Stamford Health Medical Group, Inc

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document remedial action when unacceptable Proficiency Testing (PT) scores were received in the specialty of hematology. Findings include: 1. Record review on 02/24/2026 of the 'Wisconsin State Laboratory of Hygiene (WSLH) PT Evaluation' form for 3 of 3 events in 2025 revealed the following unacceptable PT results: a. 'WSLH PT 2025- HemeReg1' i. 'Analyte: Erythrocyte (RBC) 10^12/L' ii. 'Analyte Score: 80%' iii. 'Sample: AT-3' iv. 'Results: 2.49' v. 'Range: 2.26 - 2.44' vi. 'Status: Fail' b. 'WSLH PT 2025-HemeReg2' i. 'Analyte: Lymphocytes %' ii. 'Analyte Score: 80%' iii. 'Sample: AT-7' iv. 'Results: 14.8' v. 'Range: 11.3 - 14.3' vi. 'Status: Fail' c. 'WSLH PT 2025- HemeReg3' i. 'Analyte: Platelets 10^9/L' ii. 'Analyte Score: 80%' iii. 'Sample: AT-15' iv. 'Results: 91' v. 'Range: 209 - 348' vi. 'Status: Fail' d. Lack of documentation of an investigation and remedial action for the above unacceptable PT results in 1(a) through (c) listed above. 2. Record review on 02/24/2026 of the laboratory's policies and procedures revealed 'Unacceptable proficiency result documentation form must be completed for any scores lower than 100%'. 3. Staff interview on 02/24/2026 at 12:15 PM with the laboratory's technical consultant confirmed the above findings. 4. The laboratory performs 7,728 tests annually in the specialty of 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 4 -- D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have a policy in place to assess the competency of all laboratory personnel. Findings include: 1. Review of the laboratory's personnel competency records on 3/2/2020 revealed the following: a. The laboratory did not have a policy in place to assess the competency of 8 of 8 clinical consultants and 1 technical consultant (TC). b. The laboratory did not have competency assessment documentation for the above referenced laboratory personnel. 2. Staff interview with the TC on 3/2/2020 at 11:10 AM confirmed the laboratory did not have a policy in place to assess the competency of the above laboratory personnel and they were not assessed. 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 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 -- 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory director (LD) failed to attest that proficiency testing (PT) samples were performed in the same manner as patient specimens Findings include: 1. Record review of the 2016 & 2017 PT records for hematology tests from Wisconsin State Laboratory of Hygiene on 3/9/18 revealed PT events 1- 3 attestation pages were unsigned by the testing personnel (TP) and the laboratory director (LD). 2. Interview with the technical consultant (TC) and LD on 3 /9/18 at 11:45 AM confirmed this finding. In addition, TC stated they were unaware PT attestation sheets need to be signed by LD and TP. 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 --