Advanced Internal Medicine, Pc

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the 2021 and 2022 American Proficiency Institute (API) PT records, virology and bacteriology test result documents and an interview with the technical consultant, the laboratory failed to retain copies of the sign attestation forms by the laboratory director and the testing personnel. Finding: 1. The laboratory director and the testing personnel failed to sign and date the API PT attestation forms for all third event of 2021 and third event of 2022 2. The technical consultant confirmed on an interview on 1/19/2023 about 11:00am. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 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 review of PT records from the American Proficiency Institute (API) PT program and an interview with the technical consultant, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty virology and bacteriology. The following scores were assigned: Bacteriology 0% 1st and 2nd event of 2022. Virology 0% 1st and 2nd event of 2022. D2028 BACTERIOLOGY 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 the review of 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 Bacteriology. The following scores were assigned: 2022 first event 0% 2022 second event 0% This is considered unsuccessful PT performance. D2064 VIROLOGY CFR(s): 493.831(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 the review of 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 virology. The following scores were assigned: 2022 first event 0% 2022 second event 0% This is considered unsuccessful PT performance. D3011 FACILITIES CFR(s): 493.1101(d) -- 2 of 8 -- Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation of foods and utensils in the laboratory cabinet the laboratory and food refrigerator in the laboratory, the laboratory failed to follow the laboratory's safety and universal procedures. Finding: 1. The laboratory's safety and universal procedures states, "that no food, beverages, smoking is permitted in the laboratory." 2. The surveyor observed foods and utensils in laboratory cabinets. 3. The laboratory had food refrigerator with multiple food inside under the analyzer. 4. Confirmed on an interview with technical consultant on 1/19/2023 about 11:15am. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's training and competency evaluation policy, the laboratory failed to perform annual competency for technical consultant on calendar year 2021. Findings: 1. 2021 annual competency of technical consultant documentation not available for review. 2. Confirmed on an interview with technical consultant on 1/19/2023 about 10:30am. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the review of the laboratory's Quality Assessment (QA) polices/procedures, 2020 through survey date QA records and confirmed in an interview with the technical consultant, the laboratory failed to follow the laboratory's written QA policy to identify and correct the issues below. Findings: 1. Failed to perform proficiency testing (PT) materials within time frame for 2020 third event, 2021 first and second event, 2022 first and second event. 2. Failed to report PT results for 2020 third event, 2021 first and second event, 2022 first and second event. 3. Failed to monitor and document freezer, refrigerator, and lab room temperature, and humidity between 10/13 /2021-13/31/2021. 4. Failed to identify and correct freezer temperature out of range 5 /17/2021-10/12/2021. 5. Failed to perform annual QA review 2021. 6. Failed to perform annual competency 2021 of technical consultant 7. Failed to print laboratory name and demographics on laboratory report. 8. Food in laboratory cabinet, food refrigerator under the analyzer in laboratory. 9. No second identifier in lab report 10. The centrifuge preventative maintenance not performed in calendar year 2022. -- 3 of 8 -- D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on the review of patient test report, under guidelines 493.1242(a)(3), the laboratory failed to report proper two identification. Confirmed on an interview with technical consultant. Finding: 1. The laboratory patient test report included only the patient's full name without a second unique identifier. 2. Confirmed on an interview with technical consultant on 1/19/2023 about 11:45am. 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. This STANDARD is not met as evidenced by: Based on the review of the laboratory's temperature records and confirmed in an interview with the laboratory technical consultant, the laboratory failed to document the refrigerator and freezer temperatures, humidity as required by the laboratory's log for the proper storage of Quality Control (QC) and reagent materials. Finding: 1. Freezer temperature out of range 5/17/2021-10/12/2021. 2. Temperature log of freezer, refrigerator, lab room temperature and humidity not available between 10/13 /2021-12/31/2021. 3. Confirmed on an interview with technical consultant on 1/19 /2023 about 10:30am. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: -- 4 of 8 -- Based on observation of the Quest reference centrifuge located in the laboratory used to spin sample tubes and the labeled titled, "Centrifuge Performance Test" on the centrifuge, the laboratory failed to maintain the annual maintenance for the Quest reference centrifuge for calendar year 2022. Confirmed on an interview with technical consultant on 1/19/2023 about 11am. D5779

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 on lack of proficiency testing (PT) records and confirmed in an interview with the laboratory technical consultant, the laboratory failed to enroll in an approved PT program for the respiratory panel in the calendar year 2019 and up to survey date. FINDINGS: The technical consultant confirmed on February 24, 2020 at approximately 11:00 AM that the laboratory initiated patient testing for virology on the Biofire Film Array analyzer on October 3, 2019 but did not enroll in a PT program in 2019 and the first event of 2020. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. 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 a surveyor review of records and an interview with the technical consultant, the laboratory director failed to ensure that the laboratory was enrolled in an approved PT program for the speciality of virology when testing was initiated on October 3, 2019. Refer to D2000. -- 2 of 2 --