Peacehealth Medical Group

Summary Statement of Deficiencies D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, record review, and an interview with the laboratory lead, the laboratory director (LD) director failed to specify in writing, the responsibilities and duties of the Technical Consultant (TC), Clinical Consultant (CC), and each person engaged in the preanalytic, analytic, and post analytic phases of testing since the last survey on 2/13/2024. Findings include: 1. The CMS 209 form identified five (5) testing personnel (TP) performing iSTAT Chemistry, blood gas, and troponin testing, two (2) technical consultants (TC), and one (1) clinical consultant (CC). 2. A review of the Delegation of Authority form entitled Authorized Designees, signed and dated on 4/11/2023 by the LD, revealed: a. The Clinical Consultant (CC) identified did not meet the qualifications of a state-licensed physician and was not listed on the CMS- 209 form. b. One (1) of two (2) Technical Consultants (TC) and five (5) of five (5) TP identified from the CMS 209 form were missing from the delegation form. 3. An interview with the laboratory lead on 5/8/2026 at 12:00 PM confirmed there was no updated delegation form specifying responsibilities and duties. 4. The laboratory reports performing 290 chemistry tests annually. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) 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 -- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services (CMS) 209 personnel form, competency assessment records, and an interview with the laboratory lead on 5/8/2026, the technical consultants (TC) failed to assess testing personnel (TP) competency from 2024 through the date of the survey. Findings include: 1. The CMS 209 form identified five (5) testing personnel (TP) performing iSTAT Chemistry, blood gas, and troponin testing, and two (2) technical consultants (TC). 2. A review of competency assessment records revealed the competency assessments for five (5) of five (5) TP were not assessed by the TCs listed on the CMS 209, or other personnel who meet the TC regulatory qualification requirements for assessing competency in 2024, 2025, and up to May 8 in 2026. 3. An interview with the laboratory lead on 5/8 /2026 at 12:00 PM confirmed the competency assessments were not performed by the TCs. 4. The laboratory reports performing 290 chemistry tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 condition: successful participation [proficiency testing] 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 an off-site desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) PT Report and 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 -- laboratory's 2025 College of American Pathologists (CAP) proficiency testing records, it was determine the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for Chemistry PO2 in two (2) out of three (3) testing events. See D2096. 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 an off-site PT desk review of the CASPER PT report and CAP 2025 records, the laboratory failed to achieve an overall satisfactory performance of at least eighty percent (80%) for Chemistry PO2 in two (2) out of three (3) testing events (2nd and 3rd events). The findings include: 1. A review of the CASPER 0155 report revealed the following: a. The laboratory received an unsatisfactory score of 0% for PO2 analyte on the AQIS-B 2025 event. b. The laboratory received an unsatisfactory score of 60% for PO2 analyte on the AQIS-C 2025 event. 2. A review of the proficiency testing records from CAP confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of the Proficiency Testing (PT) data report (CASPER report 155), graded results from the College of American Pathologists (CAP), and an interview with the testing person, the laboratory failed to successfully participate in PT for the Specialty of Hematology and the analyte Hemoglobin. The laboratory had unsatisfactory scores for the third event in 2022 and the second event of 2023. See D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 a review of the Proficiency Testing (PT) data report (CASPER report 155), graded results from College of American Pathologists (CAP), and an interview with the testing person, the laboratory failed to successfully participate in PT for the Specialty of Hematology and the analyte Hemoglobin. The laboratory had unsatisfactory scores for the third event in 2022 and the second event of 2023. Findings include: 1. Specialty of Hematology a. CAP 2022 Event 3 = 0% b. CAP 2023 Event 2 = 50% 2. Hemoglobin a. CAP 2022 Event 3 = 0% b. CAP 2023 Event 2 = 0% 3. An interview with the testing person on September 6, 2023 at 1:30 PM confirmed the laboratory failed to achieve satisfactory performance for the Specialty of Hematology and the analyte Hemoglobin for the third event in 2023and the second event of 2023. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of chemistry quality control records, a patient report, and an interview with Testing Person 1 (TP #1), it was determined the laboratory failed to perform and document two levels of external quality control each day patient specimens are tested using non-waived CG4+ cartridges on the Abbott i-STAT analyzer. Findings: 1. A review of patient records showed i-STAT tests were performed on 5/25/2022. The laboratory reported this had been the only patient tested at the time of the survey since the initiation of moderate complexity testing on 4/14 /2022. 2. Quality control records records did not show documentation of external i- STAT controls for the patient testing date 5/25/2022 . 3. TP #1 confirmed these findings on 7/7/2022 at 15:30. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --