Sunrise Clinical Laboratory Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Sunrise Clinical Laboratory Inc on 09/22/2025 through 10/01/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D2016 493.803 Condition: Successful Participation D5200 493. 1230 Condition: General Laboratory Systems D5400 493.1250 Condition: Analytic Systems D6000 493.1403 Condition: Moderate Complexity 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 the review of the the laboratory's American Proficiency Institute (API) proficiency testing records and interview, the laboratory did not have successful Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- participation in proficiency testing for the subspecialty of routine chemistry. (See D2097) D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) (g) Failure to achieve an overall testing event score of satisfactory performance for 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 the review of the the laboratory's American Proficiency Institute (API) proficiency testing records and interview, the laboratory did not have successful participation in proficiency testing for the subspecialty of routine chemistry. Findings included: 1. The API 2024 Chemistry-Core 1st event Performance Summary documented the laboratory had received a score of 20% for the 2023 3rd event and 60% for the 2024 1st event for TIBC (Total Iron Binding Capacity). The API 2024 Chemistry-Core 1st event Performance Summary documented "Unsuccessful". 2. Testing Personnel A (TP-A) confirmed on 9/22/2025 at 2:10 p.m., the above unsuccessful participation of the laboratory for TIBC. The Laboratory Director on 9/23 /2025 at 2:10 p.m. confirmed the documentation by API of "Unsuccessful" for the performance of TIBC due to two in a row unsatisfactory scores. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain analytic records for 6/2024, 3/2025, and 7/2025 for the speciality of Immunology (Rheumatoid Factor-RF ) testing. Findings included: 1. Review of Rheumatoid Factor-RF quality control (QC) records for 6/2024, 3/2025, and 7/2025 showed QC performance and lot numbers and expiration dates of reagents. There were no patient electronic or paper log of analytic performance of patient testing for RF for the days documented on the QC records for 6/2024, 3/2025, and 7/2025. 2. Testing Personnel A (TP-A) stated on 9 /23/25 at 9:35 a.m., patient results were entered directly into the Laboratory Information System (LIS) and that record of the patient analytic performance was not retained, only the quality control records. 3. The Laboratory Director on 9/23/2025 at 2:10 p.m. indicated he thought the laboratory kept sufficient records of the RF testing. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the -- 2 of 16 -- overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, review of the 2023 accepted Allegation of Compliance, and interviews, the laboratory failed to verify the accuracy of analytes not evaluated or scored by the proficiency testing program used by the laboratory, American Proficiency Institute (API), from 3rd event of 2023 to 2nd event of 2025 (D5215) and the laboratory failed to identify and take documented

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on September 13, 2021 for Sunrise Clinical Laboratory. Sunrise Clinical Laboratory is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 laboratory's proficiency testing records for 2021, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Refer to D 2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers 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 -- for Medicare & Medicaid Services (CMS) 153 and 155 reports, on September 13, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, red blood cell count for two consecutive testing events in 2021. D2130 HEMATOLOGY CFR(s): 493.851(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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Findings include: On September 13, 2021 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, red blood cell count (RBC), as shown below. Event #1, 2021 RBC-40% Event #2, 2021 RBC-60% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On September 13, 2021 on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive testing events for the analyte, red blood cell count, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the specialty of hematology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & -- 2 of 3 -- Medicaid Services (CMS) 153 and 155 reports on September 13, 2021 on or about 10: 00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two consecutive testing events as shown below. Event #1, 2021 Red blood cell count (RBC)-40% Event #2, 2021 Red blood cell count (RBC)-60% -- 3 of 3 --

Summary Statement of Deficiencies D0000 At the time of the announced, on-site recertification survey, Sunrise Clinical Laboratory was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory staff, the laboratory failed to maintain complete proficiency testing records for 8 of 15 API (American Proficiency Institute) testing events reviewed. The findings include: On June 22, 2021 the laboratory's proficiency testing records were reviewed. The laboratory is enrolled with the API proficiency testing program for hematology, chemistry, and immunology. During the review of the 2019 - 2021 proficiency testing records, the errors listed below were identified: API 2019 proficiency testing Testing Event #3 - Chemistry The laboratory did not retain a copy of the signed attestation sheet. API 2020 proficiency testing Testing Event #1, #2, and #3 - Hematology The laboratory did not retain a copy of the signed attestation sheet. Testing Event #3 - Immunology The laboratory did not retain a copy of the signed attestation sheet. Testing Event #1 and 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 -- #2 - Chemistry Miscellaneous The laboratory did not retain a copy of the signed attestation sheet. API 2021 proficiency testing Testing Event #1 - Immunology The laboratory did not retain a copy of the signed attestation sheet. During an interview on 6/22/21 at 10:00 AM, the General Supervisor confirmed the proficiency testing records were incomplete. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to ensure yearly maintenance was performed on the Sysmex CA-500 coagulation instrument for 2020. The findings include: The maintenance guide for the Sysmex CA-500 states "1. Replace Rinse Filter - Replace the Rinse Filter yearly." The record review of the "Sysmex CA-500 Maintenance Checklist" for January - December 2020 showed the required yearly maintenance was not marked on the form as being completed. The interview with the General Supervisor on 6/22/21 at 12:15 PM confirmed the maintenance had not been performed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to perform the calibration verification at least once every 6 months for the Coulter ACT 5 diff hematology analyzer. Findings include: The record review on 6/22/21 of the calibration documentation for the hematology analyzer showed calibration was -- 2 of 3 -- performed on 8/1/19, 12/16/20, and 5/20/21. The interview with the General Supervisor at 11:30am confirmed calibration had not been performed every 6 months as manufacturer instructions require. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 record review and staff interview, the facility's quality assessment procedure failed to detect omissions in yearly maintenance for the coagulation analyzer and failed to identify calibrations of the hematology analyzer were not performed. The findings include: The quality assessment policy reviewed on 6/22/21 referenced checklists for preanalytic, analytic, and postanalytic activities. There were no filled out checklists in the manual. During an interview with the General Supervisor at 12: 30 PM on 6/22/21, he said that they did not use the checklists any more. -- 3 of 3 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing records and interview with laboratory personnel, the laboratory did not maintain all of the proficiency testing records and did not have the required signatures on all of the documentation. Findings include: The surveyor reviewed the American Proficiency Institute (API) records for the past two years at 9: 45 a.m. on 04/09/2019 and found that the attestation and the performance evaluation for the third hematology testing event of 2018 were not signed. The laboratory received an unacceptable score of 72% for white blood cell differential, but there was no