Gl Clinical Laboratory And Research Llc

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on 05 /20/20206 for GL Clinical Laboratory and Research LLC. 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 College of American Pathologists (CAP) 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 CAP PT program, the laboratory failed to successfully participate in the Subspecialty of Routine Chemistry for the analytes of Phosphorus and Uric Acid for 2 out of 2 testing events in 2025. Findings included: Review of the CAP proficiency testing records and the review of the CMS 153 and 155 reports, on 04 /02/2026 at 11:21 AM, the laboratory had unsatisfactory testing scores for the analytes Phosphorus and Uric Acid for 2 out of 2 testing events in 2025 (See D2096). 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 College of American Pathologists (CAP) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, and email communication with the CAP PT program, the laboratory failed to successfully participate in the Subspecialty of Routine Chemistry for the analytes of Phosphorus and Uric Acid for 2 out of 2 testing events in 2025. Findings included: Review of the laboratory's CAP proficiency testing (PT) records review of the CMS CASPER 153 and 155 reports, and email communication with the CAP PT program, the laboratory failed to successfully participate in the Subspecialty of Routine Chemistry for the analytes of Phosphorus and Uric Acid for 2 out of 2 testing events in 2025. 1. Event #2 2025 Phosphorus- 60% Uric Acid- 40% 2. Event #3 2025 Phosphorus- 20% Uric Acid- 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 surveyor Proficiency Testing (PT) desk review, a review of the Centers for Medicare & Medicaid Services (CMS) Casper 155 and 155, the laboratory's College of American Pathologists (CAP) PT records, email communication with the CAP 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 analytes of Phosphorus and Uric Acid for 2 out of 2 testing events in 2025, resulting in initial unsuccessful PT participation (See 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; -- 2 of 3 -- 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 College of American Pathologists (CAP) PT records, email communication with the CAP 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 analytes of Phosphorus and Uric Acid for 2 out of 2 testing events in 2025, resulting in initial unsuccessful PT participation (See D2096). -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at GL CLINICAL LABORATORY AND RESEARCH LLC on March 17, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory Director (LD) failed to approve, sign and date the procedure manual before use since 02/26/2025 Findings included: 1-Review of the procedure manual showed that the LD approved, failed to sign and date the procedure manual before testing since 02/26/2025 when the laboratory started testing patients. 2-During an interview on 03/17/2025 at 10:35 AM, the supervisor acknowledged that the LD failed to review, approve and sign procedure manual before testing patients. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. 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 observation, record review and staff interview, the laboratory failed to label the three hematology controls for the Diatron Abacus 5 Complete Blood Cell count (CBC) analyzer with open and expiration before patient testing since 02/26/2025. Findings included: 1-During the Laboratory tour on 03/17/2025 at 10:30 AM, the surveyor found that the laboratory had one box in the refrigerator labeled CBC-3K for Abacus with lot number KK124, this box was labeled with a reception date on 02/22 /2025, this box had two sets of three control levels. The laboratory had one set in use but failed to label the opening date and the new expiration date. 2-Review of the manufacturer instructions for use R&D systems for the CBC controls, revealed the following: Stability and Storage "Unopened tubes are stable through the expiration date. Opened tubes are stable for 8 days, provided they are handled properly." 3- During an interview on 03/17/2025 at 12:30 PM with Testing Person, she confirmed that the laboratory failed to label the CBC controls with the opening date and new expiration date. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, the laboratory used expired reagents on the Beckman Coulter Analyzer AU 480 since 09/30/2024. Findings included: 1-During the laboratory tour on 03/17/2025 at 10:30 AM, the surveyor found that the laboratory used for patient testing the following expired reagents on the Beckman Coulter AU480: from Caroline (Glucose with lot number D2412 expired on 09/30/2024, Gamma Glutamyl Transferase (GGT) with lot number L2304 and expired on 10/ 31/2024, Aspartate Amino Transferase (AST) with lot number C2406 expired on 10/31/2024, Alanine Alkaline Phosphatase (ALP) with lot number L2314 expired on 10/31/2024, Albumin with lot number A2414 and expired on 11/30/2024, Lactate Dehydrogenase (LDH) with lot number 51271 and expired on 01/31/2025, HDL- Cholesterol Direct with lot number D2419 and expired on 01/31/2025 and Blood Urea Nitrogen (BUN) with lot number A2422 expired on 01/31/2025) and from Beckman Coulter (Triglyceride with lot number 2718 expired on 01/01/2025 and Total Bilirubin with lot number 2610 expired on 12/01/2024. 2- Review of patient reports, revealed that the laboratory tested three patients on 02/26/2025 with the expired reagents listed above. 3-During an interview on 03/17/2025 at 5:41 PM , with Testing Person she confirmed that the laboratory tested the 3 patients with the expired reagents listed above. -- 2 of 2 --