...
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Based on observation, interview and record review, the facility failed to ensure the environment was safe for residents and visitors, when a known tripping hazard, located in the parking lot, was not repaired timely. Facility staff were aware of the tripping hazard for more than two months, had purchased asphalt for its repair, and did not execute the repair until after a visitor tripped and fell.
This failure: 1) Caused potential for resident falls, and subsequent injury, for one unidentified resident know to wheel himself (in a wheelchair) outside independently (without supervision), 2) Caused potential for resident falls, and subsequent injury, for eight sampled residents (Resident 25, Resident 144, Resident 29, Resident 16, Resident 8, Resident 36, Resident 28, and Resident 39) and six Unsampled residents (Resident 27, Resident 17, Resident 9, Resident 34, Resident 55, and Resident 56), known to ambulate with physical therapy staff inside and potentially outside, the building, and 3) Caused one Confidential Visitor (CV) to trip, fall and sustain injuries while walking through the parking lot.
Findings:
During an observation on 10/17/22 at 1:25 p.m., a Confidential Visitor (CV) to the facility was walking to their car in the parking lot. The CV tripped (and subsequently fell) on a three-to-four-inch-deep drop in the pavement. The surrounding pavement (next to the drop) was cracked; the area was located near a corner of the building, near the physician's designated parking spot. Pictures were taken of the uneven, cracked pavement.
During an observation and concurrent interview on 10/17/22 at 1:35 p.m., the three-to-four-inch-deep drop in the pavement (and visitor fall) was reported to the Director of Nursing (DON). The DON and the CV went to the uneven pavement site (where the fall occurred), and the DON stated she had not been aware of the uneven pavement and stated the area was, large. Director A was nearby and stated the cement had, shifted.
During an observation on 10/17/22 at 2:10 p.m., the CV and three of their confidential coworkers were walking in the parking lot toward their cars. As the CV and their coworkers approached the uneven pavement site, the DON, Administrator and Director A were standing there. A bag of asphalt was on the ground, and Director A was using a shovel to fill in the three-to-four-inch-deep drop with asphalt.
During a telephone interview on 10/20/22 at 10:43 a.m., the Activity Director (Director B) was asked about types of activities offered to residents at the facility. Director B stated the facility offered multiple activities including walking. Director B stated a, couple of residents, participated in morning or after meal walks. Director B stated approximately three residents were able to walk independently, but they ambulated with supervision (of staff). Director B stated Physical Therapy (staff) would walk additional residents. When asked where residents walked outside of the building, Director B stated residents could walk on the sidewalk, from one side of the building to the other. Director B stated the sidewalk had a railing, and the parking lot was on the other side of the railing. When asked if residents walked on the other side of the railing (in the parking area), Director B stated, Yes, it depends. Director B was asked if residents walked near the physician's parking space (near the visitor fall site), and she stated she did not like them to walk there but if they asked to walk around the entire building (which included walking in the parking lot), Director B stated, We would take them.
During a telephone interview on 10/20/22 at 11:01 a.m., Physical Therapy Assistant C (PTA C) stated his job duties included assisting residents with Ambulation Goals (Physical Therapy targeting improvement of ambulation/walking). PTA C stated residents who had Ambulation Goals as part of their therapy program, were assisted by Physical Therapy staff with walking. PTA C stated twenty-five residents currently received Physical Therapy services at the facility, and north of (more than) 80% of them (approximately twenty residents) had Ambulation goals (indicating they walked with Physical Therapy staff).
During the same telephone interview on 10/20/22 at 11:01 a.m., PTA C was asked where therapy staff took residents to ambulate. He stated PT staff walked residents inside and outside the building, and the location could depend on the resident's goals and the type of terrain (stretch of land, especially its physical features) needed to achieve those goals. PTA C stated indoor terrain (inside the facility) provided a more even surface for walking. He stated outdoor terrain had some smooth pavement but also had bumpy and rough surfaces (for more challenging walking surfaces). He stated, We have a parking lot that is bumpy, and areas outside with rougher asphalt. When asked what he would do if he encountered a tripping hazard with a resident, PTA C stated, We would navigate away from it. PTA C stated the facility had had tripping hazards in the parking lot in the past. PTA C stated, if the tripping hazard needed to be fixed, he would report it to Director A and stated they were good about fixing issues. When asked if he was aware of any (outside) tripping hazards that needed repair lately, PTA C stated, No.
During a telephone interview on 10/20/22 at 11:29 a.m., the Director of Plant Management (Director A) was asked about the uneven, three-to-four-inch-deep drop in pavement located in the parking lot. Director A stated the facility had fixed the concrete (in the parking lot) in 2012, and at some point the, concrete shifted. Director A stated the shifting concrete caused a, lip to occur. When asked when the lip occurred, Director A stated it was, more than a couple of months (ago), but less than, a year. When asked why the lip had not been repaired if the facility was aware of its existence for at least a couple of months, Director A stated the facility had identified the hazard and had purchased asphalt to repair it, but the visitor had tripped and fallen over the site before he fixed it.
During the same telephone interview on 10/20/22 at 11:29 a.m., Director A was asked about the repair work he had done on the uneven pavement after the visitor fall on 10/17/22. Director A stated he used the asphalt the facility had onsite to make the repair (a patch). When asked if the asphalt patch was a cold patch (filling a pothole with asphalt material without heating it), Director A stated the repair was a cold patch and confirmed it was a temporary fix. He stated he could grind down the cement to create a permanent fix, but he did not have a cement grinder. Director A stated the facility was working on a permanent fix, and he would need to consult with the corporate owners (regarding the permanent fix).
During the same telephone interview on 10/20/22 at 11:29 a.m., Director A was asked if he was aware of any other visitors falling in the parking lot in the past years. Director A stated he was working at the facility (years ago) when a visitor had fallen in the parking lot and broken her wrist. Director A stated that past fall (resulting in the broken wrist) was not related to the cement, lip, but was due to a, loose bolt on metal in the driveway, which was removed after the fall.
During a telephone interview on 10/20/22 at 3:34 p.m., the Director of Nursing (DON) was asked if she was aware residents ambulated in the parking lot, and she stated, Yes she was aware. The DON stated residents usually used the sidewalk (adjacent to the parking lot) and walked along the fence; she stated they did not usually walk where the cars parked. The DON stated residents were, mostly supervised, and stated one wheelchair-bound resident independently went outside and wheeled around. The DON stated residents went outside and looked at the flowers, used the sidewalk area, and did not wheel around the driveway.
During the same telephone interview on 10/20/22 at 3:34 p.m., the DON was asked to provide a list of residents whose Physical Therapy included ambulation goals and walking around the facility.
Review of multiple resident medical records (provided by the DON) titled, Physical Therapy, subtitled, PT Recert, Progress Report & Updated Therapy Plan, indicated approximately fourteen residents currently had Ambulation Goals as part of their Physical Therapy treatment program. Residents 25, 144, 27, 17, 29, 34, 55, 16, 8, 36, 28, 9, 39, and Resident 56 each had documented ambulation goals ranging from 10 - 200 feet of walking around the facility.
Review of facility policy titled, Nursing, subtitled, Resident Assessment, subtitled, Fall Management System, further subtitled, Standard (undated) indicated, This facility is committed to .providing an environment that remains as free of accident hazards as possible .
Policy and procedures for Environment and for Safety were requested from facility leadership; the requested policies and procedures were not provided during the survey.
CONCERN
(D)
Potential for Harm - no one hurt, but risky conditions existed
Deficiency F0802
(Tag F0802)
Could have caused harm · This affected 1 resident
Based on observation, interview, and record review, one of two sampled Diet Aides was not able to verbalize or demonstrate how to properly test the chemical strength of the sanitation bucket in the ki...
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Based on observation, interview, and record review, one of two sampled Diet Aides was not able to verbalize or demonstrate how to properly test the chemical strength of the sanitation bucket in the kitchen. This failure had the potential for this Diet Aide not to have the correct concentration and would potentially result in ineffective sanitization of food service equipment.
Findings:
During an observation and concurrent interview on 10/18/22 at 3 PM, Diet Aide H was scooping ice cream. Upon completion of the task, Diet Aide H was asked to describe how surfaces were sanitized. Diet Aide H could not verbalize or demonstrate proper test procedure. The Director of Food Services (DFS) intervened and assisted Diet Aide H to find the correct measuring strips. Diet Aide H stuck the test strip in the solution in the red bucket for 10 seconds, read the strip on the back of the bottle of test strips, which showed Test 400.
During a review of the department document titled, Verification of Job Competency-Cooks, dated 9/2/22, for Diet Aide H, it showed she was able to verbalize sanitizing solution; test concentration and record results and when to replace the solution. The competency was signed/verified by the Director of Food Services (DFS).
During a review of the Job Description for Dietary Aides, not dated, indicated to assist in daily or scheduled cleaning duties, in accordance with established policies and procedures.
CONCERN
(D)
Potential for Harm - no one hurt, but risky conditions existed
Deficiency F0805
(Tag F0805)
Could have caused harm · This affected 1 resident
Based on observation, interview and record review, the facility failed to puree two food items per the recipe. This failure caused one puree item not to hold its shape and the other to taste grainy.
F...
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Based on observation, interview and record review, the facility failed to puree two food items per the recipe. This failure caused one puree item not to hold its shape and the other to taste grainy.
Findings:
The International Dysphagia Diet Standardization (IDDSI) Framework July 2019, provides a common terminology to describe food textures. Foods are measured from Levels 3 - 7.
Level 4 Pureed
Usually eaten with a spoon (a fork is possible) o Cannot be drunk from a cup because it does not flow easily o Cannot be sucked through a straw o Does not require chewing o Should be smooth and can be piped, layered or molded because it retains its shape, but should not require chewing if presented in this form o No lumps o Not sticky o Liquid must not separate from solid. Cohesive enough to hold its shape on a spoon.
During a tray line observation on 10/17/22 at 11:40 AM, [NAME] E was pureeing meatballs. [NAME] E stated he could add chicken broth or beef broth if he needed to. He pureed just the meatballs with nothing added.
A taste test was conducted, based on surveyor observation of pureed food production practices, on 10/17/22 at 12:36 PM, and the pureed meatball did not hold its shape. The pureed meatball looked like ground beef and fell apart in the surveyor's mouth. It tasted like ground meat. The DFS tasted the pureed meatball and stated, It is crumbly because it didn't have any gravy. The DFS confirmed the meatball was crumbly.
A test tray, in the presence of the Director of Food Service (DFS), was conducted on 10/18/22 at 8:33 AM, based on resident concerns. The test tray included an evaluation of pureed items. It was noted the pureed eggs tasted grainy and bland.
Review of the Recipe: Pureed Meats, not dated, indicated the [NAME] should puree on low speed to a paste consistency before adding any liquid. Gradually add warm liquid (low sodium broth or gravy). Starting with the smaller amount and adding more as needed to achieve the desired consistency. Puree should reach a consistency slightly softer than whipped topping.
During a review of the Recipe: Pureed Eggs, not dated, indicated the [NAME] should puree on low speed to a paste consistency before adding any liquid. Gradually add warm milk. Starting with the smaller amount and adding in more as needed to achieve the desired consistency. Puree should reach a consistency slightly softer than whipped topping.
CONCERN
(E)
Potential for Harm - no one hurt, but risky conditions existed
Pharmacy Services
(Tag F0755)
Could have caused harm · This affected multiple residents
Based on observations, interviews, and record reviews, the facility failed to provide pharmaceutical services to meet the needs of each resident when:
1. The facility pharmacist failed to identify a r...
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Based on observations, interviews, and record reviews, the facility failed to provide pharmaceutical services to meet the needs of each resident when:
1. The facility pharmacist failed to identify a risk for a potential medication administration error for one resident, Resident 144. The medication label on a controlled medication, Hydromorphone (Hydromorphone is used as a pain reliever. Hydromorphone is two to eight times more potent than morphine but shorter duration and greater sedation), was not the indication for use as written by Resident 144's physician. This failure had the potential to result in ineffective pain management or overdosing that could adversely affect the health and safety of Resident 144; and,
2. The facility failed to implement a system to consistently and accurately reconcile its inventory of Fentanyl Transdermal Patches (a potent opioid pain medication that is given and absorbed through the skin), which had the potential to result in medication diversion going unnoticed for an extended amount of time.
Findings:
1. During a review of Resident 144's, Order Summary Report, dated 10/21/22, at 10:54 a.m., the report indicated Resident 144 had medical diagnoses that included Secondary Malignant Neoplasm of Bone (Secondary bone cancer refers to a cancer that has started in another part of the body and has spread (metastasized) to the bone via the bloodstream or lymph nodes). The report indicated Resident 144's Physician wrote an order for Hydromorphone HCL (Hydrochloride) 4 mg, give 1 tablet by mouth every four hours as needed for Moderate Pain and Hydromorphone HCL 1.5 tablets (6 mg) by mouth every four hours as needed for Severe Pain.
During an observation on 10/19/22, at 11:32 a.m., inside Resident 144's room, Resident 144 was sitting in his wheelchair, and a physical therapist came in to get him ready for Physical Therapy. Resident 144 screamed in pain as he was getting repositioned in his wheelchair.
During a review of Resident 144's, Care Plan, for pain, the care plan indicated Resident 144 had pain related to left total knee replacement and left femur (thigh bone) replacement on 8/1/22. The care plan indicated Resident 144 had a history of cancer that metastasized to his left femur. The goal for the care plan was Resident 144 would not have an interruption in normal activities due to pain. The care plan indicated one of the interventions was to follow the pain scale and to medicate as ordered. Another intervention on the care plan indicated, Serious, life threatening, or fatal respiratory depression may occur with the use of Hydromorphone. Monitor for respiratory depression, especially during initiation of hydromorphone or following a dose increase.
During a concurrent observation and interview on 10/20/22, at 3:58 p.m., with Licensed Staff O, a blister pack (A blister pack is a form of tamper-evident packaging where an individual pushes individually sealed tablets through the foil in order to take the medication) for Resident 144's Hydromorphone HCL 4 mg tablets, indicated on the label, take 1(4 mg) to 1.5 (6 mg) tablets by mouth every 4 hours as needed for pain. It was shown to Licensed Staff O that the medication label did not indicate when to give 1 tablet or 1.5 tablets. Licensed Staff O was asked, when she would administer 1 tablet and when would she administer 1.5 tablets, because it was not specified on the label. Licensed Staff O stated she would ask Resident 144, and if his pain was moderate (level 4-6), she would administer 1 tablet and give 1.5 tablets if Resident 144's pain was severe (level 7-10). The blister pack for the Hydrocodone HCL had a written warning that this medication was an opioid: (Opioids are a class of drugs that include the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription). Risk of overdose and addiction.
During a review of Resident 144's, Medication Administration Record (MAR) for October 2022, the MAR indicated, Resident 144 was being monitored for pain every shift, pain level 0 was no pain, 1-3 was mild pain, 4-6 was moderate pain, and 7-10 was severe pain. On 10/11/22, at 11 p.m., Licensed Staff P assessed Resident 144's pain level at 6, moderate pain, and he was administered Hydromorphone HCL 1.5 tablets (6mg). On 10/18/22, at 7 p.m., Resident 144's pain level was 5, moderate pain, Licensed Staff P administered Hydromorphone HCL 1.5 tablets (6mg). The Physician's Order on the Order Summary Report, transcribed to the MAR, indicated Hydromorphone HCL 4 mg, 1.5 tablets (6mg) would be administered as needed every 4 hours for severe pain, not for moderate pain. On 10/11/22, at 3:54 p.m., Resident 144's pain level was assessed at 7, severe pain, Licensed Staff P administered Hydromorphone HCL 1 tablet (4mg). On 10/14/22, at 12:37 p.m., Resident 144's pain level was assessed at an 8, Licensed Staff Q administered Hydromorphone HCL 1 tablet (4mg). The MAR indicated, if Resident 144's pain was severe, per Physician's Order, he should have received Hydromorphone HCL 1.5 tablets (6mg).
During an interview on 10/21/22, at 11:31 a.m., with the facility Pharmacist, she stated she had reviewed Resident 144's medication regimen and was not concerned about how the label was written for Hydromorphone.
During a review of the, Consultation Report, dated 10/10/22, by the facility Pharmacist, the report indicated, Based upon the information available at the time of the review, and assuming the accuracy and completeness of such information, it is my judgement that at such time, the resident's medication contained no new irregularities.
During an interview on 10/21/22, at 11:49 a.m., with the Director of Nursing (DON), the DON stated she was not concerned about the medication label for Hydromorphone. The DON stated Resident 144 had a pain monitoring scale on the MAR and that was what the nurses followed in assessing Resident 144 for his pain.
During a concurrent observation and interview on 10/21/22, at 5:01 p.m., with Resident 144 was lying in bed, in his hospital gown. When Resident 144 was asked how he was feeling that day, he stated he may need to be transferred to the hospital because he was not tolerating his Physical Therapy. When asked if he got his pain medication when he needed it, he stated he got them but sometimes it helped with the pain and sometimes it did not.
A facility document titled, LTC (Long Term Care) Facility's Pharmacy Services and Procedures Manual, dated 4/5/19, indicated, Facility should request that Pharmacy perform a routine nursing unit inspection for each station in facility to assist facility in complying with its obligations pursuant to applicable law relating to the proper storage, labeling, security, and accountability of medications and biologicals.
2. Controlled Medications, are substances that have an accepted medical use (medications which fall under US Drug Enforcement Agency (DEA) Schedules II-V), have a potential for abuse, ranging from low to high, and may also lead to physical or psychological dependence.
Disposition, is the process of returning and/or destroying unused medications.
Diversion of medications, is the transfer of a controlled substance or other medication from a lawful to an unlawful channel of distribution or use, as adapted from the Uniform Controlled Substances Act.
During a Medication Administration Cart (Med Cart) inspection and concurrent interview with Licensed Nurse M (LN M), on 10/17/22, at 12:51 p.m., there was a drawer in the cart that had a separate lock which required a key in order to access the drawer. LN M stated controlled medications were stored in the double locked drawer. LN M unlocked the drawer and pulled the drawer open for inspection. In the drawer were two boxes with labels indicating they contained fentanyl transdermal patches. The prescription label on the boxes indicated an old patch would be removed and replaced every 72 hours. LN M stated she was the nurse normally responsible for applying and removing the patches. LN M was asked to describe, in detail, the steps taken from administration to eventual discontinuance of the medication.
During an interview with LN M, on 10/17/22, at 12:55 p.m., she described the facility process of handling used fentanyl patches. LN M stated she wore gloves and removed the old patch from the resident. LN M stated she folded the old patch to ensure both sticky sides were touching each other. LN M stated she put the folded patch into a thick plastic sleeve used to hold tablets that needed to be crushed. LN M stated she took the sleeve and smashed it with the pill crusher. LN M stated she put the plastic sleeve into the sharps container attached to her Medication Administration Cart (Med Cart). LN M stated that was the entire process for used fentanyl patches. LN M confirmed she carried out this procedure by herself every 72 hours. LN M stated there was no documentation requirement for this process. LN M stated she remembered a different process that required a second nurse as a witness and a signature page for used patches, but that process had not been used in a very long time.
During an interview, on 10/19/22, at 2:10 p.m., with the Pharmacist Consultant (PC), she stated the facility had a new policy for Fentanyl Patches that had gone into effect this year. The PC stated used Fentanyl patches did not require any documentation and could be thrown in the regular trash bin on the Med Cart. When asked to provide a professional reference for her statement, the PC stated she would get back with the information.
During an interview, on 10/20/22, at 3 p.m., with the Director of Nursing (DON), she stated she was responsible for medication disposition in the facility. The DON stated medication that was no longer needed should be removed from the Med Cart. The DON stated the facility expectation for controlled medication was to remove the medication and the corresponding Drug Count Sheet from the Med Cart and pass them to the DON for storage prior to destruction. The DON stated she and the Pharmacist Consultant (PC) reviewed all controlled medications and documentation at least once a month to destroy the controlled medications.
During an interview, on 10/20/22, at 3:05 p.m., with the DON, she stated the facility had a procedure in place all Licensed Nurses were expected to follow if a controlled medication was removed from its packaging and not given to the resident. The DON stated the medication needed to be wasted. The DON stated two Licensed Nurses had to verify the controlled medication was removed and sign the Drug Count Sheet with the phrase, wasted. The DON stated the medication was disposed of into a container designed to store pills safely until they could be destroyed.
During an interview, on 10/20/22, at 3:10 p.m., with the DON, she stated the facility had a procedure for the disposal of used Fentanyl Patches. The DON stated the Licensed Nurse was expected to fold the used patch so that the sticky sides adhered to each other. The DON stated the patch would be put into a plastic sleeve, and the sleeve would be crushed with the pill crusher. The DON stated the plastic sleeve was disposed of into the sharps container on the Med Cart. The DON confirmed there was no Drug Count Sheet to document or monitor the disposal of used Fentanyl patches. The DON confirmed the facility did not require a second Licensed Nurse to witness the disposal of the used Fentanyl patch. When asked how did she know the used patches were going into the sharps container and not being diverted into someone's pocket, the DON stated she did not know.
During a review of the facility policy and procedure titled, 3.12 Prescribing, Administration and Disposal of Fentanyl Transdermal Systems, dated 1/22, the policy indicated this was a new policy for the facility and would be in effect 4/1/22. The policy indicated, 14. Fentanyl Disposal: Used transdermal system should be folded so that the adhesive side of the system adheres to itself, or per applicable state or local regulations.
14.1. Dispose in trash receptacle on cart in such a way to restrict access by staff, residents and visitors. Remove trash receptacle immediately after each medication pass, or
14.2. Make the patch unusable by mixing the folded patch with an undesirable substance such as kitty litter or wet coffee grounds and place in trash, or
14.3. Place folded patch in commercially available disposal kit and dispose per package directions, or
14.4. Store used and unwanted systems securely until facility ships to a DEA approved reverse distributor or
14.5. Place used and unwanted systems in a DEA approved mail-back program and ship
via U.S. Mail
NOTE: Fentanyl patches are not biohazard waste. Fentanyl patches are not considered hazardous pharmaceutical waste by the U.S. EPA.
15. Any unused systems should be removed from their pouch folded so that the adhesive side of the system adheres to itself before disposal/destruction.
16. Facility staff should routinely reconcile the inventory of fentanyl transdermal systems by comparing the countdown sheets, to the number of systems on hand, to medication administration records.
A document request was made for the professional guidance used to create the new policy titled, 3.12 Prescribing, Administration and Disposal of Fentanyl Transdermal Systems, dated 1/22. At the time of exit no documentation was provided.
During a review of the Food and Drug Administration's (FDA) recommendations titled, Safe Medicine Disposal Options, reviewed on 11/10/22, indicated the disposal method for used medication patches. The recommendation indicated, To dispose of a drug patch, carefully remove it by the edges and avoid touching the used medicine pad; then fold the patch in half, sticky sides together . Fentanyl patches should be flushed immediately.
During a review of the document titled, Federal Register Vol. 79, No. 174, dated 9/9/14, the Rules and Regulations section indicated clarification was needed for the proper procedures of dealing with transdermal patches in an institutional setting. The document indicated after administration, if some of the medication was left on the transdermal patch but could not be further utilized; such remaining substance must be properly recorded, stored, and destroyed in accordance with Drug Enforcement Administration (DEA) regulations and all applicable Federal, State, tribal, and local laws.
During a review of the Code of Federal Regulations (CFR) Title 21 Chapter II titled, Drug Enforcement Administration, Department of Justice, last updated 10/25/22, indicated part 1317 Disposal contained Subpart C Destruction of Controlled Substances which included section 1317.95 Destruction Procedures. This section indicated the destruction of any controlled substance shall be in accordance with the following requirements, (d) If the controlled substances are destroyed at a registrant's registered location utilizing an on-site method of destruction, the following procedures shall be followed:
(1) Two employees of the registrant shall handle or observe the handling of any controlled substance until the substance is rendered non-retrievable; and
(2) Two employees of the registrant shall personally witness the destruction of the controlled substance until it is rendered non-retrievable.
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 implement its medication labeling and medication storage policies and procedures, when:
1. One vial and two boxes of medicat...
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Based on observation, interview, and record review, the facility failed to implement its medication labeling and medication storage policies and procedures, when:
1. One vial and two boxes of medication, which had no prescription labels attached to them, were found among the active supply (current prescription) of medications in the Medication Storage Refrigerator. This failure had the potential to result in administration of the wrong medication to the wrong resident; and,
2. Three liquid medications, which had been previously opened, did not have a label to indicate the date opened and/or any changes to the medication use-by date. These failures had the potential to result in administration of deteriorated medications and increased risk for ineffective treatments, resulting in residents' lower quality of life.
Findings:
1. During a Medication Storage Room inspection and concurrent interview with the Infection Prevention Nurse (IP), on 10/17/22, at 10:48 a.m., the IP stated the refrigerator inside the Medication Storage Room was used to store temperature-sensitive medications. The IP opened the refrigerator door, inside the refrigerator there were several blue plastic bins filled with insulin pens, boxes, bags, and vials of various medications.
During a Medication Storage Room inspection and concurrent interview with the IP, on 10/17/22, at 10:53 a.m., inside the Medication Storage Refrigerator there was a glass vial with a green label. The IP read the label on the vial and stated the medication was Levemir (a man-made long-acting insulin used to control high blood sugar in adults and children with diabetes) for injection, 100 U/mL 10 ml total volume. The label on the vial indicated the medication expired 3/21/24. The vial had no prescription information attached to it. The vial had no indication of who's medication it was. The IP stated she was not sure who was prescribed the vial she was holding. There were several other insulins located in the refrigerator, the vials were all secured inside a cardboard box package. The cardboard box outer packaging had prescription stickers attached to them. The IP stated she did not know why the vial was stored with no prescription information.
During a Medication Storage Room inspection and concurrent interview with the IP, on 10/17/22, at 10:56 a.m., inside the Medication Storage Refrigerator there were two white boxes, approximately 3 inches by 3 inches by 1 inch tall. The IP read the label on the boxes, and stated the medication was Genotropin (an injectable form of human growth hormone important for the growth of bones and muscles). There was no prescription information on either box. The IP stated she would have to look through the Medication Administration Reports (MAR) to figure out whose medication it was.
During a review of the facility policy and procedure titled, Storage and Expiration Dating of Medications, Biological, last revised on 7/21/22, the policy indicated the facility should destroy and reorder medications and biologicals with soiled, illegible, worn, makeshift, incomplete, damaged or missing labels.
2. During a Medication Administration Cart (Med Cart) inspection and concurrent interview with Licensed Nurse M (LN M), on 10/17/22, at 12:41 p.m., there was one open bottle of liquid Gabapentin (a medication approved to prevent and control partial seizures, relieve postherpetic neuralgia after shingles and moderate-to-severe restless legs syndrome) in the cart. LN M inspected the label on the bottle, and stated there was no open date documented on the bottle. LN M stated the only date on the bottle was the expiration date on the manufacturer's label
During a review of the medication insert titled, Package Leaflet: Patient information, last revised 5/19, the document indicated Gabapentin had specific storage instructions. The document indicated the medication should be discarded 30 days after opening.
During a Med Cart inspection and concurrent interview with LN M, on 10/17/22, at 12:43 p.m., there was one open bottle of liquid Metoclopramide Hydrochloride Solution (a medication used to treat certain conditions of the stomach and intestines) in the cart. The label on the bottle indicated the medication expired on 9/23. LN M read the label, and stated there was no open date on the bottle. LN M stated the medication was good until 9/1/2023.
During a review of the medication insert titled, Package Leaflet: Patient information, last revised 5/22, the document indicated Metoclopramide Hydrochloride Solution had specific storage instructions. The document indicated the medication should be used within one month of opening the bottle.
During a Med Cart inspection and concurrent interview with LN M, on 10/17/22, at 12:44 p.m., there was one open bottle of liquid Valproic Acid (used to treat seizure disorders, mental/mood conditions, and to prevent migraine headaches. The medication works by restoring the balance of certain neurotransmitters (natural substances) in the brain) in the cart. The label on the bottle indicated the medication expired on 4/24. LN M read the label, and stated there was no open date on the bottle. LN M stated the medication was good until 4/1/2024.
During a review of the medication insert titled, Package Leaflet: Patient information, last revised 1/22, the document indicated liquid Valproic Acid had specific storage instructions. The document indicated after first opening, discard any unused medication after 50 days.
During a review of the facility policy and procedure titled, Storage and Expiration Dating of Medications, Biological, last revised on 7/21/22, the policy indicated once any medication or biological package was opened, the facility should follow manufacturer/supplier guidelines with respect to expiration dates for opened medications. The policy indicated the facility staff should record the date opened on the primary medication container (vial, bottle, inhaler) when the medication had a shortened expiration date once opened or opened.
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 follow food safety requirements during food prep and food storage, when:
1. The facility stored flour in the bag it was delive...
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Based on observation, interview and record review, the facility failed to follow food safety requirements during food prep and food storage, when:
1. The facility stored flour in the bag it was delivered in, opened in a plastic tub;
2. One Cook, [NAME] E, was not wearing a beard cover for two days;
3. The North nursing unit resident refrigerator contained 15 expired Nutritional supplements; and,
4. The South nursing unit resident refrigerator contained an employee lunch bag in the freezer and an unlabeled/undated pink water pitcher.
These failures put residents at risk for consuming food prepared with contaminated flour, hairs falling into resident food, risk for consuming expired nutritional supplements, which could lead to dyspepsia (Dyspepsia is another word for indigestion. People with indigestion often report feelings of stomach pain, over-fullness and bloating during and after eating. Other common symptoms include acid reflux, heartburn, and excessive burping), as well as infection control concerns.
Findings:
1. During a tour of the dry storage on 10/17/22 at 10:35 AM, flour, still in the bag it was delivered in, was opened and stored inside plastic tub with a id. In a concurrent interview, the DFS (Director of Food Services) confirmed the bag was the original shipping bag which would not have been protected from dirt or dust during transportation.
The facility policy and procedure titled, Storage of Food and Supplies, dated 2020, indicated in item #6. Dry bulk foods (flour, sugar, dry beans, food thickener, spices, etc.) should be stored in seamless metal or plastic containers with tight covers, or in bins which are easily sanitized.
2. During a kitchen tour on 10/17/22 at 10:05 AM, [NAME] E was wearing a surgical mask which did not cover the hairs on his neck.
During a kitchen tour on 10/18/22 at 9:46 AM, [NAME] E was again wearing a surgical mask which did not cover the hairs on his neck.
During an observation and interview with the DFS on 10/19/22 at 2:30 PM, it was noted there was a sign on the kitchen door displaying a picture and indicating hair covering was mandatory. When the DFS was asked about the expectation, relative to beard covers related to [NAME] E, she stated, It is usually covered with a mask.
The facility policy and procedure titled, Dress Code for Dietary Staff, not dated, indicated,
Purpose: Appropriate dress in the Food and Nutrition Department; under Clothing: 7. [NAME] cover for facial hair, if applicable.
3. During a review of the resident refrigerator on the South side nurses' station on 10/19/22 at 8:51 AM, there were 15 expired nutritional supplements in the refrigerator. This was verified with Licensed nurse L on duty.
4. During a review of the resident refrigerator on the North side on 10/19/22 at 10:30 AM, the freezer contained a black canvas bag labeled, nurse. Inside was a foil wrapped food. There was no name or date on the bag. In addition, a pink water pitcher, with no name or date, was located in the freezer. The refrigerator and freezer were not clean.
During an interview with Licensed Nurse M on 10/19/22 at 10:34 AM, when shown the nurse's bag and water pitcher in the freezer, she stated, That is not mine. That is a water pitcher we give residents water. I don't know why it is in there. It is the kitchen who stocks the refrigerator.
During an interview with the DFS on 10/19/22 at 11 AM, when shown the nurse's bag and the water pitcher, she stated, It is not the kitchen's responsibility to clean the refrigerator, it is housekeeping.
During an interview with Director A on 10/19/22 at 11:15 AM, he stated he was aware of what the surveyor found, his staff was cleaning the refrigerator now, and the housekeeping staff were to wipe down the refrigerator daily.
The facility policy and procedure titled, Food for Residents From Outside Sources, dated 2018, indicated: Prepared foods, beverages, or perishable food that requires refrigeration, can be stored for the resident in the facility kitchen, nursing station refrigerator or in the residents' personal refrigerator. In the food service department, the policy on food storage will apply. Otherwise, if unopened, refrigerated, or frozen items will be disposed of by the expiration date on the container.