Ocean Parkway Pediatric Practice Pc

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on the review of the Cobas Liat manufacturer's requirements, the absence of temperature monitoring, lack of temperature and relative humidity (RH) records, and interviews with the laboratory director and testing person, the laboratory failed to monitor and document the temperatures and RH for the area where patient testing and reagent storage occurred. Findings: 1. The Cobas Liat manufacturer's requirements indicated temperature range of 15C - 32C (59F - 89.6F) and RH range of 15% - 80%. 2. The OSOM reagent manufacturer's requirements indicated temperature range of 15C - 30C (59F - 86F). 3. Approximately 500 patients were tested each year during which the temperatures and RH were not monitored and documented. 4. Confirmed the findings by interview with the testing person and laboratory director on August 17, 2023, at 11:00 A.M. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on the review of Hardy Diagnostics SSA plate manufacturer's requirements, the laboratory procedure manual, lack of temperature records, and interviews with the laboratory director and testing person, the laboratory failed to document temperatures of the refrigerator where SSA plates were stored. Findings: 1. The Hardy Diagnostics SSA plate manufacturer's requirements indicated storage temperature range of 2C - 8C (35.6F - 46.4F). 2. Although a refrigerator thermometer was present, no temperatures were documented for 2021, 2022, and 2023. 3. Approximately 500 patients were tested each year during which the temperatures were not documented. 4. Confirmed the findings by interview with the testing person and laboratory director on August 17, 2023, at 11:00 A.M. -- 2 of 2 --

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 American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in proficiency testing for the sub-specialty bacteriology/throat cultures. The following scores were assigned: 2020 first event = 20% 2020 second event = 0% [failure to participate] This is considered unsuccessful PT performance. Refer to D2028. D2028 BACTERIOLOGY 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): 493.823(e) 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 PT desk review of the CMS PT data reports and PT records from the API PT program, the laboratory failed to participate successfully in proficiency testing for the sub-specialty bacteriology/throat culture. The following scores were assigned: 2020 first event = 20% 2020 second event = 0% [failure to participate] 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 PT CMS data reports and API 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 sub-specialty bacteriology/throat cultures. 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 PT CMS data reports and API 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 sub-specialty bacteriology/throat cultures. The following scores were assigned: 2020 first event = 20% 2020 second event = 0% [failure to participate] This is considered unsuccessful PT performance. -- 2 of 2 --