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1421 OAKDALE ROAD

MODESTO, CA 95355

PHARMACIST SUPERVISION OF SERVICES

Tag No.: A0501

Based on observations, interview, and administrative record review, the pharmacy failed to ensure the implementation of a policy and procedure for labeling intravenous (IV, directly into a vein) medications. The hospital did not label a clindamycin (antibiotic) IV medication with an expiration date and time. This failure resulted in the potential for patients to be exposed to medications at other than labeled strength and quality.

Findings:

During a concurrent tour and interview, on 11/18/13 at 1:40 pm, in pre-op (area to prepare a patient for surgery), Registered Nurse (RN 1) identified a medication storage cabinet. Inspection of the cabinet showed that it contained an IV medication. Inspection of the medication showed that it was 900 milligrams of clindamycin in an ADD-Vantage system (vial of medication attached to an IV bag). Further inspection of the system showed the stopper was removed from the vial of clindamycin and the drug was mixed with the IV solution. Continued inspection did not show a hospital label on the clindamycin (no expiration date and time).

During an administrative record review, of the hospital ' s policy and procedure for Intravenous Admixtures Order Processing (PN.030, Approved: 28-June-2012) showed, Procedure:, 1. Nursing, D. "The expiration date and time on all IV labels indicates the chemical stability of the compounded product. Complete infusions by the expiration date and time on the label."

AFTER-HOURS ACCESS TO DRUGS

Tag No.: A0506

Based on observation, interview and administrative record review, the hospital failed to develop and implement a policy and procedure for removal of drugs from drug room A and B. The hospital had two drug rooms. Each drug room had a log for signing out medications. Each log entry had space for two registered nurses to sign. Eight out of ten log entries were not signed by two registered nurses. These failures resulted in the potential for patients to be exposed to avoidable medication errors.

Findings:

During a concurrent tour, interview, and administrative record review, on 11/18/13 at 2:55 p.m., Registered Nurse (RN 1) identified pharmacy drug room B. Inspection of the room showed that it contained medications and a pharmacy drug room medication log (document to track medications removed from the room). Inspection of the log showed, from 5/22/13 to 10/29/13, 14 lines were completed for drugs removed from the room. Of the 14 lines completed, 4 lines were signed by a second RN. 10 lines were not signed by a second RN.

During an interview, on 11/19/13 at 10:30 am, Administrator (Admin 1) acknowledged Drug Room B 's Pharmacy Drug Room Medication Log did not document a second RN signed each entry. Admin 1 stated that it was her expectation that each log entry was to be signed by two RN's. The facility was requested to provide the policy and procedure for RN's removing medications from the drug storage rooms A and B. The policy and procedure was not provided before the end of the survey.

DELIVERY OF DRUGS

Tag No.: A0500

Based on observation, interview, and administrative record review, the pharmacy failed to implement a policy and procedure for drug shortages. Aminophylline (drug) was not stocked in the latex (part of natural rubber) allergy cart. Hospital management was not informed that aminophylline was not available and was not in the allergy cart. This failure resulted in the potential for patients to be exposed to a delay in receiving medications in a latex allergic reaction.

Findings:

During a concurrent tour, interview, and administrative record review, on 11/18/13 at 2:30 p.m., in the recovery room (area to recover from surgery), Registered Nurse (RN 1), identified the latex allergy cart. Inspection of the cart showed the drug contents were sealed with lock #8559691. Inspection of the drug contents did not show the cart contained aminophylline. Inspection of the PostAnesthesia Care Unit latex Allergy Cart (November 2013) (list of medications in the cart) showed, Drawer 1: Medications, 7. " Aminophylline, 500 mg (milligram)/20 ml (milliliter) (2)."

During an interview, on 11/21/13 at 11:07 a.m., Administrator (Admin 1) stated that she was the hospital administrator responsible for pharmacy services. Admin 1 acknowledged that aminophylline was not stocked in the latex allergy cart. Admin 1 stated that pharmacy did not inform her that aminophylline was not available and was not stocked in the allergy cart. Admin 1 stated that it was her expectation that pharmacy notify administration when aminophylline was not available and was not stocked in the latex allergy cart.

During an administrative record review of the hospital 's policy and procedure for Managing Drug Shortages (PH.060, approved 28-June-2012), showed Policy:, " The Drug Information Service (DIS), under the auspices of the Pharmacy Therapeutic Committee is responsible for investigating and providing information about potential drug shortages that may affect patents at (The Hospital). "