William Newton Hospital

Summary Statement of Deficiencies D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: Based on review of the CMS 209 personnel form, moderate complexity testing personnel (TP) competencies for 2024, and interview with the technical consultant (TC) #1, the technical consultant failed to include direct observation of routine patient test performance in 24 of 45 moderate complexity TP competency assessments. Findings: 1. Review of the CMS 209 revealed 45 moderate complexity TP. 2. The surveyors requested 2024 TP competencies for review. Review of 24 of 24 competencies for rupture of membrane (ROM) TP revealed the dates TC #1 signed the competencies did not match the dates of assessment. 3. The surveyor asked the TC if he performed direct observation of patient testing on the 24 TP. The TC stated he did not perform direct observation of patient testing on any of the 24 ROM TP. 4. In interview on 4/23/25 at 9:25 a.m., TC #1 confirmed, the technical consultant failed to include direct observation of routine patient test performance in 24 of 45 moderate complexity TP competency assessments. 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 D6096 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(7) The laboratory director must ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified. This STANDARD is not met as evidenced by: Based on the

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on the review of the procedure manual and interview, the laboratory failed to establish and follow written procedures for specimen labeling. Findings: 1. Review of the procedure manual for "Activated Clotting Time (Kaolin), CG4 and Creatinine Abbott i-STAT" revealed under "Specimen Labeling: the following statement: "Unless the specimen is analyzed immediately after collection and then discarded, the specimen container must be labeled with the following information: Patient name /DOB Patient ID number 2. Regulation 493.1242 (a)(3) does not contain circumstance which allows for samples to be analyzed without patient name or unique identifier labeling. 3. Interview with the GS #1 on 10/26/22 at 2:20 p.m. confirmed, the laboratory failed to establish and follow written procedures for specimen labeling. 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 a lack of available documentation and confirmed during interview with General Supervisor #5 (GS) #5 the laboratory failed to have procedures approved, signed, and dated by the current laboratory director before use. Findings: 1. Upon review of the laboratory procedures, the current Laboratory Director (LD) did not approve, sign, and date the laboratory procedure/policy for: 41 of 51 immunohematology procedures in the laboratory at time of survey. 2. The following procedures were not signed by the current LD: a. Blood Transfusion Ordering Policy b. Blood Bank Quality Indicators (QI) Plan. (Blood Utilization Review) c. Blood Storage Alarm d. Blood Storage Alarm Activation Test (quarterly pm) e. Emergency Order Procedures (from Blood Supplier) f. Type and Screen - Hold Tube Policy and Procedure / Flow Chart for Blood Bank work g. Tachometer and Timer Checks for Serologic Centrifuge h. Microtyping System Equipment Maintenance i. Daily Inventory and Blood Storage Checks j. Nursing Service: Blood Transfusion procedure k. Nursing Service: Blood Warmer Protocol l. Nursing Service: Blood Components administration instructions m. Nursing Service: Blood Reactions n. Nursing Service: Autoinfusion System o. Outpatient Transfusion p. Autologous and Directed Blood Donations q. American Red Cross Blood Service Agreement r. Renal Transplant Center (Policy statement and Agreement) s. Derivatives - Factor Concentrates t. Lookback Policy and Procedure u. Biological Products Deviations (Errors and Accidents) v. Receipt of Reagents and Supplies w. Transferring and Stock Rotation of Red Blood Cell Units x. Patient Sample Labeling for Pretransfusion Testing Flow Chart for Blood Bank work y. Blood Bank Tags, Labels, and Paper z. Emergency Release OR Incompatible/Special Circumstance aa. Policy for Blood Availability due to Serological Complications bb. Blood Product Issue cc. Grading Tube Reactions dd. Identification of Passively Acquired Anti-D due to Rh Immune Globulin ee. ARC Reference Lab ff. Memo for Antibody Identification gg. Direct Antiglobulin Test (Direct Coombs or DAT) hh. Receipt and Final Disposition of Blood or Tissue ii. Cryoprecipitate jj. Transfusion Reactions kk. Therapeutic Phlebotomy ll. Tube Methods for Antibody Screens and Crossmatch (alternative to gel) mm. Prewarmed Testing nn. Massive Transfusion Protocol oo. Blood Bank Procedure for LIS Downtime 3. Interview with the GS #5 10/26/22 at 9:30 a.m. confirmed, the laboratory failed to have procedures approved, signed, and dated by the current laboratory director before use. -- 2 of 2 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: No deficiency details available. 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 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: No deficiency details available. D3019 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(b) Provision of testing. The facility must provide prompt ABO grouping, D (Rho) typing, unexpected antibody detection, compatibility testing, and laboratory investigation of transfusion reactions on a continuous basis through a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. This STANDARD is not met as evidenced by: No deficiency details available. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(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 3 -- (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: No deficiency details available. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: No deficiency details available. D6096 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(7) The laboratory director must ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified. This STANDARD is not met as evidenced by: No deficiency details available. D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) The laboratory director must employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart. -- 2 of 3 -- This STANDARD is not met as evidenced by: No deficiency details available. -- 3 of 3 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) and interview with the technical supervisor on April 12, 2019 at 1:30 PM confirmed the laboratory failed to twice annually verify the accuracy of DAT testing in 2018. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: A review of American Proficiency Institute (API) proficiency, Quality Control, Quality Assessment, and Interview with staff revealed the laboratory failed to verify the accuracy for the analyte Urine Total Protein for the 1 st event of and 1st event 2018 . Finding were as follows: 1. Based upon a review of API 1 st event 2017 Urine Total Protein received a 67% grade 1 st event 2018 67%. The laboratory failed to produce