Lynnfield Pediatrics, Llc

Summary Statement of Deficiencies D0000 A CLIA paper desk review of proficiency testing was conducted for the Lynnfield Pediatrics laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Based on evidence of unsuccessful proficiency testing performance for the Bacteriology subspecialty, the following Condition level deficiency was deemed to be not met: Condition 42 CFR 493.803 - Proficiency Testing - Successful Participation. . 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 proficiency testing review for calendar year 2020 (two testing events) of American Proficiency Testing (API) proficiency testing results, the laboratory failed 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 -- to successfully participate (achieve a score of 80 percent or more) in a proficiency testing program for the Bacteriology subspecialty as evidenced by the following: Refer to D2020 and D2028. . D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review of calendar year 2020 American Proficiency Institute (API) proficiency testing results, the laboratory failed to attain a testing event score of at least 80 percent for all Bacteriology analytes resulting in unsatisfactory performance as evidenced by the following testing event scores: Bacteriology (throat cultures): 1. 2020 API testing event 1 - score of 60 %. 2. 2020 API testing event 2 - score of 40 %. The results were confirmed with API on 11/10/20 at 3:52 PM. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 proficiency testing review of American Proficiency Institute (API) proficiency testing results for calendar year 2020 (two testing events), the laboratory failed to achieve an overall testing event score of satisfactory performance for the subspecialty of Bacteriology as evidenced by the following testing event scores: Bacteriology: 1. 2020 API testing event 1 - score of 60 %. 2. 2020 API testing event 2 - score of 40 %. The results were confirmed with API on 11/10/20 at 3:52 PM. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Lynnfield Pediatrics, LLC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: . Based on proficiency testing (PT) record review and interview on 10/30/19, the laboratory did not maintain a copy of all PT records as evidenced by the following: AccuTest PT records for throat culture screens for presumptive identification of Group A Streptococci (GAS) for calendar years 2018 and 2019 were reviewed. The review revealed that a signed attestation statement provided by the PT program, signed by the analyst and the laboratory director, was not maintained for two years for all five events. Testing Person 2 (TP2) interviewed on 10/30/19 at 10:20 AM confirmed that attestation statements provided by the PT program were not signed by the analyst and the laboratory director, documenting that PT samples were tested in the same manner as patient specimens. The laboratory performs 377 throat culture screens annually. . 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 -- D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require