Summary:
Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: =================================== Based on observation of Hematology refrigerator thermometers, review of thermometer maintenance, lack of accuracy verification prior to expiration dates and upon interview with the Nurse Manager, determined the laboratory failed to perform and document required maintenance to ensure accuracy of thermometers prior to expiration dates. The findings include: 1. Observation of two of two thermometers in Hematology refrigerator at 9:10 a.m. July 25, 2019. 2. Review of thermometer maintenance requires accuracy verification to be performed prior to expiration dates. 3. Lack of thermometer maintenance for accuracy verification prior to expiration dates for digital thermometer reading at 7.3 degrees Celsius with expiry date of 6/27/19 and for internal bottle thermometer reading at 4 degrees Celsius with expiry date of 12/9/16 set within the same Hematology refrigerator. 4. Interview at approximately 1:30 p.m. July 25, 2019 with Nurse Manager confirmed the thermometer maintenance for accuracy verification was not performed prior to expiration dates for the two of two thermometers in Hematology refrigerator with temperatures of thermometers not matching. =================================== D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: ==================================== This condition level deficiency is due to Laboratory Director position not filled since July 31, 2018 to include lack of proficiency testing review for 2018 and 2019 (D6018), lack of quality control review for 2018 and 2019 (D6020) and lack of personnel competency reviews for 2018 (D6029). ==================================== D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require