Brunswick Urgent Care

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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Hematology tests performed with the American Academy of Family Physicians (AAFP). The finding includes: 1) The laboratory scored 60% for Lymphocyte, 0% for Monocyte/Mixed and 0% for Monocyte/Mixed Absoloute for event 2-2021 with the AAFP. 2) The laboratory scored 20% for Lymphocyte, 60% for Monocyte/Mixed and 60% for Monocyte/Mixed Absoloute for event 3-2020 with the AAFP. D2130 HEMATOLOGY 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 -- 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 an office review of the proficecny testing provider reports and CASPER reports 153 and 155 and Proficiency Testing (PT), the laboratory failed to achieve a score of 80% or more in two out of three event for for Hematology tests performed with American Academy of Family Physicians (AAFP). The finding includes: 1) The laboratory scored 60% for Lymphocyte, 0% for Monocyte/Mixed and 0% for Monocyte/Mixed Absoloute for event 2-2021 with the AAFP. 2) The laboratory scored 20% for Lymphocyte, 60% for Monocyte/Mixed and 60% for Monocyte /Mixed Absoloute for event 3-2020 with the AAFP. 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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the Laboratory Director (LD) failed to provide appropriate direction to laboratory personnel to ensure that the PT surveys are performed satisfactorily and that the laboratory is in compliance with the CLIA regulations. -- 2 of 2 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to attain at least 80% or more for Hematology test performed on the Horiba ABX Micros 60 analyzer with the American Association of Bioanalysts. The finding includes: 1. The laboratory scored 60% for Hematocrit the first event of 2018. 2. The TP #1 listed on CMS form 209 confirmed on 9/18/18 at 1130 am the laboratory failed to achieve at least 80% for Hematology testing. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to undertake appropriate training and 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 -- employ technical assistance necessary to correct problems associated with PT failures performed with the American Association of Bioanalysts (AAB). The findings include: 1. There was no remedial action taken and documented for unacceptable Hematocrit result in 1-2018 event. 2. The TP #1 listed on CMS form 209 confirmed on 9/18/18 at 1130 am that