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.

HEART OF FLORIDA REGIONAL MEDICAL CENTER 40100 US HWY 27 N DAVENPORT, FL 33837 May 10, 2013
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on clinical record review, facility document review and staff interviews it was determined the facility did not identified and reduced the amount of medication errors related to timeliness of medication reconciliation, missed medications and medications given late in 5 ( #1, #3, #4, #6, #9) of 10 sampled patients .

Findings include:

1. Patient #1's medications were not given as ordered, the medication reconciliation was not completed in a timely manner, and medications were not administered in a timely manner. Patient #1's intravenous (IV) Solumedrol and IV Levaquin was not given as ordered by the physician on 3/13/13 and 3/14/14. The patient's home medication reconciliation for Lisinopril, Norvasc and Pepcid was completed on 3/14/13 at 3:00 a.m. and faxed to pharmacy (time unknown). The patient received the initial doses of Lisinopril, Norvasc and Pepcid at 9:23 p.m., approximately 18 hours after form was completed.

2. Patient #3's medication reconciliation was completed but medications were not verified or given for 2 days. Patient #3 (MDS) dated [DATE]. The home medication reconciliation was completed on 5/8/13 at 9:00 a.m. by nursing and a telephone order was received to continue home medications (that included an antibiotic azithromycin) by the physician at 1:45 p.m. The antibiotic needed to be verified, this had not been completed at the time of survey on 5/10/13.

3. Patient #4's home medication reconciliation included Abilify, Sinemet, Metformin, Amlodipine, Lisinopril, Megestrol, Synthroid, Simvastatin, Glipizide, Levemir and Sennostrate was not completed timely. A family member and the patient's medications were at the bedside in the emergency department and upon admission. The patient was admitted on [DATE] at 6:29 p.m. and the medication reconciliation form was completed on 5/9/13 at 6:00 p.m. It was signed by the physician at 9:00 p.m., an approximate twenty four hour delay.

4. Patient #6 was admitted on [DATE]. The medication reconciliation form was completed on 5/6/13 but not signed or faxed until 5/7/13.

5. Patient #9 (MDS) dated [DATE] at 10:01 a.m. and was admitted at 2:30 p.m. The home medication reconciliation was completed on admission but not signed until 5/10/13. The home medications included Amlodipine, Coreg, and Plavix, Lamotripin, Ramipril and aspirin.

A review of the facility's Performance Improvement Plan-2013, #900 A 1101, no date, revealed on page 3, section II, A. Objectives of the Performance Improvement (PI) Program... is designed to continuously generate information that will enable the facility to meet the following goals and objectives...Assure that patients receive safe, appropriate care through objective appraisal of patient outcomes; increase the probability of effective patient outcomes; to coordinate and integrate patient care delivery process across departments and services; to develop and maintain an efficient and effective system of data management and to identify variations that impact patient care, implement corrective strategies, and re-evaluate the effectiveness of the actions. A review of the Performance Improvement projects, 2012-2013, revealed Project: Medication Reconciliation, Data Frequency, Monthly.

An interview was conducted on 5/10/13 at 9:20 a.m. with the Director of Pharmacy. The Director was questioned concerning who tracks and trends medication errors and medication reconciliation compliance. The Director stated that pharmacy tracks adverse medication errors but not general medication errors or medication reconciliation compliance. She further added the Director of Quality used to do these but retired in March 2013.

An interview was conducted on 5/10/13 at 11:00 a.m. with the Chief Executive Officer (CEO) and Director of Risk Management. They were questioned concerning who does the monitoring of medication errors and medication reconciliation compliance. The Director of Risk Management stated she monitors medication errors by the event reports but does not believe these are an accurate view of the medication errors. Both concur that the Director of Quality had monitored the medication reconciliation compliance until March.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on clinical record review, staff interview and policy review it was determined the pharmacy staff failed to implement pharmacy policy for 5 (#1, #3, #4, #6, #9) of 10 sampled patients related to timeliness of medication reconciliation, missed medications, medications given late and notifying the physician for ordering of home medications.

Findings include:


1. Patient #1 presented to the Emergency Department (ED) on 3/13/13 at 1:37 p.m. for shortness of breath. The patient was given Solumedrol 125 milligrams (mg) at 2:25 p.m. The admission orders written on 3/13/13 at 5:00 p.m. revealed orders to given Solumedrol 125 mg every 8 hours times 2 more doses.

A review of the ED nursing documentation and Medication Administration Records (MAR) dated 3/13/13 revealed the Solumedrol was not given at 10:25 p.m. as orders and the 3rd dose scheduled for 6:00 a.m. on 3/14/13 was given at 7:14 a.m. approximately 1 hour late. A notation by the nurse indicated the medication was late due to increased unit activity. Further review of the admission orders written on 3/13/13 at 5:00 p.m. revealed an order for Levaquin (antibiotic) intravenously (IV) every 24 hours. A review of ED documentation and the MAR dated 3/13/13 revealed the medication was not started until 3/14/13 at 9:22 p.m., over twenty four hours later.

A review of the medication reconciliation form dated 3/14/13 at 3:00 a.m. and faxed to pharmacy, time unknown, revealed medications that included Norvasc, Lisinopril and Pepcid. A review of the MAR revealed the patient received the initial dose of the medications at 9:23 p.m., approximately 18 hours later.

2. Patient #3 (MDS) dated [DATE] for shortness of breath. The patient's medication reconciliation was completed on 5/8/13 at 9:00 a.m. by nursing. A telephone order was received to continue the home medications by the physician at 1:45 p.m. The home medications included azithromycin (antibiotic), no frequency was listed. A review of the MARs for 5/8/13 and 5/9/13 revealed the antibiotic needed to be verified. A review of the nursing documentation for 5/8/13 and 5/9/13 did not reveal that nursing had contacted the physician to verify the medication. The patient had not received the medication since admission. Further review of the medication reconciliation form revealed the documentation was incomplete do to no entry of when the patient had last taken their medications.

3. Patient #4 (MDS) dated [DATE] at 6:29 p.m. for shortness of breath. A review of the ED Hand Off Communication form dated 5/8/13 revealed the medications were with the patient. A review of the ED physician's documentation revealed the home medications were with the patient. A review of the medication reconciliation form revealed the form had been completed by nursing on 5/9/13 at 6:00 p.m. and signed by the physician at 9:00 p.m. over twenty four hour later. The home medications included Metformin, Glipizide, Levemir, Glucophage, Amlodipine and Lisinopril.

An interview was conducted with the patient's nurse on 5/10/13 at 10:00 a.m. The nurse was questioned concerning the patient's home medications. The nurse responded the medication reconciliation could not be completed until she was able to get hold of the patient's family member at 6:00 p.m. at following day

An interview was conducted on 5/10/13 at 10:30 a.m. with patient #4. The patient was questioned concerning her home medications. The patient responded she had brought the medications with her when she came to the ED and still had them when she was admitted to the Progressive Care Unit (PCU). She further stated her family member was with her when she was admitted to the ED and the PCU. When questioned where her home medications were at now she stated the facility had them locked up.

4. Patient #6 was admitted on [DATE] at 10:15 p.m. The medication reconciliation form was completed on 5/6/13 (no time) and was faxed to pharmacy on 5/7/13 at 8:54 a.m. The medications included Spirolactone, Lasix, Elavil, Flomax and Oxycodone.

Review of the MARs since admission on 5/5/13 revealed the patient did not receive the home medications until 5/7/13. A review of the nursing documentation revealed there was no nursing documentation related to notifying the physician concerning the patients home medications.

5. Patient #9 presented to the facility's ED on 5/9/13 at 10:01 a.m. and admitted at 12:49 p.m. A review of the medication reconciliation form dated 5/9/13 at 2:30 p.m. was signed by nursing. The form was signed by the physician and faxed on 5/10/13, no time indicated. There was no indication on the form of when the patient took their last dose of medications.

An interview was conducted on 5/10/13 at 11:05 a.m. with the nurse who completed the form. The nurse confirmed she had not asked the patient when her last dose of medication was. She further confirmed she had not called the physician with the home medications and waited until the physician had to come in to see the patient the following day.

A review of the pharmacy policy "Medication Reconciliation" policy # 712 IP-41 reviewed 1/2013 under paragraph "Admission" revealed the Medication Reconciliation Form is completed by the admitting nurse or admitting physician on all patients admitted to the hospital. During the admission process, the nurse should ask the patient about their home medications and record these on the form with the patient/family or caregiver to verify each medication on the list currently taken at home, ask the time/date the last dose was taken...... The list of medications must be called to the physician .... and the physician will determine whether or not to continue the medications during hospitalization .
Further review of the policy, under Clarification revealed the pharmacy shall initiate the clarification process with the nurse or the physician as deemed appropriate by the pharmacist. Upon initiating a clarification, documentation will be placed in the patient's profile, by the pharmacist, prompting the nurse every hour that clarification of the specific order must be addressed.

A review of the pharmacy policy, "Administration of Medications General" #712 P-19 reviewed 1/13, revealed drugs shall be prepared and administered in accordance with the orders of the prescriber or practitioner responsible for the patient's care and accepted standards of practice.

A review of the Pharmacy Plan for Provision of Care, page 8.9, page 15, Reconciliation of Medications, revealed patient medications are reconciled on admission to the facility, when transferred to another level of care and on discharge.