HospitalInspections.org

Based on observation, interview and document review the Critical Access Hospital (CAH) was found to be out of compliance with Life Safety Code requirements. These findings have the potential to affect all patients who received services in the CAH.

Findings include:

Please refer to Life Safety Code inspection tags: K0321, K0341, K0754

Based on interview and document review, the Critical Access Hospital (CAH) failed to ensure policies and procedures were developed and implemented related to compounded medication preparations, failed to have documented training and competency testing of pharmacy and non-pharmacy staff who compounded medications, and failed to complete routine testing to verify accuracy and sterility according to Untied States Pharmacopoeia Convention chapter 797.

Findings include:

Review of the CAH's orientation and on-going education and competency testing lacked evidence of education, training, and competencies for compounding medications for immediate use purposes or otherwise, for pharmacy and non-pharmacy staff.

On 4/9/18, at 2:30 p.m. the pharmacist stated the pharmacy was certified by the Minnesota (MN) Board of Pharmacy and was not open 24 hours per day and the hours of operation varied depending on the need but was not less than 40 hours per week, 5 days per week. The pharmacist confirmed the nurses compounded non-sterile low risk medications and only for immediate use circumstances, however, she had not provided or performed any competency testing and/or education because the nurses completed medication-compounding training along with other hospital medication training.

The CAH's last MN Board of Pharmacy Survey Report dated 4/9/15, indicated the CAH compounded low risk medications and the hood type was a Compounding Aseptic Containment Isolator (CACI). The report indicated the pharmacist had not completed the aseptic training, nor the media-fill or glove fingertip testing therefore was not in compliance with USP 797. Further document review revealed the last time the media-fill test was completed was by the pharmacist was on 6/30/15, and the glove fingertip test on 8/27/15.

On 4/10/18, at 1:30 p.m. the pharmacist stated the nurses could potentially mix any medications the physician ordered but would not prepare medications for more than one dose and the prepared dose would be administered immediately after compounding. The pharmacist stated she assumed the nurses were compounding in the medication room (room with the hood) and was not aware if nurses were compounding medications outside of the required hood area. The pharmacist stated when she mixed medications the hood was used.

On 4/11/18, at 7:30 a.m. registered nurse (RN)-A verfied the nurses compounded medications such as intravenous (IV) antibiotics which included Vancomycin and she would mix the medications at the nursing desk or in front of the Omnicell (medication dispensing unit) located at a nursing desk on the medical surgical unit. RN-A stated she would perform hand hygiene, use only gloves, and the medication would be administered immediately. RN-A stated education was provided through on-line training and had thought there had been training in November, however could not articulate what the training included. RN-A confirmed competency testing was not performed.

-At 7:35 a.m. RN-B stated nurses occasionally compounded medications such as IV antibiotics. RN-B indicated she would mix medications in the medication room, would not use the hood, would wipe down the preparation surface with a disinfecting wipe, perform hand hygiene, and use only gloves during the procedure. RN-B stated she was unaware of the CAH's training for compounding medication, however, had participated in a skills fair off the CAH's campus on her own time which included compounding medication, however, a a receipt of participation was not provided.

-At 7:55 a.m. RN-C stated she had compounded antibiotics which included IV Vancomycin, Rocephin, and Zosyn. RN-C stated she would compound medications in the pharmacy and not in the medication room and would perform hand hygiene and only use gloves. RN-C thought there was required annual on-line training and also thought there had been competency testing during orientation. RN-C stated on-going competency testing was not required or performed.

-At 8:00 a.m. RN-D stated education on compounding medications was provided during orientation, however, staff did not receive training on the compounding hood and did not think there was any competency testing performed. RN-D stated she compounded medications in the pharmacy or by the sink in the emergency room and would perform hand hygiene and only use gloves. RN-D indicated the nurse's station was the least ideal place to compound medications.

-At 8:20 a.m. the director of nursing (DON) stated nurses were supposed to compound medications in the medication room using the hood if the medication was planned. In cases of a "stat" (emergency), the medication would be mixed in the emergency room. The DON stated during orientation the nurses were shown how to compound medications but were not competency tested.

-At 8:45 a.m. human resources representative (HRR) indicated she was the person responsible for assigning orientation and ongoing education. HRR indicated the required Medication Variance training module was nine minutes long and did not think there was specific education and competency testing for compounding education. HRR provided a copy of the module, and verified the module did not address medication compounding.

-At 9:00 a.m. the pharmacist stated she had missed the glove finger-tip and media-fill testing for the last two years and it should have been completed annually. The pharmacist stated during nurse orientation she went through compounding medications, but did not train them on hood use, and did not complete competency testing.

-At 9:26 a.m. MN Board of Pharmacy Inspector (PI) stated it was the expectation that media-fill and glove tip testing be performed annually according to USP 797. The PI stated immediate use compounding should be reserved for emergency situations where the benefits of faster administration outweighed the risks of possible contamination. The PI further stated nurses who compound medications required training and annual competency testing by a qualified individual to ensure procedures are performed correctly. The PI confirmed the expectation for preparation of compounded immediate use medications which were not prepared under a hood, at minimum required the following measures: the surface must be cleaned with isopropyl alcohol, hand hygiene, clean gown, and clean gloves that once donned, were sprayed with isopropyl alcohol. The PI also stated when nurses are compounding medication a second check should be done to ensure the right medication, right fluid for mixture, and right doses was prepared. The PI stated if the nurses were to compound medications not for immediate use purposes and prepared under the hood, glove tip testing would be required.

-At approximately 1:30 p.m. administrator stated it was the expectation that the pharmacist followed all pharmacy standards of practices and governing regulations.

Senior pharmacist job description summary indicated the pharmacist was responsible to plan, organize, and manage daily activities according to policies and regulations. The summary further indicated the pharmacist was responsible for the preparation and distribution of medications and would provide counsel and education to promote optimal drug therapy and assure compliance with all accepted standards and laws pertaining to the practice of pharmacy.