Robinhood Integrative Health, Pllc

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on review of 2020, 2021, and 2022 American Proficiency Institute (API) proficiency testing (PT) records and interview with the off-site consultant 2/22/23, the laboratory failed to verify the accuracy of their carbon dioxide (CO2) testing at least twice a year in 2021 and 2022. Findings: Review of 2021 and 2022 API PT records revealed graded results for the Chemistry Core module did not include results for CO2. There was no documentation available to indicate that the laboratory performed any other activity to verify the accuracy of the CO2 testing performed during 2021 or 2022. During interview at approximately 1:30 p.m., the off-site consultant stated that the laboratory was enrolled in proficiency testing for CO2 and the samples were tested as part of the panel, but the results were not submitted to API. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2020, 2021, and 2022 API PT records, and interview with testing personnel (TP) #1 on 2/22/23, proficiency samples were not tested in the same manner as patient specimens for 10 of 11 testing events in 2022. Findings: Review of the laboratory's "Proficiency Testing Policy" revealed "... Analyze samples within the time provided by the testing agency treating all PT samples in the same manner as a patient sample. ..." Review of the laboratory's "General Laboratory Systems Quality Management Policy" revealed "... Proficiency Testing PT samples are handled and tested exactly like patient specimens. ..." Review of 2022 API PT records revealed proficiency samples were tested multiple times and on multiple days for 10 of 11 testing events. Patient samples were routinely tested only once. Examples: 1. 2022 1st Chemistry Core - routine chemistry samples tested 1/14/22, 1/18/22, 1/19/22. 2. 2022 1st Hematology test event - hematology samples tested 3/10/22, 3/11/22, 3/14/22. 3. 2022 2nd Hematology test event - hematology samples tested 3 times on 7/20/22. 4. 2022 2nd Immunology test event - C-Reactive Protein (CRP) samples tested 8/8/22, 8/9/22, 8/10/22. 5. 2022 2nd Chemistry Miscellaneous test event - testosterone samples tested 2 times on 10/13/22 and 1 time on 10/14/22. During interview at approximately 12:40 p.m., TP #1 confirmed the proficiency samples were tested multiple times. She stated she repeats the testing of proficiency samples if results are abnormal. She stated she also wants to make sure precision is there before reporting. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory procedure, review of laboratory verification of performance records and interview with laboratory manager 2/22/23, the laboratory failed to retain documentation of the verification of performance of the laboratory information system (LIS) Lab -Trak when testing began in August of 2020 and when the laboratory changed locations in November of 2022. The laboratory also failed to retain documentation of the verification of performance for the testing performed on the Medica Easy RA and the Tosoh A1A 2000 analyzers when the laboratory changed locations in November of 2022. 1. The laboratory failed to retain documentation of the verification of performance of the LIS Lab-Trak when testing began in August of 2020 and when the laboratory changed location in November of 2022. Findings: Review of laboratory procedure "LIS Data and Result Transfer Verification" revealed "Policy: Data such as patient demographics, test name, units of measure, and normal ranges will be confirmed for accuracy when said information is transferred electronically from the analyzers to the LIS....Audits will be performed at: Installation of the LIS. Six(6) month intervals for the first year. Annually each yearly following. When any major change occurs with testing procedures or LIS updates.". Review of laboratory verification of performance records revealed no documentation the LIS Lab-Trak was verified when the laboratory began testing in August of 2020 and when the laboratory changed locations in November of 2022. Interview with laboratory manager at approximately 2:00 p.m. confirmed the laboratory failed to retain the -- 2 of 6 -- documentation of the verification of the LIS Lab-Trak performed in August of 2020 and November of 2022. She stated the verification was performed but the laboratory was unable to locate the documentation. 2. The laboratory failed to retain documentation of the verification of performance for the testing performed on the Medica Easy RA and the Tosoh A1A analyzers when the laboratory changed locations in November of 2022. Findings: Review of laboratory procedure "Quality Control and Calibrations Procedure" revealed "All calibrations must be documented as to when they were performed, who performed them, and whether they were acceptable or not.". Interview with laboratory manager at approximately 1:30 p.m. confirmed the laboratory failed to retain documentation of the verification of performance for the testing performed on the Medica Easy RA and the Tosoh A1A analyzers when the laboratory moved to a new location in November of 2022. She stated calibrations were performed after the analyzers were moved but they were unaware documentation of the calibrations should be retained. 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)

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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2022 API (American Proficiency Institute) proficiency testing results 8/31/22, the laboratory failed to successfully participate in proficiency testing for chloride, glucose, and sodium in two consecutive testing events. See the deficiency cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 desk review of CMS Casper reports 153D and 155D 8/31/22 and desk review of 2022 API proficiency testing results 8/31/22, the laboratory failed to achieve satisfactory performance for chloride, glucose, and sodium in two consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper report 155D and 2022 API proficiency testing results revealed the laboratory received the following unsatisfactory scores on the 2022 Chemistry Core 1st event: a. chloride 40% b. glucose 20% c. sodium 20% 2. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory received the following unsatisfactory scores on the 2022 Chemistry Core 2nd event: a. chloride 0% b. glucose 20% c. sodium 60% 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 desk review of CMS Casper reports 153D and 155D and desk review of 2022 API proficiency testing results 8/31/22, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at D6016. 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: Based on desk review of CMS Casper reports 153D and 155D and desk review of 2022 API proficiency testing results 8/31/22, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2022 API proficiency testing results revealed the laboratory received the following unsatisfactory scores on the 2022 Chemistry Core 1st event: a. chloride 40% b. glucose 20% c. sodium 20% 2. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory received the following unsatisfactory scores on the 2022 Chemistry Core 2nd event: a. chloride 0% b. glucose 20% c. sodium 60% -- 2 of 2 --