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Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for use (IFU) and quality control (QC) records and interview with the laboratory director (LD), the laboratory failed to consistently run a positive control with each batch of specimens as specified in the manufacturer's IFU for the Quidel Solana severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) assay. Findings: 1. The manufacturer's IFU stated "A positive control (such as a positive patient sample) should be processed and tested with each batch of specimens." 2. Instrument data for "8-7-22 batch 2" showed that no QC was run with the 2 patient specimens tested in the batch. 3. During the survey on 01/19/2024 at 1:15 PM, the LD confirmed that a single set of external positive and negative QC are run each day of testing and confirmed that the manufacturer's IFU stated that a positive control should be processed with each batch of specimens tested. D5783

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview with the laboratory director (LD) the laboratory failed to have written procedures for performing SARS-CoV-2 testing with the Quidel Solana SARS-CoV-2 assay (D5401, part I); failed to follow manufacturer's procedures for performing QC when performing SARS-CoV-2 testing with the Quidel Solana SARS-CoV-2 assay (D5401, part II); failed to provide the testing personnel with written preanalytical, analytical, and post analytical policies and procedures for testing with the Quidel Solana SARS-CoV-2 assay (D5403); failed to define, monitor, and document laboratory reagent freezer and heat block temperatures to ensure proper reagent storage and reliable test system operation (D5413); failed to ensure that the laboratory validated the Solana SARS-CoV-2 Assay to demonstrate that it can obtain performance specifications comparable to those established by the manufacturer before being used for patient testing (D5421); failed to perform two levels of quality control (QC) each day of SARS-CoV-2 testing (D5445); and failed to ensure that both a positive and a negative control were run each day of testing with the Quidel Solana SARS-CoV-2 assay (D5449). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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: I. Based on review of the test manufacturer's package insert and interview with the laboratory director (LD), the laboratory did not have written procedures for performing SARS-CoV-2 testing with the Quidel Solana SARS-CoV-2 assay. Findings: 1. The laboratory performs SARS-CoV-2 testing with the Quidel Solana SARS-CoV-2 assay. 2. During a tour of the laboratory at 10:30 AM on the day of the survey the LD explained the testing process, stating that after adding the patient specimen or control to the "Process Buffer Tube" the specimen is incubated in the heat block at 95 +/-2C and then placed in the refrigerator to cool for 15 minutes while the "Master Mix" thaws. 3. The laboratory did not have a written procedure for performing SARS-CoV-2 testing at the time of the survey. Upon request, the LD provided the manufacturer's package insert which was printed from the Quidel company website. 4. Review of the "Quidel Solana SARS-CoV-2 assay" package insert showed that after adding the patient specimen or control to the "Process Buffer Tube" and incubating the specimen in the heat block at 95 +/-2C there is a statement, "NOTE: Allow the heated Process Buffer Tubes to return to Room Temperature prior to addition to Master Mix." 5. The package insert did not instruct the testing person to put the specimen in the refrigerator. 6. During an interview on 03/30/2022 at 12:45 PM, the LD confirmed that the laboratory did not have a written procedure for performing SARS-CoV-2 testing. II: Based on review of the test manufacturer's package insert, quality control (QC) records, and interview with the laboratory director (LD), the laboratory did not follow manufacturer's procedures for performing QC when performing SARS-CoV-2 testing with the Quidel Solana SARS-CoV-2 assay. Findings: 1. During a tour of the laboratory at 10:30 AM on the day of the survey the LD explained the testing process, stating that the laboratory runs a positive and negative external control monthly, and that a positive control is run with the first batch/run of specimens each day. The LD stated that no other controls are run with each subsequent batch of patient specimens. 2. The laboratory did not have a written procedure for performing SARS-CoV-2 testing at the time of the survey. Upon request, the LD provided the manufacturer's package insert which was printed from the Quidel company website. 3. The "Quidel Solana SARS-CoV-2 assay" package insert was reviewed. The section, "Quality Control" states that "A positive control (such as a positive patient sample) should be processed and tested with each batch of specimens." 4. A review of QC records from 12/15/2021 to 3/30/2022 showed that positive and negative SARS-CoV-2 QC was run daily from 12/15/2021 through 12/21 /2021, once weekly from 12/28/2021 through 2/1/2022, and then again on 3/1/2022. 5. During an interview on 03/30/2022 at 12:45 PM, the LD confirmed that the laboratory did not follow the manufacturer's instructions for performing QC with the Quidel Solana SARS-CoV-2 assay. 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 -- 2 of 7 -- 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)

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 the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2130) Findings: Repeat Deficiency 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: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, the following analyte was noted as failed in the first event of 2020, 2019 2nd and 3rd event. The technical consultant (TC) was contacted by telephone on June 5, 2020 to cease testing the CELL I.D. OR WBC DIFF analyte and submit notification of when testing was ceased. As of June 19, 2020 the notification has not been received from the TC. Findings: 1. American Proficiency Institute 2020 1st event hematology CELL I.D. OR WBC DIFF 40% 2. American Proficiency Institute 2019 3rd event hematology CELL I.D. OR WBC DIFF 0% 3. American Proficiency Institute 2019 2nd event hematology CELL I.D. OR WBC DIFF 33% D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, the following analyte was noted as failed in the first event of 2020, 2019 2nd and 3rd event. Findings: Repeat Deficiency 1. American Proficiency Institute 2020 1st event hematology CELL I.D. OR WBC DIFF 40% 2. American Proficiency Institute 2019 3rd event hematology CELL I.D. OR WBC DIFF 0% 3. American Proficiency Institute 2019 2nd event hematology CELL I. D. OR WBC DIFF 33% 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program , the laboratory director failed to ensure the laboratory successfully participate in the API PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to 2130) Findings: Repeat Deficiency D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2127 and D2130) D2127 HEMATOLOGY CFR(s): 493.851(d) 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 -- Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, the following analyte was noted as failed in the 2019 3rd event. Findings: 1. American Proficiency Institute 2019 3rd event hematology overall score 0% 2. American Proficiency Institute 2019 3rd event CELL I.D. or WBC DIFF 0% 3. American Proficiency Institute 2019 3rd event HCT, non- waived 0% 4. American Proficiency Institute 2019 3rd event HGB, non-waived 0% 5. American Proficiency Institute 2019 3rd event WBC 0% 6. American Proficiency Institute 2019 3rd event Platelets 0% D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program, the laboratory failed to successfully participate in the API PT program for hematology testing, the following analyte was noted as failed in the 2019 2nd and 3rd event. Findings: 1. American Proficiency Institute 2019 2nd event hematology CELL I.D. OR WBC DIFF 33% 2. American Proficiency Institute 2019 3rd event hematology CELL I.D. OR WBC DIFF 0% 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 review of the federal proficiency testing data report and review of the comparative evaluation summery from American Proficiency Institute (API) proficiency testing (PT) program , the laboratory director failed to ensure the laboratory successfully participate in the API PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2127 and 2130) D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform -- 2 of 3 -- 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the written procedure manual, review of hematology quality control ((QC), and interview with the technical consultant (TC), the laboratory failed to ensure that hematology QC meet the laboratory's criteria of acceptability prior to performing patient testing(Refer to D5417); failed to ensure that hematology QC meet the laboratory's criteria of acceptability prior to releasing patient results (Refer to D5481); And failed to perform