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Based on medical record review, interview and document review the facility failed to ensure that pharmacy services followed proper guidelines for 1 of 1 patients. Findings include:

The patient (patient #1) received a medication that was not ordered. The medication selected by pharmacy for administration was documented in the patient's medical record as one that would cause an allergic reaction. As a result the patient received a medication that she was known to be allergic to and developed a rash all over her body.

See tag A 500.

Based on medical record review, protocol review, and interview the facility failed to follow the patient's order for 1 of 1 patients (#1) which resulted in the patient experiencing an allergic reaction to medication given during surgery.

An interview with patient #1 was conducted on 7/12/2012 at approximately 4:30 PM. Patient #1 was queried about any reactions that occurred after her surgery. The patient stated that she required a visit to her dermatologist the same week that she had surgery related to a "weeping rash all over my body". She stated she felt "it was something that I received in the hospital" and "the dermatologist felt it was an allergic response". She also stated she had contacted the surgeon's office to let the surgeon be aware of the rash. The patient was then asked if she had ever been told what medications she was going to receive during surgery and she stated "no". When asked if her allergies were reviewed with her she stated "yes".

On 6/20/2012 at approximately 2:45 PM a review of the policy #061.033, titled "pre-operative antibiotic administration - MMC V7, states the following under Procedure, I. A. Prescribing of the pre-operative antibiotic: "Physicians shall write specific orders for all patients requiring prophylactic pre-perative antibiotic at least 24 hours prior to surgery. This allows preparation time and ensures timely administration." It further states, "The Scheduling/Order Form" (form #2097) will include the physician request for a pre-operative antibiotic if required. The physician will check the appropriate box, which includes: no antibiotics required, patient to receive pre-op antibiotic per protocol - adult form #6702, pediatric form #8956, and use alternative antibiotic".

Patient #1 chart contained a documented history and physical including known allergies which was dated and signed electronically by physician #1 on 12/23/2011 at 12:31 AM. Allergies listed include "bentyl, codeine, erythromycin, augmentin, aspirin causes gastrointestinal (GI) upset and rash. Sulfa causes nausea and vomiting, neomycin and garamycin topical cause local reaction. Ferrous sulfate - diarrhea and gi disturbance. Egg based vaccines cause rheumatoid symptoms. Azithromycin". On 6/20/2012 at approximately 9:55 AM during medical record review it was revealed patient #1 had received gentamicin (garamycin) intravenously during her surgical procedure.

The chart was reviewed from the entry order by the physician for surgery through to the discharge summary. The scheduling/order form is the first notice from the physician to schedule a patient's surgery. Noted on the schedule /order form are allergies. Allergies noted for the complainant were as follows: mycins, codeine, augmentin, eggs, ferrous sulfate, sulfa, and bentyl. Further information located on the chart included "surgical pre-operative antibiotic orders". Noted in this section was a check mark for box A which indicates "No antibiotics required " and a complete line through the sentence and box B indicating as an indication not to use, which states "patient to receive pre-op per protocol - form #6702". The form was signed by the physician on 10/21/2011 at 2:30 PM. The form was sent to the pharmacy on 12/23/2011.

Additional information included the procedure to be performed, diagnosis, demographic information, and pre-procedure orders. Further examination of the surgical scheduling / order information revealed a red pen script with the "Gent". When asked if this had been an addition by the physician, staff F stated "no". When further query as to where the handwritten addition of the word "Gent" had come from on the form, staff F stated that orders without an order for an antibiotic are flagged by a pharmacy tech II and sent to a pharmacist for protocol review. The order was reviewed by staff M. The staff M stated that when an order is flagged by staff O and it falls within surgical categories the pre-surgical protocol is put into action and an antibiotic is ordered. Review of the medication administration record for patient #1 dated 12/28/2012 on page 27 indicates an order for gentamicin entered by staff M on 12/23/2011 at 9:37 AM. An order for clindamycin was entered by staff O on 12/23/2011 at 9:39 AM.

When asked if allergies are reviewed, staff F answered "yes". The pre-anesthesia checklist showed allergies were verified by the nurse at 7:30 AM. When asked how the nurse verifies the allergies it was stated the allergies are verified online with the Cerner application Power chart. The program showed the last verification of allergies prior to entry to the hospital through pre-operative screening via phone, not on the day of surgery by the nurse. Information of medications at bedside for use included Gentamicin and Clindamycin. Staff I was asked if it was possible for the allergy list to be verified and updated on the day of surgery by the pre-operative RN. On 6/20/2012 at approximately 10:30 AM staff I answered that allergies are compared from the pre-operative screen which takes place via phone but the pre-operative nurse on the day of surgery does not update in the Cerner application Power chart. The record does not contain evidence that the surgeon had been contacted or notified by pharmacy staff regarding the determination to administer antibiotics.

The anesthesia progress note contained anesthesia evaluation entered on 12/27/2011 at 8:15 AM. Anesthesia allergies and medications were listed as follows: egg based vaccine - seizures, latex - rash, iron supplement - rash, sulfa drugs - rash, codeine - unknown or unsure, all mycins - rash, bentyl - numbness, augmentin - tongue itching, aspirin - rash. The anesthesia record notes a check box area for prophylactic antibiotics, the first check box indicates "not requested by surgeon", the second check box used to record administration of prophylactic antibiotics indicates "drug/dose" which had the following checked and written "clinda(mycin) 900 mg, genta(micin) 110 mg, start - end 9:38 - 9:55". Notes indicate an antibiotic test given with "1 cc given prior to infusion". The staff N confirmed the findings on 6/20/2012 at approximately 10:45 AM. Staff N indicated that no reaction (anaphylaxis reaction) occurred within that time period.

According to phamacology literature, including the Monthly Prescribing Reference and the Fera Pharmaceuticals, LLC manufacturer's product insert for the brand name/trademark drug garamycin (which was listed among products in the patient allergy history) the ingredient for garamycin is gentamicin sulfate [gentamicin]. An interview took place 6/20/2012 at approximately 11:20 AM with staff L. Staff L was asked if the patient had an allergic reaction to garamycin (gentamicin) topically, should the patient have received the antibiotic intravenously. Staff L answered "no".