Dr Elvin R Garcia Md Pa

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 on two of two testing events for the analyte of anti-nuclear antibody (ANA), resulting in an initial unsuccessful performance. Refer to D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 2024 and 2025 for the analyte of anti-nuclear antibody. 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 anti- nuclear antibody on two of two events: 2024 API 3rd event 40% 2025 API 1st event 40% 2. Based on review of the American Proficiency Institute's proficiency reports, the laboratory received the following unsatisfactory performances for anti-nuclear antibody on two of two events: 2024 API 3rd event 40% 2025 API 1st event 40% 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 from 2024 and 2025, the laboratory director failed to provide overall management and direction of the laboratory services resulting in an initial proficiency testing failure due to failing results for two of two events. 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 -- 2 of 3 -- participation in a HHS approved proficiency testing program for the analyte of anti- nuclear antibody for two of two events in 2024 and 2025, resulting in an initial unsuccessful performance. Refer to D2084. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director Note: The laboratory ceased testing of the specialty of Endocrinology; the specialty will be removed from the laboratory's CLIA certificate. 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 laboratory's proficiency testing (PT) records from the American Proficiency Institute (API) and confirmed in interview of laboratory personnel, the laboratory did not successfully participate in a proficiency testing 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 -- 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 immunology for the analyte Anti-streptolysin O (refer to D2084). D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 laboratory's proficiency testing (PT) records from the American Proficiency Institute (API) and confirmed in interview of laboratory personnel, the laboratory did not successfully participate 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 immunology for the analyte Anti-streptolysin O (ASO). The findings included: 1. Review of the laboratory's proficiency testing records from API for Immunology 2020 and 2021 (events 1, 2, and 3) found the following unsatisfactory score: ASO (2020 event 2) Score of 0% (cross refer to D2077) ASO (2020 event 3) Score of 60% 2. An interview with the technical consultant on February 15, 2022 at 10:15 hours in the patient exam room confirmed the finding. He agreed that he was aware that the laboratory had an initial PT failure for ASO. D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records from the American Proficiency Institute (API) and confirmed in interview of laboratory personnel, the laboratory failed to attain an overall score of at least 80% for each testing event in the specialty of general immunology. The findings included: 1. Review of the laboratory's proficiency testing records from API for Immunology 2020 and 2021 (events 1, 2, and 3) found the laboratory failed to attain an overall event score of at least 80%: ASO (2020 event 2) Score of 0% (failure to submit) 2. An interview with the technical consultant on February 15, 2022 at 10:15 hours in the patient exam room confirmed the finding. He agreed that he was aware that the laboratory had an initial PT failure for ASO. D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program -- 2 of 5 -- within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records from the American Proficiency Institute (API) and confirmed in interview of laboratory personnel, the laboratory failed to participate in 1 of 6 testing events reviewed for general immunology resulting in a score of 0%. The findings included: 1. Review of the laboratory's proficiency testing records from API for Immunology 2020 and 2021 (events 1, 2, and 3) found the laboratory failed to participate in the following event resulting in score of 0%: ASO (2020 event 2) Score of 0% 2. An interview with the technical consultant on February 15, 2022 at 10:15 hours in the patient exam room confirmed the finding. He agreed that he was aware that the laboratory had an initial PT failure for ASO. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 laboratory's proficiency testing (PT) records from the American Proficiency Institute (API) and confirmed in interview of laboratory personnel, the laboratory failed to achieve satisfactory performance (80% or greater) for Antistreptolysin (ASO) in the specialty of immunology in two consecutive testing events or two out of three consecutive testing events. Two out of three unsatisfactory scores results in unsuccessful PT performance. The findings included: 1. Review of the laboratory's proficiency testing records from API for Immunology 2020 and 2021 (events 1, 2, and 3) found the following unsatisfactory scores: ASO (2020 event 2) Score of 0% (cross refer to D2077) ASO (2020 event 3) Score of 60% 2. An interview with the technical consultant on February 15, 2022 at 10:15 hours in the patient exam room confirmed the finding. He agreed that he was aware that the laboratory had an initial PT failure for ASO. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 surveyor observation, review of manufacturer's instructions, review of patient test records, and confirmed in interview of laboratory personnel, the laboratory failed to follow the manufacturer's instructions for test performance of Rheumatoid -- 3 of 5 -- Factor for 1 of 1 test performance event observed. The findings included: 1. Surveyor observation made on February 15, 2022 at 10:45 in the laboratory found testing personnel 2 (as listed on Form CMS-209) beginning patient test run for Rheumatoid Factor using Teco Diagnostics test kit. She did not spread controls or patient samples to the edge of the testing area. 2. Review of manufacturer's instructions for Teco Diagnostics Rheumatoid Factor test kit (RF/2018) under "Procedure", it stated, "Qualitative Test: 1. Bring reagents and specimens to room temperature before use. 2. Place one drop (50 l) of the RF Positive Control on field #l of the glass slide. Place one drop (50 l) of the RF Negative Control on field #2. The remaining fields are used for test specimens. Using a pipette, place one drop of the undiluted specimens on successive fields. 3. Gently resuspend the RF Latex Reagent and add one drop to each test field. Use stir stick to spread reaction mixture over entire test field. 4. Rotate the slide manually or with a mechanical rotor at 80-100 rpm for 2 minutes and read immediately under direct light. 5. Presence of agglutination of the latex particle is a positive result (see figure 1). Agglutination indicates a RF concentration of equal or more than 8 IU/ml. Sera with positive agglutination should be run again with the Semi- Quantitative Test. 3. Review of patient test records for Specimen #51456 tested during the observed patient run found the result was negative. 4. The laboratory was asked to provide documentation of following the manufacturer's instructions for test performance on the Teco Diagnostics Rheumatoid Factor. No documentation was provided. 5. The findings were confirmed in interview with the laboratory director and technical consultant during the exit conference on February 15, 2022 at 13:00 hours in the patient exam room. Key: CMS - Centers for Medicare and Medicaid Services RF - Rheumatoid Factor IU/ml - international units per milliliter rpm - rotations per minute ul - microliter D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES resulting in a finding of IMMEDIATE JEOPARDY: D5300 - 42 C.F.R. 493.1240 Condition: Pre-Analytic Systems D5400 - 42 C.F.R. 493.1250 Condition: Analytic Systems D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director; moderate complexity NOTE: To abate the immediate jeopardy, the facility provided a letter stating they would follow manufacturer's instructions. 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 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: Based on review of the laboratory's API (American Proficiency Institute) proficiency testing records from 2016 (events 1, 2, and 3) and 2017 (events 1, 2, and 3) and confirmed in interview of facility personnel, it was determine that the laboratory had 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 -- 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 Immunology. (refer to D2084 and D2085) D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(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 laboratory's API (American Proficiency Institute) proficiency testing records and confirmed in interview with facility personnel, the laboratory failed to attain a score of at least 80% for each regulated analyte in the specialty of Immunology. The findings were: 1. Review of the laboratory's API records from 2016 (events 1, 2, and 3) and 2017 (events 1, 2, and 3) revealed the laboratory received the following unacceptable scores: API 2017 - event 1, lab received a score of 60% for Anti-Streptolysin O API 2017 - event 1, lab received a score of 60% for Antinuclear Antibody API 2017 - event 3, lab received a score of 60% for Antinuclear Antibody API 2017 - event 3, lab received a score of 40% for Rheumatoid Factor 2. An interview with the technical consultant on 01/23/2018 at 1100 hours in the office manager's office confirmed the findings. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 laboratory policy, the laboratory's API (American Proficiency Institute) proficiency testing records from 2016 (events 1,2, and 3) and 2017 (events 1, 2, and 3) and confirmed in interview of facility personnel, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance for Immunology. NOTE: Two out of three unsatisfactory scores results in unsuccessful PT performance. The findings were: 1. API 2017-1st event lab received a score of 60% for ANA. 2. API 2017-3rd event lab received a score of 60% for ANA. 3. An interview with the technical consultant on 01/23/2018 at 1100 in the office manager's office confirmed the above scores. D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on review of laboratory policy, the laboratory's API (American Proficiency Institute) proficiency testing records from 2016 (events 1,2, and 3) and 2017 (events 1, 2, and 3) and confirmed in interview of facility personnel, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance for Immunology. NOTE: Two out of three unsatisfactory scores results in unsuccessful PT performance. The findings were: 1. Review of the laboratory's policy titled, "Proficiency Testing," approved by the laboratory director on 10/16 /2013, stated, "For the initial unsuccessful performance, when 2 out of 3 failures exist, the laboratory will follow all