The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ED FRASER MEMORIAL HOSPITAL 159 N 3RD ST MACCLENNY, FL 32063 Feb. 10, 2020
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observation and staff interview, the facility failed to remove expired drugs from the refrigerator in the emergency room .



The findings include:


During survey review in the emergency room , the refrigerator was checked in the Medication Room on 2/10/20 at 10:15am. In the refrigerator, there were thirteen injectable Tetanus and [DIAGNOSES REDACTED] injectables that were expired. The Tetanus and [DIAGNOSES REDACTED] injectables expired on [DATE]. The Director of Risk Management inspected the boxes and requested the Nurse Manager to pull them from the refrigerator.


Interview with the emergency room Manager on 2/10/20 at 10:15am revealed the Pharmacist was to check expiration dates in the Medication Room and staff were to check expirations before giving the medications.


The policy and procedures for outdated drugs was requested. The Surveyor was given a policy for outdated drugs and recalled products. There was no Policy number, no effective date and no revision date. This policy stated,"The Pharmacy personnel will constantly check all medications physically for dated items and will remove all outdated packages from the shelves.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on observation and interview with Quality Management, the facility failed to maintain and revise pharmacy policies and procedures to ensure adherence with acceptable professional Standards of Practice.


The findings include:


During survey of the Pharmacy, it was discovered that there were no current pharmacy policies and procedures to govern the Pharmacy. On 2/10/19 at 1:26pm, in an interview with the Risk Manager, the policies and procedures for Pharmacy was requested. The Risk Manager presented the writer with a black manual with policies for the pharmacy dated 1990. There was one single policy dated 1993, which was stuck to the binder and was immovable. The pages of the policies were yellowed from aging. None of the policies were dated. There was only one revised policy given by the Risk Manager for Emergency after hours Access to the Pharmacy dated 2/6/20 that was completed due to the issue with drug diversion.


In an interview with the Risk Manager and Interim Director of Nursing on 2/10/91 at 1:35pm, it was revealed they hired pharmacists to update the system with the newest and greatest.
VIOLATION: FORMULARY SYSTEM Tag No: A0511
Based on observation and staff interviews, the facility failed to establish a formulary system within the hospital to ensure quality drugs were available for dispensing.


The findings include:

The pharmacy was toured on 2/10/20 at 10:40am. During an interview with Interim Consulting Pharmacist on 2/10/20 at 11:09am, the Consultant Pharmacist was asked if there was a formulary for the Pharmacy. She stated there was no formulary system in place; that she looked and could not find it. The formulary system lists medications for dispensing or administration. The formulary system would include criteria to determine what drugs were available for dispensing, indications for use, effectiveness of the drug, potential abuse and cost of the drug.


In an interview with the Risk and Quality Manager on 2/10/20 at 1:26pm, she stated that they did not know there was an issue with the formulary until the Pharmacy Consultant who was recently hired found problems in the Pharmacy. She said she did not know there was no formulary in the Pharmacy. The Risk Manager left the interview to retrieve a copy of the formulary from her office. The formulary was on a Word document with several pages. It was divided up into columns to indicate categories, such as Therapeutic Class, Description/Strength/Form. There were yellow marker cross-outs on the document. The Risk Manager and Director of Nursing did not know what the cross-outs meant. There was no date on the formulary. No documentation was found to indicate what drugs were available for dispensing. No criteria was established indicating the use of the medication effectiveness and risks.