Summary:
Summary Statement of Deficiencies D0000 An off-site CLIA proficiency testing (PT) desk review was conducted for Richmond Pediatric Associates, INC on April 23, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The laboratory was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 CFR. 493.803 Condition: Successful Participation D6000 - 42 CFR. 493.1403 Condition: Laboratories performing moderate complexity testing- Laboratory Director 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: 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 -- Based on a desk review of the Certification and Survey Provider Enhanced Reporting, the laboratory's College of American Pathologists proficiency testing (PT) records, and interview, the laboratory failed to attain a score of at least eighty percent of acceptable responses for regulated analyte, Red Blood Cell Count, on two of three hematology testing events reviewed, resulting in an initial unsuccessful PT performance. Refer to D2130 D2121 HEMATOLOGY CFR(s): 493.851(a) (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 a desk review of the CASPER 0155 report, the laboratory's proficiency testing (PT) evaluation records, and interview, the laboratory failed to achieve a score of at least eighty percent (80%), for Hematocrit (HCT) on the 2026 College of American Pathologists (CAP) PT Event 1, resulting in unsatisfactory performance. Findings include: 1. Review of the CASPER 0155 report revealed the laboratory's Hematology 2026 Event 1 recorded an unsatisfactory HCT score of 20%. 2. Desk review of the laboratory's CAP Hematology PT records on 4/23/26 revealed: 2026 Event 1- HCT scored 20%, the laboratory received unacceptable scores on the following four of five challenges: FH-01 reported as 47.80 with acceptable range 43.38-47.01; FH-02 reported as 37.90 with acceptable range 34.88-37.80; FH-03 reported as 21.20 with acceptable range 19.39-21.02; FH-04 reported as 58.70 with acceptable range 53.34-57.80); resulting in unsatisfactory performance, with CAP noting "at risk for next two PT mailings". 3. A virtual interview with the Medical Assistant/ Lab Manager on 4/23/26 at 3 PM confirmed the above findings. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 a desk review of the laboratory's CASPER 0155 report, the laboratory's proficiency testing (PT) evaluation records, and interview, the laboratory failed to achieve satisfactory performance, a score of at least eighty percent (80%), for Red Blood Cell (RBC) on two of three hematology testing events resulting in initial unsuccessful participation. Findings include: 1. Review of the CASPER 0155 report revealed the following unsatisfactory scores: Hematology 2025- Event 2 - 60% for analyte 0775 RBC; Hematology 2026- Event 1 - 60% for analyte 0775 RBC. 2. Desk review of the laboratory's College of American Pathologists (CAP) PT records on 4/23 /26 revealed: CAP 2025 Hematology Event 2: RBC scored 60% (challenge sample FH 08 reported as 3.69 with acceptable range 3.71-4.03, challenge sample FH-09 reported as 5.74 with acceptable range 5.80-6.29); CAP 2026 Hematology Event 1: RBC scored 60% (challenge sample FH-01 reported as 5.01 with acceptable range 4.59- 4.99, challenge sample FH-04 reported as 5.84 with acceptable range 5.36-5.82); resulting in an initial unsuccessful participation for analyte RBC. 3. A virtual -- 2 of 3 -- interview with the Medical Assistant/ Lab Manager on 4/23/26 at 3 PM confirmed the above findings. 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 a review of the Certification and Survey Provider Enhanced Reporting CASPER 0155 report, proficiency testing records, and interview, the laboratory director failed to provide overall direction and management of the laboratory services in ensuring satisfactory and successful participation in an approved Health and Human Services approved proficiency program. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the CASPER 0155 report, proficiency testing records, and interview, the laboratory director failed to ensure: 1. satisfactory performance in the Health and Human Services (HHS) approved program for Hematocrit on the first testing event of 2026 - Refer to D2121; 2. successful participation in the laboratory's HHS approved program for Red Blood Cell count on two of three consecutive testing events in 2025 and year to date 2026 - Refer to D2130. -- 3 of 3 --