Carestl Health

Summary Statement of Deficiencies D0000 A recertification survey was completed on September 6, 2022. It was determined that Immediate Jeopardy (IJ) existed for the following condition level deficiencies: 42 C.F. R. 493.1250 Condition: Analytic Systems 42 C.F.R. 493.1447 Condition: Technical Supervisor D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records for 2021/2022 and interview with the technical supervisor (TS), the laboratory failed to provide attestation documentation for 2 of 5 PT testing events in 2022. Findings: 1. Review of PT records for 2022 showed for PT testing event GH2-A and GB, the laboratory could not provide attestation records for testing personnel and the laboratory director to show routine integration of samples into the patient workload. 2. Interview with the TS on August 30, 2022 at 11:30 AM confirmed the laboratory could not provide 2 PT testing events attestation records. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's "Quality Assessment Program" procedure, competency/performance evaluations, quality control (QC) data, and interview with the technical supervisor (TS), the laboratory failed to follow the "Quality Assessment Program" procedure. Findings: 1. Review of "Quality Assessment Program" procedure stated "The ability of each individual to accurately perform each step of testing (i.e., their competency) must be evaluated annually" and "QC must be acceptable before testing and/or reporting of results is permitted. Any results obtained when the QC is unacceptable or not performed are invalid and must be repeated. There are no exceptions." 2. Review of personnel records showed no evaluation for competency/performance for testing personnel (TP) #1, TP #2, and TP #3 performing patient testing during 2021 and to date August 30, 2022 (Refer to D6128). 3. Review of Abbott Alinity chemistry analyzer QC results from May 1, 2022 to date August 30, 2022 showed the laboratory failed to follow established criteria for acceptability of control materials providing quantitative results for 83 of 83 testing days (Refer to D5469). 4. Review of Excyte M automated ESR analyzer quality control logs from January 5, 2022 to date August 30, 2022 showed no QC was performed on February 23, 2022, March 23, 2022, or April 25, 2022 (Refer to D5447). 5. Interview with the TS on August 30, 2022 at 12:15 PM confirmed the laboratory failed to follow the "Quality Assessment Program" procedure. 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 review of Abbott Alinity chemistry analyzer and quality control (QC), Vital Diagnostics Excyte M analyzer and QC, Sysmex XN550 analyzer, review of manufacturer's instructions, freezer temperature logs, room temperature logs and humidity logs, and interviews, the laboratory failed to meet the condition of analytic systems. The laboratory failed to provide a procedure for the Abbott Alinity chemistry analyzer (Refer to D5401); failed to provide a procedure for acceptability of QC results and reference intervals (normal values) (Refer to D5403); failed to follow manufacturer's instructions for reagent storage (Refer to D5411); failed to follow manufacturer's instructions for monitoring and documenting temperature and humidity (Refer to D5413); failed to verify performance specifications prior to reporting patient test results (Refer to 5421); failed to perform calibration verification procedures at least once every six months that included at least a minimal value, a mid-point value, and a maximum value near the upper limit to verify the laboratory's reportable range for Alk phos, ALT, AST, DLDL, HDL, chloride, potassium, sodium, thyroid-stimulating hormone (TSH), and syphilis (Refer to D5439); failed to include two control materials each day of patient testing for ESR (Refer to D5447); and the laboratory failed to follow established criteria for acceptability of control materials providing quantitative results (Refer to D5469). -- 2 of 10 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory procedures and interview with the technical supervisor (TS), the laboratory failed to ensure a chemistry procedure is available. Findings: 1. Review of procedures showed no procedure for the Abbott Alinity chemistry analyzer. 2. Interview with the TS on August 30, 2022 at 12:15 PM confirmed the laboratory failed to ensure a procedure for the Abbott Alinity chemistry analyzer is available. 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)

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on lack of verification of performance specifications for the Sysmex Hematology Analyzer, Clinitek Advantis Urine Analyzer, review of patient testing records for 2020 and interview with the technical supervisor (TS), the laboratory failed to verify manufacturer performance specifications for accuracy, precision, reportable range of test results and reference intervals (normal values) for the laboratory's patient population before reporting patient results. Findings: 1. The lack of verification of performance specifications for the Sysmex hematology analyzer for white blood cells, red blood cells, hemoglobin, hematocrit, platelets and WBC auto differential showed the laboratory failed to obtain performance specifications comparable to those established by the manufacturer for accuracy, precision, reportable range, and verifying the reportable range of test results. 2. The lack of verification of performance specifications for the Advantis urine analyzer for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leucocytes, showed the laboratory failed to obtain performance specifications comparable to those established by the manufacturer for accuracy, precision, reportable range, and verifying the reportable range of test results. 3. Review of patient testing records for 2020 showed, 3,591 Sysmex Hematology patient results were reported since May of 2020 and 516 Clinitek Advantis Urine patient results were 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 -- reported since October 2020. 4. Interview with the TS on December 08, 2020 at 10:30 AM confirmed the laboratory failed to ensure the verification of performance specifications were completed for the Sysmex Hematology Analyzer and the Advantis Clinitek Urinalysis Analyzer before reporting patient results. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on the lack of verification performance procedures, 148 total patient results reported in 2020 and interview with technical supervisor (TS), the laboratory failed to establish test system performance characteristics for a non-FDA cleared /approved Confirm Biosciences Covid -19 IgG IgM Rapid Test Cassette before reporting patient results in 2020. Findings: 1. No documentation was available to show the laboratory established performance specifications for accuracy, precision, analytical sensitivity, analytical specificity to include interfering substances, reportable range for test results of the test system and reference intervals (normal patient values) for the Confirm Biosciences Covid-19 IgG IgM Rapid Test Cassette test system. 2. Review of patient records showed the laboratory performed 148 Confirm Biosciences Covid-19 IgG IgM Rapid tests since beginning Covid testing in 2020. 3. Interview on December 08, 2020 at 10:30 AM, with the TS confirmed the laboratory failed to establish performance specifications for The Confirm Biosciences Covid-19 IgG IgM Rapid Test before reporting patient results. -- 2 of 2 --