Wmg Urgent Care Cherokee Health Park

Summary Statement of Deficiencies D0000 On November 09, 2021 an off site followup review was completed. The report revealed that

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on June 10, 2021. 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 American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in five consecutive events (Event 3 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 -- 2019 ; Events 1, 2 and 3 of 2020; Event 1 and 2 of 2021), resulting in the second unsuccessful occurrence for Cell I.D./WBC Diff #0765. The findings include: Refer to D2130 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 American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in five consecutive events (Event 3 of 2019; Events 1, 2 and 3 of 2020; Event 1 and 2 of 2021), resulting in the second unsuccessful occurrence for Cell I.D./WBC Diff #0765. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Cell I.D. /WBC Diff #0765 on Event 3 of 2019 with a score 20%, and Event 1 of 2020 with score 53%, Event 2 of 2020 with a score 0%, Event 3 of 2020 with a score of 60%, Event 1 of 2021 with a score of 53% and Event 2 of 2021 with a score of 33%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed Cell I.D./WBC Diff on Event 3 of 2019; Events 1, 2 and 3 of 2020; and Event 1 and 2 of 2021 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: 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 American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in five consecutive events (Event 3 of 2019; Events 1, 2 and 3 of 2020; and Event 1 and 2 of 2021), resulting in the second unsuccessful occurrence for Cell I.D./WBC Diff #0765 in the specialty of Hematology. The 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; -- 2 of 3 -- 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 American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in five consecutive events (Event 3 of 2019; Events 1, 2 and 3 of 2020; Event 1 and 2 of 2021), resulting in the second unsuccessful occurrence for Cell I.D./WBC Diff #0765 in the specialty of Hematology. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Cell I.D./WBC Diff #0765 on Event 3 of 2019 with a score 20%, and Event 1 of 2020 with score 53%, Event 2 of 2020 with a score 0%, Event 3 of 2020 with a score of 60%, Event 1 of 2021 with a score of 53% and Event 2 of 2021 with a score of 33% . 2. Desk review of the laboratory's proficiency testing reports from the American Proficiency Institute (API) confirmed the laboratory failed analyte #0765 Cell I.D./WBC Diff for Event 3 of 2019; Events 1, 2 and 3 of 2020, and Event 1 and 2 of 2021 resulting in the second unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 25, 2021. 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 American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in four consecutive events (Event 3 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 -- 2019 and Events 1, 2 and 3 of 2020), resulting in the first unsuccessful occurrence for Cell I.D./WBC Diff #0765. The findings include: Refer to D2130 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 American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in four consecutive events (Event 3 of 2019 and Events 1, 2 and 3 of 2020), resulting in the first unsuccessful occurrence for Cell I.D./WBC Diff #0765. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Cell I.D./WBC Diff #0765 on Event 3 of 2019 with a score 20%, and Event 1 of 2020 with score 53%, Event 2 of 2020 with a score 0%, and Event 3 of 2020 with a score of 60%. 2. The criteria for acceptable performance for the specialty of Hematology is a score of 80%. 3. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed Cell I.D./WBC Diff on Event 3 of 2019 and Events 1, 2 and 3 of 2020 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 American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in four consecutive events (Event 3 of 2019 and Events 1, 2 and 3 of 2020), resulting in the first unsuccessful occurrence for Cell I.D./WBC Diff #0765 in the specialty of Hematology. The 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; -- 2 of 3 -- 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 American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in four consecutive events (Event 3 of 2019 and Events 1, 2 and 3 of 2020), resulting in the first unsuccessful occurrence for Cell I.D./WBC Diff #0765 in the specialty of Hematology. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Cell I.D./WBC Diff #0765 on Event 3 of 2019 with a score 20%, and Event 1 of 2020 with score 53%, Event 2 of 2020 with a score 0%, and Event 3 of 2020 with a score of 60%. 2. The criteria for acceptable performance for the specialty of Hematology is 80%. 3. Desk review of the laboratory's proficiency testing reports from the American Proficiency Institute (API) confirmed the laboratory failed analyte #0765 Cell I.D./WBC Diff for Event 3 of 2019 and Events 1, 2 and 3 of 2020 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 April 11, 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: D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on Personnel competency records review and an interview with the Technical Consultant (TC), (TP # 3 CMS 209), the (TC) failed to perform annual competencies on two physicians performing PPM Microscopy. Findings include: 1. Annual competencies were not performed on the two physicians (TP #8 and #9 CMS 209) performing PPM microscopy in 2017 and 2018. 2. An interview with the Technical Consultant (TP #3 CMS 209) on April 11, 2019 in the review room at approximately 11:45 a.m. confirmed annual competencies were not performed on the physicians by the TC in 2017 and 2018. 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 --