Nasa Nutritional Biochemistry Laboratory

Summary Statement of Deficiencies D0000 A Federal Surveyor from the Division of Clinical Laboratory Improvement and Quality (DCLIQ) Survey Branch conducted an announced CLIA recertification survey on 09/03/2026. The laboratory was surveyed under 42 CFR part 493 CLIA regulations and was found to be out of compliance with standard level CLIA requirements. The following standard level deficiencies were found. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 a review of laboratory Proficiency Test (PT) records and an interview with the Technical Supervisor #2 (TS2), the laboratory failed to attest that PT samples were tested in the same manner as patient specimens for three of three PT events in 2025. Findings: 1. A review of three PT events revealed the following: 2025 CAP - BMV2- A Bone-Specific Alkaline Phosphatase CAP # 7197487 - 01 SEQ # 01 (04/22/2025) No attestation statement signature from the Laboratory Director (or Designee). 2025 UK NEQAS for Vitamin K Distribution 101 (07/31/2025) No Attestation Statement and no signatures for the Laboratory Director (or Designee) and Testing Personnel. 2025 UK NEQAS for Vitamin K Distribution 102 (10/31/2025) No Attestation Statement and no signatures for the Laboratory Director (or Designee) and Testing Personnel. 2. In an interview on 09/03/2026 at 12:50 PM, the TS2 confirmed the findings stated above. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) 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 -- The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of laboratory Proficiency Test (PT) records and an interview with the Technical Supervisor #2 (TS2), the laboratory failed to document the evaluation of PT results with reported exception codes for one of one PT event in 2025. Findings: 1. A review of PT, R-B 2025 Trace Metals (R), CAP # 7197487 - 01, Kit Sequence 1, revealed an Exception Code [30] = Scientific committee decision for analytes Copper and Zinc (sample R-05) and an unacceptable grade for Zinc (sample R-06) with no documentation of evaluation by the laboratory. 2. In an interview on 09/03/2026 at 12: 45 PM, the TS2 confirmed the findings stated above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation in the laboratory, review of Quality Control (QC) manufacturer's Instructions for Use (IFU), and an interview with the Technical Supervisor #2 (TS2), the laboratory failed to ensure 6 of 6 expired QC bottles were not available for use. 1. While touring the laboratory on 09/03/2026 at 3:05 PM, the following expired QC material for clinical testing was observed stored in the clinical use only refrigerator: BioRad Lyphocheck Urine Metals Control Level 1 Lot # 69261 Reconstituted bottle expiration date: 07/06/2026 BioRad Lyphocheck Urine Metals Control Level 2 Lot # 69262 Reconstituted bottle expiration date: 07/06/2026 UTAK NR Trace Elements Serum Control Lot # D7471 Reconstituted date: 08/03/2026 Reconstituted bottle expiration date: 08/28/2026 UTAK HR Trace Elements Serum Control Lot # D7015 Reconstituted date: 08/03/2026 Reconstituted bottle expiration date: 08/28/2026 UTAK NR Metals Urine Control Lot # D6251 Reconstituted date: 08 /03/2026 Reconstituted bottle expiration date: 08/28/2026 UTAK HR Metals Urine Control Lot # D5343 Reconstituted date: 08/03/2026 Reconstituted bottle expiration date: 08/28/2026 2. A review of the QC manufacturer's IFU's revealed the following storage stability statements: BioRad Lyphocheck Urine Metals Control Level 1(Lot# 69261) and Control Level 2 (Lot# 69262), "Reconstituted and Refrigerated: After reconstituting and storing tightly capped at 2C to 8C, this product will be stable as follows: All analytes: 5 days." UTAK NR Trace Elements Serum Control (Lot# D7471) and UTAK HR Trace Elements Serum Control (Lot# D7015), "Store reconstituted control material at 2-8C (35-46F). Reconstituted Stability (Days) 25 ..." for all analytes. UTAK NR Metals Urine Control (Lot# D6251) and UTAK HR Metals Urine Control (Lot # D5343), "Store reconstituted control material at 2-8C (35- 46F). Reconstituted Stability (Days) 25 ..." for all analytes. 3. In an interview on 09/03 /2026 at 3:05 PM, the TS2 confirmed the findings stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Federal surveyor from the Centers for Medicare & Medicaid Services (CMS) Survey Branch conducted an initial survey at the NASA NUTRITIONAL BIOCHEMISTRY LABORATORY from December 3, 2024, to December 4, 2024. The laboratory was surveyed under 42 CFR part 493 CLIA regulations and found to be in compliance with condition level CLIA Requirements. The following standards level deficiencies were found on December 3, 2024. 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 chemicals in the laboratory and interview with the laboratory director (LD) and Technical Supervisor (TS) #2, the laboratory failed to label clinical chemicals with expiration dates for a sampling (8 of 8 bottle) of Sigma-Aldrich chemicals observed in the laboratory. Findings Include: 1. Observation of the laboratory on December 3, 2024 at 3:30 pm, revealed the following sampling of 8 out of 8 clinical chemicals without expiration dates: a. Three out of three bottles - Lanthanum oxide - batch#203556-100G b. One out of one bottle - Sodium Bicarbonate - Lot#20H0774 - opened March 31,1992. c. One out of one bottle - Sodium Phosphate dibasic - Lot#STBH2634 d. One out of one bottle - Sodium Tetraborate - batch# 028k0075 - received August 1,2008 e. One out of one bottle - Zinc Chloride - batch#206096-500Gf. One out of one bottle - Zinc Dust - Lot#2099- 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 -- 88-1009 - received October 13, 2008. 2. The LD and TS#2 confirmed the findings on December 3, 2024, at 3:35 pm, that the above chemicals used for clinical testing, did not have expiration dates. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Abbott i -stat procedure, review of the Abbott i-stat quality control (QC) records and interview with the laboratory director (LD) and Technical Supervisor (TS) #2, the laboratory failed to perform QC each day of patient testing for the Abbott i-stat GC8+ cartridges used to analyze Ionized Calcium for 11 out of 33 patients from September 28, 2023, to October 22, 2024. Findings Include: 1. Review of The Abbott i-stat procedure on December 3, 2024 at 12:30 pm, revealed the GC8+ cartridges used for Ionized Calcium are performed weekly. 2. The laboratory was unable to provide QC documentation for the Abbott i-stat GC8+ cartridges used to analyze Ionized Calcium performed each day of patient testing in 2023 and 2024. 3. From September 28, 2023, to October 22, 2024, the following 11 out of 33 patients were tested with the GC8+ cartridges used to analyze Ionized Calcium, when QC was not performed: a. 10/22/2024 - LIMS ID 98625 b. 10/17/2024 - LIMS ID 98624 c. 10 /02/2024 - LIMS ID 98328, LIMS ID98327 d. 08/20/2024 - LIMS ID 96753 e. 06/26 /2024 - LIMS ID 97590 f. 04/10/2023 - LIMS ID 96845 g. 04/09/2024 - LIMS ID 96837 h. 04/04/2024 - LIMS ID 96762 i. 04/03/2024 - LIMS ID 96761 j. 09/28/2023 - LIMS ID 95054 4. The LD and TS#2 confirmed the findings above on December 3, 2024, at 1:00 pm. D6126 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limted to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on review of testing personnel competency assessment records, and interview with the laboratory director (LD) and Technical Supervisor (TS) #2, the TS failed to assess 5 out of 6 testing personnel (TP) for problem-solving skills on all six-month competency assessments for each test system in 2024. Findings Include: 1. Review of the laboratory competency assessment records on 12/3/2024 at 9:30 revealed, 5 out of 6 TP were not assessed for problem-solving skill on their 6-month competency for each test system performed in the laboratory. The TS#2 signed the six-month competency assessment records on September 25, 2024. 2. The following tests are performed by the laboratory: a. ISTAT 1 Blood analyzer b. Atomic absorption Spectrophotometry - Perkin Elmer PinAAcle 500 c. ICP-MS - Perkin Elmer NexION 350D d. ELISA kit - Serum-Intact PTH EIA kit - Biomerica e. ELISA kit - QUIDEL MicroVue Bone BAP EIA f. ELISA Kit - Zeus ELISA NTX Urine Test g. ELISA Kit -- 2 of 3 -- - QUIDEL MicroVue Bone DPD h. ELISA kit - QUIDEL MicroVue Bone PYD EIA i. RIA kit - Osteocalcin 1 RIA kit- IBL America j. BNII System - Siemens Healthineers k. Dual Channel Ion Chromatography ICS600 - Thermo Fisher Scientific l. HPLC - Agilent 1260 Infinity II High-Performance Liquid Chromatography m. LC- MS/MS - Waters Quattro Micro Tandem Mass Spec with Electro Spray Ionization (ESI) n. Axcel - Alfa Wasserman 3. The LD and TS#2 confirmed the findings above on December 3, 2024, at 10:30 am. -- 3 of 3 --