Laboratory Corporation Of America Holdings

Summary Statement of Deficiencies D0000 A Certification survey was performed at Laboratory Corporation of America Holdings, CLIA ID # 19D0959085. Laboratory Corporation of America was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803: CONDITION: Successful participation 42 CFR 493.1403: CONDITION: Laboratories Performing Moderate Complexity Testing, Laboratory Director 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 the laboratory's proficiency testing records, CASPER 155D 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 -- report, and interview with personnel, the laboratory failed to achieve a score of at least 80% for total bilirubin for two of three consecutive events, resulting in an initial unsuccessful performance. Refer to D2096. 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records, CASPER 155D report, and interview with personnel, the laboratory failed to achieve a score of at least 80% for total bilirubin for two (2) of six (6) consecutive events reviewed for 2021 and 2022 resulting in an initial unsuccessful participation. Findings: 1. Review of the CASPER 155D report, American Academy of Family Physicians (AAFP) proficiency testing records for 2021, and American Proficiency Institute (API) proficiency testing records for 2022 revealed the laboratory achieved the following unsatisfactory scores: AAFP Module 619, MultiCHEM 21 +, 2021-C, total bilirubin, score: 40% API 2022 Chemistry-Core 2nd Event, total bilirubin, score: 60 % 2. In interview on April 20, 2023 at 9:20 am, the Technical Consultant confirmed the laboratory did not achieve proficiency testing scores of at least 80% for the identified events for total bilirubin. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records, CASPER 155D report, and interview with personnel, the Laboratory Director failed to provide overall management and direction. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records, CASPER 155D report, and interview with personnel, the Laboratory Director failed to ensure proficiency testing samples were satisfactory as required. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An Initial survey was performed on March 26, 2021 at Laboratory Corporation of America Holdings, CLIA ID # 19D0959085. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: I. Based on record review and interview with personnel, the laboratory failed to retain instrument printouts for Complete Blood Counts (CBC) testing for at least two (2) years. Findings: 1. Review of the laboratory's policies revealed the following: a) "Retention of Laboratory Records and Materials: The laboratory maintains all reports and records in accordance with the regulatory standards of CLIA and JCAHO, All Quality Control and Calibration records and worksheets., Quality Assurance and Safety records/documentation , are kept on hand for 2 years." 2. Review of the laboratory's Change of Ownership forms revealed the laboratory obtained a Certificate of Compliance on July 13, 2020. 3. In interview on March 26, 2021 at 10:12 am, Testing Personnel 1 stated the laboratory does not back up the Cell-Dyn (CBC analyzer). Testing Personnel 1 further stated the laboratory can not retrieve any instrument data prior to January 2021. II. Based on record review and interview with personnel, the laboratory failed to retain calibration records for one (1) of two (2) calibrations reviewed in 2020 for the Cell-Dyn Ruby analyzer for at least two (2) years. Findings: 1. Review of the laboratory's policies revealed the following: a) "Retention of Laboratory Records and Materials: The laboratory maintains all reports and records in accordance with the regulatory standards of CLIA and JCAHO, All 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 -- Quality Control and Calibration records and worksheets., Quality Assurance and Safety records/documentation , are kept on hand for 2 years." 2. Review of the laboratory's "Calibration Verification" policy revealed "System calibrations must be validated at least every 6 months, at changes in instrumentation and when complete change in reagents for a procedure is introduced. These results will be retained for a minimum of 2 years." 3. Review of the laboratory's Change of Ownership forms revealed the laboratory obtained a Certificate of Compliance on July 13, 2020. 4. In interview on 12:54 pm, Testing Personnel 1 stated the Abbott service representative had to fix the CBC instrument in August 2020 and performed calibration. Testing Personnel 1 further stated she was unable to get documentation of the calibration from the service representative. III. Based on record review and interview with personnel, the laboratory failed to retain quality control (QC) establishment raw data for Chemistry testing for at least two (2) years. Findings: 1. 1. Review of the laboratory's policies revealed the following: a) "Retention of Laboratory Records and Materials: The laboratory maintains all reports and records in accordance with the regulatory standards of CLIA and JCAHO, All Quality Control and Calibration records and worksheets., Quality Assurance and Safety records/documentation , are kept on hand for 2 years." 2. Review of the laboratory's Change of Ownership forms revealed the laboratory obtained a Certificate of Compliance on July 13, 2020. 3. Review of the laboratory's QC records for the BioRad MultiQual controls revealed the laboratory did not have documentation of the raw data used to establish the QC means and ranges for the current lot in use : a) MultiQual: Level 1 Lot 56641, Level 3 : Lot 56643 4. In interview on March 26, 2021 at 2:23 pm, Testing Personnel 1 confirmed the laboratory did not have the QC establishment documentation for the Chemistry controls. Testing Personnel 1 stated the current lot number of MultiQual was put into use in February 2020. 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: I. Based on review of the laboratory's procedures and interview with personnel, the laboratory failed to establish complete written policies for Complete Blood Counts (CBC) flags. Findings: 1. In interview on March 26, 2021 at 10:02 am, Testing Personnel 1 stated for CBC instrument flags the samples are rerun and if flag persists the results are rejected and sent to main laboratory for a manual differential. 2. In further interview on March 26, 2021 at 12:47 pm, Testing Personnel 1 stated past results for CBC patients are reviewed. 3. Review of the laboratory's "Abbott Cell-Dyn Ruby: Complete Blood Count with a 5-Part Differential" procedure revealed the laboratory did not include detailed written instructions for handling of flagged CBC samples referred to the main laboratory. To include, but not limited do, rejection of results and review of past results. II. Based on review of the laboratory's quality control (QC) policy, manufacturer's instructions, QC records, and interview with personnel, the laboratory failed to establish their own QC ranges for Complete Blood Counts (CBC) per laboratory policy. Findings: 1. Review of the laboratory's "Abbott Cell-Dyn Ruby: Complete Blood Count with a 5-Part Differential" procedure under "Quality Control" section revealed "According to the manufacturer, each laboratory -- 2 of 5 -- must establish its own ranges. These ranges are determined by evaluating data from at least a three month period for each level of control. (Data analysis from the inter- laboratory Cell-Dyn Eqc is also used.)" 2. Review of the manufacturer's instructions revealed "The recovery ranges are intended to reflect inter-laboratory and inter- instrument variability; thus are wider than the +/- 2 SD QC range for one instrument. Always perform quality control according to good laboratory practice, laboratory director's requirements. and any regulatory or acceditational requirements." 3. Review of the laboratory's CBC quality control records for the current lot (L1025, N1025, and H1025) of Cell-Dyn 26 Plus Controls revealed the laboratory did not have documentation of establishing their own QC ranges. 4. In interview on March 26, 2021 at 12:54 pm, Testing Personnel 1 stated the laboratory establishes their own QC mean for CBC and uses the manufacturer's limits. Testing Personnel 1 confirmed the laboratory does not establish their own range for CBC quality control material. D5781