Summary:
Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the PATHNET manufacturer's operator's manual, BIO-RAD quality control inserts and interview with testing personnel at 11:25 AM on September 26, 2018, the laboratory failed to establish appropriate temperature ranges for their GE Freezer #2 storing their BIO-RAD quality control and their room humidity as documented on their Daily Temperature Chart to ensure equipment and test system performance. Findings include: 1. Review of the manufacturer's operator's manual for performance specifications for the PATHNET revealed, "Keep the environmental humidity within the following ranges. Humidity: 40 - 80%" 2. Review of BIO-RAD Liquicheck quality control package inserts for Cardiac Markers Plus Controls and D- Dimer Controls that were stored in the GE Freezer #2 confirmed the controls required storage between -20 to -70 degrees Celsius. 4. Review of the Daily Temperature Chart from January 2018 to April 2018 confirmed that the laboratory failed to properly set adequate humidity and freezer temperature ranges. The humidity range was 15 - 70% and the GE Freezer #2 temperature range was below -18 degrees Celsius. 5. Review of the Daily Temperature Chart between January 2018 thru April 2018 showed the documented GE Freezer #2 temperatures were above -20 degrees Celsius 107 days out of 119 days and the humidity was below 40% 119 days out of 119 days. 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 -- D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of documentation of serum hGC Quality Control (QC) results, observation of no serum QC materials, and interview with testing personnel #1 at 10: 15 AM on September 26, 2018, confirmed no serum hCG QC was performed on the Quickvue+ One-Step hCG Combo Test kit per manufacturer guidelines and facility procedure. D5781