HospitalInspections.org

Based on staff interview and a review of the procedure manual in current use for Immunohematology, the laboratory failed to maintain current, accurate policies that reflected current practices and current procedures for the Lookback process. The lookback process is implemented when a patient receives a unit of blood or blood products from a donor, who previously tested negative for HIV (Human Immunodeficiency Virus) or HCV Hepatitis C Virus) and subsequently tested positive on later donations.

Findings include:

I. (482.27(b)(5) Recordkeeping by the hospital)
1. A review of the Immunohematology procedure manual, dated 2006 and signed by the director, labeled, "Lookback Policy and Procedure", stated the facility obtained blood and blood products from the American Red Cross (ARC).
2. Direct observation of the blood storage refrigerator revealed all the blood products were labeled as obtained from Life Serve.
3. An interview conducted with the Laboratory General Supervisor (GS) on 12/9/14 at 11:00 AM confirmed the blood products were obtained from Life Serve rather than ARC.
4. During this same interview, the GS stated that blood segregated for quarantine was placed on the bottom shelf, however, the procedure manual stated the blood was placed in a biohazard bag and stored in the Chemistry refrigerator.
5. The GS confirmed the the procedure manual had not been updated to reflect current practices.

II. (482.27(b)(6)(iii)
1. Further review of this same policy and procedure manual also lacked the requirement of documenting the notification attempts (3) in the patient's medical record, as required.

III (482.27(b)8)(iii)
1. Additional review of the lookback policy determined it lacked provisions for any requirements or restrictions that may be imposed by counseling services offered to patients in the area.

IV. 482.27(b)(10)
1. The content of the notifications lacked provisions for notification to a legal representative, or relative if the patient had been adjudicated incompetent. The policy also lacked the required element of provisions for notification in the event patient was deceased, to notify the patient's legal representative or relative. Furthermore, the policy lacked specific guidance in the case of a minor patient, to notify the parent or legal guardian.

Based on direct observation, a lack of documented evidence and staff interview, the infection control program failed to establish and maintain an effective program for all equipment in the dietary department. The facility is licensed for 63 acute care beds.

Findings include:

A. During the tour of the dietary department on 12/9/14 at 1:00 PM conducted with the Dietary Manager, in the walk-in cooler, a large accumulation of debris build-up was observed on the fan blades, housing, seams and around the exterior of the fan in an area approximately 6" in front of the blades. The accumulated debris on the blades and housing was approximately 1/2" thick on all surfaces surrounding the area, evidencing a lack of routine and thorough cleaning.

B. A large ice machine, located just outside the walk-in cooler and measured approximately 3' wide was determined to be the only ice machine in the department. When asked, the Dietary Manager, was unable to produce a cleaning schedule or directions on how to clean the interior surfaces.

C. At 2:30 PM the Dietary Manager was notified by the maintenance department that they did not have either the walk-in cooler fan or the ice machine on any routine cleaning schedule, nor did they have directions on how to clean either piece of equipment.