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PALMS WEST HOSPITAL 13001 SOUTHERN BLVD LOXAHATCHEE, FL 33470 Dec. 13, 2011
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record reviews & interview, the facility did not ensure medications (drugs) were administered in accordance with the orders of the physicians responsible for the patient's care, accepted standards of practice, and with the facility's policies related to medication, for 4 of the 11 clinical records reviewed, (patient #1, #7, #9, and #10). Accepted standards of practice include maintaining compliance with applicable Federal and State laws, regulations and guidelines governing drug and biological use in hospitals, as well as, standards and recommendations promoted by nationally recognized professional organizations.

The findings include:

Review of the facility policies & procedures revealed: 1. Patient ' s Own Medication From Home: ...allows patients to use their own medications(s) from home while in the hospital ...an order must be received in the pharmacy that the patient may use their own medication(s) ...Home medications are to be brought to the pharmacy to be properly identified, entered into MediTech according to complete prescribing information and given a barcode for scanning purposes prior to patient administration. 3. Medication Reconciliation: guidelines for medication reconciliation in the interest of patient safety & advocacy. All inpatients will have all medications reconciled within 24 hours. The outcome of this activity is to generate the most accurate medication list available ....The list of patient ' s home medications ...are documented in the nursing assessment and on the home medication reconciliation form ...Physicians are responsibly for signing ALL medication reconciliation orders. Physicians are responsible for resuming or suspending medication on the Patient Home Meds list within 24 hours of admission and upon discharge... 4. Under the Procedure section: All home medications must be addressed within 24 hours of admission ...When compiled, the nurse must print and place the Admission Med Reconciliation form on top of the Physician Orders for the physician to review, reconcile authorize and sign ...Once all medications are reconciled, the form is faxed to Pharmacy to initialize the patient ' s medication profile ... "
Interview with the Assistant Pharmacist Clinical Manager on 12/12/2011 at approximately 1:10 PM and on 12/13/2011 at approximately 11:20 AM revealed the Admission Med Reconciliation form is considered to be a physician order form.

1. Review of the clinical record for Patient #1 revealed the patient was admitted on [DATE] with diagnoses that included psychogenic muscular-skeletal disease, attention deficit with hyperactivity (ADHD), anxiety, tremor, bipolar disorder, autistic disorder, & adverse effect anticonvulsant. The Admission Medication (Med) Reconciliation form of 10/21/2011 was completed and signed by the physician that listed Lexapro 20 mg daily; Concert 54 mg daily, and Remeron 30 mg daily as to be continued while in hospital. Review of the admission orders of 10/20/11 revealed orders that included: Admit to telemetry, seizure precautions, medications: Keppra 500 mg IV q12hr x 2 doses then orally, Ativan 1 mg IV q4 hr as needed for seizure breakthrough; Tylenol 650 mg q6h as needed for Headache, Concerta 54 mg daily and Remeron 30 mg daily. The physician orders were dated and signed initially and as a 24 hour check by the nurse for 10/20/11, 10/21/2011, and 10/23/2011.
Review of the documentation (e-MAR = electronic medication administration record) revealed the order for Concerta was scanned to Pharmacy on 10/21/2011 at 00:39 AM & entered on the eMAR and Pharmacy had responded to the order on the eMAR & documented " Clarification of Order Needed...Patient own med - arrange for patient to bring in and send to Pharmacy for verification - Also requires a written MD order to include: ok for patient to take own medication drug, dose, route, and frequency information. Please rescan to Pharmacy". The order & pharmacy response was acknowledged by the nurse on 10/21 at 1:20 AM .
Further review of order for Concerta on the eMAR dated 10/21/2011 with administration time of 9:00 AM to Pharmacy revealed Pharmacy's documentation as above remained on the eMAR but there was no evidence (initial) the nurse had given the med. Further review revealed the order was deactivated on 10/21/11 at 00:38 AM by Pharmacy. The order was edited by the physician on 10/21/11 at 10:00 AM. The same (as 10/21/11) was documented on the 10/22/2011 eMAR but no nurse initial or acknowledgement. On 10/23/11, the Concerta (drug) order was on the eMAR as being discontinued/deactivated by pharmacy. There was an additional nursing order taken (hand-written order) on 10/23/2011 that included to have parent bring home medications in tonight, ok to use own medication Concerta 54 mg daily...patient may titrate meds as needed, and may use own Lexapro 20 mg daily, Patient & family do not want sent. The order was edited by the physician on 10/24/11 and reactivated in Pharmacy on 10/24/2011.
Further review of the eMAR of 10/24/2011 revealed the ordered Lexapro 20 mg daily was not administered by the nurse or no evidence the nurse had administered this medication or the reason for not administering it.
Interview was conducted with the clinical pharmacy manager, with the Vice President (VP) of Quality & Patient Safety present on 12/12/2011 at 2:21 PM, related to what happened with the Concerta medication, revealed: the hospital does not carry Concerta in the hospital and it is not on the formulary: pharmacy lets nursing know it is not available and to have it brought in from home (see above 10/21/11 note from pharmacy). Nursing must see and acknowledge it needs to be brought in from home & requires MD / physician order; pharmacy is not responsible to notify the physician; and you cannot assume the MD / physician does not want it. The clinical pharmacist manager & the VP of Quality agreed there was a gap between the order date of 10/21/11 and 10/23/11 when an additional order is written for mother to bring meds from home. Review of information provided by the pharmacy revealed that on 10/24/11 Patient #1 ' s home medications were sent to pharmacy for verification & identification.
Review of the nursing notes of 10/21/11 at 1:30 AM (admission) revealed the Home Medications were listed and it included the Concerta.

Interview with the Manager of Telemetry (where Patient #1 had been) and the assistant Manager of Med Surg & Telemetry units, on 12/12/2011 at 2:27 PM revealed: there is no documentation or evidence in the record (nursing notes or eMAR) related to the Concerta, as to whether the family was asked to bring in the medication when pharmacy initially sent the note to the unit on 10/21/11. They agreed there was no evidence the medication, Concerta, was administered from 10/21 to 10/24/2011. Review of the eMAR revealed Concerta was administered on 10/25/2011 at 6:06 AM. The patient was discharged on [DATE].
There was documentation in the nursing notes of 10/25/11 at 1:43 PM, of dialogues between nursing and pharmacy, in which the home medications could not be located - they were eventually located in the pharmacy department. Further interview with the Assistant Manager at 3:16 PM revealed the nurses should document the family was notified to bring in meds in the nursing notes, but there is no related documentation in the record. She verbalized there is also no documentation or evidence the nurses documented on the eMAR as to why the medication was not administered (i.e. not available or waiting for family to bring in).

2. Review of the clinical record for Patient #7 revealed the patient was admitted to PICU at 10:17 PM on 11/30/2011 with a diagnosis that included Seizures. Review of the Admission Med Reconciliation form revealed the form was completed which listed the medication Risperdal, but the forms was otherwise blank with no nurse or physician signature. Review of the brief physician admit note for Patient #7 on 11/30/11 at 11:31 PM revealed the home meds were listed as Risperdal (risperidone) 1 mg q AM and 0.5 mg at noon daily. (Risperidone is listed on the formulary so available from pharmacy). Review of the eMARs revealed there was no evidence or documentation that Risperdone was administered during the patient ' s stay in hospital (11/30 thru 12/2/2011). Interview with the VP of QA and the PICU RN on 12/13/2011 at approximately 10:45 AM revealed that typically the intensivist / physician will discharge all home meds for the work-up while in hospital but there was no documentation by the physicians of this.

3. a). Review of the clinical record for Patient #9 revealed the patient was admitted on [DATE] at 6:44 PM, as a transfer from another facility with possible appendicitis. Review of the Admission Mediation Reconciliation form revealed there were 3 Home Meds listed on the form: one routine med (Bacid tablet twice daily), one 'as needed' med (Tylenol), and topical cream (Cod Liver oil / Zinc oxide). There was no evidence the form was reviewed by nursing or the physician. There were no signatures and no indication whether the physician wanted the home-meds to be continued or stopped while in hospital.

b). Review of the physician order for patient #9 revealed an order dated 11/15/2011 at 12:20 PM for ' PPN' (Pediatric Parenteral Nutrition). The nurse documented review of the order at 2:05 PM, and was faxed to pharmacy at 2:06 PM. Interview with the Pharmacist Clinical Manager on 12/13/2011 at 11:24 AM revealed the PPN was not available and the order was missed by nursing & the pharmacy so it was not administered on 11/15/11 as ordered.
Review of the facility report revealed that a PPN order was faxed to the pharmacy at 2 PM (the drug not identified on the report, but interview with the pharmacist clinical manager on 12/13/11 at 12:13 PM revealed it was for PPN / TPN). She further verbalized that when the nurse wanted to give the PPN at 10:00 PM, it was not available and the report documented that pharmacy had not gotten the order.
Review of the eMAR revealed there was no evidence or documentation the patient received the PPN the evening of 11/15/11.
Further interview with the Pharmacist on 12/13/11 at 12:15 PM revealed the patient did not get the PPN on this day (11/15/11 at 2200 hr = 10 PM). She stated the order was faxed to the pharmacy and was never followed through. Further interview with the Pharmacist revealed that PPN is not prepared at this facility so the cut off time was passed (2 PM) when the order was faxed (2:08 PM), and was put on hold by the entry pharmacist. She verbalized it was not realized that it was missed; so they could not get it that evening, but it was obtained the next day (11/16). She verbalized the physician was notified. Review of the physician notes of 11/15/2011 at 11:37 PM revealed that the physician " was notified by nursing that the pharmacy had not received the fax for PPN, the order had been faxed, but could not be found. The patient was maintained on current IV Fluids and PPN would be started in the AM " .

4. a). Review of the clinical record for Patient #10 revealed the patient was admitted on [DATE] for cardiac catheterization. Review of the physician orders revealed an order of 11/21/2011 at 7 PM for " IV Heparin as per Pharmacy please; discontinue IV Heparin at 6 AM " . Review of the pharmacy documentation revealed the order was received in pharmacy at 7:32 PM and completed at 8:18 PM. The nurse acknowledged the order on the MAR on 11/21/2011 at 8:30 PM. Review of the MARS for Patient #10 revealed an order entry on 11/21/2011 for Heparin 25,000 units/ D5W 500 ml bag at 17 mls / hour (concentration of 50 units / ml as directed). There was no evidence or documentation in the record or on the eMARs the Heparin drip was administered to the patient. The VP of Quality reviewed the eMARs with the surveyor and agreed it was not given. The eMARs were reviewed with the Charge nurse of Telemetry & the Nurse Manager on 12/13/2011 at 1:01 PM and they agreed the Heparin drip was not documented as being administered. Review of the nursing notes revealed the physician was notified. Further interview with the Charge nurse revealed the nurse did not know about the order until she was doing her shift notes near the morning, and then notified the physician. There were no additional orders from the physician. The Nurse manager stated she needs to follow up with the agency as she was a traveling nurse.

b). Further review of the file for Patient #10 revealed a Home Medication Reconciliation form completed by the nurse and signed by the physician. The form documented to continue with the Omega 3s and the MultiVitamins. Review of the eMARs revealed they were not listed on the MAR and were not administered. Interview with the VP of Quality on 12/13/2011 revealed the signed Admission Medication Reconciliation form is supposed to be faxed to pharmacy as an order.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on record reviews & interview, the facility did not ensure medications (drugs) & biologicals were procured, distributed and administered in accordance with the orders of the physicians responsible for the patient's care for 1 of 11 sampled patients (#9). Pharmaceutical Services would include: The procuring, dispensing, ordering, distributing, and administering of all medications.

The findings include:

1. Review of the physician order for patient #9 revealed an order dated 11/15/2011 at 12:20 PM for ' PPN' (Pediatric Parenteral Nutrition). The nurse documented review of the order at 2:05 PM, and it was faxed to the pharmacy at 2:06 PM.
Review of the facility report revealed that a PPN order was faxed to the pharmacy at 2 PM (the drug not identified on the report, but interview with the pharmacist clinical manager on 12/13/11 at 12:13 PM revealed it was for PPN / TPN). She further verbalized that when the nurse wanted to give the PPN at 10:00 PM, it was not available and the report documented that pharmacy had not gotten the order.
Further interview with the Pharmacist on 12/13/11 at 12:15 PM revealed the patient did not get the PPN on this day (11/15/11 at 2200 hr = 10 PM). She stated the order was faxed to the pharmacy and was never followed through. Further interview with the Pharmacist revealed that PPN is not prepared at this facility so the cut off time was passed (2 PM) but we give an approximate 10 minute leeway for orders coming in little after 2 PM. The nurse documentation revealed the order was faxed (2:06 PM), and review of the eMAR (electronic medication administration record) revealed it was put on hold by the entry pharmacist. The Pharmacist verbalized it was not realized that it was missed soon enough, so they could not get (procure & distribute) it that evening, but it was obtained the next day (11/16). She verbalized the physician was notified. Review of the physician notes of 11/15/2011 at 11:37 PM revealed that the physician "was notified by nursing that the pharmacy had not received the fax for PPN, the order had been faxed, but could not be found. The patient was maintained on current IV Fluids and PPN would be started in the AM" .
Interview with the Pharmacist Clinical Manager on 12/13/2011 at 11:24 AM revealed the PPN was not available and the order was missed by nursing & pharmacy so it was not administered on 11/15/11 as ordered.
Review of the eMAR revealed there was no evidence or documentation the patient received the PPN the evening of 11/15/11.