Star Laboratory Corporation

Summary Statement of Deficiencies 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 an office review of the CASPER reports 153 and 155 and proficiency testing provider reports, the laboratory failed to achieve 80% or more in two out of three events for Toxicology testing with the College of American Pathologists (CAP). D2111 TOXICOLOGY CFR(s): 493.845(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 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 -- 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 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 an office review of the CASPER reports 153, 155 and the performance summary form College of American Pathologists (CAP), 2024 General Chemistry /Therapeutic Drugs events A nd C. The laboratory failed to participate in the CAP aforementioned Proficiency Testing (PT) events of 2024 for Phenobarbital test. D2118 TOXICOLOGY CFR(s): 493.845(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 an office review of the CASPER report 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of at least 80% or more for Toxicology and Phenobarebital test. The finding includes: 1. The laboratory scored 0 % in event 1-2024 and 0% in event 2-2024 PT events for Phenobarbital with the College of American Pathologists. 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 2 of 2 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on an in-office review of the laboratory's requirements for a New Jersey State Clinical Laboratory License (NJCLL) under New Jersey Statutes Annotated: N.J.S.A. 45:9-42.28. License; necessity; categories and the laboratory accession log from 8/2 /24 to 2/6/24, the laboratory failed to maintain licensure for Prothrombin Time (PT), International Normalized Ratio (INR) and Partial Thromboplastin Time (PTT) as part of their NJCLL since 8/1/23 and performed PT, INR and PTT on 40 patients since 8/2 /24. The Program Manager for the Clinical Laboratory Improvement Services (CLIS) confirmed on 2/5/24, prior to the recertification survey, that the laboratory had PT, INR and PTT removed from their NJCLL license on 8/1/23 due to deficiencies found during a NJCLL survey on that date. The General Supervisor #1 and Technical Supervisor #2 as provided on the CMS-209 stated on 2/6/24 at 12:30 pm that the laboratory was not aware that PT, INR and PTT had been removed from their NJCLL. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: A) Based on surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisors (GS) the laboratory failed to review coded and unacceptable results for Therapeutic Drug Testing, General chemistry and Diagnostic Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- Immunology performed with the College of American Pathologists (CAP) in calendar years 2022 and 2023. The findings include: 1. The laboratory received Unacceptable results for event C-B 2023 General Chemistry/Therapeutic Drugs. a) Phenobarbital samples CHM-06,07,08,09,10 were graded unacceptable. 2. The laboratory received "see not [11]" results for event C-B 2022 General Chemistry/Therapeutic Drugs. a) LDL measured samples CHM-06,07,08,09,10 where graded "see not [11]" unable to analyze (documentation to be provided by laboratory) 3. The laboratory received "see not [11]" results for event S-B 2023 Diagnostic Immunology a) Rubella Ab, quant-IU /m samples RUN-06,07,08,09,10 where graded "see not [11]" unable to analyze (documentation to be provided by laboratory). 4. There was no documented evidence that aforementioned coded and unacceptable results were reviewed. 5. The GS#2 listed on CMS form 209 confirmed on 2/6/24 at 11:14 am that the laboratory did not review coded and unacceptable PT results. 48354 B) Based on surveyor review of the PT records and interview with the GS, the laboratory failed to review coded and unacceptable results for Hepatitis Viral Load (HVL) events performed with CAP in calendar years 2022. The findings include: 1. Specimen HCV2-01 for PT Event HVL- A-22 had coded message "see note 11." 2. There was no documented evidence for evaluation or

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing records and interview with the Technical Supervisor (TS), the laboratory failed to evaluate coded results obtained in 1-2018 event with the American Proficiency Institute (API). The finding includes: 1) The laboratory did not evaluate Not Graded 2 (lack of consensus) results for UDS- Opiates for sample # 2. 2) The TS confirmed on 8/27/18 at 11:50 am that the laboratory failed to evaluate coded result. D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(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-- When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual, Calibrators, Controls and interview with the Technical Supervisor (TS), the laboratory failed to use different lot numbers of calibrators to make the calibrator and control for Urine Toxicology tests from March 2018 to the date of the survey. The TS confirmed on 8/27/18 at 11:10 am the laboratory did not use different lot numbers. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Technical Supervisor (TS), the laboratory failed to report Urine Drug test results accurately from initiation of testing to the date of survey. The findings include: 1. The cut off limits were reported as a range for Alpha-Hydroxyalprazolam and Oxazepam. 2. The laboratory performed non Food and Drug Administration cleared tests and there was no statement stating "The performance characteristics of this test were determined by (Laboratory Name). It has not been cleared or approved by the U.S. Food and Drug Administration" on FR. 3. The FR stated "Drug Screening (UD) results are presumptive only and associated numerical values are not to be used for quantitation" but numerical values are not reported for UD. 4. The FR stated "For drug confirmation and quantitation it is recommended to perform GC-MS or LC-MS but the laboratory performed and reported LC-MS results. 5. The TS confirmed on 8/28 /18 at 1:30 pm that Urine Drug tests were not reported accurately. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Technical Supervisor (TS) the Laboratory Director failed to ensure that PS were adequate to perform Urine Toxicology tests on the Shimadzu LCMS 8045 from July 2018 to the date of survey. The findings include: 1. An accuracy study was not performed. 2. There was no explanation of how the precision study was performed. 3. There was no source available for cut off points. 4. There was no documented evidence of a signed and dated summary of acceptance of PS. 5. There was no validation performed to establish the expiration date of reagents, working solutions, Internal Standard, controls and calibrators used. 6. The validation of the hydrolysis control did not include validation of: a. Optimal Enzyme Concentration b. Temperature of the Heat Block c. Time on the Heat Block d. Temperature of the Incubator e. Time in the Incubator 7. There was no criteria to review chromatography. 8. There was no criteria for manual integration. 09. The TS confirmed on 8/27/18 at 3: 10 pm that the LD did not ensure the PS were adequate. D6171 TESTING PERSONNEL QUALIFICATIONS -- 2 of 4 -- CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files and interview with the Technical Supervisor (TS), the Testing Personnel (TP) was not qualified to perform high complexity Urine Drug testing performed on MGC 240 analyzers from July 2018 to the date of survey. The TS confirmed on 8/27/18 at 11:00 am that the TP was not qualified. -- 4 of 4 --