Central Clinical Labs Inc

Summary Statement of Deficiencies D0000 Based on a desk review of proficiency testing records from the Certification and Survey Provider Enhanced Reporting (CASPER) database and verified with the proficiency testing provider the laboratory was found to be out of compliance with 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 achieve satisfactory performance for the routine chemistry analyte Glycosylated Hemoglobin (Hgb A1c) for two of three PT events in 2025 (events 1 and 3 of 2025) resulting in the initial 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 routine chemistry analyte Glycosylated Hemoglobin (Hgb A1c) for two of three PT events in 2025 (events 1 and 3 of 2025) resulting in the initial unsuccessful PT performance. Findings include: 1. Review of the CASPER Report 0155D, generated on 11-03-2025, the laboratory received the following unsatisfactory scores for the routine chemistry analyte Hgb A1c. Hgb A1c Initial Unsuccessful PT Performance EVENT 1, 2025 - 0% Unsatisfactory EVENT 3, 2025 - 40% Unsatisfactory 2. Review of API PT evaluation reports (Chemistry - Core) confirmed the above unsatisfactory scores that resulted in the initial unsuccessful PT performance for the routine chemistry analyte Hgb A1c. 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 a Health and Human Services (HHS) approved PT program for the routine chemistry analyte Glycosylated Hemoglobin (Hgb A1c) resulting in the laboratory's initial 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; 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 -- 2 of 3 -- Institute (API) Proficiency Testing (PT) records, the laboratory director failed to ensure successful participation in a Health and Human Services (HHS) approved PT program for the routine chemistry analyte Glycosylated Hemoglobin (Hgb A1c) resulting in the laboratory's initial 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D - Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to successfully participate in PT for the general immunology analyte Hepatitis B surface antigen (HBsAg) during events one and two of 2024, resulting in unsuccessful PT performance for HBsAg. See D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D - Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to successfully participate in proficiency testing (PT) for the general immunology analyte Hepatitis B Surface Antigen (HBsAg) during PT events one and two of 2024. Findings include: 1. Review of the CASPER Report 0155D ran on 10/01/2024 identified the initial unsuccessful PT performance for the general immunology analyte HBsAg. GENERAL IMMUNOLOGY HBsAg - EVENT-1, 2024 = 60% - Unsatisfactory HBsAg - EVENT-2, 2024 = 60% - Unsatisfactory 2. Review of the API PT records for event 1 and event 2 of 2024 confirmed the unsuccessful PT performance for HBsAg during these two consecutive PT events. 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D - Individual Laboratory Profile and 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 general immunology analyte Hepatitis B Surface Antigen (HBsAg) in 2024. 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D - Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure successful participation in an Health and Human Services (HHS) approved PT program for the general immunology analyte Hepatitis B Surface Antigen (HBsAg), resulting in the laboratory's initial unsuccessful PT performance in event one and two of 2024. See D2084. -- 2 of 2 --

Summary Statement of Deficiencies D2025 BACTERIOLOGY CFR(s): 493.823(c) 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 record review, the federal data base, and an interview with the technical supervisor (TS) and owner, the laboratory failed to return proficiency testing results to the proficiency testing program within the time frame specified by the program and received unsatisfactory performance scores of '0' for the testing event in the specialty of Microbiology. Findings: 1. The CASPER Individual Laboratory Profile (Report 155), the American Proficiency Institute (API) proficiency testing (PT) reports for the years of 2019 and 2020, and manual were reviewed. 2. The federal Report 155 showed the laboratory received a score of '0' in the specialty of Bacteriology for event #3 of 2020. 3. The laboratory's API-PT reports revealed the laboratory zero (0*) for Event #3 of 2020 was due to late submission. 4. The laboratory failed to include in its PT policies and procedures the requirement to submit PT results to the PT program before the deadline. 5. On a Recertification survey conducted on 12/16/2020 at 12:00 PM, the TS and owner confirmed the above findings. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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: 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 -- Based on record review, the federal data base, and an interview with the technical supervisor (TS) and owner, the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event in the subspecialty of Routine Chemistry. Findings: 1. The CASPER Individual Laboratory Profile (Report 155) and the American Proficiency Institute (API) proficiency testing (PT) reports for the years of 2019 and 2020 and manual were reviewed. 2. The federal Report 155 showed the laboratory received unsatisfactory performances for the following analytes in Event #3 of 2020: *Albumin received a score of zero '0'. *Total Bilirubin received a score of 40%. *Total Protein received a score of 60%. 3. The laboratory's PT reports confirmed the above PT scores. 4. The laboratory failed to include in its PT policies step-by-step procedures to investigate PT failures. 5. On a Recertification survey conducted on 12/16/2020 at 12:00 PM, the TS and owner confirmed the above findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and an interview with the technical supervisor (TS) and owner; the laboratory failed to establish and follow written procedures that meet the requirement to assess employees performing testing in the specialty of Immunology, Hematology and Chemistry, affecting 10 out of 10 testing personnel (TP). Findings include: 1. The procedures manual and personnel records were reviewed. 2. The laboratory's competency procedure failed to include the following requirements: *Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and *The assessment of problem solving skills. The competency policy also failed to include "Procedure Review". 3. The personnel records revealed TP1, TP2, TP3, TP4, TP5, TP7, TP10, TP11, TP12, and TP13 training and evaluations were assessed with the above procedure that failed to meet competency requirements. 4. The laboratory failed to follow the written competency policy which required the assessment of test performance and problem solving skills to be included in the procedure to train and/or evaluate 10 out of 10 TP. 5. The competency policy failed to include 'procedure review' as a component of training and maintaining competency. 6. On a continuation Recertification survey conducted on 12/16/2020 at 3:00 PM, the TS and owner confirmed the above findings. 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) -- 2 of 5 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)