Guajira Family Clinic & Diabetes Care

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on July 14, 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 3 -- performance in two of two testing events for the specialty of endocrinology (refer to D2108) and the analyte of thyroid stimulating hormone (refer to D2107) resulting in an initial unsuccessful performance. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 two events in 2025 for the analyte of thyroid stimulating hormone. 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 thyroid stimulating hormone in two of two events: 2025 API 1st event 40% 2025 API 2nd event 20% 2. Based on review of the American Proficiency Institute's proficiency reports, the laboratory received the following unsatisfactory performances for thyroid stimulating hormone in two of two events: 2025 API 1st event 40% 2025 API 2nd event 20% D2108 ENDOCRINOLOGY CFR(s): 493.843(g) (g) 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 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 two events in 2025 for the specialty endocrinology. 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 the specialty of endocrinology in two of two events: 2025 API 1st event 40% 2025 API 2nd event 20% 2. Based on review of the American Proficiency Institute's proficiency reports, the laboratory received the following unsatisfactory performances for specialty endocrinology in two of two events: 2025 API 1st event 40% 2025 API 2nd event 20% 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 -- 2 of 3 -- 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 specialty endocrinology (refer to D2108) and the analyte of thyroid stimulating hormone (refer to D2107) for two of two events in 2025, resulting in an initial unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 laboratory's submitted Form CMS 209, review of the laboratory's proficiency testing records from 2023, 2024 and 2025, and staff interview, the laboratory failed to ensure 4 of 6 testing personnel participated in proficiency testing for hematology. The findings included: 1. A review of the laboratory's submitted Form CMS 209 determined the facility identified 6 personnel who performed hematology testing. 2. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2023 (events 2 and 3), 2024 (events 1, 2, and 3) and 2025 (event 1) determined only testing personnel #1 and #6 participated in proficiency testing. The records showed: a) 2023 Event 2 performed by testing personnel #1 b) 2023 Event 3 performed by testing personnel #1 c) 2024 Event 1 performed by testing personnel #1 d) 2024 Event 2 performed by testing personnel #1 e) 2024 Event 3 performed by testing personnel #1 f) 2025 Event 1 performed by testing personnel #1 and #6 3. The technical consultant confirmed the finding in an interview conducted on 06/11/2025 at 0950 hours in the reception area. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute's chemistry proficiency testing records from 2024 and staff interview, the laboratory failed to have documentation of evaluating proficiency testing results returned as "not graded" by the proficiency testing agency. The findings included: 1. A review of the laboratory's American Proficiency Institute's chemistry proficiency testing records from 2024 (events 1, 2 and 3) identified that the proficiency testing agency returned a result of "not graded" for 3 of 5 samples tested for Total Bilirubin as part of 2024 Event 1. They were: Sample Performance CH-01 Acceptable CH-02 not graded CH-03 not graded CH-04 Acceptable CH-05 not graded 2. Further review of the records determined the facility failed to have documentation of evaluating the 3 'not graded' results. 3. The technical consultant confirmed the findings in an interview conducted on 06/11/2025 at 0940 hours in the reception area. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the proficiency testing records from 2021 3rd event through 2023 1st event,and staff interview, the laboratory failed to attain an acceptable score of 80% or higher for the analyte Chloride in the 2022 Chemistry Core 1st Event and the analyte Sodium in the 2022 Chemistry Core 3rd Event resulting in unsatisfactory analyte performance. The findings included: 1. Review of the American Proficiency Institute (API) proficiency testing records found the laboratory obtained a score of 60% for the analyte Chloride in the 2022 Chemistry Core 1st Event and a score of 20% for the analyte Sodium (NA) in the 2022 Chemistry Core 3rd Event. 2 . During interview of the technical consultant conducted April 25, 2023 at 12:31 PM, she confirmed that the laboratory failed to achieve satisfactory performance for Chloride and Sodium in the two testing events. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. 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 -- This STANDARD is not met as evidenced by: Based on review of policies and procedures, the proficiency testing records from 2021 3rd event through 2023 1st event, patient test records and staff interview, the laboratory failed to take remedial action when failures occurred in two of three Chemistry proficiency testing events in 2022. The findings included: 1. Review of the policy titled PROFICIENCY TESTING found: "Use the "Proficiency Testing Troubleshooting Checklist" and the "Proficiency Testing Remedial Action Log Sheet" to help resolve and document failed proficiency testing." 2. Review of the American Proficiency Institute (API) proficiency testing records found the laboratory obtained a score of 60% for the analyte Chloride in the 2022 Chemistry Core 1st Event and a score of 20% for the analyte Sodium (NA) in the 2022 Chemistry Core 3rd Event. The laboratory did not use the "Proficiency Testing Troubleshooting Checklist" and the "Proficiency Testing Remedial Action Log Sheet" to document

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the Casper 155 Report and verified with the proficiency testing company, American Proficiency Institute (API). 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 493.807 (a) reinstatement after failure 493.1403 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: 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 -- Based on a desk review of proficiency testing records obtained from the Casper 155 Report and verified with the proficiency testing company, American Proficiency Institute (API), 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 chemistry for the analyte Calcium, Total. (refer to D2096) D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on a desk review of laboratory proficiency testing performance, the laboratory failed to participate successfully in proficiency testing for the satisfactory performance in a specialty of chemistry analyte Total Calcium for three consecutive testing events and has not demonstrated sustained satisfactory performance on two consecutive proficiency events since the unsuccessful scores. Findings: 1. API 2019 - 2nd event laboratory received unsatisfactory score of 40% for Total Calcium. 2. API 2019 - 3rd event laboratory received unsatisfactory score of 60% for Total Calcium. 3. API 2020 - 1st event laboratory received unsatisfactory score of 60% for Total Calcium. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS Form 155 and American Proficiency Institute (API) records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry. The findings were: 1. API 2019 - 2nd event the laboratory received an unsatisfactory score of 40% for Total Calcium. 2. API 2019 - 3rd event the laboratory received an unsatisfactory score of 60% for Total Calcium. 3. API 2019 - 3rd event the laboratoyr received an unsatisfactory score of 60 % for Sodium. 4. API 2020 - 1st event the laboratory received an unsatisfactory score of 60% for Total -- 2 of 4 -- Calcium. 5. API 2020 - 1st event the laboratory received an unsatisfactory score of 60% for Uric Acid. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Chemistry for the analyte Total Calcium. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. API 2019 - 2nd event the laboratory received an unsatisfactory score of 40% for Total Calcium. 2. API 2019 - 3rd event the laboratory received an unsatisfactory score of 60% for Total Calcium. 3. API 2020 - 1st event the laboratory received an unsatisfactory score of 60% for Total Calcium. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of Cassper 155 Report and American Proficiency Institute (API) proficiency testing (PT)records found that the laboratory failed to attain a satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of hematology for the analyte of Hemoglobin. The findings were: 1. 2020 API (event 1) - laboratory received an unsatisfactory score of 60% for Hemoglobin 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 laboratory proficiency testing performance it was revealed that 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) -- 3 of 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 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 proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. (refer to D2096) -- 4 of 4 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). 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 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: 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 desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API), 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 chemistry for the analyte Calcium (CA) (refer to D2096). D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS Form 155 and American Proficiency Institute (API) records found the laboratory failed to attain a score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry for the analytes calcium (CA) and Sodium (Na). The findings were: 1. API 2019 - 2nd event laboratory received an unacceptable score of 40% for (Ca). 2. API 2019 - 3rd event laboratory received an unacceptable score of 60% for (Ca). 3. API 2019 - 3rd event laboratory received an unacceptable socre of 60% for (Na). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 a proficiency testing desk review of CMS Form 155 and American Proficiency Institute (API) records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Chemistry for the analyte calcium (Ca). Two out of three unsatisfactory scores is unsuccessful PT performance. The findings were: 1. API 2019 - 2nd event laboratory received an unacceptable score of 40% for (Ca). 2. API 2019 - 3rd event laboratory received an unacceptable score of 60% for (Ca). 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: -- 2 of 3 -- Based on a desk review of laboratory proficiency testing performance it was revealed that 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) 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 proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program (Refer to D2096). -- 3 of 3 --