Topcare Medical Group Inc

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: Revisit 05/20/2019 New deficiency. Based on a review of American Proficiency Institute (API) proficiency testing records and staff interview, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of bacteriology. Refer to D2028. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: PT Desk Review conducted 08/30/2019 New deficiency. Based on review of CMS 155 report and American Proficiency Institute (API) proficiency testing records, the laboratory failed to particpate in the specialty of bacteriology (streptococcus analyte) in 2018 (2018-3) and 2019 (2019-1, 2019-2). Findings included: 1. Review of the CMS 155 report revealed the laboratory did not achieve passing scores (>/= 80%) in bacteriology: API 2018 - 3: 40% API 2019 - 1: 40% API 2019 - 2: 40% Scores from 2018 event 3 and 2019 event 1 result in initial unsuccessful performance and scores from 2019 event 1 and 2019 event 2 result in noninitial unsuccessful performance for bacteriology (streptococcus analyte). 2. The laboratory must demonstrate sustained satisfactory performance (>/= 80%) on two consecutive testing events for reinstatement. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Revisit 05/20/2019 and PT Desk Review 08/30/19 New deficiency. Based on review of the Centers for Medicare & Medicaid Services (CMS) 155 report, American Proficiency Institute (API) proficiency testing (PT) records, and staff interview, the laboratory failed to attain an overall testing event score of at least 80% for the specialty of bacteriology resulting in unsatisfactory performance in 2018 (Event 3, E- 3) and 2019 (Event 1, E-1; Event 2, E-2). Findings: 1. Review of the CMS-155 report revealed the following scores in bacteriology for 2018 E-3, 2019 E-1, and 2019 E-2: 2018 E-3: 40% 2019 E-1: 40% 2019 E-2: 40% The laboratory failed to achieve passing scores of at least 80% for the above events. 2. Review of the API PT records revealed the following scores for the streptococcus analyte tested on the Solana analyzer: 2018 E-3: 40% 2019 E-1: 40% During a telephone interview on 05/20/19 at 11:00 am, the technical consultant (TC) stated the laboratory ordered the wrong testing methodology for PT events 2018 E-3 and 2019 E-1 which resulted in the failures. This confirmed the above findings. 3. Review of API PT records obtained from the company during a PT desk review on 08/30/19 revealed the following score for streptococcus analyte tested on the Solana analyzer: 2019 E-2: 40% -- 2 of 3 -- D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Revisit 05/20/2019 and PT Desk Review 08/30/19 New deficiency. Based on review of the Centers for Medicare & Medicaid Services (CMS) 155 report, American Proficiency Institute (API) proficiency testing (PT) records, and staff interview, the laboratory failed to achieve satisfactory performance (80% or higher) for bacteriology in three consecutive testing events resulting in noninitial unsuccessful performance in 2018 (Event 3, E-3) and 2019 (Event 1, E-1; Event 2, E-2). Findings: 1. Review of the CMS-155 report revealed the following scores in bacteriology for 2018 E-3, 2019 E-1 and 2019 E-2: 2018 E-3: 40% 2019 E-1: 40% 2019 E-2: 40% The laboratory failed to achieve a passing testing event score of 80% or higher for three consecutive events for the bacteriology specialty. 2. Review of the API PT records revealed the following scores for the streptococcus analyte tested on the Solana analyzer: 2018 E-3: 40% 2019 E-1: 40% During a telephone interview on 05/20/19 at 11:00 am, the technical consultant (TC) stated the laboratory ordered the wrong testing methodology for PT events 2018 E-3 and 2019 E-1 which resulted in the failures. This confirmed the above findings. 3. Review of API PT records obtained from the company during a PT desk review on 08/30/19 revealed the following score for streptococcus analyte tested on the Solana analyzer: 2019 E-2: 40% Scores from 2018 event 3 and 2019 event 1 result in initial unsuccessful performance and scores from 2019 event 1 and 2019 event 2 result in noninitial unsuccessful performance for bacteriology (streptococcus analyte). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Revisit 05/20/2019 New deficiency. Based on review of proficiency testing records, it was revealed that the Laboratory Director failed to ensure the overall quality of the laboratory services provided. The Laboratory Director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2028. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on the onsite survey conducted 10/02/2018 and 10/03/2018, this facility was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493.1240 Preanalytic Systems 493.1403 Laboratory Director Moderate Complexity 493.1409 Technical Consultant Moderate Complexity The laboratory's failure to be in compliance with these regulations was found to pose IMMEDIATE JEOPARDY to the patients served by the laboratory. Technical Consultant 1 and 2 were informed at the exit conference on 10/03/2018 that the survey results were being sent to CMS Regional Office for evaluation and review, and that the CMS 2567 survey report would be sent by the CMS Regional Office. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: The STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer's instructions, and confirmed in interview, the laboratory failed to ensure the correct storage requirements for OSOM BVBlue Test kit. Findings: 1. During a tour of the laboratory on 10/03/2018 at 12:15 p.m., it was observed that the OSOSM BVBlue Test kit, Lot # B2394 expiration 04/2019 was stored at room temperature. Review of the manufacturer's package insert for OSOSM BVBlue Test storage requirements stated, "STORAGE AND STABILITY: Store the kit refrigerated, 2-8C (36-46F), out of direct sunlight." The laboratory did not store the above mentioned kit in refrigerated conditions (2-8C). 2. Technical Consultant (TC-1) acknowledged the OSOSM BVBlue Test kit was stored at room temperature and not refrigerated, as required on 10/03/2018 at 12:30 p.m. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) Proficiency Testing (PT) records, laboratory's CMS 209 form, and staff interview, laboratory failed to have documentation of rotating PT among testing personnel who routinely performed testing for 2 of 3 testing events in 2016 (2016 - 2), 3 of 3 testing events in 2017 (2017 -1, 2017 -2, 2017-3), and 3 of 3 testing events in 2018 (2018 - 1, 2018 -2) (hematology and endocrinology specialties). Findings: 1. Review of API PT records from 2016, 2017, and 2018 revealed Testing Person-6 (TP-6) tested the following events: Hematology: 2016 Testing Event 2 2017 Testing Events 1, 2, and 3 2018 Testing Events 1 and 2 Endocrinology: 2016 Testing Events 2 and 3 2017 Testing Events 1 and 3 2018 Testing Events 1, 2, and 3 2. Review of the laboratory's CMS 209 form revealed eight additional Testing Persons (TP-1, TP-2, TP-3, TP-4, TP-5, TP-7, TP-8, TP-9) listed as individuals who performed moderate complexity testing (hematology and endocrinology). TP-1 hire date: 04/06/2017 TP-2 hire date: 06/12 /2018 (terminated 09/2018) TP-3 hire date: 01/21/2016 TP-4 hire date: 04/18/18 (terminated, no date provided) TP-5 hire date: 11/02/2017 TP-7 hire date: 06/20/2017 TP-8 hire date: 05/30/2018 TP-9 hire date: 04/18/18 The laboratory did not ensure hematology and endocrinology PT was rotated among the above additional Testing Persons listed. 3. During an interview on 10/02/2018 at 3:08 pm, Technical Consultant - 1 confirmed the above findings. 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: I. Based on review of Qualigen daily quality control (QC) logs and in interview with staff, the laboratory failed to retain the expected value sheets for QC material used for Thyroid Stimulating Hormone (TSH) and Vitamin D tests for 3 of 3 lot number sets in 2016 and 2017. Findings included: 1. Review of "TSH DAILY QC RESULTS QUALIGEN" and "VITAMIN D DAILY QC RESULTS QUALIGEN" logs from 2016 and 2017 revealed documented lot numbers, ranges for acceptability, and daily results, as follows: Lot Number Level 1: 1605001; Lot Number Level 2: 1605002 - Date opened: 09/22/2016 and included TSH daily results from 09/22/2016 through 12 /22/2016 and 03/30/2017 through 05/26/2017. Lot Number Level 1: 1603001; Lot Number Level 2: 1603001 - Date opened: 09/22/2016 and included Vitamin D daily results from 09/22/2016 through 12/02/2016. Lot Number Level 1: 1701033; Lot Number Level 2: 1701033 - Date opened: 05/09/2017 and included Vitamin D daily results from 05/19/2017 through 07/26/2017. The laboratory did not retain the expected value sheets to assess the ranges used for acceptability were consistent with manufacturer's. 2. During an interview on 10/03/2018 at 12:30 pm, Technical -- 2 of 13 -- Consultants #1 and #2 reviewed and confirmed the above findings. II. Based on review of Quidel Solana Influenza QC data and confirmed in interview with staff, the laboratory failed to retain the lot numbers of QC material used for Influenza A&B testing from 07/14/2018 through 10/01/2018. Findings included: 1. Review of Quidel Solana Influenza A&B QC daily printouts from 07/14/2018 through 10/01/2018 (29 days) revealed the printouts did not include lot numbers of the QC material used. The daily printouts included a tube number for "ID" and sections labeled "Lot:" and "Exp Date:" were blank. 2. During an interview on 10/02/2018 at 11:45 am, Technical Consultants #1 and #2 reviewed and confirmed the above findings. III. Based on review of the laboratory's procedure manual, hematology quality control (QC) data,