Rainbow Pediatrics Inc

Summary Statement of Deficiencies D0000 A routine recertification survey was completed at Rainbow Pediatrics Inc. on November 18, 2025, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. Specific deficiencies cited are explained below. 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 two 2025 American Proficiency Institute (API) proficiency testing (PT) records, lack of documentation, and interview with laboratory testing personnel (TP1), the laboratory failed to document the evaluation of a less than 100% performance for erythrocyte count (#0775 RBC) in the second PT event of 2025 in hematology. Findings: 1. Review of two API PT evaluation reports for 2025 revealed an 80% performance for erythrocyte count (#0775 RBC) in hematology event 2 of 2025. PT Specimen HEM-07 had a reported result outside the acceptable range and scored by API as unacceptable. 2. No documented evaluation of the less than 100% performance for erythrocyte count (#0775 RBC) could be located. 3. During an interview 11/18/25 at 9:30 AM, TP1 verified that no documented evaluation of the 80% performance for erythrocyte count (#0775 RBC) could be located. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 review of the hematology instrument operator's manual, eleven 2025 monthly maintenance logs for the analyzer, lack of documentation, current CMS-209 form, and interview with two laboratory testing personnel (TP1 and TP2), the laboratory testing personnel (TP1 and TP2) failed to document whether a weekly maintenance procedure required by the manufacturer of the Horiba Micros 60 hematology analyzer was performed from January 2025 through the date of the survey. Findings: 1. Review of the Horiba Micros 60 operator manual identified a required maintenance protocol stating "weekly maintenance is to perform a concentrated cleaning with Minoclair". 2. Review of the Horiba Micros 60 analyzer monthly maintenance logs (January 2025 thru date of survey) revealed a specific area for recording the performance of a concentrated cleaning on a weekly basis. The weekly performance of a concentrated cleaning with Minoclair was not documented on 11 of 11 monthly maintenance logs reviewed. No other documentation indicating that the weekly concentrated cleaning had been performed could be located. 3. Review of the current laboratory CMS-209 form identified TP1 and TP2 as current testing personnel. 4. During an interview 11/18/2025 at 10:30 AM, TP1 and TP2 verified that the performance of the weekly concentrated cleaning had not been documented on the monthly maintenance logs for the Horiba Micros 60 analyzer. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Rainbow Pediatrics on October 21, 2021, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to attain a satisfactory performance score for platelets in 1 of 2 American Proficiency Institute (API) proficiency testing (PT) events in 2021. Findings: 1. Pre-Survey review of CASPER 155D Report for the laboratory identified an unsatisfactory score of 60% for analyte 0815 Platelets in Hematology PT 1st event 2021. 2. Review of API records confirmed the unsatisfactory performance score; Hematology event 1 2021 0815 Platelets- 60% 3. An interview with the laboratory manager, 10/21/21 at approximately 9:00 AM, confirmed the findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number 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 -- and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform and document 3 levels of daily quality control (QC) for the Horibas hematology analyzer for 10 of 61 days of patient testing. Findings: 1. Review of three random, daily task report logs identified 61 days of patient testing in January 2021, February 2021, and September 2021. 2. Review of daily QC logs for January 2021, February 2021, and September 2021 identified 10 days no daily QC was documented. 3. An interview with the laboratory manager, 10/21/21 at approximately 9:45 AM, confirmed the findings. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of written policies and procedures (P&P), lack of documentation, and interview the laboratory failed to (g) document the verification of new lots of quality control materials for the Horibas hematology analyzer in 2020 and 2021. Findings: 1. Review of P&P identified a "Procedure for Change in Lot of Assayed Control Materials" which states "Each level of the new control material must be evaluated five times, with alternating personnel and on multiple days when possible, to verify that control results fall within manufacturer stated 2SD ranges" 2. No documentation of the verification of new lots could be located for 2020 or 2021. 3. An interview with he laboratory manager, 10/21/21 at approximately 10:15 AM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute proficiency testing (PT) records and an interview with Testing Personnel 1 (TP1), the Laboratory Director (LD) failed to sign the attestation statements for 3 of 5 proficiency testing events participated in 2018 and 2019. Findings: 1. Review of the laboratory's 2018 PT events, identified the LD did not sign 1 of 3 attestation statements. The 3rd event in Hematology and Coagulation of 2018 had no LD signature on the attestation statement. 2. Review of the laboratory's 2019 PT events, identified the LD did not sign 2 of 2 attestation statements. The 1st and 2nd events in Hematology and Coagulation of 2019 had no LD signature on the attestation statements. 3. An interview with TP1, on 8/20/19 at approximately 10:00 AM, confirmed that the LD had not signed the attestation statements. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with Testing Personnel 1 (TP1), TP1 had continued performing laboratory testing with an expired West 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 -- Virginia laboratory license. Findings: 1. TP1 was found to have an expired West Virginia laboratory license required by WV 64 CSR 57, Clinical Laboratory Technician and Scientist Licensure and Certification Rule. 2. An interview with TP1, on 8/20/19 at approximately 9:00 AM, confirmed that testing was still being performed with an expired license. -- 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 review of American Proficiency Institute (API) proficiency testing records and CASPER 153D and 155D reports, the laboratory failed to successfully participate in an approved proficiency testing program. Findings: 1. CASPER report 153D, run 6 /3/2019, demonstrated a failure for the laboratory under analyte 0765. 2. CASPER report 155D, run 6/3/2019, demonstrated the following unsatisfactory proficiency testing (PT) scores: a. Hematology Event 3 of 2018 i. 73% for analyte 0765, Cell ID or WBC diff b. Hematology Event 1 of 2019 i. 62% for analyte 0760, hematology overall ii. 73% for analyte 0765, Cell ID or WBC diff iii. 60% for each of the following analytes A. 0775, RBC B. 0785, HCT C. 0795, HGB D. 0805, WBC E. 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 -- 0815, PLATELETS 3. The API Comparative Evaluations for 2018 event 3 and 2019 event 1 confirm the findings on the CASPER reports. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing records and CASPER 153D and 155D reports, the laboratory failed to successfully participate in an approved proficiency testing program. Findings: 1. CASPER report 153D, run 6 /3/2019, demonstrated a failure for the laboratory under analyte 0765. 2. CASPER report 155D, run 6/3/2019, demonstrated the following unsatisfactory proficiency testing (PT) scores: a. Hematology Event 3 of 2018 i. 73% for analyte 0765, Cell ID or WBC diff b. Hematology Event 1 of 2019 i. 62% for analyte 0760, hematology overall ii. 73% for analyte 0765, Cell ID or WBC diff iii. 60% for each of the following analytes A. 0775, RBC B. 0785, HCT C. 0795, HGB D. 0805, WBC E. 0815, PLATELETS 3. The API Comparative Evaluations for 2018 event 3 and 2019 event 1 confirm the findings on the CASPER reports. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 review of American Proficiency Institute (API) proficiency testing records and CASPER 153D and 155D reports, the laboratory failed to successfully participate in an approved proficiency testing program. Findings: 1. CASPER report 153D, run 6 /3/2019, demonstrated a failure for the laboratory under analyte 0765. 2. CASPER report 155D, run 6/3/2019, demonstrated the following unsatisfactory proficiency testing (PT) scores: a. Hematology Event 3 of 2018 i. 73% for analyte 0765, Cell ID or WBC diff b. Hematology Event 1 of 2019 i. 62% for analyte 0760, hematology overall ii. 73% for analyte 0765, Cell ID or WBC diff iii. 60% for each of the following analytes A. 0775, RBC B. 0785, HCT C. 0795, HGB D. 0805, WBC E. 0815, PLATELETS 3. The API Comparative Evaluations for 2018 event 3 and 2019 event 1 confirm the findings on the CASPER reports. 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 -- 2 of 3 -- with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing records and CASPER 153D and 155D reports, the laboratory director failed to ensure successful participation in an approved proficiency testing program. Findings: 1. CASPER report 153D, run 6/3/2019, demonstrated a failure for the laboratory under analyte 0765. 2. CASPER report 155D, run 6/3/2019, demonstrated the following unsatisfactory proficiency testing (PT) scores: a. Hematology Event 3 of 2018 i. 73% for analyte 0765, Cell ID or WBC diff b. Hematology Event 1 of 2019 i. 62% for analyte 0760, hematology overall ii. 73% for analyte 0765, Cell ID or WBC diff iii. 60% for each of the following analytes A. 0775, RBC B. 0785, HCT C. 0795, HGB D. 0805, WBC E. 0815, PLATELETS 3. The API Comparative Evaluations for 2018 event 3 and 2019 event 1 confirm the findings on the CASPER reports. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing records and CASPER 153D and 155D reports, the laboratory director failed to ensure successful participation in an approved proficiency testing program. Findings: 1. CASPER report 153D, run 6/3/2019, demonstrated a failure for the laboratory under analyte 0765. 2. CASPER report 155D, run 6/3/2019, demonstrated the following unsatisfactory proficiency testing (PT) scores: a. Hematology Event 3 of 2018 i. 73% for analyte 0765, Cell ID or WBC diff b. Hematology Event 1 of 2019 i. 62% for analyte 0760, hematology overall ii. 73% for analyte 0765, Cell ID or WBC diff iii. 60% for each of the following analytes A. 0775, RBC B. 0785, HCT C. 0795, HGB D. 0805, WBC E. 0815, PLATELETS 3. The API Comparative Evaluations for 2018 event 3 and 2019 event 1 confirm the findings on the CASPER reports. -- 3 of 3 --

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 review of the laboratory's policy and procedure manual, testing personnel training/competency records and interview with Testing Personnel #1 (TP1), the laboratory failed to follow their established policy for the initial training assessment of 4 of 4 testing personnel. Record review was from 11/13/17 until present. The findings include: 1. Review of the laboratory's policy and procedure manual identified a policy, "Staff Orientation, Training, and Competency", which states "Initial Training: Initial training on individual analyzers, equipment, test methods, and kits must be documented. Document initial training competency at the completion of each training activities. Document all initial instrument orientation the Personnel Training Checklist and the New Employee Checklist." 2. Review of the laboratory's training/competency records identified the lack of completed "Initial Personnel Training Checklist" for 4 of 4 testing personnel. 3. On 3/5/18 at approximately 1:00 PM, TP1 confirmed the findings. 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 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) 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 -- 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 review of the Horiba Micros 60 (serial #702CS96673) validation /verification records and interview with Testing Personnel #1 (TP1), the laboratory failed to verify the normal range for Complete Blood Cell (CBC) counts performed on the Horiba Micro 60 prior to analyzing patient specimens. The findings include: 1. Review of the Horiba Micros 60 validation/verification records identified a lack of documentation of the verification of the normal ranges for Complete Blood Cell counts (CBCs) performed on Horiba Micros 60. 2. On 3/5/18 at approximately 3:20 PM, TP #1 stated they did not know they had to verify the normal ranges. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of Horiba Micros 60 analyzer's patient test printouts and interview with Testing Personnel #1 (TP1), the laboratory did not maintain a record system that included the identity of the personnel who performed the Complete Blood Cell (CBC) counts on the Horiba Micros 60 for 6 of 6 patient reports reviewed. Record review was from 11/13/18 to the present. The findings include: 1. Review of 6 of 6 Horiba Micros 60 analyzer's instrument printouts revealed the laboratory was not identifying the personnel who performed the CBC counts on the Horiba Micros 60 analyzer. 2. On 3/8/18 at approximately 4:05 PM, TP1 confirmed the findings. D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on review of the laboratory's instrument validation/verification records and interview with Testing Personnel #1 (TP1), the technical consultant failed to verify the normal ranges for Complete Blood Cell counts performed on the Horiba Micros prior to beginning patient testing (see D5421). -- 2 of 2 --