Summary:
Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and interview with the General Supervisor (GS) the laboratory failed to perform function checks on the Eppendorf Repeater M4 pipette. The laboratory performs approximately 212,936 Toxicology tests annually. Finding include: 1. Record review did not include pipette calibration and function checks for precision and accuracy for the Eppendorf Repeater M4 pipette. 2. The lab failed to follow the manufactures instructions for periodic function checks for precision and accuracy. 3. In an interview on 09/29/2021 at approximately 11:55 am, the GS confirmed that the lab does not regularly check the Eppendorf Repeater M4 pipette for precision and accuracy. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. 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 direct observation, record review and interview with the General Supervisor (GS) the laboratory failed to provide a fume hood for testing personnel handling toxic chemicals. The laboratory performs approximately 212,936 Toxicology tests annually. Finding include: 1. Testing personnel was observed using acetonitrile during sample preparation without using a fume hood. 2. An observation on 09/29/2021 at approximately 11:00 AM, revealed the lab failed to have a fume hood for testing. 3. In an interview on 09/29/2021 at approximately 11:00 AM, the GS confirmed that the lab does not have a fume hood and samples are prepared with acetonitrile on the open bench. -- 2 of 2 --