Finding Description
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview, and record review, the facility failed to ensure residents were free of significant medication errors for 2 of 2 residents (Resident #7 and #51) reviewed for medication errors.
The facility failed to administer Resident #7's IV (intravenous) antibiotics as ordered by the physician on [DATE], [DATE] (two doses), [DATE], and [DATE].
An Immediate Jeopardy (IJ) was identified on [DATE] at 3:23 p.m. While the IJ was lowered on [DATE] at 11:22 p.m., the facility remained out of compliance at a severity level of no actual harm with a scope of pattern, due to the facility's need to evaluate the effectiveness of their corrective actions.
The facility failed to ensure nursing staff administered Resident #51's Insulin Glargine as ordered by the physician. LVN N failed to administer Resident #51's Insulin Glargine 7 times during a 2-month review period, per physician order. RN F failed to administer Resident #51's Insulin Glargine 4 times during a 2-month review period, per physician order. LVN D failed to administer Resident #51's Insulin Glargine 1 time during a 2-month review period, per physician order. LVN M failed to administer Resident #51's Insulin Glargine 1 time during a 2-month review period, per physician order.
These failures placed residents at risk of relapse of an ongoing infection and developing a secondary infection, and at risk of diabetic complications.
Findings include:
Resident #7
Record review of Resident #7's face sheet dated [DATE] revealed [AGE] year-old female originally admitted on [DATE] with most recent readmission on date [DATE]. Resident #7's diagnoses included: encounter for surgical aftercare following surgery on the skin and subcutaneous tissue (surgery involving skin and below skin tissue), presence of left artificial knee joint (previous left knee surgery), encounter for removal of internal fixation device (surgery revision), methicillin resistant staphylococcus aureus infection (antibiotic resistant infection), and pain.
Record review of Resident #7's quarterly MDS assessment dated [DATE] revealed: BIMS score of 13 which indicated cognition was intact. Further review of the MDS Section O Special Treatments, Procedures, and Programs revealed resident received IV medication.
Record review of Resident #7's care plan dated [DATE] revealed resident had right chest central line and was at risk for infection, pain, infiltration, cardiac, and respiratory issues. The goal was for Resident #7 to be free from infections, infiltration, and adverse effects. The facility staff approach included for staff to assess IV site q shift and prn. Further review of care plan revealed Resident #7 had post-surgical history of infection. The goal was for Resident #7's infection to be cleared by the target date and for complications related to the infection. The facility staff approach included staff will administer medications as ordered, monitor lab work as ordered and report results to physician.
Resident #7's electronic physician orders dated [DATE] revealed: meropenem 1 gram to be administered IV every 8 hours for diagnosis of infection and inflammatory reaction due to internal left knee prosthesis (left artificial knee infection).
Record review of Resident #7's electronic MAR for the months of [DATE] and [DATE] revealed meropenem had been administered:
1.
[DATE] at 4:00 p.m. by LVN A
2.
[DATE] at 8:00 a.m. by LVN A
3.
[DATE] at 4:00 p.m. by LVN A
4.
[DATE] at 12:00 a.m. by LVN A
5.
[DATE] at 8:00 p.m. by LVN A
Record review of Resident #7's lab results dated [DATE] revealed WBC was 7.97 (acceptable range between 4.0 - 11.0), ESR was 37 (acceptable range between 0 - 30), and CRP was 0.4 (acceptable range between 0.0 - 0.6).
Record review of Resident #7's lab results dated [DATE] revealed WBC was 11.42 (acceptable range between 4.0 - 11.0) indicated infection, ESR was 30 (acceptable range between 4.0 - 11.0), and CRP was 0.6 (acceptable range between 0.0 - 0.6).
Record review of Resident #7's hospital discharge paperwork dated [DATE] revealed a progress note from the IDP revealed she had original left total knee arthroplasty (surgical procedure in which parts of a damaged joint are removed and replaced) (in 2007, followed by revision in February 2020, then followed by two subsequent incision and drainage procedures in 2020. In [DATE], she underwent explant (removal of surgical hardware) of left knee arthroplasty and spacer placement. On [DATE] she underwent revision of left total knee arthroplasty. The plan was to continue meropenem (antibiotic medication), follow up on cultures, six weeks of antibiotic with end of treatment [DATE], monitor labs, supportive care, and placement of tunneled catheter ordered. Discharge planning included meropenem 1 gram every 8 hours with end date [DATE]. Patient to follow up in the ID (Infectious Disease) clinic in 3 weeks. Check lab CBC (a blood test that measures red blood cell count, white blood cell count and platelet count), CMP (a blood test that measures the body's fluid balance, electrolytes like sodium and potassium, and how well the kidneys and liver are working), ESR (a blood test that measures the level of inflammation in the body), CRP (a blood test that can measure a protein produced by the liver in response to inflammation or infection in the body) while on IV antibiotics. Provide central line dressing weekly and prn.
During an observation and interview on [DATE] at 10:49 a.m., Resident #7 had IV bag of 100 mL of NS infusing into right chest double lumen central line. On the medication bag there were instructions to *ACTIVATE VIAL PRIOR TO USE*. In the vial white powder (meropenem 1 gram) was observed and was dry. No date and time were written on IV tubing or on IV bag and it was being infused at 100 mL/hr using IV pump. There was approximately 25 mL left of NS in bag. The central line dressing loose, pulled away from skin toward bottom of the dressing, was not sealed to maintain sterile environment and moved when Resident #7 lifted shirt. Resident #7 stated she did not know when the dressing had been changed last. She stated she did not remember if facility staff had ever changed out the dressing. Date observed on central line dressing to be [DATE].
During an interview on [DATE] at 11:14 a.m., the DON stated the powdered medication in vial should have been activated by popping the seal from IV bag to powdered vial, then mixing into the solution in IV bag prior to medication being administered. She stated she had personally checked off LVN A on IV medication administration and did not know why she failed to mix medication into the bag. She stated that sometimes the pharmacy would send already mixed medication in solution and LVN A may have thought it was already mixed. She stated not mixing medication meant that resident did not get antibiotic as ordered and she had instructed LVN A to call physician to notify of missed dose. The DON stated she monitored IV medication was given correctly.
During an interview on [DATE] at 11:21 a.m., LVN A stated she had administered IV medication that morning. She stated she hung medication with new tubing but did not label tubing with date or time. She stated the central line dressing should be intact and tight to skin. She stated she would change the central line dressing. LVN A stated loose central line dressing could cause resident to have infection and should be sealed. She stated she did not mix up the medication from vial into IV bag because it was coming premixed, and she thought medication was in the bag without her having to mix it. She stated not mixing the medication meant that resident did not get antibiotic dose.
During an interview on [DATE] at 12:28 p.m., the Pharmacy Director with contracted pharmacy the facility used stated the pharmacy record showed as long as the pharmacy had been filling meropenem (antibiotic) medication to Resident #7, the facility had received medication in a snap together vial. He stated typically it was an insurance issue on how the medication was filled. He stated the pharmacy had written instructions on the bag label to activate vial prior to use but no separate instructions were sent to the facility. He stated the effect of facility staff not activating vial would interfere with mixing the medication and no antibiotic would have been infused if it was not activated prior to infusion. He stated the effect on the resident would be she would have gotten hydration with a little bit of sodium, and it would not have harmed her. He stated whatever the medication in the vial was prescribed to treat, would not have been treated and could have interfered with wound healing if Resident #7 missed doses.
During a follow up interview on [DATE] at 02:49 p.m., the DON stated IV Certificate education should include management of the IV access site including central lines, and administration of IV medication including how to prepare medication. The DON stated IV Certification education was provided outside of the facility, but the curriculum matched what the contracted pharmacy had in their training. She stated no other residents in the facility had IV medication ordered currently that had to be activated prior to administration currently. The DON stated she talked to the nurse that was responsible for changing the central line dressing on [DATE]. She stated LVN B told her the central line dressing was not changed by LVN B due to there was a treatment nurse that day and LVN B assumed the treatment nurse would change the dressing. The DON stated she expected the nurses signing the MAR to verify that all treatments had been performed prior to leaving for the day and LVN B had been in-serviced on that. She stated Resident #7's wound had been healing and the surgeon had been pleased with the progress. She stated Resident #7 continued to have a wound vac in place and no impaired healing had been observed. The DON stated the facility reached out to Resident #7's attending physician that prescribed medication to notify her of the delayed meropenem dose and the facility was awaiting response. She stated the Medical Director of facility had been informed of delayed meropenem dose and new order obtained for medication dose to be rescheduled for 1300, 2100, and 0500 because of the medication error earlier.
During a follow up interview at [DATE] at 03:30 p.m., LVN A stated it had been over a year ago when she was certified on IV medication and that she would assume that the IV Certification went over mixing IV medication. LVN A stated in the last month and a half she had been floating and working in different areas and times. She stated she usually did not work on the hall Resident #7 resided on and she had filled in 2 nights shifts on that hall. She stated she did notice the central line dressing was loose prior to administering IV meropenem medication that morning but had not noticed the date on the dressing. She stated the central line dressing was not secured to the skin and she had planned to change the dressing after medication had been administered. She stated central line dressing being loose could cause site infection. She stated she had administered meropenem to Resident #7 previously and medication had been delivered premixed with no need to activate the vial. She stated she did not feel that any negative outcome occurred to the resident from central line dressing not being changed or medication error. She stated she had called the Medical Director when she could not get ahold of the ordering physician, and a new order was received to administer another dose at 1:00 pm so that Resident #7 did not miss a dose, and then retime medication every 8 hours after the 1:00 p.m. dose.
During a phone interview on [DATE] at 04:32 p.m., the Medical Director stated he expected staff to follow pharmacy instructions when administering medications. He stated that he was not familiar with the specifics of IV medication that had snap together vials but that he expected nurses to be trained on how to prepare medications that were being administered. The MD stated the effect of not getting meropenem as ordered for sepsis or infection may aggravate the infection and could have caused a flare up from the infection or relapse of an ongoing infection. He stated he assumed the nurses and the ADON, and the DON were who monitored medication was given as directed. He stated he was notified that medication was delayed and he did give directions to give medication and readjust every 8 hours with new time so that medication would not be missed. He expected IV tubing to be changed per protocol and not changing tubing could lead to secondary infection. He stated he expected tubing and medication bag to be labeled with a date because staff will get busy and may forget when bag / tubing was hung. He stated he expected central line dressings to be changed every 7 days per protocol and that it would be changed if dressing was compromised. He expected that dressing be secured to the skin and not changing could lead to secondary infection and insertion site infection risk.
During an attempted telephone interview on [DATE] at 10:25 a.m., the Attending Physician did not answer the phone. Left message with office staff to please have her return phone call. The Attending Physician did not return call.
During an attempted phone interview on [DATE] at 10:48 a.m., LVN D did not answer the phone and a message to return the call was left. The LVN D did not return call.
During an attempted phone interview on [DATE] at 10:51 a.m., LVN B did not answer the phone and there was no option to leave a voice message.
During a phone interview on [DATE] at 10:54 a.m., LVN C stated he had worked for the facility on and off for the last 3 years. He stated that if medication came with instructions to activate vial prior to use, there was a blue stem that needed to be snapped to break the seal. LVN C stated after seal broken then he would get NS into vial and mix with powdered medication. He stated the mixed liquid and medication in the vial would be drained back into IV bag prior to being administer. He stated he did not remember any of Resident #7's IV medication being delivered to facility pre-mixed, but the pharmacy had done that in the past for other residents. He stated when medication is pre-mixed, it is time sensitive so medication would only be delivered in lesser amounts. He stated he had not noticed medication not being prepared per instructions. He stated if medications were not mixed prior to administration, the effect on the resident would be that they only received hydration. He stated central line dressings should be changed once a week and as needed. He stated central line dressing would need to be changed if it was loose and could become looser with clothing changes. He stated the effect of not changing central line dressings every 7 days or as needed is hard to determine because if the dressings were still sealed, he believed the port of entry would not be exposed in some cases, but it could lead to skin breakdown from skin not being allowed to breath. He stated he had not changed the central line dressing and that if he had signed that he had performed it was signed in error. He stated he would sign off on task in MAR prior to performing task and would have made his best effort to perform the task. He stated the error may have been due to there are a lot of distractions in the facility and may have forgotten to perform. He felt that the facility had enough staff and was not shorthanded. He stated that distractions resulted from him trying to make himself available to all residents and would be approached routinely by residents even if they were not assigned to him and he would attempt to help them.
During an interview on [DATE] at 11:15 a.m., LVN F stated she had worked at the facility for a little over a year. LVN F stated she had IV medication training prior to working at the facility and had a refresher on [DATE]. She stated if the medication label stated activate vial prior to use that meant the nurse must break seal then mix with the saline prior to IV administration. She stated Resident #7's IV medication had never come from pharmacy pre-mixed. LVN F stated she had not had any concerns about other nursing staff related to administering IV medication administration. She stated that not activating vial prior to medication administration could cause Resident #7 to not get medication, her wound may not have healed quickly, or the infection to become worse. She stated the central line dressing should be replaced every 72 hours. She stated nurses should change the central line dressing if dressing was loose, and not changing as ordered or as needed could cause infection. She stated nurses should document treatment performed in MAR after the nurse had completed the treatment.
During a phone interview on [DATE] at 11:18 a.m., RN E stated that she was the nurse at the IDP's office. She stated her expectation would be for central line dressing changes to occur every 7 days or prn for any soiled, loose, wet dressings. She stated loose meant that insertion cite was exposed by clear part of dressing becoming compromised. She stated the central line dressing site should be monitored every shift. RN E stated the effect of not changing the central line dressing routinely and as needed would cause highly increased risk for central line infection in the blood stream. She stated IDP was using meropenem to treat an active infection and she expected IV antibiotics to be administered per physician's orders. She stated IDP should be notified when IV antibiotics were missed, or medication was delayed, and she had not received any notification from the facility of the medication error. She stated the effect of missing or delaying doses of meropenem could cause Resident #7's active diagnosis to be not treated properly, delayed healing, cause the infection to worsen, and risk hurting the resident. Could also cause prolonged antibiotic treatment, rehospitalization, and incision site failure. RN E stated she was unsure if missing antibiotic doses would cause any risk for surgery hardware failure. She stated the failure of not administering antibiotics as ordered could expose residents to extended treatments. RN E stated she had made two attempts to contact facility requesting lab results as IDP ordered lab CBC w/Diff (a blood test that measures red blood cell count, white blood cell count and platelet count), CMP (a blood test that measures the body's fluid balance, electrolytes like sodium and potassium, and how well the kidneys and liver are working), ESR (a blood test that measures the level of inflammation in the body), CRP (a blood test that can measure a protein produced by the liver in response to inflammation or infection in the body) labs to be drawn weekly on Monday while on IV therapy. At that time, she stated she had not received any lab results from the facility and as a result IDP planned on drawing labs in their office during post hospitalization visit.
During a follow up interview on [DATE] at 2:49 p.m., the DON stated the only labs that the facility had drawn from Resident #7 were done on [DATE]. She stated the facility had gotten a call from IDP office requesting labs on [DATE] and she did not know that labs had not been performed. She stated the facility should have drawn labs as ordered and the order would have been found on hospital discharge paperwork. She was unsure how often the order was for at that time. She stated the facility would be drawing labs when resident returned from physicians' visits in another town and would send results to IDP office. She stated it was her expectation that documentation in EMR be done after treatment had been performed. She stated she did not know why nurses had documented without performing the treatment. She stated nurses should not document something another nurse had stated they had performed. She stated the effect on the resident could be missed treatments. She stated that she monitors treatments are done by running EMR reports that would show when treatment had been missed and observing staff perform treatments.
During an interview on [DATE] at 2:51 p.m., LVN B stated she had worked for the facility for 3 years in [DATE]. She stated she had received IV antibiotic medication administration training. LVN B stated when an IV was labeled activate prior to use and it was the antibiotic that Resident #7 used, the nurse should have snapped the connection from IV bag to vial, squeezed solution from IV bag into vial and mixed with powder, then with bag upside down squeezed bag to allow mixed solution into IV bag to prepare medication prior to it being infused. She stated she had not remembered seeing any premixed medication in the facility for Resident #7 after her most recent hospitalization. LVN B stated she had not had any concerns about other nursing staff not activating IV medication, but she would usually be the nurse who started medication dose in the morning with fresh tubing, so night nurse would not leave empty medication bag for her to observe. She stated tubing should be changed every 24 hours. She stated when new IV tubing was used then it should have a date, time, and nurses initial on it so that other staff know when it was first used. She stated missing IV antibiotic dose could cause Resident #7 to have longer healing time and would be considered a medication error. She was unsure what policy stated about central line dressing frequency but stated that it should be changed as ordered and prn when dressing was loose. LVN B stated not changing central line dressing when ordered or needed could cause another type of infection and significant problems by leaving area open for bacteria to get into insertion site. She stated she worked on [DATE] and she did sign that central line dressing had been changed since the facility had a RN performing treatments that day and she thought the RN changed the dressing. She stated usually the RN treatment nurse would let her know treatment had been performed and she would sign that it had been completed. She stated that she should have verified by observing central line dressing had been changed and did not remember why she did not verify it prior to signing that it was completed in MAR. She stated she had been in-serviced about central line dressings yesterday on changing dressing per orders and verifying treatment done prior to checking off it had been performed. She stated she should not check off treatments she had not performed.
During a follow up interview on [DATE] at 3:00 PM, the DON stated there were no labs drawn for Resident #7 since being discharged from the hospital and admitted into facility. She stated she expected the nurse to look at the EMAR to know when the lab was ordered and that if a nurse signed off the EMAR that lab was collected after procedure had been performed. She stated the nurse should send lab to the hospital if they signed off that lab was collected. She stated the order revealed labs were to be drawn by an RN as it was to be drawn from central line and should have been done weekly. The DON stated it was her as DON that did the lab trackers and with the nurses being flagged in the EMAR to alert them to draw the labs. She stated there would be potential harm to the resident based off of her labs not being drawn, which could have caused the resident to have become septic.
During a telephone interview on [DATE] at 3:26 p.m., LVN D stated she had worked for the facility for four or five years. She stated she had completed IV class but did not remember the date of original training, but the DON had a copy of certification. She stated she had received more training in IV administration on [DATE]. LVN D stated when an IV was labeled activate prior to use the seal needed to be broken and medication in vial mixed with solution from IV bag prior to administration. She stated the pharmacy had only delivered IV antibiotic medication that needed to be activated for Resident #7 since her most recent surgery. She stated she had no concerns about other nursing staff not mixing antibiotic medication prior to administering. She stated the effect of not mixing IV antibiotic could cause resident to not to get medication that she needed, and medication would not help whatever Resident #7 receiving medication for. She stated she believed the central line dressing needed to be changed every 7 days but would have to look at facility policy to verify that information. She stated the central line dressing would need to be changed if it had become loose, soiled, or damaged to prevent infection by bacteria getting under the dressing. She stated she assessed the dressing every time she administered IV medication and at least once a shift. LVN D stated she only documents completion of treatment in MAR when she completed the treatment that was ordered.
During an attempted telephone interview on [DATE] at 3:52 p.m., Resident #7's emergency family member could not be reached with directions. The phone number dialed was not a working number.
During a follow-up interview on [DATE] at 4:04 p.m., the DON stated Resident #7 was back from the ID physician's appointment and orthopedic surgeon's appointment. She provided paperwork the facility had received from ID physician's appointment but stated orthopedic surgeon did not send any additional paperwork from office visit. She stated that she was not sure why a new order from ID physician for PO antibiotic after IV antibiotic was completed. She stated Resident #7 was alert and more than likely would be able to answer basic questions about office visits. The DON stated she had started the afternoon dose of IV meropenem when the resident returned to facility after she had drawn blood from central line for lab work.
During a follow up observation and interview on [DATE] at 4:09 p.m., Resident #7 sat in wheelchair in her room with an immobilizing brace on her left leg. IV pump on and alarm beeped with IV tubing connected to her central line. A staff member entered the room and informed the resident that she had notified the nurse of the pump alarm, and she was not allowed to touch the pump. IV meropenem had been pre-mixed prior to infusion and tubing labeled with paper tape. Resident #7 stated that she had a plastic surgeon appointment scheduled for [DATE] and that appointment was made prior to her ID physician and orthopedic surgeon's appointments. She stated she did not know why ID had ordered oral antibiotic in addition to IV antibiotic. Resident #7 stated that the orthopedic surgeon did not think that the wound vac had been healing her left knee surgical wound and that was why she was scheduled to see plastic surgeon tomorrow to discuss surgical options. She stated she was nervous about having another surgery since she almost died during the last surgery. The call light was in reach.
Record review of summary of infectious disease physicians visit dated [DATE] revealed: Complete IV antibiotic on 6/20 as scheduled and we will send orders to remove PICC line. Start Levaquin 500mg PO daily on 6/21. Follow up with orthopedic surgeon in 6 weeks .next appointment [DATE].
During a follow up interview on [DATE] at 11:12 a.m., the DON stated she did not think that increased WBC lab value on [DATE] had anything due to IV antibiotic administration and stated there was no way of proving Resident #7 had any missed doses just the delayed dose on 6/10. She stated she thought the WBC lab could have been related to Resident #7's emotional distress on [DATE] or how the DON drew the lab. The DON stated that she may have drawn lab too quickly and she believed that may have affected lab value. She stated the facility faxed over lab results to IDP office and she would call and speak with RN E at the clinic to see how IDP interpreted the lab results. She stated at that time she had no information on how IDP had interpreted the lab value. She stated that she had spoken to the orthopedic surgeon's office who stated oral antibiotic daily after IV antibiotic would need to be administered for the remainder of resident's life. She stated she was told that the antibiotic may change to different antibiotic medication, but the resident would need treatment for the rest of her life.
During a follow up interview on [DATE] at 03:12 p.m., Resident #7 stated she was seen by plastic surgeon for her left knee wound. She stated during the plastic surgeon's appointment, she was told the surgeon recommended a skin graft and if the graft did not work then they wanted to amputate. She said that she did not want an amputation.
During an attempted telephone interview on [DATE] 11:23 a.m. with the MD, the MD did not answer and a message to return call was left.
During an attempted telephone interview on [DATE] 11:23 a.m. with the IDP nurse, RN E, RN E did not answer and a message to return call was left.
During an interview on [DATE] at 08:13 p.m., the ADMN stated he expected staff to not sign off on treatments unless they verified the treatment was done. He stated staff should not sign off on treatments prior to performing them. The ADMN stated that he expected dressings to be looked at to verify the date on the dressing and assess the site. He stated he felt the failure occurred due to staff becoming busy and had intention of performing but then forgot. The ADMN stated ADON monitors that treatments are performed, and DON was who monitored also. He stated the effect of not performing treatments could lead to infection.
Record review of LVN A's certificate titled Texas IV Therapy Certification dated [DATE] revealed LVN A completed 14 contact hours of the course.
Record review of LVN A's skills check off titled Medication Administration dated [DATE] revealed no evidence of activating vial on snap vial system had been performed.
Record review of LVN A's skills check off titled Medication Administration dated [DATE] revealed no evidence of activating vial on snap vial system had been performed.
Record review of facility policy titled Lab and Diagnostic Results - Clinical Protocol revised on [DATE] revealed: The physician will identify and order diagnostic and lab testing based on diagnostic and monitoring needs. The staff will process test requisitions and arrange for tests. The laboratory, diagnostic radiology provider, or other testing source will report test results to the facility.
Record review of facility policy titled Administration of IV Fluids and Medications Reconstituting and Adding Medications to an IV Bag dated 2011 revealed: Reconstituting and adding medications to an IV bag will be done by the professional nurse with documented IV education, as designated by the facility, and as allowed by state regulations. IV medication that is supplied in powdered form must be reconstituted prior to adding it to the IV bag. The nurse who administers the medication will be the same nurse who reconstituted the medication. The nurse reconstituting a medication must be aware of drug stability issues and administer the dose within the appropriate time frame. Consult with the IV pharmacist as needed. After reconstituting and adding medication to an IV bag the infusion must be started within one hour .Label IV bag with resident's name, medication added, dose, rate of infusion, date, time, and initials. Administer and document.
Record review of facility policy titled Dressing Change for Vascular Access Devices dated 2011 revealed: Central venous access device and midline dressing changes will be done at established intervals and [TRUNCATED]