Meharry Sickle Cell Center Laboratory

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observations, a review of the laboratory procedure manual, a lack of documentation, and staff interviews, the laboratory failed to follow the safety plan procedure for eyewash station and fire extinguisher inspections in 2024 and 2025. The findings include: 1. Observation of the laboratory on 09/09/2025 at 11:00 revealed the following: An eyewash station with a bottle labeled "Buffered Eye-Lert Emergency Eye & Skin Flush" with a handwritten expiration date of 07/31/2025. A fire extinguisher with a "Monthly Inspection Record Tag" with dates recorded as follows: 02/12, 03/05, 04/09, 05/08, 06/16, 07/07. The tag did not include the year of inspection. 2. A review of the laboratory procedure titled "Chemical Hygiene and Hazard Communication Safety Plan," section "Engineering Controls," revealed that "Eyewash stations shall be inspected at least quarterly and the inspection records maintained by the Safety Officer" and "Fire extinguishers shall be visually inspected on a monthly basis by laboratory personnel and serviced annually by an outside company licensed to perform such inspections." 2. On the date of the survey (09/09 /2025), documentation of the quarterly eyewash station inspections and monthly or annual fire extinguisher inspection records for 2024 and 2025 was unavailable. 3. The survey findings were confirmed in an interview with the laboratory general supervisor and testing person two on 09/09/2025 at 3:00 p.m. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on laboratory observation, review of laboratory calibration records, lack of records, and staff interviews, the laboratory failed to retain the manufacturer's assay information sheets (two of three reviewed) for the calibrators used for the Bio-Rad Variant II Hemoglobin Testing System in 2024 and 2025. The findings include: 1. Observation of the laboratory on 09/09/2025 at 11:00 a.m. revealed the Bio-Rad Variant II (Serial Number: 14085) instrument used for patient normal and abnormal hemoglobin detection. 2. A review of the laboratory's calibration records revealed the following: Calibrator Lot 64581947 performed on 08/02/2024 Calibrator Lot 64631585 performed on 03/12/2025 3. The manufacturer's assay information sheets, which provided the expected values for the calibrators, were unavailable on the survey date (09/09/2025). 4. The survey findings were confirmed in an interview with the laboratory general supervisor and testing person two on 09/09/2025 at 3:00 p.m. 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 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 observation of the laboratory, review of laboratory policy, review of final patient test reports, and staff interview, the laboratory failed to follow its own policy for specimen rejection by reporting hemoglobinopathy results on one of five patient specimens greater than 7 days old. The findings include: 1. Observation of the laboratory on 12.04.23 at 08:05 am revealed the Bio-Rad Variant II Hemoglobin Testing System (SN 1405) and the PerkinElmer Migele Gel Electrophoresis Unit (SN 21180137) in use for patient hemoglobin and hemoglobin electrophoresis testing. 2. Review of the laboratory policy "Criteria for Specimen Rejection Policy" revealed "The following procedural actions are to be followed carefully in rejecting a blood specimen that is received in the laboratory for testing. Reject when the following occur: 5. Specimen collection date greater than 7 days" 3. Review of five final patient test reports revealed the following for Sample ID 108478: - Draw Date: 4/19/2023 at 10:37 am - Delivery Date: 4/28/2023 at 10:37 am - Run Date: 5/2/2023 at 3:15 pm - Report Date: 5/2/2023 at 4:23 pm 4. Interview with the Laboratory Director and Testing Person 2 on 12.04.23 at 12:45 pm confirmed that they failed to follow their own policy for specimen rejection for one of five specimens reviewed. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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 -- The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of manufacturer's operator's manuals, lack of documentation, and staff interview, the laboratory failed to monitor temperature and humidity in the area where the hemoglobin testing systems were in operation in 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on 12.04.23 at 08:05 am revealed the BioRad VARIANT II Hemoglobin Testing System (SN: 1405) and the Perkin Elmer Migele Gel Electrophoresis Unit (SN: 21180137) in use for patient hemoglobinopathy testing. 2. Review of the manufacturers' operating manuals revealed operating environment requirements of: - Bio-Rad VARIANT II system: Temperature 15-35 Celsius, Humidity 10-90% - Perkin Elmer Migele Gel Electrophoresis Unit: Temperature 18-30 Celsius, Humidity 20-80%. 3. Review of laboratory records revealed no documentation of room temperature or humidity. 4. Interview with the Laboratory Director and Testing Person 2 on 12.04.23 at 12:45 pm confirmed the laboratory did not monitor room temperature or humidity in 2021, 2022, and 2023 in the area where the Bio-Rad VARIANT II and PerkinElmer Migele test systems were located. 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: Based on observation of the laboratory, review of laboratory policy, and staff interviews, the laboratory failed to label two of two sets of reconstituted BioRad Hemoglobin A2 controls, Level 1 and Level 2 with Identity, date prepared, expiration date, and storage instructions. The findings include: 1. Observation of the laboratory on 12.04.23 at 8:05 am revealed two aliquots of reconstituted BioRad Lyphochek Hemoglobin A2 Control, Levels 1 and 2 (Lot: 54820 Exp: 2.28.25) in use for quality control of the Bio-Rad Variant II Hemoglobin Testing System (SN: 1405). The aliquots observed were not labeled with Identity, date prepared, expiration date, and storage instructions. 2. Review of the laboratory policy "Quality Assurance Program" revealed "All reagents prepared in the laboratory will be labeled with the following: Identification, Strength, titer or concentration, Date prepared, Expiration date, Storage instructions (e.g. temperature requirements if other than room temperature), Hazardous chemical Warning Label, if applicable, and Initials of preparer". 3. -- 2 of 3 -- Interview with the Laboratory Director and Testing Person 2 on 12.04.23 at 12:45 pm confirmed the aliquots of quality control material observed in the laboratory were not labeled with identity, date prepared, expiration date, and storage instructions. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CMS-209) and Clinical Laboratory Improvement Amendments Application for Certification (CMS-116), testing personnel competency assessment records, and staff interview, the laboratory's technical consultant (TC) failed to document all six required criteria for assessing personnel competency for 3 of 3 testing personnel (TP) performing hemoglobinopathy patient testing in 2021, 2022, and 2023. The findings include: 1. Review of the CMS-209 and CMS-116 provided by the laboratory on 12.04.23 revealed three TP who perform hemoglobin variant and hemoglobin electrophoresis testing. 2. Review of testing personnel competency assessment records for 2021, 2022, and 2023 revealed competency assessments completed annually for three of three TP failed to include documentation of the six required criteria of competency that include: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, assessment of problem solving skills. 3. Interview with the Laboratory Director and Testing Person 2 on 12.04.23 at 12:45 pm confirmed the laboratory's TC failed to document the six required criteria for assessing personnel competency for three of three TP in 2021, 2022, and 2023. -- 3 of 3 --