Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have competency evaluations performed by someone who qualified as a Technical Supervisor for 2 of 3 testing personnel. Findings Included: Review of competency evaluations for testing person #2 and testing person #3 found the competency evaluations completed in 2018 and 2019 were completed by a staff member that did not qualify as a Technical Supervisor. During an interview on 06/04/19 at 11:30am, the office manager confirmed the staff member that performed the competency evaluations did not meet the CMS requirements for Technical Supervisor. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to maintain complete Histopathology quality control documentation of reagent expiration dates for 2018 and 2019. Findings Included: Record review of quality control documentation showed there was no record of expiration dates for the Immunohistochemistry (IHC) staining Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- reagents. Interview with the laboratory supervisor on 6/4/19 at 11:30am confirmed that the laboratory had not kept any quality control reagent logs showing documentation of the expiration dates for the IHC staining reagents. D5781