Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the procedure manual had not been signed by the current laboratory director. Findings include: Review of the procedure manual on 03/28/18 revealed that it had been signed by the previous laboratory director. During a telephone interview with the histotechnologist at 12:42 p.m. on 03/38/18, he confimred that the current director had not signed the procedure manual. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, there was no documentation to indicate that the histotechnologist had annual performance evaluations Findings include: Review of personnel records on 03/28/18 revealed that 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 -- the documented evaluations of the histotechnologist were dated 4/14/16, 12/05/13, and 05/07/12. During an interview with the histotechnologist by phone at 12:42 p.m. on 03/28/18, he confirmed that there was no documented evaluation since 2016. -- 2 of 2 --