Metro Spine Laboratory

Summary Statement of Deficiencies D2116 TOXICOLOGY CFR(s): 493.845(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the toxicology proficiency testing (PT) and interview with the testing person, the laboratory failed to investigate and document remedial actions for 1 of 6 unacceptable analyte testing scores. The findings include: 1.The laboratory's "Proficiency Testing Procedure" states that "All unacceptable performances/PT failures must be investigated and

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0096D CLIA Application and Survey Summary report and interview with the laboratory director, the laboratory did not authorize the Proficiency Testing (PT) agency to release the PT results to Center for Medicare & Medicaid Services (CMS) to determine successful participation. Findings: 1. The laboratory is required to authorize PT agency to submit the PT results to CMS. The results are entered into the federal data base. These results are available to the state agency (SA) for periodic review. 2. Prior to the survey the CASPER Report 0096D CLIA Application and Survey Summary (individual laboratory profile for PT results) was pulled for review. The CASPER Report 0096D report lists the year, event number, each analyte tested in the laboratory and score for three consecutive years. The report that was pulled indicated that "No routine scores found for this provider" had been received. 3. During the survey on 02/26/18 at 1:00 PM the laboratory director confirmed that the PT results did not show up on the CASPER Report 0096D for review by the SA staff. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on observation and interview with laboratory (lab) staff, the lab did not have a written procedure following manufacturer recommendations for maintaining the filter in the lab hood. This was confirmed during interview with lab staff on the day of survey. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview the laboratory manager, the laboratory did not provide a client service manual to the satellite offices with written pre-analytical instructions for the satellite office staff to follow when submitting specimens for analysis. Findings: 1. It was observed in the written procedures that the laboratory did not have a written client service manual that includes detailed descriptions for individual tests, test panels (screening and confirmatory) and reflex (confirmatory) testing performed as part of a test panel or when individual urine drug screen results are reported positive for a urine screen. 2. The requisition did not provide the client details on test methods employed by the laboratory, performance specifications established or verified, information that may affect the interpretation of test results, specimen submission requirements and descriptions of analytes tested by the laboratory. 3. The policies and procedure manuals showed that the laboratory did not have written instructions available to the satellite offices that included patient preparation, specimen collection, specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source, specimen storage and preservation, conditions for specimen transportation, specimen processing, specimen acceptability and rejection, specimen referral and how to maintain the patient log book at the offices. 4 During there survey on 02/26/18 at 1:00 PM the laboratory manager confirmed that the laboratory did not have written pre-analytical instructions available to the satellite offices for the collection and transportation of the specimens to the main laboratory. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)