Lifequest Diagnostic, Inc

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 review of the laboratory's proficiency testing (PT) records, and interview with the Technical Consultant (TC) on August 14, 2025, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the Routine chemistry analyte Sodium for the third PT event of 2024. The findings included: 1. The laboratory participated in the AAB-MEDICAL LABORATORY EVALUATION (AAB-MLE) proficiency testing (PT) program for endocrinology using the Horiba Pentra C400 analyzer. According to the AAB-MLE evaluation report, the laboratory received an unsatisfactory score of 0% for Sodium in M3-2024. 2. On August 14, 2025, at approximately 1:30 pm the Technical Consultant affirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on August 14, 2025, stated that the laboratory performed approximately 500 Routine chemistry tests including Sodium annually. Thus, the accuracy and reliability of patient test reports cannot be determined. D2098 ENDOCRINOLOGY CFR(s): 493.843(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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records, and interview with the Technical Consultant (TC) on August 14, 2025, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the Endocrinology analyte Free Thyroxine for the first PT event of 2025. The findings included: 1. The laboratory participated in the AAB-MEDICAL LABORATORY EVALUATION (AAB-MLE) proficiency testing (PT) program for endocrinology using the TOSOH AIA-360 analyzer. According to the AAB-MLE evaluation report, the laboratory received an unsatisfactory score of 0% for Free Thyroxine in M1-2025. 2. On August 14, 2025, at approximately 1:30 pm the Technical Consultant affirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on August 14, 2025, stated that the laboratory performed approximately 300 endocrinology tests including Free Thyroxine annually. Thus, the accuracy and reliability of patient test reports cannot be determined. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 12/19/2024, 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 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 Certificate and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evaluation program records (2024- 2 and 2024-3), 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 an chemistry analyte (Chloride) - resulting in unsuccessful performance. Refer to 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB-Medical Laboratory Evaluation program report, the laboratory failed to achieve satisfactory performance for two consecutive events (2024 second & third testing events) for the analyte Chloride: The findings include: 1. Chloride- 0% 2024 second testing event, Chloride - 0% 2024 third testing event. 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 AAB- Medical Laboratory Evaluation records for 2024-2 and 2024-3 proficiency 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) 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 proficiency testing desk review of the CASPER 0155D report and AAB- Medical Laboratory Evaluation records for 2024-2 and 2024-3 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2096. -- 2 of 2 --