Biomat Usa, Inc

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's calibration verification (CV) policy and procedure (P&P) with the CV records, and interview with the laboratory personnel, it was determined that the laboratory failed to follow the CLIA CV requiremenrt, to perform and document to verify the laboratory's reporting range of test results for the test system. The findings included: a. CLIA requirement for calibration verification procedures, 42 CFR part 493 1255 (b), stated that the laboratory must perform and 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 -- document to verify the laboratory's reportable range of the test result, at least once every 6 months or, if any, a complete change of reagents, major preventive maintenance or quality controls reflect unusual trend or shift, by using at least three calibrators including a minimal (or zero) value, a mid-point value and a maximum value near the upper limit of the range. b. The laboratory performed daily calibration of the Reichert Digital Refractometer (RR) for serum total protein (TP) with the pure water, as zero. c. Under the laboratory's written P&P item 6. CALIBRATION VERIFICATION written in b): Once official Proficiency Test results have been received, Refractometer will be tested by purchase of additional Off-Cycle testing samples. Center Management may order Off-Cycle test samples directly from the Proficiency Testing company. 1) Calibration verification testing should be performed by the same staff member who completed the corresponding Proficiency Test. 2) Samples drawn from Off-Cycle testing samples will be evaluated in-house via the method recommended by CLIA- comparison to published Proficiency Test results, for a minimum of three (3) testing samples with the acceptable donor reporting range [one (1) at high end, one (1) at the low end, and one (1) near the midpoint)] 3) The center's laboratory director will compare staff testing results to the published results from the Proficiency Test company. Each result must fall within its published result range to be considered verified and passed. d. The laboratory failed to follow CLIA requirement and performed the CV for their TP test in the years of 2019 and 2020. e. The laboratory performed serum TP in approximately 200 clients' sample monthly. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on review of the laboratory's calibration verification (CV) policy and procedure (P&P) with the CV records, and interview with the laboratory personnel, it was determined that the laboratory director failed to ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. The findings included: a. The laboratory failed to follow CLIA's calibration verification requirement and failed to perform CV at least once every 6 months to verify the laboratory's reportable range for its serum total protein (TP) testing, see D-5439. -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, instrument comparison records, laboratory policies, procedures, and interview with laboratory personnel, for 10 out of 10 total protein patients records reviewed from January 14, 2017 to October 20, 2018, it was determined that the laboratory failed to test proficiency testing samples the same number of times that it routinely tests patient samples. The findings included: a. The laboratory was enrolled in the Accutest proficiency testing program (lab identification number CA1216) for Total Protein. b. The laboratory has multiple Reichert refractometers in use with the following serial numbers: 0650-1113, 02533- 1207, 02532-1207, 02845-0608, and 06507-1113. c. Review of laboratory procedure entitled, "Refractometer Validation", implementation date 2/22/2016, stated "Sample drawn from the leftover Proficiency Test vial will be evaluated in-house via the method recommended by the Proficiency Test company-comparison to published results." The laboratory failed to adhere to the CLIA regulation 493.801 (b) (2): The laboratory must test samples the same number of times that it routinely tests patient samples. d. Review of Refractometer Comparison Form Records and Accutest worksheet for proficiency testing showed the test dates for total protein to be the same for the proficiency testing sample and multiple refractometers used in the laboratory. e. The laboratory affirmed 1/23/19 12:30 PM (survey date) that proficiency testing samples were not tested the same number of times that it routinely tests patient samples. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on interviews with the staff on January 23, 2019, and review of Accutest proficiency testing records from the 1st testing event of 2017 through the 3rd testing event of 2018, for one out of six proficiency testing events reviewed, the laboratory failed to attain a score of at least 80 percent in the specialty of Routine Chemistry. The findings included: a. The laboratory is enrolled in the Accutest proficiency testing program (lab identification number CA1216) for Total Protein. b. Laboratory proficiency testing records showed the laboratory attained a score of 0% for total protein testing during the 1st proficiency testing event of 2017. c. A testing person affirmed on January 23, 2019, the unsatisfactory score of 0% obtained by the laboratory for total testing during the 1st proficiency testing event of 2017. d. Based on the annual test volume reported, the laboratory performed and reported approximately 30,000 total protein tests for the specialty of Routine Chemistry. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director of moderate complexity testing failed to ensure quality testing was monitored and evaluated for the overall quality of the analytical systems and to correctly identify problems for testing performed. (See D5403) 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)