Wichita Falls - Wichita County Public Health

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for use (IFU), surveyor direct observation, and confirmed in interview, the laboratory failed to ensure storage requirements were maintained for 43 of 43 phosphate buffered saline (PBS) tubes used for patient specimen collection. Findings include: 1. Review of the manufacturer's IFU titled "Hardy Diagnostics Instructions for Use Phosphate Buffered Saline (PBS)" stated: "Storage: Upon receipt store Cat. no. K146, K163, U137 and U138 at 2-30C and Cat. no. R201 at 2-8C away from direct light" 2. On 03/20/2025 at 1327 hours, the surveyor observed 43 PBS tubes used for patient specimen collection stored on a shelf, exposed to direct light, located inside Room 627 "Storage Room" located in a patient examination area: "PBS Lot#636865 Exp. 08/07/2025" 3. The technical supervisor (as listed on the CMS-209 form) confirmed the PBS tubes used were not stored according to manufacturer instructions during an interview on 03/20 /2025 at 1329 hours in the storeroom. Key : CMS: Centers for Medicare and Medicaid Services Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on January 12, 2024, 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, and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) records, the laboratory 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 -- failed to achieve successful performance in three of four consecutive testing events for the subspecialty Bacteriology in 2022 and 2023, resulting in unsuccessful performance. 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 desk review of the CASPER Report 155 Individual Laboratory Profile, and AAB-MLE testing records from 2022 and 2023, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for three of four testing events in the subspecialty of Bacteriology, resulting in unsuccessful PT performance. The findings included: 1. A review of the CASPER Report 155 revealed the following unsatisfactory results: 2022 Bacteriology: Event 3 - Score: 70% 2023 Bacteriology: Event 1 - Score: 75% 2023 Bacteriology: Event 3 - Score: 50% 2. A desk review of AAB-MLE proficiency testing records for 2022 and 2023 confirmed the scores. 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 desk review of the CASPER Report 155 Individual Laboratory Profile, and AAB-MLE testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program in Bacteriology for three of four events in 2022 and 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 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 the CASPER Report 155 Individual Laboratory Profile, and AAB-MLE testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program in Bacteriology for three of four events in 2022 and 2023. Refer to D2028. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE). The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 Successful participation in a proficiency testing program 493.1403 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 a proficiency testing desk review of Center for Medicare and Medicaid Services (CMS) form 0155 and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) records, it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Bacteriology. Refer to D2020 and D2028. 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 a proficiency testing desk review of Center for Medicare and Medicaid Services (CMS) form 0155 and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2022 (3rd Event) and 2023 (1st Event) records, it was revealed the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two out of two consecutive testing events for the specialty of Bacteriology. Two of two consecutive unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: Bacteriology 2022 - 3rd Event laboratory received an unsatisfactory score of 70% for Bacteriology specialty. Bacteriology 2023 - 1st Event laboratory received an unsatisfactory score of 75% for Bacteriology specialty. 2. A proficiency desk review from AAB-MLE 2022 and 2023 proficiency testing records confirmed the above scores. 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 proficiency testing desk review of Center for Medicare and Medicaid Services (CMS) form 0155 and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2022 (3rd Event) and 2023 (1st Event) records, it was revealed that the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of two consecutive testing events in the specialty of Bacteriology. Two of two consecutive unsatisfactory scores result in unsuccessful PT performance. Findings included: 1. Review of the CMS 0155 report revealed the following results: Bacteriology 2022 - 3rd Event laboratory received an unsatisfactory score of 70% for bacteriology. Bacteriology 2023 - 1st Event laboratory received an unsatisfactory score of 75% for bacteriology. 2. A proficiency desk review from AAB-MLE 2022 and 2023 proficiency testing records confirmed the above scores. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 3 -- 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 proficiency testing desk review of Center for Medicare and Medicaid Services (CMS) form 0155 and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) records, the Laboratory Director failed to fulfill their responsibilities. The Laboratory Director failed to ensure proficiency testing was tested as required under subpart H. 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 a proficiency testing desk review of Center for Medicare and Medicaid Services (CMS) form 0155 and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) records, the Laboratory Director failed to ensure proficiency testing was tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2020 and 2028. -- 3 of 3 --

Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on random review of patient test records for RPR from November 2018 to February 2019 revealed the laboratory failed to document the time 15 of 15 patient specimens were received. The findings were: 1. The following is a random sample of patient specimens in which the receipt time was not documented from November 2018 to February 2019: Date Specimen Received: 11-01-2018 Last three digits of Patient ID: 034 Date Specimen Received: 11-05-2018 Last three digits of Patient ID: 067 Date Specimen Received: 11-05-2018 Last three digits of Patient ID: 958 Date Specimen Received:11-06-2018 Last three digits of Patient ID: 814 Date Specimen Received: 11-06-2018 Last three digits of Patient ID: 263 Date Specimen Received: 11-06-2018 Last three digits of Patient ID: 523 Date Specimen Received: 11-08-2018 Last three digits of Patient ID: 766 Date Specimen Received: 12-03-2018 Last three digits of Patient ID: 868 Date Specimen Received: 12-06-2018 Last three digits of Patient ID: 432 Date Specimen Received: 01-14-2019 Last three digits of Patient ID: 738 Date Specimen Received: 02-07-2019 Last three digits of Patient ID: 226 Date Specimen Received: 02-11-2019 Last three digits of Patient ID: 791 Date Specimen Received: 02-13-2019 Last three digits of Patient ID: 606 Date Specimen Received: 02-21-2019 Last three digits of Patient ID: 180 Date Specimen Received: 02-26-2019 Last three digits of Patient ID: 704 2. The above findings were confirmed in interview of the technical consultant on June 13, 2019 at 15:00 hours in the office. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to 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 -- the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the patient test records and confirmed in interview, the laboratory failed to provide instructions for transportation of specimens to the laboratory from offsite locations. The findings included: 1. Review of patient test records revealed the laboratory received specimens from at least two (2) offsite locations. 2. n an interview at 15:30 hours on June 13, 2019 in the laboratory, the technical consultant confirmed that no client instructions had ever been distributed by the laboratory to offsite locations. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient reports and staff interview, it was revealed the laboratory failed to provide reference intervals for RPR (rapid plasma regain) testing. The findings were: 1. A review of patient testing reports revealed 3 of 3 patient reports did not provide a reference range or the Expected Value for RPR. 2. The laboratory was asked to provide documentation providing reference intervals to aid providers in the assessment of patient results. No documentation was provided. 3. An interview with the technical consultant on June 13, 2019 at 14:33 hours in the office confirmed the findings. D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the Form CMS-209 form, personnel records, and in interview with staff, the technical consultant failed to evaluate and document the performance of testing persons responsible for moderate complexity testing at least semiannually during the first year patient specimens were tested for 1 of 2 testing persons. The findings included: 1. Review of the Form CMS-209 form listed testing personnel two as performing moderate complexity testing for bacteriology, mycology, parasitology, and syphilis serology. 2. Review of the laboratory's personnel records for testing personnel two (as listed on Form CMS-209) he had a hire date of June 12, 2017. The personnel records included training for bacteriology, mycology, parasitology, and syphilis serology. However, the technical consultant failed to evaluate and document competency assessments at least semiannually for testing person two, as required the -- 2 of 3 -- first year. 3. During an interview on 06/13/2019, at 13:15 hours, the technical consultant confirmed the above findings. Key: CMS - Centers for Medicare and Medicaid Services -- 3 of 3 --