L&L Diagnostics, Llc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on -3/25/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing. 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) - 0155D and American Proficiency Institute (API) records (2024-3 and 2025-1), the laboratory failed to 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 2 -- program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in the analyte Alanine Aminotransferase (ALT) resulting in unsuccessful performance. See D2118. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API - American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for two out of three consecutive events (2024-3 and 2025-1) for the analyte ALT: The finding include: 1. ALT 0% - 2024 third testing event; ALT 40% - 2025 first testing event. A review of the 2024 & 2025 scores from American Proficiency Institute (API) confirmed the above 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 a proficiency testing desk review of the CASPER 0155D report and API records for 2024-3 and 2025-1 events, 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) (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 a proficiency testing desk review of the CASPER 0155D report and API records for 2024-3 and 2025-1 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2096.. -- 2 of 2 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 American Proficiency Institute (API) proficiency testing (PT) records, six (6) randomly selected patients records, and interviews with the technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for Sodium analyte in 2023. The findings include: 1. Based on review of PT records for the third event of 2023 (Q3-2023), API reported an unsatisfactory score report as follows: Sodium PT Q3-2023 Overall score: 20% Specimen Reported Expected CHM- 11 *145 148-157 CHM-12 *126 129-138 CHM-13 *141 143-152 CHM-14 140 140- 149 CHM-15 *135 136-145 * Unacceptable result 2. The TC affirmed by interview on September 19, 2024, at approximately 110:30 a.m. that the laboratory obtained the PT scores mentioned in statement #1. 3. According to the laboratory's testing declaration submitted on the day of the survey, the laboratory performed approximately 8,5000 Routine Chemistry test samples, including Sodium analyte, during the time the laboratory had unsatisfactory proficiency testing results. D5407 PROCEDURE MANUAL CFR(s): 493.1251(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: 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 -- Based on review of the laboratory's validation documentation, policies and procedures manual, and interview with the technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed to provide validation documentation of the laboratory director approval, signature, and date of new procedures established by the laboratory as indicated in the policies and procedures. The findings included: 1. On the day of the survey September 19, 2024, at approximately 11:30 a.m. the validation documentation for new tests (endocrinology, cortisol, prolactin, microalbumin, testosterone, nail fungus, wound panel, etc.) was not approved, signed, and dated by the laboratory director before sample testing was performed. Policies and procedure manual in place included a validation of new tests policy signed and dated by the laboratory director stating his approval before sample testing. 2. The TC and TP affirmed on September 19, 2024; that the laboratory failed to follow the validation policy in place indicating a step-by-step validation protocol and approvals of new laboratory tests. 4. The laboratory's testing declaration form stated that the laboratory processes and reports approximately 38,500 microbiology and chemistry test samples for which validation of new tests was not approved, signed, and dated by the laboratory director. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 the surveyor's observation during the laboratory tour, examination of laboratory reagents, and interviews with the laboratory's technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed in using reagents when they have exceeded their expiration date. The findings include: 1. Based on the surveyor's observations during the laboratory tour, the laboratory stored 2 bottles of absolute ethanol expired 3/15/2021. 2. The TC and TP affirmed on September 19, 2024, at approximately 12:15 p.m. that the laboratory was not using the reagent listed on #1. However, the laboratory could not confirm that the reagent was not used currently. 3. Based on the laboratory's submitted testing declaration test volume, the laboratory tested and reported approximately 73,500 total tests samples where expired absolute alcohol reagent may have been used. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policies and procedures, proficiency testing records, validation of new tests established in the laboratory, six (6) randomly selected patients test records, and interviews with the technical consultant and testing personnel on September 19, 2024; it was determined that the -- 2 of 3 -- laboratory director is cited herein due to failure to ensure that several aspects of the preanalytic and analytical phases of the laboratory testing were monitored. See D2087, D5407, and D5417. -- 3 of 3 --