Document 2JYNmjM8axaOZomRdR4VgQn55

Inspection Entry Date/Time Inspection Exit Date/Time Weather Regulatory Program Type of Inspection EPA Region 10 Enforcement Division INSPECTION REPORT 08/23/2022 09:28 AM (AKT) Announced: No 08/23/2022 11:28 AM (AKT) Access: Granted N/A RCRA CEI - Compliance Evaluation Inspection Company Name Facility or Site Name Facility/Site Identifier Facility/Site Physical Address City, State, Zip Code County/Borough Generator Status NAICS Type of Operation Size of Facility Length of Facility at Location Geographic Coordinates Mailing Address/Secondary Address City, State, Zip Code Cellnetix Pathology and Laboratories Cellnetix Pathology and Laboratories AKR000204651 2490 S. Woodworth Loop, Suite 410 (Medical Plaza 1) Palmer, AK 99645 Matanuska-Susitna Borough SQG 621511 - Medical laboratories Pathology Lab 1,700 sq. Ft. 10 years 61.56198, -149.26056 Ms. Briena Mugridge, Alaska Laboratory Technical Site Supervisor 2490 S. Woodworth Loop, Suite 410 bmugridge@cellnetix.com Palmer, AK 99645 Permit Number (If Applicable) Not Applicable Additional Persons Participating in Inspection: Name Title Organization Email Phone Lead Inspector: Jon Jones JONATHAN JONES EPA Region 10 Digitally signed by JONATHAN JONES Date: 2022.10.21 12:46:35 -08'00' Jones.Jon@epa.gov (907) 271-6329 Supervisor Review: Jen Sullivan Jennifer A Sullivan EPA Region 10 SECTION I - INTRODUCTION Site Entry and Purpose of the Inspection Type of inspection: CEI - Compliance Evaluation Inspection 1 of 18 Digitally signed by Jennifer A Sullivan Date: 2022.10.24 07:29:47 -07'00' Sullivan.Jennifer.A@epa.gov (206) 553-6978 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 This was a Resource Conservation and Recovery Act (RCRA) inspection. The facility was inspected to ensure compliance with standards for hazardous waste generators (40 C.F.R. Part 262 through 272). The inspection was conducted as part of a Core Program requirement for FY 2022. This report is based on information supplied by Cellnetix Pathology and Laboratories Facility representatives, observations made by the EPA Region 10 inspector, and records and reports maintained by the facility including, but not limited to: direct observations made by the EPA Region 10 Inspector(s), photographs taken by EPA Region 10 inspector(s), physical evidence collected by the EPA Region 10 inspector(s), measurements or samples taken by EPA Region 10 inspector(s), verbal or written statements made by and supplied by the facility representatives during or subsequent to the on-site Inspection, and materials, processes, data, photographs, or documents shown, demonstrated, or submitted to the EPA Region 10 inspector(s) by the facility representatives during or subsequent to the on-site Inspection. In addition, information gathered prior to or after the Inspection from a review of USEPA, State, and public records may be included in this report. Attendees Title/Organization Name Lead Inspector/EPA Jon Jones Region 10 Alaska Laboratory Briena Technical Site Mugridge Supervisor/Cellnetix Pathology and Laboratories Phone 9072716329 Email Jones.Jon@epa.gov Opening Conf. Closing Conf. Yes Yes (907) 746-6791 bmugridge@cellnetix.com Yes Yes Opening Conference EPA Lead Inspector Jon Jones arrived at the Cellnetix Pathology And Laboratories at 09:28 AM (AKT) on 08/23/2022 for an inspection. I presented my credentials to and informed Briena Mugridge that this was an EPA RCRA inspection. The table above presents all the inspection participants in opening and closing conferences. Facility/Site Information Operating Hours Monday through Friday, 8:00 a.m. to 6:00 p.m. Weather Conditions N/A (Inspection was conducted indoors) Number of employees 10 Safety Training No Provided to Inspector(s)? What type of generator facility notified? Small Quantity Generator (SQG) What type of generator facility verified as? Verified as SQG by Ms. Mugridge 2 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 Process Description During the opening conference, I asked Ms. Mugridge to tell me about the wastes generated in the lab. Ms. Mugridge told me about the following wastes and generation rates: Silver waste (ammoniacal silver) - generated about once per year, since 2021 . Solvent waste - According to Ms. Mugridge, General H&E staining (staining of tissue) generates ignitable solvent waste that is shipped out every 3 to 4 weeks Chromic acid waste - generated since last quarter of 2021 Picric acid waste - generated very infrequently. Gold Chloride waste - generated since last quarter of 2021 According to Ms. Mugridge, the facility does not generate any universal waste or used oil. Cellnetix Pathology and Laboratories, located in Medical Plaza 1, performs specimen analytical work for the Mat-Su Regional Medical Center (adjacent to Medical Plaza 1) and Alaska Regional Hospital in Anchorage. Building(s) Building/Area/Sub-area Medical Plaza 1 Cellnetix Suite 410 Chemical room Cytology Main lab Process Description SAA/CAA - waste solvent - waste picric acid - waste gold chloride - waste chromic acid - waste ammoniacal silver Wet slide prep and staining Wet slide prep and staining Area of Concern No No Yes No No SECTION II - OBSERVATIONS Building: Medical Plaza 1/Cellnetix Suite 410/Cytology Observation #: JJ1-OB-001 Date: 08/23/2022 Person Interviewed: Briena Mugridge Contains AOC: No Contains CBI: No Title: Alaska Laboratory Technical Site Supervisor According to Ms. Mugridge, when stains and reagents become dirty the waste stains and reagents (D001) are poured into a one-gallon transfer container. The transfer container is then taken into the Chemical Room and the contents are poured into a 55-gallon satellite accumulation area (SAA) container. Photo(s) 1. IMG-202208230956445644519380.jpg 2. IMG-202208230956535653461377.jpg Building: Medical Plaza 1/Cellnetix Suite 410/Main lab Observation #: JJ1-OB-002 Date: 08/23/2022 Person Interviewed: Briena Mugridge Contains AOC: No Contains CBI: No Title: Alaska Laboratory Technical Site Supervisor 3 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 During the inspection, Ms. Mugridge showed me another area where waste stains and reagents were generated. Ms. Mugridge told me that when they are generated, the waste stains and reagents will be hazardous waste. Adjacent to this area, there was a small plastic tote that held two one-gallon containers. Only one container was present when the photo was taken. At the time of the inspection, these two containers were empty. Ms. Mugridge told me they will be used to collect and then transfer the hazardous waste stain and reagents to an SAA in the Chemical Room. These containers were not labeled with the words hazardous waste or a hazard indicator. I explained to Ms. Mugridge that the containers will need to be labeled with the words hazardous waste and a hazard indicator before any hazardous waste enters them. Photo(s) 1. IMG-20220823100136136460203.jpg 2. IMG-20220823100144144307001.jpg Building: Medical Plaza 1/Cellnetix Suite 410/Chemical room Observation #: JJ1-OB-003 Date: 08/23/2022 Contains AOC: No Contains CBI: No Person Interviewed: Briena Mugridge Title: Alaska Laboratory Technical Site Supervisor At the time of the inspection, I saw a yellow flammable storage cabinet that held several quart-size SAA containers of the following lab wastes: waste silver (ammoniacal silver) waste picric acid waste chromic acid waste gold chloride These SAA containers were all labeled with the words hazardous waste and hazard indicators. Photo(s) 1. IMG-202208231015371537327507.jpg 2. IMG-202208231015471547335149.jpg 3. IMG-202208231016311631160153.jpg 4. IMG-202208231016361636209404.jpg 5. IMG-202208231016501650182052.jpg 6. IMG-20220823101705175199327.jpg 7. IMG-202208231017221722172090.jpg Building: Medical Plaza 1/Cellnetix Suite 410/Chemical room Observation #: JJ1-OB-004 Date: 08/23/2022 Contains AOC: Yes Contains CBI: No Person Interviewed: Briena Mugridge Title: Alaska Laboratory Technical Site Supervisor During the inspection, I saw a 55-gallon SAA container being utilized to accumulate waste solvent (Stains/Reagents). Ms. Mugridge confirmed that the waste solvent in the container was hazardous waste. At the time of the inspection, the container was not labeled with the words "Hazardous Waste." A funnel was in the bung opening so the container was not closed. The container was labeled with a hazard indicator. 4 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 Ms. Mugridge removed the funnel and screwed the bung back into the bung hole, closing the container, and she also labeled it with the words "Hazardous Waste" while I was present. Photo(s) 1. IMG-202208231021432143330157.jpg 2. IMG-202208231021532153253777.jpg 3. IMG-202208231021582158296444.jpg 4. IMG-20220823102206226244563.jpg 5. IMG-202208231025442544324256.jpg 6. IMG-202208231025542554264759.jpg SECTION III - RECORDS REVIEW Record: Preparedness and Prevention Ref #: JJ1-RR-003 Reviewed By: Jon Jones AOC: Yes Reviewed Date: 08/23/2022 At the time of the inspection, Emergency Information was not posted next to a phone. Following the inspection, I provided Ms. Mugridge with a sample emergency information sheet that is publicly available on the McCoy Seminars RCRA website. On 9/8/2022, I received an email Ms. Mugridge that included a photo of the facility's emergency information and a photo showing that it was posted next to a phone. Record: Inspections Ref #: JJ1-RR-005 Reviewed By: Jon Jones AOC: Yes Reviewed Date: 10/13/2022 During the inspection, I asked Ms. Mugridge to provide me with copies of the facility's weekly hazardous waste inspections for the years 2019 through 2022. Ms. Mugridge told me that the facility's hazardous waste transporter comes to their facility to pick up their hazardous waste on a routine basis, approximately every three weeks. Ms. Mugridge told me that because of this pick-up schedule, their 55-gallon SAA container of waste solvent was never completely filled, so it has not become a central accumulation area container. According to the documents received, the facility ceased weekly hazardous waste inspections in 2020 and began conducting monthly facility inspections. Following the inspection, I reviewed the facility's manifests again in EPA's RCRAInfo E-manifest database. During this review, I saw that most of the manifests documented a waste pick-up of a single 55-gallon container of the waste solvent every few months, consistent with what Ms. Mugridge had explained. According to the weight on each of these manifests, there was a fluctuation between 300 to 525 pounds, consistent with the container not reaching full capacity prior to shipment. However, during this expanded review of the facility's manifests following the inspection, I identified the following instances where multiple 55-gallon containers of waste solvent were shipped indicating that weekly hazardous waste inspections should have been conducted in 2021 and 2022: (The list below also shows prior shipments as a reference. The shipments that include a container(s) that would have required a weekly hazardous waste inspection are marked in bold.) Manifest # Shipment Date # of containers weight of containers 003185558CLE 5/25/21 1 X 55 400 pounds 5 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 003210348CLE 6/24/21 2 X 55 800 pounds According to the previous waste shipment on 5/25/21, two, 55-gallon containers of waste solvent were generated within the following 30 days and shipped out on 6/24/21. One of the two waste solvent containers would have become full and would have become an accumulation container of waste solvent vs an SAA container. This would have resulted in the accumulation container having to be inspected during at least one week prior to the 6/24/21 shipment date. 003355180CLE 11/9/21 1 X 55 500 pounds 012646548FLE 12/10/21 2 X 55 700 pounds The same would have applied to the two, 55-gallon containers above, between the 11/9/21 and 12/10/21 shipments. This would have resulted in the accumulation container having to be inspected during at least one week prior to the 12/10/21 shipment date. 013167018FLE 4/12/22 1 X 55 440 pounds 017106661FLE 6/20/22 3 X 55 950 pounds The same would have applied to the three, 55-gallon containers above, between the 4/12/22 and 6/20/22 shipments. This would have resulted in the first accumulation container having to be inspected during at least six weeks prior to the 12/10/21 shipment date and the second accumulation container having to be inspected during at least three weeks prior to the 12/10/21 shipment date. 015839979FLE 8/6/22 2 X 55 900 pounds The same would have applied to the two, 55-gallon containers above, between the 6/20/22 and 8/6/22. This would have resulted in the first accumulation container having to be inspected during at least two weeks, possibly three weeks, prior to the 12/10/21 shipment date Document(s) 1. Manifest_013167018FLE.pdf 2. Manifest-017106661FLE.pdf 3. Manifest-015839979FLE.pdf 4. Manifest_003185558CLE.pdf 5. Manifest_003210348CLE.pdf 6. Manifest_003355180CLE.pdf 7. Manifest_012646548FLE.pdf 8. 2019 wkly inspections.pdf 9. 2020 monthly insp.pdf 10. 2021 monthly insp.pdf 11. 2022 monthly insp.pdf Record: Manifests AOC: No Ref #: JJ1-RR-006 Reviewed By: Jon Jones Reviewed Date: 10/13/2022 During another review of the facility's hazardous waste manifests following the inspection, I saw a manifest that had been signed by a Cellnetix employee who had not received DOT training. Manifest # 013166985FLE, dated 3/8/22 was signed by John Fink, MD (Cellnetix attending Pathologist). At the time, Dr. Fink had not had DOT training, which is a requirement for anyone signing a hazardous waste manifest. I contacted Ms. Mugridge on 10/12/22 by email and spoke to her over the phone regarding this area of concern. Ms. Mugridge emailed the DOT training certificates for her staff that sign manifests, as well as an internal corrective action document regarding the staff member signing the manifest and the lack of required DOT training. I did not receive a copy of Ms. Mugridge' s DOT certificate; however, she told me that she had taken the training in April of 2019. She told me that her DOT training expired in April 2022 and that she needed to 6 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 renew it prior to signing any manifests. My review of the manifests indicated that Ms. Mugridge had not signed any manifests in 2022. Document(s) 1. CA-Manifest_DOT.pdf 2. DOT Training Cert's.pdf 3. 10-12-22 email from facility.pdf 4. Manifest_013166985FLE.pdf SECTION IV - AREAS OF CONCERN The presentation of areas of concern does not constitute a formal compliance determination or violation. Building: Medical Plaza 1 JJ1-OB-004 Area: Cellnetix Suite 410 Sub-area: Chemical room During the inspection, I saw a 55gallon SAA container being utilized to accumulate hazardous waste solvent (Stains/Reagents). At the time of the inspection, the container was not labeled with the words "Hazardous Waste" and was not closed. Citations: 262.15(a)(4), 262.15(a)(5)(i) Sections: Record: Preparedness and Prevention JJ1-RR-003 Emergency information was not posted next to a phone. Record: Inspections JJ1-RR-005 Citations: Sections: 262.16(b)(9)(ii)(A), 262.16(b)(9)(ii)(B), 262.16(b)(9)(ii)(C) The facility did not conduct 13 to 14 weekly hazardous waste inspections in 2021 and 2022 when accumulation containers were stored in their Chemical Room CAA. Citations: 262.16(b)(2)(iv) (The list below also shows prior shipments as a reference. The shipments that include a Sections: 7 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 container(s) that would have required a weekly inspection are marked in bold.) Manifest #, Date, # of containers, weight 003185558CLE, 5/25/21, 1 X 55, 400 pounds 003210348CLE, 6/24/21, 2 X 55, 800 pounds 003355180CLE, 11/9/21, 1 X 55, 500 pounds 012646548FLE, 12/10/21, 2 X 55, 700 pounds 013167018FLE, 4/12/22, 1 X 55, 440 pounds 017106661FLE, 6/20/22, 3 X 55, 950 pounds 015839979FLE, 8/6/22, 2 X 55, 900 pounds SECTION V - CLOSING CONFERENCE AND FOLLOW UP Closing Conference At the end of the inspection, I held a closing conference to discuss the initial findings of my inspection with Ms. Mugridge, Cellnetix Alaska Laboratory Technical Site Supervisor. I explained that I had inspected the Cellnetix facility looking at areas where solid and hazardous wastes were managed. I discussed all the areas of concern in Section III that were identified during the on-site inspection, and I explained the follow-up process that would take place after the inspection. SECTION VI - SAMPLING ACTIVITIES AND ANALYTICAL RESULTS - No sampling was conducted. SECTION VII - LIST OF APPENDICES 1. Photo Log 2. Document Log 8 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 APPENDIX 1: PHOTO LOG [Title] IMG-202208231015371537327507.jpg 08/23/2022 10:15 AM Photographer: Jon Jones Cellnetix Suite 410/Chemical room No CBI No PII View of yellow flammable storage cabinet that held quart-size SAA containers of waste ammoniacal silver, waste picric acid, waste chromic acid, and waste gold chloride. [Title] 08/23/2022 10:15 AM Cellnetix Suite 410/Chemical room Close-up view of the SAA containers. IMG-202208231015471547335149.jpg Photographer: Jon Jones No CBI No PII 9 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 [Title] IMG-202208231016311631160153.jpg 08/23/2022 10:16 AM Photographer: Jon Jones Cellnetix Suite 410/Chemical room No CBI No PII Close-up view of the waste ammoniacal silver SAA container. [Title] IMG-202208231016361636209404.jpg 08/23/2022 10:16 AM Photographer: Jon Jones Cellnetix Suite 410/Chemical room No CBI No PII Close-up view of the waste ammoniacal silver SAA container. 10 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 [Title] IMG-202208231016501650182052.jpg 08/23/2022 10:16 AM Photographer: Jon Jones Cellnetix Suite 410/Chemical room No CBI No PII Close-up view of the waste gold chloride SAA container. [Title] IMG-20220823101705175199327.jpg 08/23/2022 10:17 AM Photographer: Jon Jones Cellnetix Suite 410/Chemical room No CBI No PII Close-up view of the waste chromic acid SAA container. 11 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 [Title] IMG-202208231017221722172090.jpg 08/23/2022 10:17 AM Photographer: Jon Jones Cellnetix Suite 410/Chemical room No CBI No PII Close-up view of the waste picric acid SAA container. [Title] IMG-202208231021432143330157.jpg 08/23/2022 10:21 AM Photographer: Jon Jones Cellnetix Suite 410/Chemical room No CBI No PII View of 55-gallon container being utilized as a SAA container to accumulate hazardous waste solvent. The container was not labeled with the words "Hazardous Waste" and was not closed. The container was labeled with a hazard indicator. 12 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 [Title] IMG-202208231021532153253777.jpg 08/23/2022 10:21 AM Photographer: Jon Jones Cellnetix Suite 410/Chemical room No CBI No PII View of the signage on wall adjacent to the hazardous waste solvent SAA container. [Title] IMG-202208231021582158296444.jpg 08/23/2022 10:21 AM Photographer: Jon Jones Cellnetix Suite 410/Chemical room No CBI No PII View looking down into the funnel, showing that the hazardous waste solvent SAA container was not closed. 13 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 [Title] IMG-20220823102206226244563.jpg 08/23/2022 10:22 AM Photographer: Jon Jones Cellnetix Suite 410/Chemical room No CBI No PII View of the funnel, showing that the hazardous waste solvent SAA container was not closed. [Title] IMG-202208231025442544324256.jpg 08/23/2022 10:25 AM Photographer: Jon Jones Cellnetix Suite 410/Chemical room No CBI No PII View of the hazardous waste solvent SAA container after Ms. Mugridge closed the container and labeled it with the words "Hazardous Waste" during the inspection. 14 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 [Title] 08/23/2022 10:25 AM Cellnetix Suite 410/Chemical room Close-up view after being labeled and closed. IMG-202208231025542554264759.jpg Photographer: Jon Jones No CBI No PII [Title] IMG-202208230956445644519380.jpg 08/23/2022 09:56 AM Photographer: Jon Jones Cellnetix Suite 410/Cytology No CBI No PII View of the stains and reagents that, when dirty, are managed as waste solvent. 15 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 [Title] IMG-202208230956535653461377.jpg 08/23/2022 09:56 AM Photographer: Jon Jones Cellnetix Suite 410/Cytology No CBI No PII Close-up view of the stains and reagents that, when dirty, are managed as waste solvent. [Title] IMG-20220823100136136460203.jpg 08/23/2022 10:01 AM Photographer: Jon Jones Cellnetix Suite 410/Main lab No CBI No PII View of one of the two transfer containers that will be used to transfer the waste solvent to a waste solvent SAA container. 16 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 [Title] IMG-20220823100144144307001.jpg 08/23/2022 10:01 AM Photographer: Jon Jones Cellnetix Suite 410/Main lab No CBI No PII Close-up view of one of the two transfer containers that will be used to transfer waste solvent to a waste solvent SAA container. 17 of 18 Cellnetix Pathology and Laboratories Inspection Date(s): 08/23/2022 APPENDIX 2: DOCUMENT LOG Document Type Document Name Contains Contains Uploaded By CBI PII Facility Map Records Review Records Review Records Review Records Review Records Review Records Review Records Review Records Review Records Review Records Review Records Review Records Review Records Review Records Review Records Review Capture.PNG No No Jon Jones Manifest_013167018FLE.pdf No No Jon Jones Manifest-017106661FLE.pdf No No Jon Jones Manifest-015839979FLE.pdf No No Jon Jones Manifest_003185558CLE.pdf No No Jon Jones Manifest_003210348CLE.pdf No No Jon Jones Manifest_003355180CLE.pdf No No Jon Jones Manifest_012646548FLE.pdf No No Jon Jones 2019 wkly inspections.pdf No No Jon Jones 2020 monthly insp.pdf No No Jon Jones 2021 monthly insp.pdf No No Jon Jones 2022 monthly insp.pdf No No Jon Jones CA-Manifest_DOT.pdf No No Jon Jones DOT Training Cert's.pdf No No Jon Jones 10-12-22 email from facility.pdf No No Jon Jones Manifest_013166985FLE.pdf No No Jon Jones Date Received 10/11/2022 10/13/2022 10/13/2022 10/13/2022 10/13/2022 10/13/2022 10/13/2022 10/13/2022 10/13/2022 10/13/2022 10/13/2022 10/13/2022 10/13/2022 10/13/2022 10/13/2022 10/13/2022 18 of 18