Johnson County Pediatrics

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 review of the CMS-209 form, personnel records, and interview with testing personnel (TP) #3, the laboratory failed to have educational credentials required to qualify one of thirty TP to perform moderate complexity testing prior to reporting patient results (refer to 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 the review of the CMS 209 form, lack of educational credentials, reported patient results and interview with TP #3, the laboratory failed to have the educational credentials to qualify one of thirty TP to perform moderate complexity laboratory testing prior to reporting patient results. Findings: 1. The CMS 209 form provided at survey listed thirty moderate complexity TP. 2. No documentation of educational credentials for TP #20 was available for review at the time of survey. 3. TP #20 reported the following moderate complexity tests on patient samples: a Streptococcus Group A on 272 patients in the year 2022. b. Complete blood counts (CBC) which consist of red blood count, white blood count, hemoglobin, hematocrit, platelet and white blood cell differential for a total of 6 patent results per CBC reported. c. CBC panels reported in 2022 were 225 for a total of 1,350 patient results d. CBC panels reported in 2023 were 117 for a total of 702 patient results. 4. TP #20 reported 2,324 patient results from 1/31/22 to 4/8/23. 5. Interview with TP #3 on 9/19/23 at 2:40 p.m. confirmed the laboratory failed to have the educational credentials to qualify one of thirty TP to perform moderate complexity laboratory testing prior to reporting patient results. -- 2 of 2 --

Summary Statement of Deficiencies 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 a lack of available documentation and confirmed during interview with the technical consultant, the laboratory failed to have a procedure approved, signed, and dated by the laboratory director for use. Findings: 1. Upon review of the laboratory procedures, the laboratory director did not approve, sign, and date the laboratory procedure: "Presumptive Identification Of Beta Strep Group A" for Strep Selective Agar and Bacitracin Disc testing at time of survey. 2. Interview with the technical consultant on March 3, 2022 at 10:50 a.m. confirmed, the laboratory failed to have a procedure approved, signed, and dated by the laboratory director for use. 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 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 a review of laboratory personnel procedures, competency records and staff interview, the laboratory failed to define by policy/procedure the manner in which competency was assessed for testing personnel. Findings include: 1. A review of the laboratory's policies/procedures showed the laboratory failed to have the six required procedures in their competency assessment for 14 0f 14 testing personnel in 2019 2. Upon review of the competency assessment documentation from 2018-2019 for testing personnel, the forms included only two to four of the six required procedures. 3. Interview with the Technical Consultant #1 on 10/30/2019 at 11:20 am confirmed the laboratory failed to define and use the six required procedures in their competency assessment. 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 D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)