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West Virginia Licensure Rule CSR 64-12-5

5.1.b.1 The following documents are adopted as construction, equipment, physical facility, and related procedural standards for all existing hospitals, all new construction and any additions, alterations, renovations, or conversions of existing buildings: The relevant sections of the 2001 edition of The Guidelines for Design and Construction of Hospitals and Health Care Facilities as recognized by the American Institute of Architects Academy of Architecture for Health with assistance from the United States Department of Health and Human Resources shall be used as planning standards;

5.1.b.2 The following documents are adopted as construction, equipment, physical facility, and related procedural standards for all existing hospitals, all new construction and any additions, alterations, renovations, or conversions of existing buildings: The National Fire Protection Association codes and standards relevant to Health Care Facilities including the National Electric Code and the 2002 Edition of N.F.P.A. 99 Standard for Health Care Facilities;

5.4.a Additions and renovations or alterations of any hospital which are begun after the effective date of this rule shall comply with the General and Psychiatric Hospital sections, as applicable, of the latest edition of Guidelines for Design and Construction of Hospitals and Health Care Facilities.

5.4.d The hospital shall submit to the Director for review, complete construction drawings and specifications for any hospital construction project which alters a floor plan, impacts life safety or requires approval under W. Va. Code ?16-2D-1 et seq. prior to beginning work on the project. An architect and/or engineer registered to practice in West Virginia, shall prepare and sign the drawings and specifications including architectural, life safety, structural, mechanical and electrical drawings and specifications. Minor renovations which alter floor plans may not require the services of an architect and a full set of drawings. However, an actual as built drawing is required for the specific area to be renovated. The approval of minor renovations shall be determined by the Secretary.

This Standard is not Met as evidenced by:

Based on observation and staff interview it was determined the hospital failed to met all standards for licensing established by The Office of Health Facility Licensure and Certification for the state of West Virginia and in accordance with West Virginia Licensure Rule CSR 64-12-5, 5.1.b.1, 5.1.b.2, 5.4.a, and 5.4.d for alterations to rooms in the hospital.

Findings include:

1. During tour of the operating room suite of the hospital on 08/31/10 at approximately 2:00 p.m., the following alterations of the hospital's original building construction was observed:

a. A room attached to the endoscopy procedure room and also a dirty utility room located in the operating room suite have been converted into dirty/clean scope reprocessing rooms. An interview with the operating room manager confirmed that the conversion of these rooms was within the past twelve (12) month period. Also, at the time of this survey there was no documentation evidence available to indicate that the conversion of these rooms were submitted to the Office of Health Facility Licensure and Certification for approval. Therefore, the conversion of these two (2) rooms to be used as clean/dirty scope reprocessing rooms have not been approved by the authority having jurisdiction (Office of Health Facility Licensure and Certification).

A. Based on observation and staff interview it was determined the hospital failed to have in areas identified for the decontamination and reprocessing of endoscopes hand washing sinks for employees to use to wash hands between the decontamination and sterilization of endoscopes. This deficient practice was identified in two (2) of two (2) rooms in the operating suite designated as areas where scopes are decontaminated and reprocessed. Failure to have hand washing facilities in areas where decontamination and reprocessing of endoscopes occurs can result in the cross contamination of reprocessed scopes by unwashed employee hands resulting in possible patient infections. Findings include:

1. During the tour of operating suite on 09/1/10 at 1130 hrs there were two rooms, one called a dirty utility and a second room adjacent to the endoscopic procedure room, identified as areas where endoscopes are washed and reprocessed in a Steris unit. Neither room had hand sinks available for employees to wash their hands when visibly soiled, contaminated or after removal of gloves. The Operating Room Manager during the tour on 9/1/10 agreed there were no handwashing sinks available to these reprocessing areas.

B. Based on observation and staff interview it was determined the hospital failed to have two (2) separate sinks in all rooms, identified for the decontamination and reprocessing of endoscopes, for the washing of endoscopes and a second sink in which to rinse the cleaned scopes which would prevent the reintroduction of biological material before reprocessing. This deficient practice was identified in one (1) of two (2) rooms designated for the decontamination of endoscopes (the dirty utility room). Failure to have a sink in which to wash an endoscope to remove the bioburden and a second clean sink to rinse can result in biological materials to be incompletely removed resulting in ineffective reprocessing with possible patient infections or injury. Findings include:

1. During the tour of the operating suite on 09/1/10 at 1130 hours a room called a dirty utility room was identified as an area where endoscopes are washed and reprocessed in a Steris unit. This room had a single bowl sink. The Operating Room Manager during the tour on 9/1/10 indicated endoscopes are washed and then rinsed in the same sink.

C. Based on observations and staff interview it was determined the hospital failed to have clean/reprocessed endoscopes stored in an area away from where scopes are washed and reprocessed which can result in cross contamination of the clean scopes. Storing cleaned endoscopes in an area where the cleaning and reprocessing of endoscopes is occurring can result in cross contamination of the clean scopes resulting in possible patient infections.
Findings include:

1. During a tour of the surgical suite on 8/31/10 at 1415 hours the room adjacent to the endoscopic procedure room was identified as the room where endoscopes are washed and reprocessed. There was an open cabinet in this room in which several endoscopes were hanging. The surgical nurse, conducting this tour, explained that after endoscopes are cleaned and reprocessed in a Steris unit the endoscopes are then hung in the cabinet in the same room.