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 an absence of thermometer function check records or certificates of accuracy and interview, the laboratory failed to define a function check protocol for the thermometers. Findings: 1. No documentation was available for function checks on 2 of 2 thermometers for a 2 year period. 2. No documentation was available for the certification of accuracy (NIST traceble) on 2 of 2 thermometers for a 2 year period. 2. Interview with the testing personnel (TP) #5 on 9/18/2020 at 11:00 a.m. confirmed, the laboratory failed to define a function check protocol for the thermometers. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: 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 -- Based on review of approved reference ranges in the laboratory procedure manual and interview, the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. Findings: 1. Review of the patient reports from the LIS system revealed three of the sixteen parameters for normal ranges did not correctly match those reference ranges for the complete blood count (CBC) test in the procedure manual. LIS patient report Procedure manual RBC 4.0-6.20 (male) 4.5- 6.20 RBC 4.0-6.20 (female) 4.0-5.20 HGB 11.0-18.0 (male) 13.2-18.0 HGB 11.0-18.0 (female) 11.0-15.6 HCT 35.0-55.0 (male) 40.0-55.0 HCT 35.0-55.0 (female) 35.0- 47.0 2. Interview with TP#5 on September 18, 2020 at 11:45 a.m. confirmed, the laboratory failed to ensure correct reference ranges approved in the procedure manual were included on the LIS patient report. -- 2 of 2 --