21st Century Diagnostic Laboratory

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) 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 Surveyor review of laboratory's proficiency testing (PT) records and interview with the laboratory technical supervisor on April 24, 2024, at 1:30 pm, the laboratory failed to attain at least 80% score at the M3 event in 2023 in the specialty of bacteriology resulted an unsatisfactory performance for the event. The findings include: 1. The laboratory failed to correctly identify the bacteria in the urine sample provided by the AAB-MLE PT organization at the M3 event in the year 2023. It correctly identified only 1 sample out of 5 samples provided. Hence the laboratory received 20% score from the AAB-MLE PT organization which was unsatisfactory performance. Therefore, the accuracy of the laboratory test results cannot be assured and may have potential to harm patients. 2. The laboratory technical supervisor on April 24, 2024, at 1:30 pm, affirmed that the laboratory received a 20% score in bacteriology from the AAB-MLE PT organization at M3 event in 2023. 3. The laboratory's testing declaration form signed by the laboratory director on 4/20/2024, stated that the laboratory performed approximately 4,321 tests in bacteriology, annually. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. 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 Surveyor review of laboratory's records and interview with the laboratory technical supervisor on April 24, 2024, at 2 pm, the laboratory failed to document all complaints that was reported to the laboratory. The findings include: 1. The laboratory could not show any records that it documented and investigated any complaints it received. The laboratory informed that it documents all complaints on the laboratory test requisition form, however, was unable to show any records. Therefore, it cannot be assured that the laboratory indeed documenting and investigating complaints it received. 2. The laboratory technical supervisor on April 24, 2024, at 2 pm, confirmed that the laboratory's system is not appropriate to find any complaint and cannot assure that the complaints were documented and investigated to resolve. 3. The laboratory's testing declaration form signed by the laboratory director on 4/20/2024, stated that the laboratory performed approximately 510,769 tests, annually. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) records and interview with the laboratory technical supervisor on April 24, 2024, at 1:30 pm, the laboratory director failed to ensure that the laboratory maintained an acceptable levels of analytical performance for bacteriology tests. The findings include: The laboratory received an unsatisfactory performance score from the proficiency testing organization in the year 2023. See D2020. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as 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 result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's personnel records and interview with the laboratory technical supervisor on April 24, 2024, at 2 pm, the laboratory director failed to assign, in writing, the duties/responsibilities to each person involved in all phases of the testing process. The findings include: The laboratory reported 3 general supervisors and testing persons on the CMS-209 form. At the interview, general supervisor #1 represented as technical supervisor. The laboratory did not have any document showing that the director had assigned the duties to each person. -- 2 of 2 --

Summary Statement of Deficiencies D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) proficiency testing (PT) records for the second event of 2020 (Q2-2020), five (5) randomly selected patients, and interview with the technical supervisor (TS); it was determined that the laboratory failed to participate a testing event for General Immunology which is unsatisfactory performance and resulted in a score of 0 for the testing event. The findings included: 1. Laboratory proficiency testing records showed the laboratory attained an overall score of 0% for General Immunology testing during Q2-2020 as follow: Anti-HIV = 0.0 % H BsAg = 0.0% Anti-HBc = 0.0% 2. The TS affirmed on May 11, 2022, at approximately 11:30 a.m. the unsatisfactory score of 0% obtained by the laboratory on General Immunology testing for Q2-2020. 3. Based on the annual test volume reported for 2021, the laboratory performed and reported approximately 12,191 tests for the specialty of General Immunology. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 2 -- A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the lack of laboratory written test procedures reflecting the current laboratory practice, review of five (5) randomly chosen patients results, and interview with the laboratory's technical supervisor (TS); it was determined that the laboratory failed to have current written procedures for all tests performed in the laboratory reflecting the current practice. The findings included: 1. On the day of the survey on May 11, 2022, at approximately 2:00 p.m. the laboratory failed to provide current written procedures for all test procedures performed in the laboratory. 2. For five (5) out of five (5) random patient test results reviewed covering period from 9/29/2020 to 2/16/2022 the patients had various test ordered, analyzed, and reported for which the laboratory had no current written tests procedures available reflecting the current practice. 3. The TS confirmed on May 11, 2022, at approximately 2:30 p.m. that the laboratory did not have current written procedures available for all test performed in the laboratory. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, proficiency testing reports, five (5) randomly chosen patients, and interview with the technical supervisor; it was determined that the laboratory director failed to be responsible for the overall operation and administration of the laboratory including assuring compliance with applicable regulations by delegating responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. See D2077 and D5401. -- 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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the subspecialty of Endocrinology constituting unsuccessful PT performance. (See 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 2 -- 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Cortisol, resulting in an "initial" (first) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, Cortisol, as follows: 2017 Q2 (60%) 2018 Q1 (0%) Q1 = First Testing Event Q2 = Second Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, Cortisol. 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 severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, Cortisol, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2108) -- 2 of 2 --