Pharmacy_PWS_-_REVISED__as_of_17_Aug.pdf
PDF 164 KB Posted
- Attached to
- Pharmacy Tech Federal contract opportunity
- Solicitation number
- FA527018QB083
About this file
Performance Work Statement
View the file
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| RFQ_FA5270-18-Q-B083_Pharmacy_Tech.pdf |
On GovTribe
Work with this file on GovTribe
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
PERFORMANCE WORK STATEMENT (PWS)
FOR
PHARMACY TECHNICIAN SUPPORT SERVICES
AT THE 18th MEDICAL GROUP
17 Aug 2018
PERFORMANCE WORK STATEMENT
TABLE OF CONTENTS
SECTION Page
1 DESCRIPTION OF SERVICES 3
2 SERVICE SUMMARY 4
3 GOVERNMENT PROVIDED PROPERTY AND SERVICES 4
4 GENERAL INFORMATION 4-17
5 APPENDICES 16-18
1. DESCRIPTION OF SERVICES.
To provide one full time equivalent Pharmacy Technician in support for pharmacy at the 18th Medical Group, Kadena Air Base.
1.1 BASIC SERVICES
Contracted services shall include, but are not limited to, transcription of prescriptions, performing pharmaceutical dispensing, prescription reconstitution, patient consultation, quality improvement and supply control duties. The Contractor shall provide all management, supervision, training, and qualified personnel. As it pertains, the Contractor and/or contract personnel shall perform IAW this Performance Work Statement (PWS), the Joint Commission on Accreditation of Healthcare Organization (JCAHO), the Air Force Medical Operations Agency (AFMOA), all AF, federal and state laws, MDG and Pharmacy Instructions and local policies. These services are considered to be non-mission essential.
1.2 PHARMACY TECHNICIAN SERVICES
Contractor personnel shall perform a full range of pharmacy technician procedures. In this capacity contractor pharmacy technician personnel shall:
1.2.1. Call-up patients using the queuing system provided. Using two patient identifiers, patient’s full name and date of birth, fill and dispense new and refill prescriptions to patients and fill and dispense hand-written and provider-ordered entry prescriptions with correct quantity; check accuracy of label and affix auxiliary labels as required. Counsel patients on each medication. (Counseling includes: medication allergies, medication storage, use, expiration, and common side effects). Monitor for drug interactions and report adverse drug reactions in patients. If questions arise while counseling that the technician does not feel confident in answering, proper channels (reference materials, more experienced technicians, patient’s health care provider or a pharmacist) shall be utilized to ensure accurate information is given to the patient.
1.2.2. Support patient requests and supporting physicians’ requests. Operate various computer systems to include current Windows version (for communication and training), Composite Health Care System (CHCS) version 1 and Innovation Pharmassist system and any updated versions of these programs, pyxis, and clinic orders.
1.2.3. Pre-package high usage medication in designated quantities and log medications as instructed.
1.2.4. Operate and perform routine cleaning and maintenance on pharmacy automated counting/dispensing equipment, as instructed by pharmacy staff. Perform daily light cleaning of countertops, supply shelves, fallen medications, disposal of medications in the right way, cleaning / sanitization of reconstitution/compounding area.
1.3 SPECIAL REQUIREMENTS. Contractor employee shall meet the following minimum qualifications:
1.3.1.. Maintain current knowledge and skills acquired through approved training (see section 1.3.3) and ability to learn new systems and processes.
1.3.2. Contractor shall read, understand, speak, and write English fluently to be able to communicate clearly with patients. The contractor shall have typing skills and be computer literate with Microsoft Windows/Office.
1.3.3. Education : High school diploma or GED equivalent and PTCB (Pharmacy Technician Certification Board) certification per AFI 44-102, Medical Care Management, within 6 months of hire.
Completion of a pharmacy technician technical education is highly recommended.
1.3.4. Experience. Contractor must have a minimum of two months experience in a setting of military inpatient or outpatient or retail pharmacy.
2.0. SERVICE SUMMARY
The Contractor service delivery requirements are summarized into performance objectives that relate directly to standards of performance required to meet mission essential needs. For the Performance Objective to be met, service delivery must be in substantial compliance with applicable performance standards. The Performance Threshold describes the minimum overall levels of service delivery required for acceptable quality control. Failure to meet these Performance Thresholds means that contractor Quality Control is unacceptable. The following is a list of the key performance objectives that will be verified as contractually compliant by government personnel, however, inspection of any contract requirement is authorized.
PERFORMANCE OBJECTIVE PWS
Para
PERFORMANCE THRESHOLD
Filling/Dispensing prescriptions -
QUALITY
1.2.1
No more than 2 errors per month
Filling/Dispensing prescriptions -
QUANTITY
Employee average a minimum of 500 to 1000 prescriptions filled per month
Customer Service
1.2.2 1.2.3 1.2.4
Receive no more than 1 customer complaint per month wherein employee is mentioned by name. Employee will not be disciplined for complaints regarding policy/procedure.
3. GOVERNMENT PROVIDED PROPERTY AND SERVICES.
Any and all tools required for the job will be procured through the section supply custodian. The Pharmacy technician will not be required to procure any of their own tools.
4. GENERAL INFORMATION:
4.1 QUALITY CONTROL.
The Contractor is required to control the quality of service delivery and offer to the Government for acceptance only services which conform to contract requirements. The overall control of quality must meet the specified performance thresholds for each requirement in the Services Summary.
4.1.1. The government shall rely on the contractor's existing quality assurance systems as a substitute for government inspection and testing, when contracting for commercial services, unless market research indicates otherwise.
4.2 QUALITY ASSURANCE.
The government will periodically evaluate the contractor’s performance by appointing a representative(s) to monitor performance to ensure services are received. The government representative will evaluate the contractor’s performance through intermittent on-site inspections of the contractor's quality control program and receipt of complaints from base personnel. The government may inspect each task as completed or increase the number of quality control inspections if deemed appropriate because of repeated failures discovered during quality control inspections or because of repeated customer complaints. Likewise, the government may decrease the number of quality control inspections if merited by performance. The government will also investigate complaints received from various customers located on the installation. The contractor shall be responsible for initially validating customer complaints. However, the government representative shall make final determination of the validity of customer complaint(s) in cases of disagreement with customer(s).
4.2.1. The Contracting Officer’s Representative (COR) or Functional Requirement Evaluator Designee (FRED) are the authorized government representative(s) who will perform assessments of the contractor’s performance. Subsequent to contract award, the identity of the COR and FRED, with a letter defining their duties and authority will be promptly furnished to the successful bidder/offeror.
4.2.2. The COR(s) will inform the contract manager in person when discrepancies occur and will request corrective action. The COR(s)/FREDs will make a notation of the discrepancy on their surveillance checklist with the date and time the discrepancy was noted and will request the contract manager (or authorized representative) to initial the entry on the checklist.
4.2.3. Any matter concerning a change to the scope, prices, terms or conditions of this contract shall be referred to the Contracting Officer and not to the COR(s).
4.2.4. The services to be performed by the contractor during the period of this contract shall at all times and places be subject to review by the Contracting Officer or authorized representative(s).
4.3. SECURITY REQUIREMENTS.
Security and base access requirements are contained in clause 5352.242-9000 “Contractor Access to Air Force Installations.” Contractor employees will be required to obtain and display identification badges.
Anticipate delays in getting commercial vehicles on base and allow time for commercial vehicles to reach their destination by driving designated routes at posted speed limits throughout the base. Procedures for commercial vehicle access to the base are subject to change without prior notice.
4.3.1 ID Passes, Badges and Vehicle Stickers: The contractor is responsible to obtain such clearances and/or passes as required for his/her employees to enter military installations on Okinawa prior to start to work. The contractor shall be responsible for all passes issued to his/her employees under this contract.
Applications shall be coordinated through the Contracting Officer or designated representative. At the time of application, Security Forces may conduct a background check on employees. Upon termination of employment, the contractor shall be responsible for returning identification cards and base passes to Security Forces within 24 hours.
4.4. PHYSICAL SECURITY.
The contractor shall be responsible for safeguarding all government property provided for contractor use.
At the close of each work period, government facilities, property, and materials shall be secured.
4.4.1. The contractor shall prohibit the use of badge issued by the Government any persons other than the contractor’s employees. The contractor shall prohibit the opening of locked areas by contractor employees to permit entrance of persons other than contractor’s employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the Contracting Officer.
4.4.2. Lock Combinations. The contractor shall establish and implement methods of ensuring that all lock combinations are not revealed to unauthorized persons. The contractor shall ensure that lock combinations are changed when personnel having access to the combinations no longer have a need to know such.
4.5. CONDUCT. The contracting officer may request that any contractor management staff or contractor personnel whose conduct, in the opinion of the Contracting Officer, interferes with proper order or professionalism at the installation where services are performed, be removed from such installation and the contractor will comply with such request.
4.6. Workdays will generally consist of eight (8) hour days. Services are generally required five (5) days each week (Monday through Friday), excluding U.S. Federal holidays. Required services are scheduled between the hours of 0730 to 1600, Monday through Friday. On 18 MDG training days the contractor may work for the day if there are Active Duty members in the section.
4.6.1. RECOGNIZED HOLIDAYS. The contractor is not required to provide service on the following federal holidays.
New Year’s Day 01 January Martin Luther King’s Birthday Third Monday in January President’s Day Third Monday in February Memorial Day Last Monday in May Independence Day 04 July Labor Day First Monday in September Columbus Day Second Monday in October Veteran’s Day 11 November Thanksgiving Day Fourth Thursday in November Christmas Day 25 December
4.6.2. Non-Duty Days. Contractor is not required to perform on government non-duty days or other times when the MTF may be closed such as Pacific Air Forces (PACAF) family days (approximately 7 – 8 days per year). The FRED at each location shall notify the contractor five (5) work days prior the family day if performance will be required. Non-duty days shall be considered non-paid days and shall be deducted from the contractor’s monthly invoice.
4.6.3. Scheduled and Unscheduled Absences. Contractor personnel are allowed to take up to twenty (20) work days of leave annually. Leave is classified as both annual, vacation or sick leave. Leave shall be taken in one (1) day increments and shall not exceed ten (10) consecutive work days. All leave is considered non-paid days and shall be deducted from the contractor’s monthly invoice. Timing and details shall be coordinated with the FRED. Scheduled absences shall be scheduled at least thirty (30) calendar days in advance and mutually agreed upon by the FRED and individual. Unscheduled absences shall be called into the COR by the contract provider within the first two (2) hours of each duty day that he/she is unable to report to work.
4.6.4. Non-paid days. The government will not be required to pay for non-duty days, scheduled/unscheduled absences or days where the contractor does not perform services ( i.e. waiting for replacement contractor personnel to arrive). Non-paid days shall be deducted from the monthly invoice amount and shall be calculated as follows:
CLIN Monthly Amount divided by thirty (30) calendar days = daily rate Daily rate divided by 8 hours = hourly rate Deduction amount = hourly rate multiplied by hours in absence
*** Thirty (30) calendar days shall be used for calculation purposes regardless of the total number of days within the month. ***
4.7. CONSERVATION OF UTILITIES.
The contractor shall instruct employees in utilities conservation practices. The contractor shall be responsible for operating under conditions which prevent the waste of utilities which include the following:
4.7.1. Lights shall be used only in areas where and when work is actually being performed.
4.7.2. Mechanical equipment controls for heating, ventilation, and air conditioning systems shall not be adjusted by the contractor or by contractor employees unless authorized.
4.7.3. Water faucets or valves shall be turned off after the required use has been accomplished.
4.7.4. Government telephones shall be used only for official government business.
4.8. RECORDS.
The contractor shall be responsible for creating, maintaining, and disposing of only those government required records that are specifically cited in this PWS or required by the provisions of a mandatory directive listed in Applicable Publications and Forms. If requested by the Government, the contractor shall provide the original record or a reproducible copy of any such record within five working days of receipt of the request.
4.9. ENVIRONMENTAL CONTROLS.
4.9.1. Compliance with Laws and Regulations. The contractor shall be knowledgeable of and comply with all applicable Japan Environmental Governing Standards (JEGS), and requirements regarding environmental protection. In the event environmental laws/regulations change during the term of this contract, the contractor is required to comply as such laws come into effect. If there is an increase or decrease in cost as a result of the change, the contractor shall inform the Contracting Officer pursuant to notice requirements and negotiate a modification to the contract.
4.9.2. Notification of Environmental Spills. If the contractor spills or releases any substance contained in 40 CFR 302 into the environment, the contractor or its agent shall immediately report the incident to Kadena AB Fire Dept at 911. The liability for the spill or release of such substances rests solely with the contractor and its agent.
4.9.3. Material Storage and Use. The contractor shall follow manufacturer’s guidelines and professional recommendations for control of humidity, temperature, cleanliness, and materials handling. This includes hazardous materials.
4.10. SAFETY REQUIREMENTS.
In performing work under this contract, the contractor shall:
4.10.1. Conform to the safety requirements contained in the contract for all activities related to the accomplishment of the work.
4.10.2. Perform work in a safe manner as required by OSHA 2206, General Industry, Occupational Safety and Health Standards (29 CFR 1910) and Japan Environmental Governing Standards (JEGS) by US Force Japan.
4.10.3. Develop and provide at the start of the orientation period or the start of the first operational performance period (if there is no orientation period) a safety plan for the protection of government facilities and property and to provide a safe work environment for contractor personnel.
4.10.4. Provide protection to government property to prevent damage during the period of time the property is under the control or in possession of the contractor.
4.10.5. Include a clause in all subcontracts to require subcontractors to comply with the safety provisions of this contract as applicable.
4.10.6. Record and report promptly (within one hour) to the FRED or COR, all available facts relating to each instance of damage to government property or injury to either contractor or government personnel.
4.10.7. In the event of an accident/mishap, take reasonable and prudent action to establish control of the accident/mishap scene, prevent further damage to persons or property, and preserve evidence until released by the accident/mishap investigative authority through the contracting officer.
4.10.8. If the government elects to conduct an investigation of the accident/mishap, the contractor shall cooperate fully and assist government personnel in the conduct of investigation until the investigation is completed.
4.10.9. Include a clause in each applicable subcontract requiring the subcontractor's cooperation and assistance in accident reporting and investigation.
4.10.10. Ensure personnel have the following on-base emergency services phone numbers programmed into their cell phones:
While working on Kadena, Okuma, Camp Shields, or Torii Station, call Kadena Dispatch at 098-934- 5911 or 098-962-9445.
While working on Camp Foster, Camp Courtney, Camp Hansen, Camp Schwab, or Camp Kinser, call Foster Dispatch at 098-911-1911.
4.11. HEALTH REQUIREMENTS. Initial immunization documentation shall be provided by the contractor to the MTF prior to the contract employee commencing work. Documentation is required for:
MMR (immunization or titer levels for Rubella and Rubeola), history of chicken pox disease or positive titer (varicella vaccination must be accomplished if lack of immunity), Tetanus Diphtheria, (Td), TB Mantoux skin Test (IPPD) if positive, minimum requirement will be follow-up with the contractor’s physician and chest x-ray. Additionally, a physician must provide documentation of “no active respiratory disease”. It is the contractor’s responsibility to pay for any medical exam necessary to ensure medical this public health compliance requirement is met.
4.12. ADMINISTRATIVE CHECKS AND REQUIREMENTS:
4.12.1 NATIONAL AGENCY CHECK. The contractor shall comply with DoD 5200.2-R, Department of Defense Personnel Security Program and AFI 33-119, electronic Mail Management and Use requirements for contractor personnel operating Government workstations that have unclassified automated information systems (e-mail, MIS, Internet, CAMS, etc.) Requests for National Agency Checks (NAC) on contractor personnel hired at the beginning of the contract shall be submitted to the Government no later than 14 working days from the contract start date. Requests for NACs on contractor personnel hired subsequent to the contract start date shall be submitted to the Government not later than five (5) workdays prior to the employee’s first duty day.
4.12.2. Contractor personnel shall submit security investigation forms per base requirements to the COR at least fourteen (14) business days prior to the employee’s required start date in the MTF. Contractor personnel shall complete the Electronic Questionnaires for Investigations Processing (e-QIP) process in accordance with requesting base or MTF policy and procedures. Failure to submit the e-AIP prior to starting performance may result in a “ stop work” on the contract until the e-QIP is completed.
4.13. COMMON ACCESS CARD. Common Access Card (CAC) is a DOD-mandated program affecting military, DOD civilians and eligible Contractors. The Contractor shall comply with the requirements of this program. Visit the website for more information: http://www.cac.mil/.
4.14. CONTRACTOR ORIENTATION AND NEW PERSONNEL REQUIREMENTS.
4.14.1. GENERAL TRAINING. The Contractor shall be responsible for ensuring personnel comply with health information privacy and security policies and procedures. The Government will provide training on Government provided forms and equipment, Air Force directives, MTF policies and procedures. Contractor personnel shall participate in continuing education programs to update and/or maintain skills and knowledge to meet annual requirements.
4.14.2. ORIENTATION TRAINING. The Contractor shall ensure that all Contractor personnel participate in the Government provided MTF orientation program for newly assigned personnel within 30 business days of performance start. Orientation training will be conducted during normal hours of operation, and will be scheduled by the COR. Orientation shall include training on regulations specific to the professional specialty, and hospital and Air Force policy and procedures, instructions on automation processing, quality assurance policies, and other information systems as they apply to the position.
4.14.3. COMPUTER TRAINING. Contractor personnel who have any interaction with the MTF computer systems must receive training for the applicable system(s). The FRED/COR will coordinate the necessary computer training. The training will be on-site and during normal hours of operation. This training will be at no cost to the Contractor. Access to patient data systems is an "Automated Data Processing Sensitive" position requiring compliance with AFI 31-501, Personnel Security Program Management. (See Appendix C, Applicable Forms and Publications)
4.15. PUBLICATIONS: The Government shall provide the contractor access to Air Force directives, MTF policies and procedures prior to start of contract performance date.
4.17. CONTRACTOR PERSONNEL
4.17.1. Contract Manager: the contractor shall provide a contract manager and alternate contract manager (responsible in the absence of the contract manager) who shall be responsible for the performance of the services. The names of the contract manager and alternate(s) shall be provided to the CO in writing prior to the beginning of the first performance period. The contract manager and alternate(s) must be able to read, write, speak, and understand English.
4.17.1.1. The contract manager and alternate shall have full authority to act for the contractor on all contract matters relating to daily operations of this contract.
4.17.1.2 The contract manager or alternate shall be available during normal duty hours within two (2) hours to meet on the installation with government personnel (designated by the CO) to discuss problems.
After normal duty hours the manager or alternate shall be available within four (4) hours.
4.17.2. Contractor Employees: the contractor shall not employ persons for work on this contract if such employee is identified to the contractor by the CO as a potential threat to the health, safety, security, general well-being or operational mission of the installation and its population.
4.17.2.1. Contractor personnel shall present a neat appearance and be easily recognized as contractor employees. This may be accomplished by wearing distinctive clothing bearing the name of the company or by wearing appropriate badges, which contain the company name and employee name in English.
4.17.2.2. The contractor shall not employ any person who is an employee of the U.S. Government if employing that person would create a conflict of interest. Additionally, the contractor shall not employ any person who is an employee of the Department of the Air Force, either military or civilian, unless such person seeks and receives approval according to DOD 5500-7-R Joint Ethics Regulation. The contractor shall not employ any person who is an employee of the Department of the Air Force if such employment would be contrary to the policies in AFI 64-106, Air Force Industrial Labor Relations Activities.
4.17.2.3. The contractor is cautioned that off-duty active military personnel hired under this contract may be subject to permanent change of station, change in duty hours or deployment. Military Reservists and National Guard members may be subject to recall to active duty. The abrupt absence of these personnel could adversely affect the contractor’s ability to perform; however, their absence at any time shall not constitute an excuse for nonperformance under this contract.
4.18 JAPANESE ROAD LAWS
4.18.1 The contractor shall comply with Japanese Road Laws while on US Military installations to specifically include: Article 43 The Road Law (Japan) (prohibited acts relative to roads.) No person shall commit the following describe acts:
4.18.2. Damaging the road, causing roads to be littered w/ debris, polluting the roads with debris or fallout from motor vehicles or otherwise defacing roads unreasonably or without due cause.
4.18.3 Article 43-2( Measures to be taken to prevent cargo or things loaded on motor vehicles from falling out).
4.18.4. The Agency managing the road may when there is reasonable cause for him to feet that items or cargo being carried in or on a motor vehicle may fall out and damage, pollute, or otherwise deface the road in such a manner as to hinder or obstruct the traffic, order the operator on the vehicle in question to take steps or measure necessary to prevent occurrence of such hindrances by stopping operation vehicle, or correcting the method of loading or traveling or operation of the vehicle.
4.19. REQUIRED CAR INSURANCE by JAPANESE LAW.
4.19.1 The Contractor shall procure and maintain during the entire period of his performance under this contract the following minimum insurance on each vehicle used by the Contractor at the work site.
4.19.2. Type: Automobile Property Damage Insurance Amount: ¥3,000,000 or Dollar equivalent Bodily Injury Insurance Amount: ¥30,000,000 or Dollar equivalent.
4.19.3. All vehicles must be properly inspected/insured in accordance with Japanese Compulsory Insurance (JCI) requirements. “All vehicles shall have the contractor’s company name displayed in English on both sides and shall be readable from a distance of at least 50 feet away”.
4.19.4. Prior to the commencement of work hereunder, the Contractor shall furnish to the Contracting Officer a certificate or written statement of the above required insurance. The policies evidencing required insurance shall contain an endorsement to the effect that cancellation or any material change in the policies adversely affecting the interests of the U.S. Government in such insurance shall not be effective for such period as may be prescribed by the laws of the state in which this contract is to be performed and in no event less than thirty (30) days after written notice thereof to the Contracting Officer.
4.20 CONTRACTOR MANPOWER REPORTING
4.20.1. The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the Air Force via a secure data collection site. The contractor is required to completely fill in all required data fields at http://www.ecmra.mil.
4.20.2 Reporting inputs will be for the labor executed during the period of performance for each Government fiscal year (FY) which runs 1 October through 30 September. While inputs may be reported any time during the FY, all data shall be reported no later than 31 October of each calendar year.
Contractors may direct questions to the CMRA help desk.
4.22. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) OF 1996
HIPAA is comprised of several different sections, each to be implemented by the Dept. of Health and Human Services. The medical facilities of the military services and the DOD health plans are specifically listed as covered by HIPAA. Currently, HIPAA Privacy and Security Rules, as set forth in the Code of Federal Regulations, are in effect for all MTFs. The specific implementation of HIPAA Privacy for DOD medical facilities is set forth in DOD 6025.18-R, and for HIPAA Security, the requirements for AF MTFs are contained in DOD 8580.02-R and AFI 41-217, which also contains additional Information Assurance requirements for all AF MTFs. DOD 6025.18-R, DOD 8580.02-R and AFI 41-217 are incorporated herein by reference. MTFs are responsible to insure overall compliance with HIPAA requirements, which includes incorporation of certain requirements in contracts entered or amended after the respective implementation dates.
IAW these regulations, the Contractor and its employees meet the definition of Business Associates.
Therefore, a Business Associate Agreement is required by law to comply with both the HIPAA Privacy and Security regulations. This clause serves as that agreement for each MTF, whereby the Contractor and its employees agree to abide by all HIPAA Privacy and Security requirements regarding health information as defined in this clause, DoD 6025-18-R, DOD 8520.02-R and AFI 41-217. Additional HIPAA requirements will be addressed when implemented.
Introduction
(a) Definitions. As used in this clause generally refer to the Code of Federal Regulations (CFR) definition unless a more specific provision exists in DOD 6025.18-R, DOD 8520.02-R or AFI 41-217.
HITECH Act shall mean the Health Information Technology for Economic and Clinical Health Act included in the American Recovery and Reinvestment Act of 2009.
Individual has the same meaning as the term “individual” in 45 CFR 164.50 1 and 164.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g).
Privacy Rule means the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.
Protected Health Information has the same meaning as the term “protected health information” in 45 CFR 164.501, limited to the information created or received by The Contractor from or on behalf of the Government.
Electronic Protected Health Information has the same meaning as the term “electronic protected health information” in 45 CFR 160.103.
Required by Law has the same meaning as the term “required by law” in 45 CFR 164.501 and 164.103.
Secretary means the Secretary of the Department of Health and Human Services or his/her designee.
Security Incident shall have the same meaning as the term “security incident” in 45 CFR 164.304, limited to the information created or received by Contractor from or on behalf of the Covered Entity.
Security Rule means the Health Insurance Reform: Security Standards at 45 CFR part 160,162 and part 164, subpart C.
Terms used, but not otherwise defined, in this Agreement shall have the same meaning as those terms in 45 CFR 160.103, 160.502, 164.103, 164.304 and 164.501.
(b) The Contractor agrees to not use or further disclose Protected Health Information other than as permitted or required by the Contract or as Required by Law.
c) The Contractor agrees to use appropriate safeguards to maintain the privacy of the Protested Health Information and to prevent use or disclosure of the Protected Health Information other than as provided for by this Contract.
(d) The HIPAA Security administrative, physical, and technical safeguards in 45 CFR 164.308, 164. 310, and 164.312, and the requirements for policies, procedures and documentation in 45 CFR 164.316 shall apply to the Contractor. The additional requirements of Title XIII of the HITECH Act that relate to security and that are made applicable with respect to covered entities shall also be applicable to the contractor. The Contractor agrees to use administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits in the execution of this Contract.
(e) The Contractor agrees to mitigate, to the extent practicable, any harmful effect that is known to the Contractor of a use or disclosure of Protected Health Information by the Contractor in violation of the requirements of this Contract.
(f) The Contractor agrees to report to the Government any security incident involving protected health information of which it becomes aware.
(g) The Contractor agrees to report to the Government any use or disclosure of the Protected Health Information not provided for by this Contract of which the Contractor becomes aware of.
(h) The Contractor agrees to ensure that any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by the Contractor on behalf of the Government agrees to the same restrictions and conditions that apply through this Contract to the Contractor with respect to such information.
(i) The Contractor agrees to ensure that any agent, including a subcontractor, to whom it provides electronic Protected Health Information, agrees to implement reasonable and appropriate safeguards to protect it.
(j) The Contractor agrees to provide access, at the request of the Government, and in the time and manner designated by the Government to Protected Health Information in a Designated Record Set, to the Government or, as directed by the Government, to an Individual in order to meet the requirements under
45 CFR 164.524.
(k) The Contractor agrees to make any amendment(s) to Protected Health Information in a Designated Record Set that the Government directs or agrees to pursuant to 45 CFR 164.526 at the request of the Government or an Individual, and in the time and manner designated by the Government.
(1) The Contractor agrees to make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by the Contractor on behalf of, the Government, available to the Government, or at the request of the Government to the Secretary, in a time and manner designated by the 'Government or the Secretary, for purposes of the Secretary determining the Government's compliance with the Privacy Rule.
(m) The Contractor agrees to document such disclosures of Protected Health Information and information related to such disclosures as would be required for the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.
(n) The Contractor agrees to provide to the Government or an Individual, in time and manner designated by the Government, information collected in accordance with this Clause of the Contract, to permit the Government to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.
General Use and Disclosure Provisions
Except as otherwise limited in this Agreement, the Contractor may use or disclose Protected Health Information on behalf of, or to provide services to, the Government for treatment, payment, or healthcare operations purposes, in accordance with the specific use and disclosure provisions below, if such use or disclosure of Protected Health Information would not violate the HIPAA Privacy Rule, DOD 6025.18-R, the HIPAA Security Rule, or DOD 8580.02-R if done by the Government. The additional requirements of Title XIII of the HITECH Act that relate to privacy and that are made applicable with respect to covered entities shall also be applicable to the Contractor.
Specific Use and Disclosure Provisions
(a) Except as otherwise limited in this Agreement, the Contractor may use Protected Health Information for the proper management and administration of the Contractor or to carry out the legal responsibilities of the Contractor.
(b) Except as otherwise limited in this Agreement, the Contractor may disclose Protected Health Information for the proper management and administration of the Contractor, provided that disclosures are required by law, or the Contractor obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Contractor of any instances of which it is aware in which the confidentiality of the information has been breached.
(c) Except as otherwise limited in this Agreement, the Contractor may use Protected Health Information to provide Data Aggregation services to the Government as permitted by 45 CFR 164.504(e)(2)(i)(B).
(d) Contractor may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR 164.502(j)(1).
Obligations of the Government
Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions
(a) Upon request the Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520, as well as any changes to such notice.
(b) The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect the Contractor's permitted or required uses and disclosures.
(c) The Government shall notify the Contractor of any restriction to the use or disclosure of Protected Health Information that the Government has agreed to in accordance with 45 CFR 164.522.
Permissible Requests by the Government
The Government shall not request the Contractor to use or disclose Protected Health Information in any manner that would not be permissible under the HIPAA Privacy Rule, DOD 6025.18R, the HIPAA Security Rule, or DOD 8580.02-R, if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this clause.
Termination
(a) Termination. A breach by the Contractor of this clause, may subject the Contractor to termination under any applicable default or termination provision of this Contract.
(b) Effect of Termination.
(1) If this contract has records management requirements, the records subject to the Clause should be handled in accordance with the records management requirements. If this contract does not have records management requirements, the records should be handled in accordance with paragraphs (2) and (3) below.
(2) If this contract does not have records management requirements, except as provided in paragraph (3) of this section, upon termination of this Contract, for any reason, the Contractor shall return or destroy all Protected Health Information received from the Government, or created or received by the Contractor on behalf of the Government. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of the Contractor. The Contractor shall retain no copies of the Protected Health Information.
(3) If this contract does not have records management provisions and the Contractor determines that returning or destroying the Protected Health Information is infeasible, the Contractor shall provide to the Government notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Government and the Contractor that return or destruction of Protected Health Information is infeasible, the Contractor shall extend the protections of this Contract to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as the Contractor maintains such Protected Health Information.
Miscellaneous
(a) Regulatory References. A reference in this Clause to a section in DOD 6025.18-R, HIPAA Privacy Regulation or DOD 8580.02-R, HIPAA Security Regulation, or any CFR or AFI provision means the section as currently in effect or as amended, and for which compliance is required.
(b) Survival. The respective rights and obligations of Business Associate under the "Effect of Termination" provision of this Clause shall survive the termination of this Contract.
(c) Interpretation. Any ambiguity in this Clause shall be resolved in favor of a meaning that permits the Government to comply with CFR HIPAA Privacy Rule, DOD 8520.02-R, the CFR HIPAA Security Rule and AFI 41-217.
5. APPENDICES
A. Acronyms & Abbreviations List
B. Estimated Workload Data
C. Publications/Forms
APPENDIX A
ACRONYMS AND ABBREVIATIONS LIST
Acronym/Abbreviation Definition
AF Air Force
AFB Air Force Base
CFR Code Federal Regulation
CHCS Composite Health Care System
CO Contracting Officer
COR Contracting Officer Representative
DEPT Department
DOD Department of Defense
FAR Federal Acquisition Regulation
FRED Functional Requirement Evaluator Designee
OSHA Occupational Safety and Health Act
PBSA Performance Based Service Acquisition
PWS Performance-Based Work Statement
QA Quality Assurance
QCP Quality Control Program
SS Services Summary
USAF United States Air Force
APPENDIX B
ESTIMATED WORKLOAD DATA
ITEM
NAME
ESTIMATED QUANTITY
1 Prescriptions filled 500-1000 Mo
APPENDIX C. PUBLICATIONS/FORMS
Publication/Instruction/Name Date Applicable Paragraph/Chapter PWS Paragraph
AFI 31-501, Personnel Security Program Management, PWS para 4.14.3
AFI- 44-102, Medical Care Management, PWS para 1.3.3.
DOD 5500-7-R Joint Ethics Regulation, PWS Para 4.17.2.2.
AFI 64-106, AF Industrial Labor Relations, 25 Mar 1994, Entire Document Applicable, PWS Para 4.17.2.2.
DOD 6025.18-R Privacy of Individuals Identifiable health Information, PWS Para 4.22.
DOD 8580.02-R DoD Health Information Security Regulation, PWS, Para 4.22.
AFI 41-211 Management of Medical Information Services, PWS, Para 4.22.
File details come from the government source that posted it.