PERFORMANCE WORK STATEMENT Controlled Substance Waste Disposal.docx

Department of Defense Defense Health Agency Performance Work Statement

Pharmaceutical Controlled Substance Waste Disposal

DCSS / Pharmacy

Solicitation Number:

Version:

Date:

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide Controlled Substance Waste Disposal.

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Controlled Substance Waste Disposal Services as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.3 Background: Currently, the Pharmacy Department has 70 containers throughout the Main Hospital that are pre-filled with deactivating, deterring and solidifying agents. (Previous Contract# N0025921P0339) Pharmacy requires same service as this is highly encouraged by the Drug Enforcement Agency (DEA) to assure that pharmaceutical wastage is not diverted.

1.4 Objectives:

· Vendor to provide 79 containers of various sizes, that are prefilled with deactivating, deterring and solidifying agents, with one-way disposal path and secured in locked bracket to ensure low potential for diversion

· Vendor must provide full service: install, repair and removal of bins when necessary

· Vendor service must be DEA approved and compliant with both State and Federal regulations

· Vendor will provide implementation training

1.5 Scope: Vendor will provide Controlled Substance Waste Disposal services. Services include: Full Service: Installation of brackets/bins, repairs, removal and replacement of bins when necessary. The contractor shall accomplish Controlled Substance Waste Disposal Services as stated in this Performance Work Statement (PWS).

1.6 Period of Performance (PoP):

Base Year: 01 October 2024 – 30 September 2025 Option Year 1: 01 October 2025 – 30 September 2026 Option Year 2: 01 October 2026 – 30 September 2027 Option Year 3: 01 October 2027 – 30 September 2028 Option Year 4: 01 October 2028 – 30 September 2029

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at:

Naval Medical Center San Diego 34800 Bob Wilson Drive San Diego, CA 92134 **specific wards will be listed in Part 5

OASIS/SARP

140 Sylvester Road San Diego, CA 92106

NTC Pharmacy 2501 Cushing Road Bldg. 624 San Diego, CA 92106-6173

Kearney Mesa Pharmacy 8808 Balboa Avenue San Diego, CA 92123-1592

North Island Pharmacy Bldg. 601 McCaine Blvd.

San Diego, CA 92135-7046

Navy Exchange Pharmacy 2260 Callagan Hwy. Bldg. 3187 San Diego, CA 92136-5036

Naval Station Pharmacy 2450 Craven Street Bldg. 3300 San Diego, CA 92136-5599

El Centro Pharmacy Bldg. 523 8th Street El Centro, CA 92243

MCRD Pharmacy 35000 Guadalcancal Ave. Bldg. 596 San Diego, CA 92140

Eastlake Pharmacy 2300 Boswell Road Suite 190 Chula Vista, CA 91914-3513

Miramar Pharmacy 2496 Bauer Road Rm. 3101 San Diego, CA 92145-2002

1.7.2 Recognized Federal holidays: Vendor is not required to perform services on Federal Holidays

Independence Day

1.7.3 Hours of operation: The contractor is responsible for conducting business Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.7.4 Emergency Services: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours.

1.10 Quality

1.10.1 Quality Control (QC): (If applicable) The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements. [Insert when and how the QCP is to be delivered, i.e., within 30 days after contract award or with the contractors proposal if it is an evaluation factor, a comprehensive written QCP shall be submitted to the CO and COR within 5 working days when changes are made thereafter.] After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system. See Part 7, Technical Exhibit 1 - CDRL A001.

1.10.2 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.11 Contractor personnel

1.11.1 CAC requirements: For all contractors who will work in Government facilities, the Facilities Security Officer (FSO)/Company's Security point of contact (POC) will provide the Government all the required information per the DHA CAC request process current version 2.1, January 2018, or more recent when updated. See process attached at Part 7 Section 7.1.1 of the PWS. A CAC is the standard identification for eligible DoD contractor personnel.

1.11.1.1 The contractor shall return all CACs to the COR upon the departure of the contractor(s).

1.11.2 Contractor onboarding and training. The contractor shall complete all requirements, training, and forms as prescribed in the following requirements:

1.11.2.1 The DHA’s “Onboarding Checklist for Contractor Employees” is located at the DHA Onboarding and Offboarding Portal at https://info.health.mil/cos/admin/hr/IO/SitePages/Home.aspx

1.11.2.2 The DHA’s contractor training instructions embedded at Part 7 Section 7.1.2. (Government (DHA) requirements development staff must cut/paste onboarding checklist at https://info.health.mil/sites/DOP/OnboardingCtr/Contractor_OnBoarding_Checklist.pdf and embed most up-to-date form in Part 7, Section 7.1.2.)

1.11.2.3 The contractor shall comply with onboarding requirements of the DHA for contractors needing to be issued CAC identification, including DoD- and DHA-directed training and forms submission, prior to network access, as displayed in the In/Out-Processing Portal at: https://info.health.mil/cos/admin/hr/IO/SitePages/home.aspx (note: Public Key Infrastructure (PKI)-restricted, printed versions available).

1.11.2.4 The DHA’s new employee handbook at Part 7 Section 7.1.4. (If applicable, if not delete)

1.11.3 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. (Insert the following sentence, if performing in a government facility.) At the close of each work period, government facilities, equipment, and materials shall be secured.

1.11.4 Key control: Reserved

1.11.5 Lock combinations: Reserved

1.12 Key personnel (Contractor): The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the CO. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 7:00 a.m. to 3:30 p.m., Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons. Qualifications for all key personnel are listed below: Must be able to perform all services performed by technician/contractor/vendor.

1.13 Data rights: Reserved

1.14 Reporting

1.14.1 Contractor Manpower Reporting (CMR): RESERVED.

1.14.2 Non-Disclosure Agreement (NDA): All contractor personnel who will obtain access to proprietary, classified, or confidential information or any information release of which is protected or governed by law or regulation associated with DHA acquisitions shall be required to complete and sign a DHA contractor NDA (DHA Form 49) prior to beginning work on the subject contract. The contractor shall execute an NDA on behalf of the company and shall ensure that all staff assigned to, including all subcontractors and consultants, or other personnel performing on contract/Task order execute an NDA protecting the procurement sensitive information of the Government and the proprietary information of other contractors. The NDA shall be executed not later than first day of employment and to be renewed upon exercising a contract option period. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the contractor. The contractor shall maintain originally signed NDAs of individual employees and provide copy to the COR.

1.14.3 Government’s COR: The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the CO and contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

1.15 Contractor Identification

1.15.1 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. All contractor personnel shall identify themselves as contractor support personnel in all forms of communication with all entities with whom DHA/Deputy Assistant Director for Acquisition (DAD-A)/Head of the Contracting Activity (HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized voice message with an introductory statement that includes the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understands that the person is contractor support personnel. Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understands that the person is contractor support personnel.

1.15.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

1.15.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

1.16 Contractor Access to Health Affairs (HA)/DHA Network(s)

1.16.1 FSO/Company's Security POC shall notify the DHA Personnel Security Office after being awarded a contract that requires access to a DoD system (If applicable, if not delete 1.16.1 and 1.16.2 and replace to 1.16 Reserved). Contractor personnel requiring access to the HA/DHA networks for performance of their tasks require a background investigation and the security awareness training. The contractor shall be prepared for this process as it could take two (2) or more weeks. The FSO/Security POC shall submit a Standard Form (SF) 85/86 to DHA's Personnel Security Office for a background investigation.

1.16.2 Company's FSO/Security POC must notify the Personnel Security Office when the contractor has submitted the SF-85/86. The FSO/Security POC, or the COR must notify the DHA Personnel Security Office in writing of a contractor's termination from the contract, including the termination date.

1.17 Personnel Security

1.17.1 The contractor shall comply with DoD 8570.01-M, “Information Assurance Workforce Improvement Program, CH4” November 10, 2015 as amended; 8500.01, “Cybersecurity”, dated March 14, 2014; DoD Manual (DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs” dated March 3, 2019, Department of Defense Instruction (DoDI) 6025.18 “HIPAA Privacy Rule Compliance in DoD Health Care Programs”, dated March 13, 2019; and DoDM 5200.02 “Procedures for the DoD Personnel Security Program (PSP),” incorporation change 3, effective September 24, 2020. Contractor responsibilities for ensuring personnel security include, but are not limited to, meeting the following requirements:

1.17.1.1 Follow the DHA Personnel Security Office guidelines for submittal of security clearances. Contact the DHA Personnel Security Office for guidance on the appropriate background investigation required for personnel on the contract. The DHA Personnel Security Office can be reached at (703) 275-6038.

1.17.1.2 Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities and required access to Controlled Unclassified Information (CUI).

1.17.1.3 DHA Personnel Security Office does not deny any access to any automated information system (AIS), network, or Controlled Unclassified Information (CUI). If a contractor receives an unfavorable background investigation, the request for access will be sent back to the FSO for further action. Any unfavorable adjudication will result in DHA Personnel Security Office not signing off on any access request.

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D-Services)

2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R-Services)

2.1.3 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 Nonpersonal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.2 Acronyms:

PART 5

5.0 SPECIFIC TASKS

5.1 Full Service: The vendor must provide weekly full service and take complete charge with service to install, repair, and remove bins when necessary. Maintain, replace, transport, dispose, and provide certification of Control Waste Destruction, upon request. Full service is required at the following locations:

Naval Medical Center San Diego 34800 Bob Wilson Drive San Diego, CA 92134

· 1 North, Building 1, 1st floor, Qty. 1

· 1 West, Building 1, 1st floor, Qty. 1

· Emergency Dept., Building 1, 1st floor, Qty. 4

· Pharmacy Dept., Building 1, 1st floor, Qty. 2

· 2 East, Building 1, 2nd floor, Qty. 1

· PICU, Building 1, 2nd floor, Qty. 1

· PICU Sedation, Building 1, 2nd floor, Qty. 1

· MRI, Building 1, 2nd floor, Qty. 1

· Special Studies (Interventional Radiology), Building 1, 2nd floor, Qty. 1

· Electrophysiology Laboratory, Building 1, 2nd floor, Qty. 1

· Cardiac Cath Laboratory, Building 1, 2nd floor, Qty. 1

· Dental Department, Building 1, 2nd floor, Qty. 1

· 3 North, Building 1, 3rd floor, Qty. 1

· 3 West,Building 1, 3rd floor, Qty. 1

· 3 East, Building 1, 3rd floor, Qty. 1

· NICU, Building 1, 3rd floor, Qty. 1

· NICU Pharmacy, Building 1, 3rd floor, Qty. 1

· PACU, Building 1, 4th floor, Qty. 1

· Anesthesia (MOR), Building 1, 4th floor, Qty. 23

· 4 North (Pain Clinic), Building 1, 4th floor, Qty. 1

· 4 West, Building 1, 4th floor, Qty. 2

· 4 East, Building 1, 4th floor, Qty. 1

· ICU, Building 1, 4th floor, Qty. 2

· MOR Pharmacy, Building 1, 4th floor, Qty. 1

· ICU Pharmacy, Building 1, 4th floor, Qty. 1

· 5 North, Building 1, 5th floor, Qty. 2

· 5 East, Building 1, 5th floor, Qty. 2

· 5 West, Building 1, 5th floor, Qty. 2

· AIC, Building 2, 2nd floor, Qty. 1

· Ophthalmology Department, Building 2, 3rd floor, Qty. 1

· ENT, Building 2, 3rd floor, Qty. 1

· Cardiology Department, 3rd floor, Qty. 1

· Pulmonary Department, 3rd floor, Qty. 1

· Urology Department, 3rd floor, Qty. 1

· GI-CEC, Building 2, 3rd floor, Qty. 2

OASIS/SARP

140 Sylvester Road San Diego, CA 92106 Qty. 1

NTC Pharmacy 2501 Cushing Road Bldg. 624 San Diego, CA 92106-6173 Qty. 1

Kearney Mesa Pharmacy 8808 Balboa Avenue San Diego, CA 92123-1592 Qty. 1

North Island Pharmacy Bldg. 601 McCaine Blvd.

San Diego, CA 92135-7046 Qty. 1

Navy Exchange Pharmacy 2260 Callagan Hwy. Bldg. 3187 San Diego, CA 92136-5036 Qty. 1

Naval Station Pharmacy 2450 Craven Street Bldg. 3300 San Diego, CA 92136-5599 Qty. 1

El Centro Pharmacy Bldg. 523 8th Street El Centro, CA 92243 Qty. 1

MCRD Pharmacy 35000 Guadalcancal Ave. Bldg. 596 San Diego, CA 92140 Qty. 1

Eastlake Pharmacy 2300 Boswell Road Suite 190 Chula Vista, CA 91914-3513 Qty. 1

Miramar Pharmacy 2496 Bauer Road Rm. 3101 San Diego, CA 92145-2002 Qty. 1

Total Bins: 77

5.1.1 Training: The Vendor shall provide staff training and instructions on proper and best practices for a controlled substance waste disposal program.

5.1.2 Brackets: The Vendor shall install lockable, wall-mounted brackets and hardware in areas required.

5.1.3 Bins: The Vendor shall provide bins for each location and exchange one for one when necessary, every week. The bins must be equipped with deactivation and deterrent elements with one way disposal path and secured in locked bracket to ensure low potential for diversion. Bins will not be automated nor require batteries to prevent further possible tampering. Bins must allow to drain IV solution, expunge solution contents, drop tablets and capsules, and patches vertically. Bins must be available in 1 gallon and 3 gallon sizes.

5.2 Special Qualifications: The Vendor must understand and follow Local, State, and Federal regulations regarding Controlled Substance Waste Disposal. This is to include, DEA, OSHA, and EPA guidelines and any specific industry regulations. Vendor must maintain proper procedures for collecting, storing, and transporting waste to prevent contamination and exposure. Vendor must minimize the risk of diversion, exposure or environmental contamination. Ensure that staff are trained in handling, packaging, and disposing of controlled substances.

5.2.1 When using education/certification in conjunction with labor categories, the COR in coordination with the CO must establish a review process of contractor personnel to ensure labor category requirements are met.

PART 7, ATTACHMENT 1

PERFORMANCE REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective (The Service required—usually a shall statement from Part 5)

Performance Requirements Summary (PRS) # 1.

The contractor shall provide [Insert an objective that relates directly to a mission essential required item, i.e., analysis of DoD Business Process and Agency Operating Models and the PWS paragraph number, i.e., PWS paragraph 5.2].

(see listing below) and who performs, i.e., Validated Customer Complaint received by COR.]

PRS # 2

(See example provided in PRS 1.)

PRS # 3

(See example provided in PRS 1.)

PRS # 4

(See example provided in PRS 1.)

The following listing provides various types of Surveillance as examples to select from and should not be included on the final document:

Random Sampling: Appropriate for frequently recurring tasks. Evaluate randomly selected samples of the lot to determine the acceptability of the entire lot.

Random Inspection Guide, Method of surveillance, Lot size, Sample size, Performance requirement, Sampling procedure, Inspection procedure.

100 Percent Inspection: Appropriate for tasks that occur infrequently. Inspect and evaluate performance each time task is performed.

Periodic Surveillance: Evaluation of samples selected on other than 100% or statistically random basis. (i.e., monthly, quarterly, semi-annually etc.)

Validated Customer Complaint: Complaints must be validated.

NOTE: You may also identify any surveillance method used in the commercial market to survey the required service. (This will be discovered when market research is conducted).

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