Cortex Lab Inc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on - 07/02/2026, 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 (2024-3 and 2025-1), 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 Hematology analyts(s) resulting in unsuccessful performances. See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 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 performance for two out of three consecutive events (2024-3, and 2025-1) for the analytes: 1. Erythrocyte Count (RBC): 2024 third test event - RBC scored 0%, and 2025 first test event - RBC scored 60%. 2. Hematocrit (HCT): 2024 third test event - HCT scored 0%, and 2025 first test event - HCT scored 60%. 3. Hemoglobin (HGB): 2024 third test event - HGB scored 0%, and 2025 first test event - HGB scored 60%. 4. Leukocyte (WBC): 2024 third test event - WBC scored 0%, and 2025 first test event - WBC scored 60%. A review of the 2024 & 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 API records for 2024-3 and 2025-1 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; 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 2024-3 and 2025-1 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2130 -- 2 of 2 --

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 the surveyor's review of the laboratory's policy and procedure, American Proficiency Institute (API) proficiency testing (PT) records, and interviews with the technical consultant (TC), testing personnel (TP), and owner; it was determined that the laboratory failed to attain at least 80 percent of the acceptable scores in Routine Chemistry for the second event of 2025 (Q2-2025). The findings include: 1. The surveyor reviewed the PT records for Q2-2025 wherein API reported unsatisfactory scores for Alkaline Phosphatase (ALP), Phosphorus, Potassium, and Uric Acid analytes. The results as follows: a. ALP PT analyte, Overall score: 0% Specimen Reported Expected CH-06 *16 20 - 31 CH-07 *206 242 - 365 CH-08 *88 103 - 155 CH-09 *155 182 - 274 CH-10 *271 331 - 497 b. Phosphorus PT analyte, Overall score: 20% Specimen Reported Expected CH-06 1.4 1.3 - 1.9 CH-07 *3.8 4.0 - 5.0 CH-08 *2.2 2.3 - 3.0 CH-09 *3.1 3.3 - 4.1 CH-10 *4.8 5.1 - 6.3 c. Potassium PT analyte, Overall score: 20% Specimen Reported Expected CH-06 2.3 2.3 - 3.0 CH-07 *5.5 5.6 - 6.3 CH-08 *3.4 3.5 - 4.2 CH-09 *4.5 4.6 - 5.3 CH-10 *6.9 7.0 - 7.7 d. Uric Acid PT analyte, Overall score: 0% Specimen Reported Expected CH-06 *2.1 1.5 - 2.0 CH-07 *10.0 7.5 - 9.3 CH-08 *4.9 3.6 - 4.6 CH-09 *7.7 5.8 - 7.2 CH-10 *13.3 10.0 - 12.4 Legend: * = unsatisfactory score reported 2. The TC, TP and owner affirmed by interviews on June 19, 2025, at approximately 9:30 a.m. that the laboratory obtained the PT unsatisfactory scores mentioned in statement #1. 3. According to the laboratory's testing declaration submitted on the day of the survey, the laboratory performed approximately 35,000 patient test samples for Routine Chemistry including the ALP, Phosphorus, Potassium, and Uric Acid analytes during Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- the time the laboratory received unsatisfactory proficiency testing scores. Thus, the quality and reliability of patient test reported cannot be determined. D2127 HEMATOLOGY CFR(s): 493.851(d) (d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) reports and an interview with the technical consultant (TC); it was determined that the laboratory failed to return the proficiency testing results for Hematology for the third quarter event of 2024 (Q3-2024) within the time frame specified resulting to an unsatisfactory performance score of zero percent (0%). The findings include: 1. The laboratory received an unsatisfactory score of 0% for the Q3- 2024 event after failure to submit results within the time frame as mandated by the API PT program. 2. The TC affirmed on June 19, 2025 at approximately 9:40 a.m. that the laboratory received the unsatisfactory score as mentioned in statement #1. 3. The laboratory analyzed and reported approximately 24,000 Hematology patient test samples during the time when an unsatisfactory score was obtained. Thus, the accuracy and reliability of patient results reported cannot be assured. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the surveyor's review of five (5) patient records, lack of personnel competency documentation, and interviews with the technical consultant (TC); as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to perform competency assessments for the testing personnel (TP) prior to the start of patient testing. The findings include: 1. Surveyor's review of 5 patient records showed that competency assessment for all TP were missed to be performed for 2025 prior to the start of patient testing. 2. The TC affirmed by interview on June 19, 2025, at approximately 1:00 p.m. that no competency records were available for review for all TP hired for the year 2025. Thus, the quality and reliability of patient reports could not be assured. 3. According to the testing declaration submitted at the time of the survey, the laboratory reported and performed approximately 71,575 patient samples annually including the time when patient testing were performed. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) -- 2 of 4 -- Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on the lack of a complete verification of performance specifications for Hematology, Chemistry, and Endocrinology and interviews with the technical consultant (TC), testing personnel (TP), administrator, and owner on June 19, 2025, it was determined that the laboratory failed to provide a complete documentation for verification of performance specifications when new instruments were obtained. The findings include: 1. Surveyor's review of the verification of performance specifications for Alinity analyzer used for Chemistry and Endocrinology, and Pentra 60C analyzer used for Hematology showed that all the documentation lacked the accuracy studies. 2. All binders presented at the time of survey containing the verification of performance specifications were not reviewed nor signed by the laboratory director. 3. The TC, TP, administrator, and owner affirmed on an interview on June 19, 2025, at approximately 10:40 a.m., that the validation documentation missed the accuracy portion of the study as mentioned in the statements above. 4. According to the testing declaration submitted at the time of survey, the laboratory performed and reported approximately 71,575 tests annually. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's validation studies for the Alinity and Horiba analyzers, the laboratory director is herein cited for failure to ensure that the verification of performance specifications were complete and valid prior to patient testing. See D5421. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require