Summary:
Summary Statement of Deficiencies D0000 A Validation survey was performed at Cenla Children's Clinic & Associates CLIA # 19D0920680, on February 13, 2025. Cenla Children's Clinic & Associates was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803: CONDITION: Successful Participation 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: Based on review of laboratory policy and proficiency testing results from the CMS- 155D and WSLH Proficiency Testing as well as interview with personnel, 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 3 -- laboratory failed to achieve a score of at least 80% for White Blood Cells (WBC) in two consecutive testing events resulting in an initial unsuccessful performance. Refer to D2130. 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 laboratory policy, proficiency testing results from laboratory records and CMS-155D, and interview with personnel, the laboratory failed to achieve a score of at least 80% for White Blood Cells (WBC) in two (2) consecutive events in 2024, resulting in an initial unsuccessful performance. Findings: 1. Review of the laboratory's policy for "Proficiency Testing" revealed "Any deficiencies will be noted and accounted for. Unsuccessful PT results will be investigated and documented on the proficiency test survey investigation form and appropriate action will be taken to remedy the cause of failure, including but not limited to additional training of personnel, recalibration, etc". 2. Review of the CMS-155D and laboratory proficiency testing records from 2024 revealed the laboratory received a score of less than 80% for the following analyte for two (2) consecutive events resulting in an initial unsuccessful performance: a) WSLH PT 2024-HemeReg1: Score of 60% for Leukocytes (WBC) b) WSLH PT 2024-HemeReg2: Score of 60% for Leukocytes (WBC) 3. In interview on February 13, 2025 at 11:33 am, Testing Personnel 1 stated the 2024-HemeReg 2 results were entered incorrectly causing failure due to clerical errors. Testing Personnel 1 confirmed the laboratory did have two (2) unsuccessful events in 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: Based on review of laboratory policy and records 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: Based on review of laboratory policy and proficiency testing reports and interview with personnel, the Laboratory Director failed to ensure proficiency samples are tested -- 2 of 3 -- as required. Findings: 1. The laboratory failed to achieve a score of at least 80% for Leukocytes (WBC) in two out of three events in 2024, resulting in an initial unsuccessful performance. Refer to D2130. -- 3 of 3 --