Summary:
Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the laboratory failed to achieve College of American Pathologists (CAP) proficiency testing (PT) scores of at least 80% (percent) for iron in one out of three testing events in 2024 and total bilirubin (tbil) in one out of three testing events in 2025 in the specialty of Chemistry resulting in unsatisfactory analyte performance. Findings Include: 1. Review of the laboratory's 2024 and 2025 CAP Chemistry PT documentation, provided on the date of the inspection, found iron was scored 40% for the first testing event of 2024 and tbil was scored 40% for the second testing event of 2025. 2. Further review of the laboratory's 2024 and 2025 CAP PT documentation of the unsatisfactory iron and tbil results revealed the unacceptable PT challenges were re-run and within acceptable limits. 3. TP#1 confirmed, on 4/15/2026 at 2:15 PM, the unacceptable iron and tbil PT scores. 4. This deficient practice had the potential to affect 1,912 patient iron tests performed between the third testing event of 2023 and the second testing event of 2024 (09/2023-05/2024) and 6,294 patient tbil tests performed between the first and third testing events of 2025 (03/2025-09/2025). D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- retain the following: This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the laboratory failed to retain analytic system activity records, including patient test records for the Architect Ci4100 Chemistry analyzer test system for the past two years with the implementation of the new instrument in January 2024. This deficient practice affected 536,102 out of 577,340 patient chemistry test results between 01/04 /2024 through 04/15/2026. Findings Include: 1. Review of all of the laboratory's policies and procedures and the "Procedure for Architect Ci4100", approved via signature and date by the Laboratory Director on 09/12/2019, did not find any mention of archive and retention requirements for the Architect Ci4100 analytic system activity. 2. Review of the laboratory's volume of patient test records revealed the laboratory completed a total of 577,340 patient chemistry test results on the Architect Ci4100 instrument between 01/04/2024 through 04/15/2026. 3. The Inspector requested the laboratory's approved record retention policy and procedure and their 2024, 2025 and 2026 Architect Ci4100 instrument patient records from TP#1. TP#1 confirmed the laboratory did not establish a record retention policy and procedure, did not routinely print patient instrument results and the Architect Ci4100 software system only retains up to 50,000 analyte results then overwrites them by first in first out. TP#1 further confirmed they were unable to access or retrieve any of the 536,102 patient results from the instrument prior to March 5, 2026 and was unable to provide at least the prior two years of patient instrument results. The interview occurred on 04/30/2026 via a telephone conversation at 10:01 AM. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) (a)(3)(i) Records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on record review and an interview with Testing Personnel (TP) #1, the laboratory failed to retain analytic system activity records for the Architect Ci4100 Chemistry analyzer test system for the past two years, to include the test system performance specification raw data conducted in January 2024 with the implementation of the new instrument since the last CLIA inspection on 11/08/2023. This deficient practice had the potential to affect 536,102 out of 577,340 patient chemistry test results between 01/04/2024 through 04/15/2026. Findings Include: 1. Review of all of the laboratory's policies and procedures and the "Procedure for Architect Ci4100", approved via signature and date by the Laboratory Director on 09 /12/2019, did not find any mention of archive and retention requirements for the Architect Ci4100 analytic system activity. 2. Review of laboratory volume test records revealed the laboratory completed a total of 577,340 patient chemistry test results on the Architect Ci4100 instrument between 01/04/2024 through 04/15/2026. 3. The Inspector requested the laboratory's 2024 performance specification raw data from the newly installed Architect Ci4100 conducted prior to patient test implementation on 01/04/2024 from TP#1. TP#1 was unable to locate the printed documentation in the laboratory records, from the installation vendor nor the instrument archived data prior to March 5, 2026. TP#1 further confirmed the -- 2 of 5 -- laboratory did not routinely print instrument results and the Architect Ci4100 software system only retains up to 50,000 analyte results then overwrites them by first in first out. TP#1 was unable to provide the requested documentation within 15 days from the date of the inspection. The interview occurred on 04/30/2026 via a telephone conversation at 10:01 AM. 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 an interview with Testing Personnel (TP) #1, the laboratory failed to establish and follow written policies and procedures to assess the competency of three out of three of the Technical Consultants (TC) based on the responsibilities of the position for moderate complexity routine chemistry, endocrinology and hematology testing procedures performed. Findings Include: 1. Review of the laboratory's Form CMS-209, approved via signature and date by the Laboratory Director on 03/31/2026 and provided on the date of the inspection, revealed three out of three qualified and listed individuals to function as TC's for the moderate complexity chemistry, endocrinology and hematology testing procedures performed. 2. Review of all of the laboratory's policies and procedures provided on the date of the inspection revealed no policy and procedure to conduct TC competency assessments based on the CLIA responsibilities of the position. 3. Review of the laboratory's 2024, 2025 and 2026 competency assessment documentation did not find any competency assessment documentation based on the TC responsibilities for TC#1, TC#2 or TC#3. 4. The Inspector requested the laboratory's approved competency assessment policy and procedure based on the responsibilities of the TC and the 2024, 2025 and 2026 TC competency assessment documentation from TP#1. TP#1 confirmed the laboratory did not establish a policy and procedure to assess the TC's based on the responsibilities of the position and did not conduct competency assessments on TC#1, TC#2 and TC#3 in 2024, 2025 and 2026. TP#1 was unable to provide the requested documentation on the date of the inspection. The interview occurred on 04/15/2026 at 1:40 PM. 5. Review of laboratory test records revealed 835,020 patient test results reported between 11/08/2023 and 04/15/2026. D5781