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Based on observation, manufacturer's requirements for the Ritter M11 UltraClave Steam Sterilizer (autoclave), review of policies and procedures, and staff interviews, it was determined the Critical Access Hospital (CAH) failed to require the autoclave was cleaned and tested, according to the manufacturer's requirements, and that all patient equipment were tested and determined safe for patients, as demonstrated by:

1. autoclave maintenance (cleaning) was not verified;
2. autoclave testing to confirm sterilization effectiveness, was not verified, and;
3. electric beds did not have scheduled maintenance to ensure patient safety.

Findings include:

The following was observed during a tour conducted on 07/28/10 at 0830:

The CAH maintains a Ritter M11 UltraClave Steam Sterilizer in the Emergency Department (ED), for autoclaving medical instruments. The autoclave was not operating at the time of the tour, however multiple processed peel-packs containing medical instruments (clamps, forceps, scissors) were on the counter next to the autoclave. The cabinet above the autoclave contained the following supplies: Attest 3M Rapid Readout 1296 steam packs (2011-06 DE) with brown top controls, 4 full boxes of Attest 1291 biological indicators (BI) lot #2002-11 AO (expired), and 5 bottles of Speed Clean (2 opened and partially filled).

1. The M11 UltraClave Steam Sterilizer manufacturer's recommendations, provided for review by the ED staff on 07/28/10, revealed: "...Daily clean external surfaces...Weekly clean chamber and trays...Monthly flush the system...perform pressure relief valve check...cleaning chamber filter...quarterly remove and clean door gasket...."

The Chief Nursing Officer (CNO) indicated during an interview conducted on 07/28/10 at 0830, that s/he was unsure of the process, or frequency, for cleaning the autoclave, and could not confirm when the autoclave was last cleaned. The CNO verified that there was no documentation to conclude the M11 UltraClave Steam Sterilizer was cleaned, according to the manufacturer's requirements.

2. Facility policy "CLEANING, DISINFECTING, AND STERILIZING OF PATIENT CARE EQUIP" (last revised 06/03) revealed: "...All reusable patient equipment will be...sterilized between uses to prevent transmission of infection...Critical items: Items which normally contact sterile parts of the body (e.g., surgical instruments) must be sterilized between patient uses...Heat sterilization, including steam or hot air (see manufacturer's recommendations)...."

The M11 UltraClave Steam Sterilizer manufacturer's requirements revealed: "...biological indicators and chemical indicators, should be included in each sterilization cycle...."

The 3M Attest 1296 Rapid Readout Biological Indicator Steam Pack product information revealed: "...Biological indicators provide the best assurance of sterility...measure true lethality...system includes rapid readout biological indicators, disposable test packs, auto-readers...This pack is used to monitor...gravity and...vacuum-assisted cycles...Fill out the requirement information on the record keeping sheet...Interpretation of Results: The positive (unprocessed) control indicator must provide a positive...result...The final negative processed RRBI (rapid readout biological indicator) reading after 3 hours of incubation indicates an acceptable sterilization process...."

No documentation was provided to confirm BI testing when patient equipment was sterilized on 06/26/10, 07/01/10, and 07/14/10. The last BI recording was on 02/18/10, when the positive control was documented as a "negative" result.

Interview with CNO on 7/28/10 at 0830, verified no documentation to conclude the proper utilization of the 3M Attest 1296 Rapid Readout Steam Pack Biological Indicators to monitor the effectiveness of the M11 UltraClave Steam Sterilizer.

3. The CAH maintains an Entech Service Agreement, effective 03/14/08, to provide scheduled maintenance, repair services, electrical safety inspections, physical inspections and functional checks, for the CAH's medical equipment.

None of the 19 electric patients' beds were observed with inspection verification tags, during a tour conducted on 07/27/10. The CNO confirmed during the tour that the beds were not included on the contractor's inventory list, and did not have preventative maintenance.

Based on observations during tour, review of CAH policies/procedures, medical records, and staff interviews, it was determined that the CAH failed to provide services, as demonstrated by:

C0271 Patient Care Policies: failure to ensure the nursing staff had access to current patient care policies and procedures;

C 0276 Patient Care Policies: the pharmacist's failure to assume responsibility for all activities of the CAH's pharmaceutical services, by approving and encouraging discharged/discontinued patients' medications to be reused and administered for other patients, creating the potential for medication errors;

C0278 Patient Care Policies: failure to require measures for assessing health care workers for communicable diseases, were implemented for 1 of 1 employees with documented tuberculosis (Employee #30).

The cumulative effect of these systemic deficient practices resulted in the CAH's failure to meet the provisions for the Condition of Participation for the Provision of Services.

Based on review of CAH policies/procedures, and staff interviews, it was determined the CAH failed to ensure that current patient care policies and procedures were available and accessible to the nursing staff.

Findings include:

The CNO stated during an interview conducted on 07/27/10, that CAH policies/procedures are available to the nursing staff in a hardcopy manual, however, the newly revised policies were available online. The CNO stated, "...all the nurses know where to find the most current policies online...."

RN #5 and LPN #4, both stated during interviews conducted on 07/29/10 at 0830, that they were unaware of the newly revised online policies, and did not know how to access them.

Based on observation, review of policies, and staff interviews, it was determined the pharmacist failed to assume responsibility for all activities of the CAH's pharmaceutical services, by approving and encouraging discharged/discontinued patients' medications to be reused and administered for other patients.

Findings include:

The CAH Position Description/Evaluation: Pharmacist (last revision 07/08) requires: "...Responsibilities include distribution, drug therapy monitoring, education and supervisory functions...Provide accurate and efficient filling of Doctor's written orders for medications...Maintain inventory control...Serves as a member of the Senior Management...and provides leadership to the team...."

CAH policy "NURSING MEDICATION ADMINISTRATION" (last revised 01/05) revealed: "...After discharge, medications dispensed by the hospital Pharmacy or any left over that was dispensed by PharMerica will be returned to the Pharmacy...Prior to the administration of medication, the nurse shall check for the: Right patient, Right medication...."

The Nurses' Station Medication Room on the patient unit, observed on 07/27/10 at 1030, included cabinets, drawers, a refrigerator, and a cart, stocked with multiple medications, as follows:

1. Nystatin oral suspension, 100,000 unit/milliliter (u/ml), 1 pint bottle opened and partially used, dated 02/18/10, with Patient #24's name crossed out (cabinet).

2. Nystatin 140 ml bottle dated 7/11/10, with Patient #25's name crossed out (cabinet).

3. Carafate 1 milligram (mg)/10 ml oral suspension, 420 ml bottle, dated 2/15/10, with Patient #26's name crossed out (cabinet).

4. Benazepril HCL 10 mg, 2 tablets remaining in a blister pack, dated 4/21/10, with Patient #27's name crossed out (drawer).

5. Diltiazem ER 240 mg, 3 capsules remaining in a blister pack, dated 4/2/10, with Patient #28's name crossed out (drawer).

The CNO stated during the tour, that all the preceding listed medications were for patients who have since been discharged.

The medication drawer was filled with blister-pack current patient medications on the left-hand side, and multiple partially used discontinued/discharged patients' blister-packs on the right-hand side. The CNO stated during the tour that the discontinued medications, dating back to 02/10, would be "picked-up" by Omnicare, the contracted pharmaceutical service. The patients' names on the blister-packs on the right-hand side of the drawer, were crossed out. The drawer also contained multiple partially used individual patient medication containers (plastic bottles) with the names of discharged patients on the bottles. The CNO stated that these medications "become floor stock" after the patient is discharged, or no longer requires the medication. In addition, a rubber-banded stack of discontinued/discharged patients' blister-packs marked with red "bar codes" were on the counter. The CNO stated that the medications were marked to return to the contracted pharmacy (Omnicare). The staff further stated that the "barcode" medications were expensive and therefore returned for credit, however the blister-pack medications, suspensions, and plastic bottle medications were maintained "as floor stock" and re-used for other patients.

The CNO on 7/28/10 at 1100, and RN #3 on 7/29/10 at 0830, indicated the nursing staff obtains physician-ordered patient medications from either the local Bashas Pharmacy, or Omnicare Phoenix (the contracted pharmaceutical service). Upon discharge, the RN or LPN will cross off the discharged patient's name on the medication. This practice is performed in the Medication Room. RN #17 and LPN #4, both verified this practice during interviews conducted on 07/28/10.

The nursing staff indicated that the patients' "first dose" medication was obtained from the local Bashas Pharmacy. Any "leftover" medication is retained for future use for other patients because "the pharmacy won't take it back anyway." The nursing staff indicated that they routinely contact Bashas for pharmaceutical needs or with questions related to patients' medications.

The pharmacist stated the following during an interview conducted on 07/29/10 at 1130:

The pharmacist is a part-time employee with the CAH, and also works part-time for the local Bashas Pharmacy. The pharmacist is not affiliated with Omnicare Phoenix. The pharmacist stated that Omnicare Phoenix contracts with Bashas to provide the "first dose" of medication to eliminate any delay in starting the patients' medications, and confirmed that the CAH has no contract or agreement directly with Bashas.

The Chief Operating Officer confirmed during an interview conducted on 07/29/10 at 0910, that the CAH does not contract with Bashas Pharmacy.

The bar-coded medications are returned to Omnicare Phoenix upon the patient's discharge, but medication without a bar code is retained in the Medication Room, to administer to other patients, in order "to save money." The pharmacist stated that the Arizona Pharmacy Board permits re-distribution of non-outdate medications, however confirmed that s/he does not re-label and dispense the medication but rather has instructed the nursing staff to cross out the discharged patient's name on the medication label and dispense to other patients. The pharmacist stated that s/he is on-call when not at the CAH, however the nursing staff seldom call. S/he was unaware of the extent of the re-issuing medication practice that included large quantities of multiple medications over a long period of time (the nursing staff verified at least 2 years), and looked only at the controlled substance medications when visiting or re-stocking the Medication Room on the nursing unit.

The CAH pharmacist approved and encouraged the practice of re-using discontinued patients' medications, for which the nursing staff administered.

Based on review of CAH policies/procedures, personnel records, and staff interviews, it was determined the CAH failed to require measures for assessing health care workers for communicable diseases were implemented for 1 of 1 employees with documented tuberculosis (Employee #30).

Findings include:

Facility policy "TUBERCULOSIS PREVENTION AND CONTROL PLAN" revealed: "...An employee with active pulmonary or laryngeal tuberculosis is excluded from work until adequate treatment has been instituted, the cough is resolved, sputum is AFB (acid fast bacilli) smear negative, a physician certifies that the employee is no longer infectious, and the employee is cleared to work by the Director of Nursing...."

Licensed Practical Nurse (LPN) #30, was hired 01/18/2010. The personnel file included a Washington State Health Department letter, dated 02/07/01, which indicated: "...This is to verify that you (LPN #30) have completed the course of tuberculosis medication prescribed...for pulmonary tuberculosis...."

Interview with the Human Resources Director on 07/29/10 at 1215, confirmed no further documentation to verify that LPN #30 was determined free from active pulmonary tuberculosis, to include a negative sputum smear, physician certification that the employee was no longer infectious, and that the Director of Nursing (Chief Nursing Officer) cleared the employee to work.