Chandler Surgical Center, Plc

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on April 15, 2026, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful Participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Enhanced Reporting (CASPER) 155 report and the API-American Proficiency Institute evaluation reports, the laboratory failed to successfully participate in two out of three consecutive testing events 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 -- regulated analyte, PO2 Blood Gas, in 2025 and 2026, resulting in an initial unsuccessful performance. Refer to D2096. 1. The laboratory's PT performance was unsatisfactory for the third event of 2025 as indicated below: - PO2 Blood Gas - 60% 2. The laboratory's PT performance was unsatisfactory for the first event of 2026 as indicated below: - PO2 Blood Gas - 20% 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 CASPER 155 report and the American Proficiency Institute (API) Proficiency Testing (PT) records from 2025 and 2026, the laboratory failed to achieve satisfactory performance (80% or greater) for two out of three consecutive testing events for the regulated analyte, PO2 Blood Gas. Findings include: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: 2025 event 3, PO2 Blood Gas 60% 2026 event 1, PO2 Blood Gas 20% 2. A review of the proficiency testing scores from API. (2025 and 2026) 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-0155 Individual Laboratory Report and American Proficiency Institute (API) 2025 and 2026 records, 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-0155 and American Proficiency Institute (API) 2025-3 and 2026-1 evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. -- 2 of 2 --

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on lack of test requisition documentation for review and interview with the Technical Consultant (TC-1), the laboratory failed to have a written or electronic request for patient testing for one out of three patient records reviewed during the survey. Findings include: 1. The laboratory began patient testing for Arterial Blood Gases (ABG) on the i-Stat analyzer in August 2023. 2. No written or electronic request for ABG testing was presented for review for one out of three patient records reviewed during the survey (patient ID: 247, tested on 8/23/23). 3. The TC-1 interviewed on October 4, 2023 at 10:35 AM confirmed the laboratory failed to have an electronic or written test requisition for Blood Gas testing for the patient indicated above. 4. The laboratory's reported annual test volume for the specialities of Chemistry and Hematology is 4,100. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 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 performance specification documentation for Arterial Blood Gas (ABG), Chem8+ panel, Activated Clotting time (ACT), and Prothrombin Time (PT) testing performed on the i-Stat analyzer and interview with the Technical Consultant (TC-1), the laboratory failed to verify the reportable ranges and the reference ranges prior to reporting patient test results. Findings include: 1. The laboratory uses four test cartridges on the i-Stat analyzer for patient testing. These include: CG4+ (for ABG testing), Chem8+, ACT, and PT/INR cartridges: - The CG4+ cartridge includes the following analytes: Lactate, pH, pCO2, pO2, TCO2, HCO3, Base Excess (BE) and SO2. - The Chem8+ cartridge includes the following analytes: Sodium, Potassium, Chloride, Glucose, Ionized Calcium, Urea Nitrogen (BUN), Creatinine, Anion Gap, Hematocrit (HCT) and Hemoglobin (HGB). -The ACT cartridge includes the test: Activated Clotting time (ACT). -The PT/INR cartridge includes the test: Prothrombin time (PT) / International Normalized Ratio (INR). 2. Prior to reporting patient test results on the i-Stat analyzer, the laboratory failed to demonstrate that it can obtain the reportable range and reference range comparable to those established by the manufacturer for each i-Stat test cartridge used by the laboratory for patient testing. 3. TC-1 interviewed on 10/04/23 at 09:50 AM confirmed the laboratory failed to provide evidence of the reportable and reference ranges for the testing listed above. 4. The annual test volume in the specialties of Hematology and Chemistry is 4,100. 5. The laboratory began patient testing using the ACT, PT/INR, and Chem8+ test cartridges in March 2022. The laboratory began using the CG4+ test cartridge for patient testing in August 2023. -- 2 of 2 --