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 lack of documentation and interview with staff, the current laboratory director failed to approve, sign and date the laboratory procedure manual for histopathology and mycology testing performed. The laboratory performed approximately 75 histopathology biopsy examinations per year and approximately 20 potassium hydroxide screens per year. Findings include: 1. The current laboratory director failed to sign and date as approved the laboratory procedure manual. 2. In an interview conducted by email on 01/20/2021 the laboratory technical consultant confirmed the current laboratory director did not sign and date the manual as approved since becoming the director in 2019. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. 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 -- This STANDARD is not met as evidenced by: Based on patient test log review, lack of documentation and interview with staff, the laboratory failed to ensure 1 of 3 the potassium hydroxide (KOH) tests reviewed was reported. The laboratory performed approximately 20 tests per year. Findings include: 1. Patient test log review included a KOH test was performed for patient C on 10/07 /2019. 2. The laboratory practice for reporting KOH test results was to record the results in the patient chart record. Neither the patient chart record nor the patient's electronic test record included the KOH test result. 3. In an interview conducted on 01 /20/2020 the technical consultant confirmed at approximately 12:00 P.M. the test results were not recorded for patient C. -- 2 of 2 --