HospitalInspections.org

Based on policy and procedure review and staff interview, the hospital's Laboratory Director failed to ensure Pathology policies and procedures were reviewed and current.

Findings included:

Review of Pathology Manual revealed policies and procedures were last reviewed on 06/16/2016 with statement "No revisions/Plan to Revise signed off by Lab Manager and Laboratory Medical Director". Review of "Plan of Care 2015 - 2016 Laboratory Services" revealed the plan was last reviewed on 02/2017 and included "Scope of Service, Model of Care, Standards of Care and Performance Improvement Plan". Review revealed "Clinical Laboratory Services 'CLIA' Assigned Responsibilities" revised 01/2017 revealed that "The Laboratory Director (Pathologist) is responsible for the overall operation and administration of the laboratory ...assuring compliance with the applicable regulations .... Ensures that an approved procedure manual is available to all personnel responsible for any aspect of the testing process." Review of the policies revealed "Breast Biopsy Procedure" was last revised 1993. Review cover sheet in front of manual used to document review by laboratory director revealed that the "Histology Manual" was last revised on 10/21/2016. The entry dated 10/21/16 revealed "manual in process of revision due to limited Histology now."

Interview with on 05/16/2018 at 1125 with Lab Manager revealed manager had been in position of Lab Manager for 20 years. Interview revealed that "basic lab tests" are performed "on facility site". Additional interview with the Lab Manager on 05/15/2018 at 1535 revealed the current Pathologist (Laboratory Director) was working on updating all of the lab policies. Interview revealed the Pathologist had updated "some policies" however "they have not been signed or approved."

The following procedures were in the front of the manual and not signed and dated by the laboratory director to indicate approval:

"Specimen Receipt, Identification, and Rejection"
"Specimen and Cassette Labeling"
"Specimen Retention and Discard"
"Health and Safety"
"Add-On Special Procedures"
"Slide Send Outs"
"Non-Pathologist Grossers"
"Surgical Pathology Ordering and Accessioning"
"NCBH Pathology Processes".

During interview 05/15/2018 at approximately 1400, the laboratory director acknowledged that the procedure manual is outdated. She stated she has initiated re-writing the manual and has completed some procedures. She stated these newly-written policies and procedures were placed in the front of the procedure manual, but she has not signed off on them. She stated she has not completed the manual revision because of her daily duties as the laboratory director and the laboratory's only on-site pathologist. She stated she has also been responsible for training the cytotechnologist to perform grossing and training one of the phlebotomist to perform other histology duties such as specimen accessioning, staining, and shipping.