Summary:
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 laboratory's policies and procedures and interview with the office administrator, the laboratory failed to have a written policy to assess laboratory personnel competency. Findings include: 1. Upon requesting the laboratory's procedure for assessing laboratory personnel, none could be produced. 2. Interview with the office administrator at 2:00pm on 03/17/2026 confirmed there was no policy for assessing laboratory personnel. 3. The laboratory performs 100 moderate complexity tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the maintenance records for the Abbott iSTAT analyzer, review of the Abbott iSTAT procedure and interview with testing personnel (TP), the laboratory failed to ensure manufacturer's guidelines for semi-annual maintenance was being performed and documented. Findings include: 1. Upon request for the iSTAT semi- annual maintenance documentation none could be produced. 2. Review of the laboratory's iSTAT procedure lacked any instruction on performing the required semi- 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 -- annual thermal probe check maintenance. 3. Interview with TP #1 at 1:30pm on 03/17 /2026 confirmed findings. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on review of Quality Control (QC) records, review of the Individualized Quality Control Plan (IQCP) policy for the Abbott iSTAT analyzer and interview with testing personnel (TP), it was revealed that QC was not being performed and documented at the frequency established by the laboratory. Findings include: 1. Upon request for documentation of QC performed on the iSTAT analyzer, none could be produced. 2. Upon review of the laboratory's IQCP policy, the established QC frequency for the iSTAT analyzer was not being followed. 3. Interview with TP #1 at 1:30pm on 03/17/2026 confirmed the findings. 4. The laboratory performs 100 iSTAT tests annually. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) (e)(4)(iv) An approved