Angel Touch Nurse Registered, Llc

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on 04 /13/2026 for Angel Touch Nurse Registered, LLC DBA Angel Touch's Labs. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D2016 493.803(a)(b)(c) Condition: Successful Participation D6000 493.1403 Condition: Moderate Complexity 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 surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, and email 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 -- communication with the API PT program, the laboratory failed to successfully participate in the specialty of Hematology for the analyte of Cell Identification for 2 out of 3 testing events in 2024, and in the subspeciality of Chemistry for the analyte of Alkaline phosphatase for 2 out of 3 testing events in 2025. Findings included: Review of the API proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on 04/02/2026 at 11:21 AM, the laboratory had unsatisfactory testing scores for the analytes, Cell Identification for 2 out of 3 testing events in 2024 and for Alkaline phosphatase for 2 out of 3 testing events in 2025. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, and email communication with the API PT program, the laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the analyte of Alkaline phosphatase (Alk phos) for 2 out of 3 testing events in 2025. Findings included: Review of the laboratory's API proficiency testing (PT) records review of the Centers for Medicare & Medicaid Services (CMS) CASPER 153 and 155 reports, and email communication with the API PT program, the laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the analyte Alk phos for 2 out of 3 testing events in 2025. 1. Event #1 2025 Alk phos - 0% 2. Event #3 2025 Alk phos- 0% D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, and email communication with the API PT program, the laboratory failed to successfully participate in the specialty of Hematology for the analyte of Cell Identification for 2 out of 3 testing events in 2024. Findings included: Review of the laboratory's API proficiency testing (PT) records review of the Centers for Medicare & Medicaid Services (CMS) CASPER 153 and 155 reports, and email communication with the API PT program, the laboratory failed to successfully participate in the specialty of Hematology for the analyte Cell Identification for 2 out of 3 testing events in 2024. 1. Event #1 2024 Cell Identification- 60% 2. Event #3 2024 Cell Identification- 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR -- 2 of 3 -- 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 surveyor Proficiency Testing (PT) desk review, a review of the Centers for Medicare & Medicaid Services (CMS) Casper 155 and 155, the laboratory's American Proficiency Institute (API) PT records, email communication with the API PT program, , the Laboratory Director failed to ensure the laboratory performed PT in such a manner as to achieve and maintain satisfactory performance with successful PT in the subspecialty of Routine Chemistry for the analyte of Alkaline phosphatase for 2 out of 3 testing events in 2025 and in the specialty of Hematology for the analyte of Cell Identification for 2 out of 3 testing events in 2024, resulting in initial unsuccessful PT participation (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 surveyor Proficiency Testing (PT) desk review, a review of the Centers for Medicare & Medicaid Services (CMS) Casper 155 and 155, the laboratory's American Proficiency Institute (API) PT records, email communication with the API PT program, the Laboratory Director failed to ensure the laboratory performed PT in such a manner as to achieve and maintain satisfactory performance with successful PT in the subspecialty of Routine Chemistry for the analyte of Alkaline phosphatase for 2 out of 3 testing events in 2025 and in the specialty of Hematology for the Cell Identification for 2 out of 3 testing events in 2024, resulting in initial unsuccessful PT participation (Refer to D2096 and D2130). -- 3 of 3 --

Summary Statement of Deficiencies D0000 An initial certification survey conducted at ANGEL TOUCH NURSE REGISTERED LLC on 04/23/2024 found the clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records and procedure manual, and interview, the laboratory failed to treat PT samples in the same manner as patient samples for one out of one event reviewed for Chemistry specialty. Findings included: -Review of the laboratory Proficiency Testing policy signed by the Laboratory Director (LD) on 09/12/2023 revealed that stated on section "Procedures: A. Testing the Unknown Samples on point 2 stated: The PT samples must be handled exact1y (as it is written) like patient specimens, utilizing usual testing methods, utilizing usual testing methods, instruments, and personnel. Repeated analysis of PT samples shall not be permitted unless the lab performs the same repetitive analysis in the routine analysis of routine patient specimens." -Review of American Proficiency Institute (API) PT records for Chemistry specialty for the first event of 2024 revealed the following: Samples CH-01, CH-02, CH-03, CH-05 results reported match with results from instrument printout on 01/25/2024 21:29:46 for the analytes: Alkaline 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 -- Phosphatase, Alanine Transaminase (ALT), Aspartate Transferase (AST), Total Bilirubin, Cholesterol Total, Creatinine, Glucose, Total Protein, For analyte Carbon Dioxide (CO2), samples CH-01, CH-02, CH-03, CH-04, CH-05 were reported from results from instrument printout on 01/25/2024 21:29:46, this analyte was not run on 01/29/2024. For analytes: Cholesterol HDL and Triglycerides all results were reported from instrument printout on 01/29/2024 22:05:04, these analytes were not run on 01/25 /2024. For Sample CH-04 Results reported to API for Alkaline Phosphatase: 136.00 Results from instrument printout on 01/25/2024 21:29:46: 130.00 Results from instrument printout on 01/29/2024 22:05:04: 136.00 Results reported to API for ALT: 15.00 Results from instrument printout on 01/25/2024 21:29:46: 15.00 Results from instrument printout on 01/29/2024 22:05:04: 15.00 Results reported to API for AST: 43.00 Results from instrument printout on 01/25/2024 21:29:46: 45.00 Results from instrument printout on 01/29/2024 22:05:04: 43.00 Results reported to API for Total Bilirubin: 0.4 Results from instrument printout on 01/25/2024 21:29:46: 0.43 Results from instrument printout on 01/29/2024 22:05:04: 0.42 Results reported to API for Calcium: 2.2 Results from instrument printout on 01/25/2024 21:29:46: 2.40 Results from instrument printout on 01/29/2024 22:05:04: 2.2 Results reported to API for Cholesterol Total: 189.00 Results from instrument printout on 01/25/2024 21:29:46: 194.00 Results from instrument printout on 01/29/2024 22:05:04: 189.00 Results reported to API for Glucose: 52.00 Results from instrument printout on 01/25/2024 21: 29:46: 55.00 Results from instrument printout on 01/29/2024 22:05:04: 52.00 Results reported to API for Total Protein: 10.8 Results from instrument printout on 01/25 /2024 21:29:46: 10.9 Results from instrument printout on 01/29/2024 22:05:04: 10.8 During an interview on 04/23/2024 at 10:30 AM, the technical consultant confirmed that the laboratory failed to run PT samples in the same manner as patient samples. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform at least two levels of quality control (QC) each day of patient testing on the Complete Blood Cell Counter (CBC) Sysmex XN-530 for one out of two testing days in January 2024. Findings included: -Review of General Quality Control policy signed by the Laboratory Director on 09/12/2023 revealed that on page 2 in Section "Laboratory Quality Control" noted "a minimum of two levels of quality control samples will be run prior and each day of patient testing." -Review of patient results revealed that on January 16, 2024, the laboratory tested 8 patients samples (P#1, P#2, P#3, P#4, P#5, P#6, P#7 and P#8). -Review of QC records revealed that the laboratory failed to run quality control samples before patient testing. During an interview on 04/23/2024 at 11:30 AM, the Technical Consultant confirmed that the laboratory failed to run QC before patient testing on the day of reference. -- 2 of 2 --