Creative Testing Solutions

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 laboratory observation, a review of the laboratory procedure manual, a review of calibration verification documents, a lack of documentation, staff interview, and electronic mail (email) communication, the laboratory failed to follow the procedure for performing calibration verification at least every six months for the Alanine Aminotransferase (ALT) and Total Protein (TP) donor testing performed on the Abbott Architect C8000 instrument in 2024 and 2025, with a total of 320,528 ALT assays and 88,181 TP assays performed during the gaps in calibration verification. The findings include: 1. Laboratory observation on 08/20/25 at 9:15 a.m. revealed two Abbott Architect C8000 instruments used for performing ALT and TP on samples from plasma donors. 2. A review of the laboratory policy titled "ABBOTT ARCHITECT C8000 MAINTENANCE, CALIBRATION AND ADMINISTRATION" in section 5.4 titled "PROCEDURE-SEMI-ANNUAL LINEARITY/CALIBRATION VERIFICATION" revealed that "Linearity / Calibration Verification is to be performed at least once every six months according to laboratory schedule." 3. A review of the laboratory's calibration verification documentation for the ALT and TP assays performed on the Abbott Architect C8000 revealed the following dates when calibration verification for the ALT and TP was performed: ALT = 01/04/24, 10/11/24, 05/02/25 TP = 11/28/23, 10/11/24, 05/02/25 There was no documentation that calibration verification was performed for the ALT assay when it was due in July 2024 or in April 2025. There was no documentation that calibration verification was performed for the TP assay when it was due in May 2024 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 -- or in April 2025. 4. The Director of Operations confirmed the survey findings during an interview on 08/21/25 at 11:15 a.m. 5. A review of an email communication received from the Quality Site Manager on 09/03/25 at 7:21 a.m. revealed that a total of 320,528 ALT assays and a total of 88,181 TP assays were performed during the gaps in calibration verification. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on laboratory observation and staff interviews, the laboratory failed to label two of two controls used on the Abbott Architect C8000 that had been poured from the primary control bottle to a secondary container. The findings include: 1. Laboratory observation of the Abbott Architect C8000 area on 08/21/25 at 12:20 p.m. revealed two liquids in an instrument sample rack sitting in a tray in the refrigerator. The containers were not labeled. Testing person ten stated during the observation that the liquids in the rack were two levels of controls that were used on the Abbott Architect C8000 to perform quality control testing for the ALT and TP analytes. 2. The Director of Operations confirmed the survey findings during an interview on 08 /21/25 at 12:26 p.m. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: CITATION NUMBER ONE: Based on laboratory observation, review of validations, lack of documentation, staff interviews, and review of an electronic mail (email) communication, the laboratory failed to verify the manufacturer's performance specifications for precision for the revised Hepatitis C Virus (HCV) antibody test with approximately 2,074,613 donor tests performed since testing began on 08/19/24. The findings include: 1. Laboratory observation on 08/20/25 at 9:15 a.m. revealed multiple Abbott Alinity s instruments used for performing donor testing for HCV Antibody, Human Immunodeficiency Virus (HIV) Antigen and Antibody, Hepatitis B Surface Antigen (HBsAg) and Hepatitis B Surface Antigen (HBsAg) confirmatory testing. 2. A review of validations performed for a revised HCV Antibody method, approved for use on 08/19/24, revealed no documentation that the laboratory had verified the precision of the method in their laboratory. 3. The Director of Operations confirmed -- 2 of 3 -- the survey findings during an interview on 08/21/25 at 3:30 p.m. 4. The Director of Operations stated during a phone interview on 08/28/25 at 2:00 p.m. that the revised HCV assay was put into use for donor testing on 08/19/24. 5. A review of an email received on 08/28/25 at 3:45 p.m. from the Director of Operations revealed the total number of donor samples tested from the date the revised HCV antibody was put into use until the date of the survey was approximately 2,074,613. CITATION NUMBER TWO: Based on laboratory observation, a review of instrument validation data, and staff interviews, the laboratory failed to verify the manufacturer's claims for precision for the tests performed on two of two new Abbott Alinity s instruments put into use since the last survey date. The findings include: 1. Laboratory observation on 08/20 /25 at 9:15 a.m. revealed multiple Abbott Alinity s instruments used for performing donor testing for HCV Antibody, HIV Antigen and Antibody, HBsAg and HBsAg confirmatory testing. 2. A review of the instrument and method validations for serial numbers 1436 and 1437 revealed that the validation data had not been evaluated to verify laboratory performance for precision. 3. The Director of Operations confirmed the survey findings during an interview on 08/21/25 at 3:30 p.m. 4. The Director of Operations stated during a phone interview on 08/28/25 at 2:00 p.m. that instrument serial number 1436 was put into use on 05/03/24 and instrument serial number 1437 was put into use on 05/07/24. -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 review of the laboratory's College of American Pathologists (CAP) proficiency testing records and staff interview, the laboratory failed to ensure eight of seventy-five proficiency testing attestation statements from 2020, 2021, 2022, and 2023 were signed by the lab director or designee. The findings include: 1. Review of the laboratory's CAP proficiency testing records revealed the following attestation statements from 2022 that had not been signed by either the lab director or designee: Transfusion Medicine (Comp) J-A 2022 Transfusion Medicine (Automated) JAT-A 2022 Electrophoresis ELP-B 2022 Sickle Cell Screening SCS-B 2022 Red Blood Cell Antigen Typing RBCAT-B 2022 Nucleic Acid Testing NAT-B 2022 Infectious Disease Serology VR3-B 2022 Syphilis Serology G-C 2022 2. Interview with the quality manager on 06/07/23 at 1:40 pm confirmed the survey findings. 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 review of personnel records, lack of records, review of personnel policies, 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 -- and interview with the quality manager, the laboratory's personnel policy failed to be in compliance with the personnel regulations in Subpart M when it did not include a requirement for technical consultant, technical supervisor or general supervisor competency assessments. The findings include: 1. Review of personnel records revealed the following: Job description and delegation of lab director duties for technical consultant, technical supervisor and general supervisor to two persons. 2. No competency assessment for either of the two personnel who were delegated the duties of technical supervisor, general supervisor and technical consultant were available. 3. Review of the laboratory personnel policy revealed consultant/supervisor competency was not included as a requirement. 4. Interview with the quality manager on 06/07/23 at 1:40 pm confirmed the laboratory failed to have a policy that was in compliance with Subpart M when it did not include consultant/supervisor competency in its' personnel policies. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory inhouse test menu, lack of records, staff interview, and email communication, the laboratory failed to verify the accuracy of the Parvo B-19 and Hepatitis A virus testing twice a year in 2021 and 2022 with approximately 2,544,234 tests performed. The findings include: 1. Observation of the laboratory on 06/05/23 at 12:00 pm revealed the Grifols Procleix Panther system in use for performing Parvo B-19 and Hepatitis A virus testing. 2. Review of the laboratory inhouse test menu revealed the laboratory began testing on plasma donors for Parvo B-19 and Hepatitis A virus in August 2020. 3. No records for twice a year verification of accuracy were available on the date of the survey for 2021 and 2022. 4. Interview with the quality manager on 06/07/23 at 1:40 pm confirmed the laboratory failed to verify the accuracy of the Parvo B-19 and Hepatitis A testing performed on the Grifols Procleix Panther twice a year in 2021 and 2022. 5. Email communication with the quality manager on 06/16/23 at 9:02 am revealed the laboratory performed a total of approximately 2,544,234 tests for Parvo B-19 and Hepatitis A virus in 2021 and 2022. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected -- 2 of 4 -- by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of manufacturer package inserts, laboratory records and lack of records, test volumes and interview with the quality manager, the laboratory failed to perform calibration verification for the Alanine Transaminase (ALT) in 2023 and failed to perform calibration verification for the total protein in 2020, 2021, 2022, and 2023, with approximately 156, 683 donor tests for ALT performed during the gap in calibration verification and approximately 446,859 total protein donor tests performed. The findings include: 1. Observation of the laboratory on 06/05/23 at 12:00 pm revealed the Abbott Architect in use for performing ALT and the Roche Cobas in use for performing total protein. 2. Review of the manufacturer package inserts revealed the following: Calibration of the ALT is performed using one calibration point with water. Calibration of the Total Protein is performed using two calibration points. 3. Review of laboratory records revealed the following: Verification of calibration for the ALT was last performed during test validation on 09/21/22. The laboratory began donor testing for ALT on 02/04/23. No six month calibration verification for the ALT had been performed. Calibration verification for the Total Protein was last performed during install/validation on 02/10 /20. No six month calibration verification documents were available for 2020, 2021, 2022, and 2023. 4. Information provided by the quality manager revealed the following test volumes during the periods when calibration verification was not performed: ALT--Donor ALT performed from 03/21/23 to the date of the survey on 06 /07/23 was 156,683. Total Protein--Donor numbers tested in 2020, 2021, 2022, and 2023 were 446,859. 5. Interview with the quality manager on 06/07/23 at 1:40 pm confirmed the laboratory failed to perform six month calibration verification for the ALT performed on the Abbott Architect in 2023 and Total Protein performed on the Roche Cobas in 2020, 2021, 2022, and 2023. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory and staff interview during observation, lack of records, and interview with the quality manager, the laboratory failed to perform instrument to instrument, and method to method comparison twice a year for multiple instruments and test methods in use in 2020, 2021, 2022 and 2023. The findings include: 1. Observation of the laboratory on 06/05/23 at 12:00 pm and staff interview during observation revealed the following multiple instruments and test methods in -- 3 of 4 -- use that perform the same tests: Alanine Transaminase (ALT) performed on the Abbott Architect (C804904 and C804905). Syphilis testing performed on the ASI Evolution (instrument #s 2009, 1009, 1014, and 1013). Chagas and Hepatitis B Core Antibody performed on the Abbott Alinity S (instrument numbers AS1347 and AS1348.) Three Erytra instruments in use for performing ABO, Rhesus Factor (Rh), Rh Phenotype, and Kell antigen typing (instrument numbers 0991, 1444, 1678). Staff interview during the observation revealed that the laboratory also uses a manual gel method to verify the ABO if there is a discrepancy on the Erytra. 2. No records were available for twice a year comparison as follows: ALT performed on the Abbott Architect for 2023. Syphilis testing performed on the ASI Evolution multiple instruments in 2020, 2021, 2022, or 2023. Chagas and Hepatitis B Core antibody for 2022 or 2023. ABO, Rh, Rh Phenotype, and Kell antigen typing performed on multiple Erytra instruments in 2020, 2021, 2022 or 2023. Manual and automated ABO determination in 2020, 2021, 2022, and 2023. 3. Interview with the quality manager on 06/07/23 at 1:40 pm confirmed the survey findings. -- 4 of 4 --

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 review of the laboratory procedure manual, and interview with the quality assurance manager, the laboratory failed to have a procedure to include blind testing for assessing personnel competency in 2019. The findings include: 1) Review of the laboratory procedure manual revealed the laboratory policy and forms for documenting competency assessment did not include blind testing as part of the competency assessment procedure and documentation. 2) Interview on October 24, 2019 at 10:45 a.m. with the quality assurance manager confirmed the testing personnel competency procedure was not in compliance with the regulations as required by the Centers for Medicare and Medicaid Services (CMS) when blind testing was not included in the procedure or documentation in 2019. 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 --