Infinity Diagnostic Laboratories

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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Diagnostic Immunology tests performed with the College of American Pathologists (CAP). The finding includes: 1) The laboratory scored a 60% for Compliment C3 in event 2-20 and 1-21 with the CAP. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) 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 -- 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 office review of the CASPER reports 153 and 155 and Proficiency Testing provider reports, the laboratory failed to achieve a score of 80% for General Immunology tests. The finding includes: 1) The laboratory scored a 60% for Compliment C3 in event 2-20 and 1-21 with the College of American Pathologists (CAP). D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory director failed to provide appropriate direction to laboratory personnel to ensure that the PT surveys are performed satisfactorily and that the laboratory is compliance with the CLIA regulations. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Quality Assurance Personnel (QAP), the laboratory failed to perform CA correctly on 13 of 13 Testing Personnel (TP) in the calendar years 2017 and 2018. The findings include: 1. The CA was not performed on each test method performed by TP. 2. Tool # 5, 'Required Competency' column on CA record was not assessed by blind samples testing if PT was performed by TP. 3. All tools listed on 'Required Competency' column on CA record did not include how assessment was done and what records were reviewed. 4. The QAP confirmed on 3/13/19 at 10:30 am that CA was not done correctly. D5315 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(c) The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. This STANDARD is not met as evidenced by: Based on surveyor review of Work Records, Final Reports and interview with the Testing Personnel (TP), the laboratory referred Urine Toxiciology Confirmation testing to a non-CLIA-certified laboratory from March 2018 to the date of survey. The finding includes. 1. The TP #10 listed on CMS form 209 reviewed, verified and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- resulted toxicology results from a non-CLIA-certified laboratory. 2. The TP # 10 listed on the CMS form 209 stated, "I read from home". 3. The General Supervisor confirmed on 3/15/19 at 2 pm that toxicology tests were reviewed and resulted from a non-CLIA-certified laboratory. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: a) Based on surveyor review of Quality Control (QC) records, Procedure manual (PM) and interview with the General Supervisor (GS), the laboratory failed use their established form for documenting of QC verification for Apolipoprotein from 5/24/18 to the date of survey. The GS confirmed on 3/15/19 at 12:00 pm that the procedure was not followed. b) Based on surveyor review of the Final Report (FR), Procedure Manual (PM) and interview with the GS, the laboratory failed to follow their procedure for reporting Triglycerides from 10/26/17 to the date of survey. The findings include: 1. The Reference Interval (RI) on the FR had borderline high 150 - 199 mg/mL. but the PM had 150 - 500 mg/mL. 2. The RI on the FR had 200 - 499 mg /dL but the PM had >500 mg/dL. 3. The GS confirmed on 3/15/19 at 1:00 pm that the laboratory did not follow the PM. 35471 c. Based on surveyor review of the PM and interview with the Testing Personnel (TP), the laboratory failed to establish a procedure to verify new lots of reagents used on the Shimadzu LCMS 8045 prior to patient testing from March 2018 to the date of survey. The TP #10 listed on CMS form 209 confirmed on 3/13/19 at 11:00 am that the laboratory did not establish the above procedure. d. Based on surveyor review of the PM and interview with the TP, the laboratory failed to establish a procedure for manual integration of chromatography peaks on the Shimadzu LCMS 8045 prior to patient testing from March 2018 to the date of survey. The TP #10 listed on CMS form 209 confirmed on 3 /13/19 at 11:10 am that the laboratory did not establish the above procedure. 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)