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Based on observations and interviews, the facility failed to ensure that medications were properly stored and monitored.

This created the potential for drug diversion.

Findings

1. The facility did not monitor and track the distribution of medications obtained from the medication room, that contained an open stock of medications, to monitor for drug diversion.

a) On 07/08/14 at 9:40 a.m., a tour of the facility's medication room was conducted with the facilities Chief Executive Officer (CEO), Assistant Director of Nursing (ADON), and the Registered Nurse (RN) in charge of medication stock. The medication room was located in the nursing station, behind a locked door. In the medication room there numerous shelves with open stock of prescription medications that included promethazine, amoxicillin, and Metoprolol . Narcotics were kept in a double locked cabinet.

b) On 07/08/14 at 10:00 a.m., an interview with RN #5, the RN in charge of medication stock was conducted. The RN #5 stated s/he did not keep track of inventory and did not perform an audit of the supply of medications. When asked about monitoring the medications for drug diversion the RN stated that was not being done and there was no way to identify if medications were removed inappropriately.

c) On 07/09/14 at 8:20 a.m., an interview with the facilities consultant pharmacist was conducted. The Pharmacist stated s/he did not keep track of the medication inventory and did not perform an audit of the amount of medications being distributed. When asked about monitoring the medications for drug diversion the Pharmacist stated that s/he was not doing this.

2. The facility did not lock the cart where anesthesia medications were stored.

a) On 07/08/14 at 10:20 a.m., a tour of the facilities surgical area was conducted with the facilities CEO, ADON, the Surgical RN and the Manger of Plant Operations. There was one operating room (OR) with a door leading into the OR that had a padlock on the outside of the door. The padlock was unlocked by the Surgical RN, and once inside the room there was a cart located next to the anesthesia equipment. The cart was unlocked and contained medication used by anesthesia, including narcotics.

b) On 07/08/14 at 10:30 a.m., an interview with the Surgical RN was conducted. The RN stated the cart no longer locked and that was why there was a padlock on the outside of the OR door. The RN stated that on surgery days the cart remained unlocked as well as the door to the OR. S/he also stated there was traffic in and out of the OR as the room was cleaned after each procedure and they were not tracking the contents of the anesthesia cart.

Based on observation, interviews, and document review, the facility failed to use enzymatic cleaner to pre-clean endoscopy equipment in a manner consistent with manufacturer's recommendations and failed to prepare and store surgical instruments and endoscopes appropriately.

The failure created the potential for patient harm related to transmission of infectious agents between patients from improperly cleaned equipment and/or contamination of endoscopy equipment and surgical instruments prior to use.

REFERENCES

According to the Centers for Disease Control and Prevention [CDC (2008)] guideline for disinfection and sterilization in healthcare facilities, "Thorough cleaning is essential...because inorganic and organic materials that remain on the surface of instruments interfere with the effectiveness of (sterilization and disinfection)".

The manufacturer's instructions for Endozime AW Plus, the enzymatic cleaner used by the facility, stated 1/2 ounce of Endozime should be used per each gallon of water for cleaning of surgical instruments and endoscopes prior to sterilization [(Ruhof, n.d.) Endozime AW Plus: bacteriostatic multi-tiered enzymatic cleaner].

POLICY

According to the policy Flexible Endoscope Cleaning, when storing the endoscopes, place on shelf, coiled in air dryer unit and keep door closed to prevent contamination.

FINDINGS

1. The facility stored uncovered endoscopy equipment on a wall in a high traffic corridor in the operating room area where it could potentially be contaminated prior to use.

a) During a tour of the operating room area on 7/8/14 10:25 a.m., six endoscopes were observed hanging uncovered on a wall in the corridor between the hall and the operating suite. When asked, Registered Nurse (RN) #5 stated s/he would hang the endoscopes on the wall after cleaning, reprocess them again 2-5 days prior to use, and hang them back on the wall at that time. RN #5, the Chief Executive Officer (CEO), the Assistant Director of Nursing (ADON), and the Maintenance Manager were unaware that endoscopes should be covered to prevent contamination.

2. Facility staff did not prepare a mixture of enzymatic cleaner according to the manufacturer's recommendation for use in pre-cleaning endoscopy equipment.

a) On 7/8/14 at 10:30 a.m. a tour of the operating room was conducted with the (CEO), the(ADON), and the Maintenance Manager. When asked, RN #5 stated s/he was responsible for pre-cleaning endoscopy equipment, and s/he used a mixture of 100 cc of enzymatic cleaner with 1000 cc of water. The RN stated s/he did not know what the manufacturer's recommendations were for the product.

3. The facility did not protect surgical instruments from contamination prior to sterilization, which was not consistent with the above referenced CDC guideline.

a) A tour of the facility's central processing department was conducted on 7/9/14 at 8:50 a.m. with the CEO and ADON. An area where surgical instruments were packaged prior to sterilization was observed in an unrestricted area with high traffic flow. A shelf above the area was cluttered with nonsterile items including books, binders, and papers. When asked, the Central Sterilization Tech (Employee #6) stated s/he did not wear a surgical cap or mask while packaging instruments and did not follow manufacturer's recommendations for mixing enzymatic detergent for pre-cleaning of surgical instruments.