Lifeline Medical Associates, Llc

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 Endocrinology tests performed with the American Association of Bioanalysts (AAB). The findings include: 1) The laboratory scored a 0% for Human Chronic Gonadotropin (hCG) in event 3-20 and 1-21 with the AAB. 2) The laboratory scored a 0% for Thyroid Stimulating Hormone (TSH) in event 3-20 and 1-21 with the AAB. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 Endocrinology tests. The finding includes: 1) The laboratory scored a 0% for Human Chronic Gonadotropin (hCG) in event 3-20 and 1-21 with the American Association of Bioanalysts (AAB). 2) The laboratory scored a 0% for Thyroid Stimulating Hormone (TSH) in event 3-20 and 1-21 with the AAB. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of Patient Testing Records and interview with the Testing Personnel (TP), the laboratory failed to retain working records for Semen Counts, Morphology and Motility for Semen Analysis testing from 3/23/17 to the date of survey. The finding includes: 1. The TP stated he wrote results on a piece of paper but didn't keep the paper. 2. The TP confirmed on 1/23/19 at 1:00 pm that patient test records were not retained. 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 Testing Personnel (TP), the laboratory failed to perform CA correctly on one of one TP in the calendar years 2017 and 2018. The finding includes: 1. The CA did not include assessment of test performance through testing previously analyzed samples, internal blind testing samples or external proficiency testing samples. 2. The TP confirmed on 1/23/19 at 1:15 pm that CA was not done correctly. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to verify the accuracy of Semen Motility (SM) twice annually in the calendar years 2017 and 2018. The TP confirmed on 1/23/19 at 2:00 pm that the laboratory did not verify the accuracy of SM twice annually. 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: Based on surveyor review of Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow the written procedures for Semen Analysis tests from 3/22/17 to the date of survey. The findings include: 1. The PM stated to "spin semen sample at 600g but the TP stated the laboratory spun samples at 1400 rpms. a. The TP did not know if 1400 rpms was equivalent to 600g. 2. The PM stated "To repeat the count in two other strips of 10 and determine the average. Repeat the procedure on another counting chamber . The final number is the average of all counts" but there was no documented evidence the count was done more than one time. 3. The PM stated " When no sperm cells are visible, the specimen is centrifuged, and the pellet microscopically analyzed for the presence of any sperm but the TP stated the laboratory did not perform the above procedure for Azoospermia. 4, The PM stated for Sperm Motility (SM): A vital stain is used to differentiate viable sperm for nonviable sperm if motility is less that 30% but there was no vital stain observed in the laboratory. a. The TP stated the laboratory did not use a vital stain for SM. 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)