Little Rock Children's Clinic P A

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 CMS 209 form, personnel records, and interview it was determined that the competency of the Clinical Consultant (CC) was not assessed by the laboratory director on an annual basis. Findings follow: A) Review of Clinical Consultant (CC) personnel files on the CMS 209 form, one of one CC personnel revealed that the annual evaluation of the competency of the CC personnel was not documented annually for 2023, 2024, and 2025. B) Upon request, the laboratory was unable to provide other competency evaluations of the CC personnel on the CMS 209 form, no 2023, 2024 and 2025 competency evaluation for CC. C) In an interview on 9 /19/2025 at 0945 a.m. Laboratory Directory on the CMS 209 form said, "no competency evaluations were present and available". 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 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: Review of the 2023 and 2024 CMS Casper Reports 096D, 0153D, and the American Proficiency Institute proficiency testing results, showed the laboratory failed to have initial successful participation in proficiency testing for the analyte Total Bilirubin. (TBIL) and the specialty of Routine Chemistry. Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2096. Failure to achieve satisfactory performance for the specialty in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2097. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the 2023 and 2024 CMS Casper Reports 096D, 0153D and API proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte TBIL. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 0% for the analyte TBIL in the second proficiency testing event of 2023. B. A review of the proficiency testing results revealed the laboratory received a score of 60% for the analyte TBIL in the first proficiency testing event of 2024. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the 2023 and 2024 CMS Casper Reports 096D, 0153D and API proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the specialty of Routine Chemistry. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 0% for the specialty of Routine Chemistry in the second proficiency testing event of 2023. B. A review of the proficiency testing results revealed the laboratory received a score of 60% for the specialty of Routine Chemistry in the first proficiency testing event of 2024. 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: Review of 2023 and 2024 proficiency testing results, showed the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. 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 -- 2 of 3 -- 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: Review of the 2023 and 2024 proficiency testing events, showed the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the specialty of Routine Chemistry and the analyte TBIL. Refer to D2096 and D2097. -- 3 of 3 --

Summary Statement of Deficiencies 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: Through observations made during a tour of the laboratory, it was determined the laboratory had reagents available for use when they had exceeded their expiration date. Survey findings follow: A) During a tour of the laboratory at 12:45 p.m.on 11/16 /23 ten of ten Eosin-Methylene Blue (EMB) microbiology media agar plates, lot # 23423 expiration date 11/14/23, were observed available for use when they had exceeded their expiration date. B) In an interview on 11/16/23 at 12:45 p.m., the laboratory staff member (# 1 on the CMS 209 form) confirmed that the media identified above had exceeded the expiration date and was available for use. 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 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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: . Through a review of the policy and procedure manual, temperature logs for 2021, lack of documentation and interviews with staff, it was determined the laboratory failed to monitor and document room, refrigerator, incubator temperatures, and humidity conditions that are essential for the proper storage of reagents and supplies. Survey findings follow: A. A review of the policy and procedure manual revealed the policy for the documentation of laboratory temperatures: "Temperature control is to ensure proper reaction temperatures, to maintain high quality results and to ensure storage of reagents. Temperatures must be monitored once a day and recorded on the daily temperature log." B. A review of the laboratory temperature logs revealed the temperature ranges: Refrigerator range 2-8 degrees Celsius: Room Temperature Range 15-25 degrees Celsius, Incubator 35-37 degrees Celsius and Humidity 20- 80%." C. A review of the temperature logs for January- December 2021 (twelve of twelve months) revealed the laboratory failed to monitor and document temperatures and humidity on two of thirty-one days in March, and one of thirty-one days in May. D. In an interview on 2/22/2022 at 10:30, the technical consultant confirmed the laboratory failed to monitor or document room temperature and humidity on the days mentioned. 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 --