Guajira Family Clinic

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] 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 review of the Certification and Survey Provider Enhanced Reporting 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 -- (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory failed to achieve satisfactory performance in two of two testing events for the analyte of hematocrit (refer to D2131) resulting in an initial unsuccessful performance. D2131 HEMATOLOGY CFR(s): 493.851(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 proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute's proficiency reports (2025 event 3) and 2026 (event 1), the laboratory failed to achieve satisfactory performance for two of two events for the analyte of hematocrit. The findings included: 1. A review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for hematocrit on two of two events: 2025 Event 3 20% 2026 Event 1 0% 2. A review of the American Proficiency Institute's proficiency testing reports from 2025 and 2026 confirmed the findings. 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 proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute's proficiency testing reports from 2025 (Event 3) and 2026 (Event 1), the laboratory director failed to provide overall management and direction of the laboratory services resulting in an initial proficiency testing failure for the analyte hematocrit (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 proficiency desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute's proficiency testing reports from 2025 (Event 3) and 2026 (Event 1), the laboratory director failed to ensure successful participation in a HHS -- 2 of 3 -- approved proficiency testing program for the analyte of hematocrit for two of two events in 2025 and 2026, resulting in an initial unsuccessful performance (refer to D2131). -- 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 American Proficiency Institute's proficiency testing records from 2023 (events 2 and 3), 2024 (events 1, 2, and 3) and 2025 (events 1 and 2), and staff interview, the laboratory failed to ensure 2 of 3 testing personnel participated in proficiency testing. The findings included: 1. A review of the laboratory's submitted Form CMS 209 determined the laboratory identified 3 testing personnel. 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 (events 1 and 2) identified that testing personnel number 1 (as listed on Form CMS 209) performed testing for 7 of 7 events. They were: 2023 event 2 2023 event 3 2024 event 1 2024 event 2 2024 event 3 2025 event 1 2025 event 2 3. Further review determined testing personnel number 2 and number 3 (as listed on Form CMS 209) did not participate in proficiency testing. 4. The technical consultant confirmed the findings in an interview conducted on 11/18/2025 at 0930 hours in the office. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of the laboratory's calibration records for the Horiba Micros 60 hematology analyzer, and staff interview, the laboratory failed to have documentation of performing calibrations every six months for 1 of 2 events. The findings included: 1. A review of the laboratory's policy titled "Instrument Operation and Maintenance" (approved 3/4/2008) identified the following: "Calibration of all laboratory instruments will be every six months, every time there is a complete change in lot numbers, or when controls don't give the desired results." 2. A review of the laboratory's calibration records for the Horiba Micros 60 hematology analyzer determined calibration was performed in November 2024 upon installation of the instrument. The laboratory did not have documentation of another calibration being performed as of the day of the survey (12 months later). 3. The technical consultant confirmed the findings in an interview conducted on 11/18 /2025 at 0950 hours in the office. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions for the Horiba Micros 60 hematology analyzer, review of patient test records from November 13, 2025, November 14, 2025 and November 17, 2025, and staff interview, the laboratory failed to have documentation of following manufacturer's instructions for the resolution of flags on 17 of 18 results. The findings included: 1. A review of the manufacturer's instructions for the Horiba Micros 60 hematology analyzer (RAB043JEN) under the section titled "6.3.2. Flags on WBC Distribution curve" identified the the following flags and correction actions to be taken to resolve the flags: a) L1 "Indicates an abnormal number of cells, in comparison with the Lymphocytes, in the 30fl to 60fl zone. The pathological elements which may be found in this area include: - Platelet aggregates - Nucleated Red Blood cells" b) M2 "Indicates an excessive number of cells in the 130fl to 160fl zone. The pathological elements which may be found in this area will include: - Lymphoblasts - Myelocytes - Atypical Lymphocytes - Basophilia" c) G1 "Indicates an excessive number of cells in the 160fl to 220fl zone. The pathological elements which may be found in this area will include: - Eosinophilia - Myelocytes - Neutrophil polynuclease" d) G2 "Indicates an excessive number of cells larger than 400fl. The pathological elements which may be found in this area will include: - Metamyelocytes - Many types of Large Immature Cells" 2. The manufacturer's instructions also included the

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D6063 - 42 C.F.R. 493.1412 Condition: Testing Personnel Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. 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 D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was 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 to be 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 No Tags No deficiency details available. 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 --