Tlc Laboratory

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (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 interview with Technical Supervisor (TS), review of Proficiency Testing (PT) evaluation records and review of ten (10) randomly chosen patients records on March 17, 2025, it was determined that the Laboratory failed to attain a score of at least 80% of acceptable responses for Chloride in the second event of 2024, which was unsatisfactory analyte performance for the testing event. The findings include: 1. The laboratory enrolled in the American Proficiency Institute (API) proficiency testing program for Chloride testing using Horiba Medical Pentra 400 instrument in 2023, 2024 and 2025. According to the API evaluation, the laboratory attained a score of 40% in the second event of 2024 for Chloride as follow: Event /Analyte Sample Repored Expected Result Result Q2 2024 Chloride CH-06 103 106-118 Q2 2024 Chloride CH-08 80 81-90 Q2 2024 Chloride CH-10 83 84-94 2. On March 17, 2025, at approximately 12:00 pm the Technical Supervisor affirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on March 13, 2025, stated that the laboratory performed approximately 7000 Routine Chemistry tests including Chloride annually. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of laboratory proficiency testing reports and interview with the technical supervisor on March 17, 2025, the laboratory Director failed to provide overall management and direction in accordance with 493.1445 of this subpart. See D2087 -- 2 of 2 --

Summary Statement of Deficiencies D0000 THE LABORATORY IS IN COMPLIANCE WITH THE REQUIREMENTS OF 42 CFR PART 493, REQUIREMENTS FOR CLINICAL LABORATORIES. 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in 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 -- two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performance. (See 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Chloride (CL), resulting in an non-initial unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, CL, as follows: 2021 Q3 2022 Q2 CL 0% 20% Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an subsequent unsuccessful performance for the analyte, CL. Note: Laboratory was cited for an initial unsuccessful CL proficiency performance: 2021 Q2 2021 Q3 CL 40% 0% 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required -- 2 of 3 -- under subpart H. of this part. The findings included: For the analyte, CL, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in subsequent unsuccessful PT performance. (see D2016 and 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Routine Chemistry constituting unsuccessful PT performance. (See D2096) 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 -- 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Chloride (CL), resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, CL, as follows: 2021 Q2 2021 Q3 CL 40% 0% Q1 = First Testing Event Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analytes, CL. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, CL, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (see D2016 and D2096) -- 2 of 2 --

Summary Statement of Deficiencies D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records for evaluation of proficiency testing performance from CMS, laboratory proficiency reporting from API, and an interview with laboratory technical personnel (TP) on 5/19/21 between 1: 00 p.m.and 3:00 p.m., it was determined that there were several unacceptable (below 80 %) proficiency testing (PT) results for Thyroid Stimulating Hormone (TSH) for Cycle 1 in the testing year 2019. Findings include: 1. On 5/19/21, an inspection was conducted between 1:00 p.m. and 3:00 p.m. 2. During a review of the laboratory documentation from API (agency providing the proficiency specimens), it was noted at approximately 2:30 p.m. that there were several unacceptable PT results for cycle Q1 TSH on the 2019 report. The laboratory utilizes the Horiba Pentra 400 instrument for general chemistry testing The TP recognized these atypical results. 3. The findings and acceptable ranges were as follows: Analyte: TSH (3/5 Unacceptable) Sample Actual Result Expected Result (range) CH03 5.79 3.86-5.34 CH04 0.50 0.34-0.46 CH05 3.25 2.14-2.88 4. The TC affirmed the unacceptable results listed above. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) Ensure that testing systems developed and used for each of 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 -- 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 a review of the proficiency laboratory documentation records and interviews with the LP, it was determined that the laboratory director failed to ensure the verification and accuracy of test results of regulated analytes and to identify failures as they occurred for the previously mentioned Cycle 1 2019 proficiency testing. The findings include: See D-2099 -- 2 of 2 --

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the specialty of Hematology constituting unsuccessful PT performance. (See D2130) 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, platelet count, resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, platelet count, as follows: 2020 Q1 2020 Q2 Platelet count 20% 0% Q1 = First Testing Event Q2 = Second Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, platelet count. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, platelet count, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2130) -- 2 of 2 --

Summary Statement of Deficiencies D5783