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Based on observations, document review, medical record review, and staff interviews, it was determined that the facility failed to ensure that pharmacy services are provided in safe manner.

Findings include:

1. The facility failed to ensure that pharmacy services were provided under the supervision of a registered pharmacist. (Cross Refer to Tag A-0492)

2. The facility failed to ensure that facility specific policies and procedures that address the provision of pharmacy services were developed and implemented. (Cross Refer to Tag A-0491)

3. The facility failed to ensure that a current DEA (Drug Enforcement Administration) registration was in place for the facility. (Cross Refer to Tag A-0491)

4. The facility failed to ensure that medication refrigerators were monitored and maintained in accordance with accepted standards of practice (Cross Refer to Tag A-0491)

5. The facility failed to ensure the development and implementation of policies and procedures that address a system to monitor the receipt, distribution, and disposition of all Controlled Dangerous Substances (CDS) in the facility. (Cross Refer to Tag A-0494)

6. The facility failed to ensure that policies and procedures that address unit inspections of all areas where medications were stored are developed and implemented. (Cross Refer to Tag A-0500)

7. The facility failed to ensure that policies and procedures that address the return of unused medication to the pharmacy were developed and implemented in accordance with accepted standards of practice. (Cross Refer to Tag A-0500)

8. The facility failed to ensure that expired medications were removed from active inventory. (Cross Refer to Tag A-0505)

Based on document review, one of twelve medical records (MR) reviewed, MR 7, and staff interviews, it was determined that the facility failed to ensure that medications are administered in a safe manner, in accordance with facility policy.

Findings include:

On 5/9/23 at 1:40 PM, during the review of a Medication Error Reporting Form dated 5/2/23, it was identified that Patient (P)7 was administered an incorrect medication.

During an interview on 5/9/23 at 2:17 PM, Staff (S)11, a Pharmacist, confirmed that a medication error involving P7 occurred. S11 stated that on 4/27/23, the physician ordered Minoxidil (a medication to lower blood pressure) 2.5 mg (milligrams) to be administered twice daily. S11 stated that the offsite provider pharmacy made an error transcribing the medication order and sent Midodrine (a medication to increase blood pressure) 2.5 mg to the facility. The medication was provided in unit dose packaging labeled for P7 as "Midodrine 2.5mg." This was also confirmed by S1, the Executive Director of Nursing during an interview conducted on 5/11/23 at 12:38 PM.

Review of the medical record for P7 was conducted on 5/11/23 between 9:30 AM and 11:30 AM. The documentation found in the medical record was as follows:
A physician order, dated 4/27/23 at 5:04 PM, "...Minoxidil 2.5 mg po [by mouth] bid [twice daily]..."

The physician's order was transcribed onto the paper MAR (Medication Administration Record) correctly. The MAR first dated 4/28/23 states, "... Medications... Minoxidil 2.5mg PO BID..." However, between 4/28/23 and 5/2/23 six nurses, S8, S10, S25, S30, S31, and S32, failed to identify that the medication name on the medication label did not match the medication name on the MAR, and administered medication labeled as "Midodrine 2.5mg" instead of "Minoxidil 2.5mg" to P7. This finding was confirmed by S1, the Executive Director of Nursing on 5/11/23 at 10:40 AM.

During an interview on 5/11/23 at 12:20 PM, S1 stated that on 5/2/23, S32, a nurse, identified that Midodrine is administered to increase blood pressure, and contacted the physician for clarification of the order and administration parameters. S32 was not available for interview, however S1 stated that during the facility investigation, S32 stated that he/she thought that Midodrine was a generic name for Minoxidil. On 5/2/23, the medication error was identified and the physician, S33, and S1 were notified. S1 contacted the provider pharmacy, a stat (immediate) dose of Minoxidil 2.5mg was delivered, and the pharmacy and the facility initiated their investigations.

On 5/9/23 during a facility tour, medication references were observed. On 5/11/23 at 12:48 PM, during an interview, S1 confirmed that all nursing staff have access to medication reference books, access to online drug reference websites on the units, and nursing staff have access to the provider pharmacists 24 hours a day by telephone. S1 could not provide an explanation for six nurses administering medication labeled as "Midodrine," which did not match the medication "Minoxidil" listed on the MAR and the physician's order. The staff members failed to follow the facility's medication administration policy referenced below, and check the medication label three times prior to administration.

On 5/11/23, S1 provided documentation that all nursing staff working in the facility were re-educated on the five rights of medication administration immediately after the event. S1 provided evidence that the medication error reporting policy was followed and that an emergent Quality Assurance meeting was held on 5/3/23, in response to the event.

However, on 5/9/23 at 9:51 AM during an observation of medication administration to P4, S7, a RN, checked the label of the medications he/she was administering once prior to removing the medications from their packaging and administering them to P4, not three times as required by facility policy.

Reference: Facility policy received on 5/9/23 at 12:20 PM, titled "Administering Medications" undated, states, "...Medications are administered in a safe and timely manner... The individual administering the medication checks the label THREE (3) time to verify the right resident, right medication, right dosage... before giving the medication..."

Based on the review of facility policies and staff interviews, it was determined that the facility failed to ensure: 1) the development and implementation of facility specific policies and procedures that direct the provision of Pharmaceutical Services and minimize drug errors in accordance with accepted professional principles; 2) that the facility's Medical Director, the provider responsible for the facility's Controlled Dangerous Substances (CDS), has a current Drug Enforcement Administration (DEA) registration specific to the facility location; and 3) the development and implementation of policies and procedures that address monitoring of the medication/vaccine refrigerator temperatures, in accordance with nationally recognized guidelines.

Findings include:

1. During the entrance conference conducted on 5/9/23 at 9:30 AM, policies and procedures directing medication administration and pharmacy services were requested from Staff (S)1, the Executive Director of Nursing, S2, the Vice President of Growth, S3, the Assistant Administrator, S4, the Chief Executive Officer and Administrator, and S5, the Vice President of Operations. Policies and procedures were requested again from S1 and S4 on 5/10/23 at 10:36 AM. Review of facility policies conducted between 5/9/23 and 5/10/23 revealed that the following policies were written in accordance with Federal regulations for Long Term Care facilities - 42 CFR 483 Requirements for States and Long Term Care Facilities, and not in accordance with 42 CFR 482-Conditions of Participation for Hospitals. The policy titles were:

"Storage of Medication" received on 5/9/23 at 12:20 PM, references 42 CFR 483.45 (h)

"Administering Medications" received on 5/9/23 at 12:20 PM, references 42 CFR 483.10 (c)(7), 483.21(b)(2)(ii), 483.30 (a), 483.30 (b), 483.45, 483.45(a), 483.45 (c), 483.80(a), and 483.70(f)

"Controlled Substances" received on 5/10/23 at 1:27 PM, references 483.45(h)

"Medication Orders and Receipt Record" received on 5/10/23 at 12:40 PM, references 42 CFR 483.45

"Accidents and Incidents-Investigating and Reporting" received on 5/10/23 at 12:40 PM, references 42 CFR 483.25(d)

"Medication Ordering and Receiving from Pharmacy" received 5/10/23 at 1:27 PM, references 42 CFR 483.45

On 5/10/23 at 4:23 PM, S1 and S4 confirmed that the policies and procedures listed above were written in accordance with Federal regulations for Long Term Care Facilities. S1 and S4 confirmed that the facility could not provide policies and procedures specific to the acute care facility.

The following policies and procedures included the header "___ [name] Pharmacy." Review of these policies on 5/10/23 revealed that they direct processes conducted by the offsite provider pharmacy either in their pharmacy or in any of the facilities they are contracted with, however they are not facility specific policies. These policies are titled:

"Electronic Emergency Kit" received on 5/10/23 at 9:45 AM

"Medication Ordering and Receiving from Pharmacy" received 5/10/23 at 1:27 PM

"Look-Alike/Sound-Alike Medications LASA" received on 5/10/23 at 1:27 PM.
"High Alert Medications" received on 5/10/23 at 1:27 PM

During an interview on 5/10/23 at 4:23 PM, S1 and S4 confirmed that the policies and procedures listed above are not facility specific.

The processes included in the following policies and procedures provided, do not match the processes followed in the facility. The titles are as follows:

"Refrigerator Temperature Monitoring" received on 5/10/23 at 11:05 AM, states "...the Helmer Pharmaceutical Refrigerator is maintained at the correct temperature for refrigerated medication..." During the facility tour on 5/9/23, it was determined that the facility does not have a Helmer Pharmaceutical refrigerator.

"Control of Controlled Dangerous Substances" received on 5/11/23 at 9:25 AM, states, "...a registered or licensed practical nurse shall come to the pharmacy with the unit's controlled drug record (CDR)... All Class II CDS [controlled dangerous substances] will be purchased using a DEA [Drug Enforcement Administration] form e222. A pharmacist and his/her designee will inventory the CDS monthly..." The facility does not have an onsite pharmacy or pharmacist; the facility does not use DEA e222 Forms; and the facility does not have pharmacists onsite who conduct monthly CDS audits.

These findings were confirmed by S12, a Pharmacist, on 5/11/23 at 10:00 AM.

During an interview on 5/10/23 at 10:10 AM S1 and S2 stated that all of the facility policies and procedures were reviewed and adopted by the new Governing Body. On 5/10/23 at 12:40 PM, S2 provided a document dated 2/1/23 that states, "The St. Lawrence Rehabilitation Center and Nursing Policies and Procedures have been reviewed and have been found to be adequate in meeting the day-to-day needs of the facility and our residents. The administrator has been delegated the administrative authority, responsibility, and accountability of assuring all personnel, residents, and the community are aware of said policies and procedures as required." The document was signed by the Administrator, Director of Nursing, and the Medical Director.
However, on 5/10/23 at 4:23 PM, S1 and S4 confirmed that the policies and procedures listed above, adopted by the Governing Body on 2/1/23, are not facility specific and/or in accordance with acute care regulations. S1 and S4 confirmed that the facility could not provide policies and procedures specific to the acute care facility.

2. During an interview by phone on 5/9/23 at 2:05 PM, S11, a Pharmacist, stated that the Controlled Dangerous Substances (CDS) stored in the MedBank, an automated drug dispensing cabinet, were under the control and DEA (Drug Enforcement Administration) registration of the offsite provider pharmacy because the facility Medical Director, S29, did not have a current DEA registration specific to the Acute Care Rehabilitation Hospital. This was confirmed by S12, a Pharmacist, during a phone interview on 5/9/23 at 3:10 PM. S12 stated that the application for the facility specific registration was submitted, however it was not in place yet. S12 explained that the facility was not using DEA 222 Forms to purchase the Schedule II CDS found stored in the Medbank. S12 stated that prior to February 2023, the facility had an onsite institutional pharmacy and all CDS were purchased, stored, and administered under the pharmacy's DEA registration. On 5/10/23, the survey day, the onsite pharmacy was no longer present.

The credential file for S29, the Medical Director, was requested and reviewed on 5/10/23 at 3:45 PM, in the presence of S1 and S4. The DEA registration for S29 was expired on 3/2/22. This was confirmed by S1 and S4 at the time of discovery. The facility did not have a current DEA registration for the purchase, storage, and administration of CDS in accordance with Federal regulations for the acute care facility.

Reference: Code of Federal Regulations Section 1301.12: (a) "A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed... or dispensed by a person."

3. On 5/9/23 at 10:15 AM, during a tour of the Medication Room located on the third floor, a small white dorm style refrigerator with a freezer compartment was used for medication storage. The medications were found stored in the top section of the refrigerator next to the freezer compartment and the interior of the refrigerator was wet. S8, a Registered Nurse, was questioned about the maintenance of the medication refrigerator and S8 stated that the temperatures are checked once daily and that a work order was placed for this refrigerator because of the water inside. When asked if the medication refrigerator was plugged into an outlet connected to the generator to ensure the safe storage of medications, S8 was not sure. On 5/9/23 at 10:17 AM, S4 confirmed that the outlet used for the refrigerator was not connected to the emergency generator. The medication refrigerator temperature logs for March, April, and May 2023 were requested and reviewed. The logs indicated that the refrigerator temperature was checked once daily.

During a tour of the Medication Room located on the fourth floor on 5/9/23 at 10:40 AM, medications and Prevnar 20, a vaccine, were found stored in the medication refrigerator. The "filled date" typed on the vaccine label was 3/2/23. S10, a Nurse, confirmed this finding and stated that the vaccine was brought from the offsite provider pharmacy on 3/2/23 and stored in the refrigerator. S10 confirmed that the refrigerator was used to store medications and vaccines. On 5/9/23 at 10:45 AM, S10 stated that the medication refrigerator temperatures are checked and documented once a day. The medication refrigerator temperature logs for March, April, and May 2023 were requested and reviewed.

The "St. Lawrence Rehabilitation Center Medication Refrigerator Temperature Log" states, "...Record temperature-Medication Refrigerator must be between 36-46 [degrees Fahrenheit]. Use Corrective Action column to indicate corrective steps if temperature is not in proper range. If corrective action is required, document temperature recheck in 2 hours."
The Medication Refrigerator Temperature Log for the fourth floor indicated that on 3/7/23, the temperature was out of range at 48 degrees Fahrenheit. The corrective action column states "temp [temperature] adjusted." The log lacks evidence that the temperature was rechecked and documented 2 hours after the temperature was adjusted, as required by facility policy.
The medication/vaccine refrigerator temperature logs indicate that the temperatures were checked once daily except the logs lacked documentation that the temperature was checked on 3/18/23, 3/9/23, and 5/4/23. This was not in accordance with facility policy or Centers for Disease Control and Prevention (CDC) vaccine storage guidelines referenced below, which states that refrigerators used for vaccine storage should have the temperature documented at least twice daily. These findings were confirmed by S10 on 5/9/23 at 10:50 AM.

The facility policy provided on 5/10/23 at 11:05 AM, titled "Refrigerator Temperature Monitoring" dated 4/21/22 states, "At the beginning of every month, the temperature log and the events log of the Helmer Pharmaceutical Refrigerator will be downloaded and copied to the Director's computer..." This policy does not correspond with the practice followed in the facility or with the type of refrigerator or temperature monitoring device utilized. The facility does not have a Helmer Pharmaceutical Refrigerator or a digital data logger for recording and downloading temperatures.

Reference: The Centers for Disease Control and Prevention (CDC) Vaccine Storage and Handling Toolkit (January 2023) states, " ...Check and record storage unit minimum and maximum temperatures at the start of each workday. If your TMD [temperature monitoring device] does not read minimum/maximum temperatures, then check and record the current temperature a minimum of two times per workday (at the start and end of the workday). Record: Minimum/maximum temperature, Date, Time, Name of person who checked and recorded the temperature, Any actions taken if a temperature excursion occurred ..."

Based on staff interviews and the review of facility documents, it was determined that the facility failed to ensure that pharmacy services are provided under the supervision of a registered pharmacist.

Findings include:

During the entrance conference on 5/9/23 at 9:30 AM, Staff (S)1, the Executive Director of Nursing, S2, the Vice President of Growth, S4, the Chief Executive Officer and Administrator, and S5, the Vice President of Operations, explained that the facility recently changed ownership. As part of that change, the institutional pharmacy that was previously onsite was closed, and medications were supplied by an offsite provider pharmacy. A pharmacy consultant provided other services. The contracts for these services were requested at this time.

On 5/9/23 at 11:45 AM, the facility provided the "___ [name of Pharmacy] Pharmacy Pharmacy Services Provider Agreement" and the "Consultant Pharmacist Provider Agreement."
Upon review, it was determined that the "___ [name of Pharmacy] Pharmacy Pharmacy Services Provider Agreement" dated 2/1/23, failed to include the provision of pharmacy oversight functions.

On 5/9/23 upon review, the "Consultant Pharmacist Provider Agreement" states, "... The Pharmacy Consultant [name of consulting company] provides Consultant services to long-term care facilities and their residents in accordance with Applicable Law..."

On 5/9/23 at 12:47 PM, S2 confirmed that the pharmacy consultant was contracted for the long-term care facility located in the same building. A pharmacy consultant contract and recent consultant reports for the acute care hospital were requested a second time.

On 5/9/23 at 3:40 PM, S1 stated that the acute care facility did not have a contract with a pharmacy consultant and did not have a pharmacy consultant involved with the oversight of pharmacy services in the acute care facility.

On 5/9/23 at 1:33 PM, in response to the request for the identification of the person appointed by the facility to have oversight of Pharmacy Services, the facility provided a one page printout that stated in its entirety "[name of Staff #11 (S11)] Director of Pharmacy [space] Designee [name of Staff #12 (S12)]."

On 5/9/23 at 2:00 PM, a personnel file for S11, the person identified as the Director of Pharmacy, was requested. The facility failed to provide a complete personnel file for S11.

During an interview on 5/10/23 at 2:53 PM, with S11 by telephone, and S12, a Pharmacist-in person, asked this surveyor why S11's personnel file was requested. When told that S11 was identified by the facility as the Director of Pharmacy Services, S11 denied holding that position. S11 and S12 both stated that S11 was not the Director of Pharmacy Services for the facility. S11 stated they were the pharmacist in charge of the provider pharmacy only, and did not have oversight of the facility's pharmacy services.

During an interview on 5/10/23 at 3:00 PM, S1, S2, and S4 were notified that S11 denied being the Director of Pharmacy Services. S1, S2, and S4 confirmed that the facility did not have a designated Director of Pharmacy Services since the change in ownership when the institutional pharmacy was closed. S1, S2, and S4 also confirmed that the acute care facility did not have a contract with a pharmacy consultant. The facility failed to ensure that pharmacy services are provided under the direction of a Registered Pharmacist.

Based on the review of facility documents and staff interviews, it was determined that the facility failed to ensure the development and implementation of policies and procedures that address a system to monitor the receipt, distribution, and disposition of all Controlled Dangerous Substances (CDS) in the facility.

Findings include:

On 5/9/23 at 2:15 PM, during an interview by phone, Staff (S)11, a Pharmacist, stated that there was no set schedule for conducting inventory counts (cycle counts) of Controlled Dangerous Substances (CDS) stored in the Med Bank, an automated medication dispensing cabinet.

On 5/9/23 at 3:15 PM, during an interview by phone S12, a Pharmacist, stated that patient specific CDS are stored in the medication cart, and floor stock CDS are stored in the Med Bank, an automated medication dispensing cabinet. S12 confirmed that there is a process in place to count and inventory patient specific CDS each day, however S12 was not sure that a process was developed to ensure the CDS inventory in the Med Bank was accurate. S12 stated that nursing staff are prompted to conduct a blind count of CDS if a dose is removed from the Med Bank. When questioned about who has the authority to resolve discrepancies in the CDS inventory, S12 stated that the Director of Nursing or the Med Bank field technician could resolve and clear a discrepancy.

On 5/9/23 at 2:50 PM, during an interview S1, the Executive Director of Nursing stated that nursing staff do not perform regular inventory counts of the CDS stored in the Med Bank. S1 stated that nursing staff would only count the CDS during the blind count conducted after removing a dose of CDS.

On 5/10/23 at 11:20 AM, during a tour of the fourth floor with S12, the medication storage areas were observed. The Med Bank was located in a space behind the nurses' station. S12 stated that the Med Bank was utilized to store medications needed for emergent first doses or when the provider pharmacy was closed. The Med Bank contained Schedule II Controlled Dangerous Substances (CDS) including but not limited to: Fentanyl 50 mcg (microgram) patches, Oxycodone 5 mg (milligram)tablets, Oxycodone 10 mg tablets, Hydromorphone 4 mg tablets, Fentanyl 25 mcg patches, and Oxycodone ER (extended release) 20 mg tablets.

On 5/10/23 at 11:45 AM, S27, a Med Bank field technician, was contacted by phone, During an interview, S27 stated that he/she visits the facility monthly to maintain the medications stored in the Med Bank. When questioned about conducting cycle counts of CDS to ensure accountability, S27 stated that he/she does not conduct cycle counts on a regular basis, only if a count discrepancy was flagged electronically. S27 stated that the "account manager should conduct [CDS] cycle counts" to ensure the accountability of CDS stored in the MedBank.
On 5/10/23 at 11:50 AM, S12 stated that the facility did not have an assigned account manager and that he/she was not conducting an inventory count of the CDS.
The facility did not have a process in place to ensure the accountability for CDS stored in the Med Bank.

During an interview on 5/9/23 at 3:10 PM, S12 stated that the facility was not utilizing DEA (Drug Enforcement Administration) 222 Forms to purchase Schedule II CDS used for floor stock from the provider pharmacy. S12 stated that the facility maintained the purchase invoices for all CDS, including Schedule II CDS since the change to the offsite provider pharmacy in February 2023.

During a tour of the fourth floor on 5/10/23 at 12:10 PM in the presence of S12, the CDS invoices and packing slips were requested. S10, a Registered Nurse, stated that the nursing staff kept the CDS invoices, however S10 stated he/she did not know where they were stored and could not locate them. S10 failed to provide documentation of the receipt of CDS upon request.
During a tour of the third floor on 5/10/23 at 12:20 PM in the presence of S12. the CDS invoices and packing slips were requested. S8, a Registered Nurse, provided a white binder that contained many medication invoices for both CDS and non-controlled medications. S8 stated that the binder should contain all of the medication invoices since February 2023 and if any were missing, he/she didn't know where the invoices were stored besides the binder.
On 5/10/23 at 12:25 PM, S12 confirmed that the facility failed to develop a process to maintain a verifiable record for the receipt of CDS.

Polices and procedures that address the receipt, administration, and disposition of CDS in the facility were requested from S1, the Executive Director of Nursing, and S12, a Pharmacist. The policies and procedures that were provided were not developed in accordance with State and Federal regulations for acute care rehabilitation hospitals, and did not correspond with current facility processes. The following was identified:

Facility policy titled "Controlled Substances" undated, received on 5/10/23 at 1:27 PM refers to 42 CFR 483.45(h), Requirements for States and Long Term Care Facilities, and is not in accordance with 42 CFR 482-Conditions of Participation for Hospitals.

Facility policy titled "Medication Orders and Receipt Record" undated, received on 5/10/23 at 12:40 PM, references 42 CFR 483.45, Requirements for States and Long Term Care Facilities, and is not in accordance with 42 CFR 482-Conditions of Participation for Hospitals.

Facility policy titled "Control of Controlled Dangerous Substances" dated 1/25/22, received on 5/11/23 at 9:25 AM, states, "...The CDRs [controlled drug record] from the previous day will be placed in the Pharmacy bin on each nurse station for pickup by the pharmacy tech...These records will be kept on file in the pharmacy for 1 year... All Class II CDS will be purchased using a DEA Form e222. The Director of Pharmacy may order CII through the secured "Controlled Substance Online Service" or CSOS... A pharmacist and he/her designee will inventory the CDS monthly." This policy addresses practices that the facility does not follow. The facility does not have an onsite pharmacy, pharmacists, or pharmacy technicians. The facility does not utilize DEA 222 Forms or CSOS to order Class II CDS.

On 5/10/23 at 4:23 PM, S1 and S4, the Chief Executive Officer and Administrator, confirmed that the policies and procedures listed above are not facility specific.

Based on observations, review of facility documents, and staff interviews, it was determined that the facility failed to ensure that: 1) policies and procedures that address inspections of all areas where medications are stored are developed and implemented; and 2) policies and procedures that address the return of unused medication to the pharmacy are developed and implemented in accordance with accepted standards of practice.

Findings include:

1. On 5/9/23 at 9:40 AM, during a facility tour of the Medication Room located on the third floor with Staff (S)1, the Executive Director of Nursing, and S4, the Chief Executive Officer and Administrator, purple plastic bags, orange tackle boxes, and a black pharmaceutical waste container were found stored on the floor. The countertop next to the sink was cluttered with medication containers and the sink was visibly dirty. The inside of the medication refrigerator, and the medications stored inside, were wet. During an interview on 5/9/23 at 9:48 PM, S7, a Registered Nurse (RN), explained that the purple plastic bags contained medications that needed to be returned to the provider pharmacy and the orange tackle boxes contained a supply of back up medications. This finding was confirmed by S4 on 5/9/23 at 9:50 AM.

On 5/9/23 at 10:35 AM, during a tour of the Medication Room located on the fourth floor with S4, expired medications were identified (Cross Refer to Tag A-0505). The countertop next to the sink was cluttered with medication containers. During an interview on 5/9/23, S10, a RN, stated that he/she was not aware that any one was assigned to check the medication storage areas for expired medications and supplies. This finding was confirmed by S4 on 5/9/23 at 10:40 AM.

On 5/9/23 at 11:30 AM, the pharmacy unit inspection reports were requested from S1 for the facility which consists of two units, the third and fourth floor.

On 5/9/23 at 3:40 PM, S1 stated that the facility did not have unit inspection reports or a policy that addresses the need to conduct unit inspections of medication storage areas in accordance with State regulations.

On 5/10/23 at 9:40 AM, "Medication Room Inspection" forms dated 2/8/23, 3/9/23, and 4/6/23, were provided by S12, a pharmacist. During an interview on 5/10/23 at 10:14 AM, S12 confirmed that the "Medication Room Inspection" forms did not include all medication storage areas, and therefore did not meet the requirements of the State regulations.

Reference: New Jersey Board of Pharmacy Regulations N.J.A.C. 13:39-9.23 (b) states, " ...The pharmacist-in-charge or... the director of pharmaceutical services shall establish a system of control for all drugs dispensed for use in the drug therapy of patients of the facility. Inspections shall be conducted of all medication areas located in the facility or any other service area of the facility at least once every two months to check for expiration or use by dates, proper storage, misbranding, physical integrity, security and accountability of all drugs. These inspections shall be fully documented. Written inspection reports shall be prepared and signed by the inspecting pharmacist or by the pharmacy technician, intern or extern and co-signed by his or her supervising pharmacist. The pharmacist-in-charge shall be responsible for ensuring that, prior to performing any inspections pursuant to this subsection, pharmacy technicians, interns and externs are trained and can successfully demonstrate competency. Procedures for the review of these reports shall be developed and instituted by the pharmacist-in-charge and can be incorporated into the overall quality assurance program of the health care facility ..."

2. On 5/9/23 at 10:40 AM during a facility tour of the Medication Room on the fourth floor, one vial of Prevnar 20 vaccine labeled for Patient (P)1 was found stored in the refrigerator. During an interview, S10, a Registered Nurse, confirmed this finding and stated that P1 was discharged. S10 stated that the vaccine should have been returned to the pharmacy. Review of the medical record indicated that P1 was discharged on 3/15/23. The facility failed to provide a policy that addressed the process to return medications to the pharmacy upon request on 5/10/23 at 10:36 AM.

Based on observations, document review, and staff interviews, it was determined that the facility failed to ensure that expired medications are removed from active inventory.

Findings include:

During a facility tour conducted on 5/9/23 at 10:40 AM in the presence of Staff (S)4, the Chief Executive Officer and Administrator, the following expired medications were found stored in the Medication Room located on the fourth floor, available for patient use:

Two - 31 gram packages of Instaglucose with an expiration date of 12/22.
Two - containers of Cefazolin 2 grams/100 ml (milliliter) with expiration dates of 4/26/23. This IV (intravenous) antibiotic was labeled for Patient (P)2 who was discharged from the facility prior to the survey day.
One - container of Daptomycin 500 mg (milligrams)/ 50ml with an expiration date of 4/27/23. This IV antibiotic was labeled for P3, who was discharged from the facility prior to the survey day.

During an interview on 5/9/23 at 10:50 AM, S10, a Registered Nurse (RN), confirmed these findings. S10 stated that he/she was not aware of who was responsible for checking the medication storage areas for expired medications. S10 stated that pharmacy staff members used to check the medication storage areas for outdated medications, however the institutional pharmacy that was onsite was closed and replaced by an offsite provider pharmacy on 2/1/23.

On 5/9/23 at 11:00 AM on the fourth floor, three expired prefilled 0.9% saline flushes were found stored in the code cart drawer. Two of the flushes were expired on 8/31/19 and one was expired on 5/31/19. This finding was confirmed by S10 and S1, the Executive Director of Nursing. S1 stated that the provider pharmacy was responsible for checking the medication drawer and the nursing staff on the night shift was responsible for checking the rest of the code cart. Code carts maintenance logs were reviewed and they indicated that staff were checking the contents of the code cart on a routine basis. However, the staff members failed to remove the expired items.

Reference: Facility policy titled "Storage of Medications" undated, states, "...Discontinued, outdated, or deteriorated drugs or biologicals are returned to the dispensing pharmacy or destroyed..."

Reference: Facility policy titled "Code Cart Checks" dated 8/21, states, "...The licensed nurse will check all contents for expiration dates, proper working order, and appropriate amount of supplies. Expiration date on supplies and medications are to be documented and replaced if expired..."

Based on observations and staff interviews, it was determined that the facility failed to ensure: 1) that a facility approved diet manual is available to all staff on patient care units; and 2) the development and implementation of policies and procedures addressing the availability of therapeutic diet manuals.

Findings include:

On 5/10/23 at 2:24 PM, during tour of the third floor, the therapeutic diet manual was requested. Staff (S)8, a Licensed Practical Nurse (LPN) and S20, a Unit Clerk were unable to provide a diet manual. S8 stated that there was no diet manual available on the units.

At 3:09 PM during an interview, S22, a Registered Dietician, confirmed that a diet manual was not available on the unit.

On 5/10/23 at 3:09 PM, the facility failed to provide a policy and procedure addressing the availability of therapeutic diet manuals on patient care units upon request.