Quest Diagnostics Massachusetts Llc

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Quest Diagnostics Massachusetts, LLC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform calibration verification as appropriate as evidenced by the following: a) A review of quality 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 -- control records for calendar years 2019 and 2020 was performed. The review revealed that calibration verifications of at least 3 points were not performed once every six months for eleven (11) of eleven (11) quantitative chemistry analytes performed (glucose, urea nitrogen, calcium, sodium, potassium, chloride, CO2, total cholesterol, HDL cholesterol, and triglyceride) on the Horiba Pentra C400 chemistry analyzer. Calibration verifications were not performed at least once every six months for the above tests during calendar year 2019. They were only performed once on 9/12/19. b) The technical consultant interviewed on 3/10/21 at 9:50 AM confirmed that calibration verifications of at least 3 points had not been performed at least once every six months for the tests listed above. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA paper desk review of proficiency testing was conducted for the Quest Diagnostics Massachusetts, LLC 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 Chloride analyte, 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 2019 (three testing events), the laboratory failed to successfully participate (achieve a score of 80 percent or more) in 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 -- the American Proficiency Institute (API) proficiency testing program for the Chloride analyte. 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 unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off site desk review of the laboratory's 2019 and 2020 American Proficiency Institute's (API) proficiency testing (PT) records and an email interview with the laboratory general supervisor the laboratory failed to achieve satisfactory performance for the Chloride analyte for two out of three testing events resulting in unsuccessful performance for the analyte as evidenced by the following: 1. Desk review of the laboratory's 2019 and 2020 API PT records revealed the laboratory achieved a score for Chloride scores of less than eighty percent for the following Routine Chemistry testing events: 2019 second testing event - Chloride score of twenty (20) percent; and, 2020 first testing event - Chloride score of sixty (60) percent. 2. In an email received on April 3, 2020 the laboratory general supervisor confirmed the above PT scores were correct. -- 2 of 2 --