Associated Specialists Inc

Summary Statement of Deficiencies D0000 An offsite proficiency testing (PT) desk review was conducted for Associated Specialists Inc., on March 25, 2025, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations were reviewed for successful participation and compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. The identified unsuccessful participation is an initial occurrence and explained below. 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 CASPER 155D proficiency testing (PT) report, laboratory PT evaluations from American Proficiency Institute (API), and phone interview with 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 -- testing personnel (TP1), the laboratory failed to achieve satisfactory performance for the specialty #0525 Endocrinology in two consecutive testing events in 2024 and 2025, resulting in an initial occurrence of unsuccessful participation. Refer to D2108. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) (g) Failure to achieve an overall testing event score of satisfactory performance 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 review of CASPER 155D proficiency testing (PT) report, laboratory PT evaluations from American Proficiency Institute (API), and phone interview with testing personnel (TP1), the laboratory failed to achieve satisfactory performance for the specialty of #0525 Endocrinology in two consecutive testing events in 2024 and 2025, resulting in an initial occurrence of unsuccessful participation in PT. Findings: 1. Review of CASPER 155D PT report identified the following unsuccessful participation for the #0525 Endocrinology specialty: 30% event 3 2024 65% event 1 2025 2. Review of API PT evaluations confirmed the unsatisfactory performance for the #0525 Endocrinology specialty in two consecutive testing events with the following unsatisfactory analyte scores: 2024 Event 3 #0545 Free TY 0% #0585 TSH 60% 2025 Event 1 #0541 Folate, Serum 40% #0600 Vitamin B12 20% 3. A phone interview with TP1, 3/25/25 at 8:45 AM, verified the occurrence of unsuccessful participation in PT for specialty #0525 Endocrinology. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Associated Specialists Inc. on February 15, 2024, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. 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) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Associated Specialists Inc on January 5, 2022, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to (ii) verify the manufacturer stated values for new lots of assayed quality control (QC) material for all 7 of 7 analytes tested on the Roche Cobas e411 analyzer in 2021. Findings: 1. Review of 2021 QC records revealed no documentation for the verification of manufacturer stated value ranges for new lots of QC material for the following analytes: TSH, Vitamin D, Vitamin B12, FT4, PSA, Folate, and Ferritin. 2. An interview with the technical consultant and testing personnel 1, on 1/5/22 at 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 -- approximately 12:00 PM, confirmed that no verification of new lot QC ranges for the 7 analytes on the Roche analyzer were being performed. -- 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 a review of the proficiency testing (PT) records of American Proficiency Institute (API) and CASPER reports 155D and 153D, the laboratory failed to successfully participate in PT for each analyte on the CLIA test menu. Findings: 1. Review of the CLIA database, via CASPER report 153D for unsuccessful PT participation, identified a PT failure of the laboratory for analyte 0355 (Chloride). 2. Review of the individual laboratory PT scores, via CASPER report 155D and API, identified the following unsatisfactory scores for analyte 0355 Chloride: a. 20% for Chloride in API 2nd event 2019 b. 40% for Chloride in API 1st event 2020 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 -- 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 a review of CASPER report 155D and the proficiency testing (PT) records from the American Proficiency Institute (API), the laboratory produced unsatisfactory results for the same analyte (0355 Chloride) in Chemistry for 2 out of 3 testing events. Findings; 1. Review of the individual laboratory PT report scores (CASPER report 155D) and comparative evaluation scores from API, identified the following unsatisfactory scores for analyte 0355 Chloride: a. 20% for Chloride API 2nd testing event 2019 b. 40% for Chloride API 1st testing event 2020 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 a review of proficiency testing (PT) records from the CLIA database (CASPER reports 153D and 155D) and comparative evaluation records from the American Proficiency Institute (API), the laboratory director failed to provide overall anagement and direction in accordance with CLIA regulations. Findings: 1. Review of CASPER reports 153D and 155D, and API evaluation scores identified unsatisfactory analyte scores for 0355 Chloride in 2 of 3 testing events. a. 20% for Chloride API 2nd testing event of 2019 b. 40% for Chloride API 1st testing event 2020 D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, 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 American Proficiency Institute (API) proficiency testing (PT) scores and CASPER reports 153D and 155D, the laboratory director failed to ensure satisfactory performance form the laboratory in proficiency testing. Findings: 1. Review of API PT evaluation scores, CASPER reports 153D and 155D, identified -- 2 of 3 -- unsatisfactory scores for analyte 0355 Chloride in 2 of 3 testing events. a. 20% for Chloride API 2nd testing event 2019 b. 40% for Chloride API 1st testing event 2020 -- 3 of 3 --

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 a review of the laboratory American Proficiency Institute (API) proficiency testing (PT) records and an an interview with Technical Consultant 1 (TC1), the laboratory failed to attain a score of at least 80 percent for analytes in the API Chemistry Core testing events of 2018 and 2019. Findings: 1. A review of API PT records identified an unsatisfactory performance of 20 percent for the analyte Total Bilirubin in the Chemistry Core 2018 3rd testing event. 2. A review of API PT records identified an unsatisfactory performance of 20 percent for the analyte Chloride in the Chemistry Core 2019 2nd testing event. 3. An interview with TC1, on 11/14/19 at approximately 10:45 AM, confirmed the findings. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 a review of the laboratory American Proficiency Institute (API) proficiency testing (PT) records and an interview with Technical Consultant 1 (TC1), the laboratory failed to attain a score of at least 80 percent for the analyte Free Thyroxine in the 2nd Chemistry Core- Endocrinology 2019 testing event. Findings: 1. A review of API PT records identified an unsatisfactory performance of 20 percent for 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 -- analyte Free Thyroxine in the Chemistry Core- Endocrinology 2019 2nd testing event. 3. An interview with TC1, on 11/14/19 at approximately 10:45 AM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --