Color Country Pediatrics

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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: . Based on record review and interview with the technical consultant (TC), the laboratory failed to perform proficiency testing (PT) using the laboratory's routine methods by not having all testing personnel (TP) perform PT. The laboratory performed approximately 7,500 hematology tests a year. . Findings include: 1. Review of CMS-209 Laboratory Personnel Form showed the laboratory had nine TP that performed hematology testing. 2. PT record review revealed that the laboratory TC performed PT for three out of three American Proficiency Institute (API) hematology /coagulation events in 2023 and three out of three API PT hematology/coagulation events in 2024. 3. In an interview on 04/23/2025 at 12:20 PM, the TC confirmed that not all hematology TP performed PT. . D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. 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 -- This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory director failed to delegate, in writing, the duties and responsibilities to each person involved in all phases of the testing process. The laboratory performed approximately 7,500 hematology tests a year. . Findings include: 1. Record review of American Proficiency Institute proficiency testing (PT) performance review and

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)

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 results review and confirmation from American Proficiency Institute (API) on 8/16/21, the laboratory failed to achieve successful participation in two out of three consecutive events for Bacteriology proficiency testing performance. (seeD2025). D2025 BACTERIOLOGY CFR(s): 493.823(c) Failure to return proficiency testing results to the proficiency testing program within 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 time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on proficiency testing results review and confirmation from American Proficiency Institute (API), the laboratory failed to submit proficiency testing (PT) results to the proficiency testing program (API) within the time frame specified for two out of three consecutive PT events for Bacteriology. Findings include: 1. API summary report included documedntation that the laboratory failed Bacteriology proficiency testing for two out of three consecutive events (third PT event of 2020 and second PT event of 2021), with scores of 0% and 0%. 2. API summary report ncluded a note for both the third PT testing event of 2020 and second PT testing event of 2021 of "failure to participate". -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation, and interview with staff, the laboratory failed to retain six of six American Proficiency Institute, (API) bacteriology signed and dated attestation statements for at least two years. Findings include: 1. Proficiency testing record review failed to include the signed and dated statements that the testing person and laboratory director attest to the fact the laboratory performed API proficiency testing from Group A Streptococcus (GAS) the same as patient tests for 2019 and 2020 tests performed. 2. In interview conducted on 11/20/2020 at approximately 2:00 P.M., the laboratory technical consultant and manager confirmed the laboratory did not have signed and dated attestation statements for Bacteriology API proficiency tests. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including 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 -- instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on patient and quality control records review lack of documentation and interview with staff, the laboratory failed to retain the Solana instrument printouts for molecular Group A Streptococcus (Strep) detection from throat swabs for at least two years. The laboratory performed approximately 40 tests per year in 2018 and 2019. Findings include: 1. The laboratory patient test records for Solana Group A Strep failed to include the cartridge sticker label (printout) from the Solana test system for patient DOB 02152019 for a Group A Strep performed on 05/13/2019. 2. Interview conducted on 11/20/2020 at approximately 3:30 P.M. with the laboratory manager /technical consultant confirmed the laboratory discontinued retaining the printouts for patient DOB 02152019. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on Individualized Quality Control Plan (IQCP) review, lack of documentation, and interview with staff, the laboratory director failed to review the IQCP at least annually for Solana molecular Streptococcus testing in 2019. The laboratory has temporarily discontinued Solana Strep testing since March 2020. The laboratory performed approximately 40 tests per year before suspending the test. Findings include: 1. IQCP review lacked documentation the director had reviewed the plan, quality control performance, proficiency testing results, reagent storage and testing environmental situations (such as contaminaton), to ensure patient test were not affected by changes to the system and the decreased frequency of control performance in 2019. 2. In an interview conducted on 11/20/2020 at approximately 3:30 P.M. staff confirmed the lab suspended testing in 2020 but did not document the IQCP was evaluated at least annually in 2019 to identify problems that may require more frequent quality control performance. 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 educational records review, lack of documentation, and interview with staff, one of six new moderate complexity testing personnel failed to have educational documentation to qualify as a moderate complexity testing person. (See D6065.)_ -- 2 of 3 -- 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: Based on testing personnel educational records review, lack of documentation, and interview with staff, one of six new moderate complexity testing personnel failed to have educational documentation to qualify as a moderate complexity testing person. (New Test Person A). Findings include: 1. Personnel educational records review failed to include a high school diploma or transcript, a GED, an Associates, Bachelor's, Masters' or Doctorate Degree (or transcript) for 1 of 6 new testing personnel. 2. In an interview with the laboratory manager on 11/20/2020 at approximately 2:30 P.M. staff confirmed test person A did not have a copy of their highest diploma in the laboratory testing personnel credential records. -- 3 of 3 --

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 lack of documentation, patient test records review, and interview with staff, the laboratory failed to enroll in proficiency testing for the specialty of bacteriology prior to the survey date for 1 of 1 new bacteriology test performed, Solana Group A Streptococci testing. The Laboratory performed approximately 5 tests per week. Findings include: 1. The laboratory began testing for the confirmation of Group A Streptococci (Strep) December 18, 2017. 2. The laboratory failed to enroll in proficiency testing by 01/29/2018. 3. In an interview with the director on 01/29/2018 at approximately 3:15 P.M. staff confirmed the laboratory had not enrolled in proficiency testing for 2018 for Group A Strep testing performed using the Solana test system. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the 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 -- manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on Solana Group A Streptococci (GAS) test verification documentation, lack of documentation, patient test record review, and interview with staff, the laboratory failed to verify Group A detection precision for 1 of 1 new test systems reviewed. The laboratory performed approximately 5 tests per week. Findings include: 1. New test verification documentation failed to include the laboratory verified the Solana test system was capable of reproducing positive and negative test results to verify GAS test precision. 2. Patient test record reviewer included documentation the laboratory tested patient 16020328109802 on 01/25/2018. 3. In an interview with the director on 01/29/2018 at approximately 3:00 P.M. the director confirmed they had not verified test precision by testing positive and negative tests more than once. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control record review, lack of an approved Individualized Quality Control Plan (IQCP), and interview with the director, the laboratory failed to perform two levels of quality control each day of Solana Group A Streptococci (GAS) for 1 of 1 day of testing reviewed. The laboratory performed approximately 5 tests per week. Findings include: 1. Quality control records review failed to include the laboratory failed to document a positive and negative control each day of testing for testing performed on 01/25/2018 for patient # 16020328109802. 2. The laboratory failed to have an approved IQCP for Solana GAS to verify reduced quality control frequency. 3. In an interview with staff on 01/29/2018 at approximately 3:00 P.M. the director stated the laboratory did not have an IQCP that included a risk assessment, quality control plan and quality assessment plan to verify reduced quality control frequency . -- 2 of 2 --