Cornerstone Pediatrics

Summary Statement of Deficiencies D0000 A Recertification survey was performed on August 31, 2022 at Cornerstone Pediatrics, CLIA ID # 19D0982563. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation during the laboratory tour, review of the laboratory policy and calibration records as well as interview with personnel, the laboratory failed to retain calibration documentation for the Horiba ABX Micros 60 hematology analyzer in 2021. Findings: 1. Observation by surveyor during the laboratory tour on August 31, 2022 at 1:00 pm revealed the laboratory utilized the Horiba ABX Micros 60 Hematology analyzer for Complete Blood Count (CBC) testing. 2. Review of the laboratory's policy for Hematology calibration revealed the laboratory performs calibrations for the Horiba ABX Micros 60 Hematology analyzer every six (6) months per manufacturer requirements. 3. Review of the laboratory's hematology calibration records for 2020, 2021, and 2022 revealed the laboratory did not retain the documentation of calibration for the following two (2) of four (4) events in 2021: a) May 2021 b) November 2021 4. In interview on August 31, 2022 at 2:50 pm, Testing Personnel 1 stated that the field service representative performs the hematology calibrations but she could not find the documentation to support the calibrations. Testing Personnel 1 confirmed the laboratory did not have calibration documentation for the identified events. 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 -- 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 and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed and retained documentation of test methods as required. Refer to D3031. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on May 25, 2018 at Cornerstone Pediatrics - CLIA #19D0982563 and was found in compliance with 42 CFR 493, Requirements for Laboratories. However, standard level deficiencies were cited. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it identifies and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 2. Interview with Personnel 2 on May 25, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory policy and procedure manual, and interview with personnel, the laboratory failed to establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to establish written policies and procedures that include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel involved in any phase of 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. Interview with personnel 2 on May 25, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to have a complete policy and procedure manual. Findings: 1. Review of the laboratory policy and procedure manual revealed the laboratory did not have detailed instructions for: Proficiency Testing (PT): a) Ordering and ensuring that you are enrolled for Proficiency Testing. b) What to do when you receive samples from the PT Provider. c) How to handle the samples; who will test, when to test, how do you assure no inter and intra laboratory communication takes place d) How to record results to send into the PT Provider to be scored. e) What records to maintain. f) How to evaluate when you receive your scores from the PT Provider. g) What steps to take if