Grace Primary Care A Division Of Summit Medical

Summary Statement of Deficiencies D0000 During a recertification survey completed on May 4, 2026, the laboratory was found out of compliance with the following condition: 493.1409 Condition: Laboratories Performing Moderate Complexity Testing; Technical Consultant 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 observations of the laboratory, a review of the laboratory procedure manual, and staff interviews, the laboratory failed to ensure its competency assessment policy was in compliance with Subpart M of the Clinical Laboratory Improvement Amendments (CLIA) regulations when it did not include the six required elements defined in Subpart M. The findings include: 1. Observation of the laboratory on 05.04.2026 at 8:20 a.m. revealed the Abbott Cell Dyn (serial number 8394) hematology analyzer used for complete blood count with automated differential (CBC w/ diff) patient testing. 2. A review of the laboratory policy titled "Training and Competency of Lab Testing Personnel" revealed that the procedure did not include the six required elements (A. Direct observation of patient testing, B. Monitoring the recording and reporting of test results, C. Record review, D. Direct observation of instrument and maintenance function checks, E. Blind testing, F. Evaluation of problem solving), as defined in Subpart M of the CLIA regulations. 3. An interview with the Laboratory Lead and Site Manager on 05.04.2026 at 12:20 p.m. confirmed the survey findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- (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: Citation One: Based on laboratory observation and staff interviews, the laboratory failed to ensure that it did not use Becton, Dickinson and Company (BD) Dipotassium Ethylenediaminetetraacetic Acid (K2EDTA) Vacutainer tubes for blood collection for patient testing after their expiration date on the survey date, 05.04.2026. The findings include: 1. Observation of the laboratory on 05.04.2026 at 08:20 a.m. revealed an Abbott Cell Dyn (serial number 8394) hematology analyzer used for complete blood count with automated differential (CBC w/ diff) patient testing. Also observed were 3 BD K2EDTA Vacutainer blood collector tubes (used for collecting CBC w/ diff samples), lot number 4257276, expiration date 01.31.2026. 2. An interview with the Laboratory Lead on 05.04.2026 at 8:30 a.m. confirmed the above survey findings. A subsequent interview on 05.04.2026 at 12:20 p.m. with the Site Manager confirmed that 1,524 patient samples were run for CBC w/ diff from 02.01.2026 through 05.03.2026. Citation Two: Based on laboratory observation and staff interviews, the laboratory failed to ensure that it did not use Becton, Dickinson and Company (BD) Serum Separator Tubes (SST) Vacutainer tubes for blood collection for reference laboratory patient testing past their expiration date on the survey date, 05.04.2026 The findings include: 1. Observation of the laboratory on 05.04.2026 at 8:20 a.m. revealed the following: 28 expired BD SST collection tubes used for reference laboratory patient testing, which included: -5 tubes, lot number: 4059220, expiration date of 02.28.2025 -4 tubes, lot number: 4100336, expiration date of 03.31.2025 -2 tubes, lot number: 4136935, expiration date of 04.30.2025 -9 tubes, lot number: 4302039, expiration date of 09.3.2025 -3 tubes, lot number: 4345039, expiration date of 11.30.2025 -1 tube, lot number: 5042682, expiration date of 01.31.2026 -4 tubes, lot number: 5071289, expiration date of 02.28.2026 2. An interview on 05.04.206 at 8:30 a.m. with the Laboratory Lead confirmed the above survey findings. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) (e)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) Laboratory Personnel Report (CLIA) (Form CMS-209), review of personnel records, lack of documentation, and staff interview, the laboratory director failed to ensure that the person performing technical consultant duties in 2024 through the survey date (05.04.2026) had the appropriate education to qualify as technical consultants (TC) (Refer to D6033 and D6035). The findings include: 1. A review of the Form CMS- 209 revealed thirteen testing personnel (TP) who performed moderately complex complete blood count with automated differential (CBC w/ diff) patient testing and one TC. 2. A review of the laboratory's personnel records revealed the following: Competency Assessments were initialized by TP1 in the "reviewer" box and signed by -- 2 of 4 -- TP1 in the "reviewer signature" section for the following twelve TPs. TP2: Annual Competency on 09.10.2024 and 06.17.2025 TP3: Annual Competency on 09.10.2024 and 06.17.2025 TP4: Annual Competency on 09.10.2024 and 06.17.2025 TP5: Annual Competency on 09.10.2024 and 06.17.2025 TP6: Annual Competency on 09.10.2024 and 06.17.2025 TP7: Annual Competency on 09.10.2024 and 06.17.2025 TP8: Annual Competency on 09.10.2024 and 06.17.2025 TP9: Six Month Competency on 10.22.2024 and Annual Competency on 05.01.2025 TP10: Initial Competency on 02.24.205, Six Month Competency on 07.30.2025, and Annual Competency on 01.13.2026 TP11: Initial Competency on 03.08.2024, Six Month Competency on 08.08.2024, and Annual Competency on 06.17.2025 TP12: Initial Competency on 03.06.2024, Six Month Competency on 08.08.2024, and Annual Competency on 06.17.2025. TP13: Initial Competency on 01.06.2025, Six Month Competency on 06.17.2025, and Annual Competency on 12.09.2025. 3. There was no evidence in the personnel records that TP1 met the minimum regulatory requirements to qualify as a technical consultant at CFR 493.1411. 4. An interview with the Laboratory Lead and Site Manager on 05.04.2026 at 12:20 p.m. confirmed the above survey findings. Word Key: CLIA = Clinical Laboratory Improvement Amendments D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of testing personnel competency assessments and personnel education verification records, the person who performed testing personnel competency assessments did not meet the minimum requirements to perform technical consultant duties. (Refer to D6035) D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; AND (b)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(3)(i)(B) Meet either requirements in 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); AND (b)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the -- 3 of 4 -- designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B) Meet 493.1405(b)(5)(i)(B); and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and (b)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. (b)(6) For blood gas analysis, the individual must- (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3) or (4) of this section; or (b)(6)(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (b)(6)(ii)(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or (b) (7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: Based on a review of testing personnel competency assessments, personnel education verification, and an interview with the Laboratory Lead, TP1, who performed technical consultant duties, did not have the required education to perform those duties on the survey date (05.04.2026). The findings include: 1. A review of the laboratory's personnel records revealed the following: Competency Assessments were initialized by TP1 in the "reviewer" box and signed by TP1 in the "reviewer signature" section for the following twelve TPs. TP2: Annual Competency on 09.10.2024 and 06.17.2025 TP3: Annual Competency on 09.10.2024 and 06.17.2025 TP4: Annual Competency on 09.10.2024 and 06.17.2025 TP5: Annual Competency on 09.10.2024 and 06.17.2025 TP6: Annual Competency on 09.10.2024 and 06.17.2025 TP7: Annual Competency on 09.10.2024 and 06.17.2025 TP8: Annual Competency on 09.10.2024 and 06.17.2025 TP9: Six Month Competency on 10.22.2024 and Annual Competency on 05.01.2025 TP10: Initial Competency on 02.24.205, Six Month Competency on 07.30.2025, and Annual Competency on 01.13.2026 TP11: Initial Competency on 03.08.2024, Six Month Competency on 08.08.2024, and Annual Competency on 06.17.2025 TP12: Initial Competency on 03.06.2024, Six Month Competency on 08.08.2024, and Annual Competency on 06.17.2025. TP13: Initial Competency on 01.06.2025, Six Month Competency on 06.17.2025, and Annual Competency on 12.09.2025. 2. A review of the documentation of the highest level of education revealed that TP1 did not have the required education as defined in the regulations to perform the TC duties. 3. An interview with the Laboratory Lead and Site Manager on 05.04.2026 at 12:20 p.m. confirmed the above survey findings. Word Key: TP = Testing Personnel -- 4 of 4 --

Summary Statement of Deficiencies 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: Based on observation of the laboratory, review of the laboratory procedure manual, review of calibration verification records, and staff interview, the laboratory failed to follow its written policy for calibration verification frequency in 2024. The findings include: 1. Observation of the laboratory on 06.20.2024 at 9:00 a.m. revealed a Cell- Dyn Emerald hematology analyzer (Serial Number: 8394) in use for patient Complete Blood Count (CBC) testing. 2. A review of the laboratory's hematology procedure revealed calibration verification is performed and documented at least every six months. 3. A review of laboratory calibration verification records revealed calibration verification was not performed every six months in 2024. 4. Interview on 06.20.2024 at 10:40 a.m. with the site manager confirmed the above survey findings. 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 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: =================================== Hematology: The laboratory failed to maintain satisfactory participation in two consecutive events for the Red Blood Cell (RBC) analyte resulting in the initial unsuccessful proficiency testing (PT) occurrence for RBC. (Refer to D2130) =================================== D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- 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 CMS CASPER Report 0155D and the laboratory's 2020/2021 Proficiency Testing (PT) performance summary records from the American Proficiency Institute (API) Proficiency Testing program, the laboratory failed to maintain satisfactory performance for the Red Blood Cell (RBC) analyte in the 3rd event 2020 and 1st event 2021, resulting in the initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed unsatisfactory RBC analyte scores of 60% for the 3rd event of 2020 and 40% for the 1st event of 2021. 2. A review of the laboratory's API Proficiency Testing records revealed the 2020 3rd event had unacceptable performance for RBC resulting in a 60% score. 3. A review of the laboratory's API Proficiency Testing records revealed the 2021 1st event had unacceptable performance for RBC resulting in a 40% score, resulting in the initial unsuccessful PT occurrence. =================================== -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: _____________________________________ Based on review of the Proficiency Testing (PT) Attestation records for 2016 and 2017, documented competencies for 11 of 12 testing personnel and upon interview with the Primary and Assistant Laboratory Leaders, determined the PT samples were not rotated among all testing personnel as listed on the Laboratory Personnel Report Form 209 for the patient testing they are currently performing as noted on their competency forms. The findings include: 1. A review of the 2016 and 2017 PT attestation records for Chemistry and Microbiology revealed only 1 of 4 testing persons showed participation in testing PT samples. 2. A review of the 2016 and 2017 PT attestation records for CBC testing revealed only 4 of 11 testing persons showed participation in testing PT samples. 3. A review of documented competencies for 2016 and 2017 showed 4 of 12 testing personnel competent for performing Chemistry and Microbiology testing and 11 of 12 testing personnel competent for performing CBC testing. 4. An interview with the Primary Laboratory Leader at approximately 1:00 p.m. January 24, 2018 confirmed that all testing personnel had not been participating in the PT for which they are currently performing patient testing in. ______________________________ 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 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 -- laboratory's routine methods. This STANDARD is not met as evidenced by: ____________________________________ Based on lack of director's signature on attestation sheets for Hematology testing events 3 of 2016 and 1 of 2017 and interview with the Primary Laboratory Leader, the Laboratory Director failed to attest to integration of proficiency testing (PT) samples into the routine patient workload for these 2 events. The findings include: 1. Lack of director's signature on attestation sheets for Hematology testing events 3 of 2016 and 1 of 2017. 2. Interview at approximately 12:00 p.m. January 24, 2018 with the Primary Laboratory Leader confirmed the Laboratory Director failed to attest to integration of PT samples into the routine patient workload by lack of signature on events 3 of 2016 and 1 of 2017. ____________________________________ D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: ___________________________________ Based on a review of the Laboratory's protocol for performing the Calibration Verification every 6 months on the Hematology analyzer, lack of calibration verification documentation since 5/20/16 and an interview with the Primary Laboratory Leader, determined the laboratory failed to ensure calibration verification was performed every six months per protocol. The findings include: 1. Review of the Laboratory's protocol for performing calibration verification every 6 months on the Hematology analyzer. 2. Lack of calibration verification documentation since 5/20/16. 2. Interview at approximately 2: 00 p.m. January 24, 2018 with the Primary Laboratory Leader confirmed the laboratory failed to follow protocol for performing calibration verification on the Hematology analyzer every 6 months since 5/20/16. ___________________________________ -- 2 of 3 -- D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: _____________________________________ Based on lack of the 6 competency assessment criteria upon review of 12 of 12 testing personnel competency evaluations and interview with the Primary and Assistant Laboratory Leaders, determined the Technical Consultant failed to include all 6 required competency assessment criteria for 2016 and 2017. The findings include: 1. Upon review of competency evaluations for 12 of 12 testing personnel, it was revealed they lacked the 6 required competency criteria for 2016 and 2017. 2. An interview at approximately 1:00 p.m. January 24, 2018 with the Primary and Assistant Laboratory Leaders, confirmed the Technical Consultant failed to include the 6 criteria for assessing competency for 12 of 12 testing personnel for the two year period. ______________________________________ -- 3 of 3 --