Vascular Labs Of The Rockies Asc, Llc

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the laboratory manager. The facility was found to be out of compliance with the conditions of the CLIA program. The following condition level deficiencies were found to be out of compliance: 42 C.F. R. 493.803 Condition: Successful Participation [proficiency testing]; 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 routine desk review of the CMS-155 report for proficiency testing performance and phone communication with the laboratory manager, the laboratory failed to achieve satisfactory performance scores for the Wisconsin State Laboratory 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 -- of Hygiene proficiency testing for Hemoglobin (non-waived) for two out of three PT events, (event 1 in 2024 and event 3 in 2024). See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 routine desk review of the CMS-155 report for Proficiency Testing (PT) performance, and a phone call with the laboratory's manager, the laboratory failed to achieve a satisfactory score for two out of three Wisconsin State Laboratory of Hygiene (WSLH) PT events for the analyte: Hemoglobin (non-waived), for event 1 and event 3 in 2024. Findings include: 1. A review of the CMS-155 report for PT performance on February 7, 2025, at 9:33 AM, revealed the WSLH PT results for the analyte: Hemoglobin (non-waived), was 60% for event 1, and 0% for event 3 in 2024. 2. A phone call with the laboratory manager on March 21, 2025, at approximately 9: 40 AM, confirmed that the laboratory failed to achieve satisfactory PT scores for two out of three events for the following analyte: Hemoglobin (non-waived), for event 1 and event 3 in 2024. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a record view and an inteview with the laboratory's technical consultant (TC), the lab failed to follow the written policy for the evaluation of testing personnel competency, as well as establish a policy for technical consultant competency. The laboratory employs two testing personnel, one of which is also designated as the TC. Findings include: 1. A review of the lab's policies revealed the lack of a written policy for competency evaluation for consultants. 2. An interview with the TC on 12.19.2023 at 9:30AM confirmed that no policy for evualation of TC competency was in place. 3. A review of the lab's testing personnel competency assessments showed that competency evaluations were not signed off by a competent trainer, such as the LD or a TC with approved competencies. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. 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 4 -- Based on a laboratory observation and an interview with the laboratory's technical consultant (TC), the lab failed to label control and calibration materials with preparation and expiration dates. The laboratory performs 430 chemistry and hematology tests annually. Findings include: 1. Observation during a laboratory tour revealed that no preparation or expiration dates were written on opened QC or calibration reagents. 2. An interview with the TC on 12.19.2023 at 12PM confirmed that these dates were not written on materials when opened. 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: Based on record review and an interview with the laboratory's technical consultant (TC), the laboratory failed to regularly perform and document calibration verifications for the I-STAT instrument used for Blood Gas and Chemistry testing every six months, as required under CLIA regulations. The laboratory performs 230 chemistry and tests annually. Findings include: 1. A review of the lab's policies showed that there was no written policy for calibration verification. 2. A review of the lab's calibration verification logs revealed that since 2021 only one calibration verification was documented for Blood Gas (May 2023) and only two calibration verifications were documented for Chemistry (May 2023 and August 2022). 3. An interview with the TC on 12.19.2023 at 11AM confirmed that the lab had failed to perform calibration verifications every six months. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units -- 2 of 4 -- of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a record review and an interview with laboratoy's technical consultant (TC), the lab failed to list the address of the location where the test was performed. The laboratory performs 430 chemistry and hemotology tests annually. Findings include: 1. A record review of patient test reports showed that no address was listed. 2. An interview with the TC on 12.19.2023 at 12PM confirmed that the patient test report reviewed was all that would be sent to a patient upon request and did not list the address of the lab. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require