HospitalInspections.org

Based on observation, interview, and record review, the hospital failed to post the patient rights sign in the ED waiting area as per the hospital's P&P. This failure put the patients at risk for not knowing how to exercise their rights.

Findings:

Review of the hospital's P&P titled Patient Rights and Responsibilities, HS 1354, revised 5/16 showed in part, to provide the patients with a Notice of Rights and Responsibilities, including posting of the signs in lobbies and waiting areas.

On 5/4/21 at 1325 hours, during a tour of the ED conducted with NCE 1, an observation of the waiting area was conducted. There was no patient rights sign posted in the ED patient waiting area.

NCE 1 concurred with the finding.

Based on observation and record review, the hospital failed to ensure the confidentiality of patient medical records was safeguarded when the documents containing the patient protected health information were left in an unlocked and unattended room. This failure increased the risk of unauthorized disclosure of patients' protected health information.

Findings:

On 5/5/21 at 1352 hours, a tour of the NICU, Perinatal Unit, and Nursery (on the 5th floor) was conducted with Nursing Professional Development Specialist 1, Nursing Professional Development Specialist 2, and Nursing Director 6.

Before entering the Perinatal unit, the family waiting room was observed with a temporary sign labeled "NICU/Perinatal Command Center Employee Only." The room was unlocked and unattended. Observed on the table were two sets of documents (Documents 1 and 2) containing the patients' protected health information. The visitors were observed in the vicinity.

* Document 1, "POSTPARTUM," included seven pages which were printed by Physician 2 on 5/4/21 at 1736 hours. The documents consisted of the patients' protected health information including bed number, first and last name, age, gender, primary/medical problem, medical record number, allergies, medications, past history, and Covid test information.

* Document 2, "GYNECOLOGY," included nine pages which were printed by Physician 3 on 5/4/21 at 1736 hours. The documents consisted of the patients' protected health information including bed number, first and last name, age, gender, primary/medical problem, medical record number, allergies, medications, surgery information, and past medical history.

On 5/5/21 at 1352 hours, Physician 1 was interviewed regarding the above mentioned unattended documents. Physician 1 stated the documents might have been left by the night team. Physician 1 identified Physicians 2 and 3 as the interns in the Gynecology and Postpartum rotation night team. Physician 1 stated the night team printed these documents for their follow up care and shift report. Physician 1 stated the hospital had been using the 5th floor family waiting room as a temporary staff conference room since the beginning of the COVID-19 pandemic.

Physician 1 further stated the conference room should be locked at all times.

Based on observation, interview, and record review, the hospital failed to ensure the use of restraint was in accordance with the physician's order and hospital's P&P for one of 63 sampled patients (Patient 32). The nursing staff failed to obtain a physician's order for the application of bilateral soft wrist restraints and failed to assess for the need to continue or discontinue the use of bilateral soft wrist restraints. This failure posed the risk of violating the patient's rights and restraining the patient unnecessarily.

Findings:

Review of the hospital P&P titled Restraints, HS 1321 revised 7/20 showed in part, the orders for non-violent or non-self destructive use of restraints must be in accordance of a physician, NP or PA who is responsible for the care of the patient. A written order is obtained from the physician, NP, PA and entered into the patient's medical record following notification and consultation, not to exceed two hours. The observation and monitoring and documentation every two hours for the need of continued use of restraints is reassessed and the readiness for discontinuation of restraints is addressed.

On 5/5/21 at 1100 hours, a tour of the Cardiothoracic ICU was conducted with CNS 2, RN 8, Nursing Director 3, Director Nursing Adult 1, and NCE 2.

Patient 32 was observed to have the bilateral soft wrist restraints (non-behavioral restraints).

Review of Patient 32's medical record was conducted. Patient 32 was admitted to the hospital on 4/25/21 with COVID pneumonia.

Review of the restraint flowsheet showed the following:

- On 4/30/21 at 1200 hours, the patient had the bilateral soft wrist restraints. There was no documented evidence the nursing staff assessed for the need of continued use or the need for discontinuation of bilateral soft wrist restraints.

- On 5/1/21 at 0800 hours, the bilateral soft wrist restraints were off. There was no documented evidence the nursing staff assessed for the need of continued use or the need for discontinuation of bilateral soft wrist restraints.

Review of the order history for non-behavioral restraints showed the order for restraints had expired on 4/30/21 at 1159 hours. There was no new order obtained prior to or after the application of bilateral soft wrist restraints on 4/30/21 at 1200 hours.

On 5/6/21 at 1325 hours, the above findings were verified with CNS 1.

Patient 32 had the bilateral soft wrist restraints applied on 4/30/21 at 1200 hours, with no physician's order. There was no documented evidence Patient 32 was assessed on 4/30/21 after 1200 hours, for the need to continue or discontinue the use of bilateral soft wrist restraints.

Based on observation, interview, and record review, the hospital failed to ensure one of 63 patients (Patient 30) was monitored, assessed, and reassessed to determine if the restraints could be safely discontinued. This failure posed the increased risk of violating the patient's rights.

Findings:

Review of the hospital's P&P titled Restraints: Care of Patients in Restraints, Nur-HS G1008 revised 9/20 showed the intervention for non-violent or non-self destructive restraints, the RN may discontinue restraints and document restraints "OFF" when the restraints are no longer needed.

On 5/5/21 at 0907 hours, a tour of the CCU was conducted with Nursing Director 2, CNS 2, NCE 2, RNs 2 and 3. Patient 30 was observed orally intubated connecting to the breathing machine and had the soft wrist restraints.

Medical record review for Patient 30 was conducted with Nursing Director 2, CNS 2, NCE 2, RNs 2 and 3. The medical record showed Patient 30 was admitted to the hospital on 3/30/21.

Review of the order history for non-behavioral restraints showed the physician's order for two points soft wrist restraints dated 5/4/21 at 1630 hours. The order history further showed the restraint order was canceled on 5/5/21 at 0906 hours.

The restraint Flowsheet was reviewed for the dates from 5/4/21 at 1600 hours through 5/5/21 at 0900 hours. There was no documented evidence the nursing staff had assessed Patient 30 for the following:

- Justification: clinical justification for the use of restraints such as agitation, pulling and tugging invasive lines.

- Restraints type and location: such as soft wrist or vest.

- Restraints monitoring: circulation, LOC, sensory and motor, hygiene, elimination, hydration, release, provided ROM, and reassessment of the need to continue or discontinue the use of restraints.

When asked about the lack of documentation on the restraint Flowsheet, Nursing Director 2 stated Patient 30 did not require the restraints on 5/4/21; however, the RN should have documented the assessment or reassessment of the need for restraints and should have documented "OFF" when the restraints were not needed.

Based on interview and record review, the hospital failed to ensure the Review Committee had performed an annual review of the PCS for the GOU. This had the potential to negatively affect the patient care needs.

Findings:

Review of the hospital's P&P titled Staffing Requirements/Patient Classification System, Nur-HS 211, revised 10/17 showed in part, it is the responsibility of the Unit Director/designee to plan the unit staffing schedule based upon each unit's need, mandated staffing ratios and budgeted staff matrix. Patient Classification rating tools and mandated staffing ratios will be utilized in determining staffing levels on a shift by shift basis on all inpatient units. The Review Committee consists of an RN unit expert from each department. The Committee meets with a PCS representative annually to review the distribution curves of each unit and ensure that the current acuity definitions accurately measure the patient care needs, if the definitions are no longer accurate, the specialty group will revise them. Adjustment(s) will be implemented within 30 days.

On 5/5/21 at 1455 hours, the GOU was toured with Nursing Director 5. Nursing Director 5 stated the GOU utilized the staff matrix and patient acuity system for staffing and reviewed their PCS annually. Nursing Director 5 stated a champion was designated to evaluate the GOU PCS to ensure the staffing ratios met the patients' needs.

On 5/5/21 at 1510 hours, the Director Nursing Administration and Director Nursing Adult 1were interviewed regarding the annual Review Committee record. The Director Nursing Administration stated the most recent Review Committee Meeting was in 2019 and there was no documented evidence the GOU representative had attended that meeting.

Based on observation, interview, and record review, the hospital failed to ensure the licensed nurses followed the P&P for high alert medication administration for five of 63 patients (Patient's 11, 22, 33, 56, and 61), creating the risk for medication errors and poor health outcome to the patients. In addition, the medication error for one of 63 sampled patients (Patient 60) was not promptly reported as per the hospital's P&P, creating the risk for not identifying the cause of medication errors to prevent reoccurrence.

Findings:

Review of the hospital's P&P titled Medication Administration, HS 1450, revised 3/21 showed the high alert medication (see Policy HS1383) must be independently verified by two licensed healthcare professionals for who medication administration is in their scope of practice. In an independent double check of a high alert medication, it must be completed at change of shift, transferring of a patient, and when infusions are started, reconnected, or changed (new bag or syringe, or a new concentrations). Two clinicians independent (separately) will check each component of the order including patient's name, MRN (medical record number) or birthdate, medication, dose, route, concentration, and rate of infusion. After the independent verification, the clinicians will document in the electronic health record (EHR).

Review of the hospital's P&P titled High Alert Medication Policy, HS 1383, revised 10/2020 showed the high alert medications are those medications that bear a heightened risk of causing significant patient harm when they are used in error. High alert medications may be involved in a high percentage of medication error and or sentinel events and are medications that carry a higher risk for abuse, error or other adverse outcomes. High alert medications include insulin and heparin require verification by two licensed healthcare professionals for whom medication administration is in their scope of practice. An independent double check of a high alert medication is completed at change of shift, patient transfer, when infusions are started, reconnected, or changed. In an independent double check (IDC) of a high alert medications, two clinicians independently (separately) check each component of the order, including patient's name, MRN or birthdate, medication name, dose, route, concentration, rate of infusion, and programming of the pump for infusions. Tubing must be traced from the medication infusion bag or syringe, to the pump, and then to the patient to ensure that it is connected to the proper port. After the independent verification, the clinicians should compare their results and document in the EHR.

Review of the hospital's P&P, titled Insulin Infusion Therapy, Nur-HS 164, revised 12/19 showed the insulin administration required the independent double check by two registered nurses (RN) of the patient's name, MRN, medication, dose, route, concentration, and rate of infusion, prior to beginning infusion, every shift change, when changing the bag, and when a bolus is given.

1. On 5/4/21 at 1330 hours, a tour of the fifth floor pediatric unit was conducted with Clinical Nurse Specialist 8. During the unit tour, Patient 11 was observed to have the IV pump with high alert IV medication hanging at the bedside.

On 5/6/21 at 1115 hours, a medical record review and concurrent interview was conducted with Clinical Nurse Specialist 8, for Patient 11. The MAR for high alert medications from 4/17/21 to 5/2/21, was reviewed with Clinical Nurse Specialist 8. The MAR showed the two RN verification and IDC at the change of shift (0700 and 1900 hours), was not documented. Clinical Nurse Specialist 8 verified the change of shift occurred daily at 0700 and 1900 hrs, and the IDC with two RN verification were not done at the change of shift for Patient 11.

2. On 5/4/21 at 1345 hours, a tour of the fifth floor pediatric intensive care unit (PICU) was conducted with the Nursing Director 7 and Clinical Nurse Specialist 7. During the tour, Patient 56 was observed to have the IV pump with several high alert IV medications hanging at the bedside.

On 5/6/21 at 0942 hours, medical record review for Patient 56 and concurrent interview was conducted with Clinical Nurse Specialist 8. The MAR from 4/25/21 to 5/3/21, was reviewed for high alert medications with Clinical Nurse Specialist 8. The MAR showed no IDC with two RN verification done at the shift change. In addition, on 5/1/21 at 2100 hours, the new medication bag/syringe/cartridge was changed with no IDC and two RN verification. Clinical Nurse Specialist 8 verified the IDC and two RN verification were not done as per the hospital's P&P.

3. On 5/4/21 at 1530 hours, a tour of the eighth floor north medical surgical unit was conducted with the Nursing Director 2. During the tour, Patient 22 was observed to have the IV pump with high alert IV medication hanging at the bedside.

On 5/6/21 at 0830 hours, medical record review for Patient 22 and concurrent interview was conducted with Clinical Nurse Specialist 8. The MAR from 5/3/21 through 5/4/21, was reviewed for high alert medications with Clinical Nurse Specialist 8. The MAR showed no IDC and two RN verification was done at the change of shift and when there was a change in the rate or dose. Clinical Nurse Specialist 8 stated the IDC and two RN verification were not done as per the hospital's P&P.

4. On 5/5/21 at 0934 hours, a tour of the fourth floor intensive care unit was conducted with Nursing Director 9, CNM 1, CNS 1, CNS 9, and CN 1.

At 1039 hours, medical record review for Patient 61 and concurrent interview was conducted with RN 15.

The MAR was reviewed for the high alert medication Heparin from 5/5/21 through 1018 hours. During the record review, it was identified no IDC and two RN verification was done at the change of shift on 5/5/21, by the incoming day shift nurse (RN 15) and the night shift nurse (RN 17).

RN 15 stated the IDC and two RN verification were not done as per the hospital's P&P.


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5. On 5/5/21 at 1330 hours, a tour of the CTICU was conducted with CNS 2, NCE 2, Nursing Director 1 and the Director Nursing Adult 1.

During the unit tour, Patient 33 was observed the IV pump with IV medications hanging at the bedside.

An interview and concurrent medical record review was conducted with RN 13.

Patient 33 was admitted to the hospital on 5/1/21, for a heart transplant.

RN 13 stated the patient received several IV drip medications including an Insulin drip.

Review of the P&P for Insulin Infusion Therapy, with a review date of 12/19 was conducted with CNS 2. The P&P showed to lock the pump during the infusion of Insulin drip.

RN 13 was asked if the Insulin pump was locked. RN 13 did not answer. The Director Nursing Adult 1 checked the Insulin IV pump and stated the key pad was not locked.

6. Review of the hospital's P&P titled Medication Administration, HS 1450, revised date 3/2021 showed in part, in the event that a medication is administered incorrectly (e.g., wrong dose), the physician, charge nurse, and pharmacist are notified immediately; and Pharmacy Administration, the Unit Director and risk management are also notified through the on-line Event Reporting System.

On 5/4/21 at 1337 hours, a medical record review for Patient 60 and concurrent interview was conducted with CNM 1, CNS 1, and NCE 3.

When asked, CNM 1, CNS 1, and NCE 3 explained the medication administration actions associated with the Heparin IV Drip Protocol Order, including associated lab orders and review of orders for accuracy based on patient weight; and safety features with Heparin including the independent double check process by two RNs.

The MAR from 5/3/21 to 5/4/21, for Patient 60 was reviewed for the high alert medication Heparin.

The laboratory results from 5/3/21 to 5/4/21, were reviewed for aPTT results. The results showed the aPTT of 144.9 on 5/3/21 at 1907 hours.

The current physician order and administration instructions for Heparin were reviewed to determine if the Heparin dose, following the aPTT result of 144.9, was administered as ordered by the physician and as per the Heparin administration instructions.

The MAR showed Patient 60 received the wrong dose of Heparin from 5/3/21 at 2115 hours through 5/4/21 at 1300 as a result of not using the correct dosing weight as ordered by the physician.

During an interview, CNM 1, CNS 1, and NCE 3 stated the RN did not follow the physician's order and administered the wrong dose of Heparin as a result of not using the ordered dosing weight.

On 5/6/21 at 1325 hours, a subsequent medical record review for Patient 60 and concurrent interview was conducted with CNM 1.

When asked if the medication error had been reported as per the hospital's the P&P, CNM 1 stated the medication error had been reported to NP 1 and via the hospital's on-line Event Reporting System (SOFI).

Upon further review of Patient 60's medical record and review of the SOFI Reporting System with CNM 1, the nursing documentation showed RN 16 created an entry on 5/5/21 at 1633 hours (approximately 26 hours after the medication error had been identified) that showed NP 1 had been notified of "pt's heparin gtt dosing on 5/3/21 at 2115."

In addition, the SOFI Reporting System showed the report had been submitted on 5/5/21 at 2342 hours (approximately 34 hours after the medication error had been identified), however, it could not be confirmed if the event was specific to the Heparin administration error. CNM 1 stated the details of the report were confidential.

CNM 1 acknowledged the medication error had not been reported immediately as per the hospital's P&P.

Based on interview and record review, the hospital failed to ensure the medications were administered as ordered by the physician and as per the hospital's P&P for two of 63 patients (Patients 37 and 60), which resulted in a medication error and created the risk for poor health outcomes to the patients.

Findings:

1. Review of the hospital's P&P titled Medication Administration, HS 1450, revised 3/2021 showed in part, the purpose of this policy is to specify the requirements for safe and accurate administration of medications.

Review of the hospital's P&P titled High Alert Medication Policy, HS 1383, revised 10/2020 showed the high alert medications are those medications that bear a heightened risk of causing significant patient harm when they are used in error. High alert medications may be involved in a high percentage of medication error and or sentinel events and are medications that carry a higher risk for abuse, error or other adverse outcomes. High alert medications include insulin and heparin require verification by two licensed healthcare professionals for whom medication administration is in their scope of practice. An independent double check of a high alert medication is completed at change of shift, patient transfer, when infusions are started, reconnected, or changed. In an independent double check (IDC) of a high alert medications, two clinicians independently (separately) check each component of the order including: patient's name, MRN or birthdate, medication name, dose, route, concentration, rate of infusion, and programming of the pump for infusions. Tubing must be traced from the medication infusion bag or syringe, to the pump, and then to the patient to ensure that it is connected to the proper port. After the independent verification, the clinicians should compare their results and document in the EHR.

On 5/4/21 at 1300 hours, a tour of the sixth floor ICU was conducted with Nursing Director 8, CNS 1, CNM 1, and NCE 3.

On 5/4/21 at 1337 hours, medical record review for Patient 60 and concurrent interview was conducted with CNS 1, CNM 1, and NCE 3.

When asked, CNS 1, CNM 1, and NCE 3 explained the medication administration actions associated with the Heparin IV Drip Protocol Order, including associated lab orders and review of orders for accuracy based on the patient's weight; and the safety features with Heparin including the independent double check process for each component of the Heparin order by two RNs and required dual sign documentation needed to be completed.

The MAR from 5/3/21 through 5/4/21, for Patient 60 was reviewed for the high alert medication Heparin.

The laboratory results for aPTT were reviewed for 5/3/21 through 5/4/21. The results showed the aPTT value of 144.9 on 5/3/21 at 1930 hours.

The corresponding physician order and administration instructions for Heparin were reviewed to determine if the Heparin dose, following the aPTT result of 144.9, was administered as ordered by the physician and titrated as per the Heparin administration instructions.

The Heparin administration instructions showed in part:

* RN to titrate drip based on 82 kg.

* For aPTT 140.1 - 180, hold heparin infusion for 1 hour.

* Restart based on the following:

- patient weight of 50 to 83 kg: decrease by 300 units/hr,
- patient weight >83 kg: decrease by 400 units/hr.

The MAR showed Patient 60 received the wrong dose of Heparin from 5/3/21 at 2115 through 5/4/21 at 1300 hours, as a result not using the correct dosing weight of 82 kg as ordered by the physician.

CNM 1 and NCE 3 confirmed the findings.


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2. During a review of the hospital's P&P titled Medication Administration dated 3/2021, the P&P indicated, "The medications listed in Appendix B may be administered IV push by RNs per the designated parameters identified in the guidelines...Appendix B: Adult IV Push Medication Guidelines...Methylprednisolone Succinate...Over >or= (greater or equal) 1 min (Administer doses of 250 mg over 5 min)...Rate dependent upon dose and severity of condition; typical intermittent infusion is administered over 15 - 60 min; severe adverse effects, including hypotension, cardiac arrhythmia, and sudden death, have been reported in patients receiving doses >250 mg administered over < 30 min"

On 5/5/21 at 0845 hours, a medication pass observation was conducted with RN 9 on the fifth floor Medical - Surgical unit. RN 9 was observed administering methylprednisolone 100 mg via IVP to Patient 37 in approximately 6 seconds.

During a concurrent interview and record review with the MSO, RNs 9 and 11 on 5/5/21 at 0950 hours, RN 9 was asked how long he should administer methylprednisolone 100 mg IVP. RN 9 stated he should administer methylprednisolone 100 mg IVP over one minute. RN 9 confirmed that he administered methylprednisolone IVP in approximately 6 seconds.

3. During a review of the hospital's P&P titled, "Medication Administration" dated 3/2021, the P&P indicated, "Before administration, the individual administering the medication must: ...Verify that the medication is being administered at the proper time, in the prescribed dose and by the correct route"

On 5/5/21 at 0845 hours, a medication pass observation was conducted with RN 9 for Patient 37. When asked about the medications for Patient 37, RN 9 stated these medications that he prepared were all of the patient's medications for this morning. RN 9 did not prepare cetirizine 20 mg to administer for Patient 37.

During a concurrent record review and interview with the MSO, RNs 9 and 11 on 5/5/21 at 0940 hours, Patient 37's medical record was reviewed.

Review of the Medications and Medication Administration Report showed an order for cetirizine 20 mg by mouth two times per day on Monday, Tuesday, Wednesday with the start date of 5/4/21, and the end date of 5/10/21. RN 9 stated he missed cetirizine 20 mg dose this morning and he should have reviewed the MAR before administering the medications for Patient 37. RN 9 further stated cetirizine should be given to Patient 37 this morning. The MSO and RN 11 confirmed the finding.

Based on observation, interview, and record review, the hospital failed to develop and implement the hospital's P&P for the safe and effective storage and disposition of the medications as evidenced by:

1. The hospital failed to develop their P&P for the contents of medication supply in their malignant hyperthermia (MH) kit in accordance with the MHAUS (Malignant Hyperthermia Association of the United States) guidelines. This failure had the potential to delay in treatment of patients with malignant hyperthermia.

2. Two different neuromuscular blocking agents (used to relax skeletal muscles and induce paralysis) were stored in the same bin in the medication refrigerator. This failure had the potential for giving incorrect neuromuscular blocking agents to patients.

3. The hospital failed to ensure the patient's personal medications were destroyed in accordance with the hospital's P&P for two of 63 sampled patients (Patients 35 and 36). This failure had the potential to create the risk of misuse of the medications.

Findings:

1a. Review of the hospital's P&P titled Malignant Hyperthermiadated 4/1/19, showed "To establish guidelines for the contents and placement of Malignant Hyperthermia Kits at (name of hospital) ...Malignant hyperthermia is a life threatening condition that develops during or after the administration of drugs commonly used in anesthesia. Volatile inhalational anesthetics ...and/or ...neuromuscular blocking agents (succinylcholine) are the most frequently identified triggering agents ...Each malignant hyperthermia kit shall contain the appropriate standard medication, diluent and associated supplies ...Appendix A ...Malignant Hyperthermia Kit Contents ...
3 - 250 mg dantrolene (muscle relaxant medication) vial
3 - 50 ml dextrose 50% (medication used to treat low blood sugar) vial
3 - 10 ml sterile water for injection vial
6 - 18 gauge needles
6 - blunt needles
1 - drape for ice
3 - 5 ml syringe
3 - 60 ml syringe
MHAUS guidelines
Pharmacy requisition order form"

Review of the MHAUS website, www.mhaus.org/healthcare-professionals/be-prepared/ (2021), under the section for "What Should be on an MH Cart?" indicated, "Dantrolene ...Sodium bicarbonate (8.4%) (medication used to neutralize excess acid levels in the blood) - 50 ml x 4 ...Calcium chloride (10%) (calcium salt, electrolyte supplement) - 10 ml vial x 2 ...Lidocaine (medication used to treat irregular heartbeat) for injection (2%) - 100 mg/5 ml or 100 mg/10 ml in preloaded syringes (3) ..." showed the following:

- Malignant Hyperthermia Association of the United States (MHAUS) is a 501 (c)(3) nonprofit organization. The mission of MHAUS is to promote optimum care and scientific understanding of MH and related disorders.

- MH is a potentially fatal, inherited disorder usually associated with the administration of certain general anesthetics and/or the drug succinylcholine (neuromuscular blocking agent) and the MH cart contains medications and supplies necessary for the immediate treatment of life-threatening MH emergencies.

During a concurrent observation and interview with the MSO, RPH 5, and AN II in the ED on 5/6/21 at 0850 hours, the MH kit was inspected. The MH kit did not have sodium bicarbonate, calcium chloride, and lidocaine. RPH 5 stated the contents of MH kit had been reviewed by the pharmacy management. The MSO stated the contents of MH kit should be kept in one place.

During a follow-up interview with the DIP and MSO on 5/6/21 at 1305 hours, and 5/7/21 at 0800 hours, the DIP stated the hospital followed the MHAUS guidelines. The MSO confirmed four vials of 50 ml sodium bicarbonate (8.4%), two vials of 10 ml calcium chloride (10%), and three syringes of 5 ml lidocaine (2%) were not available in the ED's MH kit on 5/6/21 at 0850 hours.

b. On 5/6/21 at 0845 hours, the Surgical Department was toured and the MH Kit was inspected; and the following medications were included in the MH kit: Three 250 mg vials of dantrolene (for treatment of MH) and three 50 ml vials of dextrose 50% (to treat low blood sugar level or high blood potassium level).

In a concurrent interview, the DIP confirmed the above medications in the kit. The DIP also stated the injectable vial of regular insulin (medication used for high blood sugar) was located in the second floor satellite pharmacy not specifically marked for use in MH medical emergencies.

2. Review of the hospital's P&P titled Medication Storage/Security dated 1/21/21, showed "All medications shall be stored under appropriate conditions of sanitation ...and segregation to ensure product safety and stability ...Medications that may be easily confused (e.g., sound-alike/look-alike) shall be physically separated or visually segregated (e.g., signage) ..."

Review of the hospital's P&P titled High Alert Medication Policy dated 10/2020, showed "High alert medications are those medications that bear a heightened risk of causing significant patient harm when they are used in error ...high alert medications are identified as the following: ...Neuromuscular blocking agents ...High Alert medications stored in the Pyxis medstations will have a "high alert" warning affixed to the Pyxis cubie to alert the staff that this is a high alert medication."

During an observation and concurrent interview with the MSO, RPH 5, AN II, and NCE 1 in the ED's medication room on 5/6/21 at 0755 hours, the medication refrigerator linked to the Pyxis was unlocked. In the medication refrigerator, 10 vials of rocuronium (neuromuscular blocking agent) 50 mg/5 ml were stored in the same orange bin with 10 vials of succinylcholine 200 mg/10 ml. These vials had a similarly colored label on them. These vials had the sign "WARNING: Paralyzing agent." There was no high alert warning on these vials. RPH 5 stated these vials should be separated.

During a follow-up interview with the DIP and MSO on 5/6/21 at 1305 hours, the MSO stated neuromuscular blocking agents should be in separated bins in the refrigerator. The Rocuronium and succinylcholines vials should be separated.

3. Review of the hospital's P&P titled Receipt and Storage of Patient's Personal Medication dated 6/20/20, showed "To establish a uniform procedure for receipt ...and disposition of patient's personal medication ...Medications left in the pharmacy after the patient has been discharged shall be stored in the appropriate inpatient pharmacy practice area for 30 days. If, after this time the medication remains unclaimed, it shall be destroyed."

During an observation and concurrent interview with the DIP, MSO, and RPH 9 in the seventh floor satellite pharmacy on 5/4/21 at 1540 hours, the patient's personal medications were inspected. One bottle of moxifloxacin (an antibiotic) 400 mg that belonged to Patient 35 and one bottle of pilocarpine (medication used to treat dry mouth) 5 mg that belonged to Patient 36 were stored with other medications in the drawer. RPH 9 stated Patients 35 and 36 were already discharged from the hospital; Patient 36 was discharged from the hospital on 2/17/21 (more than two months ago). RPH 9 further stated the patient's personal medications should be disposed after the patient had been discharged for 30 days. The DIP stated the patient's personal medications should be returned to the patient at the time of discharge. The DIP further stated after patient had been discharged for 30 days, the patient's personal medications should be discarded.

During an interview and concurrent record review with the DIP and MSO on 5/6/21 at 1325 hours, the DIP and MSO confirmed Patient 35 was discharged from the hospital on 12/25/20 (more than four months ago), and Patients 35 and 36's personal medications should be discarded.

Based on interview and record review, the hospital failed to ensure the current and accurate records of the control substances as evidenced by:

1. Failure to implement the hospital's P&P for accountable destruction of the control substances (CS) when the nursing staff did not carry out the medication wasting of hydromorphone (a control substance medication for pain management) 0.5 mg until at least 5 hours later for one of 59 sampled patients (Patient 38).

2. The CS surveillance and audit tool called, "Proactive Diversion Report," was not reviewed by the Pharmacy Department in accordance with the hospital's P&P; and

3. Failure to ensure the actual waste and documentation of partially used CS was performed in a timely manner and not at an unspecified amount of time later. In addition, the late wasters of partial CS doses were not be captured on the hospital's currently utilized artificial intelligence (AI) software report.

These failures had the potential for the diversion of controlled medications and may negatively impact the patients' health and safety.

Findings:

1. During a review of the hospital's P&P titled, "Wasting Controlled Substances" dated 3/2020, the P&P indicated, ""Medication wasting" is the accountable destruction of a controlled medication which requires additional accountability to confirm that the destruction was documented and carried out appropriately ...Medication wasting is required when an ordered dose of controlled substances (e.g. fentanyl [a control substance medication for pain management]) is less than the amount contained in the drug container ...Medication wasting shall be performed with a witness, prior to administration, if waste is present when the dose is removed from the automated dispensing cabinet (ADC) (e.g. Pyxis). Waste after administration may be performed in areas where nursing workflow and patient care doesn't allow for prior wasting (e.g. PACU, OR, MPU) ...Medications removed from an ADC shall be wasted and witnessed via an ADC ..."

Patient 38's medical record was reviewed on 5/7/21. Patient 38 was admitted to the facility on 5/3/21.

Review of the Medication Administration Report for Patient 38 from 5/1/21 to 5/7/21, showed hydromorphone 1.5 mg IV every four hours as needed for severe pain with the start date of 5/6/21.

During an interview and concurrent record review with RPH 10 and RN 10 on 5/7/21 at 1000 hours, RN 10 stated Patient 38 was in the Medicine unit. RPH 10 stated hydromorphone 2 mg was removed from the ADC (Pyxis) for Patient 38.

Review of Patient 38's MAR showed hydromorphone 1.5 mg was administered to Patient 38 on the following dates and times:

- On 5/6/21 at 2053 hours, and

- On 5/7/21 at 0043 hours.

Review of Patient 38's Pyxis report showed hydromorphone 0.5 mg was wasted on the following dates and times:

- On 5/7/21 at 0629 hours, (more than 9 hours since administering of hydromorphone 1.5 mg) and

- On 5/7/21 at 0629 hours (more than 5 hours since administering of hydromorphone 1.5 mg).

RN 10 stated hydromorphone 0.5 mg should be wasted and witnessed from the Pyxis. RN 10 further stated the nurse should waste hydromorphone 0.5 mg as soon as they administered hydromorphone 1.5 mg to Patient 38. RN 10 and RPH 10 acknowledged the nurse had hydromorphone 0.5 mg with them for more than 9 hours and 5 hours, respectively before wasting it. RN 10 stated it would be too long for the nurse to waste hydromorphone 0.5 mg at the end of the shift.

During a follow-up interview with the DIP and MSO on 5/7/21 at 1415 and 1445 hours, the DIP stated hydromorphone 0.5 mg wasting should be as soon as possible when the nurse administered hydromorphone 1.5 mg. It would be inappropriate to waste hydromorphone 0.5 mg after more than 5 hours, or 9 hours of administering hydromorphone 1.5 mg. The DIP further stated the nurse took too long to waste hydromorphone 0.5 mg. The DIP and MSO confirmed the finding.

2. The hosptial's P&P titled, "Distribution of Inpatient Medications via the Pyxis Medstation," with the effective date of 1/31/2020 indicated:

"Proactive Diversion Reports...

A report of the previous month shall be generated electronically and sent to the Nurse Managers and the Director/Assistant Director of Nursing on a monthly basis. This report is designed to identify users who remove significant quantities of controlled substances compared to hospital-wide users and compared to team members working in the same patient care area. If a particular user stands out above an expected or reasonable number of removals, the manager may want to review additional patient information to determine if the removals were appropriate..."

On 5/6/21 at 1340 hours, in a discussion to address the controlled substance use and monitoring, RPH 4 stated she would be the primary person that reviewed the CS reports from Monday to Friday. RPH 4 stated the Proactive Diversion Reports were not reviewed at all but instead she reviewed the AI based program called, "Protenus."

3. The hospital's P&P titled, "Wasting Controlled Substances," with the approved date of "02/2020," indicated:

"Medication Wasting is the accountable destruction of a controlled medication which requires additional accountability to confirm that the destruction was documented and carried out appropriately...

Medication wasting shall be performed with a witness, prior to administration, if waste is present when the dose is removed from the automated dispensing cabinet (ADC) (e.g. Pyxis). Waste after administration may be performed in areas where nursing workflow and patient care doesn't allow for prior wasting (e.g. PACU, OR, MPU)..."

On 5/6/21 at 1340 hours, during an interview, RPH 4 stated the undocumented CS waste report was generated daily for the nurse managers and directors to review and resolve, and the resolution of undocumented waste was reviewed by RPH 4 for appropriateness. RPH 4 stated the documented resolution of the waste would close the loop and would be considered resolved regardless of the amount of time taken to resolve and document the waste.

Review of "Undocumented Waste" report with the date range from 5/5/21 at 0000 hours to 5/6/21 at 2359 hours, showed one ICU staff accessing two injectable vials of hydromorphone (narcotic pain medication) 1 mg/ml as follows: one vial on 5/6/21 at 1024 hours and another vial at 1009 hours; and used 0.5 mg of each.

The waste documentation on another report provided by RPH 4 showed the wasting of two 0.5 mg hydromorphone were documented on 5/6/21 at 1735 and 1736 hours, approximately 9 hours later.

On 5/7/21 at 0910 hours, during an interview, RPH 4 stated either nursing or pharmacy policy did not address the appropriate timeframe between the administration and waste of CS.

In a concurrent interview, the DIP confirmed the P&P did not address specific time frame for staff to document the waste of CS.

In a concurrent interview, RPH 4 stated the Protenus Suspicious Activity Monitoring Report would be generated automatically for 7 to 10 users having access to the CS weekly. The Protenus reports for suspicious users were generated based on the internal algorithm with the suspicious score.

One example of Protenus report for a user with the suspicion score of 77 during the assessment period between 10/14/20 and 11/13/20, was reviewed. One of the factors accounting for the score was "waste of the full amount dispensed as compared to the user's peer group." However, the report did not factor in wasting of the partial amount of CS after administration.

In a concurrent interview, RPH 4 acknowledged the report did not include the number of partial dose waste of CS.

Based on observation, interview, and record review, the hospital failed to ensure the evaluation of medication therapy related to lab values and distribution of medications as evidenced by:

1. The triglycerides blood levels for one of 63 patients (Patient 57) was not obtained while receiving 20% intravenous fat emulsion and propofol (anesthetic) IV drip.

2. Adequate supply of medications/antidote was not made available to the PICU for the emergency treatment of benzodiazepines (medications used for sedation) as indicated on the facility's dosing guideline.

3. Emergency medication maintained in the pediatric emergency medication supply carts (crash carts) was not corresponding to the dosing guidelines available for immediate treatment, without delay, of pediatric patients undergoing life-threatening conditions.

4. Medications were not stored to preserve potency and integrity according to the manufacturer's recommendations to protect them from light.

These created the potential for delay in emergency treatment and patients receiving non-sterile, ineffective injectable medications.

Findings:

1. According to Lexicomp, propofol is formulated in oil-in-water emulsion. If the patient is on parenteral nutrition, such as 20% intravenous fat emulsion and propofol, the amount of lipids infused may need to be adjusted. Fat emulsions are a source of calories and fatty acids for patients requiring parenteral nutrition for extended use (usually longer than 5 days). Following IV infusion of fat emulsion, a transient increase in plasma triglycerides concentrations occur.

On 5/4/21 at 1310 hours, a tour of the eight floor ICU was conducted with CNS 6, Nursing Director 1, and the Director of the Critical Care. Patient 57 was observed orally intubated with multiple IV medication drips. During the unit tour, RN 1 was interviewed and stated the patient was admitted to the hospital on 4/16/21, with diagnosis of chronic liver failure, liver cirrhosis due to alcoholism, and listed as a liver transplant recipient.

When asked, RN 1 stated Patient 57 had several IV drip medications ordered including 20% intravenous fat emulsion and propofol. RN 1 added, Patient 57 received 20% intravenous fat emulsion for 12 hours daily.

On 5/6/21 at 0915 hours, medical record review for Patient 57 was conducted with RNs 6 and 7.

Review of the propofol drip order history showed the physician's order dated 4/21/21, to infuse propofol 10 mg/ml drip at 50 mcg/kg/min x 70.7 kg, continuous at 21.21 ml/hr, target goal of RASS score 0 (awake) to -1 (drowsy); and to initiate drip at 5 mcg/kg/min, increase or decrease by 5-10 mcg/kg/min every 30 minutes until the goal RASS achieved, to a maximum dose of 80 mcg/kg/min.

Further review of the propofol drip order history showed the new physician's order dated 4/27/21, for 50 mcg/kg/min continuous at 21.21 ml/hr, target goal of RASS - 1 (drowsy) to -2 (light sedation); and to Initiate drip at 5 mcg/kg/min, increase or decrease by 5-10 mcg/kg/min every 30 minutes until the goal RASS achieved, to a maximum dose of 50 mcg/kg/min.

Review of the fat emulsion order history showed the physician's order dated 4/27/21 at 2200 hours, to infuse 250 ml 20% intravenous fat emulsion (250 ml) at a rate of 20.83 ml/hr for 12 hours.

On 5/6/21 at 1230 hours, medical record review and concurrent interview was conducted with the MSO. When asked about triglycerides blood level for the patients receiving 20% intravenous fat emulsion and propofol IV infusions, the MSO stated the triglycerides blood levels should be checked once a week.

Review of the hospital's P&P titled TPN Per Pharmacy Protocol revised 1/21/19, was conducted with the MSO. The hospital's TPN P&P did not show that triglycerides blood levels had to be checked once a week.

The MSO verified the above findings and stated as per the Proper Monitoring of TPN guidance, it was necessary for triglycerides blood levels to be checked on day 4 after the lipid was started and every Monday thereafter for all TPN and fat emulsion ordered by the pharmacy or the physician.

Patient 57's triglycerides blood levels from 4/26/21 through 5/4/21 were reviewed. The MSO stated there was no documentation showing the triglycerides blood levels were checked on day 4, after the 20% intravenous fat emulsion was started.


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2. On 5/5/21 at 1535 hours, the PICU was toured and the Adult/Pediatric Crash Cart was inspected and identified to not include an injectable medication called, flumazenil (a rescue drug used to treat overdose of sedatives such as benzodiazepines).

The hospitals Pyxis MedStation, an automated drug dispensing system, located in the medication room did not contain flumazenil either.

In a concurrent interview, Clinical Nurse Specialist 8 stated instead of Broselow Tape (A color-coded length-based tape measure that is used for pediatric emergencies. The Broselow Tape relates a child's height as measured by the tape to his/her weight to provide medical instructions including medication dosages.), the hospital would use system generated dosing guideline based on the patient's weight called, "Pediatric Emergency Drug Sheet."

Review of the Pediatric Emergency Drug Sheet showed flumazenil and the dose based on the patient's weight was included as an antidote.

In a concurrent interview, the DIP confirmed the injectable flumazenil was not included in the crash cart or Pyxis MedStation in the PICU medication room.

3. On 5/5/21 at 1535 hours, the PICU was toured and the Adult/Pediatric Crash Cart was inspected and identified to contain an injectable medication called, magnesium sulfate (a medication used to treat electrolyte imbalance and dangerously irregular heartbeat during an emergency).

However, review of the weight based Pediatric Emergency Drug Sheet showed no dosing guideline for magnesium sulfate.

In an interview on 5/5/21 at 1600, the Director of Pediatrics Unit (DPU) stated the facility would follow PALS (Pediatric Advanced Life Support) guidelines by American Heart Association (AHA) and all unit staff were PALS certified.

According to the AHA Circulation article, "2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care":

"Magnesium is indicated for the treatment of documented hypomagnesemia or for torsades de pointes (polymorphic VT associated with long QT interval)...

Magnesium sulfate...25-50 mg/kg IV/IO over 10-20 minutes, faster in torsades de pointes Maximum dose 2 g..."

According to Lexicomp, a leading pharmacy drug reference:

"Torsades de pointes, ventricular tachycardia...IV, Intraosseous: 25 to 50 mg/kg/dose; if pulseless, administer as a bolus; if pulse, administer over 10 to 20 minutes (...PALS [Kleinman 2010])..."

4. Review of the hospital's P&P titled, "Medication Storage/Security" with the effective date of 1/21/21 indicated:

"Medications shall be stored appropriately...Medications requiring protection from light shall be stored in a light-resistant container (e.g., opaque plastic, amber glass/plastic, cardboard container)..."

On 5/6/21 at 0745 hours, during a tour of the third floor pediatrics satellite pharmacy, the following medications were exposed to ambient light:

- 55 injectable vials of neostigmine (medication used to treat autoimmune disease that caused muscle weakness) 10 mg/10 ml

- 1 injectable vial of phenylephrine (medication to increase blood pressure) 10 mg/ml

- 24 injectable vial of nicardipine (medication used to manage blood pressure) 25 mg/10 ml

- 10 injectable syringes containing epinephrine (medication to increase blood pressure) 1 mg/10 ml

- 10 injectable syringes containing phenylephrine (medication to increase blood pressure) 1 mg/10 ml.

The instruction on the label of above medications showed to "Protect from light."

In a concurrent interview, the DIP confirmed the instruction on the label and agreed that the above medications were not protected from light.

Based on observation, interview, and record review, the hospital failed to implement the hospital's P&P for the safe sterile compounding in accordance with the USP <797> when:

1. The pharmacy failed to ensure the ceiling in the negative pressure clean room (buffer area, where the IV hood is located) for compounding hazardous products was cleaned.

2. The pharmacy failed to ensure the outside company cleaned the entire area behind IV hood (equipment use for compounding of sterile preparations) and the back wall.

3. The hospital failed to ensure only low risk level sterile compounding of IV medications took place inside the IV hood in an area designated as segregated compounding area (SCA) in the OR pharmacy.

These failures had the potential to increase the risk of contamination of the sterile compounding products and for exposing patients to contaminated IV products.

Findings:

During an interview with the Director of Inpatient Pharmacy (DIP) and the Medication Safety Officer (MSO) on 5/4/21 at 1330 hours, the DIP stated the hospital followed the USP Chapter <797> as the hospital's standards for the compounding of CSPs.

1. During a review of the hospital's P&P titled, "Cleaning Procedures in Sterile Compounding Areas" dated 2/5/21, the P&P indicated, "Exterior work surfaces and other hard surfaces in the cleanroom or segregated compounding area such as walls, floors, ceilings, shelves, tables and chairs must be smooth, impervious, free from cracks and crevices, and non-shedding. In the cleanroom, junctures of ceilings to walls should be coved or caulked to avoid cracks and crevices where dirt can accumulate ...The minimum frequency of cleaning and disinfecting of compounding areas can be found in the following table: ...Ceilings ...Weekly " USP Chapter <797> is one of the references of this hospital's P&P.

Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations (last revised 2008) in the section Facility Design and Environmental Controls showed, "The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the buffer area shall be smooth, impervious, free from cracks and crevices, and nonshedding, thereby promoting cleanability and minimizing spaces in which microorganisms and other contaminants may accumulate ...The exterior lens surface of ceiling lighting fixtures should be smooth, mounted flush, and sealed. Any other penetrations through the ceiling or walls shall be sealed ..."

During an observation and concurrent interview with RPHs 2 and 3, and RXT 1 in the negative pressure clean room for compounding hazardous products of the I.V. Additive Service (pharmacy) on 5/5/21 from 1345 to 1445 hours, RPH 2 stated this negative pressure clean room was used to compound the chemotherapeutic drugs (medications used to treat cancer). The following was observed on the ceiling of the negative pressure clean room:

- Black spots and holes on the caulking around the light.
- Two missing screws on one of the light.
- Greenish substances around the concealed sprinkler head.
- Three rusty screw heads.

RPHs 2, 3, and RXT 1 confirmed the findings.

A follow-up interview was conducted with RPH 4 on 5/5/21 at 1550 hours, RPH 4 acknowledged there was a potential for bacterial growth in the greenish substances around the concealed sprinkler head.

2. During a review of the hospital's P&P titled, "Cleaning Procedures in Sterile Compounding Areas" dated 2/5/21, the P&P indicated, "An outside company will be trained on both the cleaning procedure and garbing prior to initiating the cleaning process ...The (hospital's name) I.V. Additive Service shall have an outside company clean the laminar hoods, BSC (Biological Safety Cabinet), walls, ceilings, floors and storage shelving on a weekly basis utilizing a sporicidal agent followed by sterile water ...An outside company shall clean all segregated compounding areas including the laminar hoods, walls, ceilings, floors and storage shelving on a monthly basis utilizing a sporicidal agent followed by sterile water ...An outside company shall clean weekly for all segregated compounding areas including the laminar hoods, walls, ceilings, floors and storage shelving on a weekly basis utilizing PREempt RTU followed by sterile water."

Review of the USP General Chapter <797> Pharmaceutical Compounding - Sterile Preparations (last revised 2008) in the section Cleaning and Disinfecting the Compounding Area showed, "Environmental contact is a major source of microbial contamination of CSPs. Consequently, scrupulous attention to cleaning and disinfecting the sterile compounding areas is required to minimize this as a source of CSP contamination."

a. During an observation and concurrent interview with the DIP in the SCA of the sixth floor satellite pharmacy on 5/4/21 at 1430 hours, there was a Laminar Airflow Workbench (LAFW, an IV hood) in the SCA. The LAFW was observed bolted to the floor to prevent it from moving. There were walls on both sides and the back of the LAFW. The gap between the LAFW and the sidewalls were about five to six inches. The gap between the LAFW and the back wall was about three inches. When asked about the area behind the LAFW, the DIP stated the outside company cleaned the area weekly, and she had not seen them clean the area behind the LAFW. The DIP acknowledged there was not enough room for the outside company to use the mop to clean the area behind the LAFW. The DIP would like to contact them to find out. The DIP stated they probably did not clean the areas behind the LAFW and the back wall.

b. During an observation and concurrent interview with the DIP in the SCA of the eighth and seventh floor satellite pharmacies on 5/4/21 from 1450 to 1550 hours, , the DIP stated there was the same issue regarding cleaning of the area behind the hood.

During an interview with the DIP and MSO on 5/6/21 at 1325 hours, the DIP stated six of the satellite pharmacies located on the second, fourth, fifth, sixth, seventh, and eighth floors had the similar issues of cleaning the area behind the hoods.

On 5/7/21 at 0810 hours, an interview was conducted with the DIP and RPH 4. RPH 4 stated the outside company could not clean the area behind the hoods entirely. The DIP stated the outside company might clean a little bit but not completely the entire area behind the hoods and back walls.

On 5/7/21 at 0945 hours, during an observation and concurrent interview with the DIP in the SCAs of the second, fourth and fifth floor satellite pharmacies, the DIP confirmed the gap between the hoods and back walls was about two to three inches, and the area behind the hoods could not be cleaned entirely.

c. During an observation and concurrent interview with RPHs 2, 3, and RXT 1 in the negative pressure clean room for compounding hazardous products of the I.V. Additive Service on 5/5/21 from 1345 to 1445 hours, RPH 2 stated this negative pressure clean room was used to compound the chemotherapeutic drugs. There was a BSC in the negative pressure clean room. The BSC was observed bolted to the floor to prevent it from moving. There were walls on the left side and back of the BSC. The gap between the sidewall and BSC was about two inches. The gap between the back wall and BSC was about three inches. There was a workstation on the right side of the BSC with a small gap between the BSC and the counter of the workstation. RPH 2 stated the outside company could not clean the area on the left side and behind the BSC.

During a follow-up interview with the DIP and MSO on 5/6/21 at 1325 hours, the DIP stated the outside company could clean the side of the BSC but could not clean the area behind the BSC. The DIP further stated there was no way for the outside company to clean the entire area behind the BSC; and the area behind the BSC should be cleaned.

3. Review of the hospital's P&P titled, "Compounding of Intravenous Admixtures - Overview," with the effective date of 2/2/21, indicated:

"The inpatient satellite pharmacies...do not function in a USP 797 cleanroom. They are segregated compounding areas where compounding occurs in an ISO Class 5 laminar airflow hood that is not located in an ISO Class 7 cleanroom. The beyond use date [BUD] for products compounded in these areas is no greater than 12 hours..."

American Society of Health-System Pharmacists (ASHP), a nationally recognized pharmacy organization, represents pharmacists who serve as patient care providers in acute and ambulatory settings and is at the forefront of efforts to improve medication use and enhance patient safety.

According to "ASHP Guidelines on Compounding Sterile Preparations,

"...A beyond-use date (BUD) is the date or time after which administration of a CSP shall not be initiated. As described in previous ASHP guidelines and in USP chapter 797, the BUD is determined from the date or time the preparation is compounded, its chemical stability, and the sterility limits described later in these guidelines. Both the stability of the components and the sterility limits described above must be taken into consideration when determining BUDs, and the BUD must be the shorter of the sterility dating or chemical stability dating...

Medium-Risk CSPs, this category encompasses preparations requiring more complex compounding processes, including: o Multiple doses of sterile products combined or pooled to prepare a product that will be administered either to multiple patients (i.e., batching of syringes or large volumes), or one patient on multiple occasions (e.g., preparation for use over several days)."

According to USP Chapter <797>,

" Low-Risk Conditions...

The compounding involves only transfer, measuring, and mixing manipulations using not more than three commercially manufactured packages of sterile products and not more than two entries into any one sterile container or packages (e.g., bag, vial) of sterile products or administration container/device to prepare the CSP...

Segregated Compounding Area: A designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSPs with 12-hour or less BUD. Such area shall contain a device that provides unidirectional airflow of ISO Class 5 (see Table 1) air quality for preparation of CSPs and shall be void of activities and materials that are extraneous to sterile compounding..."

Review of the OR satellite pharmacy's "Sterile Compounding Log" indicated a CSP with the following instruction was made in the OR satellite pharmacy's SCA on 5/3/21:

Alteplase (medication used to clear catheter obstruction) 2 mg...Dilute 2 mg vial with 2.2 ml sterile water to make concentration 2 mg/2 ml...5 ml in an IV bag containing Sodium chloride 0.9% 500 ml.

On 5/7/21 at 0840 hours, during an interview, the MSO stated the OR pharmacy IV compounding area was classified as a SCA with an IV hood used only to make low risk level CSPs with BUD of 12 hours. The MSO confirmed the final IV product was prepared in the OR pharmacy.

The MSO explained each vial, when mixed, would result in a concentration of 2 mg/2 ml and to arrive at the finished IV product the compounder would need three vials of alteplase 2 mg mixed with sterile water then, transfer 5 ml to the 500-ml normal saline 0.9% IV fluid bag.

The MSO acknowledged the final compounded product would be considered a medium risk level compounding and stated it should have been prepared in a USP <797> certified IV clean room located in the basement.

Based on observation, interview, and record review, the hospital failed to keep the IV solutions securely when two bags of 1000 ml 0.9 % sodium chloride (IV fluid) injection were stored on the top of the Pyxis in the ED's Trauma 2. This failure had the potential for IV solutions to be accessible to unauthorized persons and possible misuse of the medications.

Findings:

During a review of the hospital's P&P titled, "Medication Storage/Security" dated 1/21/21, the P&P indicated, "Medications shall be stored in secure areas in such a manner that visitors, patients, or other unauthorized staff may not obtain access ...Medications shall be stored only in the following locations:
i. locked medication rooms
ii. locked medication cabinets
iii. Pyxis medstations/towers
iv. locked refrigerators or refrigerators in locked medication rooms
v. locked medication carts
vi. pharmacy practice areas.
vii. Omnicell automated dispensing devices (plain IV solutions) ...
Medications may be stored outside of a locked area only when the area in which the drugs are stored is under constant direct observation by a licensed individual authorized to handle medications."

During an observation and concurrent interview with the MSO, AN II, NCE 1, and RN 11 in the ED's Trauma 2 on 5/6/21 at 0815 hours, two bags of 1000 ml 0.9% sodium chloride injection were observed on the top of the Pyxis. AN II stated the IV solutions should not be on the top of the Pyxis and these bags should be returned to the Pyxis. The MSO, NCE 1 and RN 11 acknowledged the finding.

Based on observation, interview, and record review, the hospital failed to ensure only authorized personnel had access to the unlocked refrigerators in the medication rooms. This failure had the potential for medications to be accessible by unauthorized persons and possible misuse of the medications.

Findings:

Review of the hospital's P&P titled Medication Storage/Security dated 1/21/21, showed "Only the following authorized staff members (e.g., licensed personnel who by virtue of their state licensure are authorized to handle medications or those whose job description includes the management of medications as part of the medication use process) may access medications: ...Material Management personnel (IV solutions w/o [without] drugs) ...Individuals whose job description includes specific tasks related to medication handling may have limited access to medications or medication storage areas solely for the performance of the tasks delineated in their job functions."

1. During a concurrent observation and interview with the MSO and RPH 5 in the ED's medication room on 5/6/21 at 0850 hours, CST II was observed in the locked medication room without supervision of the authorized personnel. There was an unlocked refrigerator in the medication room with the label "Unlocked Med (medication) Refrigerator". Insulin (medication to lower blood sugar) vials (Humulin R and Novolog) were in the bin in the unlocked refrigerator. CST II stated he had the access to this locked medication room and he did not need anyone to be in the room with him. The MSO stated CST II should not have access to this unlocked refrigerator because CST II was not an authorized personnel to access to the medication in this unlocked refrigerator.

2. During an observation and concurrent interview with the MSO, Nursing Director 5, and DLMM in the medication room of the observation unit on 5/6/21 at 0925 hours, an unlocked refrigerator was observed in the medication room. Cefepime (an antibiotic) 1 gm in dextrose (IV fluid) 5% 50 ml and diltiazem (blood pressure, chest pain medication) 5 mg in dextrose 5% 50 ml were in the unlocked refrigerator. The DLMM stated the central service staff had access to the medication room. When asked about the unlocked refrigerator, the DLMM stated the central service staff had nothing to do with the refrigerator. Nursing Director 5 stated the central service staff could be in the medication room by themselves. The MSO and Nursing Director 5 acknowledged the refrigerator was unlocked.

During a follow-up interview with the DIP and MSO on 5/6/21 at 1310 hours, the DIP stated CST II was not an authorized personnel and should not have access to the unlocked refrigerator.

Based on observation, interview, and record review, the hospital failed to ensure the outdated (no longer useful), expired, or deteriorated (reduced quality) medications were not available for patient use as evidenced by:

1. One outdated IV bag of insulin (medication to lower blood sugar) was found in the oral medication bin labeled, "look alike sound alike," on the sixth floor satellite pharmacy.

2. One expired bag of D5W [Dextrose 5% in water (an IV solution)] 50 ml was found on the eighth floor satellite pharmacy and one expired bag of the pre-mixed sodium bicarbonate (medication use to neutralize excess acid levels in the blood) was found in the seventh floor satellite pharmacy.

These failures had the potential of exposing patients to expired or deteriorated medications that could lead to ineffective treatment (such as longer hospitalization or condition deterioration) for patients.

Findings:

Review of the hospital's P&P titled Managing Unusable, Contaminated, Deteriorated, and/or Expired Medications in the Hospital Setting dated 11/2020, showed "To prevent the inadvertent distribution and administration of an outdated or unusable (contaminated or deteriorated) medication to a patient ...Expired, expiring ...and unusable medications shall be identified, removed, and sequestered from medication storage areas as discovered and during monthly inspections of medication storage or patient care areas, and anywhere hospital medications, procured for patients under the Hospital license, are found ...Expired and expiring medications will be placed in segregated bins labeled as such...Medications that have expired shall be removed immediately from the pharmacy practice areas."

1. During an observation and concurrent interview with the DIP, MSO, and RPH 6 in the sixth floor satellite pharmacy on 5/4/21 at 1400 hours, one bag of insulin 100 units/0.9 % sodium chloride (an IV solution) 100 ml and hydroxyzine (medication used to treat allergic conditions) 25 mg tablets were observed stored in the bin with the label of look alike, sound alike. The insulin bag was labeled with BUD RT: 05/02/2021. The MSO and RPH 6 confirmed the observation. The MSO stated the insulin bag should not be stored at the room temperature and should not be in the same bin with the hydroxyzine tablets. RPH 6 stated the insulin bag should not be used and should be discarded.

2a. During an observation and concurrent interview with the DIP, MSO, and RPH 8 in the eighth floor satellite pharmacy on 5/4/21 at 1450 hours, the "Code Stroke Packet" was inspected. One bag of D5W 50 ml with the expiration date of 12/2019, and one extension tubing with the expiration date of 3/28/21, were identified. RPH 8 stated the D5W bag and extension tubing should not be in the Code Stroke Packet and should be discarded. The DIP acknowledged the finding.

b. During an observation and concurrent interview with the DIP, MSO, and RPH 7 in the seventh floor satellite pharmacy on 5/4/21 at 1530 hours, the bag of COVID code kit was inspected. One bag of pre-mixed 150 mEq sodium bicarbonate in 5% dextrose 1000 ml injection had the expiration date of 12/9/20. RPH 7 stated the sodium bicarbonate bag should be discarded. The MSO confirmed the finding.