Vita Medical Associates Pc

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) policy, American Proficiency Institute (API) PT records, and interview with Testing Personnel (TP)#1 (CMS 209 personnel #1) the laboratory failed to verify the accuracy of the PT results obtained for 2 of 3 API PT hematology/coagulation testing events performed in 2023 and 1 of 3 API PT chemistry testing event performed in 2024. Findings Include: 1. The laboratory's Proficiency testing policy states, "We will grade any proficiency testing challenge that is not officially graded by the proficiency testing program due to a lack of participant consensus or any other reason, because we did not participate (instrumentation down, for example), or because our results were late. We will respond to this score in the same manner we respond to an official score." 2. On the day of survey, 03/25/2025 at 9:13 am., review of the laboratory's API PT records revealed that the laboratory failed to verify the accuracy for the following analytes that were not scored by the PT agency in 2023 and 2024: API 2023 Hematology /Coagulation - 1st event: Lymphocytes (%) DXH-04 - 3rd event: Lymphocytes (%) DXH-11, DXH-14 API 2024 Chemistry Core - 1st event: Bilirubin, total CH-02, CH- 03, CH-05 3. TP #1 confirmed the findings above on 03/25/2025 at 1:10 pm. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(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 -- All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assessment Plan (QAP) for Proficiency Testing (PT), American Proficiency Institute (API) PT records, and interview with Testing Personnel (TP)#1 (CMS 209 personnel #1), the laboratory failed to document the evaluation and verification activities performed for 2 of 3 API PT chemistry testing events in 2023 and for 2 of 3 API PT chemistry testing events and 1 of 3 API PT hematology/coagulation testing event in 2024. Findings include: 1. The laboratory's QAP for PT states, "The director will carefully evaluate any unacceptable, unsatisfactory, or unsuccessful proficiency testing result in an effort to identify the cause of failure. If a cause is found, we will take necessary

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of documentation, and interview with testing personnel #1 (TP), the laboratory failed to assess the maintenance/ function checks for 4 of 4 pipettes used for chemistry and hematology testing in the laboratory from 1/29/2021 to the day of survey. Findings Include: 1. On the day of survey, 03/23 /2023 at 01:25 pm, the laboratory could not provide maintenance/function check records for the following 4 of 4 pipettes used from 01/29/2021 to 03/23/2023: - Diamond Pro 1000 microliter pipette S/N: RC694399. -Eppendorf Research 1000 microliter pipette S/N: 2252649 - Eppendorf Research 100-1000 microliter pipette S /N: RE768387. -Eppendorf Research 100 microliter pipette S/N: 3756329. 2. The laboratory performed 67,500 tests in 2022 (CMS 116 annual volume). 3. TP #1 confirmed the findings above on 03/23/2023 around 2:30 pm. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) 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 -- Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based upon review of the Beckman Coulter DxH 520 calibration records, laboratory procedure manual, and interview with testing personnel #1 (TP), the laboratory failed to perform calibrations on the Beckman Coulter DxH 520 analyzer used to perform complete blood count (CBC) tests from 02/23/2022 to the date of the survey. Findings Include: 1. The laboratory's Hematology Procedure states, "calibration is performed every 6 months or when advised by Coulter representative". 2. On the day of the survey, 03/17/2023 at 12:30 pm, review of the Beckman Coulter DxH 520 analyzer calibration records revealed the laboratory did not perform calibrations every 6 months as per their policy on the Beckman Coulter DxH 520 analyzer from 02/23 /2022 to 03/17/2023. 3. TP #1 confirmed the finding above on 03/17/2023 around 02: 30 pm. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of the laboratory's quality assurance (QA) documents and interview with testing personnel #1 (TP), the laboratory director (LD) failed to ensure QA programs were maintained and documented to assure the quality of laboratory services provided from September 2022 to the date of the survey. Findings Include: 1. On the day of survey, 03/23/2022 at 01:19 pm, the laboratory could not provide QA documentation of the periodic evaluation used by the laboratory to assess its preanalytical, analytical, and postanalytical processes from September 2022 to March 2023. 2. TP #1 confirmed the findings above on 03/23/2023 around 02:30 pm. -- 2 of 2 --

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 a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte Sodium. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in a proficiency testing for the analyte: Sodium, which is in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 1st event of 2020 and the 3rd event of 2020. Findings include: Analyte Year Event Score Sodium 2020 1 60%. Sodium 2020 3 60%. -- 2 of 2 --