Tyler Office Of Pediatrics

Summary Statement of Deficiencies D0000 The laboratory declared bankrupcty and went out of business. An onsite investigation was conducted on 12/08/2021 to verify the facility had closed. Please see the CMS- 116 web application for notes regarding the termination. _________________________ Based on a proficiency testing desk review survey performed on September 15, 2021, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Academy of Family Physicians proficiency testing records, the facility failed to achieve successful performance in two of three consecutive testing events for the specialty Bacteriology, resulting in unsuccessful performance. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Academy of Family Physicians, the facility failed to attain a score of at least 80 percent for Bacteriology in two of two consecutive testing events in 2021. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Academy of Family Physicians,, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the specialty of Bacteriology in two of two consecutive events: 2020 AAFP 3rd event 60% 2021 AAFP 2nd event 60% 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Academy of Family Physicians, the facility failed to achieve an overall testing event score of satisfactory performance for two of three consecutive testing events in Bacteriology in 2020 and 2021. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Academy of Family Physicians, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the specialty of Bacteriology in two of three consecutive events: 2020 AAFP 3rd event 60% 2021 AAFP 2nd event 60% 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: -- 2 of 3 -- Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Academy of Family Physicians testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for the specialty of Bacteriology. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Academy of Family Physicians proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for the specialty of Bacteriology. Refer to D2016. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on the survey conducted 06-21-2018, the laboratory was found to be out of compliance with the following conditions of 42 CFR: 493.1441 Laboratory Director . D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: . Based on review of American Association of Family Practice (AAFP) proficiency testing (PT) documentation for 2017 and 2018 and staff interview, the laboratory failed to test PT samples using personnel who routinely perform paitient testing. Findings: 1. Review of the signatures on attestation statements for AAFP PT events 1- 3 in 2017 and events 1-3 in 2018 revealed that all sample testing for those events was performed by testing person 1 (CMS form 209). 2. In an interview at the site on 11-21- 2018, testing person 2 stated that she routinely performed patient testing in the laboratory. In the same interview, testing person 2 confirmed that all proficiency testing in 2017 and 2018 was performed by testing person 1. . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on review of laboratory PT documentation for 2017 and 2018, confirmed by Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- staff interview, the laboratory failed to verify the accuracy of immunology testing performed using the Hitachi CLA luminometer at least twice annually. Findings: 1. Laboratory documentation included materials indicating use of a Hitachi CLA-1 luminometer for allergen-specific IgE testing beginning in May of 2017 and continuing to the date of the survey. 2. No documentation of accuracy verification concurrent with patient testing for 2017 or 2018 was found or could be made available during the survey. In an interview at the time of the survey, testing person 2 stated that no accuracy verification testing had been performed during that time. 3. Review of patient testing records revealed that from 03-01-2017 to 11-21-2018, a total of 39 patients had been tested using the system. . D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of