Doctors Plus Urgent Care

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based upon review of 2023 laboratory records and interview with TP (Testing Personnel) #4 on 1/18/24, the laboratory failed to enroll into an HHS (Health and Human Services) approved PT (Proficiency Testing) program for 10 of 10 analytes performed on the Cepheid instrument. Findings: The review of 2023 laboratory records revealed no enrollment into an HHS approved PT program for the following analytes performed on the Cepheid instrument: 1. Chlamydia trachomatis 2. Neisseria gonorrhoeae 3. Bacteria vaginosis 4. Candida species 5. Candida glabrata/Candida krusei 6. Trichomonas vaginalis 7. Severe acute respiratory syndrome coronavirus 2 8. Influenza A 9. Influenza B 10. Respiratory syncytial virus In interview at approximately 9:20 a.m., TP#4 stated the following: 1. The laboratory is not enrolled into a PT program for analytes performed on the Cepheid instrument. 2. She was recently made aware of this requirement. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 upon review of records to verify instrument performance specifications, review of personnel records, review of the laboratory's procedure manual and review of quality control records, the LD (Laboratory Director) failed to provide overall management and direction for the laboratory services provided. Findings: The LD failed to ensure the verfication of performance specifications for 6 of 10 analytes performed on the Cepheid instrument (see D6013). The LD failed to ensure that 4 of 4 Testing Personnel met the educational requirements for the complexity of testing offered (see D6029). The LD failed to provide an approved procedure manual to all personnel (see D6031). The LD failed to ensure the laboratory had a qualified Technical Consultant (see D6033). The LD failed to ensure that Testing Personnel adhered to the laboratory's quality control policy (see D6072). D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based upon review of Cepheid performance specification records and interview with TP (Testing Personnel) #4, the Laboratory Director failed to ensure the verification of performance specifications for the following analytes performed on the Cepheid instrument: 1. Chlamydia trachomatis 2. Neisseria gonorrhoeae 3. Bacteria vaginosis 4. Candida species 5. Candida glabrata/Candida krusei 6. Trichomonas vaginalis Findings: Review of the Cepheid performance specification records revealed: 1. The laboratory retained documentation of the performance of verification samples for CTNG (Chlamydia trachomatis/Neisseria gonorrhoeae) cartridges, but there were no expected results available to determine whether the laboratory's results were accurate. 2. The laboratory retained documentation of the performance of verifications samples for Bacterial vaginosis, Candida species, Candida glabrata/Candida krusei, and Trichomonas vaginalis included in the MVP (Multiplex Vaginal Panel) cartridges, but there were no expected results available to determine whether the laboratory's results were accurate. In interview at approximately 10:00 a.m., TP#4 stated results received from the performance of verfication samples were not compared to the expected results to ensure accuracy. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) 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 5 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based upon review of a random patient test report and interview with TP (Testing Personnel) #4 on 1/18/24, the Laboratory Director failed to ensure that patient test reports contained all components required for interpretation of patient test results. Findings: The review of a random patient test report revealed the following: 1. The laboratory uses the Cepheid instrument printout as the patient test report. 2. The patient test report did not contain the laboratory's address. 3. The patient test report did not contain the normal/reference range for each analyte. In interview at approximately 11:00 a.m., TP#4 reviewed the report and confirmed the findings. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based upon review of the laboratory's policies and procedures and interview with TP (Testing Personnel) #4 on 1/18/24, the current Laboratory Director has not ensured that an approved procedure manual is available to all laboratory staff. Findings: Review of the procedure manual revealed the following: 1. The current Laboratory Director has not reviewed and signed the laboratory's policies and procedures. 2. The laboratory's procedure manual was signed by the previous Laboratory Director. In interview at approximately 11:45 a.m., TP#4 stated the current Laboratory Director began directing in April 2023. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based upon review of personnel records and interview with TP (Testing Personnel) -- 3 of 5 -- #4, the Laboratory Director failed to specify in writing the duties of each individual involved in the testing process. Findings: Review of personnel records revealed the absence of a job description for the following positions: 1. Laboratory Director 2. Clinical Consultant 3. Technical Consultant 4. Testing Personnel In interview at approximately 9:45 a.m., TP#4 stated the laboratory did not have written job descriptions. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based upon review of personnel records and interview with the LD (Laboratory Director) on 1/18/24, the laboratory does not have a qualified Technical Consultant who meets the minimum requirements and provides technical oversight. Findings: Review of personnel records revealed the following: 1. The LD is currently listed as the Technical Consultant. 2. The LD is a licensed medical doctor. 3. The LD's resume does not reflect at least one year of laboratory training or laboratory experience. In interview at approximately 10:00 a.m., the LD stated that he serves as the Technical Consultant. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based upon review of personnel records and interview with TP (Testing Personnel) #4 on 1/18/24, the laboratory failed to ensure that 4 of 4 Testing Personnel have the appropriate education for the complexity of testing offered. Findings: 1. Review of personnel records revealed the absence of documents to verify the education of 4 of 4 Testing Personnel. 2. In interview at approximately 9:45 a.m., TP#4 stated the laboratory did not retain documentation of education for each individual performing patient testing. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based upon review of the laboratory's policies and review of 2022 and 2023 external Cepheid quality control records, Testing Personnel failed to adhere to the laboratory's -- 4 of 5 -- quality control policy. Findings: Review of the laboratory's IQCP (Individualized Quality Control Program) for the Cepheid instrument revealed "... If IQCP report has been implemented quality controls are done monthly or with every new lot of testing cartridges..." Review of 2022 and 2023 external Cepheid quality control records revealed the following: 1. CTNG (Chlamydia trachomatis/Neisseria gonorrhoeae) cartridge quality control was performed in the following months: October 2022, November 2022, December 2022, May 2023, September 2023. 2. MVP (Multiplex Vaginal Panel) cartridge quality control was performed in the following months: December 2022, May 2023 3. 4Plex (Severe acute respiratory syndrome coronavirus 2, Influenza A, Influenza B, Respiratory Syncytial Virus) cartridge quality control was performed in the following months: November 2022, December 2022, May 2023, September 2023, November 2023. -- 5 of 5 --