HospitalInspections.org

Based on review of documentation and interviews, the hospital failed to ensure that drugs and biologicals were prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioner responsible for the patient's care as specified under 482.12 (c) and accepted standards of practice.

Findings included:

Background information:

Review of the ED record dated 1/27/10 indicated the chief complaint was unresponsiveness. Review of ED documentation indicated the Patient was diagnosed with an episode of unresponsiveness/confusion/syncope [fainting] and UTI with generalized weakness - similar to which brought the Patient to the ED the prior week. ED documentation indicated the 90 year old Patient was admitted for antibiotic therapy.

1) Review of the ED record, section on medications taken at home, indicated the Patient took Cymbalta [an antidepressant] 60 mg once a week.

2) Review of the inpatient medical record indicated the Patient was admitted to the Medial Surgical floor on 1/27/10 at 9 pm. Review of the Hospitalist's admission orders indicated that Cymbalta 60 mg was ordered daily - not in dosage agreement with medications taken at home documentation on the ED record.

3) Review of the Inpatient Medication Reconciliation Form dated 1/27/10 indicated the Patient was taking Cymbalta 60 mg once weekly. Documentation indicated that medications were reviewed with the Physician and the medication was ordered to continue while an inpatient. Review of the Medication Administration Record [MAR] dated 1/27/10 through 1/28/10 indicated that Cymbalta was "taken at home" that day and not administered. There was no indication that Cymbalta was recorded on the typed, pharmacy record for ongoing daily administration. Because Cymbalta was not recorded on the pharmacy record, the medication was not administered on a daily basis.

4) According to interview with the Complainant, it was noted the Patient had become more and more depressed and the Complainant noted the Cymbalta was not being administered. The Complainant said a discussion was held with the Hospitalist who could not give an explanation of why the medication was not being administered.

5) As a result of this initial transcription error, the Patient did not receive the Cymbalta for 10 days: from January 28 through February 10.

Review of documentation on the Physician Order Sheet dated 2/10/10 at 9:26 am indicated the Hospitalist ordered the Cymbalta 60 mg daily.

Based on review of documentation and interviews, the Hospital failed to ensure that there was a hospital procedure for reporting transfusion errors, adverse drug reactions, and errors in administration of drugs.

Findings included:

Please see A 404 for background information and additional supporting evidence.

1) The Director of Nursing and the Senior Director Nursing/Patient Operations were interviewed in person on 3/9/10 at 8 am. They said there is no formal written policy for the 24 hour medication order check conducted by the nursing staff. They said the daily clinical practice consists of the night shift nurse being responsible for checking the MAR against the day's physician order sheet and ensuring that all new or discontinued orders have been noted and sent to pharmacy to be updated. Review of the Patient's medical record indicated that in the upper left hand corner of the MAR was the notation: "MAR Verified by -_______ with the nurse signature" was consistently documented. However, review of the MAR for the dates 1/27/10, 7 am through 1/28/10, 7 am indicated the nurse signed off as having checked the physician orders and the MAR as correct. It was noted the MAR was handwritten for 1/27/10 with Cymbalta documented as being taken at home that day by the Patient. This information was to be transcribed by Pharmacy, who then types up the MAR and prepares the daily medications to be administered. Review of the typed up MAR prepared by Pharmacy dated 1/28/10 did not include Cymbalta on the daily medications list. The nurse who signed off for the check that day made an error which was not discovered by Pharmacy. Because each nurse is responsible for checking only one day, the error that was made on day one of the Patient's inpatient stay was carried through the following days - in this case, for 10 days.

2) The Pharmacy Director of Operations [DOP] was interviewed in person on 3/9/10 at 10:35 am. The Pharmacy DOP reviewed the computerized MAR and compared it to the written documentation for Inpatient Medication Reconciliation Form and the Physician's Order sheet and acknowledged the error. The Pharmacy DOP said the written order did not make it to the Pharmacy's written MAR record and was not caught until 2/10/10 when it was brought to the Hospitalist's attention. The Pharmacy DOP said that Pharmacy also did not discover the error - the error had "fallen out of radar." The Pharmacy DOP said the 24 hour double check system performed by nursing failed. The Pharmacy DOP said the Pharmacy also did not note the error.

3) The Senior Director said and review of the Patient's medical record confirmed that nurses were implementing the double check system/documentation method for medications inconsistently. The Physician Order sheet was noted to have both a number of red rubber stamps stating: "24 hour medication check with nurse signature and date" and handwritten notes stating the same throughout the Physician Order sheets. That documentation was noted in addition to the MAR left upper corner documentation consistently done with the exception of two MAR sheets dated 1/31/10 7 am through 2/1/10 7 am and 1/30/10 7 am and 1/31/10 7 am.

The Nursing system for medication double check system is not reliable and demonstrated that if an error is made on one day; the following days are affected by the error and are carried through.