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.

UF HEALTH LEESBURG HOSPITAL 600 E DIXIE AVE LEESBURG, FL 34748 March 11, 2013
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 facility failed to provide an effective Pharmaceutical Service to ensure patient safety. For this reason, the Condition of Governing Body was found to be out of compliance.

Findings:

Reference A 0490: Based on observation, interview, medical record review, personnel record review, and review of policies and procedures, the hospital failed to ensure, including pharmacy and nursing staff, that the correct medications were administered to all patients.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, medical record review, personnel record review, and review of policies and procedures, the hospital failed to ensure the correct medications were administered.

Findings:

A review of the records and interviews revealed:
Patient #1 History of Ischemic [DIAGNOSES REDACTED] (Ejection fraction 30-35 % on 12/12/2012)
Congestive heart failure
Systolic dysfunction
BMI 32
Diabetes
Cardiovascular disease
Atrial fibrillation
[DIAGNOSES REDACTED]
Diverticular disease
Sleep apnea Hypersomnia
Reflux
Restless leg syndrome
Severe pulmonary hypertension
Stage 4 chronic kidney disease


Timeline:
02/11/2013 11:33 AM Patient is a direct admit from physician ' s office
02/11/2013 1240 Physician ' s order for Primacor 0.025 mcg/kg/min x 48 hours
02/11/2013 RN "A" faxed order for Primacor to pharmacy: Primacor 0.025 mcg/kg/min
02/11/2013 Pharmacist calls RN "A" for clarification of Primacor order
02/11/2013 1422 RN "A" called Physician to clarify Primacor order dosage 0.25 mcg/kg/min
02/11/2013 RN "A" sends corrected order for Primacor to pharmacy
02/11/2013 Pharmacy Technician #1 gets Pharmacy Technician #2 to locate the medication bin (Primacor)
02/11/2013 Pharmacy Technician #2 pulls Esmolol from a bin
02/11/2013 Pharmacy Technician #2 puts Primacor label on Esmolol IV medication bag
02/11/2013 Pharmacy Technician #2 puts the labeled medication for the pharmacist to check and initial
02/11/2013 Pharmacist signs on the label indicating he checked medication bag
02/11/2013 Medication is put into bin for courier to transport to the unit
02/11/2013 RN "A" starts administration of medication by pump (Esmolol instead of Primacor)
02/11/2013 RN "A" gave report to 7 PM to 7 AM shift RN "B" and reported Primacor infusing
02/12/2013 0800 RN "B" gave report to 7 AM to 7 PM shift LPN "C" and reported Primacor infusing.
02/12/2013 1330 LPN "C" notices a change in condition, notifies charge nurse. Patient exhibiting respiratory distress. Resp. rate 36
02/12/2013 1330 Charge nurse checks patient, did not check medication, notifies Cardiovascular Medical Unit Director. Cardiovascular Medical Unit Director observes Esmolol infusing. Stops infusion.
02/12/2013 1345 Patient develops agonal breathing. Code Blue called. Emergency Department Physician to bedside for Code. CPR, ACLS (Advanced Cardiac Life Support)
02/12/2013 1415 Terminated Code effort

Interviews:

On 03/12/2013 at 12:53 PM an interview conducted with Pharmacy Technician #1 revealed she was the Main Technician in pharmacy on 02/11/2013. She explained the pharmacist puts the information for the medication into the computer from the order. The IV printer prints labels. She did not know where to locate the Primacor. She asked for help from the IV Pharmacy Technician #2. Technician #2 took the medication from the bin and put the Primacor label on the medication when she picked it up. Pharmacy Technician #1 stated she never looked at the bag of medication. Pharmacy #2 put the medication on the counter to be checked by the pharmacist.

On 03/12/2013 at 2:00 PM an interview conducted with Pharmacy Technician #2 revealed the main Pharmacy Technician #1 did not know where the Primacor medication was stored. Pharmacy Technician #2 showed Pharmacy Technician #1 where the bins were, and then Pharmacy Technician #2 took the medication out of the bin, put the Primacor label on the (Esmolol) bag. She then placed the bag on the counter for the pharmacist to check.

On 03/12/2013 at 12:12 PM an interview conducted with (Registered Nurse) RN "A" revealed the order was written for Primacor on 02/11/2013. He called the physician to get a verification of the Primacor dosage. Primacor 0.25 mcg/kg/min. The order was sent to pharmacy. Pharmacy sent the medication. RN "A" added he scanned the label, and the patient's identification band. He did not keep the label attached to the outside of the bag. He said the policy of the hospital is to check the 5 rights (including right medication). He said he did not check the bag for the name of the medication and assumed it was Primacor. He gave report to the nurse RN "B"on the next shift.

On 03/11/2013 at 7:06 PM an interview with RN "B"revealed the patient had complications of shortness of breath, and she checked the SAT ' s (pulse Oximetry). She had the charge nurse assess him. She got the Duoneb order from the physician. She stated the medication should have been Primacor, but was Esmolol. She received report from RN "A". She did not look at the orders that day because it was a busy day. The medication was already infusing when she came in. She did not have to hang another bag, so she did not check the bag. She gave report to LPN "C" and reported Primacor was infusing.

On 03/11/2013 at 4:49 an interview with RN"D", Charge Nurse, revealed the patient was short of breath and his blood pressure was up. LPN "C" asked the charge nurse to look at the patient. The charge nurse stated she looked at him and knew he did not look right. When she was called in, she looked at the patient, and did not check medication, but looked at the pump and noted the rate was correct. She asked the Director, RN "E" to come in. She did not call the CAT (critical assessment team).

On 03/11/2013 4:45 PM an interview with RN "E" Director of Cardiac Medical Unit revealed the charge nurse checked the patient, then went and got the Director. The Director went to the room and asked the LPN what medication the patient was on. The Director stated she was told the patient was on Primacor. She checked the bag and found Esmolol hanging. She turned the pump off. Vital signs were being taken. She then called respiratory. Cardiology wanted the patient to go to ICU. The CAT (critical access team) team was not called. A Code was called when the phlebotomist was in the room to draw stat labs and the patient started seizing.

A review of the hospital's Policies and Procedures: Medication Administration (Last Revision 09/26/2012) revealed:
The "5 Rights of Drug Administration" must be carefully followed and include:
1. Right patient
2. Right drug
3. Right dose
4. Right route
5. Right time

Each healthcare provider administering medications will verify medications as noted on the MAR (medication administration record) with written physician orders prior to the first dose and at the beginning of each shift.

Healthcare providers will administer only medications that have been fully labeled with medication name, dose to administer, dose form, route, any special storage information, expiration date, and all applicable warnings.

The staff member administering medications is responsible to:
a. identify patient using two identifiers, patient name and date of birth
b. Verify the correct medication is being administered by confirming medication label with MD order or MAR that has been verified with the MD order.
c. Verify the medication is stable based on visual examination for particulate or discoloration and that the medication has not expired.

The patient should be monitored for therapeutic effectiveness and/or adverse reactions. These observations should be appropriately communicated to the physician.

The Policies and Procedures dated 06/26/2012 for Pharmacy Sterile Product Preparation and IV Admixture Processes revealed:
IV (Intravenous) solutions and medications are dispensed using premixed solutions, Mini-Bag system, Add-vantage system, or in extemporaneously prepared bags, vials, or syringes using the following process:
Labeling: The CSP's (compounded sterile products) are to be labeled with at least the following information: Patient name and account number, control or lot number (if batch prepared), all solutions an ingredients names, amounts, strengths, and concentrations, expiration, administration route, rate, appropriate auxiliary labels, storage requirements, preparation personnel identification, device specific instructions, state for federal information.

Verification of accuracy is completed by visually confirming additive labels and quantities match the final product label/CSP order.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on observation, interview, medical record review, personnel record review, and review of policies and procedures, the hospital failed to ensure, including pharmacy and nursing staff, that the correct medications were administered to all patients.

Findings:

Reference A0405: Based on observation, interview, medical record review, personnel record review, and review of policies and procedures, the hospital failed to ensure the correct medications were administered to 1 of 11 patients sampled.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, medical record review, personnel record review, and review of policies and procedures, the hospital failed to ensure the correct medications were administered to 1 of 11 patients sampled.

Findings:

A review of the records and interviews revealed:
Patient #1 History of Ischemic [DIAGNOSES REDACTED] (Ejection fraction 30-35 % on 12/12/2012)
Congestive heart failure
Systolic dysfunction
BMI 32
Diabetes
Cardiovascular disease
Atrial fibrillation
[DIAGNOSES REDACTED]
Diverticular disease
Sleep apnea Hypersomnia
Reflux
Restless leg syndrome
Severe pulmonary hypertension
Stage 4 chronic kidney disease


Timeline:
02/11/2013 11:33 AM Patient is a direct admit from physician ' s office
02/11/2013 1240 Physician ' s order for Primacor 0.025 mcg/kg/min x 48 hours
02/11/2013 RN "A" faxed order for Primacor to pharmacy: Primacor 0.025 mcg/kg/min
02/11/2013 Pharmacist calls RN "A" for clarification of Primacor order
02/11/2013 1422 RN "A" called Physician to clarify Primacor order dosage 0.25 mcg/kg/min
02/11/2013 RN "A" sends corrected order for Primacor to pharmacy
02/11/2013 Pharmacy Technician #1 gets Pharmacy Technician #2 to locate the medication bin (Primacor)
02/11/2013 Pharmacy Technician #2 pulls Esmolol from a bin
02/11/2013 Pharmacy Technician #2 puts Primacor label on Esmolol IV medication bag
02/11/2013 Pharmacy Technician #2 puts the labeled medication for the pharmacist to check and initial
02/11/2013 Pharmacist signs on the label indicating he checked medication bag
02/11/2013 Medication is put into bin for courier to transport to the unit
02/11/2013 RN "A" starts administration of medication by pump (Esmolol instead of Primacor)
02/11/2013 RN "A" gave report to 7 PM to 7 AM shift RN "B" and reported Primacor infusing
02/12/2013 0800 RN "B" gave report to 7 AM to 7 PM shift LPN "C" and reported Primacor infusing.
02/12/2013 1330 LPN "C" notices a change in condition, notifies charge nurse. Patient exhibiting respiratory distress. Resp. rate 36
02/12/2013 1330 Charge nurse checks patient, did not check medication, notifies Cardiovascular Medical Unit Director. Cardiovascular Medical Unit Director observes Esmolol infusing. Stops infusion.
02/12/2013 1345 Patient develops agonal breathing. Code Blue called. Emergency Department Physician to bedside for Code. CPR, ACLS (Advanced Cardiac Life Support)
02/12/2013 1415 Terminated Code effort

Interviews:

On 03/12/2013 at 12:53 PM an interview conducted with Pharmacy Technician #1 revealed she was the Main Technician in pharmacy on 02/11/2013. She explained the pharmacist puts the information for the medication into the computer from the order. The IV printer prints labels. She did not know where to locate the Primacor. She asked for help from the IV Pharmacy Technician #2. Technician #2 took the medication from the bin and put the Primacor label on the medication when she picked it up. Pharmacy Technician #1 stated she never looked at the bag of medication. Pharmacy #2 put the medication on the counter to be checked by the pharmacist.

On 03/12/2013 at 2:00 PM an interview conducted with Pharmacy Technician #2 revealed the main Pharmacy Technician #1 did not know where the Primacor medication was stored. Pharmacy Technician #2 showed Pharmacy Technician #1 where the bins were, and then Pharmacy Technician #2 took the medication out of the bin, put the Primacor label on the (Esmolol) bag. She then placed the bag on the counter for the pharmacist to check.

On 03/12/2013 at 12:12 PM an interview conducted with (Registered Nurse) RN "A" revealed the order was written for Primacor on 02/11/2013. He called the physician to get a verification of the Primacor dosage. Primacor 0.25 mcg/kg/min. The order was sent to pharmacy. Pharmacy sent the medication. RN "A" added he scanned the label, and the patient's identification band. He did not keep the label attached to the outside of the bag. He said the policy of the hospital is to check the 5 rights (including right medication). He said he did not check the bag for the name of the medication and assumed it was Primacor. He gave report to the nurse RN "B"on the next shift.

On 03/11/2013 at 7:06 PM an interview with RN "B"revealed the patient had complications of shortness of breath, and she checked the SAT ' s (pulse Oximetry). She had the charge nurse assess him. She got the Duoneb order from the physician. She stated the medication should have been Primacor, but was Esmolol. She received report from RN "A". She did not look at the orders that day because it was a busy day. The medication was already infusing when she came in. She did not have to hang another bag, so she did not check the bag. She gave report to LPN "C" and reported Primacor was infusing.

On 03/11/2013 at 4:49 an interview with RN"D", Charge Nurse, revealed the patient was short of breath and his blood pressure was up. LPN "C" asked the charge nurse to look at the patient. The charge nurse stated she looked at him and knew he did not look right. When she was called in, she looked at the patient, and did not check medication, but looked at the pump and noted the rate was correct. She asked the Director, RN "E" to come in. She did not call the CAT (critical assessment team).

On 03/11/2013 4:45 PM an interview with RN "E" Director of Cardiac Medical Unit revealed the charge nurse checked the patient, then went and got the Director. The Director went to the room and asked the LPN what medication the patient was on. The Director stated she was told the patient was on Primacor. She checked the bag and found Esmolol hanging. She turned the pump off. Vital signs were being taken. She then called respiratory. Cardiology wanted the patient to go to ICU. The CAT (critical access team) team was not called. A Code was called when the phlebotomist was in the room to draw stat labs and the patient started seizing.

A review of the hospital's Policies and Procedures: Medication Administration (Last Revision 09/26/2012) revealed:
The "5 Rights of Drug Administration" must be carefully followed and include:
1. Right patient
2. Right drug
3. Right dose
4. Right route
5. Right time

Each healthcare provider administering medications will verify medications as noted on the MAR (medication administration record) with written physician orders prior to the first dose and at the beginning of each shift.

Healthcare providers will administer only medications that have been fully labeled with medication name, dose to administer, dose form, route, any special storage information, expiration date, and all applicable warnings.

The staff member administering medications is responsible to:
a. identify patient using two identifiers, patient name and date of birth
b. Verify the correct medication is being administered by confirming medication label with MD order or MAR that has been verified with the MD order.
c. Verify the medication is stable based on visual examination for particulate or discoloration and that the medication has not expired.

The patient should be monitored for therapeutic effectiveness and/or adverse reactions. These observations should be appropriately communicated to the physician.

The Policies and Procedures dated 06/26/2012 for Pharmacy Sterile Product Preparation and IV Admixture Processes revealed:
IV (Intravenous) solutions and medications are dispensed using premixed solutions, Mini-Bag system, Add-vantage system, or in extemporaneously prepared bags, vials, or syringes using the following process:
Labeling: The CSP's (compounded sterile products) are to be labeled with at least the following information: Patient name and account number, control or lot number (if batch prepared), all solutions an ingredients names, amounts, strengths, and concentrations, expiration, administration route, rate, appropriate auxiliary labels, storage requirements, preparation personnel identification, device specific instructions, state for federal information.

Verification of accuracy is completed by visually confirming additive labels and quantities match the final product label/CSP order.