HospitalInspections.org

Based on observation, staff interview, policy and procedure review, department memo review and job description review, the facility failed to ensure that outdated, mislabeled, or otherwise unusable drugs and biologicals were not available for patient use on four (4) of four (4) survey days.

Findings Include:

During a tour of the facility emergency room pharmacy on 12/18/2023 at 12:50 p.m. to 2:00 p.m., in the presence of the Director of Nursing (DON) and the Director of Pharmacy (DOP), 18 drugs were observed to be expired, four (4) multidose vials were not labeled with open or use by dates, one (1) medication vial observed with visible crystallization, and one (1) single dose medication vial opened with partial dose remaining in vial observed sitting in drug cabinet.

The following drugs were expired: Vitamin D3 1000 units per tablet with count of five (5) and expiration label of 08/2023, Vitamin D3 5,000 units per tablet with count of four (4) tabs with expiration date of 10/2023, Spironolactone 50 milligram (mg) tablets with expiration date of 11/2023 on bag of 10 tablets, Spironolactone 25 mg tablets with expiration date of 11/2023 on bag of 14 tablets, Lisinopril five (5) mg tablets with expiration date of 10/2023 on bag of three (3) tablets, Lisinopril five (5) mg tablets with expiration of 10/2023 on bag of six (6) tablets, Hydralazine 10 mg tablets with expiration 11/2023 on four (4) tablets, Fluconazole 100 mg tablets with expiration date on bag of 10/2023, three (3) Haldol 5 mg per milliliter (ml) injectable vials with expiration dates 10/2023, Mannitol 25% 12.5 grams/50 ml injectable with expiration date of 11/01/2023 and visible crystallization formed in vial, Dobutamine 250 mg/20 ml injectable with expiration date of 10/2023, Phenergan 25 mg suppositories - eight (8) expired on 4/2023, Albuterol inhalation 2.5/3 ml-20 packs expired on 7/2023, Metronidazole 500 mg (5 mg/ml) for IV use- eight (8) bags expired 6/1/2023, Gentamycin Sulfate 80 mg/100 ml- two (2) bags expired 3/2023, Gentamycin Sulfate 120 mg/100 - one (1) bag expired 9/2022;

The following multidose vials were not labeled with use by or open dates:
Kenalog injectable multidose vial of 50 mg per five (5) milliliters opened with approximately two (2) milliliters in vial with expiration date of 09/2024 and no open date or use by date recorded on label, one opened vial of injectable Labetalol 100 mg per 20 milliliter multidose vial with no open date or use by date recorded on label, Lantus N 100 10 ml vial opened with no open or use by date recorded on label, and Humulin R 10 ml vial opened with no open or used by date recorded on label;

The following drug was observed crystallized: Mannitol 25% 12.5 g/50cc injectable with expiration date of 11/01/2023 with visible crystallization formed in vial.

The following drug for single use observed opened in the drug cabinet: Thiamine single dose vial injectable opened and sitting loose on storage shelf with partial dose remaining in vial.

Interview with the DON on 12/18/2023 at 1:15 p.m. confirmed she expected the nurses to date multi-use vials when opened.

Interview with the DOP on 12/18/2023 at 1:25 p.m. confirmed he, "checks the medications every couple of weeks for expiration dates but, I guess I could have missed some." The DOP further said he gets most of the expired drugs out when he checks."

Interview with DON on 12/18/2023 at 1:30 p.m. confirms the drugs identified are expired, mislabeled, or otherwise unusable.

Interview with DOP on 12/18/2023 at 1:30 p.m. confirms the drugs identified are expired, mislabeled, or otherwise unusable.

Policy and procedure review of document titled, "Category: Pharmacy, Policy: Management of Multi-Dose Vials", dated 03/31/2023 reveals, "1. Initial labelling: ...Multi-dose vials are initially labeled upon receipt in the pharmacy or upon preparation ...Labels will include ...expiration date, and beyond-use-date after ...2. Distinct identification: Multi-dose vials should be clearly distinguished from single-dose vials ...3. Expiration dates and Beyond-use Dates: Expiration date: Ensure that the expiration date on the label is clearly visible and up to date to prevent the use of expired medications ...".

Policy and procedure review of document titled, "Category: Pharmacy, Policy: Expired Medication Surveillance and Management", dated 03/31/2023 reveals, "1. Identification and Removal: Regular inventory checks: Pharmacists and authorized personnel routinely check inventory to identify and segregate expired medications. Immediate Removal: Expired medications are promptly removed from shelves, cabinets, or patient care areas upon identification. 2. Segregation and Labeling: Clearly marked containers: Expired medications are placed in clearly labeled containers or designated areas separate from active stock ...4. Disposal Procedures: compliance with regulations: follow federal, state, and local regulations for the safe and legal disposal of expired medications ...".

Review of memo, "To: All Department Managers From ...Pharmacy Director", dated March 20, 2023, reveals, "Re: Pharmacy Protocol For Handling Single Dose and Multi-dose vials. The pharmacy department has support responsibilities to ...departments ...We use the CDC's Recommendations ...".

Review of memo attachment titled, "Multi-dose Vials - Managing Multi-dose Vials of Injectable Medication" dated with no date reveals on pages three (3) through four (4), " ...Expiration Dating of Multi-dose Vials ...If a multi-dose has been opened or accessed ...the vial should be dated with the last date the product should be used ...and discarded within 28 days unless the manufacturer specifies a different ...date for that opened vial ...".

Review of memo titled, "To: All Department Managers From ...Pharmacy Director", dated March 20, 2023, reveals, "Re: Pharmacy Protocol For Identifying Outdated Drugs and Their Handling ...The pharmacist or pharmacy tech will each month check all areas where drugs are kept, and determine if the inventory in question has an in dated expiration date and is suitable for distributions. If any drug is found to be out of date the pharmacy staff will remove it from inventory ...".

Review of job description titled "Subject: Job Title: Director of Pharmacy", dated with no effective date reveals, " ...Job Summary: Responsible for planning, organizing and directing the overall operation to the Pharmacy; ensures compliance with patient care quality standards ...inventory maintenance of pharmaceuticals and related substances and supplies ... Duties and Responsibilities: ...Directs and controls ...inventory maintenance of pharmaceuticals ...Oversees the storage and distribution of all pharmaceutical items ...".

During an exit conference on 12/21/2023 at 5:30 p.m. with the DON the survey findings were discussed, and she confirmed knowledge that findings were accurate and provided the policy and procedures requested for expired medications and multidose medication use. No further documentation was submitted for review.

(Part I)

Based on observations, the facility failed to provide all the generator required components as in accordance to NFPA 110 section 5.6.6 and NFPA 99 section 6.4.1.1.17. The deficient practice affected the entire facility on the day of survey.

Findings Include:

On 12/20/2023 at 10:05 AM, observation revealed the generator lacked a complete remote annunciator panel in a constantly monitored location of the facility (ex. Nurses station or receptionist desk ...).

The finding was acknowledged by the Administrator and Maintenance Supervisor verified this observation during the exit interview on 12/20/2023.

__________

(Part II)

Based on the review of documentation, the facility failed to properly document records of testing the generator annually as directed by NFPA 110 section 8.4.2, NFPA 99 sections 6.4.4.1.1.3 and 6.4.4.2. This deficient practice had potential of affecting the entire facility on the day of facility survey.

Findings Include:

On 12/20/2023 at 1:15 PM, the facility could not produce the documentation for weekly inspections, monthly load test, or an annual inspection of the generator with the calendar year 2022.

The finding was acknowledged by the Administrator and Maintenance Supervisor verified this observation during the exit interview on 12/20/2023.

(Part I)

Based on observations, the facility failed to have a properly installed fire alarm control panel as per NFPA 101 section 9.6.6. The deficient practice affected the entire facility on the day of survey.

Findings Include:

On 12/18/2023 at 10:55 AM, observation revealed the fire alarm system lacked a remote annunciator panel in a constantly monitored location of the facility (ex. Nurses station or receptionist desk ...).

The finding was acknowledged by the Administrator and Maintenance Supervisor verified this observation during the exit interview on 12/18/2023.


(Part II)

Based on record review, the facility failed to provide a properly maintained fire alarm system as required by NFPA 72 Table 14.3.1 and section 14.4.5.3.2. This deficiency affected the entire facility on day of survey.

Findings Include:

On 12/18/2023 at 3:35 PM, observation also revealed the fire alarm panel was in "trouble mode" for dialer issue.

On 12/20/2023 at 10:30 AM, observation and record review revealed the facility was unable to provide the years 2021 or 2022 documentation of annual and sensitivity inspection of the fire alarm system.

The finding was acknowledged by the Administrator and Maintenance Supervisor verified this observation during the exit interview on 12/20/2023.


(Part III)

Based on observations the facility failed to provide the required 30-minute fire resistance rating for smoke barrier walls in accordance with NFPA 101 sections 19.3.7.3, 8.5, 8.5.6. This deficiency affected the entire facility on day of survey.

Findings Include:

On 12/18/2023 at 2:50 PM, observation revealed open, unsealed penetrations all in smoke barrier walls of the facility.

The finding was acknowledged by the Administrator and Maintenance Supervisor verified this observation during the exit interview on 12/18/2023.

(Part IV)

Based on record review and interviews, the facility failed to properly perform fire drills as per NFPA 101 section 19.7.1.2. The deficient practice affected all smoke compartments and patients in facility on the day of survey.

Findings Include:

On 12/18/2023 at 3:50 PM, the facility could not provide complete and proper documentation of fire drills for the last calendar year 2022.

The finding was acknowledged by the Administrator and Maintenance Supervisor verified this observation during the exit interview on 12/18/2023.