Waterville Family Practice

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: Based on review of the proficiency testing (PT) data report (Casper Report 155D) and PT graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate for the regulated analyte 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 consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the Proficiency Testing (PT) data report (CASPER Report 155), and graded results from the proficiency testing organization American Proficiency institute (APl), the laboratory failed to successfully participate in the Chloride analyte, and has sustained an unsuccessful participation in PT for Chemistry. Findings include: 1. Record review on 12/5/22 of the CASPER 155, and graded results from API revealed: a. API 2022 Event 2 for Chloride, the score was 20% and was unsatisfactory. b. API 2022 Event 3 for Chloride, the Score was 60% and was unsatisfactory. 2. Interview with the laboratory manager (LM) on 12/22/22 at 12: 00pm confirmed the above findings. 3. The laboratory performs 35,000 tests annually under the specialty of Chemistry. -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 Waterville Family Practice is not in compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The following requirements have not been met: 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 record review, the laboratory failed to successfully participate in 2 out of 3 proficiency testing events for the regulated analyte of sodium. Findings include: 1. A record review of American Proficiency Institute Proficiency Testing (PT) results on October 9, 2018 at approximately 3 PM revealed that the laboratory failed to obtain a satisfactory score of 80% leading to unsuccessful 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 -- participation in 2 out of 3 testing events for the regulated analyte of sodium. 2. The laboratory received the following PT scores: Event# Score 2017 Event - 3 40% 2018 Event - 2 60% This is the first unsuccessful PT performance for the regulated analyte of sodium. 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 record review and staff interview, the laboratory failed to successfully achieve satisfactory performance in 2 out of 3 proficiency testing events in the specialty of chemistry for the regulated analyte of sodium. Findings include: 1. A record review of American Proficiency Institute Proficiency Testing (PT) results on October 9, 2018 at approximately 3 PM revealed that the laboratory failed to obtain an acceptable score of 80% leading to unsuccessful PT participation in 2 out of 3 PT events for the regulated analyte of sodium. Event# Score 2017 Event - 3 40% 2018 Event - 1 60% 2. During an interview on October 9, 2018 at approximately 3:00 PM, the laboratory manager confirmed the the laboratory failed 2 out of 3 PT events for the regulated analyte of sodium. 3. The laboratory performs approximately 250 sodium tests annually. -- 2 of 2 --