Massachusetts Eye Research & Surgery

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Massachusetts Eye Research & Surgery Institution laboratory on 06/24/2025 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to test Proficiency Test (PT) samples the same number of times that it routinely tests patient samples. Findings include: 1. Record review of the Laboratory Procedure Manual reviewed: a. The Laboratory "Proficiency Testing" policy states, "PT samples are tested the same number of times that patient sample are tested." b. Laboratory "MERSI Laboratory Repeat Criteria" Policy states: I. Read the print out and repeat if results are less than or greater than specified acceptable range. II. Look for the flags and repeat if there is a "L" flag. 2. Record review on 6/24/2025 of the laboratory's raw date for Wisconsin State Laboratory of Hygiene Proficiency Testing revealed: a. 2024 Event 1 PT sample AT4 was run in duplicate and the result was within acceptable range and had no flags. b. 2024 Event 3 PT sample AT12 was run in duplicate and the result was within acceptable range and had no flags. c. 2025 Event 1 AT1 and AT2 were run in duplicate and the result was within acceptable range and had no flags. 3. Staff Interview on 6/24/2025 at 10:45 AM with the Technical Consultant confirmed patient samples are not routinely run in duplicate and that these PT samples were run in duplicate. 4. The laboratory performs 28,200 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 1 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Massachusetts Eye Research & Surgery Institution laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Please refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review of the laboratory procedure manual and patient test logs, observation of testing personnel (TP) and interview with the regulatory consultant (RC, TP#1 and TP#2, the laboratory failed to follow the procedure manual as written in the specialty of Hematology. Findings include: 1. Surveyor observation of the laboratory on 5/24/2023 at 11:50 AM revealed, ten EDTA lavender top tubes containing blood in a specimen rack. Each tube only had a hand written 4 digit number on the tube as an identifier. 2. Surveyor observation of TP#1 performing phlebotomy on 5/24/2023 at 11:55 AM revealed, TP#1 drew an EDTA lavender top tube from the patient and only wrote a 6 digit number on the tube as an identifier. 3. Record review on 5/24/2023 of the 5/24/2023 patient log revealed: a. A column titled 'Lab ID' b. Each patient had a 6 digit number written in the 'Lab ID' column by their name on the log. 4. Record review on 5/24/2023 of the laboratory's 'Venipuncture Procedure' revealed, "Label the tube with the patient's name immediately. Correct labeling is critical. Included with the patient's name on the tube should be the date drawn, chart number, initials of technician drawing the specimen and tests requested." 5. Staff interview with the RC, TP#1, and TP#2 on 5/24/2023 at 12:00 PM confirmed: 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 -- a. The 10 EDTA tubes indicated in #1 above only had a 4 digit number on the tube as an identifier and does not follow the procedure as written in the 'Venipuncture Procedure' indicated in #4 above. b. The EDTA tube drawn by TP#1 and observed by the surveyor was labeled with only a 6 digit number as an identifier and does not follow the procedure as written in the 'Venipuncture Procedure' indicated in #4 above. c. The 4 digit numbers on EDTA purple top tubes indicated in #1 above are the last 4 digits of the 6 digit number on the patient log. d. The 6 digit number on the patient log corresponds to the 6 digit number written on the patient specimen indicated in #2 above. 6. The laboratory performs 27,000 Complete Blood Counts annually in the specialty of Hematology. 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)