City Of Laredo Health Department

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records and staff interview, the laboratory failed to have documentation of the technical consultant performing annual competencies for 1 of 4 testing personnel in 2024. The findings included: 1. A review of the laboratory's personnel records identified 4 testing personnel who required annual competency assessments in 2024. 2. Further review of the records determined the laboratory failed to have documentation of the an annual competency assessment for testing personnel number 1 (as listed on Form CMS 209) being performed in 2024. 3. The technical consultant confirmed the findings after his review of the records on 06 /17/2024 at 1000 hours in the break room. D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of the laboratory's instrumentation, review of the laboratory's personnel records, and staff interview, the laboratory failed to have documentation of the technical consultant performing competency assessments for 5 of 5 testing personnel after the installation of a new hematology analyzer. The findings included: 1. A review of the laboratory's instrumentation determined the laboratory placed 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 -- new hematology analyzer in use in January 2025. 2. A review of the laboratory's personnel records determined the laboratory failed to have documentation of competency assessments being performed on 5 of 5 testing personnel prior to patient testing being performed. 3. The technical consultant confirmed the findings after reviewing the records on 06/17/2025 at 1000 hours in the break room. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) (b)(6)(ii) Have documentation of laboratory training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has- (b)(6)(ii)(A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens; (b)(6)(ii) (B) The skills required for implementing all standard laboratory procedures; (b)(6)(ii) (C) The skills required for performing each test method and for proper instrument use; (b)(6)(ii)(D) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(6)(ii) (E) A working knowledge of reagent stability and storage; (b)(6)(ii)(F) The skills required to implement the quality control policies and procedures of the laboratory; (b) (6)(ii)(G) An awareness of the factors that influence test results; and (b)(6)(ii)(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's instrumentation, review of the laboratory's personnel records and staff interview, the laboratory failed to have documentation of training for 4 of 6 personnel performing testing on the Sysmex XN-530 analyzer. The findings included: 1. A review of the laboratory's instrumentation determined the laboratory placed a Sysmex XN-530 hematology analyzer in use in January 2025. 2. A review of the laboratory's personnel records determined the laboratory failed to have documentation of training for 4 of 6 testing personnel on the Sysmex XN-530 analyzer. They were (as listed on Form CMS 209): Testing personnel 1 Testing personnel 2 Testing personnel 3 Testing personnel 5 Note: The laboratory provided documentation of training for the identified personnel dated the day of the survey and the day following the survey - six months after the installation of the analyzer. 3. The technical consultant confirmed the findings in an interview conducted on 06/17/2025 at 1100 hours in the break room. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control records for microscopic urinalysis testing from January 2022 to December 2022, and staff interview, it was revealed the laboratory failed to have documentation of monitoring quality control values over time for quantitative red blood cell counts and quantitative white blood cell counts for 12 of 12 months. The findings include: 1. A review of the laboratory's microscopic urinalysis quality control records from January 2022 to December 2022 revealed the laboratory performed daily quality control testing utilizing two levels for quantitative red blood cell counts and quantitative white blood cell counts. 2. The laboratory was asked to provide documentation of assessing the quality control values over time 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 4 -- monitor accuracy and precision of test performance. No documentation was provided. 3. An interview with the general supervisor on 01/04/2023 at 1620 hours in the break room confirmed the laboratory did not monitor the quality control results over time. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's test menu and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual method comparisons between automated and manual differentials. The findings include: 1. A review of the laboratory's test menu revealed the facility performed automated differentials and manual differentials. 2. The laboratory was asked to provide documentation of performing method comparison studies in 2022. No documentation was provided. 3. An interview with the general supervisor on 01/04/2023 at 1200 hours in the break room revealed the laboratory did not perform method comparisons between automated and manual differentials. This confirmed the findings. D5785

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies 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: Review of the CMS 209 Laboratory Personnel Report, personnel records and confirmed in interview, the laboratory's competency assessment policy failed to include a procedure to evaluate the competency of all supervisors and consultants performing moderate complexity. The findings included: 1. Review of the CMS report 209 Laboratory Personnel Report found that the laboratory designated two technical consultants for moderate complexity testing. 2. Review of personnel files found no documentation of competency assessment for technical consultant two (as listed on Form CMS-209). 3. Interview of technical consultant one (as listed on Form CMS- 209) on July 17, 2019 at 10:15 hours confirmed that the laboratory director had not evaluated the competency of all supervisors and consultants. Key: CMS - Centers for Medicare and Medicaid Services D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- A. Based on review of laboratory polices, review of patient records, and confirmed in staff interview, it was revealed that the laboratory failed to follow its own policy for documenting Gram Stain quality control. The findings were: 1. Review of the laboratory's policy titled, "Standard Operating Procedure: Gram Stain" reviewed and approved by the technical director on March 10, 2019 under "Quality Control" it stated, "Quality control slides are available and should be done at least once per day that the procedure is performed or whenever a new lot of stain is opened. Results should be documented in the appropriate QC manual and signed by the Tech performing the test. QC slide contain both Gram Positive Cocci and Gram Negative Bacilli in different areas of the slide." 2. Interview with testing personnel three (as listed on Form CMS-209) on July 17, 2019 at 16:00 hours in the laboratory revealed that the laboratory's practice is to perform a patient Gram Stain if the colony count is greater than 100,000 for females and greater than 10,000 for males. 3. Review of Gram Stain quality control records from January 2019 to July 2019 found the following female patient records when the colony count was greater than 100,000 and the laboratory failed to follow its own policy to document quality control test performance based on patient culture colony counts: 387699 58494 385207 384413 383288 382611 382130 381834 380966 4. The laboratory failed to follow its own policy for Gram Stain quality control documentation. Key: QC - quality control CMS - Centers for Medicare and Medicaid Services B. Based on review of laboratory policy, manufacturer's instructions, review of patient records, and confirmed in interview the laboratory failed to follow its own written policy for sending platelet flagged results to a reference laboratory for 1 of 1 patients in 2019 (random review June-July 2019). Findings: 1. Review of CBC Confirmation policy page 5 stated: "6) Giant platelet/Platelet Clumps These may be counted as WBC's and may show in the histogram. If this is the case send the specimen out to the reference laboratory for correct count and pathology review." 2. Review of the Sysmex operator's manual revealed the following: "Suspect, PLT Clumps? The PLT Clumps? IP Message is determined by abnormal clustering if the DIFF scattergrams. Asterisks (*) will appear next to the PLT result. Dashes may appear in place of data for the MVP or the MPV may be marked with an asterisk (*). The asterisk (*) indicates these results may be unreliable and should be confirmed according to your laboratory protocol prior to reporting." 3. Review of patient records in 2019 (random review) revealed the following: Patient ID 28653 CBC test date 06/14/2019 at 09:41 WBC result: 6.49* [10*3/uL] PLT result: 144*[10*3/uL] On the bottom of the result was a platelet estimate calculation: "12/8 X100= 150,000" The CBC was repeated on 06/14/2019 at 09:44 WBC result: 6.49*[10*3/uL] PLT result: 157*[10*3/uL] On the bottom of the result was a had written note stating: "platelet clumps" and a label stating: "VERIFIED BY REPEAT ANALYSIS AND BLOOD SMEAR" The laboratory failed to follow its own written policy and send the specimen to the reference laboratory for correct count and pathology review. 4. During an interview on 07/17 /2019 at 3:03 pm, testing person 1 (as documented on the CMS 209 form) stated that platelet clumps seen on a blood smear are sent out to the reference laboratory. 5. During an interview on 07/17/2019 at 3:30 pm, the laboratory director stated the patient's specimen was not sent to the reference laboratory, confirming the laboratory failed to follow its own written policy for sending platelet flagged results to a reference laboratory. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, -- 2 of 8 -- storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)