Bay Parkway Physicians Pc

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 proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the College of American Pathologist (CAP) PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Hematology and the test analyte's White Blood Cell count (WBC), Red Blood Cell Count (RBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet and Cell Identification (Cell I.D.)/White Blood Cell Differential (WBC Diff.). The following scores were assigned: 2020 second event = 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 -- 0% (incorrect response) 2020 third event =100% 2021 first event = 0% (non- participation) This is considered unsuccessful PT performance. Refer to D2130 and D3131. D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 PT desk review of the CMS PT data reports and PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analytes Hepatitis B surface Antigen (HBsAg ), Anti-Human Immunodeficiency Virus (HIV) and Hepatitis B Core Antibody (Anti-HBc). The following score was assigned: 2021 first event = 0% This is considered unsatisfactory PT performance. D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT data reports and PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the speciality General Immunology. The following scores was assigned: 2021 first event = 0% This is considered unsatisfactory performance. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 PT desk review of the CMS PT data reports and PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Total Iron. The following score was assigned: 2020 second event = 40% This is considered unsatisfactory PT performance. D2098 ENDOCRINOLOGY CFR(s): 493.843(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: -- 2 of 4 -- Based on PT desk review of the CMS PT data reports and PT records from the CAP PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Thyroxine (TT4). The following score was assigned: 2020 second event = 60% This is considered unsatisfactory PT 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 proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the College of American Pathologist (CAP) PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Hematology and the test analyte's White Blood Cell count (WBC), Red Blood Cell Count (RBC), Hemoglobin (Hgb), Hematocrit (Hct), Platelet and Cell Identification (Cell I.D.)/White Blood Cell Differential (WBC Diff.). The following scores were assigned: 2020 second event = 0% (incorrect response) 2020 third event =100% 2021 first event = 0% (non- participation) This is considered unsuccessful PT performance. Refer to D2130 and D3131 D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the College of American Pathologist (CAP) PT program, the laboratory failed to participate successfully in proficiency testing for the speciality Hematology. The following scores were assigned: 2020 second event = 0% (incorrect response) 2020 third event =100% 2021 first event = 0% (non-participation) This is considered unsuccessful PT 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 PT desk review of the CMS PT and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in -- 3 of 4 -- a PT program, approved by CMS, for the speciality Hematology, General Immunology and the test analyte's WBC, RBC, Hgb, Hct, Platelet, Cell I.D./WBC Diff , HBsAg, HIV, Anti-HBc, TT4 and Total Iron. 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 PT desk review of the CMS PT and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the speciality Hematology, General Immunology and the test analyte's WBC, RBC, Hgb, Hct, Platelet, Cell I.D./WBC Diff , HBsAg, HIV, Anti-HBc, TT4 and Total Iron. The following scores were assigned: Speciality Hematology and WBC, RBC, Hgb, Hct, Platelet, Cell I.D./WBC Diff 2020 second event = 0% (incorrect response) 2020 third event =100% 2021 first event = 0% (non-participation) This is considered unsuccessful PT performance. The following score was assigned: Speciality General Immunology and HBsAg, HIV and Anti-HBc 2021 first event = 0% Thyroxine 2020 second event = 60% Total Iron 2020 second event = 40% This is considered unsatisfactory PT performance. -- 4 of 4 --

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 a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT reports and PT records from the College of American Pathologists (CAP) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty Endocrinology and the test analyte Triiodothyronine (T3). The following scores were assigned: Endocrinology 2018 first event = 70% 2018 second event = 75% 2018 third event = 55% Triiodothyronine-T3 2018 first event = 0% 2018 second event = 0% 2018 third event = 20% This is considered repeatedly unsuccessful PT performance. Refer to D2107 and D2108. 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 -- D2098 ENDOCRINOLOGY CFR(s): 493.843(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 a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Thyroid Stimulating Hormone (TSH). The following scores were assigned: 2018 third event = 0% This is considered unsatisfactory PT performance. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Triiodothyronine (T3). The following scores were assigned: 2018 first event = 0% 2018 second event = 0% 2018 third event = 20% This is considered repeatedly unsuccessful PT performance. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a PT desk review of the CMS PT reports and PT records from the CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty Endocrinology. The following scores were assigned: Endocrinology 2018 first event = 70% 2018 second event = 75% 2018 third event = 55% This is considered repeatedly unsuccessful PT 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: -- 2 of 3 -- Based on PT desk review of the CMS PT and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialty Endocrinology and the test analytes T3 and TSH. 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 PT desk review of the CMS PT and CAP PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialty Endocrinology the test analytes T3 and TSH. The following scores were assigned: Endocrinology 2018 first event = 70% 2018 second event = 75% 2018 third event = 55% Triiodothyronine-T3 2018 first event = 0% 2018 second event = 0% 2018 third event = 20% This is considered repeatedly unsuccessful PT performance. Thyroid Stimulating Hormone (TSH). 2018 third event = 0% This is considered unsatisfactory PT performance. -- 3 of 3 --