Laboratory Corporation Of America

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 laboratory policies and procedures, American Proficiency Institute (API) proficiency testing (PT) records, lack of documentation, and interview with the technical supervisor (TS); the laboratory failed to attest to the routine integration of PT samples into the patient workload for 2 of 12 PT events reviewed, starting in 2023 through 2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "Proficiency Testing Policy", which stated, "14. The proficiency testing attestation statement is signed by the laboratory director or designee and the individual performing the testing." 2. Review of API PT records revealed that the laboratory director and testing personnel failed to sign the attestation statement for testing in routine chemistry for one of six events reviewed in the years of 2023 through 2025. Event: Year: 3 2025 3. Review of API PT records revealed that the laboratory director failed to sign the attestation statement for testing in Hematology for one of six events reviewed in the years of 2023 through 2025. Event: Year: 3 2023 4. Interview with the TS on 10/08/2025, at 11:20 am, confirmed the laboratory failed to attest to the routine integration of PT samples into the patient workload for one of six PT events reviewed for chemistry and one of six PT events reviewed for hematology testing in the years of 2023 and 2025. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the 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 -- manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual, review of quality control (QC) results and interview with the technical supervisor (TS), the laboratory failed to maintain control procedures to monitor quality control testing on the integra 400 plus for one of six patient testing dates reviewed. Findings include: 1. Review of the laboratory policy and procedure manual identified the policy, "Creatinine plus ver 2.0", under the section titled "quality control", which stated the following "If control results are out of the specified acceptable ranges,

Summary Statement of Deficiencies D0000 A Proficiency Testing (PT) Desk survey was performed on August 15, 2025. The laboratory was found to be out of compliance with the 42 CFR Part 493 CLIA requirements for the following CONDITION level deficiencies: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency 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 -- Institute (API) Proficiency Testing (PT) records, the laboratory failed to successfully participate and achieve satisfactory performance for the analyte, Chloride in the subspecialty of Routine Chemistry for two consecutive PT events in 2022 and 2023 (event 3 of 2022 and event 1 of 2023) and 2025 (event 1 and event 2 of 2025) resulting in the laboratory's subsequent unsuccessful PT performance. 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 a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to achieve satisfactory performance for the analyte, Chloride in the subspecialty of Routine Chemistry for two consecutive PT events in 2022 and 2023 (event 3 of 2022 and event 1 of 2023) and 2025 (event 1 and event 2 of 2025) resulting in the laboratory's subsequent unsuccessful PT performance. Findings include: 1. Review of the CASPER Report 0155D, generated on 08-01-2025, the laboratory received the following unsatisfactory scores for the analyte, Chloride. Chloride Initial Unsuccessful PT Performance EVENT 3, 2022 - 20% Unsatisfactory EVENT 1, 2023 - 40% Unsatisfactory Subsequent Unsuccessful PT Performance EVENT 1, 2025 - 60% Unsatisfactory EVENT 2, 2025 - 60% Unsatisfactory 2. Review of API PT evaluation reports (Chemistry - Core) confirmed the above unsatisfactory scores that resulted in the laboratory's subsequent unsuccessful PT performance for the analyte, Chloride. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in their PT program for the analyte, Chloride in the subspecialty of Routine Chemistry resulting in the laboratory's subsequent unsuccessful PT performance. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in their PT program for the analyte, Chloride in the subspecialty of Routine Chemistry resulting in the laboratory's subsequent unsuccessful PT performance. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies 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 CASPER Report 0155D and review of American Proficiency Institute (API) proficiency testing (PT) reports the laboratory failed to successfully participate in PT for the routine chemistry analyte chloride (Cl) during event three of 2022 and event one of 2023, resulting in unsuccessful PT performance for Cl. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 Report 0155D and review of American Proficiency Institute (API) proficiency testing (PT) documentation the laboratory failed to successfully participate in PT for the routine chemistry analyte chloride (Cl) during event three of 2022 and event one of 2023, resulting in the unsuccessful PT performance for Cl. Findings include: 1. Review of the CASPER Report 0155D ran on 4-3-2023 identified the initial unsuccessful PT performance for the specialty of chemistry for chloride (Cl). ROUTINE CHEMISTRY Cl - EVENT-3, 2022 = 20% - Unsatisfactory Cl - EVENT-1, 2023 = 40% - Unsatisfactory 2. Review of API PT documentation confirmed the unsuccessful PT performance for Cl during event three of 2022 and event one of 2023. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CASPER Report 0155D and review of American Proficiency Institute (API) proficiency testing (PT) reports the laboratory director failed to meet the requirements of this condition. The laboratory director failed to ensure test methods were performed as required to provide accurate and reliable results for the specialty of chemistry analyte chloride in 2022 through 2023. See D6087. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D and review of American Proficiency Institute (API) proficiency testing (PT) reports the laboratory director failed to ensure test methods were performed as required to provide accurate and reliable results for the specialty of chemistry analyte chloride in 2022 through 2023. Findings Include: 1. The laboratory failed to ensure successful participation in proficiency testing for the chemistry analyte chloride during event three of 2022 and event one of 2023. See D2096. -- 2 of 2 --