Acorn To Oak Pediatrics

Summary Statement of Deficiencies D0000 A proficiency testing desk review was performed on September 15, 2025 for ACORN TO OAK PEDIATRICS, CLIA ID #19D2122735. The following condition level deficiencies were identified: 493.803: Successful Participation 493.1403: Laboratory Director, Moderate Complexity 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 proficiency testing results from the CMS-153D, CMS-155D and American Proficiency Institute (API), the laboratory failed to achieve a score of at least 80% for White Blood Cell (WBC) Differential for two consecutive events, resulting in an initial unsuccessful performance in Hematology. Refer to D2130. 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 -- D2127 HEMATOLOGY CFR(s): 493.851(d) (d) Failure to return proficiency testing results to the proficiency testing program within 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 review of the CMS-155D report and American Proficiency Institute (API) proficiency testing results, the laboratory failed to submit results to API prior to the event cutoff for Event 1 in Hematology resulting in a score of 0. Findings: 1. Review of the API records and CMS-155 for individual laboratory PT data revealed Event 1 of 2025 score of 0* for all Hematology analytes. 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 review of proficiency testing results from the CMS-153D and CMS-155D reports, and American Proficiency Institute (API), the laboratory failed to achieve a score of at least 80% for White Blood Cell (WBC Count) Differential in two consecutive events in 2025, resulting in an initial unsuccessful performance. Findings: 1. Review of proficiency testing records from the CMS-153D, CMS 155D and API reports revealed the laboratory received the following scores for two consecutive events resulting in initial unsuccessful performance in Hematology: a. 2025 Event 1: Score of 0% for WBC Differential (automated) b. 2025 Event 2: Score of 60% for WBC Differential (automated) 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 record review and interview with personnel, the Laboratory Director failed to provide overall management and direction. 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: -- 2 of 3 -- Based on proficiency testing record review, the Laboratory Director failed to ensure proficiency samples are tested as required. Findings: 1. The laboratory failed to submit results to API prior to the event cutoff for Event 1 in Hematology resulting in a score of 0. Refer to D2127 2. The laboratory failed to achieve a score of at least 80% for White Blood Cell (WBC) differential in two consecutive events in 2025, resulting in an initial unsuccessful performance in Hematology. Refer to D2130 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Certification survey was performed on June 21, 2023 at Acorn to Oaks Pediatrics, CLIA ID # 19D2122735. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation by surveyor and interview with personnel, the laboratory failed to ensure supplies did not exceed expiration dates. Findings: 1. Observation by surveyor during the laboratory tour on June 21, 2023 at 2:40 pm revealed the following expired items: eSwab Collection & Preservation of Aerobic, Anaerobic, & Fastidious Bacteria Lot N2009550; Expiration 05/31/2023; Quantity: 32 swabs 2. In interview on June 21, 2023 at 3:00 pm, Personnel 2 confirmed the identified supplies exceeded the expiration date. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation by surveyors, review of maintenance records, and interview 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 -- with laboratory personnel, the laboratory failed to ensure the weekly and monthly maintenance on the Beckman Coulter DxH 500 was performed as required by the manufacturer. Findings: 1. Observation by surveyor during the laboratory tour June 21, 2023 at 2:40 pm revealed laboratory utilized a Beckman Coulter DxH 500 analyzer for Complete Blood Count (CBC) testing in the specialty of Hematology. 2. Review of the maintenance log for the Beckman Coulter DxH 500 hematology analyzer revealed the following weekly and monthly maintenance to be performed: a) Weekly: * Reviewed Levey Jennings * Problems, shifts, trends noted with Levey Jennings b) Monthly: * EyeWash Check * DxH 500 Bleach cycle (performed monthly or every 1,000 cycles) 3. Review of the maintenance records for the Beckman Coulter DxH 500 analyzer from January 2022 through April 2023 revealed the laboratory did not perform the following maintenance: a) Weekly: January 27, 2023 b) Monthly Bleach cycle: * September 2022 * November 2022 * February 2023 * March 2023 * April 2023 4. In interview on June 21, 2023 at 4:15 pm, Personnel 2 stated the monthly bleach cycle is performed every 1,000 cycles instead of monthly but she did not document maintenance forms as needed. Personnel 2 confirmed the identified maintenance was not performed as required. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of laboratory policy and records along with interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to ensure supplies did not exceed expiration dates. Refer to D5417. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on review of laboratory policy and records as well as interview with personnel, the Laboratory Director failed to ensure that the laboratory performed required maintenance. Findings: 1. The laboratory failed to ensure the weekly and monthly maintenance on the Beckman Coulter DxH 500 was performed as required by the manufacturer. Refer to D5429. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed on October 11, 2021 at Acorn to Oaks Pediatrics, CLIA ID # 19D2122735. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 the laboratory's policy and procedure manual, and the American Proficiency Institute (API) proficiency testing records as well as interview with personnel, the laboratory failed to document remedial actions for unacceptable Hematology scores. Findings: 1. Review of the laboratory's Proficiency Testing policy revealed "The laboratory will seek consultation to remedy the causes of any unsuccessful results and follow approved

Summary Statement of Deficiencies D0000 A Recertification Survey was performed at Acorn to Oaks Pediatrics-CLIA ID # 19D2122735 on March 14, 2019. Acorn to Oaks Pediatrics was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1421 CONDITION: Laboratories performing moderate complexity testing; Testing Personnel 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 record review and interview with personnel, the laboratory failed to establish complete written policies and procedures to assess competency for testing personnel. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. In interview on March 14, 2019 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- at 10:23 am, Personnel 2 stated she was unable to locate the policy for competency assessment. Personnel 2 confirmed the laboratory did not have a policy which includes the identified six (6) procedures. 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 observation, record review, and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure testing personnel performing moderate complexity testing met educational requirements. Refer to D6029. 2. The Laboratory Director failed to ensure policies and procedures were established for assessing personnel competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Refer to D6030. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure testing personnel performing moderate complexity testing met educational requirements. Refer to D6065. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were established for assessing personnel competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Findings: 1. The laboratory failed to establish complete written policies and procedures to assess competency for testing personnel. Refer to D5209. 2. The Technical Consultant failed to ensure that competency of testing personnel was assessed as required. Refer to D6046. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Consultant failed to ensure that competency of testing personnel was assessed as required. Findings: 1. Review of the Laboratory Personnel Report (Form CMS-209) revealed Personnel 1 serves as the Laboratory Director and Technical Consultant. 2. Review of personnel records revealed the laboratory did not maintain documentation for the 2018 competency assessments for the following personnel: Personnel 2-5 3. In interview on March 14, 2019 at 11:10 am, Personnel 2 stated she was unable to find the documentation of competency assessements for 2018. Personnel 2 confirmed the above competencies were not accurately accounted for. 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 record review and interview with personnel, the laboratory failed to provide documentation all testing personnel met education requirements for moderate complexity. Refer to D6065. 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 -- 3 of 4 -- 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 record review and interview with personnel, the laboratory failed to provide documentation that one (1) of four (4) testing personnel reviewed met the educational qualifications for performing moderate complexity testing. Findings: 1. Review of personnel records on March 14, 2019 revealed the laboratory failed to maintain documentation of at least a High School Diploma or equivalent for the following personnel: Personnel 4 2. In interview on March 14, 2019 at 11:08 am, Personnel 2 confirmed the laboratory did not maintain documentation of education for Personnel 4. -- 4 of 4 --