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Based on interview, record review and policy review, the hospital failed to adequately analyze the causes and implement actions as part of their Quality Assurance and Performance Improvement (QAPI, process for reporting and/or identifying adverse events, near misses or review of high risk, problem prone areas for patient safety) program, to prevent potential diversion and misuse of controlled substances. These failures had the potential to adversely affect the quality of care, safety and care outcomes of all patients in the hospital. The hospital census was 16.

The severity and cumulative effects of these systemic practices resulted in the hospital's non-compliance with 42 CFR 482.21 Condition of Participation: QAPI Program and resulted in the hospital's failure to ensure quality health care and safety.

Based on observation, interview, record review and policy review, the hospital failed to ensure the following:
- There was an effective wound care and prevention program that would prevent new or worsening wounds from occurring. (A-0395)
- Staff knew how to correctly perform sterile dressing changes. (A-0398)
- Staff performed patient monitoring for patient's who received infusions of medications. (A-0410)
- Staff correctly entered telephone orders from physicians. (A-0410)

These practices resulted in a systemic failure and noncompliance with 42 CFR 482.23 Condition of Participation: Nursing Services. The hospital census was 16.

Please see A-0395, A-0398 and A-0410 for additional information.

Based on observation, interview, record review and policy review, the hospital failed to:
- Ensure the pharmacy department was competently supervised. (A-0492)
- Identify and investigate possible diversion of controlled substances (drugs or medication that are high risk for personal consumption or abuse) in a timely fashion. (A-0494)
- Ensure controlled substances were locked within a secured area. (A-0503)
- Ensure that controlled substance losses were investigated and reported to proper agencies when drugs were found missing on five separate occasions. (A-0509)
- Provide up-to-date reference material on drug therapy in hard copy format for instances when intranet format was unavailable. (A-0510)

These practices resulted in a systemic failure and noncompliance with 42 CFR 482.25 Condition of Participation (CoP): Pharmaceutical Services.

The hospital census was 16.

The Severity and cumulative effect of these practices had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ). On 01/20/22, after the survey team informed the hospital of the IJ, staff created educational tools and began to educate all staff and put interventions into place to protect the patients.

As of 01/21/22, at the time of the survey exit, the hospital had provided an immediate action plan sufficient to remove the IJ by implementing the following:
- Education to all nursing staff on discrepancy resolution, controlled substance medication removal, administration and wastage.
- Education to all nursing staff on controlled substance diversion.
- The Chief Clinical Officer (CCO) or designee will conduct audits on 100% of all controlled substances on 100% of patients that are on controlled substances to ensure compliance with the physician's order and documentation on the patient's electronic medication administration record (EMAR).
- Pharmacy will audit controlled substances of 100% of patients daily that have an order on their medication profile by reviewing the Medication Dispensary reports, specifically the returns and wastes report, the all device events report, the all discrepancy report and the undocumented waste report. The Pharmacy staff will compare and review the patients' medication report and original order from the electronic medical record.
- If anything is identified on the undocumented waste report for controlled substances not being wasted appropriately, the Director of Pharmacy (DOP) will immediately contact the CCO to follow up with the identified nursing staff to re-educate on the process and an incident report will be completed and submitted to the Director of Quality Management (DQM).
- Upon discovery of any unresolved discrepancies, the DOP or pharmacist staff will document findings on an incident report and notify the CCO and DQM.
- The Regional Pharmacist will have oversight on a daily basis with the DOP to ensure that all reports have been ran and that all controlled substances have been reviewed and any identified issues or discrepancies have been immediately resolved and followed up on.
- The DOP and all pharmacy staff will be educated on controlled substance oversight and the DOP will be educated on job responsibilities and accountability.

Based on interview, record review and policy review, the hospital failed to adequately analyze the causes and implement actions to prevent potential diversion and misuse of controlled substances by two employees (Staff U and Staff V) for seven incident reports that included two current patients (#6 and #13) and five discharged patients (#17, #20, #27, #28 and #31). This failure had the potential to put all patients at risk for sub-standard quality of health care and adverse outcomes. The hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Patient Safety Risk Management Plan," dated 10/2020, showed that the patient safety risk management goals are to continuously improve patient safety and minimize and/or prevent the occurrence of errors, events and system breakdowns leading to harm to patients, staff and visitors through proactive risk management and patient safety activities. The patient safety and risk management functional responsibilities included the following:
- Developing systems for and overseeing the reporting of adverse events, near misses and potentially unsafe conditions.
- Ensuring the collection and analysis of data to monitor the performance of processes that involve risk or that may result in serious safety events (SSE).
- Overseeing the organizational incident reporting process for data collection and processing, information analysis and generation of statistical trend reports for the identification and monitoring of SSE's.
-Analyzing data collected on SSE, near misses and potentially unsafe conditions. Providing feedback to providers and staff and using this data to facilitate system improvements to reduce the probability of future occurrence.
- Facilitating and ensuring the implementation of patient safety initiatives and provider and staff participation in education programs on patient safety and risk management.

Review of the hospital's policy titled, "Incident Reporting," revised 04/06/21, showed the following:
- The objective of incident reporting was to ensure immediate management of an incident when required and that every incident is appropriately prioritized, investigated and managed, and to mitigate risk and prevent future incidents through development of appropriate action plans, recommendations and ongoing review.
- In the event of a reportable incident, the employee will notify risk management within 24 to 48 hours of the event either in person, by telephone or through completing an incident report.
- All incident reporting and completion of the incident report needs to be completed before the end of the employee's shift.
- Investigate all incidents that involve equipment, power, utility failures, infectious or hazardous exposures, security problems or unsafe conditions, and report all findings and outcomes to the Director of Quality, Risk Management.
- The department management will thoroughly investigate all incidents for their areas immediately upon receipt of the incident and document their findings on the incident report in the designated area on the form.
- The Director of Quality Management (DQM) will review all investigations and collaborate with the department management to ensure that all investigations are handled appropriately and timely.

Review of the hospital's document titled, "All Device Events Report," dated 08/24/21 through 08/25/21, showed that Staff U, Registered Nurse (RN), did not remove fentanyl (controlled substance, a medication used to treat severe pain, and is a high risk drug for theft and personal use) or any other medication for Patient #20 from the medication dispensary on 08/24/21, however wasted five doses of fentanyl for Patient #20.

Review of an incident report dated 08/24/21, showed that Staff U, RN, between the hours of 12:19 AM and 5:11 AM, wasted five doses of fentanyl for Patient #20. There was no investigation into why the doses were wasted or where the wasted doses of fentanyl came from.

Review of an incident report dated 10/05/21, showed that Staff U, RN, removed 100 micrograms (mcg, unit of measure) of fentanyl for Patient #17 without a physician's order, did not scan the medication during administration, and did not document that she administered the medication to the patient. Attached to the incident report was a verbal warning for Staff U, which showed that Staff U stated she received a verbal order for the fentanyl from a physician, however, there was no indication that a follow-up occurred with the ordering physician to ensure what Staff U reported was verified, as part of the hospital's investigation of the incident.

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that on 11/15/21 Staff V, RN, removed a vial of fentanyl for Patient #13 at 8:20 AM, 1:57 PM and 5:50 PM. Staff V documented partial administration of the vials of fentanyl to Patient #13 on 11/15/21 at 8:03 AM, 10:37 AM and 4:00 PM. Staff V wasted partial vials that were not administered on 11/16/21 at 8:04 AM (the following day). There was one partial vial of fentanyl that was unaccounted for.

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that on 11/15/21 Staff V, removed a vial of fentanyl for Patient #31 at 6:07 PM. Staff V documented she administered a partial vial of fentanyl to Patient #31 at 6:07 PM, and did not waste what was not administered until the following day, approximately 14 hours later.

Review of an incident report dated 11/25/21, showed that Staff V, RN, removed a vial of dilaudid (medication used to treat severe pain) for Patient #27 at 4:39 PM and 4:43 PM, but only documented that one dose was administered at 4:43 PM. There was no investigation documented on the incident report related to why the second dose of dilaudid was not documented as administered, or wasted.

Review of an incident report dated 11/26/21, showed that Staff V, RN, removed doses of dilaudid for Patient #27 at 6:30 AM and 1:50 PM, and did not document the administration. Staff V was not assigned to care for Patient #27 that day and Staff K, RN, who was assigned to Patient #27, documented the doses were administered. There was no investigation documented on the incident report.

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that from 11/24/21 through 11/26/21, there were 17 vials of dilaudid removed from the medication dispensary for Patient #27, eight doses were documented as administered, and nine were unaccounted for. Of the nine doses unaccounted for, Staff V was responsible for eight of them.

Review of an incident report dated 11/28/21, showed that Patient #6 complained that he did not receive his pain medications, and that he did not want Staff V to continue to provide his care. The patient's medication administration record was compared to the medication dispensary's report, and showed that Staff V documented she administered the patient's pain medication 24 minutes before she removed it from the medication dispensary. Investigation of the incident showed that Staff V's medication dispensary activity had been audited by Staff AA, Pharmacy Director, to ensure the medications she removed were administered, and that nursing leadership and human resources were investigating Staff V for inappropriate behavior. Pharmacy reports attached to the incident report, indicated that on 11/28/21 between 3:38 AM and 7:48 PM, Staff V removed three vials of fentanyl, 100 mcg per two milliliters (ml, units of measure) for a total of 300 mcg, however, wasted seven doses of 75 mcg each (total amount wasted was 525 mcg, 225 mcg more than what was pulled to administer).

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that for Patient #6 on 11/29/21, there was one oxycodone 5 mg tablet that was unaccounted for, and from 11/27/21 through 11/28/21, 800 mcg of fentanyl were removed, 175 mcg were administered and 750 mcg were wasted, which created a discrepancy that could not have occurred.

Review of an incident report dated 12/04/21, showed that Staff V, RN, documented that she gave fentanyl 50 mcg and ativan (a medication that has a calming effect, used to treat anxiety or sleep difficulty) to Patient #28 with no physician's order for the medications. It was later noted that Staff V entered a telephone order at 7:44 PM for the medication. There was no investigation documented on the incident report.

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that from 12/04/21 through 12/05/21, Staff V removed nine vials of fentanyl and six vials of ativan for Patient #28, which resulted in two vials of fentanyl and one vial of ativan that were unaccounted for.

Review of an incident report dated 12/04/21, showed that two staff members found open needles, blood spots, and an empty narcotic "plastic sleeve" on the floor in the women's locker room at 6:30 PM. There were also rubber bands used to bind a tourniquet, as well as three caps to intravenous needles found (all items are potentially related to the injection of drugs). Additionally, four nurses reported that Staff V spent most of the day in the bathroom, and that they had concerns about Staff V's behavior. Investigation of the incident showed Staff A, Chief Clinical Officer, documented that her investigation conflicted with what the staff had reported, but that further investigation would be done with Human Resources and Staff V.

The hospital failed to thoroughly investigate each of these incidents, which resulted in continued discrepancies and possible diversion of controlled substances from 08/24/21 through 12/05/21. It was not until 01/19/22, when the survey team questioned the hospital regarding the discrepancies, did the hospital realize there were unaccounted controlled substances from these incident reports.

During an interview on 01/11/22 at 10:45 AM and 01/19/22 at 11:20 AM, Staff B, DQM, stated that prior to 11/2021, in-depth reviews and process improvements of adverse events and incident reports had not occurred. There was not a comprehensive incident report review between pharmacy and nursing, and it was not taken to the level of urgency it deserved.

During an interview on 01/20/22 at 1:56 PM, Staff C, Chief Executive Officer (CEO), stated that during the course of the survey, he was made aware that there were nine vials of dilaudid that were unaccounted for, over 800 unresolved medication discrepancies, and that the hospital had not implemented any new processes to prevent the possible diversion of controlled substances.









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29047

Based on observation, interview, record review and policy review, the hospital failed to have an effective wound care and prevention program that prevented new or worsening wounds from occurring for six current patients (#1, #3, #5, #6, #12 and #16), and one discharged patient (#21), of 11 patients with wounds reviewed. These failures had the potential to lead to poor outcomes for patients with wounds, and those at risk for skin breakdown. The hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Clinical Practice Guidelines," dated 07/17/17, showed that pictures of wounds would be taken upon admission during the patient admission assessment along with measurements and a full description.

Review of the hospital's policy titled, "Wound Care Scope of Services," dated 09/2020, showed the following:
- Wound prevention and care is an interdisciplinary approach between members of the patient care team which begins with a complete skin assessment upon admission with ongoing re-assessments.
- The wound care practitioner coordinates the skin and wound care program including patient management and ongoing treatment.
- Nursing completes a head to toe assessment and a comprehensive wound assessment within 24 hours of admission and then continues as part of the daily nursing shift assessment.

Review of the hospital's policy titled, "Negative Pressure Wound Therapy (NPWT)," dated 10/15/14, showed the following:
- Do not allow the NPWT to be off for more than two hours per day with the NPWT dressing in place.
- Most NPWT pressure ranges are between 60 and 125 millimeters of mercury (mmHg, refers to an amount of suction when related to wound therapy).
- Wound vacuum assisted closure (wound V.A.C., a device that decreases air pressure on a wound to help it heal more quickly) dressings, should be changed every 48 to 72 hours, but not less than three times per week as ordered by physician, for non-infected wounds.

2. Review of Patient #1's medical record from 12/29/21 through 01/13/22, showed the following:
- He was a 72 year old male admitted to the hospital on 12/29/21 for acute hypoxic respiratory failure (a condition where there is not enough oxygen reaching the tissues of the body caused by a failure of the respiratory system) due to COVID (highly contagious and sometimes fatal virus) pneumonia.
- He had a sacral shearing (injury to the skin caused by friction) wound noted prior to admission. The wound care team was consulted to help with management.
- On 12/30/21 at 12:30 PM, a wound care admission assessment was completed and the patient had two separate wounds noted; #1 Left Buttock and #2 Right buttock/gluteal fold (area where the skin of the buttock meets the leg). Two separate medication orders were placed for each wound to be changed every 48 hours. Wound pictures and measurements were obtained by the wound nurse.
- A physician order for wound #1 directed staff to cleanse with normal saline, apply skin prep around the wound, apply medihoney (medical grade honey, used in wounds to provide moisture and prevent infection) to the inside of the wound, cover with a non-adhering dressing, cover with an absorptive gauze, and change every 48 hours or as needed with soiling, saturation or unscheduled removal.
- A Physician order for wound #2 directed staff to cleanse with normal saline, apply skin prep around the wound, polymem (an absorptive dressing that helps to provide moisture to the wound bed, and contains silver to assist with infection) in gluteal fold, medihoney to the inside of the wound on the right buttock, cover with a non-adhering dressing, cover with an absorptive gauze, and change every 48 hours as in wound #1.
- On three days, there were no skin assessments documented on the night shift.
- On three days, showed the patient had two wounds, but were not labeled according to the admission wounds.
- On six days, the nursing assessment showed the patient had two wounds, but only documented on wound one.
- On 11 days, the nursing assessment showed the patient had one wound.
- On four days, the nursing assessment showed the patient's dressing was changed, but there was no description of the wound or type of dressing applied. One day showed the type of dressing applied but the dressing was not as ordered for the patient.

Review of Patient #3's medical record from 11/29/21 through 01/10/22, showed the following:
- He was a 38 year old male admitted to the hospital on 11/29/21 with a sacral (triangular shaped bone which lies above the tailbone) wound with a wound V.A.C. in place.
- The physician order dated 11/30/21, was for a wound V.A.C. to be placed on wound #2 - sacrum, with continuous therapy at 125 mmHg and puracol (a collagen based dressing with antibacterial properties to help with infection) to the wound bed, to be changed twice weekly. In the event that the wound V.A.C. had suction blockage, or failure beyond two hours, the nurses were to apply a wet to damp dressing and change it twice a day and as needed for soiling, saturation or unscheduled removal, until the wound nurse could follow up.
- Wound care practitioner documentation showed an assessment on 11/30/21 identifying wound #1 - left hip, a closed surgical incision that required gauze and a secondary bandage. The dressing was to be changed weekly and as needed. Wound #2 was the sacral wound and measured a length of 3.5 cm, a width of 3.5 cm and a depth of 1.0 cm.
- For five dressing changes, wound #1 was identified as the sacral wound.
- For seven dressing changes, there was no identifier for the sacral wound.
- For one dressing change, wound #1 was identified as the left buttocks.
- For five dressing changes, a dressing change was documented but there was no description of the type of dressing applied.
- On 12/07/21, a new wound was identified as wound #3 - right elbow. The wound care practitioner applied polymem to the wound and secured it with a secondary bandage. There was no physician's order for the dressing and no frequency indicated for dressing changes.
- The wound care practitioner changed wound #3's dressing on 12/07/21, it continued to be open at that time. There was no other documentation of wound #3 after 12/07/21 in the medical record.
- On 01/05/22, wound #2 - sacral wound, measured a length of 4.0 cm, a width of 2.3 cm, a depth of 1.8 cm, and had tunneling (a passageway underneath the surface of the skin) at the two o'clock position of 2.4 cm. The wound measured larger in both the width and depth and had tunneling which wasn't present on his admission.

Review of Patient #5's medical record from 12/02/21 through 01/10/22, showed the following:
- He was a 37 year old male admitted to the hospital on 12/02/21 with wounds to the right inside of the ankle, moisture associated dermatitis (inflammation of the skin) to his testicles, a wound on the left lumbar (lower back) area, and a wound on the left iliac crest (the curved area at the top border of the pelvic bone).
- The physician order dated 12/03/21, was for a wound V.A.C. to be placed on wound #4 - left lumbar, with continuous therapy at 125 mmHg and puracol to the inside of the wound, to be changed twice a week. In the event that the wound V.A.C. had suction blockage or failure beyond two hours, the nurses were to apply a wet to damp dressing and change it twice a day and as needed for soiling, saturation, or unscheduled removal until the wound nurse could follow up.
- Nursing documentation showed a wet to damp dressing was applied, but did not indicate why a wet to damp was placed, on seven days between 12/02/21 through 01/06/22, the dressing was only changed once per day.
- Nursing documentation showed a dressing change, but did not include the type of dressing the patient had in place for 12 days between 12/02/21 through 01/06/22.
- Nursing documentation was inconsistent with the wound number and location when they identified wound #1 as the right medial ankle on five dressing changes, the sacrum on six dressing changes, the right heel on one dressing change, the left hip on two dressing changes, the left distal (away from a specific area) gluteal (muscle in the buttocks) on one dressing change, the lumbar area on two dressing changes, the ischial tuberosity (the round bone that makes up the bottom of the pelvis) on one dressing change, and pressure red on one dressing change.
- Nursing documentation was inconsistent with the wound number and location when they identified wound #2 as the testicles on four dressing changes, the left iliac crest on one dressing change, and ankle on one dressing change.
- Nursing documentation was inconsistent with the wound number and location when they identified wound #3 as the left iliac crest on one dressing change, and the left lumbar area on four dressing changes.
- Nursing documentation was inconsistent with the wound number and location when they identified wound #4 as the iliac crest on four dressing changes, and the left lumbar area on one dressing change.
- Nursing documentation showed no wound identification number for five dressing changes.
- Nursing documentation showed no wound identification number or wound location on two dressing changes.
- From 12/15/21 until 01/06/22, wound #2 - testicles, wound #3 - left lumbar and wound #4 - left iliac crest had no documentation of an assessment or a dressing change, there was no idication as to why there was no assessment or dressing change.

Review of Patient #6's medical record from 10/14/21 through 01/06/22, showed the following:
- He was a 64 year old male admitted to the hospital on 10/14/21 with wounds to his buttocks.
- The admission history and physical indicated that the wound team would consult for his wounds.
- On 10/19/21, (five days after his admission), the wound nurse examined Patient #6 and identified two wounds, wound #1 - to his left sacral area and wound #2 - right sacral area. Neither wound required a wound V.A.C. at that time.
- On 10/27/21, the wound nurse put in an order for a wound V.A.C. to be placed to both wound #1 and wound #2, with continuous therapy at 125 mmHg, to be changed twice a week. In the event that the wound V.A.C. had suction blockage or failure beyond two hours, the nurses were to apply a wet to damp dressing and change it twice a day and as needed for soiling, saturation, or unscheduled removal, until the wound nurse could follow up.
- Nursing documentation showed a wet to damp dressing was applied, but did not indicate why, on four days from 10/27/21 through 01/10/22, and only changed once per day.
- On 11/08/21 Patient #6 developed a new wound, wound #4 - right chest tube site, when the physician removed a chest tube. The wound nurse put in an order for polymem to be placed in the wound and secured with a secondary bandage. The dressing was to be changed twice a week.
- There was no dressing change or wound assessment completed for wound #4 from 11/08/21 until 11/16/21, there was no idication in the medical record as to why the wound was not assessed and no dressing change was completed.
- On 11/19/21, Patient #6 developed a new wound, wound #5 - left chest tube site, when the physician removed a chest tube. The wound care practitioner put in an order for polymem to be placed in the wound bed and covered with a secondary bandage. There was no frequency for the dressing change. There was no physicians order for the dressing change.
- On 11/23/21 the wound care practitioner placed an order for wound #5 - left chest tube site to be changed every three days.
- On 11/30/21 and 12/03/21, nursing documentation by the wound care practitioner indicated that Patient #6 had a wet to damp dressing on his wound, but did not indicate which wound, and there was no documentation in the medical record to show when the wet to damp dressing had been applied.
- From 11/30/21 until 12/15/21, wound #5 - left chest tube site did not have a dressing change or assessment documented. On 12/15/21, documentation showed that wound #5 had green drainage, a culture was obtained, and the dressing change frequency was changed to three times per week.
- From 12/15/21 through 01/10/22, there was no documentation of an assessment or dressing change for wound #5 - left chest tube site.
- On his admission, Patient #6 had two separate wounds on his buttocks, and no bone was exposed. The last wound assessment documented on 01/07/22 showed that the wounds had joined becoming one wound, and bone was exposed.

Review of Patient #12's medical record from 01/07/22 through 01/13/22, showed the following:
- She was a 40 year old female admitted to the hospital on 01/07/22.
- The wound care team was consulted to help with management of wounds.
- On 01/07/22 at 9:52 PM, the wound care nurse assessed the patient and wound orders were placed for five wounds: #1 - Right anterior upper arm, change twice weekly or as needed; #2 - Right posterior upper arm, change twice weekly or as needed; #3 - Right pannus (abdominal fold), change non-adhering every other day or as needed; #4 - Abdominal midline (in the middle of), NPWT, to run continuously at 125 mmHg, change dressing twice weekly; #5 - Sacral, NPWT connected to #4, change dressing twice weekly.
- A picture was taken on 01/07/22 of Wound #6, right ischial, but no orders were placed until 01/10/22 for a dressing to be changed every three days.
- On four days, the nursing assessment showed the patient had five to six wounds, but they were not labeled according to the admission wounds.
- On two days, the nursing assessment showed the patient had eight wounds. The location was documented as other, multiple wounds. There was no description of wound locations.
- On one day, the nursing assessment showed the patient had five wounds with dressings and no other documentation.
- On one day, the nursing assessment showed the patient had six wounds with dressings and no other documentation.
- There was no documentation that showed Wound #3 - Pannus dressing was changed every other day as ordered.

Review of Patient #16's medical record from 01/06/22 through 01/20/22 showed the following:
- She was a 30 year old female admitted to the hospital on 01/06/22 with a wound to her abdomen, right pelvis and left pelvis.
- The wound care practitioner evaluated her on 01/07/22 and identified wound #1 - abdominal midline with orders for polymem to be placed in inside the wound and secured with a secondary bandage. The dressing was to be changed every 48 hours and as needed for soiling, saturation or unscheduled removal. Wound #2 - right pelvic and wound #3 - left pelvic, both had orders for polymem to the wound and secure with a secondary bandage. The dressing was to be changed every 72 hours and as needed.
- There was no documentation of an assessment or dressing change for wound #1- abdominal midline between 01/07/22 and 01/10/22, or between 01/10/22 through 01/14/22.
- Nursing staff identified each wound location differently on eight days of documented dressing changes.
- On 01/13/22, nursing documentation showed that Patient #16 had four wounds at 1:17 AM, and only two wounds at 5:38 PM.
- On 01/15/22, nursing documentation showed that Patient #16 had five wounds at 2:00 AM, and two wounds at 6:59 PM.

Review of an incident report dated 10/06/21, showed that Patient #21 had an order for interdry (a thin moisture wicking fabric with silver to prevent infection, most often used for skin folds) on 10/01/21, to be placed under her breast and changed daily to prevent skin breakdown. The incident report stated that only one nurse placed the interdry in five days, Patient #21 developed a fungal infection and skin breakdown under her left breast. Investigation of the incident showed that Staff Q, Nurse Practitioner (NP), discussed the issue with a Registered Nurse (RN) regarding the way orders were seen for interdry. The RN assigned to Patient #21 informed Staff Q, that the orders for interdry appear differently on the medication administration record (MAR).

Wound documentation was inconsistent with the wound identification number and wound locations, making it difficult for staff to determine when dressings had been changed, were due to be changed, and what type of dressings were to be applied. Documentation did not always include the type of dressing that was placed, so wound nurses were not aware when a wound V.A.C. patient had on a wet to damp dressing instead of NPWT. Wound assessments were not completed on every shift. Wound dressings were not applied to the correct wounds, per the order or frequency. These failures resulted in infected wounds, new wounds and wound deterioration.

During an interview on 01/13/22 at 9:55 AM, Staff A, CCO, stated that she would expect staff document what type of dressing was applied to the wound with a dressing change. Nursing staff were supposed to use a wound log book to communicate issues regarding wounds, with the wound care practitioner.

During an interview on 01/18/22 at 4:30 PM, Staff M, RN, stated the following:
- He numbered wounds whatever he wanted.
- He would typically look at the wound care practitioners documentation to keep the location consistent.
- When a patient had more than one wound, it was very difficult to determine when a dressing change was due.
- Nurses had to check the MAR to determine if a dressing change was needed.
- He was not aware of a wound log or communication book, but felt it was a good idea.

During an interview on 01/19/22 at 4:05 PM, Staff O, Licensed Practice Nurse (LPN), Wound Care Practitioner, stated the following:
- Nursing staff and physicians communicated with the wound care practitioners either through a verbal report, or by putting a note in the wound log book.
- If there were issues with wounds on the night shift, the nurses put a note in the wound log book so the wound care practitioners knew there was an issue.
- She did not number wounds.
- She was not aware of a policy for wound documentation.
- She agreed that not labeling wounds with the same numbers or names would be confusing for nurses.


39562

Based on observation, interview and policy review the hospital failed to ensure that contracted (agency) nursing staff (Staff K) were orientated and verified to be competent in the patient care they provided, and that the Chief Clinical Officer (CCO) fulfilled their responsibility to ensure that all nursing personnel knew the hospital's policies and procedures and adhered to them. This resulted in the contamination of a peripherally inserted central catheter (PICC line, a flexible tube inserted into an arm, leg or neck vein to infuse fluids, blood products, and medications, or to withdraw blood for testing) dressing change for one current patient (#1), which required a sterile procedure to prevent infection. There were 10 patients with PICC lines. The hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Clinical Practice Guidelines," dated 07/17/17, showed that PICC dressings will be changed using sterile technique and a central line dressing kit.

During an observation on 01/11/22 at 4:00 PM, Staff K, Agency Registered Nurse (RN), performed a dressing change for Patient #1 to his PICC line in his right upper arm. Staff K put on sterile gloves, and then touched Patient #1's skin (contaminating her sterile gloves) and removed the old dressing. Without changing into new sterile gloves, she cleaned the insertion site, then moved to the skin around the insertion site, then went back to clean the insertion site.

During an interview on 01/11/22 at 5:00 PM, Staff K, stated the following:
- She did not use sterile technique, but a PICC line dressing should be "as sterile as you could be."
- She did not touch the actual insertion site so it was fine.
- She did not receive any training for PICC line dressing changes.
- The contents of the sterile package for a PICC line dressing change were all new and she was not familiar with the contents.
- She would have liked for someone to show her how to perform a sterile PICC line dressing change.

During an interview on 01/13/22 at 9:55 AM, Staff A, CCO, stated the following:
- She expected nursing staff to be trained in sterile technique, and know how to change a PICC line dressing.
- Agency nurse competency was completed by the agency that assigned them.
- If the agency said that the staff were competent with PICC line dressing changes then she assumed that they were.
- Agency nurses had orientation on the patient floor for one day, and then were on their own.

Based on observation, interview, record review and policy review, the hospital failed to ensure safe patient monitoring of one patient (#1) of one patient on a Precedex (a sedative that can keep you asleep during surgery or other medical procedures) infusion, and to correctly enter a telephone order from a physician for one patient (#28). This had the potential to place all patients who receive a Precedex infusion at risk for adverse outcomes when vital signs were not monitored as indicated, and for patients to receive the correct medications when telephone orders were not properly entered. The hospital census was 16.

Findings included:

1. Review of the hospital's document titled, "Precedex Protocol," revised 10/12/21, showed the following:
- Indications were to provide sedation for ventilated patients.
- Must be ordered by the physician.
- Precedex drip is a high risk medication and must be mixed by the pharmacy.
- The patient must be on continuous cardiac monitoring while receiving a Precedex drip.
- Precedex has some analgesic effects, and pain medication may need to be reduced by 50 percent.
- Document vital signs at initiation, five minutes after initiation of therapy, every 15 minutes times four, every 30 minutes times four, then every hour for the duration of therapy.
- Monitor for decreased blood pressure, decreased heart rate and abnormal heart rhythm.

Review of Patient #1's medical record showed the following:
- He was a 72 year old male admitted to the hospital on 12/29/21 for acute hypoxic respiratory failure (a condition where there is not enough oxygen reaching the tissues of the body caused by a failure of the respiratory system) due to COVID (highly contagious and sometimes fatal virus) pneumonia.
- He had a tracheostomy (an opening created in the neck in order to place a tube into a person's windpipe that allows air to enter the lungs) placed on 12/20/21, he was on a ventilator (a machine that supports breathing) and was admitted for ventilator weaning.
- An order for continuous Precedex infusion was placed on 12/30/21 at 8:22 AM.
- On 12/30/21, vital signs were documented in the flowsheets at 10:32 AM, 11:38 AM, 2:58 PM, 6:00 PM (vital signs should be assessed and documented every hour for the duration of therapy, per policy).
- On 12/31/21, vital signs were documented in the flowsheets at midnight, 3:56 AM, 6:49 AM, 10:32 AM, 3:35 PM, 7:41 PM and 11:39 PM.
- On 01/01/22, vital signs were documented in the flowsheets at 2:00 AM, 10:33 AM, 2:30 PM and 8:00 PM.
- On 01/02/22, vital signs were documented in the flowsheets at midnight, 4:00 AM, 6:47 AM, 5:00 PM, 6:00 PM, 8:00 PM and 10:20 PM.
- On 01/03/22, vital signs were documented in the flowsheets at 6:05 AM, 8:04 AM, 9:03 AM, 10:10 AM, 12:21 PM, 2:14 PM, 4:25 PM, 6:18 PM and 11:57 PM.
- On 01/04/22, vital signs were documented in the flowsheets at 6:38 AM, 8:29 AM, 12:44 PM, 2:04 PM, 6:48 PM and 11:59 PM.
- On 01/05/22, vital signs were documented in the flowsheets at 3:05 AM and 6:51 AM.
- On 01/06/22, vital signs were documented in the flowsheets at 8:07 AM and 7:30 PM.
- On 01/07/22, vital signs were documented in the flowsheets at 10:17 AM, 3:19 PM, 5:08 PM and 11:49 PM.
- On 01/08/22, vital signs were documented in the flowsheets at 12:45 AM, 1:00 AM, 2:00 AM, 3:40 AM, 7:12 AM, 10:29 AM, 3:29 AM and 4:11 PM.
- On 01/09/22, vital signs were documented in the flowsheets at 7:07 AM, 10:36 AM, 12:26 PM and 2:32 PM.
- On 01/10/22, vital signs were documented in the flowsheets at 6:53 AM, 8:45 AM, 10:37 AM, 1:31 PM, 2:40 PM, 4:49 PM
- On 01/11/22, vital signs were documented in the flowsheets at 8:51 PM, 10:34 PM and 11:33 PM.
- On 01/12/22, vital signs were documented in the flowsheets at 3:23 AM, 7:29 PM and 11:32 PM.
- On 01/13/22, vital signs were documented in the flowsheets at 3:15 AM, 6:30 AM and 7:00 PM.

For 15 days, Patient #1's vital signs were not documented hourly as per policy.

During an interview on 01/10/22 at 4:00 PM, Staff G, Licensed Practical Nurse and Graduate Registered Nurse (RN), stated that when a patient was on a Precedex drip, vital signs should be monitored every hour to check for low blood pressure.

During an interview on 01/12/22 at 3:10 PM, Staff S, RN, stated that patients on a Precedex drip should have their blood pressure and level of consciousness checked every hour.

During an interview on 01/13/22 at 10:30 AM, Staff A, Chief Clinical Officer (CCO), stated that her expectation of nursing staff was to follow the Precedex protocol and document hourly blood pressures.

Review of Patient #28's medical record showed a telephone order for morphine (a medication used to treat moderate to severe pain, and is a high risk drug for theft and dependence) injectable 2 milligrams (mg, a measure of dosage strength) per milliliter (ml, a measurement of liquid) solution (this would indicate the medication was ordered as an intravenous [IV, in the vein] drip). With instruction to give 2 mg every 10 minutes as needed for pain (this would indicate that it be given as an IV push medication). The telephone order was requested by Staff V, RN, on 12/04/21 at 7:34 PM, and electronically signed by Staff NN, Physician, on 12/13/21 at 8:55 AM (nine days after the order was requested).

During an interview on 01/18/22 at 8:40 AM, Staff GG, Pharmacist, stated that an order for an IV drip medication be administered, with instructions as an IV push medication, was an incorrect telephone order.


41474

Based on observation, interview, record review and policy review, the hospital failed to ensure the Pharmacy Director competently supervised the pharmacy when:
- The Pharmacy Director was unaware that nine vials of dilaudid (medication used to treat severe pain), a controlled substance, were unaccounted for and had no process in place to accurately reconcile controlled substances.
- The Pharmacy Director failed to complete incident reports on events that pertained to diversion of controlled substances for five incidents that involved four patients (#13, #27, #28 and #31).
- The Pharmacy Director failed to resolve 885 discrepancies in the medication dispensary since 07/21/20.

These failures had the potential to put all patients at risk for sub-standard quality of health care and adverse outcomes. The hospital census was 16.

Findings included:

1. Review of the hospital's document titled, "Incident Reporting," dated 01/2020, showed the following:
- An incident was defined as an unusual event or circumstance not consistent with quality and safe patient care or hospital standards. This would include situations that may potentially or actually result in injury, harm, or loss to any patient, visitor, employee, or any event that resulted in damage or potential damage of hospital property, patient property or specified employee property.
- It is the responsibility of any employee who identifies or becomes aware of a potential or an actual problem, error, adverse outcome or injury to notify risk management within 24 hours of the event, unless after hours/weekends and to complete the incident report.
- Examples of events which require incident reporting include medication errors and any other incidents that are considered unusual or problematic.

Review of the hospital's document titled, "Job Description Standards of Performance/Evaluation Pharmacy Director," dated 01/2019, showed the following:
- The Director of the Pharmacy will implement policies and procedures that ensure the pharmacy department provides optimal pharmaceutical services that meet all legal, accreditation and certification requirements.
- The Director of Pharmacy will establish and maintain strict controls and accountability for all medications stored in the hospital and dispensed or administered to patients, including controlled and non-controlled medications.
- The Director of Pharmacy will ensure all wastage of controlled substances are in accordance with federal and state regulations.

During an interview on 01/20/21 at 8:45 AM, Staff GG, Pharmacist, stated the following:
- On 11/24/21, 11/25/21 and 11/26/21, there were a total of nine vials of dilaudid unaccounted for with Patient #27.
- Until asked on 01/19/22 to reconcile the medications, pharmacy staff were not aware that there were nine vials unaccounted for.
- The system for tracking controlled substances was not effective and could be improved.

Pharmacy staff were not aware of unaccounted medications until they were asked by the state agency on 01/19/22 to provide a record of the removal, administration and waste of controlled substances for Patient #27 on 11/24/21. Prior to being asked to show evidence of medication reconciliation for controlled substances, there was not a system in place that tracked medications from entry in the hospital to administration or waste.

Review of the hospital's document titled, "Wastes and Returns2," dated 11/17/21, an audit completed by Staff JJ, Pharmacy Technician, showed she had the following concerns regarding high risk medication wastes on 11/16/21:
- There were four doses of fentanyl (a medication used to treat severe pain, and is a high risk drug for theft and personal use) documented as wastes in the medication dispensary that appeared to be from doses given by Staff V, Registered Nurse (RN), on the day shift of 11/15/21 (the day before the wastes occurred).
- A waste of 75 micrograms (mcg, a measure of dosage strength) of fentanyl by Staff V, for Patient #13 on 11/16/21 at 8:04:23 AM.
- A waste of 75 mcg of fentanyl by Staff V, for Patient #13 on 11/16/21 at 8:04:43 AM.
- A waste of 50 mcg of fentanyl by Staff V, for Patient #31 on 11/16/21 at 8:20:06 AM.
- A waste of 50 mcg of fentanyl by Staff V, for Patient #31 on 11/16/21 at 8:21:29 AM.

There was no incident report completed for the waste of high risk medications the day after the drug was administered.

During an interview on 01/13/22 at 3:23 PM, Staff JJ, Pharmacy Technician, stated that nurses should not be allowed to waste controlled substances at the end of their shift, or be allowed to take the medication home and waste it the next day because the vial could contain something other than the remainder of the medication.

Review of the hospital's document titled, "Counseling and Problem Solving Record," dated 12/10/21, showed that Staff V was placed on suspension for the following:
- On 11/25/21, Staff V removed a dose of dilaudid for Patient #27 at 4:39 PM and 4:43 PM, but only documented one dose was administered at 4:43 PM.
- On 11/26/21, Staff V removed a dose of dilaudid for Patient #27 at 6:30 AM and 1:50 PM, and did not document that the doses were administered. The nurse who was assigned to the patient removed, administered a dose, and documented the same medication at 5:07 PM.
- On 12/04/21, Staff V gave fentanyl and ativan (a medication that has a calming effect, used to treat anxiety or sleep difficulty and is a high risk drug for theft and personal use) to Patient #28 at 6:50 PM, and did not have an order for it.

There were no incident reports completed for these medication discrepancies that resulted in Staff V being placed on suspension.

During an interview on 01/13/22 at 9:00 AM, Staff AA, Pharmacist, stated the following:
- She checked the waste log daily and kept a record of it.
- It was her responsibility to make sure nursing staff wasted doses at the end of their shift.
- The hospital policy was for nurses to waste medications as soon as they were removed from the medication dispensary, or as soon as it was administered.
- She was aware that nursing staff were giving medications, but not documenting them as being given, and that a patient could get too much medication as a result. There should be measures in place to prevent a patient from getting too much medication.
- There were no incident reports completed for the medication events related to Patient #13 and #31, when Staff V wasted narcotics the day after she worked. She verbally informed Staff A, Chief Clinical Officer (CCO), of the incident.
- There were no incident reports completed when Staff V removed two doses of dilaudid for Patient #27 and only administered one. She verbally informed Staff A of the incident.
- There was no incident report completed when Staff V removed and administered fentanyl and ativan to Patient #28 without a physician's order. She verbally informed Staff A of the incident.

2. Review of the hospital's policy titled, "Automation Discrepancies," dated 01/2019, showed that the pharmacy will ensure that all discrepancies are resolved promptly and accurately. Any controlled substance discrepancy discovered will be reported immediately to the nurse in charge. The pharmacy department will review the discrepancy log for valid explanations and for discrepancies which may require further investigation.

Observation and concurrent interview on 01/13/22 at 12:30 PM conducted in the hallway medication room, showed a medication dispensary. Staff K, RN, demonstrated how to remove a controlled substance from the medication dispensary. During this demonstration, a highlighted icon appeared on the machine, and through interview with Staff K, this indicated that there were medication discrepancies that needed to be resolved. Staff K stated that no one resolved discrepancies at end of their shift.

During a telephone interview on 01/13/22 at 12:35 PM, Staff AA, Pharmacy Director, stated that there were 885 unresolved discrepancies in the medication dispensary since 07/21/20. She had not informed hospital administration about this. Staff AA added that it was the nurse's responsibility to resolve the discrepancy.


39562

Based on review of the hospital's investigation, interview, personnel file and policy review, the hospital failed to identify and investigate possible diversion of a controlled substance in a timely fashion allowing diversion to continue by one staff member (Staff V). This failure had the potential to affect all patients, through misappropriation of patient medications and the potential for impaired patient care. The hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Controlled Drugs Administration," dated 10/2021, showed the following:
- Administration of designated controlled drugs should be recorded on a medication administration record (MAR), electronic MAR (eMAR) or a controlled substances administration record (CSAR). If using a medication dispensing machine, the removal will be recorded as a transaction.
- Electronic or manual records must include the date and time of administration to the patient or adjustment to stock, drug name, dose, strength, quantity of drug administered and or wasted, or quantity of drug issued/returned/and/or brought forward, signature of the person who administered the drug, signature of the witness to adjustment or destruction of wasted portion. Subtract the units administered from the previous balance and enter in the proper column. Entries should reflect the balance on hand.
- The disposition of the remainder of a controlled drug from an ampule, vial, or syringe must be documented.
- A pharmacist should randomly verify entries or transactions, and should include proof that a current, valid physician's order exists, comparison with patient records to ensure the amounts administered agree on all documents, and reconciliation of amount on hand with the balance on the record.
- Pharmacy should review a daily report of all controlled substance transactions and confirm all discrepancies have been resolved, overrides appropriate, documentation (including waste) complete.

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that on 11/15/21 Staff V, Registered Nurse (RN), removed a vial of fentanyl for Patient #13 at 8:20 AM, 1:57 PM and 5:50 PM. Staff V documented partial administration of the vials of fentanyl to Patient #13 on 11/15/21 at 8:03 AM, 10:37 AM and 4:00 PM. Staff V wasted partial vials that were not administered on 11/16/21 at 8:04 AM (the following day). There was one partial vial of fentanyl that was unaccounted for.

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that on 11/15/21 Staff V, removed a vial of fentanyl for Patient #31 at 6:07 PM. Staff V documented she administered a partial vial of fentanyl to Patient #31 at 6:07 PM, and did not waste what was not administered until the following day, approximately 14 hours later.

Review of an incident report dated 11/25/21, showed that Staff V, removed a vial of dilaudid (medication used to treat severe pain) for Patient #27 at 4:39 PM and 4:43 PM, but only documented that one dose was administered at 4:43 PM. There was no investigation documented on the incident report related to why the second dose of dilaudid was not documented as administered, or wasted.

Review of an incident report dated 11/26/21, showed that Staff V, RN, removed doses of dilaudid for Patient #27 at 6:30 AM and 1:50 PM, and did not document the administration. Staff V was not assigned to care for Patient #27 that day and Staff K, RN, who was assigned to Patient #27, documented the doses were administered. There was no investigation documented on the incident report.

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that from 11/24/21 through 11/26/21, there were 17 vials of dilaudid removed from the medication dispensary for Patient #27, eight doses were documented as administered, and nine were unaccounted for. Of the nine doses unaccounted for, Staff V was responsible for eight of them.

Review of an incident report dated 11/28/21, showed that Patient #6 complained that he did not receive his pain medications, and that he did not want Staff V to continue to provide his care. The patient's medication administration record was compared to the medication dispensary's report, and showed that Staff V documented she administered the patient's pain medication 24 minutes before she removed it from the medication dispensary. Investigation of the incident showed that Staff V's medication dispensary activity had been audited by Staff AA, Pharmacy Director, to ensure the medications she removed were administered, and that nursing leadership and human resources were investigating Staff V for inappropriate behavior. Pharmacy reports attached to the incident report, indicated that on 11/28/21 between 3:38 AM and 7:48 PM, Staff V removed three vials of fentanyl, 100 mcg per two milliliters (ml, units of measure) for a total of 300 mcg, however, wasted seven doses of 75 mcg each (total amount wasted was 525 mcg, 225 mcg more than what was removed to administer).

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that for Patient #6 on 11/29/21, there was one oxycodone 5 mg tablet that was unaccounted for, and from 11/27/21 through 11/28/21, 800 mcg of fentanyl were removed, 175 mcg were administered and 750 mcg were wasted, which created a discrepancy that could not have occurred.

Review of an incident report dated 12/04/21, showed that Staff V documented that she gave fentanyl 50 mcg and ativan (a medication that has a calming effect, used to treat anxiety or sleep difficulty) to Patient #28 with no physician's order for the medications. It was later noted that Staff V entered a telephone order at 7:44 PM for the medication. There was no investigation documented on the incident report.

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that from 12/04/21 through 12/05/21, Staff V removed nine vials of fentanyl and six vials of ativan for Patient #28, which resulted in two vials of fentanyl and one vial of ativan that were unaccounted for.

Review of an incident report dated 12/04/21, showed that two staff members found open needles, blood spots, and an empty narcotic "plastic sleeve" on the floor in the women's locker room at 6:30 PM. There were also rubber bands used to bind a tourniquet, as well as three caps to intravenous needles found (all items associated with the injection of drugs). Additionally, four nurses reported that Staff V spent most of the day in the bathroom, and that they had concerns about Staff V's behavior. Investigation of the incident showed Staff A, Chief Clinical Officer (CCO), documented that her investigation conflicted with what the staff had reported, but that further investigation would be done with Human Resources and Staff V.

During an interview on 01/13/22 at 9:00 AM, Staff AA, Pharmacy Director, stated the following:
- Current policy stated a telephone order must be in the patients' medical record prior to staff withdrawing medications, but nursing staff were able to pull fentanyl and other high risk medications without a physician's order.
- She kept a waste log daily, and made sure nursing were wasting doses at the end of their shift.
- Hospital policy was for nursing staff to waste as soon as the medication was removed from the medication dispensary.
- She had reported all questionable incidents involving extra wastes and the lack of medication administration documentation to Staff A, CCO, who told her to keep watching Staff V, RN, and gather more evidence.
- She had been auditing nursing staff for their medication removals and administration documentation because of suspected diversion.

During an interview on 01/13/21 at 3:23 PM, Staff JJ, Pharmacy Technician, stated nurses who had extra wasting for medications were doing it to make it difficult for pharmacy staff to figure out diversions, and to figure out a count in the medication dispensary so that they could divert high risk medications. She had been watching Staff V for diversion since she began working there on 10/15/21, because she had diverted medications when she worked there previously.

Review of the hospital's document titled, "Counseling and Problem Solving Record," dated 12/10/21, showed that Staff V was placed on suspension for the following:
- On 11/25/21, Staff V removed a dose of dilaudid at 4:39 PM and 4:43 PM, but only documented one dose was administered at 4:43 PM.
- On 11/26/21, Staff V removed a dose of dilaudid at 6:30 AM and 1:50 PM, and did not document the medication was administered to the patient.
- On 11/26/21, Staff V removed dilaudid at 5:53 PM, and did not document that the dose was administered. The nurse who was assigned to the patient removed, administered, and documented the same medication at 5:07 PM.
- On 12/04/21, Staff V administered fentanyl and Ativan at 6:50 PM, and did not have an order for it.
- On 12/10/21, Staff V removed fentanyl at 8:08 AM, but documented that she gave it at 7:07 AM, and removed oxycodone at 9:25 AM, but documented that she gave it at 9:22 AM.

Review of the hospital's document titled, "Personnel Action Form," dated 12/10/21, showed the following:
- Staff V was informed by Staff A, CCO, that there were suspicions regarding documentation of drugs, provided examples, and shared that there were concerns from coworkers that she frequently disappeared into the restroom.
- Staff A informed Staff V that there were over 30 doses of dilaudid removed by Staff V, and there was no documentation to justify the medication.
- Staff C, Chief Executive Officer (CEO), questioned Staff V regarding medications removed on 12/10/21, when Staff V explained she had removed one of the medications by mistake. A staff member noted that Staff V removed the medications, but was never observed to have administered them to the patient.
- Staff V was offered to take a urine drug test and she agreed and signed a consent form, then refused, and was terminated on 12/10/21.

The hospital failed to identify possible diversion of a controlled substance in a timely fashion, and once identified, failed to investigate and take immediate action. This allowed Staff V to continue to have access to controlled substances, with the potential to provide care for patients while under the influence of a controlled substance.









29047

Based on interview, record review, and policy review, the hospital failed to ensure controlled substances (medications that are high risk for abuse) were locked within a secured area when two staff members (Staff V, Registered Nurse [RN], and Staff U, RN) were allowed to keep doses of controlled substances in their possession, and wasted non-administered doses at the end of their shift, or on the following day. These failures had the potential to affect all patients, through misappropriation of patient medications and the potential for impaired patient care. Hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Controlled Drugs Administration," dated 10/2021, showed that pharmacy should review a daily report of all controlled substance transactions and confirm all discrepancies have been resolved, overrides appropriate, and documentation (including waste) complete.

Review of an incident report dated 08/24/21, along with the hospital's document titled, "All Device Events Report," dated 08/24/21 through 08/25/21, showed that Staff U, RN, between the hours of 12:19 AM and 5:11 AM, wasted five doses of fentanyl for Patient #20, however, there was no investigation as to where the wasted doses came from, as Staff U had not removed fentanyl for Patient #20 on 08/24/21 or 08/25/21 (indicating she had fentanyl in her possession for greater than 24 hours).

Review of pharmacy reports completed by Staff GG, Pharmacist, on 01/19/22, showed that on 11/15/21 Staff V, RN, removed doses of fentanyl (a medication used to treat severe pain, and is a high risk drug for theft and personal use) for Patient #13 at 8:20 AM, 1:57 PM and 5:50 PM. Staff V documented she administered fentanyl to Patient #13 on 11/15/21 at 8:03 AM, 10:37 AM and 4:00 PM. Staff V wasted two doses (of three expected doses to be wasted) of fentanyl for Patient #13 on 11/16/21 at 8:04 AM (approximately 16 to 24 hours after the partial fentanyl doses had been documented as administered).

During an interview on 01/18/22 at 4:30 PM, Staff S, RN, stated the following:
- The process for administration of narcotic medications was to remove the medication from the medication dispensary, and waste any medication at that time. There must be a second nurse to witness and verify the waste of the medication.
- He would not have been comfortable witnessing the waste of a medication in a syringe or an opened vial of medication.
- He was the witness to the waste of medications that Staff V, RN, documented on 11/16/21 for Patient #13, but did not know what was in the vial, or realize the medication was from the previous day.

Review of pharmacy reports completed by Staff GG, Pharmacist, on 01/19/22, showed that on 11/15/21 Staff V, RN, removed doses of fentanyl for Patient #31 at 6:07 PM. Staff V documented she administered fentanyl to Patient #31 on 11/15/21 at 6:07 PM. Staff V wasted doses of fentanyl for Patient #31 on 11/16/21 at 8:20 AM and 8:21 AM (more than fourteen hours after the medications had been removed).

During an interview on 01/13/22 at 9:55 AM, Staff A, Chief Clinical Officer (CCO), stated that there was nothing in place to prevent a nurse from keeping narcotics in their pockets and wasting the medication at the end of their shift, or even on a different day.

During an interview on 01/13/22 at 9:00 AM, Staff AA, Pharmacy Director, stated that all wastes should be completed as soon as the controlled substance was removed from the medication dispensary, or immediately after the partial dose was administered to the patient.

Based on interview, record review, and policy review, the hospital failed to ensure that controlled substance (drugs or medications that are high risk for personal consumption or abuse) losses were investigated and reported to proper agencies when four drugs (oxycodone [synthetic pain medication with a high risk for misuse], fentanyl [a medication used to treat severe pain, and is a high risk drug for theft and personal use], dilaudid [medication used to treat severe pain] and ativan [a medication that has a calming effect, used to treat anxiety or sleep difficulty]) were found missing on five separate occasions. This had the potential to affect all patients, through misappropriation of patient medications and the potential for impaired patient care. The pharmacy dispensed an average of 1,951 controlled substances per month. The hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Substance Abuse," dated 04/2021, showed that drugs include, but may not be limited to, inhalants, illegal drugs, controlled substances and prescription drugs unless such prescription drugs are taken as directed by the employee's physician. Illegal drug and controlled substances includes but may not be limited to a drug which is not legally obtainable, may be legally obtainable but has been illegally obtained, is being used in a manner for a purpose other than as prescribed, forgetting or attempting to fill or pass an illegal prescription on or off duty, in possession of someone other than the person they were lawfully prescribed to.

Review of the hospital's policy titled, "Controlled Drugs, Drug Diversion Prevention, Detection and Response," dated 10/2021, showed the following:
- The prevention, detection, and reporting of drug diversion is the responsibility of all staff.
- All suspected incidents of drug diversion will be thoroughly investigated.
- Drug diversion by personnel is grounds for corrective action and will be reported to all government licensing, regulatory and law enforcement agencies.

Review of the hospital's policy titled, "Controlled Drugs Storage, Distribution, and Accountability," dated 09/2014, showed that suspected or know abuses or losses of controlled substances will be immediately reported to the Director of Pharmacy, the [contracted pharmacy] Services Account Director, the Board of Pharmacy, the appropriate Drug Enforcement Agency (DEA) office, and law enforcement may need to be contacted depending on state regulations. In addition the administration will be informed and consulted. Centers for Medicare Services (CMS) also requires the loss be reported to the Hospital Chief Executive Officer (CEO).

Review of the hospital's document titled, "Security Breaches," dated 10/2021, showed that thefts, suspected thefts, or abuses of controlled drugs should be reported to the Director of Pharmacy, appropriate hospital administrator, and appropriate state board entity. In addition, the DEA should be contacted.

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that on 11/15/21 Staff V, RN, removed a vial of fentanyl for Patient #13 at 8:20 AM, 1:57 PM and 5:50 PM. Staff V documented partial administration of the vials of fentanyl to Patient #13 on 11/15/21 at 8:03 AM, 10:37 AM and 4:00 PM. Staff V wasted partial vials that were not administered on 11/16/21 at 8:04 AM (the following day). There was one partial vial of fentanyl that was unaccounted for.

Review of an incident report dated 11/25/21, showed that Staff V, RN, removed a vial of dilaudid (medication used to treat severe pain) for Patient #27 at 4:39 PM and 4:43 PM, but only documented that one dose was administered at 4:43 PM. There was no investigation documented on the incident report related to why the second dose of dilaudid was not documented as administered, or wasted.

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that from 11/24/21 through 11/26/21, there were 17 vials of dilaudid removed from the medication dispensary for Patient #27, eight doses were documented as administered, and nine were unaccounted for. Of the nine doses unaccounted for, Staff V was responsible for eight of them.

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that for Patient #6 on 11/29/21, there was one oxycodone 5 mg tablet that was unaccounted for.

Review of discrepancy documents, which were not completed until 01/19/22 (during the survey), showed that from 12/04/21 through 12/05/21, Staff V removed nine vials of fentanyl and six vials of ativan for Patient #28, which resulted in two vials of fentanyl and one vial of ativan that were unaccounted for.

During an interview on 01/20/22 at 9:00 AM, Staff AA, Director of Pharmacy, and Staff GG, Pharmacist, stated that they would report a large diversion of narcotics to the DEA but they were not sure what the threshold was. There had been nothing reported to outside agencies related to drug diversion at that time.

During an interview on 01/20/22 at 2:00 PM, Staff C, CEO, stated that he was not aware of medications that were unaccounted for.



29047

Based on observation, interview and policy review, the hospital failed to provide up-to-date reference material on drug therapy in hard copy format, for instances when intranet format was unavailable. This failure had the potential to affect the quality of care and safety of all patients. The hospital census was 16.

Findings included:

1. Even though requested, the hospital failed to provide a policy that directed staff on how to obtain drug therapy reference material.

Observation on 01/18/22 at 1:20 PM, in the Pharmacy Department, showed a reference manual for injectable drugs dated 2011. The hospital's intranet was down at this time.

During an interview on 01/18/22 at 1:15 PM, Staff GG, Pharmacist, stated that pharmacy and nursing staff had access to web based clinical pharmacology reference material on the intranet. If the Intranet was down, the Pharmacist could use their mobile hot spot to access the internet. He was unaware that the reference manual for injectable drugs was outdated.

During concurrent observation and interview, on 01/18/21 at 1:50 PM, at the nurses station, Staff MM, Registered Nurse (RN), stated that there was no medication reference manual or web based material on the intranet that she was aware of, to look up medications if she had questions. The cabinet where she thought a drug handbook may have been located, showed no reference manual for medications.


41474