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.

TRI COUNTY HOSPITAL - WILLISTON 125 SW 7TH ST WILLISTON, FL July 5, 2011
VIOLATION: ACCESS TO LOCKED AREAS Tag No: A0504
Based on staff interviews and facility record review the facility failed to ensure that only authorized personnel have access to the pharmacy.

Findings:

Interview on 07/01/2011 at 8:20 AM of the contacted Director of Pharmacy revealed that he worked full time at the local pharmacy and would come in when he had time and that he may even come in at midnight if that is when he had time. When asked if the dispensing and administration of medication was delayed until he came in to review the orders he stated that the floor nurse had a key to the pharmacy and when needed could come in pharmacy and obtain medications for the patients. The nurse is to sign out any medications taken from the pharmacy. When asked if the sign out sheet were reviewed and compared to the patients' records he stated that they were not. When asked if there was a system in place to determine if medications were missing from the inventory he stated that unless it is very obvious he could not tell if medications were missing from the pharmacy. When asked if there was a policy and procedure for non-pharmacy staff removing medication from the pharmacy he stated that he did not know of one. When asked if there is a written policy and procedure for the nurse to follow relating to entering the pharmacy and removing medications the pharmacist stated no there was note one.

Interview with the inpatient Registered Nurse on 07/01/2011 at 2:00 PM revealed when asked what do you do when you have a new admission and the pharmacist is not in the facility the nurse stated the following. "I would take the medication orders and write them on the Medication Administration Record and place a copy in the box on the door to the pharmacy. If any medications were due I would go to the pharmacy and sign them out and give them to the patient." When asked if the pharmacist review the orders prior to administration the nurse stated "no, I hardly ever see him". When asked if there were any pharmacy or nursing policy and procedures to guide her she stated that the Director of Nursing was working on some.

Review of nursing policy and procedures did not reveal any policy and procedures relating to non-pharmacy staff/nurses entering the pharmacy or obtaining medications when the pharmacist was not in the facility.
VIOLATION: AFTER-HOURS ACCESS TO DRUGS Tag No: A0506
Based on staff interviews and facility record review the facility failed to ensure that only authorized personnel removed medications from the pharmacy when the pharmacist is not in the facility.

Findings:

Interview on 07/01/2011 at 8:20 AM of the contacted Director of Pharmacy revealed that he worked full time at the local pharmacy and would come in when he had time and that he may even come in at midnight if that is when he had time. When asked if the dispensing and administration of medication was delayed until he came in to review the orders he stated that the floor nurse had a key to the pharmacy and when needed could come in pharmacy and obtain medications for the patients. The nurse is to sign out any medications taken from the pharmacy. When asked if there was a policy and procedure for non-pharmacy staff removing medication from the pharmacy he stated that he did not know of one. Asked if there is a written policy and procedure for the nurse to follow relating to entering the pharmacy and removing medications the pharmacist stated no there was note one.

Interview with the inpatient Registered Nurse (RN) on 07/01/2011 at 2:00 PM revealed that she when there is a new admission and the pharmacist is not in the facility the nurse would take the medication orders and write them on the Medication Administration Record, (MAR) and place a copy in the box on the door to the pharmacy. According to the (RN) if any medications were due she would go to the pharmacy and sign them out and give them to the patient. When asked if the pharmacist review the orders prior to administration the nurse stated "no, I hardly ever see him". When asked if there were any pharmacy or nursing policy and procedures to guide her she stated that the Director of Nursing was working on some.

Review of nursing policy and procedures did not reveal any policy and procedures relating to non-pharmacy staff/nurses entering the pharmacy or obtaining medications when the pharmacist was not in the facility.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on staff interviews and record review the facility failed to have an effective governing body to ensure that the medical staff practiced within the facility by-laws and State of Florida requirements, facility failed to provide an effective Pharmaceutical Service to ensure patient safety, and the facility failed to meet EMTALA requirements. For this reasons, the Condition of Governing Body was found to be out of compliance

Findings:

1. Reference A 0044 Based on interviews and review of credentialing files the facility failed for 4 of 4 Physician Assistants to ensure that the Physician Assistants (PA) practicing under a utilization plan, (Protocols) in collaboration with supervising Physician as required by the Physician Assistant Practice Act.

2. Reference A0090 Based on staff interviews and facility document review the facility failed to ensure that medications profiles are performed and medication orders are reviewed by a licensed pharmacist before being administered to the patient. The facility failed to develop and implement pharmacy policy and procedures. The facility failed to exercise control of entry of non-pharmacy staff into the pharmacy when pharmacy staff is not present.
VIOLATION: MEDICAL STAFF Tag No: A0044
Based on interviews and review of credentialing files the facility failed for 4 of 4 Physician Assistants to ensure that the Physician Assistants (PA) practicing under a utilization plan (Protocols) in collaboration with supervising Physician as required by the Physician Assistant Practice Act.

Findings:

Review of the Medical Staff Bylaws dated 08/31/2010 revealed on page 25 under Article 5. Clinical Privileges under subsection 5.1.1 PHYSICIAN ASSISTANT "The Physician Assistant may not practice without a utilization plan and in collaboration with the supervising Physician. The utilization plan must be approved each year by the supervising Physician and the Florida Board of Medicine or the Florida Board of Osteopathic Medicine. The Physician Assistant may perform those duties, responsibilities and procedures that are approved for that Physician Assistant in the utilization plan approved by Florida Board of Medicine or the Florida Board of Osteopathic Medicine." Review of the Physician Assistant Practice Act revealed that it is consistent with the facility's Bylaw.

Review of the credentialing file for 2 of 3 PAs, (#1 and #2), employed to work in the emergency (ER) did not reveal practice protocols.

Interview with PA #1 on 06/30/2011 at 12:05 PM revealed when asked if he has a collaborative Protocol, (utilization plan), he stated that he did not remember signing one at this hospital, but had signed one at the previous hospital he had been employed.

Review of PA #1's credentialing file revealed a utilization plan for the Rural Health Clinic, but not for the Hospital.

Review of the credentialing file for Physician Assistant #2, revealed only a utilization plan for the Rural Health Clinic and not for the hospital.

Interview with the Human Resource person on 06/30/2011 at 2:30 PM revealed that she was not aware what a utilization plan was and did not review the credentialing files for one.

Review of the credentialing file for a third Physician Assistant, revealed that a utilization plan was part of the credentialing file, but was dated 2006. The credentialing did not contain a current plan.

Interview with the Human Resource Director on 06/30/2011 at 2:30 PM revealed that a forth Physician Assistant did not have a credentialing file or a practice protocol on file. The Human Resources Director stated that he only worked in the ER a couple of shifts.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on interviews and record review the facility failed to ensure that medications profiles are performed and medication orders are reviewed by a licensed pharmacist before being administered to the patient. The facility failed to develop and implement pharmacy policy and procedures regarding non-pharmacy staff. The facility failed to exercise control of entry of non-pharmacy staff into the pharmacy when pharmacy staff is not present.

Findings

1 .Reference A0491: Based on staff interviews the facility failed to ensure the safe and appropriate uses of medications for all inpatients. Failure to develop and implement pharmacy policy and procedures places patients at risk of not receiving safe and effective medications.

2. Reference A0492: Based on interview and record review the pharmacist failed to ensure that medication profiles are developed and that medication orders are reviewed prior to dispensing and administration medications to all inpatients.

3. Reference A0500: Based on staff interview and observation the facility failed to ensure that medications are adequately controlled and distributed to provide for patient safety.

4. Reference A0504: Based on staff interviews and facility record review the facility failed to ensure that only authorized personnel have access to the pharmacy.

5. Reference A0506: Based on staff interviews and facility record review the facility failed to ensure that only authorized personnel removed medications from the pharmacy when the pharmacist is not in the facility.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on staff interviews the facility failed to ensure the safe and appropriate uses of medications for all inpatients. Failure to develop and implement pharmacy policy and procedures places patients at risk of not receiving safe and effective medications.

Findings:

Interview on 07/01/2011 at 8:20 AM of the contacted Director of Pharmacy revealed that the pharmacy is currently operating without the guidance of written and approved policy and procedures. The Director of Pharmacy stated that he is working on new policy and procedures, but does not know when it will be completed and approved. When asked how he knows how to perform his functions as a director he stated that he applies the same principles as he does at the local pharmacy where he is employed full-time.

Interview with the inpatient Registered Nurse on 07/01/2011 at 2:00 PM revealed when asked what do you do when you have a new admission and the pharmacist is not in the facility the nurse stated the following: "I would take the medication orders and write them on the Medication Administration Record, [MAR] and place a copy in the box on the door to the pharmacy. If any medications were due I would go to the pharmacy and sign them out and give them to the patient." When asked if the pharmacist reviews the orders prior to administration the nurse stated "no, I hardly ever see him". When asked how she knows if the medications ordered are safe to administer she stated that she knows the medications and if there is one that she does not know she will look it up. When asked if there were any pharmacy policy and procedures to guide her she stated that the Director of Nursing was working on some.
VIOLATION: PHARMACIST RESPONSIBILITIES Tag No: A0492
Based on interview and record review the pharmacist failed to ensure that medication profiles are developed and that medication orders are reviewed prior to dispensing and administration medications to all inpatients.

Findings:

1. Interview on 07/01/2011 at 8:20 AM of the contacted Director of Pharmacy revealed that the pharmacy is currently operating without the guidance of written and approved policy and procedures. The Director of Pharmacy stated that he is working on new policy and procedures, but does not know when the will be completed and approved. Asked if he develops a medication profile on all inpatients receiving medications, he stated that he did not and that he relied on the Medication Administration Record, (MAR), written by the nurse as his medication profile document. The pharmacist stated that his pharmacy medical record reviews were retrospective and not concurrent.

Further interview on 07/01/2011 at 8:20 AM with the contacted Director of Pharmacy revealed that the physician orders for medications were reviewed in the facility when he came in. He stated that he worked full time at a local pharmacy and would come in when he had time and that he may even come in at midnight if that is when he had time. When asked if the dispensing and administration of medication was delayed until he came in he stated that the nurse would review the orders and go to the pharmacy and get the medications themselves and then give the medications as ordered. The pharmacist stated that the charts are reviewed for errors when time permitted. According to the contacted Director of Pharmacy the floor nurse had a key to the pharmacy and when needed could come in to the pharmacy and obtain medications for the patients. The nurse is to sign out any medications taken from the pharmacy. When asked if the sign out sheet were reviewed and compared to the patient records he stated that they were not. When asked if there was a system in place to determine if medications were missing from the inventory he stated that unless it is very obvious he could not tell if medications were missing from the pharmacy. When asked if there was a policy and procedure for non-pharmacy staff removing medication from the pharmacy he stated that he did not know of one.

2. Review of the Nursing Policy and Procedure dated as revised 06/06/2011 titled Administration of Medications stated under POLICY in the second paragraph "Medications shall be administered according to procedures and guidelines established by the Pharmacy and Therapeutics Committee, as approved for the limitations of the intravenous administration of medications and the timing of administration of doses". Interview on 07/01/2011 at 8:20 AM of the contacted Director of Pharmacy revealed that the pharmacy does not have written policy and procedures.

Review of the "CONTRACT FOR SERVICES OF PHARMACIST" dated 05/11/2011 revealed under Responsibilities only "Provide consulting duties as Registered Consultant Pharmacist and Chair the Pharmacy and Therapeutics Committee". Under Compliance it states, "Compliance to the regulations, policies and procedures set forth by the State of Florida, Agency for Health Care Administration, Department of Professional Regulation and TriCounty Hospital-Williston". Review of the contract does not provide any specific duties guidelines as related to developing and maintaining patient medication profiles or reviewing medications orders prior to administration of the medications.

3. Interview with the inpatient Registered Nurse on 07/01/2011 at 2:00 PM revealed when asked, what she would do when she have a new admission and the pharmacist is not in the facility the nurse stated the following. "I would take the medication orders and write them on the Medication Administration Record and place a copy in the box on the door to the pharmacy. If any medications were due I would go to the pharmacy and sign them out and give them to the patient." When asked if the pharmacist reviewed the orders prior to administration the nurse stated "no, I hardly ever see him". When asked how she knows if the medications ordered are safe to administer she stated that she knows the medications and if there is one that she does not know she will look it up. When asked if there were any pharmacy policy and procedures to guide her she stated that the Director of Nursing was working on some.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on staff interview and observation the facility failed to ensure that medications are adequately controlled and distributed to provide for patient safety.


1. Interview on 07/01/2011 at 8:20 AM of the contacted Director of Pharmacy revealed that he did not develop medication profiles for inpatients, instead he relied on the Medication Administration Record, (MAR), written by the nurse as his medication profile document. The pharmacist stated that his pharmacy medical record reviews were retrospective and not concurrent.

Interview on 07/01/2011 at 8:20 AM of the contacted Director of Pharmacy revealed that the physician orders for medications were reviewed in the facility when he came in. He stated that he worked full time at the local pharmacy and he would come in when he had time, that he may even come in at midnight if that when he had time. Asked if the dispensing and administration of medication was delayed until he came in to review the orders he stated that the nurse would review the orders and go to the pharmacy, get the medications themselves and then give the medications as ordered. The pharmacist stated that the charts are reviewed for errors when time permitted. The contacted Director of Pharmacy further revealed that the floor nurse had a key to the pharmacy and when needed could come in pharmacy and obtain medications for the patients. The nurse is to sign out any medications taken from the pharmacy. When asked if the sign out sheet were reviewed and compared to the patient records he stated that they were not. When asked if there was a system in place to determine if medications were missing from the inventory he stated that unless it is very obvious he could not tell if medications were missing from the pharmacy. When asked if there was a policy and procedure for not pharmacy staff removing medication from the pharmacy he stated that he did not know of one.

2. Review of the Nursing Policy and Procedure dated as revised 06/06/2011 titled Administration of Medications stated under POLICY in second paragraph "Medications shall be administered according to procedures and guidelines established by the Pharmacy and Therapeutics Committee, as approved for the limitations of the intravenous administration of medications and the timing of administration of doses". Interview on 07/01/2011 at 8:20 AM of the contacted Director of Pharmacy revealed that the pharmacy does not have written policy and procedures.

Review of the "CONTRACT FOR SERVICES OF PHARMACIST" dated 05/11/2011 revealed under Responsibilities only "Provide consulting duties as Registered Consultant Pharmacist and Chair the Pharmacy and Therapeutics Committee". and under Compliance "Compliance to the regulations, policies and procedures set forth by the State of Florida, Agency for Health Care Administration, Department of Professional Regulation and TriCounty Hospital-Williston". Review of the contract does not provide any specific duties guidelines as related to developing and maintaining patient medication profiles or reviewing medications orders prior to the administration of the medications.

3. Interview with the inpatient Registered Nurse on 07/01/2011 at 2:00 PM revealed when asked what she does when she has a new admission and the pharmacist is not in the facility the nurse stated the following. "I would take the medication orders and write them on the Medication Administration Record and place a copy in the box on the door to the pharmacy. If any medications were due I would go to the pharmacy and sign them out and give them to the patient." When asked if the pharmacist review the orders prior to administration the nurse stated "no, I hardly ever see him". When asked how she knows if the medications ordered are safe to administer she stated that she knows the medications and if there is one that she does not know she will look it up. When asked if there were any pharmacy policy and procedures to guide her, she stated that the Director of Nursing was working on some.