Newton Clinic Pc

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing records and the Laboratory Test List & Annual Volume form (IA-CLIA-PS01), observations during the survey and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at 10:04 am on 05/07/2024, the laboratory failed to enroll in an HHS approved proficiency testing program for the analyte, quantitative human chorionic gonadotropin (hCG) testing for two out of two years from 1/1/2023 - 5/8/2024. The findings include: 1. The Laboratory Test List & Annual Volume form stated the laboratory performed quantitative hCG testing using the Tosho analyzer. 2. Tour of the laboratory confirmed quantitative hCG reagent in the laboratory refrigerator. 3. The laboratory did not enroll in proficiency testing for the analyte, quantitative hCG in 2023 or 2024. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at 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 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on lack of Cepheid GeneXpert maintenance records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at 11:22 am on 05/07/24, the laboratory failed to perform and document daily, weekly, monthly, and quarterly maintenance on the Cepheid GeneXpert instrument for 128 out of 128 days, 19 out of 19 weeks, five out of five months and one out of one quarter from 1/1 /2024 - 5/7/2024. The findings include: 1. The GeneXpert Maintenance log stated the laboratory must daily perform the following: *Clean the work area *Close all module doors *Discard used cartridges 2. The GeneXpert Maintenance log stated the laboratory must weekly perform the following: *Power down the GeneXpert instrument *Power down the GeneXpert computer 3. The GeneXpert Maintenance log stated the laboratory must monthly perform the following: *Archive tests *Purge tests 4. The GeneXpert Maintenance log stated the laboratory must quarterly perform the following: *Clean plunger rod and cartridge bay *Clean the instrument surfaces 5. At the time of the survey, the laboratory did not perform and document any of the above daily, weekly, monthly or quarterly maintenance from 1/1/2024 - 5/7/2024. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of Cepheid GeneXpert calibration certificates and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 11:22 am on 5/7/2024, the laboratory failed to perform annual calibrations on the Cepheid analyzer for one out of two years from 5/7/2022 - 5/7/2024. The findings include: 1. The Cepheid GeneXpert needs to be calibrated annually. 2. On 11/1/2022, the laboratory performed a calibration on the Cepheid GeneXpert. 3. At the time of the survey, the laboratory had not performed a calibration on the Cepheid GeneXpert since 11/1/2022. -- 2 of 2 --

Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the procedure manual, prostate specific antigen calibration verification records, VITROS chemistry verifier I and II instructions for use, the VITROS performance verifier I and II assayed quality control (QC) package inserts, VITROS QC results, monthly quality assurance checklist and confirmed by laboratory personnel identifer #1 (refer to the Laboratory Personnel Report), the laboratory failed to meet the chemistry requirements for having procedures as specified in D5403; performing calibration verification as specified in D5439; correctly defining the analyte-specific mean and acceptable QC ranges as specified in D5469, taking

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 proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, lactate dehydrogenase for two out consecutive proficiency testing events: 2019 event 3 and 2020 event 1 (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: Based on review of proficiency testing reports and records, the laboratory fails to achieve satisfactory performance for the analyte, lactate dehydrogenase, for two consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of zero for 2019 testing event 3 and 60% for 2020 testing event 1. -- 2 of 2 --

Summary Statement of Deficiencies D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, red blood cell, for two out of three consecutive testing events: 2017 event 2 and 2018 event 1 (refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) reports and records, the laboratory fails to achieve satisfactory performance for the analyte, red blood cell, for two out of three consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of zero for 2017 testing event 2 and zero for 2018 testing event 1. -- 2 of 2 --

Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the Ace Alera chemistry analyzer quality control (QC) records, the Ace Alera QC package inserts, laboratory procedure manual, calibration verification records, and confirmed by laboratory personnel identifiers #2 and #3 (refer to the Laboratory Personnel Report), the laboratory failed to meet chemistry requirements for: having a quality control procedure with acceptable result criteria as specified in standard D5403; performing and documenting calibration verification procedures as specified in the standard D5439; taking