National Institute On Aging Irp/Lci

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 interview with laboratory staff, the laboratory failed to have a policy to assess competency for technical consultant and clinical consultant for 2 of 2 years reviewed. Findings included: 1. Review of the form CMS 209 (Laboratory Personnel Report) signed by the laboratory director on June 9, 2025, found the laboratory had one Technical Consultant and three Clinical Consultants. 2. Review of the Standard Operating Procedures manual found no policy or procedure for assessing the competency of the Technical Consultant or the Clinical Consultants. 3. Review of laboratory staff competency assessment documentation found no assessments for the one Technical Consultant and three Clinical consultants for 2023 and 2024. 4. During interview on June 11, 2025, at 10:25 am, Testing Personnel 1 (TP 1) stated the laboratory has never performed competency assessments for the Technical Consultant or the Clinical Consultants. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) 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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and 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 -- interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, review of manufacturer's instructions, lack of humidity records, and interview with staff, the laboratory failed to ensure the humidity range was within manufacturer's specifications for the operation of 3 of 3 chemistry analyzers. Findings included: 1. During a tour of the laboratory on June 11, 2025, at approximately 12 pm, two YSI 2900 chemistry analyzers (serial numbers 18B100529 and 18B100530) and one Horiba Pentra C400 analyzer (serial number 701C4-0472) were observed. 2. The operator's manual for the YSI 2900 analyzer stated the following: "1.4 2900 Series General Specifications ... Working Environment:... Relative Humidity 10% - 75%, (non-condensing)" 3. The operator's manual for the Horiba Pentra C400 analyzer stated the following: "2. 2 Humidity and Temperature Conditions ... Humidity Conditions: Relative humidity of 20% - 85% maximum, without condensation." 4. The surveyor requested and did not receive records documenting humidity levels in the laboratory. 5. During interview on June 11, 2025, at approximately 12:10 pm, Testing Personnel 1 (TP 1) stated humidity levels were not monitored or documented in the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on review of the specimen log book, procedure CL-050 Oral Glucose Tolerance Testing (OGTT) Sample Processing and Result Reporting, and interview with the laboratory director, technical consultant, and testing person (TP 1), the laboratory failed to document the date and time the specimen was received in the laboratory. The findings include: 1. The BLSA OGTT log book (Baltimore Longitudinal Study on Aging Oral Glucose Tolerance Test logbook) did not list the received date of the patient specimens. 2. Procedure CL-050 (on pages: 4, 5, 8, 10, 13, and 16) states the requirement for documenting the sample collection date, but the received date is not mentioned. 3. At approximately 1pm, the laboratory director, technical consultant, and TP 1 confirmed that the collection date was being recorded but not the received date. 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 and interview with the laboratory director, technical consultant, and testing person (TP 1), the laboratory failed to have an up-to-date 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 -- written procedure manual for the specific procedures used in the National Institue on Aging (NIA) laboratory for the testing person to follow. The findings include: 1. The table of contents did not match the procedures in the manual. TP 1 had to flip through the large notebook in search of procedures the surveyor needed to review. 2. The manual did not include the procedure to record room temperature, refrigerator temperatures, or freezer temperatures for the NIA laboratory. a. There was a procedure for recording the refrigerator/freezer temperatures in the Core Laboratory. b. At approximately 1pm, the laboratory director, technical consultant, and TP 1 of the laboratory being surveyed (the NIA laboratory) stated that the Core laboratory was a separate laboratory and certified under a different CLIA certificate. c. The procedure did not contain a process to record room temperature values. d. The manufacturer room temperature requirement for the Pentra 400 is listed in the user guide in the Appendix on Table 11 as: "Ambient temperature 15-32 degrees centigrade". e. The testing person was recording refrigerator, freezer, and room temperatures on a temperature chart. The chart indicated that 'NU' was to be used for 'Not in use' and a slash or an 'NR' was to be used for 'Not recorded'. The exact meaning of 'Not in Use' and 'Not recorded' was not explained in any procedure that was found in the manual. 3. The manual included a