Ocean Avenue Medical Practice 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 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 test analyte Thyroid Stimulating Hormone (TSH) The following scores were assigned: 2018 first event = 60% 2018 second event = 60% 2018 third event = 100% 2019 first event = 0% This is considered repeatedly unsuccessful PT performance. Refer to D2107. D2087 ROUTINE CHEMISTRY 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 -- 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 a PT desk review of the CMS PT reports review of PT records from the CAP PT program, it was determined that the laboratory failed to successfully participate in a PT program approved by the CMS for the test analytes Amylase and Sodium. Amylase: 2019 first event = 0% Sodium: 2019 first event = 20% This is considered an 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: Based on a PT desk review of the CMS PT reports and PT records from CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte serum Human Chorionic Gonadotropin (hCG). 2019 first event = 0% This is considered a unsatisfactory PT performance. D2099 ENDOCRINOLOGY CFR(s): 493.843(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 a PT desk review of the CMS PT reports and PT records from CAP PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the subspecialty Endocrinology. 2019 first event = 66% This is considered a 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 Thyroid Stimulating Hormone (TSH). The following scores were assigned: 2018 first event = 60% 2018 second event = 60% -- 2 of 4 -- 2018 third event = 100% 2019 first event = 0% This is considered repeatedly unsuccessful PT performance. D2109 TOXICOLOGY CFR(s): 493.845(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 Lithium. The following scores were assigned: 2019 first event = 0% This considered unsatisfactory PT performance. D2110 TOXICOLOGY CFR(s): 493.845(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 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 subspecialty Toxicology. The following scores were assigned: 2019 first event = 0% This considered unsatisfactory 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 PT CMS data reports 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, for the subspecialties Endocrinology and Toxicology, and the test analytes TSH, hCG, Amylase, Sodium and Lithium. 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; -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on PT desk review of the PT CMS data reports 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, for the subspecialties Endocrinology, Toxicology and the test analytes TSH, hCG, Amylase, Sodium and Lithium. Thyroid Stimulating Hormone (TSH) The following scores were assigned: 2018 first event = 60% 2018 second event = 60% 2018 third event = 100% 2019 first event = 0% This is considered repeatedly unsuccessful PT performance. Endocrinology 2019 first event = 66% This is considered a unsatisfactory PT performance. hCG/Amylase/ Toxicology and Lithium 2019 first event = 0% This is considered a unsatisfactory PT performance. Sodium 2019 first event = 20% This is considered a 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 the surveyor's review of CAP proficiency testing ( PT) records and an interview with the technical consultant, 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 first event = 60% 2018 second event = 60% This is considered unsuccessful PT performance. REFER TO: D2107 D2107 ENDOCRINOLOGY CFR(s): 493.843(f) 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 -- 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 the surveyor's review of College of American Pathologists (CAP) Proficiency Testing (PT) test reports, the laboratory failed to participate and perform successfully in a PT program approved by the Centers for Medicare and Medicaid Services (CMS) for the test analyte Thyroid Stimulating Hormone (TSH). The following scores were assigned: 2018 first event = 60% 2018 second event = 60% 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 the surveyor's review of proficiency testing (PT) records from the CAP PT program and confirmed with the technical consultant, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved satisfactory performance and successfully participated in a PT program, approved by CMS, for the analyte 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 the surveyor's review of the CAP PT program records and confirmed with the technical consultant, the laboratory director failed to ensure that the laboratory successfully participated in a PT program for the test analyte Thyroid Stimulating Hormone (TSH). The following scores were assigned: 2018 first event = 60% 2018 second event = 60% This is considered unsuccessful PT performance. Refer to: D2107 -- 2 of 2 --