Neoanalytics Laboratory

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on 07/18/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate 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 American Proficiency Institute (API) records (2025-1 and 2025-2), 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 3 -- 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 analytes: Bilirubin, Total; Cholesterol, Total; Cholesterol, Low Density; Glucose (non-waived); Iron, Total; Total Protein; Triglyericides; BUN; and Uric Acid resulting in unsuccessful performances. See 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API - American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performances for: two of three consecutive events (2025-1 and 2025-2). The findings include: Bilirubin, Total 60% - 2025 first testing event, Bilirubin Total 0% - 2025 second testing event; Cholesterol, Total 0% - 2025 first testing event, Cholesterol Total 0% - 2025 second testing event; Cholesterol, Low Density 0% - 2025 first testing event, Cholesterol, Low Density 0% - 2025 second testing event; Glucose (non- waived) 0% - 2025 first testing event, Glucose (non-waived) 0% - 2025 second testing event; Iron, Total 20% - 2025 first testing event, Iron, Total 0% - 2025 second testing event; Total Protein 0% - 2025 first testing event, Total Progein 0% - 2025 second testing event; Triglycerides 0% - 2025 first testing event, Triglycerides 0% - 2025 second testing event; BUN 20% - 2025 first testing event, BUN 0% - 2025 second testing event; Uric Acid 60%, 2025 first testing event, Uric Acid 0%, 2025 second testing event. A review of the 2025 scores from American Proficiency Institute (API) confirmed the above findings. 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 proficiency testing desk review of the CASPER 0155D report and American Proficiency Institute records for 2025-1 and 2025-2 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 proficiency testing desk review of the CASPER 0155D report and American Proficiency Institute records for 2025-1 and 2025-2 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation of the reagents, controls and calibrators in the refrigerator and interview with the technical consultant, it was determined that the laboratory has been using reagents, solutions and other supplies that have exceeded their expiration date. The findings included: a. On the day of the survey (8/14/2019, 11:00) based on a direct observation, randomly selected materials inside the refrigerator, the following reagents, controls and calibrators were expired: Microgenics Corp. DRI Ecstasy Cal (750 mg/ml) Lot # 72778952, Exp.date 10/2018. DRI Ecstasy Cal (250 mg/ml) Lot # 72778949, Exp. date 9/2018. Total IgG THC (20 mg/ml), Lot # 72713744, and Exp. date 3/2018 MGC Primary DAU Control Set Lot # 72850720 Exp date 4/2019 DRI Multi Drug urine CAl 3 (TS), Lot # 72774503 Exp date 6/30/2019 Thermo Scientific Oxycodone Cal 100 Lot # 72772292 Exp Date 1/2019 Drug of Abuse Low, Lot # 73106161 Exp date 7/2019 Drug of Abuse High, Lot # 72791314 Exp date 8/2018 b. The technical consultant confirmed (8/14/2019, 11:00) that the controls, calibrators and other reagents were expired, but was inside the refrigerator which could have the potential to be used or being used. c. Based on the laboratory's annual testing declaration for 2018-2019 the laboratory analyzed and reported approximately 960 Toxicology tests that its accuracy could have been affected by the expired reagents, calibrators and controls used. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) 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 -- (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on direct observation of the reagents, controls and calibrators in the laboratory's refrigerator and interview with the technical consultant, it was determined that the laboratory did not follow written policies and procedures with regards to using reagents, controls and calibrators and other supplies not exceeding the expiration dates. The findings included: a. The laboratory's policy and procedure under title; "Test systems, equipment, instruments, reagents, materials and supplies." stated: "2. Reagents, solutions, control materials, calibration materials and other supplies shall not be used when they have exceeded their expiration date, have deteriorated or are substandard quality." 2. See D 5417. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on direct observation of the reagents, controls and calibrators in the laboratotyr's refrigerator and interview with the technical consultant, it was determined that; the laboratory director failed to ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. See D 5417 and D 5791. -- 2 of 2 --