STATE OF INDIANA		)	SS:	BEFORE THE INDIANA DEPARTMENT OF
		)
COUNTY OF MARION		)		ENVIRONMENTAL MANAGEMENT
COMMISSIONER OF THE DEPARTMENT					)
OF ENVIRONMENTAL MANAGEMENT,					)
					)
Complainant,					)
					)
	v.				)	Case No. 2017-24793-S
					)
MEDASSURE OF INDIANA, LLC,					)
					)
Respondent.					)

AGREED ORDER

Complainant and Respondent desire to settle and compromise this action without hearing or adjudication of any issue of fact or law, and consent to the entry of the following Findings of Fact and Order. Pursuant to IC 13-30-3-3, entry into the terms of this Agreed Order does not constitute an admission of any violation contained herein. Respondent’s entry into this Agreed Order shall not constitute a waiver of any defense, legal or equitable, which Respondent may have in any future administrative or judicial proceeding, except a proceeding to enforce this order.

I. FINDINGS OF FACT

1. Complainant is the Commissioner (“Complainant”) of the Indiana Department of Environmental Management (“IDEM”), a department of the State of Indiana created by Indiana Code (“IC”) 13-13-1-1.

2. Respondent is MedAssure of Indiana, LLC, which operates a solid waste processing facility with SW Program ID 49-6, located at 1013 South Girls School Road in Indianapolis, Marion County, Indiana (the “Site”).

3. IDEM has jurisdiction over the parties and the subject matter of this action.

4. Pursuant to IC 13-30-3-3, IDEM issued a Notice of Violation (“NOV”) via Certified Mail to:

Joe Delloiacovo, Executive Vice-President	Vcorp Services, LLC, Registered Agent
MedAssure of Indiana, LLC	MedAssure of Indiana, LLC
1013 South Girls School Road	200 Byrd Way, Suite 205
Indianapolis, IN 46231	Greenwood, IN 46143

5. During an investigation including inspections conducted on August 4, 2017; August 24 - August 25, 2017; August 29, 2017; October 3, 2017; and October 25, 2017, by a representative of IDEM, the following violations were found:

a. Pursuant to 329 Indiana Administrative Code (“IAC”) IAC 11-13.5-6(a)(1), a solid waste processing facility must have an enclosed building, with solid walls and a door or doors except as specified in subsection (h). The door must be closed when the facility is not in operation.

As noted during some or all of the inspections, Respondent had some overhead doors that were not working and did not close all the way.

b. Pursuant to 329 IAC 11-13.5-6(a)(3)(A)(B), a solid waste processing facility must have one of the following:

(A) Waste storage areas equipped with spill prevention mechanisms, such as curbs, aprons, or spill prevention kits.

(B) Waste is stored in leak-proof containers.

As noted during some or all of the inspections, Respondent’s spill prevention kit had items stacked on top of it, making it inaccessible. Waste was not stored in leak-proof containers. Some of the cardboard boxes had liquid leaking from them.

c. Pursuant to 329 IAC 11-13.5-6(b) solid waste must be confined to the designated storage, processing, loading, and unloading areas of the processing facility. Solid waste processing that includes MSW must occur only in the enclosed building required in subsection (a)(1). The processing facility and adjacent areas must be maintained clean and litter free when not in use.

As noted during some or all of the inspections, Respondent had solid waste outside of the designated storage, processing, loading, and unloading areas of the facility. Vials of dried blood were on the ground outside the wash bay. Also, needles were located outside the wash bay doors.

d. Pursuant to 329 IAC 11-13.5-7(a), vectors, dust, odors, spills, and noise must be controlled at all times such that there is no nuisance or health hazard at the facility.

As noted during some or all of the inspections, Respondent had flies and maggots that had infested several boxes in the warehouse and in the wash bay restroom.

e. Pursuant to 329 IAC 11-13.5-9(b), the owners or operators of solid waste processing facilities shall maintain the records and reports required in 329 IAC 11-13.5-9(a)(2) until certification of post-closure is deemed acceptable.

As noted during some or all of the inspections, Respondent did not have the facility operating records and training records for the facility and employees; they were incomplete or unavailable.

f. Pursuant to 329 IAC 11-13.5-15, the following conditions apply to all Indiana transfer stations that hold a valid permit under this article and are authorized to accept segregated infectious waste:

(1) Infectious waste must be stored in a manner that:

(A) preserves the integrity of containers; and

(B) is not conducive to rapid microbial growth and putrefaction.

The maximum duration for storage or containment of infectious waste must be limited to seven (7) days unless the department grants prior written approval for a longer period based on specific circumstances.

(2) Storage and containment of infectious waste must be in:

(A) a secure, vector free, and dry area separate from other solid waste at the facility; and

(B) such a manner and location that eliminates the possibility of exposure to:

(i) the environment;

(ii) facility personnel; and

(iii) the public.

Infectious waste must not be mixed with, or come into contact with, other solid waste. In addition, storage areas must protect infectious waste from weather, be ventilated to the outdoors, be accessible only to authorized persons, and be marked with prominent warning signs. The warning signs must include the nationally recognized biohazard symbol, Unicode U+2623, and be easily read from a distance of twenty-five (25) feet. Outside storage areas containing infectious waste must be locked to prevent unauthorized access.

(3) Infectious waste received by the facility must be packaged and labeled in accordance with the rules of the state department of health at 410 IAC 1-3, and the packaging and labeling must be maintained by the facility.

(4) Containers used to contain other containers of infectious waste must be marked with prominent warning signs or conspicuously labeled with the biohazard symbol or the word "INFECTIOUS".

(5) In addition to the requirements of this section, infectious waste must be labeled and packaged in accordance with applicable United States Department of Transportation regulations.

(6) Infectious waste must be transported and delivered to a facility that:

(A) holds a valid permit under this article and is authorized by the department in writing to accept and treat the waste; or

(B) is permitted by the appropriate governmental agency or agencies if located in another state, territory, or nation.

(7) Reusable containers for infectious waste must be thoroughly washed and decontaminated each time they are emptied, unless the surfaces of the containers have been completely protected from contamination by using disposable liners, bags, or other devices that are removed with the infectious waste. Reusable containers used for the storage of infectious waste must be disinfected before they are used for the storage or containment of any other solid waste or for other purposes.

As noted during some or all of the inspections, Respondent had containers of infectious waste that were damaged and leaking. Also, red bags containing infectious waste were on the floor. Putrefaction had already taken place in some of the boxes and flies and maggots were in the storage, wash bay, and restroom areas. The tracking system that was in use did not provide sufficient documentation to prove that all containers of infectious waste had not been held more than seven (7) days before processing. Non-reusable sharps containers were opened before treatment and disposal. Infectious waste was not properly packaged and labeled in accordance with Department of Transportation regulations. Cytotoxic waste was accepted by the facility; which is a hazardous waste.

g. Pursuant to Operating Permit Condition A2, the permittee must operate and maintain the solid waste processing facility (facility) as described in the approved plans and specifications. The permittee must request approval before modifying the facility or facility operating procedure.

As noted during some or all of the inspections, Respondent failed to operate and maintain the facility as described in the approved plans. The acceptance of the cytotoxic waste was in direct violation of Section 4-1 of Respondent’s Treatment Facility Plan. The acceptance of waste that are not properly packaged is in direct violation of Section 4-1 vii of Respondent’s Treatment Facility Plan. Non-reusable containers with sharps were not properly handled, treated and disposed of. Respondent opened non-reusable sharps containers before treatment and disposal. Respondent failed to depict on the floor plan, dated January 2, 2017, the area where non-reusable sharps containers had been stored. The lack of a proper waste tracking system and record keeping is in direction violation of Section 3 and 4-1 of Respondent’s Treatment Facility Plan. Respondent failed to provide approved protective equipment for all employees in violation of Section 5-1 ii of Respondent’s Treatment Facility Plan. Respondent had incomplete or incorrect training records in violation of Section 2 of Respondent’s Treatment Facility Plan. Respondent had numerous cardboard boxes containing infectious waste that that were not properly packaged or labeled property, they were leaking and/or had exposed waste.

During an examination of the training records for the plant manager on August 29, 2017, Respondent failed to accurately document the dates when the plant manager completed training. The plant manager’s expertise could not be verified because the different areas of expertise were not included on the form. The training records were not documented in the employee files.

h. Pursuant to Operating Permit Condition A3, the permittee must call (888) 233-7745 (IDEM’s emergency response line) as soon as possible after learning of any event related to the facility that may cause an imminent and substantial endangerment to human health or the environment, such as a reportable spill (327 IAC 2-6.1) or a fire or explosion that requires the response of the local fire department.

The permittee must also report to the permit manager assigned to the facility any other event that may cause endangerment to human health or the environment. The permittee must report these events within 24 hours from the time that the permittee becomes aware of the event or the next business day if the detection occurs over a weekend or holiday. Such events include but are not limited to:

a. An abnormal operating condition which causes potential exposure to infectious waste or violates an operating requirement, including Requirements C2, C3, C13, and C16.

b. An unscheduled shutdown of any of the microwave disinfection units (MDUs) or associated equipment.

c. Any damage to any of the MDUs or associated equipment that, if not repaired, could result in exposure to infectious waste or results in exceeding a requirement specified in the permit.

d. Any biological indicator test failure indicating a lack of effective treatment.

The permittee must also submit a written report to the address listed in Requirement A4 within 5 business days after the event. The report must describe the event, and actions taken or planned to correct the event and prevent its recurrence.

As noted during the inspection conducted on August 24, 2017, Respondent had a substantial number of containers of cytotoxic waste on the floor of the facility mixed in with other containers of infectious waste, which is in violation of the operating permit. Respondent was uncertain on the exact date the waste was received. A verbal and written report was not filed with IDEM regarding the acceptance of the waste within the required time frame. A written report was eventually filed on September 5, 2017.

As noted during the inspection conducted on August 24, 2017, due to a sensor malfunction, Respondent shut down MDU #1 for approximately a day while it was being worked on. Neither a verbal nor a written report was ever filed with IDEM regarding the unscheduled shutdown.

During an investigation conducted by a representative of IDEM, it was revealed that an incident occurred in the spring of 2017 that was in violation of Respondent’s operating and Treatment Facility Plan. IDEM’s Office of Land Quality was first made aware of the incident during a telephone conversation with representatives of MedAssure, Covanta, and Ray’s Trash Service on September 14, 2017. A shipment of medical waste from MedAssure was delivered to Covanta on March 2, 2017, by Ray’s Trash Service. When the load was dumped on the tipping floor of Covanta, an operator observed a sharps container mixed in with shredded medical waste. A thorough examination of the load by a QA/QC employee also revealed the presence of whole syringes. Covanta contacted Ray’s Trash Service and questioned a representative whether the load had been treated. After contacting MedAssure, Ray’s Trash Service was assured by a MedAssure representative that the waste had been treated, which was reported back to Covanta. Based on this information, the medical waste was treated as a solid waste and incinerated. Photos provided to IDEM by Covanta clearly show whole syringes, a sharps container, cardboard boxes and red bags, indicating the load did not receive adequate shredding or treatment prior to leaving the processing facility (MedAssure).

i. Pursuant to Operating Permit Conditions C1a-c, the permittee must comply with 329 IAC 11-13.5 (Operational Requirements) and the following:

a. Maintain the processing facility and adjacent areas clean and litter free when they are not in use.

b. Monitor the storage and processing areas each operating day for potential problems as described in Section 5-3, titled “Treatment Facility Plan”, included in the documentation dated January 2, 2017 (VFC #80412896).

c. Perform daily housekeeping and maintenance of the processing areas.

As noted during the inspection conducted on August 24-25, 2017, not all of the overhead doors at the facility would close all the way.

As noted during the inspection conducted on August 24-25, 2017, several containers of infectious waste were damaged, red bags containing infectious waste were on the floor, and several containers of infections waste were leaking and infested with flies and maggots.

As noted during the inspections conducted on August 4, 2017 and August 24-25, 2017, litter, vials containing dried blood, and needles were outside the container wash area. The bathroom located in the container wash areas was in a very unsanitary condition. Feces and maggots were observed on the floor and in the toilet. The toilet was not in proper working condition, and there was no water supply running to it.

j. Pursuant to Operating Permit Condition C1e, the permittee must comply with 329 IAC 11-13.5 (Operational Requirements) and, operate the MDUs and effectively treat the infectious waste (410 IAC 1-3-26) as detailed in documentation dated April 15, 2011 (VFC #61887730); May 31, 2011 (VFC #62514071); January 2, 2017 (VFC #80412896); and further detail described in HG-A-250S-Microwave Disinfection Unit – Attachment 1 and the general efficacy documentation. Page 18 of 27 of the HG-A-250S-Microwave Disinfection Unit-Attachment 1 describes the automatic shutdown sequence which ensures that all waste material is treated before exiting the microwave section (MWS).

Processing infectious waste through the Sanitec MDUs is a two-stage process and all medical waste that go through the MDU gets shredded and treated. When the MDU is operating correctly, it would be impossible for a load of infectious waste to be shredded without being treated. Conversely, it could not be treated without being shredded. During a phone conversation on September 19, 2017, between Mr. Tim Hotz of IDEM and Mr. Joe Delloiacovo with MedAssure, Mr. Delloiacovo stated that there had obviously been a deliberate act taken by a MedAssure employee to bypass the shredding and treatment process. This action is a violation of operating permit condition C1e.

As noted during an inspection conducted on August 29, 2017, waste was exiting the MWS while the MWS exit temperature was less than the required minimum temperature of 95 degrees C. Mr. Delloiacovo informed Mr. Daniel Harper of IDEM that the automatic shutdown procedure had not been followed, which allowed waste to exit the MWS while the temperature was less than the required minimum temperature of 95 degrees C.

k. Pursuant to Operating Permit Condition C1h, the permittee must comply with 329 IAC 11-13.5 (Operational Requirements) and inspect the pressure drop across the HEPA filter daily. Replace filters when pressure drop exceeds 3 inches of water column (0.75kPa). Maintain inspection results in the facility operating record.

As noted during the inspection conducted on August 29, 2017, Respondent did not have any documentation to prove that an inspection of the HEPA filter had been conducted daily.

l. Pursuant to Operating Permit Condition C2, the permittee must accept only non-category A infectious waste not specifically prohibited in Requirement C3 that meets the definition of infectious waste found at 410 IAC 1-3-10 for processing in the MDUs.

Pursuant to operating Permit Condition C3, the permittee must not process the following wastes:

a. Hazardous waste as defined by 329 IAC 3.1

d. Chemotherapy waste except for trace amounts that may be considered medical waste

The permittee must only accept infectious waste that can be processed in the MDU. If the permittee determines infectious waste received for treatment contains any waste prohibited in their permit, or is a waste not allowed or suitable for treatment in the MDU, the permittee must reject and return it to the generator for proper disposal or transfer it to another permitted facility for proper disposal. The permittee must follow proper packaging and labeling requirements when waste is returned to generator.

As noted during the inspection conducted on August 24-25, 2017, Respondent accepted cytotoxic waste from Daniels Sharpsmart. This waste is a hazardous waste and cannot be accepted by Respondent. The cytotoxic waste was not immediately isolated or placed in a secure area of the warehouse, separate from other infectious waste. During the August 29, 2017 inspection, the cytotoxic waste had not been returned to the generator.

m. Pursuant to Operating Permit Condition C2, the permittee must only accept wastes that are properly packaged in accordance with Indiana Department of Transportation (INDOT), local, state, and federal regulations.

As noted during the inspection conducted on August 24-25, 2017, Respondent had numerous cardboard boxes containing infectious waste at the facility. The boxes were damaged, leaking, and/or infested with flies and maggots.

n. Pursuant to Operating Permit Condition C5, the permittee must comply with the following regarding manifests:

a. Refuse to accept any infectious waste without a manifest/shipping document that complies with 410 IAC 1-3-28.

b. Record the date and weight of infectious waste received at the facility.

c. Generate a manifest for each shipment of the treated waste for the transporter to provide to the receiving facility (329IAC 11-15-4).

As noted during some or all of the inspections, Respondent only had a tracking system in place for MedAssure customers. The waste from Daniels Health USA and Daniels Sharpsmart did not contain bar codes; therefore, there was no feasible way to determine when a specific container of infectious waste from a third party customer was received by Respondent. Two manifests provided by the facility to an IDEM representative were purported to be documentation showing when the cytotoxic waste was received. However, the facility representative had also stated several times that they could not be sure the documentation provided were the correct manifests, or if that was the waste received in one load or multiple loads. An inspection log of all containers accepted by the facility was not maintained.

o. Pursuant to Operating Permit Condition C7, the facility must have a manager who has successfully completed a program of classroom instruction or on-the-job training to conduct the facility’s operations properly in compliance with the permit.

During an examination of the training records for the plant manager on August 29, 2017, Respondent failed to accurately document the dates when the plant manager completed training. The plant manager’s expertise could not be verified, because the different areas of expertise were not included on the form. The training records were not documented in the employee files.

p. Pursuant to Operating Permit Condition C8, the permittee must train operators to do the following:

a. Recognize hazardous waste

b. Use personal protective equipment properly when handling infectious waste

c. Operate the MDUs properly

As noted during the August 24, 2017 inspection, an IDEM representative observed that not all employees were wearing approved personal protective equipment, specifically disposable Tyvek suits, personal hard hat, and personal eye goggles.

q. Pursuant to Operating Permit Condition C9, the permittee must follow all requirements of 329 IAC 11-13.5-15, such as infectious waste warning signs, transportation requirements, and packaging criteria.

As noted during some or all of the inspections, Respondent had several boxes containing infectious waste at the facility that were not packaged or labeled properly.

r. Pursuant to Operating Permit Condition C11, staging of infectious waste and solid waste shall be limited to the areas delineated on the plan titled, “As-Built FACILITY FLOOR PLAN –Rev. 01-02-2017”, and dated January 2, 2017 (VFC #80412895). Storage of infectious waste is limited to the designated areas of the facility, specifically on trucks at the loading dock, the waste staging area adjacent to the loadings docks, and the temporary radioactive waste storage. The following additional requirements also apply:

a. Store received infectious waste for a maximum of 7 days before processing.

b. Remove treated infectious waste from the site within a week except for holidays and weekends.

As noted during some or all of the inspections, Respondent failed to correctly indicate on the As-Built Facility Floor Plan the area where containers of infectious waste and empty contains had been stored. Infectious waste was stored outside the area listed on the facility floor plan as container storage or waste staging area. The outside lot adjacent to the container wash area had non-reusable empty sharps containers stored on it. This container storage was not depicted on the facility floor plan.

As noted during the inspections conducted on August 24-25, 2017 and August 29, 2017, without a tracking system in place for third party customers, it was impossible to prove this permit condition had been met.

6. On January 25, 2018, a representative of IDEM conducted an inspection of the Site and found all of the violations had been corrected.

7. In recognition of the settlement reached, Respondent waives any right to administrative and judicial review of this Agreed Order.

II. ORDER

1. This Agreed Order shall be effective (“Effective Date”) when it is approved by Complainant or Complainant’s delegate, and has been received by Respondent. This Agreed Order shall have no force or effect until the Effective Date.

2. Respondent shall comply with the statutes, rules, and/or permit conditions listed in the findings above.

3. Immediately upon the Effective Date, Respondent shall comply with 329 IAC 11, and SW Program ID 49-6.

4. Respondent is assessed and agrees to pay a civil penalty of Twenty-Seven Thousand Dollars ($27,000). Said penalty amount shall be due and payable to the Environmental Management Special Fund in twelve (12) monthly installments. The first installment of Two Thousand Two Hundred and Fifty Dollars ($2,250) shall be paid within thirty (30) days of the Effective Date; the 30^th day being the “Due Date”. Thereafter, subsequent monthly payments in the amount of Two Thousand Two Hundred and Fifty Dollars ($2,250) shall be due on the 30^th day being the “Due Date”.

5. The civil penalty is payable by check to the “Environmental Management Special Fund.” Checks shall include the Case Number of this action and shall be mailed to:

Indiana Department of Environmental Management

Office of Legal Counsel

IGCN, Room N1307

100 North Senate Avenue

Indianapolis, IN 46204

6. In the event that the monies due to IDEM pursuant to this Agreed Order are not paid on or before their Due Date, Respondent shall pay interest on the unpaid balance at the rate established by IC 24-4.6-1. The interest shall be computed as having accrued from the Due Date until the date that Respondent pays any unpaid balance. Such interest shall be payable to the Environmental Management Special Fund, and shall be payable to IDEM in the manner specified in Paragraph 5, above.

7. This Agreed Order shall apply to and be binding upon Respondent and its successors and assigns. Respondent’s signatories to this Agreed Order certify that they are fully authorized to execute this Agreed Order and legally bind the party they represent. No change in ownership, corporate, or partnership status of Respondent shall in any way alter its status or responsibilities under this Agreed Order.

8. In the event that any terms of this Agreed Order are found to be invalid, the remaining terms shall remain in full force and effect and shall be construed and enforced as if this Agreed Order did not contain the invalid terms.

9. Respondent shall provide a copy of this Agreed Order, if in force, to any subsequent owners or successors before ownership rights are transferred. Respondent shall ensure that all contractors, firms and other persons performing work under this Agreed Order comply with the terms of this Agreed Order.

10. This Agreed Order is not and shall not be interpreted to be a permit or a modification of an existing permit. This Agreed Order, and IDEM’s review or approval of any submittal made by Respondent pursuant to this Agreed Order, shall not in any way relieve Respondent of its obligation to comply with the requirements of its applicable permits or any applicable Federal or State law or regulation.

11. Complainant does not, by its approval of this Agreed Order, warrant or aver in any manner that Respondent’s compliance with any aspect of this Agreed Order will result in compliance with the provisions of any permit, order, or any applicable Federal or State law or regulation. Additionally, IDEM or anyone acting on its behalf shall not be held liable for any costs or penalties Respondent may incur as a result of Respondent’s efforts to comply with this Agreed Order.

12. Nothing in this Agreed Order shall prevent or limit IDEM’s rights to obtain penalties or injunctive relief under any applicable Federal or State law or regulation, except that IDEM may not, and hereby waives its right to, seek additional civil penalties for the same violations specified in the NOV.

13. This Agreed Order shall remain in effect until IDEM issues a Resolution of Case letter to Respondent.

TECHNICAL RECOMMENDATION:				RESPONDENT:
Department of Environmental Management
By: _________________________				By: _________________________
	Nancy Johnston, Section Chief
	Enforcement Section			Printed: ______________________
Office of Land Quality
				Title: ________________________
Date: __________________				Date: _______________________
				COUNSEL FOR RESPONDENT:
				By: ________________________
				Date: ______________________
APPROVED AND ADOPTED BY THE INDIANA DEPARTMENT OF ENVIRONMENTAL
MANAGEMENT THIS		______	DAY OF	________________________,	20__.
				For the Commissioner:
				Signed March 19, 2019
				Peggy Dorsey, Assistant Commissioner
				Office of Land Quality