Forest Park Pediatrics

Summary Statement of Deficiencies D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of lab director qualifications, and review of proficiency testing (PT), the laboratory failed to meet the condition of laboratory director (LD). The LD failed to ensure the required documentation to qualify the individual serving as laboratory director (Refer to D6003); and the LD failed to ensure an approved

Summary Statement of Deficiencies 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 review of the temperature log sheet, policies and interview with the practice manager, the laboratory failed to follow policy for room temperature for 113 out of 292 days. Findings: 1. Review of the policy, "Temperature Checklist 2023," states "correct temperature range in between 10C - 25C." 2. Review of the temperature log sheets from January 2022 to date May 26, 2023, showed the temperature did not fall within the stated parameters on log sheet. For the following days: 2022 February 17 March 2, 8, 10, 16, 18, 19, 23, 25, 29, and 31 April 9, 22, and 28 May 5, 11, 13, 14, 19, 28, and 31 June 4, 6, 7, 8, 9, 11, 12, 13, 15, 16, 17, 18, 23, 28, and 30 July 2, 5, 6, 7, 8, 9, 11, 12, 13, 14, 18, 19, 20, 21, 22, 28, 29, and 30 August 1, 2, 3, 8, 9, 12, 15, 19, 20, and 30 September 2, 3, 4, 5, 6, 10, 13, 14, 19, 20, 21, 22, 23, 24, 26, 27, and 28 October 1, 2, 4, 5, 6, 7, 13, 15, 24, 26, 27, and 31 November 1, 9, 15, 21, 23, 25, and 26 April 29 May 1, 2, 3, 4, 6, 8, 9, 10, 11, 19, 20, and 22 3. Interview with the practice manager on May 23, 2023 at 10:30 AM, confirmed the laboratory failed to follow policy for room temperature for 113 out of 292 days. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of TSA II 5% SB agar, Taxo A disc, policies, and interview with practice manager , the laboratory failed to check new lot numbers and shipments of TSA, Taxo A discs for positive and negative reactivity from 2021 to date May 23, 2023. findings: 1. Policy Comprehensive Quality Assurance Program states "inspect culture media on arrival of each shipment. Check plates from each batch or shipment of blood agar plates for signs of hemolysis, cracking, drying, contamination, freezing, excessive bubbles, and leaking. Record on TSA Media Quality Control Log the lot number, expiration date, and finding of media check. If media is visually acceptable upon arrival, store properly and use within expiration date. Let Lab Assistant know there are plates to QC. Once QC has been performed and is acceptable, Lab Assistant will write "QC" on stacks of plates to let everyone know they can now be used. 2. Laboratory had no documentation for positive and negative reactivity for Taxo A discs or TSA logs available for 2021 to date May 23, 2023. 2. Interview with the practice manager on May, 23, 2023 at 10:30 AM confirmed the laboratory failed to check new lot numbers and shipments of TSA, Taxo A discs for positive and negative reactivity from 2021 to date May 23, 2023. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of test reports and interview with the office manager, the laboratory failed to include the name and address of the location where the test was performed. Findings: 1. Review of patient test reports showed the laboratory failed to include the name and address of the location where the test was performed. 2. Interview with the office manager on February 26, 2019 at 3:00 PM confirmed the laboratory failed to include the name and address on the patient test report. 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 --