Summary:
Summary Statement of Deficiencies 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: Review of Profile-V MedTox package inserts and both quality control (QC) and patient records from May to July 2017, and interview with the General Supervisor revealed that the laboratory failed to perform quality control required by the manufacturer. Findings were: 1. The package insert for the PROFILE-V MEDTOXSCAN Test states that external controls should be run once per week. 2. Review of quality control records for March 2018 to July 2018 found that QC was performed March 1, 2018, April 1, 2018, and May 1, 2018 for lot TA970E19 and May 2, 2018, June 1, 2018, and July 1, 2018 for lot TA011K19. 3. Review of patient records for May 2018 to July 2018 showed 6 patients tested during the weeks QC was performed with a total of 17 patients tested during the three months. 4. Interview with the General Supervisor at 11:45 AM on July 30, 2018 confirmed QC was performed monthly and not weekly per manufacturer guidelines. D5783