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 interview, the laboratory failed to perform competency evaluations on 2 out of 11 testing personnel for 2 out of 2 years (2017-2019) reviewed. Findings Included: Review of the CMS 209 revealed 11 Testing Personnel. Review of the 11 Testing Personnel files revealed no competency for 2 out of 11 testimg personnel evaluations from January 2017 through February 2019. During the interview on 2/13/19 at 10:45 AM , testing person # 3 confirmed that no documentation of competency evaluations were performed. 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. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to monitor the humidity to 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 -- ensure optimal operation of the hematology analyzer, CDS M-Series for 2 out of 2 years ( 2017-2019) of the documents reviewed. Findings included: Review of the documents from January 2017 through February 2019, showed that there was no humidity recorded on the logbook. Interview on 2/13/19 at 11:00 AM, testing person # 3 confirmed that the laboratory was not aware of the requirements of the CDS M- Series hematology analyzer to check and record the humidity daily. -- 2 of 2 --