Stone Clinical Laboratories, Llc

Summary Statement of Deficiencies D0000 A Complaint Survey was performed at Stone Clinical Laboratories, LLC- CLIA ID 19D2108253 on September 28, 2020 through September 30, 2020. Stone Clinical Laboratories, LLC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES which constitute an IMMEDIATE JEOPARDY to the patients serviced by the laboratory: 42 CFR 493.1240 CONDITION: Preanalytic Systems 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing, Laboratory Director 42 CFR 493.1447 CONDITION: Laboratories performing high complexity testing, Technical Supervisor D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, complaint records, and interview with personnel, the laboratory failed to have a system for handling complaints and issues reported to the laboratory. Findings: 1. Review of the laboratory's "Communication and Complaints SOP Gen 5.1 Effective date 9/9/2020" located in the laboratory's MediaLab revealed the following: "All communication /complaints between the laboratory and clients/patients will be documented. The following information will be recorded on Incident Tracker Log in SharePoint: a) Date of communication b) Form of communication (e-mail, fax, phone) c) Communication recipient d) Brief summary of communication ( to include copies of email or fax) e)

Summary Statement of Deficiencies D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Supervisor failed to evaluate and document personnel competency annually for one (1) of eleven (11) personnel reviewed. Findings: 1. Review of the 2018 and 2019 personnel records on October 15, 2019 revealed the Technical Supervisor failed to perform a competency assessment for the following one (1) of eleven (11) personnel performing high complexity testing: Personnel 6 2. In interview on October 15, 2019, the Technical Supervisor stated the laboratory has updated the competency assessment policy to include a time frame to complete assessments. The Technical Supervisor confirmed an annual competency assessment was not performed for 2018 and 2019. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 with personnel, the laboratory failed to follow their laboratory policy to verify the accuracy of all non-regulated analytes at least twice annually. Findings: 1. Review of the laboratory's "Proficiency Testing" policy revealed the following: a) The laboratory will enroll in PT for every regulated analyte performed in-house and for every unregulated analyte performed in-house if PT is readily available. b) The laboratory will perform split sample analysis twice yearly for unregulated analytes when PT is not available. 2. Review of the laboratory's Task 1 and 3 Form submitted to surveyors on November 13, 2018 revealed the laboratory performed Urine Toxicology Confirmation testing which includes: 6-MAM, 7- Aminoclonazepam, Alpha hydroxyalprazolam, Amitriptyline, Amphetamine, Benzoylecgonine, Buprenorphine, Carisoprodol-SOMA, Citalopram, Codeine, Cyclobenzaprine, Desmethyldoxepin, Duloxetine, EDDP, Fentanyl, Fluoxetine, Gabapentin, Hydrocodone, Hydromorphone, Ketamine, Lorazepam, MDA, MDMA, Meperidine, Meprobamate, Methadone, Methamphetamine, Mirtazapine, Morphine, Naloxone, Naltrexone, Norbuprenorphine, Nordiazepam, Norfentanyl, Norhydrocodone, Normeperidine, Noroxycodone, Nortriptyline, O-Desmethyl-Cis- Tramadol, Oxazepam, Oxycodone, Oxymorphone, Paroxetine, Phencyclidine-PCP, Phentermine, Pregabalin, Propoxyphene, Sertraline, Tapentadol, Temazepam, THC- 11-Nor-Delta-9-Carboxy, Tramadol, Venlafaxine, Zolpidem, 2- hydroxyethylflurazepam, 6-Beta-Naltrexol, 7-AminoFlunitrazepam, Carbamazepine, Desipramine, Diazepam, Hydroxybuproprion, Imipramine, MDEA, MDPV, Mephedrone, Mitragynine, N-Demethyltapentadol, Ritalinic Acid, Zaleplon, Zopiclone, EtG, EtS, Amobarbital, Butabarbital, Butalbital, Pentobarbital, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Phenobarbital,, and Secobarbital. 3. Interview with Personnel 3 and 15 on November 16, 2018 revealed the laboratory had written policies and procedures for performing split sample testing twice a year for Urine Toxicology Confirmation Testing. Personnel 15 also revealed the laboratory had not implemented the twice a year testing. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: A REVISIT Survey was performed at Stone Clinical Laboratory LLC, CLIA ID # 19D2108253, on November 13, 2018 through November 16, 2018. I. Based on observation, record review, and interview with personnel, the laboratory failed to have performance specification verification studies for the BioFire FilmArray system. Findings: 1. In interview on November 13, 2018, Personnel 15 stated the laboratory installed a BioFire and began patient testing on April 24, 2018. 2. Observation by surveyors on November 13, 2018 revealed the laboratory utilizes the following: a) BioFire FilmArray Respiratory Panel 2 (RP2) for identification of the following: Adenovirus, Coronavirus 229E, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A (including subtypes H1, H1-2009, and H3), Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Respiratory Syncytial Virus, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, and Mycoplasma, pneumoniae. b) Gastrointestinal (GI) Panel for identification of the following: Campylobacter (jejuni, coli, and upsaliensis), Clostridium difficile (toxin A/B), Plesiomonas shigelloides, Salmonella, Yersinia enterocolitica, Vibrio (parahaemolyticus, vulnificus, and cholerae). Vibrio cholerae, Enteroaggregative E. coli, Enterpathogenic E. coli, Enterotoxigenic E. coli, Shiga-like toxin-producing E. coli, E.coli 0157, Shigella/Enteroinvasive E. coli, Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Adenovirus F40/41, Astrovirus, Norovirus GI/GII, Rotavirus A, Sapovirus (I, II, IV, and V). 3. Review of the laboratory's BioFire records revealed the laboratory did not have documentation of performance verification studies: to include accuracy, precision (run-to-run, day-to- day, within run, and operator variance), reportable and reference range studies, acceptability criteria and Laboratory Director's signature of approval. 4. In interview on November 16, 2018, Personnel 8 stated the previous Laboratory Director had the validation studies for the BioFire. Personnel 8 confirmed the laboratory did not have performance verification studies for the BioFire. 5. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performs 315,000 respiratory and 330,000 GI testing annually. II. Based on record review and interview with personnel, the laboratory failed to have complete performance specification verification studies for valproic acid. Findings: 1. In interview on November 16, 2018 at 10:11 am, Personnel 16 stated the laboratory added valproic acid to the Siemens Dimension Vista 500 on October 4, 2018. 2. Review of the laboratory's validation records for valproic acid did -- 2 of 6 -- not include the following: a) accuracy, reportable range, and reference range studies b) Laboratory Director's approval/signature 3. In interview on November 16, 2018, Personnel 8 confirmed the laboratory did not include the identified items in their validation records. 4. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performs 12,000 valproic acid tests annually. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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 qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A REVISIT Survey was performed at Stone Clinical Laboratory LLC, CLIA ID # 19D2108253, on November 13, 2018 through November 16, 2018. Based on observation, record review and interview with personnel, the laboratory failed to perform a positive and negative control each day of patient testing for the Biofire Filmarray Gastrointestinal (GI) Panel and Respiratory Panel (RP) performed on the Biomereaux BioFire Filmarray Analyzer for thirty one (31) days of thirty one (31) days reviewed. Findings: 1. Observation by surveyor on November 13, 2018 revealed the laboratory utilized the Biomereaux Biofire System for the reporting of 2 Panels: a) GI Panel for: Campylobacter (jejuni, coli, and upsaliensis), Clostridium difficile (toxin A/B), Plesiomonas shigelloides, Salmonella, Vibrio (parahaemolyticus, vulnificus, and cholerae), Vibrio cholerae, Yersinia enterocolitica, Enteroaggregative E. coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC) lt /st, Shiga-like toxin-producing E. coli (STEC) stx1/stx2, E.coli O157, Shigella /Enteroinvasive E coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Adenovirus F 40/41, Astrovirus, Norovirus GI/ GII, Rotavirus, and Sapovirus. b) Respiratory Panel for: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Human Rhinovirus/Enterovirus, Influenza A, Influenza A/H1, Influenza A/H3, Influenza A/H1-2009, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza virus 3, Parainfluenza 4, and Respiratory Syncytial Virus (RSV). 2. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to establish written policies and procedures for Quality Control for the GI and RP Panels performed on the Biomereaux BioFire Filmarray Analyzer. 3. Review of Patient Test Records from July 13, 2018 through November 12, 2018 revealed the following fifty one (51) patient samples were tested and reported on twenty nine (29) patient test days without performing a positive and negative control each day of patient testing. a) For the GI Panel: On July 13, 2018 Patient 1. On July 18, 2018 Patient 2. On July 20, 2018 Patient 3. On July 23, 2018 Patient 4. On July 26, 2018 Patients 6 and 11. On August 1, 2018 Patient 8. On August 2, 2018 Patients 7 and 15. On August 10, 2018 Patients 9 and 14. On August 14, 2018 Patient 5. On August 15, 2018 Patient 13. On August 17, 2018 Patient 12. On August 31, 2018 Patient 16. On September 18, 2018 Patient 10. b) For the Respiratory Panel: On July 19, 2018 Patients 18, 20, 21, 22, 23, and 38. On July 20, 2018 Patient 42. On July 24, 2018 Patients 19, 30. On July 27, 2018 Patient 24. On July 31, 2018 Patients 32, 33, 34, 35, 36, 46, 47, and 48. On August 2, 2018 Patient 37. On August 21, 2018 Patient 31. On August 25, 2018 Patient 43. On September 11, -- 3 of 6 -- 2018 Patients 40, 49, 50, and 51. On September 18, 2018 Patients 17, and 39. On September 25, 2018 Patient 27. On September 26, 2018 Patient 26. On October 18, 2018 Patient 41. On October 27, 2018 Patients 25, and 29. On November 2, 2018 Patient 28. On November 12, 2018 Patients 44, and 45. 4. Interviews with Personnel 8, 15 and 16 revealed after the installation studies were completed on the Biomerieux BioFire Filmarray Analyzer on April 24, 2018 and that the laboratory has performed no external Quality Control. Personnel 8, 15 and 16 confirmed that all patients were tested and reported for GI or RP Panel performed on the BioFire Filmarray Analyzer without having any external quality control performed. 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: A REVISIT Survey was performed at Stone Clinical Laboratory LLC, CLIA ID # 19D2108253, on November 13, 2018 through November 16, 2018. Based on review of the laboratory's

Summary Statement of Deficiencies D0000 A REVISIT Survey was performed at Stone Clinical Laboratories, LLC, CLIA ID # 19D2108253, on Februa through March 1, 2018. Stone Clinical Laboratories, LLC was found not in compliance with the following CO LEVEL DEFICIENCIES: 42 CFR 493.801 CONDITION: Enrollment and testing of samples 42 CFR 493.12 CONDITION: Analytic Systems 42 CFR 493.1409 CONDITION: Laboratories performing moderate comple Technical Consultant 42 CFR 493.1441 CONDITION: Laboratories performing high complexity testing, Lab Director ________________________________________________________________________________________ 11040 A Validation/Complaint Survey was performed at Stone Clinical Laboratories, LLC - CLIA 19D21082 9, 2017 through May 12, 2017. Stone Clinical Laboratories, LLC was found not in compliance with the follow CONDITION LEVEL DEFICIENCIES which constitute an IMMEDIATE JEOPARDY to the patients servic laboratory: 42 CFR 493.1240 CONDITION: Preanalytic Systems 42 CFR 493.1250 CONDITION: Analytic CFR 493.1441 CONDITION: Laboratories performing high complexity testing, Laboratory Director 42 CFR CONDITION: Laboratories performing high complexity testing, Technical Supervisor 42 CFR 493.1459 CO Laboratories performing high complexity testing, General Supervisor 42 CFR 493.1487 CONDITION: Labor performing high complexity testing, Testing Personnel 42 CFR 493.1771 CONDITION: Inspection D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this pa approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as pat specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to S 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this s effective January 1, 1994. This CONDITION is not met as evidenced by: A REVISIT Survey was performed at Stone Clinical Laboratory LLC, CLIA ID # 19D2108253, on February 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 -- through March 1, 2018. Based on observation, record review, and interview with personnel, the laboratory fa in a HHS approved proficiency testing program for Chemistry and Immunology testing. Findings: 1. Observa surveyors during laboratory tour on February 28, 2018 revealed the laboratory utilizes the following instrume Chemistry and Immunology testing: a) Siemens Dimension Vista 500: utilized for testing of Sodium, Potassiu Chloride, Carbon Dioxide, Blood Urea Nitrogen, Creatinine, Glucose, Total Calcium, Total Protein, Albumin Bilirubin, Direct Bilirubin, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, G Glutamyltransferase, Magnesium, Phosphorus, Uric Acid, Total Cholesterol, Triglycerides, High Density Ch Low Density Cholesterol, Total Creatine Kinase, Iron, Total Iron Binding Capacity, Ferritin, Vitamin B12, H A1c, High Sensitivity C-Reactive Protein, Total Testosterone, Beta Human Chorionic Gonadotropin, Luteiniz Hormone, Follicle-Stimulating Hormone, Progesterone, Prolactin, Thyroid Stimulating Hormone, Free Triiod (T3) , Free Thyroxine (T4), Thyroid Uptake, Rheumatoid Factor, Apolipoprotein A1, Apolipoprotein B, Cyst terminal pro-Brain Natriuretic Peptide, Cardiac Troponin I, C-Reactive Protein, Amylase, Lipase, Transferrin Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin M, Complement C3, Complem Lithium, Carbamazepine, Phenytoin, Digoxin, Random Urine Creatinine, Random Urine Total Protein, and R Urine Microalbumin. b) Siemens Centaur XP: Vitamin D, Cortisol, Dehydroepiandrosterone sulfate, Estradio Homocysteine, Prostate Specific Antigen, Intact Parathyroid Hormone, Sex Hormone-Binding Globulin, Tota Thyroid Peroxidase Antibody, Thyroglobulin Antibody, and Cyclic Citrullinated Peptide Antibody IgG. 2. R laboratory's proficiency records for 2018 revealed the laboratory did not have documentation of enrollment fo interview on February 28, 2018, Personnel 10 stated the laboratory's payment for proficiency testing enrollme College of American Pathologists (CAP) was submitted February 16, 2018. Personnel 10 further stated per co with CAP a confirmation letter for enrollment will not be issued until payment has been processed. 4. In inter March 1, 2018 at 10:44 am, Personnel 2 stated the laboratory began patient testing on the Siemens Dimension Centaur instruments on December 1, 2017. -- 2 of 2 --