Lawrence Medical Center

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Lawrence Medical Center laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on procedure, record review and interview, the laboratory failed to define all statistical parameters for quality control utilized in the performance of toxicology testing as evidenced by the following: a) The laboratory runs three levels of quality control at the beginning and end of urine toxicology screens performed by Liquid Chromatography/Mass Spectroscopy (LC/MS) . The criteria for quality control acceptability in the procedure manual was stated as plus or minus twenty five percent of the mean. The procedure also included the mean of each individual quality control level for the tests performed. b) A review of quality control for calendar year 2022 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 -- was performed. The review revealed the fact that there were no calculated ranges (upper and lower limits) available to compare to the quality control results obtained for each of the drug screen runs performed. c) The laboratory director confirmed in an interview on 12/22/22 at 10:45 AM that the calculated upper and lower limits were not available for each of the toxicology analytes performed. d) The laboratory performs forty seven (47) drugs of abuse and metabolites with a total annual volume of approximately 159,198. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Lawrence Medical Center laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing review and interview, the laboratory failed to properly document the handling of proficiency testing samples as evidenced by the following: a) A review of proficiency testing records for calendar years 2019 and 2020 (3 testing events) revealed the fact that the program report forms and the attestation statements provided by the proficiency testing program were not completed for one (1) of the three (3) College of American Pathologists (CAP) proficiency testing events reviewed (UDS6 A 2020). The technical supervisor interviewed on 3/3/21 at 11:20 AM confirmed that the program report forms and the attestation statements for the above event were not completed by the laboratory director and the laboratory technologist. . D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE 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 -- 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 record review and interview, the laboratory failed to provide documentation to verify that adequate validation studies to validate all aspects of test performance were performed as evidenced by the following: a) Sciex liquid chromatography-mass spectrometry (LC-MS) : In April of 2019 the laboratory put into place an LC/MS for the qualitative and quantitative testing of thirty two (32) high complexity toxicology analytes (7-aminoclonazapan, 6-acetylmorphine, benzoylecgonine, 2-ethylidene-1,5- dimethyl-3,3-diphenylpyrrolidine (EDDP), hydrocodone, lorazepam, 3,4- methylenedioxyamphetamine (MDA), 3,4-Methylenedioxy-N-ethylamphetamine (MDEA), buprenorphine, norfentanyl, nordiazepam, oxazepam, oxymorphone, oxycodone, tapentadol, gabapentin, tetrahydrocannabinol (THC) amphetamine, alpha- hydroxyalprazolam, codeine, fentanyl, hydromorphone, morphine, 3,4- Methylenedioxymethamphetamine (MDMA), methadone, methamphetamine, tramadol, norhydrocodone, temazapam, noroxycodone, norbuprenorphine, pregabalin, and ritalinic acid ). A review of the validation summary for the thirty two (32) analytes revealed the following issues: a) Precision: There was no indication in the validation summary that both intra- and inter-assay precision was performed. There was only one precision statistic given for each of the analytes. b) Accuracy: There was no indication in the validation summary that accuracy studies for the thirty two (32) analytes had been performed. An interview on 3/3/21 at 10 50 AM with the technical supervisor who had taken over from the previous technical supervisor in March of 2020 could not address the issues above as he was not involved in the initial validation of the LC/MS and the testing being implemented The laboratory performs 224,000 toxicology tests annually. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Lawrence Medical Center laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain a copy of the corrected report when errors in the reported patient test results were detected as evidenced by the following: a) In March and October of 2018 the laboratory had to correct results that were erroneously reported due to the wrong cut-off values for fentanyl and ethanol being entered incorrectly into the laboratory information system (LIS) by the technical representative for the toxicology analyzer. This affected 61 fentanyl test results reported between 1/19/18 and 10/12/18 as well as 190 ethanol test results reported between 1/19/18 and 3/20/18. b) A review of two corrected reports from 1/8/18 and 8/20/18 revealed that the reports failed to indicate that they were in fact corrected results. c) Interview with the laboratory technologist on 10/24/18 at 11: 45 am revealed that the final reports were archived in the laboratory's LIS after one month. After that time they could not be altered. d) Based on this evidence there was no assurance the medical care providers were provided with most updated test results to ensure proper diagnosis and care. The laboratory performs approximately 76,932 toxicology tests annually. 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 -- D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on record review and interview, the technical consultant failed to fulfill the responsibility for verification of the laboratory's test performance characteristics as evidenced by the following: a) The technical consultant failed to ensure that validation studies were reviewed and approved prior to implementing new test methodologies. b) A review of two (2) test validations (fentanyl and ethanol) impleneted in January of 2018 revealed that the technical consultant failed to review and approve them for patient testing. Review of the validation study documentation revealed that the laboratory director, who does not qualify as technical consultant, had documented a review of the validation studies. c) The laboratory technologist confirmed in an interview on 10/24/18 at 10:34 AM that the validation studies for the two toxicology tests had been reviewed and approved by the laboratory director, not the technical consultant. . D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on record review and interview, the technical consultant failed to evaluate the competency of the staff through review of quality control records as evidenced by the following: a) A review of toxicology quality control records for calendar years 2017 and 2018 revealed that the technical consultant had not documented a review of quality control results for testing performed under hematology. b) The laboratory technologist confirmed in an interview on 10/24/18 at 10:34 AM that cumulative quality control results were being reviewed by the laboratory director who does not qualify as a technical consultant. -- 2 of 2 --