Pediatric Associates Mont County

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: A. Based on record review, the laboratory did not document the testing of proficiency test (PT) samples to show that the testing person performing and reporting hematology proficiency test results to the proficiency test provider for evaluation did not compare their test results with test results from other staff prior to submitting their results for evaluation. Findings: 1. Testing person A submitted their proficiency testing results for evaluation by the proficiency test provider on November 9, 2022 (3rd PT event of 2022), and submitted the results to the PT provider on November 17, 2022, but on that same day two other staff members tested the same proficiency test samples and another staff member tested the samples on November 15, 2022. There was no record to show that testing person A submitted their test results for evaluation without comparing their results with those of the other three staff members. 2. There was no written procedure to ensure that the testing person submitting their proficiency test results to the PT provider did not compare their test results with results obtained from other staff. 3. The technical consultant confirmed that the laboratory politicizes did not ensure PT test results were not compared prior to submission for evaluation by the PT provider. B. Based on record review and interview, the laboratory did not rotate proficiency testing among testing personnel. Findings: 1. Testing person A tested and reported hematology results for all three proficiency test events in 2022 and two proficiency test events in 2023. The testing was not rotated among other testing personnel. 2. The technical consultant confirmed that the proficiency testing was not rotated among all testing staff during interview on the afternoon of the of the survey. 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 --

Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the duties and responsibilities, monthly quality assurance (QA) review worksheets, proficiency testing (PT) records, quality control (QC) records, and interview with the technical consultant (TC), the laboratory director (LD) failed to be actively involved in the operation of the laboratory by assuring that others are performing the delegated duties and responsibilities. Findings: 1. The "Clinical Consultant Duties and Responsibilities" procedure identifies a Clinical Consultant (CC) who acts as the assistant lab director. According to the procedure the CC "is actively involved in monitoring the laboratory's Quality Assurance, Quality Control and Proficiency Testing programs." The CLIA regulations do not recognize the position of an assistant lab director under the moderate or high complexity testing personnel requirements. 2. The monthly QA review records and QC graphs for 2021 and 2020 were reviewed. The review signatures included the TC, CC, and testing personnel but not the LD. 3. During the survey on 08/16/2021 at 12:30 PM, the TC confirmed that the LD does not document review of the QA reviews, PT, and QC records. This is done by the CC who is not qualified as a LD (have at least 20 continuing medical education credit hours in laboratory practice commensurate with 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 director responsibilities defined in 493.1407) and does not provide the LD with a documented summary of the QA reviews. The LD delegated duties and responsibilities and failed to ensure that all duties were properly performed on a routine basis by reviewing the monthly summary provided by the TC. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the hematology patient log and interview with the technical consultant (TC), the laboratory director failed to ensure that written instructions were provided to the testing personnel for recording proficiency testing (PT) samples on the patient log in the same manner as the patient specimens. Findings: 1. Review of the hematology procedure manual showed that the PT procedures did not instruct the testing personnel to record the PT results on the patient logs in the same manner as the patient specimens. 2. During the survey on 08/18/2021 at 11:30 AM, the TC that the hematology procedure manual did not provide instruction to the testing personnel for recording the PT samples on the hematology patient log in the same manner as the patient specimens. -- 2 of 2 --

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 competency check evaluations and interview, the laboratory (lab) did not perform competency checks for the technical consultant. Findings: 1. The competency check assessments performed by the labs technical consultant were reviewed and these records did not include the directors assessment of the technical consultant: and 2. During interview on the morning of the day of survey, the technical consultant stated that the lab director did not perform competency assessments for her duties as technical consultant. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on record review and interview, the lab did not perform parallel quality control checks prior to placing a new lot number of control reagent in use in order to verify the manufacturer's stated values for each level of control (low, normal and high) when tested alongside the previous lot number of control reagent. Findings: 1. The test lab 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 -- records did not include parallel quality control testing; and 2. The technical consultant stated that the lab did not perform parallel quality control checks. -- 2 of 2 --