Rgv Endocrine Center

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on November 8, 2024, 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 evaluation reports, the laboratory failed to achieve satisfactory performance 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 -- in three of four testing events for the analyte cortisol, resulting in a non-initial unsuccessful performance. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 evaluation reports, the laboratory failed to achieve satisfactory performance for three of four events in 2023 and 2024 for the analyte of cortisol. 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 cortisol in three of four events: 2023 API 3rd event 60% 2024 API 1st event 60% 2024 API 3rd event 60% 2. Based on review of the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory performances for cortisol in three of four events: 2023 API 3rd event 60% 2024 API 1st event 60% 2024 API 3rd event 60% 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 evaluation 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) 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency -- 2 of 3 -- Institute evaluation reports, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for the analyte of cortisol for three of four events in 2023 and 2024, resulting in a non-initial unsuccessful performance. Refer to D2107. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Pentra 400 User Manual, the laboratory's records, and staff interview, the laboratory failed to have documentation of performing the required bimonthly maintenance procedures on the Pentra 400 chemistry analyzer for four of fourteen months from June 2023 to August 2024. Findings include: 1. A review of the Pentra 400 User Manual (1300107504) revealed the following: "Bimonthly Procedures (Every Two Months) - To Check Glycol Level Check the cooling unit glycol level on a bimonthly basis (every two months). - To Replace Filter Replace the filter at the back of the instrument on a bimonthly basis (every two months)." 2. A review of the laboratory's records from June 2023 to August 2024 revealed the laboratory failed to have documentation of performing the required bimonthly maintenance procedures on the Pentra 400 chemistry analyzer (serial number: 301C4- 1481) for the following months: - August 2023 - October 2023 - December 2023 - February 2024 3. Further review of the laboratory's records revealed the laboratory estimated performing 7,200 chemistry tests annually. 4. In an interview on 9/24/24 at 11:03 a.m. in the break room, after review of the records, the technical supervisor (as indicated on the CMS 209 form) confirmed the above findings. D5807 TEST REPORT 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 -- CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a random review of patient test reports from July to December 2023 and staff interview, the laboratory failed to provide documentation of the reference intervals for Urine Creatinine and Urine Albumin on the final reports for eight of eight patient's reports reviewed. Findings include: 1. A random review of patient test reports from July to December 2023 revealed the following 8 patient's reports without reference intervals for Urine Creatinine and Urine Albumin: Specimen ID: 230711028 Resulted: 7/18/23 Specimen ID: 230726032 Resulted: 7/26/23 Specimen ID: 230810005 Resulted: 8/10/23 Specimen ID: 230825006 Resulted: 8/25/23 Specimen ID: 231103026 Resulted: 11/3/23 Specimen ID: 231103034 Resulted: 11/3/23 Specimen ID: 231106033 Resulted: 11/6/23 Specimen ID: 231213003 Resulted: 12/13 /23 2. In an interview on 9/24/24 at 11:03 a.m. in the break room, after review of the records, the technical supervisor (as indicated on the CMS 209 form) confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The laboratory was found to be NOT in compliance with the conditions of participation of the CLIA program based on the following CONDITION LEVEL DEFICIENCIES: 493.803 Successful participation [proficiency testing] 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 a desk review of proficiency testing records obtained from the CMS (Center 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 -- for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API), 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 had unsuccessful participation in the subspecialty of endocrinology for the analyte cortisol (refer to D2107). D2107 ENDOCRINOLOGY CFR(s): 493.843(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 desk review of the CMS 155 report and proficiency testing records from American Proficiency Institute (API), the laboratory failed to successfully participate for the same analyte in two consecutive testing events or two out of three consecutive testing events in the subspecialty of Endocrinology for the analyte cortisol resulting in an initial proficiency testing failure. The findings include: 1. A review of the CMS 155 report revealed the laboratory received the following unsatisfactory scores (passing = >80%) for the analyte Cortisol: Third testing event 2023 60% First testing event 2024 60% 2. A desk review of the laboratory's American Proficiency Institute's results from the third event of 2023 and the first event of 2024 confirmed the proficiency testing scores: Third testing event 2023 60% First testing event 2024 60% 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, 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, the laboratory director failed to -- 2 of 3 -- ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program (refer to D2107). -- 3 of 3 --