Vascular Access Services (Va Beach Endovascular)

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Vascular Access Services (Virginia Beach Endovascular) on October 9, 2024 by the Virginia Department of Health's Office of Licensure and Certification.. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: 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 a review of procedures, analyzer maintenance records, lack of documentation, and an interview, the laboratory failed to document performance of three of four required maintenance checks every six (6) months during the twenty-two (22) months of review (review timeframe: January 2023 - October 9, 2024). Findings include: 1. Review of the laboratory manual revealed procedures for non-waived Chemistry 8 (Sodium, Potassium, Chloride, Glucose, Urea Nitrogen, Calcium), Hematology Prothrombin Time with International Normalized Ratio, and Activated Clotting Time (ACT) utilizing the Abbott iSTAT analyzer. The iSTAT manufacturer's procedures outlined instructions to "perform iSTAT Thermal Probe Check every 6 months." 2. Review of the laboratory's iSTAT Thermal Probe maintenance logs from January 2023 to the date of the inspection on 10/09/24 revealed that documentation of the every 6 month maintenance checks outlined above was performed once in the 22 months reviewed (performed 1/10/23). The inspector requested to review additional thermal probe maintenance documentation. No additional records were available. 3. An exit interview with the laboratory's nurse clinical coordinator on 10/09/24 at 12:30 PM confirmed the above findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 An off-site CLIA proficiency test desk review was conducted for Vascular Access Services (Virginia Beach Endovascular) on September 7, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The desk review also included interviews with proficiency testing vendor representative, director of operations, and lead laboratory coordinator on 9/7/23, 9/8/23, and 9/11/23 respectively. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) 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 a review of Centers for Medicare and Medicaid Services (CMS) ASPEN 116 database, off-site proficiency testing (PT) desk review of the facility's 2023 PT documentation, and interviews, the laboratory failed to ensure Abbott iSTAT Chem 8 cartridge analytes Sodium (Na), Potassium (K), Chloride (CL), Glucose (GLU), and Urea Nitrogen (BUN) PT results were returned to College of American Pathologists (CAP) for one (1) of two (2) events reviewed for calendar year 2023. Findings include: 1. Review of the laboratory's CMS ASPEN 116 database for PT scores revealed the following analytes as reported with failed scores: Na, K, CL, GLU, and BUN for 2023 Event 2. 2. Review of the laboratory's CAP 2023 PT documentation (Events 1, 2) revealed that the laboratory failed to submit and received failure to participate scores for 2023 Event 2 for five (5) of 5 analytes: 2023 Critical Care iSTAT Chemistry Event 2 (AQI-B) 0% scores for Na, K, CL, GLU, and BUN. 3. An interview with CAP customer service representative on 9/7/23 at 1 PM revealed that the laboratory failed to submit results for 2023 Event B. An interview with facility's 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 -- laboratory coordinator and director of operations on 9/8/23 at 12 noon revealed that the laboratory had contacted CAP and ordered replacement PT challenges for 2023 Event 2 outlined above. 4. An interview with the facility's laboratory coordinator and director of operations on 9/11/23 at 11:30 AM confirmed the above findings. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services (CMS) CASPER 0096D report, proficiency testing (PT) records, and interviews, the laboratory director (LD) failed to ensure proper enrollment for five (5) of 5 nonwaived chemistry analytes Sodium (Na), Potassium (K), Chloride (CL), Glucose (GLU), and Urea Nitrogen (BUN) performed on the Abbott iSTAT analyzer for four (4) of 5 PT events reviewed for calendar years 2022 and 2023. Findings include: 1. A PT desk review of the laboratory's CASPER 0096D summary report revealed no reported PT scores for routine nonwaived regulated chemistry analytes Na, K, CL, GLU, and BUN for 2022 Events 1-3 and 2023 Event 1. The inspector noted that the CASPER 0096D reported 2023 Event 2 scores as Na 0%, K 0%, CL 0%, GLU 0%, BUN 0%. 2. Review of the laboratory's College of American Pathologists (CAP) PT submission records and results revealed that the laboratory submitted results under waived status for the 5 nonwaived analytes outlined above on the following events: 2022 Critical Care iSTAT Chemistry Event 1 (AQI-A); 2022 Critical Care iSTAT Chemistry Event 2 (AQI-B); 2022 Critical Care iSTAT Chemistry Event 3 (AQI-C); 2023 Critical Care iSTAT Chemistry Event 1 (AQI-A). The inspector inquired regarding the zero scored results for 2023 Critical Care iSTAT Chemistry Event 2 (AQI-B). The director of operations stated on 9/8/23 at 11 AM, "We did not receive the second kit due to a shipping problem and we contacted CAP. They sent us replacement PT samples. We will contact CAP to correct reporting code from waived to nonwaived. We were unaware CAP had changed anything regarding how to enter result codes." 3. An interview with the facility's laboratory coordinator and director of operations on 9/11 /23 at 11:30 AM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Vascular Access Services (Virginia Beach Endovascular) on January 25, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: 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 -- Based on a review of procedures, calibration verification records for the facility's Abbott iSTAT point of care chemistry analyzer, lack of documentation, and an interview, the laboratory failed to follow their six (6) month calibration verification protocol for eight (8) of 8 chemistry analytes in calendar years 2021 and 2022. Findings include: 1. Review of procedures revealed a policy to perform iSTAT calibration verification once every six months. 2. Review of the laboratory's 2021 and 2022 calibration verification records for Sodium (Na), Potassium (K), Chloride (Cl), TCO2, Ionized Calcium (iCa), Glucose (Glu), Urea Nitrogen (BUN)/Urea, and Creatinine (Creat) reported on the iSTAT analyzer (Serial Number 368216), revealed the following two records: 07/13/21 Calibration Validation study to establish reportable range performed and accepted by testing personnel (TP) and lab director (LD); 12/07/22 Calibration Verification performed and accepted by TP and LD. The inspector requested to review additional documentation of calibration verification for Na, K, Cl, TCO2, iCa, Glu, BUN, and Creat on the iSTAT performed in 2021 and 2022. No additional documentation was available for review. The charge nurse stated on 1/25/23 at approximately 11:30 AM, "We missed doing the every six month verifications because some times it was hard to get our reagents". 3. An exit interview with the charge nurse on 1/26/23 at approximately 12:30 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Vascular Access Services (Virginia Beach Endovascular) on February 23, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey included entrance interview on 02/11/2021 with initial virtual record review on 02/18/21. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The laboratory was not in compliance with the following Condition under 42 CFR part 493 CLIA Regulations: D6000- 42 CFR. 493.1403 Condition: Moderate Complexity Laboratory Director. Specific deficiencies cited are as follows. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records and an interview, the laboratory failed to document evaluation of results and

Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA proficiency testing (PT) desk review was conducted for Vascular Access Services, PLLC on April 3rd and April 6, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 off-site desk review of the laboratory's College of American Pathologists proficiency testing (PT) records (2019 Third Event, 2020 First Event) and interviews, the laboratory failed to attain a score of at least eighty percent of acceptable responses 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 -- for Prothrombin Time and International Normalized Ratio in two consecutive Hematology testing events resulting in unsuccessful PT performance. See 2130. 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 a review of proficiency testing (PT) records and interviews, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for Prothrombin Time with International Normalized Ratio (INR) on two (2) consecutive Hematology testing events reviewed, resulting in unsuccessful PT performance. Findings include: 1. An unannounced off-site desk review of the laboratory's College of American Pathologists (CAP) Hematology Whole Blood WP3 module PT records (2019 Event 3, 2020 Event 1) revealed scores of less than 80% for the following 2 consecutive events: 2019 Event 3: Prothrombin Time with INR score 0% (failure to participate); 2020 Event 1: Prothrombin Time with INR score 60% (specimen WP3- 02 and WP3-05 scored as unacceptable); resulting in an unsuccessful PT performance. 2. In an email correspondence with the clinical coordinator on 04/03/20 at approximately 3:00 PM, and a telephone interview and email with CAP technical support specialist on 04/06/20 at approximately 9:00 AM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Vascular Access Services, PLLC on October 25, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 laboratory's 2017 and 2018 College of American Pathologists (CAP) proficiency testing (PT) records and interview with the practice manager on October 25, 2018, it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for hemoglobin in four (4) out of 4 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 -- iSTAT AQI testing events reviewed resulting in unsuccessful PT performance. (Cross Reference D 2130.) 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 pre-survey checks, proficiency testing (PT) records, and interviews, the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for hemoglobin in four (4) of 4 iSTAT AQI testing events reviewed resulting in unsuccessful PT performance. **REPEAT DEFICIENCY Findings include: 1. In a pre-survey preparation review of the Centers for Medicare and Medicaid Services (CMS) Casper 0096 D report, the inspector noted the laboratory failed to attain a score of at least eighty (80) percent for hemoglobin in seven (7) of 7 testing events from 2016 to 2018. A pre-survey review of an off-site CLIA PT Desk Review performed on May 3, 2017, revealed that the laboratory was cited for failing to attain a score of at least 80 % of acceptable responses for hemoglobin for the following College of American Pathologists (CAP) events: 2016 3rd Event - score of 0% 2017 1st Event - score of 0% 2. Review of the laboratory's CAP PT record book on the day of the inspection, 10/25/18, revealed hemoglobin scores of less than 80% were reviewed by the lab director for the following Hematology events: 2017 2nd event - score of 0%, 2017 3rd event - score of 0%, 2018 1st event - score of 0%, 2018 2nd event - score of 0%. 3. The inspector asked the practice manager at approximately 1:00 PM to describe the