Alamo Heights Complete Care

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed on October 22, 2025. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. This STANDARD is not met as evidenced by: Based on review of laboratory quality control (QC) worksheets and reminders, QC records, laboratory patient records, and confirmed in interview, the laboratory failed to run two levels of D-Dimer QC on the Quidel Triage analyzer, before patient testing occurred for two of twelve patients reviewed in August 2025. The findings included: 1 . Review of the laboratory quality control (QC) worksheets for D-Dimer coagulation testing on the Triage analyzer, included the following statement at the top of the page: "Run QC EVERY 8 hrs (+/- 15 minutes) for a 24 hr period." 2. Surveyor observed, in the laboratory, the following reminder attached to a white board above the Quidel Triage analyzer: "D Dimer QC Every 8 Hours You must run QC, on D-Dimer, before every PT (patient) test, if one has not been done in the last 8 hours." 3. Review of laboratory QC records and the laboratory "Laboratory Master Specimen Log" from August 1, 2025, through August 20, 2025, included eight days where patient D-Dimer testing occurred to include the following day where QC had not been performed within an 8-hour window prior to patient testing: August 10, 2025 Account Number 24703-1 2393-1 4. In an interview on 10/22/2025 at 16:00, in the laboratory, the technical consultant confirmed D-Dimer QC had not been performed prior to patient testing on August 10, 2025. 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 March 18, 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: 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory failed to achieve satisfactory 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 -- performance in two of three testing events for the analyte potassium, resulting in an initial unsuccessful performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in 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 American Proficiency Institute's proficiency reports, the laboratory failed to achieve satisfactory performance for two of three events in 2024 and 2025 for the analyte of potassium. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for potassium in two of three events: 2024 API 2nd event 60% 2025 API 1st event 0% 2. Based on review of the American Proficiency Institute's proficiency reports, the laboratory received the following unsatisfactory performances for potassium in two of three events: 2024 API 2nd event 60% 2025 API 1st event 0% 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory director failed to provide overall management and direction of the laboratory services. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for the analyte of potassium for two of three events in 2024 and 2025, resulting in an initial unsuccessful performance. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on August 30, 2023. The laboratory was found to be in compliance with the CLIA regulations found at 42 CFR, with standard level deficiencies cited. 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 a review of the submitted CMS form 209, laboratory policy, and confirmed in staff interview, the laboratory failed establish and follow a policy for assessing the competency for 1 of 1 Technical Consultants. Findings included: 1. A review of the submitted CMS form 209 listed one Technical Consultant. 2. A request was made for a policy for assessing the competency of Technical Consultants. No policy was provided. 3. During an interview on 08/30/2023 at 1030 hours in the breakroom, after review of the above records, the Technical Consultant confirmed the findings. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. 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 3 -- Based on direct observation, a review of Triage patient records, review of Triage quality control records, and confirmed in staff interview, the laboratory failed to perform 2 levels of D-dimer controls within 8 hours prior to performing patient testing for 4 of 72 patients. Findings included: 1. During a tour of the laboratory on 08/30 /2023 at 0845 hours, 1 Triage (serial number 74881) was observed. 2. A review of patient and quality control records for the D-dimer testing performed on the Triage instrument (June 01, 2023 through July 31, 2023) revealed the following: Patient ID 7202315 Patient test date and time: 07/20/2023 at 1755 hours Last completed quality control: 07/20/2023 at 0950 hours Total elapsed time: 8 hours and 5 minutes Patient ID 6252307 Patient test date and time: 06/25/2023 at 1358 hours Low level quality control completed: 06/25/2023 at 1324 hours Only 1 level of quality control was completed before performing patient testing. Patient ID 6222301 Patient test date and time: 06/22/2023 at 0217 hours Last completed quality control: 06/21/2023 at 1001 hours Total elapsed time: 15 hours and 26 minutes Patient ID 6172306 Patient test date and time: 06/17/2023 at 1120 hours Last completed quality control: 06/17/2023 at 0318 hours Total elapsed time: 8 hours and 2 minutes The laboratory failed to perform 2 levels of D-dimer quality control within 8 hours prior to performing patient testing. 3. During an interview on 08/30/2023 at 1145 hours in the breakroom, after review of the above records, Technical Consultant #1 confirmed the findings. D6055 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 whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of laboratory records, personnel records, and confirmed in staff interview, the Technical Consultant failed to evaluate employee competency prior to performing patient testing for 11 of 14 Testing Personnel (TP). Findings included: 1. A review of laboratory records revealed the laboratory changed to a Sysmex XP-300 (serial number C4550) for hematology testing in February 2022. 2. A review of personnel records (TP#1 - TP#14, as listed on the submitted CMS form 209) revealed the following training and competency records for the Sysmex XP-300: TP#1 Initial training on the Sysmex XP-300 completed 02/25/2022 Initial Sysmex XP-300 competency assessment completed 07/26/2022 TP#2 Initial training on the Sysmex XP-300 completed 02/25/2022 Initial Sysmex XP-300 competency assessment completed 09/30/2022 TP#3 Initial training on the Sysmex XP-300 completed 02/25 /2022 Initial Sysmex XP-300 competency assessment completed 10/08/2022 TP#5 Initial training on the Sysmex XP-300 completed 02/25/2022 Initial Sysmex XP-300 competency assessment completed 12/17/2022 TP#6 Initial training on the Sysmex XP-300 completed 02/25/2022 Initial Sysmex XP-300 competency assessment completed 10/18/2022 TP#7 Initial training on the Sysmex XP-300 completed 02/25 /2022 Initial Sysmex XP-300 competency assessment completed 09/28/2022 TP#9 Initial training on the Sysmex XP-300 completed 07/01/2022 Initial Sysmex XP-300 competency assessment completed 08/02/2022 TP#10 Initial training on the Sysmex XP-300 completed 02/25/2022 Initial Sysmex XP-300 competency assessment completed 09/15/2022 TP#12 Initial training on the Sysmex XP-300 completed 02/25 /2022 Initial Sysmex XP-300 competency assessment completed 05/26/2022 TP#13 -- 2 of 3 -- Initial training on the Sysmex XP-300 completed 02/25/2022 Initial Sysmex XP-300 competency assessment completed 07/30/2022 TP#14 Initial training on the Sysmex XP-300 completed 02/25/2022 Initial Sysmex XP-300 competency assessment completed 03/16/2022 The Technical Consultant failed to assess testing personnel competency prior to performing patient testing after a change in hematology instrumentation. 3. In an interview at 1000 hours in the breakroom, after review of the above records, Technical Consultant #1 (as listed on CMS form 209) confirmed the findings. Word Key: CMS = Centers for Medicare and Medicaid Services -- 3 of 3 --

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