Accordia Urgent Care And Family Practice

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 19, 2022. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780 resulting in the 2nd unsuccessful PT performance. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory 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 -- performance in four (4) consecutive events (2021 events 1, 2, 3, and 2022 event 1 ), resulting in the second unsuccessful occurrence for Cell ID/WBC diff #0765. Findings include: Refer to 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 the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in four consecutive testing events (2021# 1, 2, 3, and 2022 #1), resulting in the second unsuccessful performance for Cell ID or WBC Diff, analyte # 765. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #756, Cell ID or WBC Diff on Event 1 of 2021 with a score of 20%, Event 2 of 2021 with a score of 53%, Event #3 with a score of 53% and & Event 1 of 2022 with a score of 67%.. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirms the laboratory failed Cell ID or WBC Diff on the aforementioned events, resulting in the second unsuccessful performance. 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: The laboratory director failed to maintain compliance with successful white blood cell (WBC) differential proficiency testing (PT) for four (4) consecutive events resulting in the second unsuccessful PT occurrence for WBC differential. Findings include: Refer to 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 a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2021 and 2022 proficiency testing (PT) evaluation reports, the laboratory director failed to ensure the laboratory maintained satisfactory -- 2 of 3 -- performance for four (4) consecutive proficiency testing events for the automated white blood cell (WBC) differential resulting in the second unsuccessful PT occurrence for WBC differential. The findings include: 1. Review of the CMS 155 revealed the following unsatisfactory automated WBC differential scores: 2021 event 1=20%, 2021event 2= 53% , 2021 event 3= 53%, and 2022 event 1= 67%. 2. Review of the 2022 event one evaluation report revealed unacceptable scores for WBC differential resulting in the second PT occurrence for WBC differential #765. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on February 28, 2022. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (1st event of 2016 and 3rd event of 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 -- 2016), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) #765. Findings include: Refer to 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to maintain satisfactory performance in three of five consecutive events (1st, 2nd, and 3rd events of 2021), resulting in the first unsuccessful occurrence for wbc diff #765. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte wbc diff #765 on events 1, 2, and 3 of 2021 with scores of 20%, 53%, and 53% consecutively. 2. Desk review of the laboratory's proficiency testing reports from API confirms the laboratory failed wbc diff #765 on events 1,2, and 3 of 2021 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in three of five consecutive events (1st, 2nd, and 3rd events of 2021), resulting in the first unsuccessful occurrence for wbc diff #765. . Findings include: Refer to D 6016 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory -- 2 of 3 -- maintained satisfactory performance in three of five consecutive events (1st, 2nd, and 3rd events of 2021), resulting in the first unsuccessful occurrence for wbc diff #765. . Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte wbc diff #765 on events 1, 2, and 3 of 2021 with a scores of 20%, 53%, and 53%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed wbc diff #765 on Events 1, 2, and 3 of 2021, resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on June 12, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 review of the Calibration records, and staff interview, the Laboratory failed 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 -- to calibrate the Horiba Micros 60, Hematology Analyzer every six months. Findings: 1. Review of the calibration records for the Horiba Micros 60, Hematology Analyzer, showed that calibrations were performed on the following dates: 1-4-17 7-13-17 - six months 2-5-18 - seven months 9-1-18 - seven months 4-5-19 - seven months 2. Interview with staff #6 (CMS 209 form), on 6/12/19, at approximately 5 pm in the facility break room, confirmed the dates of calibration, as listed above. -- 2 of 2 --