HospitalInspections.org

.
Based on observation, document review, interview and review of hospital policy and procedures, the hospital failed to ensure that pharmaceutical services were delivered according to regulatory requirements and accepted standards of practice.

Failure to ensure controlled substance accountability standards are maintained, diversion-monitoring audits performed, and evaluate quality control activities of Pharmacy Services risks patient safety, theft, and diversion of controlled substances.

Findings included:

1. Failure to perform monthly unit inspections and monitor, assess and evaluate quality control activities of Pharmacy Services.

Cross-reference: A0491

2. Failure to complete and review diversion-monitoring audits in all clinical service areas where controlled substances are administered.

Cross-reference: A0494

3. Failure to maintain accurate records for controlled substance accountability and administration.

Cross-reference: A0494

4. Failure to secure medications from unauthorized usage.

Cross-reference: A0502

Due to the scope of the deficiencies cited under 42 CFR 482.25, the Condition of Participation for Pharmaceutical Services was NOT MET.
.

.
Based on document review, interview, and review of hospital policy and procedures, the hospital staff failed to conduct monthly inspections of all drug storage areas to prevent the administration of outdated medications.

Failure to ensure that hospital staff members check medication storage areas for outdated or otherwise unusable mediations puts patients at risk for receiving medications with compromised sterility, integrity, and security.

Findings included:

1. Document review of the hospital's policy and procedure titled, "Inspections: Medication Areas," policy number 7151495, last revised 11/04/19, showed that the Director of Pharmacy or designee, shall conduct routine monthly inspections of all medication areas. Upon completion of a inspection of a medication storage area, the responsible staff will complete an medication storage inspection form. Inspection records will be retained by the Pharmacy. Any unresolved discrepancies will be brought to the attention of the operations supervisor or Director of Pharmacy.

2. Document review of the hospital monthly medication unit inspection reports dated from March 2020 to October 2020 (an 8 month period) showed that 15 out of 42 clinical areas were missing at least one monthly medication storage inspection being completed. Of the 42 clinical areas, 11 clinical services had three or more missing monthly medication storage inspections.

3. On 10/27/20 at 10:30 AM, Investigator #3 interviewed the Lead Pharmacy Technician Supervisor (Staff #301) about monthly pharmacy inspections. Staff #301 stated that each technician is assigned and responsible for performing monthly inspections of several clinical areas. The unit inspections are to be completed by the 25th of each month. Investigator #3 and Staff #301 reviewed the monthly pharmacy medication inspection report for the period of March 2020 to October 2020. Staff #301 confirmed that several required pharmacy monthly inspections had not been completed. Staff #301 acknowledged that she was unaware that so many clinical areas had not been completed or documented in the pharmacy inspection compliance database.

4. At the time of the review, a subsequent follow-up interview with the Director of Pharmacy (Staff #302) confirmed that he was unaware of the department's current compliance with performing monthly pharmacy medication storage area inspections.
.

.
Based on observation, document review, interview, and review of hospital policy and procedures, the hospital failed to implement, monitor, and evaluate a proactive diversion monitoring program that included all clinical areas and services (Item #1) and failed to ensure compliance with use and accountability of controlled substances in accordance with state and federal laws and regulations (Item #2).

Failure to maintain a comprehensive proactive diversion program and ensure accurate records for controlled substance accountability places patients at risk for harm, poor pain control and potential diversion from staff.

Findings included:

Item #1- Proactive Diversion Monitoring Program

1. Document review of the hospital's policy and procedure titled, "Controlled Drugs: Tools for Diversion, Prevention, and Detection - SWSA," policy number 7125167, last revised 12/06/19, showed that controlled substance diversion prevention was supported throughout the hospital, and every hospital employee was responsible for preventing controlled substance diversion.

The review showed that the controlled substance diversion prevention plan included a monthly proactive diversion report (Rx Auditor) that was uploaded onto the hospital's network drive and used by the nurse managers and directors to identify staff who removed larger than normal qualities of controlled substances from the automated medication dispensing system (PYXIS) within the previous three months. If suspicious patterns were detected, the Pharmacy Manager or their designee would run further reports as requested by the nursing leader. If diversion was suspected, the Nurse Manager would continue to investigate using the Drug Diversion Screening tool. Document review showed that the policy and procedure applied to licensed nursing staff, Nurse Managers, Nursing Directors, the Director of Pharmacy, and the Chief Nursing Officer but failed to specify that it applied to credentialed providers responsible for the administration of controlled substances to patients.

2. On 10/21/20, Investigator #3 requested the meeting minutes for Diversion Monitoring from the hospital. The hospital Support Survey Manager (Regulatory Compliance) (Staff #304) provided meeting minutes dated 10/15/20, 10/01/20, 06/02/17, and 02/24/17. She stated the diversion task force meeting had only recently restarted and had not met on a regular basis since 2017.

3. On 10/21/20 at 9:45 AM, Investigators #1, #2, and #3 interviewed the Pharmacy Manager (Staff #104). During the interview, the Pharmacy Manager stated that the inventory discrepancy and diversion monitoring reports were run and reviewed by the Regional Pyxis Coordinator. Staff #104 stated that the staff member would notify him if there were issues, and he (Staff #104) would provide "ad hoc assistance" as needed.

4. On 10/21/20 at 12:08 PM, Investigator's #1 and #2 interviewed the Regional Pyxis Coordinator (Staff #103). Staff #103 stated that he uploaded the monthly Rx Auditor reports to the hospital's shared drive by the 10th of each month and used a distribution list to send email notification of the report's availability to leadership staff. Staff #103 stated that he did not know when the distribution list was last updated or if it included the perioperative services medical director. When asked about controlled substances contained in the locked anesthesia boxes on the traveling anesthesia carts (non-PYXIS), Staff #103 stated that physicians "checked each other" and used paper documentation to sign off on controlled substance wastage. When asked if audits were performed on the traveling anesthesia cart documentation, Staff #103 stated he reviewed the paper sheets "from time to time", but no formal chart audits to confirm medication administration is performed by pharmacy.

5. On 10/22/20 at 9:30 AM, Investigators #1, #2, and #3 re-interviewed the Regional Pyxis Coordinator (Staff #103), the Pharmacy Manager (Staff #104), a Clinical Nurse Manager (Staff #105), and the Assistant Regional Director of Pharmacy Services (Staff #106) about the hospital's diversion monitoring process and the Rx Auditor report system. The interview showed that:

Staff #103 stated that he did not know if the anesthesiologists had the ability to access the Rx Auditor reports in the shared drive. Staff #103 stated that aside from reviewing the monthly Rx Auditor reports, he did not know if the anesthesia providers used any other methods to monitor providers for narcotic diversion. When asked how he knew how the proactive diversion reports were read and audits were conducted, Staff #103 stated, "the only time I get feedback is if nursing asks for something (a report) out of Pyxis," and "if they don't do it, they don't do it. They're not accountable to me."

Staff #106 verified that the hospital did not have a current a process to show that department leaders were monitoring staff for narcotic diversion, and she stated that they were currently in the process of discussing best practices for the proactive diversion reporting process.

When asked about the pharmacy Rx Auditor reports review process, Staff #104 stated that he reviewed the reports based on request by the clinical nurse leaders or the Regional Pyxis Coordinator.

Staff #105 stated that nurse leaders did not have a formal process to confirm that they had reviewed the monthly Rx Auditor reports. She stated that they operated on a "no news is good news system," meaning that if they did not request additional reports from pharmacy, they did not find any concerns with the reports.

6. On 10/22/20 at 10:02 AM, Investigator #1 interviewed the Perioperative Services Medical Director (Staff #102). Staff #102 stated that he used to receive pharmacy reports for narcotics usage by anesthesiologists, but they stopped coming to him. He stated that he had not received any reports for "a long time," and now, he was only notified of narcotic discrepancies. Staff #102 stated that he did not receive any information regarding drug utilization by anesthesiologists, and that he did not have access to any Rx Auditor diversion monitoring reports. Staff #102 stated that when using the lock boxes on the anesthesia carts, the provider verified the count at the beginning of the shift. He stated that if a provider used medication from the lock box, he would document the amount used and wasted on the paper form. He stated that he did not audit the paper forms; any audits of the paper forms were conducted by the pharmacy staff, and they would notify him if discrepancies were found.

7. On 10/22/20 at 11:00 AM, Investigator #1 interviewed the Operating Room (OR) Nurse Manager (Staff #101). During the interview, Staff #101 stated that she received no formal training on the hospital's Rx Auditor reporting system, she did not have access to the shared drive where the reports were stored, and she did not review any proactive diversion reports. The OR manager stated that she did not have access to the Pyxis medication system since her role did not require that she administer medications to patients, and any Pyxis discrepancies were resolved by the charge nurse. Staff #101 stated that the three lock boxes containing narcotics on top of the anesthesia carts were reconciled nightly by pharmacy.

Item #2- Controlled Substance Accountability

1. Document review of the hospital's policy and procedure titled, "Controlled Drugs: in Patient Care Areas (Non-Pyxis)," policy number 7125015, last revised 11/04/19, showed that controlled medications used in patient care areas would be issued, stored, administered, destroyed, and monitored in accordance with state and federal regulations. In areas without PYXIS (automated drug dispensing machine), controlled drugs would be inventoried twice a day. When the counts and entries were complete and verified, the controlled drug inventory (CDI) sheet would be signed by two licensed staff. The healthcare provider who signed out the controlled drug was accountable for the subsequent administration, waste, and documentation.

Document review of the hospital's policy and procedure titled, "Controlled Drugs: Disposition/Destruction - SWSA," policy number 7391368, last revised 01/06/20, showed that anesthesiologists would destroy (waste) unused partial quantities of controlled substances and document the waste on the Anesthesiology Controlled Drug Inventory form for their anesthesia narcotic box used.

Document review of the hospital's form titled, "Anesthesiology Controlled Drug Inventory," no form number, no date, showed that a medical doctor will fill out their name, date, ( to include signature) and verification of the beginning and ending inventory count totals of controlled substances located in the traveling anesthesia locked box. The form did not include how wastage of controlled substances was to be documented.

2. On 10/21/20 at 11:00 AM, Investigator #3, the Director of Surgical Services (Staff #305), the Operating Room Nurse Manager (Staff #306) toured and inspected the anesthesia workroom area. The observation showed three locked traveling anesthesia carts with a secured metal box containing controlled substances located on top of each cart.

At the time of the observation, Investigator #3 interviewed the lead Anesthesia Nurse (Staff #307) about the controlled substances located in the locked metal boxes. The investigator asked if the controlled substances were inventoried or counted since they are not part of the PXYIS machine. Staff #307 stated that the keys opening the anesthesia locked metal boxes are located in the PXYIS machine, but no controlled substance inventory is counted when the key is retrieved from the PXYIS machine. He confirmed that no twice daily counting of controlled substances is performed as required by hospital policy. Staff #307 stated the anesthesia providers and pharmacy are responsible for performing inventory counts upon opening the boxes and upon return to the Pharmacy for refilling.

3. On 10/21/20, Investigator #3 reviewed the 19 Anesthesia Controlled Drug Inventory sheets for the period 06/22/20 to 10/19/20. The review showed the following:

a. 4 of 19 Anesthesia Controlled Drug Inventory sheets did not have an opening inventory count of controlled substances performed and verified as required by hospital policy.

b. 5 of 19 Anesthesia Controlled Drug Inventory sheets did not have a closing inventory count of controlled substances performed and verified as required by hospital policy.

c. 11 of 19 Anesthesia Controlled Drug Inventory sheets did not have the controlled substances wastage verified and documented by a second person as required by hospital policy.

4. On 10/22/20 at 11:00 AM, Investigator #2 and #3 reviewed the available Anesthesia Controlled Drug Inventory sheets filed in the Pharmacy. Attached to an Anesthesia Controlled Drug Inventory sheet dated 06/22/20 was a handwritten note by a Pharmacy Technician (Staff #302) who documented, "When refilling the traveling narcotic box, I found that a Ketamine 100mg/ml vial was missing and not documented that it was used on a patient."

A subsequent interview with the Regional PYXIS coordinator (Staff #303) and the Pharmacy Manager (Staff #302) confirmed that Staff #303 did not notify the Pharmacy Manager (Staff #302) at the time of the discovery. No formal investigation was initiated at the time of discovery. A hospital incident report was not written and forwarded to Quality Management as required by hospital policy. As a result of the discovery of potential missing controlled substance by the investigators, a review of the patient's chart was performed by the hospital staff. Their review showed the administration of the ketamine medication was documented by the provider in the electronic health record but not on the anesthesia-controlled drug inventory sheet as required by hospital policy.
.

.
Based on observation, interview, and document review, the hospital failed to secure medications from unauthorized usage.

Failure to secure medications risks potential diversion, theft, tampering, and patient safety.

Findings included:

1. Document review of the hospital policy and procedure titled, "Controlled Drugs: In Patient Care Areas (Non-Pyxis)," policy number 7125015, last revised 11/04/19, showed that controlled drugs will be kept, stored, and monitored in accordance with state and federal regulations. Controlled drug cabinets or storage lockers must be kept locked at all times and only licensed staff may carry narcotic keys.

2. On 10/21/20 at 11:00 AM, Investigator #3, the Director of Surgical Services (Staff #305), the Operating Room Nurse Manager (Staff #306), and the lead Anesthesia Nurse (Staff #307) toured and inspected the anesthesia workroom area. The observation showed three locked traveling anesthesia carts, each with a metal box containing controlled drugs secured to the top of the cart. The investigator asked Staff #307 how the controlled drugs were accessed and used since they were not part of the PYXIS machine. He stated that the keys opening the anesthesia locked metal boxes were located in the PYXIS machine.

During the inspection, the investigator opened a cabinet door and observed a key hanging on the inside. The investigator asked Staff #307 what items or areas the key opened. Staff #307 stated that it opens a locked box located on the wall near the cabinet. He specified that the keys in the lock box primarily opened additional rooms where other equipment and supplies were stored. The investigator opened the locked box on the wall and observed 3 sets of keys labeled "anesthesia cart". The investigator asked what the three sets of keys were used for. Staff #307 stated they were old keys left over and not used anymore after the hospital purchased PYXIS anesthesia carts for each of the operating rooms. Using the keys labeled "anesthesia cart," the investigator successfully opened 2 of the 3 locked controlled substance boxes attached to the traveling anesthesia carts.

3. Immediately following the observation, Investigator #3 interviewed the lead Anesthesia Nurse (Staff #307) about the finding. Staff #307 stated he was unaware that those keys were able to successfully open the locked boxes on the traveling anesthesia carts.
.