Wasatch Pediatrics-Cottonwood

Summary Statement of Deficiencies 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 Record review and interview with Testing Personnel #1 (TP #1), the laboratory failed to twice annually evaluate the accuracy of their test system for direct bilirubin since the last survey conducted on 11/18/2020. The laboratory performs approximately 800 routine chemistry tests annually. Findings include: 1. Record review on 5/2/2023 at 10:20 AM, revealed that the laboratory failed to verify twice annually the accuracy of direct bilirubin since the last survey conducted on 11/18 /2020. 2. In an interview on 5/2/2023 at 10:25 AM, with TP #1 confirmed that direct bilirubin was not twice annually evaluated for accuracy. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of competency evaluation documentation and an interview with Testing Personnel #1 (TP #1), the laboratory failed to perform and document semi- annual competency evaluations since the last survey on 11/18/2020 for 4 of 4 Testing Personnel during their first year of performing moderately complex patient testing on the Piccolo chemistry analyzer. Findings include: 1. A review of competency 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 -- evaluation records at approximately 9:30 AM on 5/2/23 revealed that 4 of 4 TP did not have documentation of a semi-annual competency assessment during their first year of performing moderately complex patient testing on the Piccolo chemistry analyzer since last survey on 11/18/2020. 2. An interview with the TP #1 at approximately 9:35 AM on 5/2/23 confirmed that 4 of 4 TP reviewed since the last survey on 11/18/2020 did not have documentation of a semi-annual competency assessment during their first year of performing moderately complex patient testing on the Piccolo chemistry analyzer. -- 2 of 2 --

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on testing personnel credentials review,lack of documentation, and interivew with staff, one of seven new testing personnel lacked documentation to qualify as a moderate complexity testing person performing total and direct bilirubin tests. (See D6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: 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 -- Based on testing personnel credentials review,lack of documentation, and interivew with staff, one of seven new testing personnel lacked documentation to qualify as a moderate complexity testing person performing total and direct bilirubin tests. Findings include: 1. Educational credentials review for testing person E failed to include a high school diploma or GED, an Associates Degree, Bachelor's degree, Masters or Doctorate degree to qualify as a moderate complexity testing person. 2. In an interview with staff on 11/18/2020 at approximately 4:00 P.M. the laboratory manager confirmed testing person E did not currently possess a high school diploma and was in the process for obtaining a GED. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing records review and confirmation by staff, the laboratory failed to achieve successful proficiency testing participation for 1 of 1 test analyte Blood Urea Nitrogen, by failing to receive a score of greater than or equal to 80% for the 1st and 2nd American Association of Bioanalysts proficiency testing events of 2018. (See D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing records review and confirmation by staff, the laboratory failed to achieve successful proficiency testing performance for 1 of 1 test analytes, Blood Urea Nitrogen (BUN), by failing to receive a score of greater than or equal to 80% for the 1st and 2nd American Association of Bioanalysts (AAB) proficiency testing events of 2018. Findings include: 1. Proficiency testing records review included documentation the laboratory failed the 1st AAB proficiency test of 2018 (Q1) for BUN scoring 60%. The laboratory reported specimen #4 as 18 mg/dl and reported specimen #5 as 25 mg/dl. The acceptable range for specimen #4 was 19-23 mg/dl and for specimen #5 was 26-31 mg/dl. 2. Proficiency testing records review included documentation the laboratory failed the 2nd AAB proficiency test of 2018 (Q2) for BUN scoring 60%. The laboratory reported specimen #3 as 33 mg/dl and reported specimen #5 as 30 mg/dl. The acceptable range for specimen #3 was 34-41 mg/dl and for specimen #5 was 31-37 mg/dl. 3. In an interview conducted on 07/27 /2018 at approximately 11:00 A.M. staff confirmed the laboratory failed BUN proficiency tests in the 1st and 2nd AAB testing events. The laboratory performed approximately 0 to 4 BUN tests per month. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on procedure manual review, lack of documentation, and interview with staff, the laboratory director failed to sign and date as approved 1 of 3 test procedures reviewed, microscopic urinalysis, before use. The laboratory tested approximately 15 to 20 specimens per year. Findings include: 1. The procedure manual review for microscopic urinalysis failed to include the director's signature and date of approval for performing microscopic urinalysis. 2. In an interview 07/26/2018 at approximately 10:30 A.M., staff confirmed the procedure manual did not include the director's signature and date the microscopic procedure was approved. -- 2 of 2 --