Healthcare Clinical Laboratory, Inc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 8/12/2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; D6000 - 42 C.F.R. 493.1403 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evalustion records (2023-3 and 2024-2), the laboratory failed to successfully participate in a proficiency testing 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 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the subspecialty of Hematology for the analyte Antibody Detection resulting in an unsuccessful performance. Refer to D2172. D2172 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(e) Failure to achieve an overall testing event score of satisfactory for 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 desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation reports, the laboratory failed to achieve satisfactory performance for two of three events proficiency events in 2023 and 2024 for analyte Antibody Detection. The finding include 1. The laboratory received the following scores: 0% on the 2023 Antibody Dection third event 0% on the 2024 Antibody Detection second event 2. A review of the 2023 and 2024 proficiency Testing scores from AAB confirmed the above findings. 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 proficiency testing desk review of the CASPER 155 report AAB records for 2023-3 and 2024-2 events, the laboratory director failed to provide overall management and a direction of the laboratory services. Refer to D2172. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

Summary Statement of Deficiencies 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: Based on review of the American Association of Bioanalysts (AAB) proficiency testing (PT) records, randomly chosen patient results' review, and interview with the technical supervisor (TS); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the following analytes: Chloride, Sodium, and Potassium for the third event of 2021 (Q3-2021). The finding included: 1. Based on review of PT records for the Q3-2021 AAB reported the following unsatisfactory scores: Analyte Score Chloride 0% Sodium 0% Potassium 60% 2. Based on the laboratory testing declaration submitted at the time of the survey on January 26, 2022 the laboratory analyzed and reported approximately 3,898 Routine Chemistry tests for each year during the time the laboratory had unsatisfactory proficiency testing results. 3. The TS affirmed on 01/26,2022at approximately 11:00 a. m. that the laboratory received the above unsatisfactory proficiency testing scores. 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 review of the laboratory's American Association of Bioanalysts (AAB) testing records, five (5) random patients sampling, and interview with the technical 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 -- supervisor (TS); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Hematology on the third event of 2021 (Q2-2021). The findings included: 1. The AAB proficiency program gave an overall unsatisfactory score of 59 % for Hematology for Q3-2021 which included: Analyte Score WBC 20% RBC 20% Hemoglobin 20% Platelets 20% 2. Based on the laboratory's annual testing declaration submitted on the day of the survey January 26, 2022; the laboratory analyzed and reported approximately 2,134 Hematology samples which included WBC, RBC, Hemoglobin, and platelet counts during the time the laboratory had unsatisfactory proficiency testing results. 3. The TS confirmed on 01/26 /2022 at approximately 11:45 a.m. that the laboratory received the above proficiency score of 59% for Hematology as described in 1. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's records for proficiency testing results and interview with the technical supervisor and laboratory testing personnel on January 26, 2022; it was determined that the laboratory director failed to ensure that several aspects of the preanalytic, analytic, and postanalytic phases of laboratory testing were monitored when processing, testing, and reporting proficiency samples. See D2121 and D2087. -- 2 of 2 --