Exhibit C Draft SOW Medicine Management.pdf

EXHIBIT C

Amendment Contract Number: 2022*0297 AMD #1 Ver. 01.11.19

STATEMENT OF WORK

To Original Contract Number

These provisions are to be read and interpreted in conjunction with the provisions of the contract specified above.

I. Project Description:

This project serves to expand the Colorado Household Medication Take-Back Program. The Colorado Household Medication Take-Back Program provides the public a convenient, environmentally sound disposal option for unwanted and unused household medications, which could otherwise be distributed for illicit use. The project will maintain and expand the Colorado Household Medication Take-Back Program through enrollment of law enforcement agencies currently collecting household medications and new collection sites including law enforcement agencies, retail pharmacies, and hospital/clinics with on-site pharmacies. In addition to increasing citizen access to medication collection sites, this project serves to modify the program by implementing methods for the collection of prescribed controlled substances.

New collection receptacles will be provided to collection sites, except where existing receptacles are compatible with the Contractor’s methods of operation and suitable for continued use. Supplies necessary for the packaging and common carrier delivery of collected medications to the Contractor’s Drug Enforcement Administration (DEA)-registered facility will be provided to all collection sites in sufficient quantity to ensure uninterrupted collection activities. The Contractor will transport acquired medications from the Contractor’s DEA-registered storage facility to a municipal solid waste incinerator and witness the destruction of the acquired medications to a non-retrievable state.

II. Definitions:

1. CDPHE or Department: The Colorado Department of Public Health and Environment and its authorized agents and employees.

2. Collection Receptacle: A securely locked, substantially constructed container with a permanent outer container and a removable inner liner. A small opening in the outer container allows contents to be added to the inner liner, but does not allow removal of the inner liner's contents.

3. Collection Site: A DEA-registrant or law enforcement agency approved by the department for the collection of unused household medications.

4. Common Carrier: A for-hire carrier that holds itself out to serve the general public at reasonable rates and without discrimination.

5. Controlled Substance: For purposes of this agreement, a drug or other substance, or immediate precursor, included in Schedule II – V of the Controlled Substances Act (Title 21 U.S.C.).

6. DEA: The Drug Enforcement Administration and its authorized agents and employees.

7. Delivery Manifest: A form used to document a sealed inner liner’s delivery from a collection site to the

Contractor’s DEA-registered location.

8. Disposal Location: A site approved by the department where unused household medications are destroyed in compliance with applicable laws and are rendered non-retrievable and cannot be diverted for illicit purposes.

9. Household Medications or Medications: Controlled substances approved for collection by federal law, prescription drugs, and over-the-counter medications in the possession of an individual.

10. Inner Liner: An opaque, waterproof, tamper-evident, tear-resistant bag clearly marked with its size and bearing a unique identification number, used to capture medications deposited into a collection receptacle or contain medications collected at a take-back event.

11. Liner Bundle: A Contractor-provided set of materials used by a collection site to capture medications deposited into a collection receptacle, or consolidate medications collected at a take-back event, and deliver them by common carrier to the Contractor’s DEA-registered location. A liner bundle includes an inner liner, outer shipping container, security seal tag, delivery manifest, and pre-paid common carrier shipping label.

12. Non-Retrievable: For the purpose of destruction, the condition or state to which household medications shall be rendered following a process that permanently alters the household medications’ physical or chemical condition or state through irreversible means and thereby renders the household medications unavailable and unusable for all practical purposes thus preventing their diversion to illicit purposes.

The process to achieve a non-retrievable condition or state may be unique to a household medication’s chemical or physical properties. A controlled substance is considered non-retrievable when permanently altered in such manner and it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue.

13. Start-up Materials: A minimum of three (3) liner bundles, each including an inner liner, outer shipping container, security seal tag, delivery manifest, and pre-paid common carrier shipping label; instructions for inner liner installation, removal, sealing, packaging, and shipping; and Contractor contact information.

14. Take-Back Event: A scheduled, organized occasion of limited duration managed by a law enforcement agency for the collection of household medications, including controlled substances collected from ultimate users and individuals lawfully entitled to dispose of an ultimate user decedent’s property.

15. Transport Manifest: A form used to document a sealed inner liner’s transport from the Contractor’s DEA-registered facility to a disposal location.

16. Reverse Distribute: To acquire controlled substances from another registrant or law enforcement for the purpose of:

a. Return to the registered manufacturer or another registrant authorized by manufacturer to accept returns on the manufacturer’s behalf; or

b. Destruction.

17. Reverse Distributor: A person registered with the Drug Enforcement Administration to reverse distribute controlled substances.

III. Work Plan:

Goal #1: To promote and improve Colorado’s environment and human health through education, collaboration, and compliance assurance while promoting sustainability practices.

Objective #1: No later than the expiration date of this contract, the Contractor shall maintain and increase as needed citizen access to the Colorado Household Medication Take-Back Program by maintaining existing collection sites, increasing the number of permanent collection sites as needed and supporting local medication take-back events.

Primary Activity #1

The Contractor shall attend a kick-off meeting, no later than one month from the contract effective date, to discuss the following:

a. the implementation of medication collection services

b. the implementation of medication disposal services

Sub-Activity #1

1. The Contractor shall attend a meeting with the department’s Medication Takeback Coordinator to describe the procedures to be employed for the collection, acquisition, and destruction of household medications from department-designated collection sites.

a. The Contractor shall review the following with the department’s Medication Takeback Coordinator:

i. standards/requirements

ii. metrics

iii. deliverables

iv. invoicing procedures

Primary Activity #2

The Contractor shall provide the following to each department new approved collection site:

a. a collection receptacle

b. start-up materials

Primary Activities #3

1. The Contractor shall obtain written confirmation of collection receptacle installation from a collection site owner/operator.

Sub-Activities #3

1. At the department’s direction, each new Contractor-provided collection receptacle shall be shipped directly to a department-designated collection site or to a department-designated storage facility for later delivery by the department to a collection site.

2. Written confirmation of collection receptacle installation shall include:

a. the date of installation

b. collection site name

c. collection site address

d. collection site DEA-registration number (if applicable)

e. collection site owner/operator name and signature

Primary Activity #4

The Contractor shall provide all department-designated collection sites with materials needed for on-going delivery of medications to the Contractor’s DEA-registered facility for subsequent destruction, for the duration of this contract.

Primary Activities #4

The Contractor shall ship replacement liner bundles to collection sites in sufficient quantity and frequency to ensure uninterrupted collection activity.

a. Representatives at each collection site will contact the Contractor directly to request changes to the quantities or frequency of liner bundle shipments.

Primary Activity #5

The Contractor shall maintain the facilities and procedures that the Contractor has in place for acquisition, storage, and destruction of sealed inner liners containing medications collected in collection receptacles and at medication take-back events.

Sub-Activities #5

1. The Contractor shall acquire sealed inner liners by common carrier delivery at the Contractor’s DEA-registered facility.

2. The Contractor shall store sealed inner liners at the facility.

3. The Contractor shall transport sealed inner liners to a disposal location for destruction.

4. The Contractor shall use the following procedures for receipt and storage of a sealed inner liner delivered from a collection site:

a. The Contractor shall verify that the outer shipping container has not been tampered with upon receipt of a sealed inner liner by common carrier delivery at the Contractor’s DEA-registered facility.

b. The Contractor shall verify delivery manifest information.

i. The Contractor shall contact the collection site if information is missing or discrepancies are noted.

c. The Contractor shall remove the sealed inner liner from the shipping container and verify that the sealed inner liner’s security seal tag is intact and lacks evidence of tampering.

d. The Contractor shall inspect the sealed inner liner to verify the inner liner identification number and security seal tag identification number match the manifest information.

e. The Contractor shall weigh the sealed inner liner.

f. The Contractor shall complete the delivery manifest.

g. The Contractor shall securely store the sealed inner liner prior to transport to the disposal location.

h. The Contractor shall enter the following information into the Contractor’s inventory:

i. the date of sealed inner liner receipt

ii. sealed inner liner size

iii. sealed inner liner identification number

iv. collection site information including:

i. name

ii. address

iii. DEA registration number (if applicable).

5. The Contractor shall use the following procedures for transportation and destruction of a sealed inner liner:

a. The Contractor shall transport, with two Contractor employees, the sealed inner liner to the designated disposal location for destruction.

b. The two transporting Contractor employees shall witness destruction of the sealed inner liner.

c. The Contractor shall complete a transport manifest.

d. The Contractor shall complete a DEA Form 41.

Primary Activity #6

The Contractor shall provide liner bundles to law enforcement agency collection sites conducting household medication take-back events.

Sub-Activities #6

1. The department’s Medication Takeback Coordinator will notify the Contractor via e-mail indicating the number of liner bundles to be shipped.

2. The Contractor shall ship liner bundles to a law enforcement agency collection site for use at a medication take-back event in response to a department request.

Primary Activity #7

The Contractor shall create monthly reports and invoices.

Sub-Activities #7

The monthly invoice shall include:

a. All invoiced bundles shall be included in alphabetical order by site name, and shall include

a. permit number (provided by CDPHE to be included in reports)

b. name

c. address

d. description of item

e. date shipped

f. quantity

g. unit rate

h. total

The monthly report shall include:

b. For each sealed inner liner acquired at the Contractor’s DEA-registered facility:

a. the date acquired

b. weight in pounds

c. inner liner serial number

d. inner liner order number

e. collection site information including:

i. permit number (provided by CDPHE to be included in reports)

ii. name

iii. address

c. For each sealed inner liner destroyed:

a. the date of destruction

b. place and method of destruction

c. collection site information including:

i. permit number (provided by CDPHE to be included in reports)

ii. name

iii. address

d. For each collection location pending expiration of their DEA controlled substance registration certificate:

a. permit number (provided by CDPHE to be included in reports)

b. name

c. address

d. DEA number

e. expiration date

f. notes on any attempted contact

Standards and Requirements

3. The content of electronic documents located on CDPHE and non-CDPHE websites and information contained on CDPHE and non-CDPHE websites may be updated periodically during the contract term. The Contractor shall monitor documents and website content for updates and comply with all updates.

4. The Contractor shall be DEA-registered as a reverse distributor allowing for the collection of controlled substances for the purpose of destruction.

5. The Contractor’s employees assigned to the project shall pass employee criminal background checks.

6. The Contractor shall not employ, as an agent or employee who has access to or influence over acquired household medications, any person who has been convicted of any felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or suspended, or has surrendered a DEA registration for cause. “For cause” means in lieu of, or as a consequence of, any Federal or State administrative, civil, or criminal action resulting from an investigation of the individual’s handling of controlled substances.

7. The Contractor’s Project Manager and Contract Manager shall attend the project kick-off meeting either in person at the department or via conference telephone call. If attendance is via conference telephone call, the department’s Medication Takeback Coordinator will provide the call-in line and meeting logistics.

8. Contractor-supplied collection receptacles shall be 18” deep x 20” wide x 48” tall in size and manufactured by the Porter’s Group per the specifications included as Exhibit D.

a. Bundles provided must fit two types of collection receptacles, and so bundles must be offered in both 16x16x24 and 20x14x20 box sizes.

1. The Contractor shall retain the services of a common carrier for delivery of sealed inner liners from collection sites to the Contractor’s DEA-registered facility.

2. The Contractor shall comply with requirements of applicable federal, state, tribal, and local laws and regulations.

3. The Contractor shall comply with the Drug Enforcement Administration’s rules for disposal of controlled substances found in Title 21 CFR Part 1317, Effective October 9, 2014. This information is located on the US Department of Justice web site http://www.deadiversion.usdoj.gov/21cfr/cfr/2117cfrt.htm and is incorporated and made part of this http://www.deadiversion.usdoj.gov/21cfr/cfr/2117cfrt.htm contract by reference. The Contractor shall take particular care in complying with the following subsections of 21 CFR Part 1317:

a. Contractor-provided collection receptacles must meet the design requirements in 21 CFR

1317.75(e).

b. Inner liners must meet the requirements in 21 CFR 1317.60(a).

c. The Contractor shall store sealed inner liners at the Contractor’s DEA-registered facility in a manner consistent with the security requirements for Schedule II controlled substances as required in 21 CFR 1317.55.

d. Sealed inner liners shall be destroyed no later than 30 calendar days after the sealed inner liners are received by common carrier delivery at the Contractor’s DEA-registered facility as required in 21 CFR 1317.15(d).

e. Sealed inner liners shall be destroyed in compliance with applicable Federal, state, tribal, and local laws and regulations by a method that renders the household medications, including controlled substances that might be present, non-retrievable as required in 21 CFR 1317.90(a).

4. A delivery manifest shall be used to track the delivery of a sealed inner liner from a collection site to the Contractor’s DEA-registered facility. A completed delivery manifest must include:

a. the manifest number

b. common carrier pick-up date

c. common carrier drop-off date

d. sealed inner liner identification number

e. sealed inner liner size

f. sealed inner liner weight in pounds

g. security seal tag number

h. collection site information including:

i. name

ii. address

iii. contact name

iv. telephone number

v. DEA-registration number (if applicable)

i. name(s) and signature(s) of collection site employee(s) making delivery

j. name(s) and signature(s) of Contractor employee(s) accepting delivery and transferring the sealed inner liner to storage

5. A transport manifest shall be used to track the transport of a sealed inner liner from storage at the

Contractor’s DEA-registered facility to the disposal location. A completed transport manifest shall include:

a. the manifest number

b. date of sealed inner liner removal from storage and loading on the transport vehicle

c. sealed inner liner identification number

d. security seal tag number

e. date of arrival at the disposal facility

f. date of destruction

g. place and method of destruction

h. names and signatures of the two Contractor employees that witnessed destruction of the sealed inner liner

6. The Contractor shall maintain a record of inner liner destruction on DEA Form 41.

7. The Contractor shall maintain copies of delivery manifests, DEA Form 41, and completed transport manifests until contract expiration, to be available to the CDPHE Program Coordinator upon request

8. The Contractor shall provide monthly reports as requested by the CDPHE Program Coordinator.

9. The Contractor shall provide reports in the format requested by CDPHE. The format is subject to change and will be based on evolving program needs.

a. CDPHE will give notice of requested report and format a minimum of 30 days in advance.

Expected Results of the Activity

1. Increased number of permanent collection sites as needed participating in the Colorado Household Medication Take-Back Program.

2. Permanent collection sites have an uninterrupted supply of materials for delivery of medications to the Contractor’s DEA-registered facility.

3. Law enforcement agencies have a sufficient number of liner bundles for delivery of medications collected at take-back events.

Measurement of Expected Results

1. Number of collection receptacles shipped to department-designated collection sites or to a department-designated storage facility for later delivery by the department.

2. Number of sealed inner liners and the weight of each sealed inner liner acquired by the Contractor at its DEA-registered facility from each collection site.

3. Number of complaints received from collection sites regarding the adequacy of quantities and frequency of replacement liner bundle deliveries.

4. Number of law enforcement agencies provided liner bundles for use at medication take-back events.

5. Number of complaints received from law enforcement agency collection sites regarding the timeliness of deliveries of liner bundles for use at take-back events.

6. All sealed inner liners destroyed within 30-days of acquisition by the Contractor at its DEA-registered facility.

Completion Date

Deliverables

1. The Contractor shall submit written confirmation of collection receptacle installation to the department’s Medication Takeback Coordinator via e-mail.

No later than ten (10) business days following date of installation

2. The Contractor shall submit a monthly report to the department’s Medication Takeback Coordinator via email.

No later than ten (10) business days following the last day of each month.

IV. Monitoring:

CDPHE’s monitoring of this contract for compliance with performance requirements will be conducted throughout the contract period by the department’s Medication Takeback Coordinator. Methods used will include a review of documentation determined by CDPHE to be reflective of performance to include progress reports, manifests, invoices, medication collection site visits, medication collection site telephone inquiries, and other fiscal and programmatic documentation as applicable. The Contractor’s performance will be evaluated at set intervals and communicated to the Contractor. A Final Contractor Performance Evaluation will be conducted at the end of the life of the contract

V. Resolution of Non-Compliance:

The Contractor will be notified in writing within thirty (30) calendar days of discovery of a compliance issue.

Within forty-five (45) calendar days of discovery, the Contractor and the State will collaborate, when appropriate, to determine the action(s) necessary to rectify the compliance issue and determine when the action(s) must be completed. The action(s) and time line for completion will be documented in writing and agreed to by both parties. If extenuating circumstances arise that requires an extension to the time line, the Contractor must e-mail a request to the department’s Medication Takeback Coordinator and receive approval for a new due date. The State will oversee the completion/implementation of the action(s) to ensure time lines are met and the issue(s) is resolved. If the Contractor demonstrates inaction or disregard for the agreed upon compliance resolution plan, the State may exercise its rights under the provisions of this contract.