Laboratory Corporation Of America Holdings

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 review of observation of 2 of 2 pipettes and interview with the general supervisor, the laboratory failed to define and perform a function check to verify the accuracy of the pipettes. Findings: 1. Observation of the 100 microliter and 20 microliter, Eppendorf pipettes located in the laboratory available for use showed no function check since 2017. 2. Interview with the general supervisor on February 12, 2019 at 1:00 PM confirmed, the laboratory failed to define a protocol and perform a function check to verify the accuracy of the volumes of 2 of 2 pipettes. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: A review of documentation for manual calculation reveal the laboratory failed to periodically verify the accuracy of the International Normalized Ratio (INR) and interview with staff. Finding were as follows: a. At the time of the survey the laboratory failed to produce documentation for the calculation for INR this was confirmed in interview with the Technical Consultant from the CMS form 209 on May 1, 2018 at 10:00 in the office of the Technical Consultant. A review of Citrol coagulation control package inserts and interview with staff revealed the laboratory failed to follow the manufactuer's instructions. Findings were as follows: a. Siemens Dade Ci-Trol coagulation Control Level 1 and Level 3 package insert preparation of the control instructions state, "Add exactly 1 mL of distilled water." b. Interview with Technical Consultant from the CMS form 209 on May 1, 2018 at 09:05 confirmed Ci- Trol controls were prepared using Fisher deionized water, lot 173847. Therefore, the accuracy of the quality control can not be verified. 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 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 -- 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: A review of Temperature and humidity logs and interview with staff revealed the laboratory failed to meet the humidity requirements for the laboratory as the Sysmex XS-1000i hematology analyzer and Sysmex CA-540 coagulation analyzer requires. Findings were as follows: 1. Based upon review of manufacture's operator guide for the Sysmex XS-1000i hematology analyzer, the laboratory failed to meet the humidity requirement of 30% to 85% for the months of January, February, March, and April 2018. 2. Based upon review of manufacture's operator guide for the Sysmex CA-540 coagulation analyzer, the laboratory failed to meet the humidity requirement of 30% to 85% for the months of January, February, March, and April 2018. 3. The documented humidity readings were at or below 25% for January, February, March, and April 2018 and confirmed by Technical Consultant #2 from the CMS 209 form on 05/01/2018 at 10:00 a.m. D5783