Brookhaven Health And Wellness 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider ) on 8/30/18, the laboratory has not successfully participated in proficiency testing for RED BLOOD CELL COUNT (RBC) and HEMATOCRIT. Findings include: Our records indicate the following proficiency testing scores for your laboratory for RED BLOOD CELL and HEMATOCRIT. PROFICIENCY TESTING PROVIDER: AAB RBC HEMATOCRIT Year 2017 2nd Event 0% 0% Did not participate Year 2018 1st Event 0% 0% Did not participate Year 2018 2nd Event 40% 40% Scored 40% on each Scores less than 80% for these analytes or parameters indicate failure for 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 -- unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial unsuccessful performance. 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider ) on 8/30/18, the laboratory has not successfully participated in proficiency testing for RED BLOOD CELL COUNT (RBC) and HEMATOCRIT. Findings include: Our records indicate the following proficiency testing scores for your laboratory for RED BLOOD CELL and HEMATOCRIT. PROFICIENCY TESTING PROVIDER: AAB RBC HEMATOCRIT Year 2017 2nd Event 0% 0% Did not participate Year 2018 1st Event 0% 0% Did not participate Year 2018 2nd Event 40% 40% Scored 40% on each Scores less than 80% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider ) on 8/30/18, the laboratory has not successfully participated in proficiency testing for RED BLOOD CELL COUNT (RBC) and HEMATOCRIT. Findings include: Our records indicate the following proficiency testing scores for your laboratory for RED BLOOD CELL and HEMATOCRIT. PROFICIENCY TESTING PROVIDER: AAB RBC HEMATOCRIT Year 2017 2nd Event 0% 0% Did not participate Year 2018 1st Event 0% 0% Did not participate Year 2018 2nd Event 40% 40% Scored 40% on each Scores less than 80% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial unsuccessful performance. 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 -- 2 of 3 -- 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider ) on 8/30/18, the laboratory has not successfully participated in proficiency testing for RED BLOOD CELL COUNT (RBC) and HEMATOCRIT. Findings include: Our records indicate the following proficiency testing scores for your laboratory for RED BLOOD CELL and HEMATOCRIT. PROFICIENCY TESTING PROVIDER: AAB RBC HEMATOCRIT Year 2017 2nd Event 0% 0% Did not participate Year 2018 1st Event 0% 0% Did not participate Year 2018 2nd Event 40% 40% Scored 40% on each Scores less than 80% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial unsuccessful performance. -- 3 of 3 --

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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the Proficiency Testing Provider) on 8/9/18, the laboratory had not successfully participated in proficiency testing for Hematology. Findings include: Our records indicate the following proficiency testing scores for your laboratory for Hematology: Proficiency Testing Provider: AAB Hematology: Year 2017 - 2nd Event: 0% Year 2018 - 1st Event: 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. 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 -- D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the Proficiency Testing Provider) on 8/9/18, the laboratory had not successfully participated in proficiency testing for Hematology. Findings include: Our records indicate the following proficiency testing scores due to failure to participate for your laboratory for Hematology: Proficiency Testing Provider: AAB Hematology: Year 2017 - 2nd Event: 0% Year 2018 - 1st Event: 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Failure to participate is considered unsatisfactory performance. 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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the Proficiency Testing Provider) on 8/9/18, the laboratory had not successfully participated in proficiency testing for Hematology. Findings include: Our records indicate the following proficiency testing scores for your laboratory for Hematology: Proficiency Testing Provider: AAB Hematology: Year 2017 - 2nd Event: 0% Year 2018 - 1st Event: 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --