City Of Lubbock Health Dept Laboratory

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on November 3, 2025 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: Laboratories performing moderate complexity testing; laboratory director. 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, College of American Pathology and American Association of Bioanalyst proficiency testing 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 3 -- failed to achieve successful performance in two of three consecutive testing events for Bacteriology, resulting in unsuccessful performance. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) (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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, College of American Pathology (CAP) proficiency records from 2023, and American Association of Bioanalyst (AAB) proficiency testing records from 2024, the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for two of three consecutive testing events for Bacteriology. Two out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. The findings included: 1. A review of the CASPER Report 155 listed the following scores for the PT Program Bacteriology: PT Program Year/Event Specialty Score CAP 2023 Event 2 Bacteriology 0% AAB 2024 Event 1 Bacteriology 0% 2. A desk review of CAP and AAB proficiency testing records from 2023 and 2024 confirmed that the laboratory received a Bacteriology score of 0% for 2023 event 2, and 0% for 2024 event 1. 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, College of American Pathology (CAP) proficiency records from 2023, and American Association of Bioanalyst (AAB) proficiency testing records from 2024, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program in Bacteriology for two of three events from 2023 to 2024. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, College of American Pathology (CAP) proficiency records from 2023, and American Association of Bioanalyst -- 2 of 3 -- (AAB) proficiency testing records from 2024, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for Bacteriology for two of three events from 2023 to 2024. Refer to D2028. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure, proficiency testing and interview, the laboratory failed to ensure the attestation statement was signed by testing personnel for two of 12 testing events reviewed in 2023. Findings follow. A. Review of the laboratory's policy and procedure titled Proficiency Testing Test Procedure, updated 10/20/2023, under "4. Clinical Laboratory PT Testing - External" at 4.2 stated, "PT Survey samples are performed using the same testing methods as patient specimens" and at 4.3.1 stated, "...Supervisor and analyst will sign and date original paperwork". The attestation statement was not explicitly stated. B. Review of the American Association of Bioanalysts (AAB) for the M2 and M3 events in 2023 for the Genital Gram Stain revealed the attestation statements were not signed by the testing personnel. The attestation stated "The undersigned analyst attests that samples were tested in the same manner as patient samples." C. Interview with the technical consultant on November 1, 2023 at 1100 hours confirmed the attestation statements for AAB were not signed. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- 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 and interview, the laboratory failed to assess competency for one of one clinical consultant, one of one technical supervisor, one of one general supervisor, and one of one technical consultant. Findings follow. A. Review of competency evaluations showed none for the positions of clinical consultant, technical supervisor, general supervisor, and technical consultant. Competency evaluations were requested on November 1, 2023 at 0955 but not provided. B. Interview with the Technical Supervisor/Technical Consultant on November 1, 2023 at 0955 hours in the break room confirmed they had not been performed. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, the laboratory's policy and procedure, rotator speed checks, patient testing records and interview, the laboratory failed to perform rotator speed checks at least once per day of patient testing for the ASI (Arlington Scientific Inc) RPR card test for Syphilis for 25 out of 34 days of patient testing from 11/02/2021 - 12/29/2021. Findings follow. A. Review of the ASI RPR Card Test for Syphilis package insert (6004-900 11-2016), under Assay Procedure for Qualitative at step 5 stated, "Place the card on an automatic rotator and cover to maintain humidity. Rotate at 100 +/- 5 rpm for 8 minutes (7 minutes 50 seconds to 8 minutes 30 seconds). Following rotation, a brief hand rotation and tilting of the card (at least 3-4 times) should be performed to aid in differentiating nonreactive from minimally reactive results." And the Assay Procedure for Semiqualitative for titers at step 8 stated, "Place the card onto the automatic rotator and cover to maintain humidity. Rotate at 100 +/- 5 rpm for 8 minutes (7 minutes 50 seconds to 8 minutes 30 seconds). Following rotation, a brief hand rotation and tilting of the card (3-4 times) should be performed to aid in differentiating nonreactive from minimally reactive results." B. Review of the laboratory's policy and procedure titled "Rapid Plasma Reagin 18mm Circle card (RPRC) ASI Card Test for Syphilis," revised 04/14/2016, under 13. Test Procedure at 13.1 Pre-Test Quality Control at 13.1.2 Verify Rotator Speed stated, "13.1.2.1. Rotator speed must be 100 +/- 5 rpm 13.1.2.2. Check the number of rotations per minute by lightly holding a pencil against the rotator platform. Using a digital timer, count the number of rotations in a 1 minute period. 13.1.2.3. Record results on the QC checklist. 13.1.2.4. QC Frequency: 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 -- Weekly." C. Review of the rotator speed checks from 11/02/2021 - 12/29/2021 showed the rotator speed check was performed once per week: 1. 11/01/2021 2. 11/08 /2021 3. 11/15/2021 4. 11/22/2021 5. 11/29/2021 6. 12/06/2021 7. 12/13/2021 8. 12/20 /2021 9. 12/28/2021 D. Review of patient testing records showed rotator speed checks not performed on the following 25 days of patient testing: 1. 11/02/2021: 11 patients 2. 11/04/2021: 12 patients 3. 11/05/2021: 1 patient 4. 11/09/2021: 2 patients 5. 11/10 /2021: 7 patients 6. 11/11/2021: 4 patients 7. 11/12/2021: 8 patients 8. 11/16/2021: 18 patients 9. 11/17/2021: 8 patients 10. 11/18/2021: 6 patients 11. 11/19/2021: 6 patients 12. 11/24/2021: 4 patients 13. 11/30/2021: 13 patients 14. 12/01/2021: 3 patients 15. 12/02/2021: 51 patients 16. 12/03/2021: 4 patients 17. 12/07/2021: 6 patients 18. 12/08/2021: 7 patients 19. 12/09/2021: 11 patients 20. 12/14/2021: 14 patients 21. 12/15/2021: 8 patients 22. 12/16/2021: 11 patients 23. 12/21/2021: 2 patients 24. 12/22/2021: 2 patients 25. 12/23/2021: 6 patients E. Interview with the Technical Consultant #2, listed on the CMS Form 209, on January 18, 2022 at 1130 in the breakroom acknowledged they performed the rotator speed checks weekly. Interview with the Technical Consultant #1, listed on the CMS Form 209, on January 18, 2022 at 1400 confirmed she had spoken to technical support and the rotator speed check was to be performed at least once each day of patient testing. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, review of patient logs, and interview, the laboratory failed to ensure reagents were not used beyond their expiration date for wet preps and KOH (Potassium Hydroxide) preps on 8 patients reviewed from 9/21/2020 - 10/08/2020. Findings follow. Observation of an open box of Remel saline tubes in the refrigerator showed 13 available tubes with an expiration date of 9/11/2020. These tubes were used to collect the wet prep/KOH preps. Review of the patient log from 9/21/2020- 10 /08/2020 showed 8 wet preps and KOH preps were performed on the following patients: PH1809610 collected and tested on 9/21/2020, LB050408 collected and tested on 9/22/2020, LB047953 collected and tested on 9/23/2020, LB031342 collected and tested on 9/29/2020, LB050574 collected and tested on 10/01/2020, LB052371 collected and tested on 10/05/2020, LB048584 collected and tested on 10/5 /2020, and PH1838194 collected and tested on 10/06/2020. Interview with the technical consultant on 10/08/2020 at 1420 hours in the laboratory verified the wet prep/KOH saline tubes were expired. Interview with the technical consultant on 10/08 /2020 at 1500 hours in the breakroom acknowledged the nurses maintained those supplies. 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 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 -- 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's College of American Pathologist's (CAP) proficiency testing records from 2019 and 2020 and interview of facility personnel, the laboratory director failed to ensure the laboratory was enrolling in proficiency testing for the absence and or presence of gram negative diplococci. The findings included: 1. A review of the laboratory's CAP proficiency testing records from 2019 and 2020 found the laboratory participated in a proficiency testing program for Gram Staining consisting of five challenges each, three times each year for Gram Stain and Morphology. a. Proficiency testing event D5-A 2019 Gram Stain did not include the identification of Gram negative diplococci b. Proficiency testing event D5-B 2019 Gram Stain included one specimen challenging the identification of Gram negative diplococci c. Proficiency testing event D5-C 2019 Gram Stain included one specimen challenging the identification of Gram negative diplococci d. Proficiency testing event D5-A 2020 Gram Stain included one specimen challenging the identification of Gram negative diplococci e. Proficiency testing event D5-A 2020 Gram Stain did not include the identification of Gram negative diplococci 2. The laboratory was asked to provide documentation of being enrolled as required. No documentation was provided. 3. An interview with the technical consultant conducted on October 8, 2020 at 10:15 AM confirmed the laboratory was not enrolled in proficiency program specific for the absence or presence of gram negative diplococci. She also confirmed that they were not enrolled in a proficiency testing program for dark field microscopy to demonstrate Treponema pallidum. She thought participation in the proficiency testing program for gram stain would cover that. -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of Proficiency Testing records and interview with facility personnel, the laboratory failed to evaluate proficiency testing results that were not scored by the proficiency testing agency in 3 of 3 Bacteriology testing events for 2017. Findings included: 1. Review of the College of American Pathologists (CAP) Proficiency Testing results for 2016 and 2017 found no documentation of review of proficiency results when an artificial score of 100% was given with exception codes reported in three of three testing events for 2017. a. D5-A 2017 Gram Stain The laboratory was given a score of 100% for Morphology on specimen D5-09 and results were not evaluated by the laboratory when the exception code [27] was reported by the proficiency testing agency. Exception Code 27 = Lack of participant or referee consensus. The Laboratory was given a score of 100% for Leukocytes. Five of Five results were not evaluated by the laboratory when the exception code [26] was reported by the proficiency testing Agency. Exception Code [26] = Educational Challenge. b. D5-B 2017 Gram Stain The laboratory was given a score of 100% for Morphology on specimen D5-05 and results were not evaluated by the laboratory when the exception code [27] was reported by the proficiency testing agency. Exception Code 27 = Lack of participant or referee consensus. The Laboratory was given a score of 100% for Leukocytes. Five of Five results were not evaluated by the laboratory when the exception code [26] was reported by the proficiency testing Agency. Exception Code [26] = Educational Challenge. c. D5-C 2017 Gram Stain The 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 -- Laboratory was given a score of 100% for Leukocytes. Five of Five results were not evaluated by the laboratory when the exception code [26] was reported by the proficiency testing Agency. Exception Code [26] = Educational Challenge. 2. Review of the CAP Actions Laboratories should take when a PT result is not graded found "The College uses Exception Reason Codes that signify the proficiency testing (PT) for an analyte that has not been graded. The Exception reason Code is located on the evaluation report in brackets to the right of the result. Your laboratory must identify all of the analytes with an Exception Reason Code and investigate the acceptability of performance with the same rigor as if it were an unacceptable performance. " 3. Interview of Technical Supervisor 2 listed on the CMS Report 209 conducted on March 27, 2018 at 10:45 Am confirmed that the laboratory did not review results with Exception codes. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require