Solicitation Amendment HT941026QE0250001 SF 30.pdf

R

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

16C. DATE SIGNED

Previous edition unusable STANDARD FORM 30 (REV. 11/2016) Prescribed by GSA FAR (48 CFR) 53.243

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBE

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

The purpose of this amendment is to: Block 14 (Description of Amendment/Modification):

1. Update PWS paragraph 3.7 OPSEC to remove 3.7.1 AT Level I Training and 3.7.3 iWATCH/Suspicious Activity Reporting Training.

2. Respond to questions received.

QUESTIONS AND ANSWERS

Question 1: PWS 3.7 OPSEC. Does this pertain to just the field service technicians performing work on-site or does this pertain to every employee at our company?

Answer 1: PWS paragraph 3.7 has been updated to remove 3.7.1 AT Level I Training and 3.7.3 iWATCH/Suspicious Activity Reporting Training.

Question 2: Supplies or Services & Prices or Costs: Are the quantities reflected in the RFP/RFQ based on number of tests required on each item per option year or is this based on number of units/year?

Answer 2: The quantity stated in each Line Item represents the number of tests required per equipment for each period.

Question 3: For your Sterile Compounding Room: You have requested Airflow Test - turbulent airflow, unidirectional airflow, room pressurization, airflow displacement, HEPA filter installation leak test & Airborne Non-Viable Particle Count (Surface & Air). Part 1: Please provide the following information: Square footage for each room, total number of ceiling HEPA filters. Part 2: Please clarify the Non-Viable Particle count requirement (Non-Viable particle counting is exclusively for air sampling); does this pharmacy need VIABLE Air and Surface sampling as well? (if YES, please specify the number of Air and Surface Samples required by the pharmacy for each semi-annual visit)

Answer 3:

Part 1: Sterile Compounding Room. Please provide the following information: Square footage for each room, total number of ceiling HEPA filters.

Square footage for each room:

- Ante Room: 115 sq ft

- Non-hazard (797) Room: 59 sq ft

- Hazard (USP 800) Room: 63 sq ft

Total number of ceiling HEPA filters (4 total):

- Ante Room: 2

- Non-hazard (797) Room: 1

- Hazard (USP 800) Room: 1

Part 2: Please clarify the Non-Viable Particle count requirement (Non-Viable particle counting is exclusively for air sampling); does this pharmacy need VIABLE Air and Surface sampling as well? (if YES, please specify the number of Air and Surface Samples required by the pharmacy for each semi-annual visit)

Non-viable particle count requirement:

- Ante Room: ISO class 7: 352,000 particle count per cubic meter

- Non-hazard (797) Room: ISO class 7: 352,000 particle count per cubic meter

- Hazard (USP 800) Room: ISO class 7: 352,000 particle count per cubic meter

Yes, According to USP 797, viable and surface sampling are needed as well. Number required:

- Air sampling: 4 locations

- Surface sampling: 7 locations

Solicitation/Contract Form

The following modifications were made:

Information From To Response Due Time Zone Hawaii-Aleutian Daylight Time (UTC -10) Hawaii-Aleutian Standard Time (UTC -10) Response Due Date 06 Aug 2026 07 Aug 2026

Description/Specifications/Statement of Work

Header Miscellaneous Text (Modified):

ERFORMANCE WORK STATEMENT

Inspection, Testing and Certification of Fume Hoods, Biosafety Cabinets and Cleanrooms Bassett Army Community Hospital Fort Wainwright, Alaska

TABLE OF CONTENTS

SECTION TITLE

1.0 INTRODUCTION

2.0 ADMINISTRATIVE INFORMATION

3.0 SCOPE OF WORK

4.0 QUALITY MANAGEMENT

5.0 SAFETY / SECURITY REQUIREMENTS

6.0 APPLICABLE TECHNICAL ORDERS, SPECS, REGULATIONS, AND MANUALS

7.0 ACRONYMS AND DEFINITIONS

HT941026QE0250001

1. INTRODUCTION.

1.1 This requirement is for inspection, testing and certification of fume hoods, biosafety cabinets and cleanrooms for sterile compounding of medications and handling possible infectious organisms. Equipment shall be tested and certified in accordance with original equipment manufacturer (OEM) specifications.

Pharmacy compound room and Biological Safety Cabinets (BSC) testing and certification shall follow the standards of United States Pharmacopeia (USP) 797, USP 800, National Sanitation Foundation/American National Standards Institute (NSF/ANSI) 49, Occupational Safety and Health Administration (OSHA), National Institutes of Health/Centers for Disease Control (NIH/CDC), Department of the Army Pamphlet 385-69, Joint Commission Standards. The Contractor shall furnish all labor, travel, and equipment required to test and certify the equipment and rooms located at Bassett Army Community Hospital (BACH) at Fort Wainwright, Fort Greely and Joint Base Elmendorf-Richardson (JBER), Alaska.

1.2 This contract is a non-personal services contract 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.

1.3. The fume hoods, biosafety cabinets and cleanrooms are located at Fort Wainwright, JBER, and Fort Greely, Alaska.

2. ADMINISTRATIVE INFORMATION.

2.1 Hours of Operation. BACH provides services 24 hours a day, 365 days a year (366 days during leap years) including holidays.

2.1.1 Normal business hours for the Equipment Management Branch (EMB) are 0700 - 1600, Monday - Friday. Clinics have designated operating hours.

2.1.2 The contractor shall make every practical effort to provide services during normal business hours, excluding Federal holidays. However, in certain cases, permission may be granted to the contractor to provide services outside of normal operating hours if during these hours (1) access to the equipment being serviced is limited or unavailable, (2) servicing the equipment would cause impactful impedance to patient care, or (3) the contractor provides any other justified reasoning for unavailability that is accepted by the Medical Maintenance NCOIC. Approval to perform services outside of normal business hours will be given by the Government's Representative.

2.1.3 BACH Medical Maintenance Department provides emergency services after-hours by means of an on-call technician. In the event any contractor is performing services outside normal business hours, the on-call technician will be available to perform duties of BACHl Medical Maintenance Department (i.e.

periodically checking on the progress of contractor personnel to ensure the security of the hospital, verifying the quality of services rendered meets or exceeds the standards set forth in the PWS, and assist the contractor personnel in signing out in BACH Medical Maintenance Department with badge return).

2.1.4 This contract is NOT a time and materials effort. It is not to be billed hourly and does not cover over-time, after-hours emergencies or Federal holiday coverage.

2.1.5 Holidays. The following is a list of legal federal holidays. Any of the federal holidays falling on a Saturday will be observed on the preceding Friday. Any holidays falling on a Sunday will be observed the following Monday.

New year's Day, January 1st Martin Luther King's Birthday, 3rd Monday in January President's Day, 3rd Monday in February Memorial Day, Last Monday in May Juneteenth Independent Day, June 19th Independence Day, July 4th Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran's Day, November 11th Thanksgiving Day, 4th Thursday in November Christmas Day, December 25th

NOTE: Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. If the area in which a contract employee is scheduled to work is closed due to the holiday and the employee is not required to report in, payment will not be made for those hours.

Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner.

2.2. Contractor Representative. The Contractor shall designate, in writing, a primary point of contact for contract coordination and implementation not later than five business days after receiving notice of contract award. Changes in the primary point of contact (POC), at any time, shall require the Contractor to notify the Contracting Officer (KO) of the new representative at least five working days prior to the change. This notification shall be in writing and shall state the name and contact information for the new point of contact.

2.3. The Government's Representative will be the KO's authorized representative in administering the contract at the MTF level. The Contractor's representative shall be available to discuss any problems that the Contractor's personnel may be experiencing during the performance of this contract. Problems experienced by the Government with the Contractor's performance will be discussed and resolved. Unresolved problems will be referred to the KO for resolution.

2.4 Combatting Human Trafficking. Combating Trafficking in persons (awareness program) shall be 100% compliance (zero tolerance) regarding trafficking in persons policy in accordance with FAR 52.222-50 and FAR 22.1703.

3. SCOPE OF WORK.

3.1 See Appendix A for Equipment Listing.

3.2 Specific Tasks and Deliverables. The contractor, or contractor representative, shall report to the Government Representative or on-site Equipment Maintenance Coordinator (EMC) (1F303 / 907-361-5632), prior to commencing all on-site services (Preventive Maintenance Checks and Services (PMCS), software updates, and/or repairs).

3.2.1 All service visits shall be coordinated between the contractor, the Medical Maintenance Technician requesting service, and the Government Representative.

3.2.2 Any deliverables (i.e. replacement parts, supplies, tools) shall be shipped to Medical Maintenance at the address below and will be provided to the contractor upon initial check-in at the Medical Maintenance front desk.

Bassett Army Community Hospital 4076 Neely Road ATTN: MCUC-LO-EM, Medical Maintenance, RM 1F303 Fort Wainwright, AK 99703

3.3 General Work Requirements.

Contractor responsibilities include:

OEM certified and licensed technicians capable of performing the testing and certification of the equipment listed in Appendix A.

Controlling Environment Testing Association (CETA) certified/licensed technician capable of performing testing and certification of the clean rooms, and buffers.

Contractor shall ensure that testing equipment meets calibration requirements in accordance with manufacturer recommendations.

3.3.1 The performance of all services shall meet the specifications of the OEM. Pharmacy compound room and BSC testing and certification shall follow standards of USP 797, USP 800, NSF/ANSI 49, OSHA, NIH/CDC, Department of the Army Pamphlet 385-69, and Joint Commission Standards.

3.3.2 Pharmacy compound room and BSC testing and certification shall follow the guidance of the latest approved version of USP 797, USP 800, NSF/ANSI 49, OSHA, NIH/CDC, CETA and OEM specifications. If the guidance varies between certifying guidelines, the Government's Representative will instruct which guidelines to follow. The most stringent guidelines shall be followed unless the Government's Representative chooses a lesser standard because of manufacturer or engineering limitations. If the compound rooms or the BSCs were not engineered to meet those guidelines, the certification will be based on the manufacturer's guidelines for the BSC or the engineering design guidelines for the compound room.

3.4 If applicable, the contractor shall adhere to all DHA cyber security measures when accessing the equipment remotely. The contractor shall not remotely access the equipment from locations outside of the United States. The contractor shall ensure that all appropriate approvals are granted prior to accessing the network and that a service report is generated and delivered to the COR/Government Representative once completed.

3.5 Specific Tasks: Contractor shall perform inspection of the equipment and clean rooms in Appendix A. Pharmacy compound room and BSC testing, certification and inspection shall meet Joint Commission standards and shall follow latest approved standards of USP 797, USP 800, NSF/ANSI 49, OSHA, NIH/CDC, CETA and OEM specifications.

3.5.1 Testing: Contractor shall perform testing of the fume hoods, biosafety cabinets and cleanrooms to include testing of cleanroom high efficiency particulate air (HEPA) filtration system. Testing and certification shall be completed one week prior to previous certification expiration date.

3.5.1.1 BSC testing shall include the following:

Inflow velocity measurements - ensures proper inflow is maintained for operator protection and environmental protection.

Downflow velocity measurements - documents the air in the work area is unidirectional and functioning as designed, preventing cross contamination, and providing product protection from the environment.

HEPA filter integrity testing - documents leakage or defects and ensures HEPA filters provide required filtration to prevent both product and environmental contamination.

Smoke pattern testing - qualitatively verifies airflow directions using a small source of visible fog.

Site installation testing and alarm calibration - confirms alarm performance and assesses installation of units for NSF and OSHA compliance.

Viable sampling shall be done following the most current USP 797 guidelines, to include growth medium, incubation periods, temperatures and identifications of all air growth to the genres level (level 1) and identification of surface growth that exceeds the acceptable level to the genres level (level 1).

3.5.2 Compounding rooms will be certified according to the latest approved version of USP 797, USP 800, NSF/ANSI 49, OSHA, NIH/CDC, and CETA. Testing shall include:

Airflow test - turbulent airflow Unidirectional airflow Room pressurization Airflow Displacement HEPA Filter Installation Leak Test Airborne Non-Viable Particle Count (surface and air)

3.5.3 Testing Failure: Deficiencies noted shall be reported immediately to Medical Maintenance, Pharmacy and/or Laboratory for equipment or sterile compounding room. Discrepancies need to be reported to Facilities in addition to the aforementioned Chief of Pharmacy for proper corrective actions. The Government is responsible for correcting issues found during certification testing. The re-qualification test cost will be the responsibility of the Government.

3.5.4 Certification: When inspections and tests conform to OEM, Army Regulatory and Joint Commission Standards, USP 797, USP 800, NSF/ANSI 49, OSHA, NIH/CDC, and CETA the Contractor shall provide certification documentation to the Government Point Contact (GPOC) provided at the time of service.

3.5.5 Parts Replacement: Contractor shall have a sufficient supply of parts available to complete service. Parts shall meet OEM standards.

3.5.6 Service Report: Upon completion of any on-site services by the contractor's service representative, a written service report shall be provided to the Medical Maintenance and Pharmacy/ Laboratory staff. In the event all information is not available to the contractor's service representative when services are performed, the initial service report shall include all available information.

3.5.6.1 The formal report shall be received within 48 hours of service completion. Report shall include:

Equipment identification data: system nomenclature, room number, location, model and serial number, and equipment control numbers (ECN).

Documentation of test results in an informative and comprehensive report shall be provided as a formal completion to the certification process.

Name, address and contact information for the certifying organization also listing key personnel with appropriate accreditations.

Confirming remark that the most current version of regulations and guidelines was referenced for this certification and the actual date the certification was completed.

Simple and clear method of identification of the approximate location of the collected data in relation to the physical layout of the equipment or facility tested, including specific and clear nomenclature for the data locations.

Explanation of test procedure used for data collection and justification for any deviations from established industry practices encountered during the certification process.

Collected data will be compared to expected values or specific equipment performance criteria established in Standard Operating Procedures supplied by the Government. In the absence of client SOPs, the certifying organizations SOPs or industry accepted standards, recommended practices and manufacturer's specifications would be used.

Provide a list of equipment utilized in data collection to include make, model, serial number, and calibration date and when requested a facsimile of the current calibration documentation for each piece of equipment, when applicable.

Test equipment used for certification of sterile compounding facilities should be calibrated on a calibration frequency not to exceed 12 months or more frequently if recommended by the manufacturer. Calibration certificates should be provided upon request by the customer for all calibrated test equipment.

3.5.7 Forms: After performing on-site Inspection, Testing, and Certification services, the Government technician will affix and/or update DD Form 2163 (Medical Equipment Verification/Certification) in accordance with the instructions provided in TB 38-750-2, or by the Medical Maintenance activity's internal SOP. The documentation shall be included with equipment shipment when equipment is returned to contractor for service.

3.5.8 Damage: The Contractor is not responsible for the sustainment of MD/MDS listed when damage resulted from acts of God, or Government neglect/misuse/ abuse, or when services were conducted by personnel other than the contractor.

3.5.9 Compliance: The Contractor shall comply with applicable federal, state, and local laws and regulations.

3.5.10 Services Outside of the Scope: The Contractor may perform only services covered in the scope of this contract. Any requests for services outside of the terms and conditions of this contract are not authorized for action by the Contractor. The Contracting Officer maintains the sole authority to determine scope.

3.6 Licensure/Certification/Qualifications:

OEM certified and licensed technicians capable of performing the testing and certification of the equipment listed in Appendix A.

Controlling Environment Testing Association (CETA) certified/licensed technician capable of performing testing and certification of the clean rooms, and buffers.

3.6.1 Experience: Services under this contract shall be performed by individuals who have demonstrated knowledge, and competence in servicing and maintaining the specified equipment under this contract. The Contractor shall ensure repair technicians have been fully trained and experienced in testing and repairing the equipment and components on contract. The chosen representative(s) by the contractor shall have experience in testing and certifying the equipment specified in this PWS.

3.6.2. Contract personnel shall comply with MTF policies regarding personal appearance and conduct.

3.6.3 Compliance. The Contractor and contract personnel shall abide by all MTF standards, rules and procedurals. Such regulations include, but are not limited to, general safety, fire prevention, waste disposal, infection control, JC, and patient safety initiatives. The contractor shall ensure all personnel performing services under this contract shall be informed of the guidelines and contractual requirements set forth in the PWS and contract, including but not limited to, all safety/security protocol and credential verification procedures.

3.7. OPSEC.

3.7.1 Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within an Army-controlled installation, facility, or area. Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office. Contractor workforce must comply with all personal identity verification requirements (CFR clause 52.204-9, Personal Identity Verification of Contract Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

4. QUALITY MANAGEMENT

4.1 The Contractor shall have a planned and systematic quality management process for monitoring and analyzing its contract performance.

4.2. The Contractor shall ensure that all contract employees comply with the MTF quality management/process improvement activities.

4.3 Quality Assurance

4.3.1 Inspection. The inspection and acceptance point for all services rendered under this contract will be the Government's Representative. The performance by the contract personnel, the quality of services rendered, and any documentation or written material in support of same, shall be subject to continuous inspection, surveillance and review for acceptance by the KO or Government Representative. Any services rendered by the contract personnel to patients or interaction with military/civilian personnel deemed unprofessional, threatening, or dangerous by the KO may be grounds for immediate termination for default or cause. Quality Assurance procedures established by the MTF shall be used for continuous monitoring. Other performance evaluation factors will be monitored that are not quantified by numerical measurements which include: Contractor providing services not meeting the minimum qualification standard; contractor relationship with hospital staff/Government contracting personnel; compliance with hospital healthcare policies and procedure.

5. SAFETY / SECURITY REQUIREMENTS

5.1 Equipment Safety Procedures. The contractor shall furnish and install all manufacturers' mandatory modifications and apply recalls by FDA. The contractor must comply with specified lubrications, cleaning (other than operators), calibrations, parts, and replacements IAW OEM specifications.

5.1.1 When required, the contractor's service representative shall comply with the Office of Safety and Health Administration (OSHA) lockout/tag-out standards while performing maintenance on equipment.

5.2 Hazardous Items. The government and the contractor's service representative shall exchange hazard communication information (i.e. MSDS, etc.) before the commencement of any service for the safety of all parties.

5.3 MTF Security. Contractor personnel and/or any representative of the contractor entering the MTF shall abide by all security regulations and be subject to security checks. The contractor and/or his representative shall report to the Medical Maintenance Work Order desk (1F303) to sign-in and receive a temporary access badge; the badge shall be returned to the front desk clerk and the representative shall sign out before departing the installation.

5.4 Network Security Requirements. When applicable, the contractor shall abide by all procedures and regulations set forth by Information Management Division (IMD), Bassett Army Community Hospital, to include remote access to the network.

5.4.1 If applicable, the contractor shall be granted an Interim Authority to Operate (IATO) of six months to meet MTF minimum security requirements. These include:

5.4.2 The contractor shall use the MTF's approved method of connection for vendors requiring remote access capabilities for support of their applications / systems.

The contractor shall coordinate with Information Management Division (IMD), Information Systems Engineering (ISE) Branch to meet current technical requirements for a VPN connection.

5.4.3 The contractor shall identify employees requiring an MTF network account for remote connectivity and shall submit (DOD) DD Form 2875 System Authorization Access Request (SAAR) for those employees supporting the application remotely.

5.4.4 The contractor shall ensure a Security Background Investigation has been initiated by the contracting organization. Security Background Investigations are required for all network users. The MTF uses Standard Form 85P - Questionnaire for Public Trust Positions. This can be accessed at the link below. Once at the website, click on SF Form 85P.

http://www.opm.gov/forms/standard-forms/

Note: Foreign Nationals will not be granted access to the MTF network until a satisfactory Security Background Investigation has been completed and they have been approved for access by the Designated Approving Authority (DAA) / Hospital Commander.

5.4.5 The contractor shall complete all IA training requirements as outlined by the Authorized User Policy (AUP). DOD and DHA have mandated IA training be completed initially and then annually for anyone accessing a DOD network. The contractor shall submit a 'Certificate of Training' from the DISA DoD IA Awareness Training.

5.4.6 The contractor shall read and sign the Acceptable Use Policy (AUP) is required initially and then required to be signed annually for all network users. The contractor shall sign the AUP initially and annually thereafter or at time of contract renewal, whichever is earlier. should be provided to the Vendor by the System Administrator assigned to the application/system.

6.0. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND MANUALS.

Following is a list of basic publications applicable to this performance based statement of work. The Contractor is obligated to follow these publications.

Applicable Publications

Public Law:

Public Law 91-596 Occupational Safety and Health Act of 1970 Public Law 104-191 Health Insurance Portability and Accountability Act of 1996

Accreditation Manuals:

The Joint Commission (TJC) Manual (Current Edition)

Defense Health Agency:

DHA-AI 001 Telework Program DHA-AI 003 Physical Security Program DHA-AI 034 Drug-Free Workplace Program DHA-AI 050 Accounting of Disclosures of Personally Identifiable Information (PII) and Protected Health Information (PHI) DHA-AI 5015.01 Records Management DHA-AI 5200.02 Information Security Program DHA-AI 5200.03 Operations Security (OPSEC) Program

DHAPI 6000.03 Life Support Training Certification Requirements and Guidance DHAPI 6010.02 MHS Prescription Drug Monitoring Program DHAPI 6015.02 Beneficiary Counseling and Assistance Coordinator (BCAC) and Debt Collection Assistance Officer (DCAO) DHAPI 6025.04 Pain Management and Opioid Safety in the MHS DHAPI 6025.06 Standardized Templates for Primary Care Clinical Encounter Documentation DHAPI 6025.10 Standard Processes, Guidelines, and Responsibilities of the DoD Patient Bill of Rights and Responsibilities in the Military Health System (MHS) Military Medical Treatment Facilities (MTFs) DHAPI 6025.20 Medical Management (MM) Program within the Military Health System (MHS) DHAPI 6025.26 Standard Processes for the Military Health System (MHS) Nurse Advice Line (NAL) DHAPI 6025.27 Integration of Primary Care Behavioral Health (PCBH) Services into Patient-Centered Medical Home (PCMH) and Other Primary Care Service Settings within the Military Health System (MHS) DHAPI 6025.28 Standard Processes and Procedures for Communication of Laboratory and Radiology Results DHAPI 6025.29 Provision of Human Immunodeficiency Virus (HIV) Pre-Exposure Prophylaxis (PrEP) for Persons at High Risk of Acquiring HIV Infection DHAPI 6025.33 Acupuncture Practice in Military Treatment Facilities DHAPI 6025.39 Medical Ethics in the Military Health System DHAPI 6025.42 Routine Adult Transthoracic Echocardiogram (TTE) Standards for all Military Medical Treatment Facilities (MTFs) DHAPI 6040.07 Medical Coding of the DOD Health Record DHAPI 6401.01 Dental Sedation Medical Management DHAPI 6490.02 Behavioral Health (BH) Treatment and Outcomes Monitoring DHAPM 6025.01 Primary Care Behavioral Health (PCBH) Standards DHAPM 6025.13, Volumes 1-7 Clinical Quality Management in the Military Health System www.health.mil/Reference-Center/DHA-publications

Department of Defense (DoD):

DoD 5200.1-R Information Security Program DoD 5200.2 Personnel Security Program DoDI 5200.46 DoD Investigative and Adjudicative Guidance for Issuing the Common Access Card DoD 5210.42-R Nuclear Weapons Personnel Reliability Program (PRP) Regulation DoD 5400.7-R DoD Freedom of Information Act DoD 5400.11-R Department of Defense Privacy Program DoD 6010.13-M Medical Expense and Performance reporting System for Fixed Military Medical And Dental Treatment Facilities Manual DoD 6010.15-M Military Treatment Facility Uniform Business Office (UBO) Manual DoD 6015.1-M Glossary of Healthcare Terminology DoD 6025.18-R DoD Health Information Privacy Regulation DoD 6055.5-M Occupational Medical Examinations and Surveillance Manual DoD 8580.02-R HIPAA Security Rule DoDD 5144.02 Information Technology Standards in the DoD DoDD 5205.2 DoD Operations Security (OPSEC) Program DoDD 5400.11 DoD Privacy Program DoDD 5500.07 Standards of Conduct DoDD 6000.14 Patient Bill of Rights and Responsibilities in the Military Health System (MHS) DODM 6025.13 Medical Quality Assurance (MQA) in the Military Health System (MHS) DoDD 6040.41 Medical Records Retention and Coding at Military Treatment Facilities DoDD 6205.02E Policy and Program for Immunizations to Protect the Health of Service Members and Military Beneficiaries DoDD 8190.3 Smart Card Technology DoDD 8500.01E Information Assurance DoDI 1100.22 Policy and Procedures for Determining Workforce Mix

DoDI 1402.5 Criminal History Background Checks on Individuals in Child Care Services DoDI 3020.37 Continuation of Essential DoD Contractor Services During a Crises DoDI 5200.02 DoD Personnel Security Program (PSP) DoDI 6000.11 Patient Movement DoDI 6015.23 Delivery of Healthcare at Military Treatment Facilities: Foreign Service Care; Third Party Collection; Beneficiary Counseling and Assistance Coordinators (BCACs) DoDI 6025.8 Ambulatory Procedure Visit (APV) DoDI 6025.13 Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health System DoDM 6025.13 Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health System (MHS) DoDI 6025.18 Privacy of Individual Identifiable Health Information in DoD Health Care Programs DoDI 6040.40 Military Health System Data Quality Management Control Procedures DoDI 6040.42 Medical Encounter and Coding at Military Treatment Facilities DoDI 6040.43 Custody and Control of Outpatient Medical Records DoDI 6205.2 Immunization Requirements DoDD 6459.01 Sexual Assault and Response (SAPR) Program

7.0. ACRONYMS AND DEFINITIONS.

ADM - Ambulatory Data Module ADS - Ambulatory Data System AHA - American Hospital Association AHLTA - Armed Forces Health Longitudinal Technology Application AMA - American Medical Association AOD - Administrative Officer of the Day CAC - Common Access Card CAMH - Comprehensive Accreditation Manual for Hospitals CFR Code of Federal Regulations CHCS - Composite Health Care System CLIN Contract Line Item Number COR Contracting Officer's Representative CPT - Current Physicians Terminology DA Department of the Army DoD Department of Defense DODI Department of Defense Instruction EFT - Electronic Funds Transfer FAR - Federal Acquisition Regulation FSO - Facility Security Officer FTE Full Time Equivalent HCP - Healthcare Provider HIPAA - Health Insurance Portability & Accountability Act of 1996 HRP - Health Readiness Platform, i.e. Military Treatment Facility JC The Joint Commission KO - Contracting Officer LADS - Labor and Delivery Statistics System MEDCENs - Army Medical Centers MEDCOM Medical Command MHS - Military Healthcare System MTF Military Treatment Facility OIC Officer in Charge OSHA Occupational Safety and Health Administration PAM Pamphlet PAR - Performance Assessment Report POC - Point of Contact PWS - Performance Work Statement PL - Public Law QASP - Quality Assurance Surveillance Plan QC Quality Control RVU - Relative Value Units SF Standard Form TA - Trusted Agent UCAPERS - Uniform Charts of Accounts Personnel System

END OF PERFORMANCE WORK STATEMENT

APPENDIX A - Equipment Listing

Installation Location Manufacturer / Model Nomenclature Serial # Base Period: Cost

Per Test Base Period: Cost

Per Retest

Fort Greely Aid Station

Labconco Cabinet, Biological Safety, Class I

140491511

Fort Wainwright Patholo gy

Nuaire /

NU-543-400

Cabinet, Biological Safety, Class

II

1958691223 gy

Nuaire /

NU-543-400

Cabinet, Biological Safety, Class

II

2019891104

Pharma cy

Germfree Laboratories Inc. /

LFGI3USP

Glove Box, Isolation/ Containment

3S-15-

LGU-14469

cy

Germfree Laboratories Inc. /

LFGI3USP

Glove Box, Isolation/ Containment

LGU-14470

Joint Base Elmendorf- Richardson

Veterina ry Clinic / 47815

Air Science / P5-36

Laboratory Hood, Chemical Fume

P82859

Fort Wainwright

Veterina ry Clinic/

Air Science / P5-36

Laboratory Hood, Chemical Fume

P82860

Fort Wainwright Pharma cy / 130-22

N/A Sterile Compounding Room

N/A

Installation Location Manufacturer / Model Nomenclature Serial # Option I: Cost Per

Test Option I: Cost Per

Retest

Fort Greely Aid Station

Labconco Cabinet, Biological Safety, Class I

140491511

Fort Wainwright Patholo gy

Nuaire /

NU-543-400

Cabinet, Biological Safety, Class

II

gy

Nuaire /

NU-543-400

Cabinet, Biological Safety, Class

II

cy

Germfree Laboratories Inc. / LFGI3USP Glove Box, Isolation/ Containment cy

Germfree Laboratories Inc. /

LFGI3USP

Glove Box, Isolation/ Containment

Veterina ry Clinic / 47815

Air Science / P5-36

Laboratory Hood, Chemical Fume

P82859

Fort Wainwright

Veterina ry Clinic/

Air Science / P5-36

Laboratory Hood, Chemical Fume

P82860

Fort Wainwright Pharma cy / 130-22

N/A Sterile Compounding Room

N/A

Installation Location Manufacturer / Model Nomenclature Serial # Option II: Cost Per

Test Option II: Cost Per

Retest

Fort Greely Aid Station

Labconco Cabinet, Biological Safety, Class I

140491511

Fort Wainwright Patholo gy

Nuaire /

NU-543-400

Cabinet, Biological Safety, Class

II

gy

Nuaire /

NU-543-400

Cabinet, Biological Safety, Class

II

cy

Germfree Laboratories Inc. /

LFGI3USP

Glove Box, Isolation/ Containment cy

Germfree Laboratories Inc. /

LFGI3USP

Glove Box, Isolation/ Containment

Richardson Veterina ry Clinic / 47815

Air Science / P5-36 Laboratory Hood, Chemical Fume

P82859

Fort Wainwright

Veterina ry Clinic/

Air Science / P5-36

Laboratory Hood, Chemical Fume

P82860

Fort Wainwright Pharma cy / 130-22

N/A Sterile Compounding Room

N/A

Installation Location Manufacturer / Model Nomenclature Serial # Option III: Cost

Per Test Option III: Cost Per

Retest

Fort Greely Aid Station

Labconco Cabinet, Biological Safety, Class I

140491511

Fort Wainwright Patholo gy

Nuaire /

NU-543-400

Cabinet, Biological Safety, Class

II

gy

Nuaire /

NU-543-400

Cabinet, Biological Safety, Class

II

cy

Germfree Laboratories Inc. /

LFGI3USP

Glove Box, Isolation/ Containment cy

Germfree Laboratories Inc. /

LFGI3USP

Glove Box, Isolation/ Containment

Veterina ry Clinic / 47815

Air Science / P5-36

Laboratory Hood, Chemical Fume

P82859

Fort Wainwright

Veterina ry Clinic/

Air Science / P5-36

Laboratory Hood, Chemical Fume

P82860

Fort Wainwright Pharma cy / 130-22

N/A Sterile Compounding Room

N/A

Installation Location Manufacturer / Model Nomenclature Serial # Option IV: Cost

Per Test Option IV: Cost Per

Retest

Fort Greely Aid Station

Labconco Cabinet, Biological Safety, Class I

140491511

Fort Wainwright Patholo gy

Nuaire /

NU-543-400

Cabinet, Biological Safety, Class

II

gy

Nuaire /

NU-543-400

Cabinet, Biological Safety, Class

II

cy

Germfree Laboratories Inc. /

LFGI3USP

Glove Box, Isolation/ Containment cy

Germfree Laboratories Inc. /

LFGI3USP

Glove Box, Isolation/ Containment

Veterina ry Clinic / 47815

Air Science / P5-36

Laboratory Hood, Chemical Fume

P82859

Fort Wainwright

Veterina ry Clinic/

Air Science / P5-36

Laboratory Hood, Chemical Fume

P82860

Fort Wainwright Pharma cy / 130-22

N/A Sterile Compounding Room

N/A

2739T ROOSEVELT DRIVE, OFFICE 143, BUILDING H-201T

CAMP PENDLETON, CA 92055

UNITED STATES

Tina Koike, Email: tina.w.koike.civ@health.mil Telephone: 8084339516 AdminBy:

SCD: PAS: