Nassir Medical Corporation 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 the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records and interviews with the testing personnel (TP) on January 27, 2026, it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for the Total Bilirubin (TBil) analyte during the first event of 2023 (Q1-2023). The findings include: 1. The surveyor reviewed the PT records wherein API reported an unsatisfactory score of 60% for the TBil analyte in the Routine Chemistry subspecialty for the Q1-2023. 2. The TP affirmed by an interview on January 27, 2026, at approximately 9:40 a.m. that the laboratory obtained the unsatisfactory PT scores for the TBil analyte as mentioned in statement #1. 3. According to the laboratory's testing declaration form (Lab-144) submitted at the time of the survey, the laboratory performed approximately 105,000 patient test samples annually in Routine Chemistry including the TBil analyte during the time when the laboratory received unsatisfactory proficiency testing scores. D2121 HEMATOLOGY CFR(s): 493.851(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 3 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) records, and an interview with the testing personnel (TP) on January 27, 2026, it was determined that the laboratory failed to attain a score of at least 80% of the acceptable responses for Red Blood Cell (RBC) count which is an unsatisfactory analyte performance for the testing event. The findings include: 1. The surveyor's review of the PT documentation indicated that the laboratory participated in the API PT program for the first event of 2024 (Q1-2024) and obtained a score of 20% for RBC count. Therefore, the accuracy of the patient test results for WBC count reported by the laboratory during the failed proficiency testing period cannot be assured and might have caused potential patient harm. 2. On January 27, 2026, at approximately 9:40 a.m., the TP affirmed by an interview that the laboratory received less than 80% score at the Q1-2024 PT event for the RBC count analyte in Hematology specialty. 3. The laboratory's testing declaration form, signed by the laboratory director on 01/26/2026 stated that the laboratory performed approximately 50,000 tests in Hematology annually which included the RBC count analyte. 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 the laboratory's policy and procedure, ten randomly chosen patient records, personnel competency documentation, and an interview with the testing personnel 1 (TP1); as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to follow their policy that the personnel competency assessment was performed by the laboratory director prior to patient testing. The findings include: 1. The surveyor reviewed ten randomly chosen patient records wherein, two out of three testing personnel had competency assessments performed by TP1 who was an unqualified technical consultant or a laboratory director. The competency records are as followed: a. TP1 performed TP2's competency assessment for the years 2022 and 2023. b. TP1 performed TP3's competency assessment for the years 2023, 2024 and 2025. 2. Further review of the personnel competency documentation revealed that the competency assessment for TP2 was missed to be performed in the years 2024 and 2025. No

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on January 26, 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 (2025-1 and 2025-3), 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 the analyte Hematocrit resulting in unsuccessful performances. See D2121. D2121 HEMATOLOGY CFR(s): 493.851(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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and American Proficiency Institute (API) report, the laboratory failed to achieve a satisfactory performance for two out of three consecutive events (2025-1 and 2025-3) for the analyte Hematocrit (specialty Hematology): The finding include: 1. Hematocrit 60% - 2025 first testing event; Hematocrit 60% - 2025 third 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 the American Proficiency Institute records for 2025-1 and 2025-3 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 2025-1 and 2025-3 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2121 Hematocrit analyte deficiency/deficiencies. -- 2 of 2 --