Mercyone Newton Medical Center

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on June 2, 2026. The laboratory was found to be out of compliance with 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 Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute, the laboratory failed to successfully participate in two 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 -- analyte, immunoglobulins IgM. The laboratory had unsatisfactory scores for 2025 event 3 and 2026 event 1. Refer to D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate in two consecutive testing events for the analyte, immunoglobulins IgM. The findings include: 1. For 2025 event 3, the laboratory received an unsatisfactory performance score of 60% for the analyte, immunoglobulins IgM. 2. For 2026 event 1, the laboratory received an unsatisfactory performance score of 60% for the analyte, immunoglobulins IgM. 3. The CASPER 155 report and graded results from API confirm the findings listed above. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (2025 event 3 and 2026 event 1), 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2084. -- 2 of 2 --

Summary Statement of Deficiencies 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) 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 review of the performance specifications for the Sysmex XP-300 hematology analyzer and confirmed by the general supervisor at approximately 2:30 pm on 10/22/2025, the laboratory failed to verify the performance specification of reportable range when the laboratory put into use the Sysmex XP-300 hematology analyzer in November 2024. The findings include: 1. The laboratory director reviewed, signed and dated the Sysmex XP-300 hematology verification of performance specifications on 11/1/2024. 2. At the time of the survey, the general supervisor confirmed the verification of performance specifications for the XP-300 hematology analyzer did not include a verification of the reportable range. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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 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 -- 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of MedTox quality control (QC) records and laboratory procedures and confirmed by interview with the general supervisor at 11:45 am on 10/22/2025, the laboratory failed to perform weekly QC for the MedTox test system for two out of seven weeks from 6/1/2025 - 7/14/2025. The findings include: 1. The procedure titled, "The Rapid Drug Screen using the Profile-V Medtox Scan Drugs of Abuse Test System" and the MedTox Individualized Quality Control Plan procedure both stated that a positive and negative liquid QC would be performed weekly. 2. Review of Medtox QC records revealed that laboratory did not perform a positive and negative QC the week of 6/15/25 - 6/21/25 or the week of 7/6/25 - 7/12/2025. 3. At the time of the survey, the general supervisor confirmed the laboratory did not have Medtox QC records for the weeks of 6/15/2025 - 6/21/2025 and 7/6/2025 - 7/12/2025. -- 2 of 2 --