Central Labs Inc

Summary Statement of Deficiencies D0000 An offsite proficiency testing (PT) desk review was conducted for Central Labs Inc., on March 25, 2025, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations were reviewed for successful participation and compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. The identified unsuccessful participation is an initial occurrence and explained below. 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: Based on review of CASPER 155D proficiency testing (PT) report, laboratory PT evaluations from American Proficiency Institute (API), and confirming phone interview with testing personnel (TP1), the laboratory failed to achieve satisfactory 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 -- performance for #0345 total calcium and 0505 BUN in two of three consecutive testing events in 2024 and 2025, resulting in an occurrence of unsuccessful participation in PT. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER 155D proficiency testing (PT) report, laboratory PT evaluations from American Proficiency Institute (API), and phone interview with testing personnel (TP1), the laboratory failed to achieve satisfactory performance for the analytes #0345 total calcium and #0505 BUN in two of three consecutive events in 2024 and 2025, resulting in an occurrence of unsuccessful participation in PT. Findings: 1. Review of CASPER 155D PT report revealed the following unsatisfactory scores for analyte #0345 total calcium: 0% 2024 event 2 60% 2025 event 1 2. Review of CASPER 155D PT report revealed the following unsatisfactory scores for analyte #0505 BUN: 0% 2024 event 2 60% 2025 event 1 3. Review of API evaluation reports confirmed the unsatisfactory scores for analytes #0345 total calcium and #0505 BUN in two of three consecutive PT events. 4. A phone interview with TP1, 3/25/25 at 10:35 AM, verified the occurrence of unsuccessful participation in PT for analytes #0345 total calcium and #0505 BUN. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Central Labs, Inc., on October 2, 2024, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratories Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of CASPER 155D report, proficiency testing (PT) records, and interview, the laboratory failed to successfully submit test results to the American Proficiency Institute (API) for one of three PT events in 2024 (Chemistry Core 2024 2nd Event). Findings: 1. Review of CASPER 155D report revealed an unsatisfactory score of 0% for the specialty of Chemistry in the 2024 2nd testing event. 2. Review of API evaluation records confirmed the 0% score (failure to participate) for the 34 Chemistry analytes in the 2024 2nd testing event. 3. An interview with the laboratory director, on 10/2/24 at 9:45 AM, confirmed the failure of the laboratory to submit the results to API before the deadline for the 2nd testing event in Chemistry, resulting in a 0% score. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to achieve satisfactory scores for the analyte TIBC (measured) for two consecutive proficiency testing (PT) events in 2024, resulting in an unsuccessful performance. Findings: 1. Review of American Proficiency Institute (API) evaluation records revealed the following unsatisfactory PT scores for TIBC(measured): 60% 1st event 2024 0% 2nd event 2024 2. An interview with the laboratory director, 10/2/24 at 9:45 AM, confirmed the unsuccessful scores for the analyte TIBC (measured) in the two consecutive testing events, resulting in an unsuccessful PT performance for the unregulated analyte. 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 record review, lack of documentation, and interview the laboratory failed to evaluate the appropriateness of the reference intervals (normal values) for 16 of 16 complete blood count (CBC) parameters during the verification of the Medonic hematology analyzer performance specifications in February of 2023. Findings: 1. Review of the verification of the performance specifications for the Medonic hematology analyzer (put in use 2/15/2023) revealed no evaluation of the CBC reference intervals (normal ranges) for the patient population served by the laboratory. 2. No documentation the laboratory evaluated specimens to verify the manufacturer established reference intervals (normal ranges) or published reference intervals (normal ranges) for 16 of 16 CBC parameters. 3. An interview with the laboratory director, 10/2/24 at 10:40 AM, confirmed that no documentation could be located and the CBC reference intervals (normal ranges) had not been evaluated by the laboratory for the patient population served. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Central Labs Inc. on November 2, 2022, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D2121 HEMATOLOGY CFR(s): 493.851(a) 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 record review and interview the laboratory failed to achieve satisfactory performance for the analyte #0775 RBC in one of two proficiency testing (PT) events of 2022. Findings: 1. Review of American Proficiency Institute (API) PT records identified an unsatisfactory score of 40% for the analyte #0775 RBC in the 2nd testing event of 2022. 2. An interview with the laboratory director, 11/2/22 at approximately 9:30 AM, confirmed the unsatisfactory performance of the analyte. D5781

Summary Statement of Deficiencies 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 test records and interview with the Director /Technical Supervisor, the laboratory director did not attest to the routine integration of samples for some of the Chemistry and Hematology Proficiency Testing (PT) Event for 2018. Findings include: 1. The 1st Chemistry Core PT event for 2018 attestation statement documentation was not signed by the Laboratory director. 2. The 2nd Hematology PT event for 2018 attestation statement documentation was not signed by the laboratory director. 3. On September 21, 2018 at approximately 12: 30PM, the Laboratory Director/Technical Consultant stated that he had missed signing the attestation documents for the 1st Event Chemistry Core and the 2nd event Hematology PT events for 2018. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 review of Chemistry records and interview with Director/Technical Consultant, the laboratory did not verify acceptable limits of calibration at least at the minimal, mid-point and maximum values to verify reportable range of the Dimension Expand Plus Chemistry system. Findings include: 1. There were no record to support the laboratory had verified reportable ranges of manufacturer's literature limits for all chemistry analytes from 2016-2018. 2. On September 21, 2018 at approximately 11: 45 PM, the Laboratory Director stated that the chemistry analyte reportable ranges had not been verified in-house. The manufacturer limits were available and used as the reportable ranges. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on observation and interview with the Laboratory Director/Technical Consultant, the laboratory has in use thermometers which monitored freezer, refrigerator and room temperatures daily. All of the thermometers were beyond the manufacturer instructions for calibration due date. Findings include: 1. The Fisher Scientific refrigerator thermometer calibration due date was 5/28/2018. 2. The Fisher Scientific room temperature thermometer calibration due date was 2/26/2018. 3. The Fisher Scientific freezer temperature thermometer calibration due date was 4/6/2014 4. On September 21, 2018 at approximately 12:45 PM. The Laboratory Director /Technical Supervisor stated that he had not realized the thermometer calibrations were due. 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 -- 2 of 3 -- 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 Hematology Calibration records and interview with testing personnel, it was determined that laboratory was not following policy on frequency of calibrations for 2017 and 2018. Findings include: 1. The calibration records according to policy were to be performed at least twice per year or when a preventive maintenance occurred. 2. The Calibrations records available for the Medonic Hematology analyzer for 2017 was dated 9/7/2017. It was the only calibration record available for 2017. 3. The Calibration record available for the Medionic Hematology Analyzer for 2018 was dated 5/16/2018. 4. The Preventive Maintenance records were found but no calibration data found during the 2017 timeframe. 5. The Laboratory Director and Testing personnel stated that they typically performed Hematology Analyzer calibrations 2 X per year in February and September. That data was found for 2016 but not at that frequency for 2017 and 2018. -- 3 of 3 --