Kids Care Pediatric Associates Pc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of Standard Operating Procedures (SOPs), lack of temperature records, as well as interview with the Laboratory Director (LD), the laboratory failed to monitor and document temperature. FINDINGS: 1. There was no documentation of temperature for Throat Culture Incubator Boekel Serial Number (SN) 191263734 in the laboratory. 2. The Kids Care Pediatric Associates; PC SOPs did not include instructions for temperature monitoring and documentation of Throat Culture Incubator Boekel SN# 191263734. 3. The LD confirmed the findings on May 7, 2026, at approximately 10:00 A.M. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient 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 -- testing is conducted. This STANDARD is not met as evidenced by: Based on lack of SOPs, thermometer calibration records, as well an interview with the LD, the laboratory failed to define a function check protocol that ensures instrument performance that is necessary for accurate and reliable test results and result reporting. FINDINGS: 1. There was no documentation of calibration for the generic thermometer utilized for Throat Culture Incubator Boekel SN 191263734 in the laboratory. 2. The Kids Care Pediatric Associates, PC failed to draft and approve procedures for thermometer calibration. 3. The LD confirmed the findings on May 7, 2026, at approximately 10:30 A.M. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that-- This STANDARD is not met as evidenced by: Based on review of SOPs, lack of Proficiency Testing (PT) records, as well as interview with the LD, the LD failed to ensure that the laboratory is enrolled in an HHS approved PT program for the testing performed. FINDINGS: 1. There was no documentation of PT performance for calendar year 2025. 2. It was noted that Kids Care Pediatric Associates, PC enrolled in the College of American Pathologists (CAP) PT program in 2026. 3. The Kids Care Pediatric Associates, PC SOPs did not include instructions for enrollment and performance of PT. 4. The LD confirmed the findings on May 7, 2026, at approximately 11:30 A.M. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on the lack of Quality Assessment (QA) programs, the LD failed to ensure that the QA programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. Refer to 6015. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (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 analyzer manufacturer's requirements, laboratory Standard Operating Procedures (SOPs), as well as interview with Office Manager (OM), the laboratory failed to comply with analyzer manufacturer's requirements for humidity monitoring. FINDINGS: 1. Medonic M Series analyzer manufacturer's requirements specify humidity range of 10 - 90%. 2. There was no documentation of humidity monitoring from 2023 through survey date. 3. The current, approved SOPs did not include instructions for performing such activity. 4. OM confirmed the findings on May 28, 2025, at approximately 12:30 P.M. 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 lack of annual competency records for testing person (TP) #7, the laboratory failed to perform the 2022 annual competency for TP #7. Confirmed findings by interview with laboratory director (LD) on November 16, 2023, about 11:00 A.M. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of CAP PT reports, the laboratory failed to evaluate and document

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 Test (PT) desk review of the Center for Medicaid & Medicare Services (CMS) PT data reports and PT summary reports from College of American Pathologists CAP) PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte Hematocrit (HCT) The following scores were assigned: 2021 third event = 40% 2022 first event = 40% This is considered unsuccessful PT performance. Refer to D2130 D2130 HEMATOLOGY CFR(s): 493.851(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 in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports and PT summary reports from CAP PT program, the laboratory failed to participate successfully in CMS approved proficiency testing program, for the test analyte HCT The following scores were assigned: 2021 third event = 40% 2022 first event = 40% This is considered unsuccessful PT performance. 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 PT desk review of the CMS PT data reports and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the test analyte HCT Refer to D6016 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 PT desk review of the CMS PT data reports and the CAP PT summary reports, the laboratory director failed to fulfill the laboratory director's responsibilities to ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the test analyte HCT. The following scores were assigned: 2021 third event= 40% 2022 second event = 40% This is considered unsuccessful PT performance. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of Center for Medicaid and Medicare Service (CMS) PT data reports, the laboratory failed to enroll in an approved PT program for the specialty Hematology/Complete Blood Count (CBC) in the calendar year 2020. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. 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 PT desk review of the CMS PT data reports, the laboratory director failed to enroll the laboratory in an approved PT program for the specialty Hematology/CBC in the calendar year 2020. Refer to D2000. -- 2 of 2 --