Genesis Reference Laboratories Llc

Summary Statement of Deficiencies D0000 Recertification survey was conducted on August 1, 2023 to December 14, 2023. Genesis Reference Laboratories clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. The following Condition was not met: D5400 - 493.1250 - Analytic Systems D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to store Covid-19 positive, Covid-19 Mastermix, Covid-19 No template control, Luna One Step Reaction mix, Fast Tag Advanced Master Mix, Luna Enzyme Mix, and Ultra Distilled Water, IDT E Ph 7.5 as per the manufacturer's temperature guidelines (D5413).The laboratory failed to document positive, negative and internal controls to confirm if test passed or failed for the following PCR test urinary tract infection (UTI), sexual transmitted infections (STI), H. pylori, Respiratory Pathogen Panel (RPP) and antibiotic resistance (ABR) from 6/1/2021 to present. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and 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 -- test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to store Covid-19 positive, Covid-19 Master mix, Covid-19 No template control, Luna One Step Reaction mix, Fast Tag Advanced Master Mix, Luna Enzyme Mix, and Ultra Distilled Water, IDT E Ph 7.5 as per the manufacturer's temperature guidelines. Findings Included: On 8/3/2023 at 11:30 AM, a tour of the laboratory revealed a refrigerator labeled M2 and a freezer labeled M1. Reagents contain in M2 were: Covid-19 positive control read store "-40 C to -16 Celsius (C)." Covid-19 Master mix read" store 40 C to-16 C." Covid-19 No template control read " store -40 C to -16 C." Reagents contained in M1 were: Fast Advance Master mix read stored at 2 C to 8 C. Luna Probe One-Step read stored at -20 C. Luna Enzyme mix read stored at -20 C. Ultra-Pure Distilled Water read store at 15 to 30 C. IDtE ph. 7.5 read store at room temperature. Review of Reagent Management Policy signed by the laboratory director on 6/5/2023 read," all materials must be stored as outlined by the manufacturer." Review of 2023 M2 temperature log read "2 to 8 C" storage. Review of 2023 M1 temperature log read "-15 to -25 C" storage and temperature log revealed the following: 4 out of 31 days for 5/2023 temperature was above -20 C. 6 out of 31 days for 6/2023 temperature was above -20 C. 3 out of 31 days for 7/31 temperature was above -20 C. On 8/14/2023 at 4:00 PM, laboratory director confirmed the laboratory failed to store Covid-19 positive, Covid-19 Master mix, Covid-19 No template control, Luna One Step Reaction mix, Fast Tag Advanced Master Mix, Luna Enzyme Mix, and Ultra Distilled Water, IDT E Ph 7.5 as per the manufacturer's temperature guidelines. D5455 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(v)(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 molecular amplification procedure, include two control materials and, if reaction inhibition is a significant source of false negative results, a control material capable of detecting the inhibition. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, and observation, the laboratory failed to document positive, negative and internal controls to confirm if test passed or failed for the following PCR test urinary tract infection (UTI), sexual transmitted infections (STI), H. pylori, Respiratory Pathogen Panel (RPP) and antibiotic resistance (ABR) from 6/1/2021 to present. Findings: Review of test menu revealed the following: ABX targets: Ampicillin (ampC) Carbapenem (VIM) Carbapenem (KPC) Carbapenem (IMP-7) Carbapenem (OXA-48_1) Carbapenem (OXA-48_2) Carbapenem (NDM_1) Carbapenem (NDM_2) ESBL (TEM) ESBL (CTX-M group1) ESBL (SHV) ESBL (CTX-M group2) Fluoroquinone (QnrA) Fluoroquinone (QnrB) Macrolide (ErmA) -- 2 of 4 -- Macrolide (ErmB) Macrolide (mefA) Methicillin (mecA) Vancomycin (vanA2) Vancomycin (vanB) UTI Panel Enterobacter cloacae Enterococcus faecalis Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Mycoplasma hominis Proteus mirabilis Providencia stuartii Pseudomonas aeruginosa Serratia marcescens Staphylococcus aureus Staphylococcus saprophyticus Streptococcus agalactiae Ureaplasma urealyticum Candida albicans Candida glabrata Candida krusei Candida lusitaniae Candida parapsilosis Candida tropicalis STI Trichomanas vaginalis Ureaplasma urealyticum Chlamydia trachomatis Neisseria gonorrhoeae Mycoplasma genitalium Mycoplasma hominis (Thermo) Gardnerella vaginalis Mycoplasma genitalium Mycoplasma hominis Trichomonas vaginalis Ureplasma urealyticum Candida albicans Candida auris Candida glabrata Candida krusei Candida lusitaniae Candida parapsilosis Candida tropicalis Chlamydia trachomatis Herpes Simplex Virus 1 Herpes Simplex Virus 2 HPV 16 HPV 18 HPV 31 HPV 33 Neisseria gonorrhoeae Treponema pallidum Mpox RPP: Influenza A Parainfluenza Virus 1 Influenza A/H3 Parainfluenza Virus 2 Influenza B Influenza C Influenza A/H1-2009 Parainfluenza Virus 3 Parainfluenza Virus 4 Human Coronavirus NL63 Human Parechovirus Human Coronavirus HKU1 Human Metapneumovirus A/B Human Coronavirus 229E Human Coronavirus OC43 Adenovirus Human Rhinovirus Bocavirus Human Enterovirus MERS SARS Respiratory Syncytial Virus A Chlamydia pneumoniae Klebsiella pneumoniae Legionella pneumophila Legionella pnuemophila/longbea Mycoplasma pneumoniae Streptococcus pneumoniae Bordetella bronchiseptica/parapertussis Bordetella pertussis Haemophilus influenzae B Haemophilus influenzae Staphylococcus aureus mecA Bordetella holmesii Coxiella burnetii Moraxella catarrhalis Pneumocystis Jirovecii COVID-19 Panel H. Pylori Panel On 8/1/2023 at 9:00AM, lab tour showed: Area 1A is the Plating room. Area 1B is the kingfisher plate. Area 2 is 5 quant studio 5 location. Review of ABR quality controls excel spreadsheet forms from 5/1/2022 to present revealed there were no dates listed for positive control runs for Quant studio instrument, and no documentation for negative and internal control runs. Review of H. Pylori quality controls excel spreadsheet forms from 3/6/2023 to present revealed there were no dates listed for positive control runs for Quant studio instrument, and no documentation for negative and internal control runs. Review of RPP quality controls excel spreadsheet forms from 5/1/2022 to present revealed there were no dates listed for positive control runs for Quant studio instrument, and no documentation for negative and internal control runs. Review of Covid quality controls excel spreadsheet forms from 5/1/2022 to present revealed there were no dates listed for positive control runs for Quant studio instrument, and no documentation for negative and internal control runs. Review of STI quality controls excel spreadsheet forms from 5/1/23 7/31 /2023 to present revealed there were no dates listed for positive control runs for Quant studio instrument, and no documentation for negative and internal control runs. Review of UTI quality controls excel spreadsheet forms from 6/1/2023 to 6/9/2023 present revealed there were no dates listed for positive control runs for Quant studio instrument, and no documentation for negative and internal control runs. Review of SOP # MOL 19.0 SOP # MOL 19.0 - QUALITY MANAGEMENT - QUALITY CONTROL (MOLECULAR) signed by laboratory director on 6/7/2023 read, "A) QM /QC Data. All QM/QC data will be reviewed monthly. In the event that an unacceptable trend is discovered in the data from an instrument or assay, the necessary

Summary Statement of Deficiencies D0000 Unannounced Complaint Investigation #2020007055 was conducted on April 20, 2020. Genesis Reference Laboratories LLC was not in compliance with 42 CFR 493, requirements for clinical laboratories. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure test results for COVID-19 were reported promptly for 2 of 7 patient test results examined (#1 & 2). Findings: Patient #1's tests results showed that the sample was received by the laboratory on 4/11/20 at 12:29 PM and reported on 4/14/20 at 11:00 PM. Patient #2's tests results showed that the sample was received by the laboratory on 4/11/20 at 12:32 PM and reported on 4/14/20 at 11:00 PM. Patient #1 and #2 tests results were reported 82 hours after receiving the samples in the laboratory. The laboratory has performed 4,508 COVID-19 tests on patients between 3/17/20 and 4/20/20. During the interview on 4/20/20 at 4:41 PM, the Operations Manager stated they tell 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 -- physicians that the turn around time for COVID-19 results is 24 to 48 hours. At 4:55 PM, the Operations Manager stated that test result on Patient #1 and #2 were reported after 48 hours. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: The laboratory did not have a copy of the diploma and foreign equivalency evaluation for 1 of 6 testing personnel (F), which is required to verify what the foreign education would be in the United States. Findings: Cross Reference D6171. Based on record review and interview, the laboratory failed to have a copy of the diploma and foreign equivalency evaluation for 1 of 6 testing personnel (F) out. D6171 TESTING PERSONNEL QUALIFICATIONS 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 -- 2 of 3 -- 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. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have a copy of the diploma and foreign equivalency evaluation for 1 of 6 testing personnel (F). The foreign equivalency evaluation is required to verify what the foreign education would be in the United States. Findings: Testing Personnel (TP) F's resume` in her personnel folder revealed a diploma from the country of Columbia. However, therre was no diploma or proof of a foreign equivalency evaluation. During an interview on 4/20/20 at 1:26 PM, the technical supervisor state they did not have the degree or the foreign equivalency evaluation in TP F's personnel file. -- 3 of 3 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify the accuracy of the testing methods for urine toxicology and ethanol biomarkers in 2018 at least twice annually. Findings: Review of the College of American Pathologist (CAP) records showed that the laboratory received remedial samples on 12/27/18 for urine toxicology and ethanol biomarkers. review of the test result printout showed that the urine toxicology samples were run on 3/5/19 and the ethanol biomarkers were run on 2 /27/29. The laboratory failed to perform proficiency testing on the following analytes: 4-Methylethcathinone, 6-Acetylmorphine, 7-Aminoclonazepam,7- Hydroxymitragynine, 7-Hydroxyquetiapine, Alpha-PVP (Alpha Pyrrolidinopentiophenone) Alpha-Hydroxyalprazolam, Alpha-Hydroxytriazolam, Alprazolam, Amitriptyline, Amphetamine, Barbiturate, Benzodiazepine, Benzoylecgonine, Buprenorphine, Bupropion Butabarbital, Butalbital, Carbamazepine, Carisoprodol, Citalopram, Clonazepam, Cocaine, Codeine, Cotinine, Cyclobenzaprine, Desalkylflurazepam, Desmethyloxepin, Desipramine, Dextromethorphan, Dextrorphan, Diazapam, Dihydrocodeine, Doxepin, Ecstasy (MDMA), EDDP (2-ethylidene-1,5-dimethly-3,3-diphenylpyrrolidine), Ethanol, Fentanyl, Flunitrazepam, Fluoxetine, Gabapentin, Hydrocodone, Hydromorphone, Imipramine, JWH-018 4-Hydroxypentyl, JWH-073 3-Hydroxybutyl, JWH-018 5- Pentanoic Acid, JWH-073 4- Butanoic Acid, Ketamine, Lorazepam, Maprotiline, Meprobamate, MDA (3,4 Methylenedioxyamphetamine), MDEA (3,4- Methylenedioxy-N-ethylamphetamine), MDPV (Methylenedioxypyrovalerone), Meperidine, Mephedrone, Methylone, Methadone, Methamphetamine, Methlyphenidate, Midazolam, Mitragynine, Morphine, Naloxone, Naltrexone, 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 -- Norbuprenorphine, Nordiazepam, Norfentanyl, Norketamine, Noromeperidine, Norpropoxyphene, Noroxycodeine, Nortriptyline, Opiate, Oxazepam, Oxcarbazepine, Oxycodone, Oxymorphone, Paroxetine, Pentabarbital, pH, Phencyclidine, Phenobarbital, Pregabalin, Propoxyphene, Quetiapine, Ritalinic Acid, Sertraline, Specific Gravity, Sufentanil, Secobarbital, Tapentadol, Temazepam, THC (Tetrahydrocannabinol), THC-COOH (11-nor-9-carboxy-THC), Trazodone, Tramadol, Triazolam, Urine Creatine , UR-144 (Synthetic Cannabinoid), Venlafaxine, XLR-11 (Synthetic Cannabinoid), Zaleplon, Zolpidem, and Zopiclone. During an interview on 5/06/19 at 2:08 PM, the Technical Supervisor acknowledged the 2018 remedial samples were not run until 2019, and that no split testing was done in 2018. -- 2 of 2 --