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 review of employee competency records and interview with the Histotechnologist, the laboratory failed to perform competency evaluations on 6 out of 7 Testing Personnel (# 2, # 3, # 4, # 5, # 6, # 7 ) for Mycology and Histopathology subspecialties for 2 out of 2 (2017-2019) years reviewed. Findings Included: Review of employee competency records found no competency evaluations performed on Testing Person # 2, # 3, # 4, # 5, # 6 and # 7 for Mycology and Histopathology subspecialties from 03/01/17 through 03/01/19. Interview with the Histotechnologist confirmed on 03/01/19 at 11:00 AM. confirmed that there was no documented competency evaluations for Testing Person #2, # 3, # 4, # 5, # 6, and # 7. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 record review and interview with the Histotechnologist, the laboratory failed to document room temperature and humidity for 2 out of 2 years ( 2017-2019 ) reviewed. Findings Included: Review of maintenance records from 03/01/17 through 03/01/19 found no room temperature and humidity documented. During an interview on 03/01/19 at 11:30 AM, the Histotechnologist confirmed that there were no room temperature and humidity recorded. -- 2 of 2 --