Northfield Hospital & Clinics-Northfield Clinic

Summary Statement of Deficiencies D0000 The Northfield Hospital and Clinics - Northfield Clinic laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on February 28, 2025. The following standard-level deficiencies were cited: 493.1253 Establishment and verificaiton of performance specifications . 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 observation, document review, and interview with laboratory personnel, the laboratory failed to complete required performance verification (PV) activities for the single Hematology analyzer implemented by the laboratory in 2024. Findings are as follows: 1. The laboratory performed Erythrocyte Sedimentation Rate (ESR) testing under the Hematology specialty as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:04 a.m. on February 28, 2025. 2. An Alcor miniiSED analyzer was observed as present and available for use during the tour. The laboratory performed ESR testing on this analyzer beginning on July 1, 2024. 3. The laboratory was required to perform accuracy, precision, reportable range, and reference interval verification when adding a new analyzer as indicated in the CLIA Verification of Performance Specifications for New Tests/Instrumentation policy provided by the laboratory on the date of survey. 4. PV documentation for ESR 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 -- on the Alcor miniiSED found in the Alcor miniiSED Start-Up - NFLD section of the PV Activities Book included accuracy, precision, and reportable range verification. Reference interval verification documentation was not found. The laboratory was unable to provide the missing documentation upon request. 5. In an interview at 12:55 p.m. on 02/28/2025, the TC confirmed the above findings and indicated the laboratory performed 105 ESR tests on patient samples using the Alcor miniiSED between July 1, 2024 and the date of survey. . -- 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 observation, document review, and interview with laboratory personnel, the laboratory failed to perform quality control (QC) activities as established in the Bacteriology Individualized Quality Control Plan (IQCP) in 2 of 4 months reviewed . Findings are as follows: 1. The laboratory performed Bacteriology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 10:05 a. m. on 03/16/21. 2. A Meridian Bioscience Revogene molecular analyzer was observed as present and available for use during the tour. The laboratory began performing the Revogene Strep A assay in August 2020 as indicated by the TC and confirmed in laboratory records. 3. Revogene Strep A QC performance was required every 30 days as established in the Gene POC Strep A using Meridian Revogene procedure and in the laboratory's IQCP for the test, both found in the Clinic Laboratory Policy and Procedure Manual. 4. The laboratory exceeded the 30 day time interval for QC performance in 2 of 4 months reviewed, potentially affecting 4 patient (Pt)test results. See below. QC date Pt test date Days elapsed 10/26/20 11/30/20 35 12/01/20 01/05/21 36 01/06/21 37 01/07/21 38 5. In an interview at 2:30 p.m. on 03/16/21, the TC confirmed the above finding. 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 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of non-graded proficiency testing (PT) results. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 1/2/19 at 9:05 a.m. 2. The laboratory performed PT using the American Proficiency Institute (API) as PT provider. 3. The laboratory received non-graded results from API due to no consensus for the event and test listed below. Event = 2018 Hematology / Coagulation 1st Event Sample ID = BCI-01 Test = Blood Cell Identification 4. An evaluation of the non- graded PT result was not found during review of laboratory records. The laboratory was unable to provide the evaluation upon request. 5. In an interview on 1/2/19 at 11: 00 a.m., the TC confirmed the above findings. . D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: 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 -- . Based on document review and interview with laboratory personnel, the laboratory failed to ensure all procedures were approved, signed and dated by the laboratory director prior to use. Findings are as follows: 1. The laboratory performed General Immunology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 1/2/19 at 9:05 a.m 2. An Individualized Quality Control Plan (IQCP) procedure specific to AmnioSure Rupture of Membrances (ROM) testing was found in the Laboratory Policy and Procedure manual 3. The Laboratory Director did not approve, sign or date the IQCP procedure prior to the implementation. 4. In an interview on 1/2/19 at 12:30 p.m., the TC confirmed the above findings. . D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to ensure accurate reference ranges were listed on a Hematology test report reviewed during the survey. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory on 1/2/19 at 9:05 a.m. 2. A Sysmex XN-430 hematology analyzer was observed as present and available for use during the tour. 3. The reference ranges found in the Sysmex XN-430 Hematology Analyzer procedure, located in the on-line Policies and Procedure manual, were not consistent with that included on the test report (Female - 41 years, Date of testing = 12/21/18) reviewed on the date of survey, as follows: Parameter: Procedure: Test Report: WBC* 5.00 - 10.00 4.5 - 11.0 RBC* 3.90 - 5.03 4.00 - 5.20 HGB* 12.0 - 15.5 12.0 - 16.0 HCT* 34.9 - 44.5 33 - 51 MCV* 82 - 98 80 - 100 MCH* None found 26 - 34 MCHC* None found 32 - 36 PLT* None found 140 - 440 5. In an interview on 1/2/19 at 12:35 p.m., the TC confirmed the above findings. * WBC = White Blood Cell Count * RBC = Red Blood Cell Count * HGB = Hemoglobin * HCT = Hematocrit * MCV = Mean Corpuscular Volume * MCH = Mean Corpuscular Hemoglobin * MCHC = Mean Corpuscular Hemoglobin Concentration * PLT = Platelet Count -- 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 proficiency testing reports from the American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for Cell ID or WBC Differential testing under the specialty of Hematology. Findings are as follows: D2122 - the laboratory failed to obtain a PT score for Cell ID or WBC Differential testing of at least 80 percent in two testing events D2131 - the laboratory failed to achieve satisfactory performance for Cell ID or WBC Differential testing in two of three testing events D2122 HEMATOLOGY 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 -- CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to obtain a PT score for Cell ID or WBC Differential testing of at least 80 percent which resulted in unsatisfactory performance for the analyte. Unsatisfactory PT performance of Cell ID or WBC Differential testing was obtained in the following events. - 2017 2nd event: 67% - 2018 1st event: 0% . D2131 HEMATOLOGY CFR(s): 493.851(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 proficiency testing scores from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for Cell ID or WBC Differential in two out of three consecutive testing events, constituting unsuccessful performance for the analyte. Review of results from API revealed that the laboratory had unsatisfactory performance for Cell ID or WBC Differential in two out of three consecutive events, leading to unsuccessful performance. Unsatisfactory PT performance of the Cell ID or WBC Differential was obtained in the following events. - 2017 2nd event: 67% - 2018 1st event: 0% . -- 2 of 2 --