Austin Public Health

Summary Statement of Deficiencies D0000 The laboratory was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements. The condition not met was: D5012 - 42 C.F.R. 493.1207 Condition: Syphilis serology. D5012 SYPHILIS SEROLOGY CFR(s): 493.1207 If the laboratory provides services in the subspecialty of Syphilis serology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on manufacturer's instructions, policies and procedures, observation, function check, testing logs, test reports, presurvey paperwork, and interview, the laboratory failed to meet the requirements for the Specialty when they failed to follow the manufacturer's instructions for verifying the dispense volume of the needle used for delivering the carbon antigen when testing 12 of 12 patient samples for the RPR (Rapid Plasma Reagin) card test on January 15, 2025. See D5431. 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 competency evaluations, laboratory policies and procedures, and interview, the laboratory failed to assess competency for one of one clinical consultant 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 -- and one of one technical consultant. Findings follow. A. Review of competency evaluations showed none for the positions of clinical consultant and technical consultant. Competency evaluations were requested on January 15, 2025 at 1040 hours but not provided. B. Review of the laboratory's policies and procedures showed no policy and procedure for competency evaluations. A policy and procedure was requested on January 15, 2025 at 1540 hours in the office but not provided. C. Interview with testing personnel #1 (as listed on the CMS Form 209) on January 15, 2025 at 1040 hours in the office confirmed they had not been performed. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of accuracy assessments, laboratory policies and procedures, presurvey paperwork, and interview the laboratory failed to access at least twice per year accuracy of its darkfield microscopy for the identification of Treponema pallidum testing for two of two years (four of four events) reviewed. Findings follow. A. Review of the laboratory's accuracy assessment records from 2023 and 2024 showed no accuracy assessments for the darkfield microscopy for the identification of T. pallidum. B. Review of the laboratory policies and procedures showed none for accuracy assessments for darkfield microscopy for T. pallidum. The policy and procedure was requested on January 15, 2025 at 1540 hours in the office but not provided. C. Review of the presurvey paperwork titled Annual Test Volume & Proficiency Testing (PT) Programs Worksheet showed "peer review" in the column for PT Program and 36 test per year for darkfield microscopy. D. Interview with testing personnel #1 (as listed on the CMS Form 209) on January 15, 2025 at 1305 hours in the office confirmed accuracy assessments were not performed. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) 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 do the following: This STANDARD is not met as evidenced by: Based on manufacturer's instructions, laboratory policies and procedures, observation, function checks, testing logs, test reports, presurvey paperwork, and interview, the laboratory failed to follow the manufacturer's instructions for verifying the dispense volume of the needle used for delivering the carbon antigen when testing 12 of 12 patient samples for the RPR (Rapid Plasma Reagin) card test on January 15, 2025. Findings follow. A. Review of the package insert for the ASI (Arlington Scientific Inc) RPR card test for syphilis, 10/1997, found under the heading Handling and Procedural Notes "1. In order to obtain reliable and consistent results, the instructions -- 2 of 3 -- in the package insert must be strictly followed. Do not modified the handling and storage conditions for reagents or samples. 2. ASI RPR test cards are plastic coated and specifically designed to be used with the RPR antigen. In handling, take care not to fingermark the card areas, as this may result in an oily deposit and improper test result. When spreading specimen within the confines of the circle area, avoid scratching the card with the stirrer pipets. If the specimen does not spread in the test area or spreads outside the test area, use another test circle. 3. The needle assembly must be thoroughly washed in distilled or deionized water and air-dried after each shift. Do not wipe the needle dry. Place the needle back into the plastic sleeve. Do not remove bottle tip when washing the needle assembly. Let the assembly air dry. Before next use, make sure that no large water droplets remain in the dropping bottle by shaking the bottle and squeezing it. 4. The needle should deliver 60 +/- 2 drops of antigen suspension per milliliter when held in a vertical position. To perform accuracy check on the needle, attached the needle to a 1 or 3 mL syringe. Fill the syringe with antigen suspension and, holding the syringe in a vertical position, count the number of drops delivered in 0.5 mL. The needle is considered a satisfactory if 30 +/- 1 drops are obtained in 0.5 mL..." B. Review of the laboratory policy and procedure titled ASI- RPR Test Procedure, effective 12/03/2003, under XII. Procedure Notes/Sources of Error stated, "d. The needle should deliver 60 +/- 2 drops of antigen suspension per milliliter when held in a vertical position. To perform accuracy check on the needle, attach the needle to a 1 or 3 ml syringe. Fill the syringe with the antigen suspension and, holding the syringe in a vertical position, count the number of drops delivered in 0.5 ml. The needle is considered satisfactory if 30 +/- 1 drops are obtained. The results are recorded on a daily basis on the RPR Quality Control Log." C. During demonstration of the RPR antigen needle drop check by the technical consultant /testing person #2 (as listed on the CMS Form 209) conducted January 15, 2025 at 1355 hours in the laboratory dispensed 26 drops of 0.5 mL carbon antigen vertically into the vial. The result of the test was 52 drops in 1 mL after multiplying 26 times 2: the needle drop check failed. He then repeated the needle drop check two more times and obtained 28 drops both times in 0.5 mL of carbon antigen; the result was multiplied by 2 to obtain 56 drops in 1 mL: the needle drop check failed. D. Review of the RPR Quality Control Log from Feb 2023 to January 15, 2025 showed 60 was documented for the needle drop check for 486 out of 486 days reviewed. E. Review of the Communicable Disease Laboratory Accession/Testing Log showed 12 patients had been performed on January 15, 2025 as listed by account number: 1. 64197 2. 531401 3. 505931 4. 142476 5. 382943 6. 147894 7. 144809 8. 552183 9. 135588 10. 92116 11. 551897 12. 107369 F. Review of the test reports for the 12 patients performed on January 15, 2025 showed the 12 patients had been reported. G. Review of the presurvey paperwork titled Annual Test Volume & Proficiency Testing (PT) Programs Worksheet showed a test volume of 8638 per year. H. Interview with the technical consultant/testing person #2 on January 15, 2025 at 1355 hours in the laboratory confirmed the needle did not dispense the correct volume of carbon antigen. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on April 10, 2023, 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: Based on a review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, American Proficiency Institute (API) proficiency testing records, and College of American Pathologists 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 -- (CAP) proficiency testing records, the laboratory failed to achieve successful performance in two of three consecutive testing events for Bacteriology between the second event of 2022 and the first event of 2023, resulting in unsuccessful participation. Refer to D2028. 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 a review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 Individual Laboratory Profile report, American Proficiency Institute (API) proficiency testing records, and College of American Pathologists (CAP) proficiency testing records, the laboratory failed to successfully participate in two of three consecutive testing events for Bacteriology between the second event of 2022 and the first event of 2023, resulting in unsuccessful participation. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 Individual Laboratory Profile report, the laboratory received a score of 60 percent for the second event of 2022 for Bacteriology and a score of 60 percent for the first event of 2023 for Bacteriology. 2. Based on review of the College of American Pathologists (CAP) proficiency testing records from 2022, the laboratory received a score of 60 percent for the second event of 2022 for Bacteriology. 3. Based on review of the American Proficiency Institute (API) proficiency testing records from 2023, the laboratory received a score of 60 percent for the first event of 2023 for Bacteriology. 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 a review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 Individual Laboratory Profile report, American Proficiency Institute (API) proficiency testing records, and College of American Pathologists (CAP) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for two of three events for Bacteriology between the second event of 2022 and the first event of 2023. 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 -- 2 of 3 -- 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 Individual Laboratory Profile report, American Proficiency Institute (API) proficiency testing records, and College of American Pathologists (CAP) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program for two of three events for Bacteriology between the second event of 2022 and the first event of 2023. Refer to D2028. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and interview, the laboratory failed to test proficiency testing samples the same number of times that it routinely tests patient samples on 6 out of 8 events reviewed in 2022. Findings follow. A. Review of the College of American Pathologists proficiency testing records for the first and second events in 2022 showed proficiency testing was used for competency testing prior to, or on the submission due date: 1. Viral Markers Series 6, VM-A, Survey Result Form showed the "Results are due no later than midnight, Central Time: February 08, 2022". Review of testing records showed testing personnel #4 and #2 both tested in this event prior to the submission due date/time on February 8, 2022. The event was for the moderately complex HIV Ag/Ab combo. 2. Viral Markers Series 6, VM-B, Survey Result Form showed the "Results are due no later than midnight, Central Time: May 31, 2022". Review of testing records showed testing personnel #2 tested this event on May 16, 2022, and testing personnel #1, 3, & 4 all tested in this event prior to the submission due date/time in May (day not documented), 2022. The event was for the moderately complex HIV Ag/Ab combo. 3. Urinalysis and Clinical Microscopy, CM-B, Survey Result Form showed the "Results are due no later than midnight, Central Time: September 28, 2022". Review of testing records showed testing personnel #1 & 3 tested this event on September 28, 2022, and testing 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 -- personnel #2 tested this event on September 20, 2022, all prior to the submission due date/time. The event was for the moderately complex KOH and vaginal wet prep. 4. Gram Stain, D5-B, Survey Result Form showed the "Results are due no later than midnight, Central Time: September 6, 2022". Review of testing records showed testing personnel #2 tested this event on September 1, 2022, testing personnel #3 tested this event on August 30, 2022, and testing personnel #1 tested this event on September 6, 2022, all prior to the submission due date/time. The event was for the moderately complex gram stain and morphology. 5. Syphilis Serology, G-A, Survey Result Form showed the "Results are due no later than midnight, Central Time: May 3, 2022". Review of testing records showed testing personnel #4 tested this event on April 20, 2022, testing personnel #1, 2, & 3 tested this event in May (day not documented) 2022. The event was for the moderately complex RPR and titer and the Syphilis Health Check immunoassay test. 6. Syphilis Serology, G-B, Survey Result Form showed the "Results are due no later than midnight, Central Time: August 16, 2022". Review of testing records showed testing personnel #2 tested this event on August 10, 2022, and testing personnel #4 tested this event on August 12, 2022, all prior to the submission due date/time. The event was for the moderately complex RPR and titer and the Syphilis Health Check immunoassay test. B. Interview with testing personnel #1 on November 16, 2022, at 1145 in the office confirmed the findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of competency evaluations and interview, the technical consultant failed to ensure competency evaluations were performed at least annually for one of one years reviewed. Findings follow. Review of competency evaluations for testing personnel from 2021 showed none available for review. The competency evaluations for testing personnel #1, 2, & 3 was performed on January 18, 2022. The competency evaluation for testing personnel #4 was performed on February 23, 2022. Interview with testing personnel #1 on November 16, 2022, at 1140 in the office confirmed 2021 competencies were performed late, and they had already planned to perform competencies for 2022 in December. -- 2 of 2 --