Summary:
Summary Statement of Deficiencies D0000 A Federal Surveyor from the Division of Clinical Laboratory Improvement and Quality (DCLIQ) Survey Branch conducted an onsite validation survey on 09/01 /2026. The laboratory was found to be in compliance with condition--level deficiencies. The following standard-level deficiencies were cited. 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 interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory temperature logs, and an interview with the Technical Consultant #2 (TC2), the laboratory failed to establish and monitor a normal room temperature range consistent with the manufacturer's requirements for 258 out of 258 blood collection tubes. 1. During a tour of the main laboratory on 09/01 /2026 at 3:30 PM, the following blood collection tubes were observed stored in a cupboard for use with a manufacturer's storage temperature requirement of 4C to 25C: BD Vacutainer - Serum Lot #: 5260139 Expiration Date: 2027-09-30 Quantity = 38 tubes BD Vacutainer - Serum Separator Tube (SST) Lot #: 6047573 Expiration Date: 2027-02-28 Quantity = 47 tubes BD Vacutainer - Sodium Floride Lot #: 5350931 Expiration Date: 2027-04-30 Quantity = 100 tubes BD Vacutainer - Ethylenediaminetetrraacetic Acid (EDTA) Lot #: 5351561 Expiration Date: 2027-04- 30 Quantity = 49 tubes BD Vacutainer - Acid Citrate Dextrose Solution A (ACD-A) 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 -- Lot #: 5015942 Expiration Date: 2027-01-31 Quantity = 24 tubes 2. A review of the main laboratory room temperature log sheets revealed an acceptable room temperature range of 18C to 28C and the following 25 days where the room temperature exceeded 25C: Date Room Temperature 01/22/2025 27C 03/10/2025 28C 03/26-28/2025 26C 04 /13/2025 26C 04/23/2025 26C 11/18/2025 28C 05/02/2026 26C 05/05-06/2026 26C 06/06-08/2026 26C 06/09/2026 27C 06/10-11/2026 28C 06/12-13/2026 26C 06/15-16 /2026 26C 07/09/2026 26C 07/11/2026 26C 07/13-14/2026 26C 3. In an interview on 09/01/2026 at 3:30 PM, the TC2 confirmed the findings stated above. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of laboratory test reports and an interview with the Technical Consultant #2 (TC2), the laboratory failed to include the specimen source in 6 out of 6 laboratory test reports. 1. A review of the following 6 randomly selected laboratory test results revealed no specimen source was identified in the test reports: ACCT# 2601918 Collection Date & Time: 06/25/2026 @ 0714 Report Date & Time: 06/25 /2026 @ 1116 Test Ordered: Basic Metabolic Panel (BMP) ACCT# 2502562 Collection Date & Time: 10/31/2025 @ 0740 Report Date & Time: 10/31/2025 @ 1417 Test(s) Ordered: Comprehensive Metabolic Panel (CMP) and Valproic Acid ACCT# 2600593 Collection Date & Time: 02/28/2026 @ 1230 Report Date & Time: 02/28/2026 @ 1307 Test Ordered: Hepatic Function Panel ACCT# 2601553 Collection Date & Time: 06/25/2026 @ 1237 Report Date & Time: 06/25/2026 @ 1346 Test Ordered: CBC with Differential ACCT# 2502864 Collection Date & Time: 02/28/2026 @ 0958 Report Date & Time: 02/28/2026 @1044 Test Ordered: CBC with Differential ACCT# 2502163 Collection Date & Time: 10/30/2025 @ 1311 Report Date & Time: 10/30/2025 @ 1345 Test Ordered: CBC with Differential 2. In an interview on 09/01/2026 at 3:50 PM, the TC2 confirmed the findings stated above. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of the laboratory test method verification policy, laboratory test reports, and an interview with the Technical Consultant #2 (TC2), the laboratory failed to report reference ranges consistent with its verified reference ranges for three of three laboratory test reports reviewed. 1. In reviewing the Laboratory Policy # -- 2 of 3 -- ACH LSS 920 006, Appendix D - Beckman Coulter DxC 500 Chemistry Analyzer Test Method Verification, pages 11-12, the following test names and reference intervals were stated: Test Name Reference Range Sodium 136-145 mmol/L Potassium 3.5-5.1 mmol/L Chloride 98-107 mmol/L Calcium 8.6-10.3 mg/dl Total Protein 6.0-8.3 g/dl Albumin 3.5-5.7 g/dl AST 19-39 U/L 2. In reviewing three randomly selected chemistry test reports, the following reference ranges were reported: Acct# 2601918 Report Date & Time: 06/25/2026 @ 1116 Sodium: Reference Range = 134-144 mmol/L Potassium: Reference Range = 3.5-5.2 mmol/L Chloride: Reference Range = 96-106 mmol/L Calcium: Reference Range = 8-10 mg /dl ACCT# 2502562 Report Date & Time: 10/31/2025 @ 1417 Sodium: Reference Range = 134-144 mmol/L Potassium: Reference Range = 3.5-5.2 mmol/L Chloride: Reference Range = 96-106 mmol/L Calcium: Reference Range = 8-10 mg/dl Total Protein: Reference Range = 6.4-8.9 g/dl Albumin: Reference Range = 3.7-5.7 g/dl AST: Reference Range = 13-39 IU/L ACCT# 2600593 Report Date & Time: 02/28 /2026 @ 1307 Total Protein: Reference Range = 6.4-8.9 g/dl Albumin: Reference Range = 3.7-5.7 g/dl AST: Reference Range = 13-39 IU/L 3. In an interview on 09/01 /2026 at 3:50 PM, the TC2 confirmed the findings stated above. -- 3 of 3 --