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Based on interviews and record review, the hospital failed to establish a Controlled Substance Diversion Prevention Program (CSDPP) committee or task force and its charter (a structured organization which includes goals, scope of service, membership, commitment, etc.) to oversee, provide leadership and directions, and develop policies and procedures for the CSDPP as in accordance with the current professional standards of practice.

The failure resulted in the hospital not having an effective CSDPP to readily identify and minimize controlled drug (medications that can be easily abused and are under strict government control)diversion. CS diversion can lead to serious patient safety issues including impaired healthcare worker performance, medication errors, and inadequate pain relief for patients.

Findings:

A review of the "ASHP [American Society of Health System Pharmacists, a national organization advocating and supporting the professional practice of pharmacists in hospitals, health systems, and other settings spanning the full spectrum of medication use] Guidelines on Preventing Diversion of Controlled Substances," dated July 28, 2022, indicated:

"Controlled substances (CS) diversion in health systems can lead to serious patient safety issues, harm to the diverter, and significant liability risk to the organization. Diversion puts patients at risk of harm, directly or indirectly, including inadequate relief of pain, inaccurate documentation of their care in the medical record, exposure to infectious diseases from contaminated needles and drugs, and impaired healthcare worker (HCW) performance."

On 6/28/24, the California Department of Public Health received an Entity Reported Incident where a Certified Registered Nurse Anesthetist (CRNA, a licensed advanced practice nurse who administers anesthesia and related care to patients before, during, and after surgery) was brought into the Emergency Department after being in a car accident. While at the scene, the police found one 2-milliLiter (mL, unit of measurement) vial of hydrocodone (a potent narcotic for pain) injection 2 milligrams/mL, two 2-mL vials of midazolam (a controlled medication for induction of anesthesia) injection 1 mg/mL, and one 1-mL vial of diphenhydramine (a sedative to produce sleep) injection 50 mg/mL in her possession.

During the survey entrance conference on 8/19/24 at 1:20 p.m., the hospital was requested to provide the CSDPP committee charter and its policy and procedures.

In an interview on 8/20/24 at 4:30 p.m., the Director of Pharmacy (DOP) stated the hospital had processes in place for accountability and monitoring of CS use throughout the hospital but did not have a CSDPP committee or charter.

During a follow-up interview and record review on 8/21/24 at 9:20 a.m., the DOP provided the document named "Controlled Substance Diversion Prevention Program Committee Charter," dated 7/29/24 (3 weeks before the survey date). He stated the charter is "still in draft" and "has not been approved yet because we are still getting feedback from individuals involved." He also stated, "We have the process but this [referring to the CSDPP committee charter] will provide more structure."

On 8/21/24 at 10:10 a.m., in an interview and record review with the Pharmacy Operations Manager (POM) and the Manager of Risk Management (MRM), the POM stated the hospital investigation discovered the CRNA in question removed three 2-mL vials of midazolam 1 mg/mL (6 mg total) for Patient 45's surgery but only charted 4 mg in the anesthesia (surgery) record as being given on 6/24/24 (two days before the car accident). The POM stated he discovered this discrepancy on 6/27/24 and filed the incidence report the same day. The MRM showed the photos of the medications found by the police on the day of the accident. The POM stated the found medications' lot numbers (unique identifier assigned to a batch of products during manufacturing to track and trace them throughout the supply chain) matched the ones the pharmacy carried.

During a group interview with multiple hospital administration staff members on 8/22/24 at 2:06 p.m., the Chief Medical Office (CMO) confirmed the CSDPP Committee had not been put in place yet and stated, "We haven't been taking this as seriously as it should be. The plan is to activate it right away. This will provide more structured process."

A review of the above-mentioned ASHP Guidelines on Preventing Diversion of Controlled Substances indicated:

"It is imperative that organizations establish a CSDPP that discourages diversion and strengthens accountability, rapidly identifies suspected diversion and responds to known or suspected diversion incidents, and continually seeks to improve controls. Strong organization oversight with broad HCW [healthcare worker] participation and a clear accountability structure provides a framework for a capable program...

"The pharmacy executive, whose central role is responsibility for the organization's medication use system, will be an essential resource for a successful CSDPP. Key elements for organization oversight and accountability include... The organization establishes an interdisciplinary CSDPP committee to provide leadership and direction for developing policies and procedures and for overseeing the CSDPP. The CSDPP committee is proactive in its prevention efforts and addresses prevention control, diversion detection, incident investigation, reporting procedures, and quality improvement activities...

"The CSDPP committee... Establishes a charter that includes membership composition, roles and responsibilities, reporting structure, and meeting frequency... Is proactive in its prevention efforts and actively addresses prevention control, diversion detection, incident investigation, and reporting procedures...

"The functions of the CSDPP committee are integrated with existing compliance management programs, and the committee reports at least quarterly directly to the senior leadership of the organization."

Based on interview and record review, the hospital failed to reconcile a control drug (medication that can be easily abused and are under strict government control) discrepancy promptly as in accordance with the hospital policy and procedures for one of 6 patients (Pt 44).

The failure had the potential to result in hospital staff diverting controlled drugs, which could place patients at risk for potential adverse outcomes including inadequate pain relief and impaired healthcare worker performance.

Findings:

During the survey, the controlled substance discrepancy for 6 patients was selected for review.

On 8/21/24 at 9:32 a.m., a review of Pt 44's clinical record with the Director of Pharmacy (DOP), the Pharmacy Operations Manager (POM), and the Pharmacy Automation Specialist (PAS) indicated Pt 44 was admitted to the hospital for hip fracture and choledocholithiasis (common bile duct stone). On 2/29/24, she underwent a surgical procedure called ERCP (endoscopic retrograde cholangiopancreatography, a procedure that uses an endoscope and X-rays to examine the liver, gallbladder, bile ducts, and pancreas). A review of the automated dispensing cabinet (ADC, where medications are stored and electronically tracked) activity report indicated, on the day of the surgery, the CRNA (a licensed advanced practice nurse who administers anesthesia and related care to patients before, during, and after surgery) removed one 2-mL vial of midazolam (a controlled medication to induce anesthesia, or the temporary loss of consciousness/awareness, during a procedure) 1 milligram per milliliter (mg/mL) at 2:06 p.m., and another vial at 3:39 p.m. (4 mg total). However, a review of the anesthesia record indicated the CRNA only documented she administered 2 mg during the procedure, resulting a discrepancy of 2 mg.

During the interview and review above, on 8/21/24 at 9:42 a.m., the POM and the PAS stated the pharmacy staff audits all anesthesia records a day or two after the procedures were complete to reconcile controlled medication use versus the ADC activities. Any discrepancy would be sent to the Medical Director of Anesthesia (MDA) for forwarding to the anesthesia provider for response, and the pharmacy would send again if there is no response within 7 days. Further review of Pt 44's clinical record indicated the CRNA corrected the anesthesia record by manually crossing out "2 mg" and replacing it with "4 mg" in the entry of midazolam use, on 3/25/24 at 3:33 p.m. (25 days after the discrepancy was made). Both the POM and PAS acknowledged the discrepancy report was not reconciled and responded to timely.

During a group interview with the hospital administration staff members including the MDA on 8/21/24 at 2:03 p.m., the MDA stated he would work on the discrepancy reports sent by the pharmacy as soon as they are given to him but some anesthesia providers are not on regular schedule so he had to wait for when they come back for their next case. When advised that the CRNA worked the following week (first week of March) after the discrepancy was made, the MDA confirmed and stated a 25-day response for the controlled drug discrepancy report was too long.

A review of the surgery schedule, provided by Director of Accreditation (DA), indicated the CRNA was on the schedule every day, Monday through Friday, during the month of March 2024.

A review of the hospital's policy and procedures titled "THE MANAGEMENT OF CONTROLLED SUBSTANCES," revision date 3/14/24, indicated, "Diversion monitoring reports will be sent to the Nursing Manager (or Designee) for investigation and follow up. The Nurse Manager will review and investigate and report all findings to the Director of Pharmacy or designee within 7 days (if no findings report as none)."

Based on observation, interview, and record review, the hospital failed to correctly store and label Lorazepam (a controlled medication to treat anxiety and seizures) Injection Carpujects (syringe device for the administration of injectable fluid medication) as in accordance with the manufacturer's specifications. They were labeled with a 90-day expiration date while the manufacturer indicated they were good for up to 30 days when stored at room temperature (temp).

The failure had the potential for the medication to be used past the date it would be effective for patient use.

Findings:

During a visit to the pharmacy on 8/19/24 at 2:15 p.m., the Pharmacy Operations Manager (POM) stated lorazepam injection products are stored in the medication refrigerator until they are dispensed to the nursing units; the products would be short-dated (given a shorter expiration date than that on the product) when stored at room temp.

A visit to the Emergency Department's (ED) Green Zone Medication Room was conducted with the POM, the Director of Pharmacy (DOP), and the Manager of Intensive Care Unit (MICU) on 8/20/24 at 9:02 a.m. Four 1-milliliter (mL) Lorazepam Injection Carpujects 2 milligrams per mL (mg/mL), made by Manufacturer A, were observed stored at room temp in the automatic dispensing cabinet (ADC, where medications are stored and electronically tracked). Each had yellow expiration date sticker on its body; three indicated they expire on 11/11/24, and one had 11/13/24 expiration date (86 days from survey date). The POM stated the pharmacy short-date lorazepam injection products based on the manufacturer; most products are good (stable) for 30 days, but those made by Manufacturer A, would be good for 90 days at room temp. He was asked to provide Manufacturer A's supporting literature for this storage.

On 8/20/24 at 9:20 a.m., during the visit to the ED's Red Zone Medication Room with the POM, the DOP, and the MICU, 11 Lorazepam Injection Carpujects 2 mg/mL, by Manufacturer A, were observed in the ADC. They all had expiration date of various dates in November 2024.

On 8/20/24 at 10:15 a.m., a visit was made to the 2North Medical/Surgical Unit with the DOP, the MICU, and the Pharmacy Automation Specialist (PAS). Five Manufacturer A's Lorazepam Injection Carpujects 2 mg/mL were observed stored at room temp in the ADC. Each had an expiration label of various dates in November 2024.

On 8/20/24 at 10:35 a.m., a visit was made to the 3North Medical/Surgical Unit with the DOP, the MICU, and the PAS, inspection of the ADC showed it had two lorazepam 2 mg/mL vials with 30-day expiration dating, and three Manufacturer A's Lorazepam Injection Carpujects 2 mg/mL with 90-day expiration dating, expiring in November 2024.

During a concurrent interview and record review on 8/20/24 at 12:55 p.m., the DOP provided a letter, dated 12/2/2011, from Manufacturer A's representative indicating that stability testing showed its lorazepam injection product could be stored for up to 3 months at room temperature. However, this information was 13 years old. The DOP was asked to provide more current information on room temp stability of lorazepam injection by Manufacturer A.

During a follow-up interview and record review with the DOP and the POM on 8/22/24 at 10:20 a.m., the DOP stated a clinical pharmacist reached out to Manufacturer A and was given the information that all its Lorazepam Injection Carpujects are good (or stable) up to 30 days at room temp. The DOP provided the "Medical Information," last updated 5/16/24, from a drug company that owns Manufacturer A. Its review with the DOP indicated to store the lorazepam injection products under refrigeration, and internal study by the company showed its Lorazepam Injection Carpujects 2 mg/mL with the specified NDC (National Drug Code, a unique identifier for each drug), could be stored for "a period of 1 month" at room temp. The DOP confirmed the NDC addressed on this medical information matched the products the pharmacy carried. Both the DOP and POM confirmed they had been assigning the wrong expiration date for Manufacturer A's Lorazepam Injection Carpujects 2 mg/mL, which had the potential for them to be given past the period for which they are stable.

A review of the hospital's policy and procedures titled "MEDICATION MANAGEMENT (STORAGE OF MEDICATIONS)," revised 6/27/24, indicated medications requiring refrigeration will be stored in a refrigerator, and those requiring storage at room temp will be maintained at room temp. However, the policy did not address the short-dating of refrigerated products when stored at room temp.

Based on observation, interview, and record review, the hospital failed to ensure an expired medication was removed from active stock to avoid it being given to the patients; and intravenous fluid bags were kept in the protective outerwrap until used to maintain the fluid concentration as labeled.

Findings:

A visit to the Emergency Department's (ED) Green Zone Medication Room was conducted with the Pharmacy Operations Manager (POM), the Director of Pharmacy (DOP), and the Manager of Intensive Care Unit (MICU) on 8/20/24 at 9:16 a.m. Random inspection of the medications in the automatic dispensing cabinet (ADC, where medications are stored and electronically tracked) identified one of two ketamine (an anesthetic used for induction and maintenance of anesthesia, temporary loss of sensation or awareness) 50 milligrams/5 milliliter syringes with the expiration date of 8/7/24. The POM verified that one syringe had expired and should not be kept in the ADC.

On 8/20/24 at 9:53 a.m., during a visit to the ICU's medication room with the DOP, the MICU, and the Pharmacy Automation Specialist (PAS), a 1-liter bag of 5% dextrose and 0.9% sodium chloride (hydration solution) injection solution was identified on a shelf without the outerwrap and without the date it was opened. The DOP stated it should be stored in the outerwrap until used to maintain its concentration.

On 8/20/24 at 10:15 a.m., a visit to the 2North Medical/Surgical Unit's medication room with the DOP, the MICU, and the PAS identified a 1-liter bag potassium chloride 20 milliEquivalent (unit of measurement) in 5% dextrose and 0.45% sodium chloride solution (for fluid and electrolyte replenishment) was identified on the shelf without the outerwrap and the date it was opened. The staff present verified this finding.

A review of the hospital's policy and procedure titled "MEDICATION MANAGEMENT (STORAGE OF MEDICATIONS)," revised 6/27/24, indicated in part: "5. Medications will not be removed from their containers and/or protective wrapping until it is time to dispense and/or administer the medications... Expired...medications shall be stored separate from other medications..."

Based on observation, interview, and record review, the hospital failed to maintain a clean environment to avoid sources of transmission of infection when:

1. Three of three microwave ovens in patient pantries were visibly dirty in 2 South, 2 North, and the Emergency Department.
2. Dusty supplies were found in one of two clean utility rooms on 2 South.
3. A bin in a patient medication refrigerator had brown/black substance on the inner bottom of bin, underneath the medication and stains on the bottom shelf.

These failures had the potential to allow for the spread of infectious organisms to patients and staff.

Findings:

1. During an observation and interview on 8/19/24 at 3:39 p.m. on 2 North medical unit with the Manager of the Intensive Care Unit (MICU) and the Manager of Risk Management (MRM), the microwave oven in the patient pantry had discolorations that appeared to be dried on food spatters on the interior sides and top. The MICU stated, "It needs to be cleaned. It's gross." The MICU stated the dried on food on the top could drop on the food that was being warmed for another patient and contaminate the food.

During an observation and interview on 8/19/24 at 4:26 p.m. on 2 South with MICU, MRM, and Director of Infection Prevention (DIP), the microwave in the patient pantry had discolorations that appeared to be dried on food splatters inside the microwave on sides and on top. The MICU stated it appeared to be food in the corners and on the sides of the microwave. The DIP stated a dirty microwave can be a source of contamination and could allow for the spread of infection.

During an observation and interview on 8/20/24 at 10:40 a.m. in the Emergency Department with the Manager of the Emergency Department (MED) and the DIP, the microwave oven in the patient pantry had discolorations that appeared to be dried on food spatters on the interior sides and top. The MED stated it needed to be cleaned. The MED stated there was potential for bacteria buildup and that it was an infection control issue. The DIP stated the microwave was dirty and needed to be cleaned. The DIP stated housekeeping was responsible to clean the microwave.

2. During an observation and interview on 8/19/24 at 4:26 p.m. on 2 South with MICU, MRM, and DIP, the Clean Utility Room (a room for clean supplies and equipment) had a wire shelving unit, approximately 6 feet tall and 2 feet deep. The shelving unit held medical supplies. The MICU removed an item from the top shelf and identified it as a "wound vac dressing pack" (a package that contains sterile supplies for a piece of equipment used for treating patient wounds.) The wound vac dressing pack had a layer of dust on it that filled the air in the room with dust when lightly brushed with MICU's hand. The MICU stated staff clean the room every day, but "obviously they aren't cleaning on top of the racks." The MICU stated the clean utility room is expected to be clean, and dust could be a source for the spread of infection.

3. During an observation and interview on 8/20/24 at 10:15 a.m. on 2 North Medical/Surgical Unit with the Director of Pharmacy (DOP), the Manager of Intensive Care Unit (MICU), and the Pharmacy Automation Specialist (PAS) a medication refrigerator inside the medication room was observed. Inspection of the medication refrigerator identified six 2-milliliter vials of famotidine (to treat or prevent ulcers of the stomach and intestines) 20 milligrams per 2 milliliter injection solution inside a medication bin. The entire inner bottom of the bin was observed with black and brown stains. When shown to the PAS, she stated, "Not good!" The bottom shelf of the medication refrigerator was also observed with yellow and brown dusty stains. The pharmacy staff present acknowledged medications should be stored in clean and sanitary condition to avoid contamination.

A review of the hospital's policy and procedure titled "MEDICATION MANAGEMENT (STORAGE OF MEDICATIONS)," revised 6/27/24, indicated in part: "Medications are stored in such a manner as to prevent...contamination, mold growth, or spoilage."

During a review of hospital policy titled, "Sanitary Environment in Healthcare Facilities" revised 6/20/23, the policy indicated, " ...COMPLIANCE - KEY ELEMENTS ... B. Written cleaning methods and schedules for routine cleaning will be maintained by Environmental Services ... 2. This will include regular disinfection of all restrooms, counter tops, elevators, surfaces in patient rooms and nursing stations, and on-patient care areas."

In a research article from Frontiers in Microbiology dated 8/7/24 titled, "The Microwave Bacteriome: Biodiversity of Domestic and Laboratory Microwave Ovens" retrieved from https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2024.1395751/full, the article indicated, "Thirty microwave ovens (10 from domestic use, 10 of domestic shared-use, and 10 of laboratory use) were sampled and used to culture microbial strains on Columbia agar, TSA, YM, R2A, and NA. This yielded a collection of 101 isolates dominated by strains belonging to the genera Bacillus, Micrococcus, and Staphylococcus, followed by Brachybacterium, Paracoccus, and Priestia. Members of the genera Acinetobacter, Bhargavaea, Brevibacterium, Brevundimonas, Dermacoccus, Klebsiella, Pantoea, Pseudoxanthomonas, and Rhizobium were found only in domestic microwaves."