Med Screen Laboratories

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: provider reports, the laboratory failed to achieve a score of 80% or more for General Immunology tests performed with the College of American Pathologists (CAP). The finding includes: 1) The laboratory scored a 0% for Rubella in event 3-2021 and 2- 2021 with the CAP. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing provider reports, the laboratory failed to achieve a score of 80% for General Immunology tests. The finding includes: 1) The laboratory scored a 0% for Rubella in event 3-2021 and 2-2021 with the College of American Pathologists (CAP). D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the Laboratory Director (LD) failed to provide appropriate direction to laboratory personnel to ensure that the PT surveys are performed satisfactorily and that the laboratory is in compliance with the CLIA regulations. -- 2 of 2 --

Summary Statement of Deficiencies D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(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-- When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual, Calibrators, Controls and interview with the Technical Supervisor (TS), the laboratory failed to use different lot numbers of calibrators to make the calibrator and control for Urine Toxicology confirmation tests from July 2018 to the date of the survey. The TS confirmed on 11 /20/18 at 11:40 am the laboratory did not use different lot numbers. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Technical Supervisor (TS) the Laboratory Director (LD) failed to ensure that PS were adequate to perform Urine Toxicology confirmation tests on the Shimadzu LCM-8060 from July 2018 to the date of survey. The findings include: 1. There was no validation performed to establish the expiration date of reagents, 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 -- working solutions, Internal Standard, controls and calibrators used. 2. The validation of the hydrolysis control did not include validation of: a. Optimal Enzyme Concentration b. Temperature of the Heat Block c. Time on the Heat Block 3. Sample stability studies were not adequate. 4. The TS confirmed on 11/20/18 at 1:40 pm the laboratory did not ensure PS were adequate. -- 2 of 2 --