Salem Pediatric Clinic

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of Proficiency testing (PT) records and discussion with the Technical Consultant (TC) and General Supervisor (GS), the laboratory failed to ensure the attestation was signed by the Laboratory Director (LD). Findings include: 1. Upon review of the PT events #1, #2 and #3 for 2020, the attestation form for all three (3) lacked the LD's signature for Hematology, Microbiology and Chemistry. 2. Upon review of the PT events for 2019, there was no signature by the LD on the attestation form or the Director Review for PT event #3 for Hematology and Chemistry. 3. In an interview with the TC during survey on 01/04/2021 at approximately 1:00 pm, she confirmed the LD had not signed the attestation documents mentioned in this deficiency. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of Proficiency testing (PT) records and discussion with the Technical Consultant (TC), the laboratory failed to perform

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 College of American Pathologists (Excel) (CAP) proficiency testing (PT) shows laboratory had unsuccessful participation for the following analytes, Cholesterol total, Cholesterol, high density lipoprotein, and Triglycerides in Routine Chemistry. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Record review of the College of American Pathologist (CAP) Excel proficiency testing (PT) results reveals that your laboratory has had unsatisfactory performance on two consecutive PT events. Findings are: 1. 2nd event 2018 Cholesterol Total = 0% Cholesterol HDL = 0% Triglycerides = 0% 2. 3rd event 2018 Cholesterol Total = 0% Cholesterol HDL = 0% Triglycerides = 0% -- 2 of 2 --