Revision_1_Attachment_4_-_Sample_Medical_Task_Request_0004.pdf

REVISION I ORIGINAL SAMPLE MEDICAL TASK REQUEST 0004, 03/20/2015

Domestic Medical Support Services Performance Work Statement

Division of Global HIV/AIDS (DGHA)

Independently provide Medical/Scientific support services to satisfy the overall operational objectives of the International Laboratory Branch within the Division of Global HIV/AIDS , located in the CDC Atlanta office.

International Laboratory Branch (ILB)

Service Requirement 1-2:

Perform CD4, hematology, chemistry, and microbiology laboratory testing at CDC/GAP/ILB Atlanta campus.

Perform duties consistent with Conducts Clinical Lab Improvement Amendments (CLIA) and College of

American Pathologist (CAP) requirements which include practices and documentation for implementation of good clinical laboratory procedures.

Participate in the update and implementation of procedures and policies for maintenance of the College of American Pathologist (CAP) accreditation.

Provide a safe and efficient work environment for the laboratory and office giving priority to a proper handling of biohazards associated with working in a HIV Laboratory.

Evaluate clinical laboratory assays and equipment for their use in USG programs in all DGHA PEPFAR countries (Asia, Central America, Caribbean, Central Asia, South Africa, Africa) and to support in country programs of care and treatment of HIV-infected patients.

Provide training to personnel form PEPFAR countries, DGHA programs, and other that support the

PEPFAR program on clinical laboratory assay such CD4 testing, hematology assay, and clinical chemistries, equipment maintenance and support, information systems, bio-safety, and quality management systems.

Perform as laboratory consultant, working in collaboration with DGHA professional staff, for all laboratory-related aspects of DGHA programmatic activities at headquarter and in DGHA countries.

Provide technical expertise on laboratory science to Ministry of Health staff, CDC DGHA staff in DGHA countries, Co-operative agreement partners, implementing partners, and laboratory suppliers and manufactures.

Provide monitoring and evaluation to determine efficiency and reliability of the laboratories, the proficiency of the staff and the ability of the laboratories to support the various programs that DGHA intends to implement.

Provide documents and manuscripts in support of the DGHA laboratory efforts to strengthen the services of PEPFAR, PEPFAR-related programs, and international laboratory networks.

Core Hours: Each individual service requires 40 hours per week in accordance with the core duty hours.

Hours Beyond Core Hours: Each individual service requires 20 hours beyond core.

Period of Performance: July 1, 2015-June 30, 2016

Place of Performance: Atlanta, GA Point of Contact upon arrival: TBD

Domestic Travel: N/A

International Travel: N/A

Minimum Experience:

Bachelor of Science and Clinical Laboratory certification.

Formal training in Clinical laboratory science including hematology, Biology and Chemistry

Minimum of two years’ work experience in clinical laboratory sciences.

Teleworking: This service is eligible for teleworking no more than 2 days per the week. The following Government Furnished Equipment is available for contractor’s use, as applicable: Laptop computer, external keyboard, monitor, mouse, multi-function printer/scanner/fax, expansion docking bar, key fob, telephone handset, and Blackberry (data only).

Service Requirement 3-4:

Evaluate and validate new HIV diagnostic assays tests, including rapid tests, to ensure adequate performance for their use in USG programs in Global AIDS program countries and to support in country programs.

Provide various laboratory techniques for HIV incidence and diagnostic such as EIA’s, western blot and rapid testing for HIV studies and provide support testing for various evaluation projects.

Prepare, analyze and characterize serum panels for PT, QC and HIV Rapid Test validation and maintenance of specimen inventories. Process of serum and red blood cells for the production of dried blood spots for QC and PT materials

Establish laboratory infrastructure, order supplies and perform daily, weekly, monthly, quarterly, and annual instrument maintenance.

Implement laboratory practices consistent with Clinical Lab Improvement Amendments (CLIA) and

College of American Pathologist (CAP) requirements including preparation of documents and implementation of standard operating procedures for the laboratory.

Update laboratory procedures and procedure manual.

Adhere to all Clinical Lab Improvement Amendments (CLIA) mandated laboratory records. Observe universal precautions for handling human biological samples and adhere to the CDC guidelines for inventory and disposal of human products, chemicals and sharps.

Prepare and deliver written or oral reports on progress and outcomes of projects assigned to a variety of individuals and groups in both formal and informal settings.

Assist with the implementation of various study protocols, instrumentation and methodologies.

Develop and distribute appropriate laboratory training materials such as manuals, booklets, training panels and controls.

Perform technical assistance —which is variable and contingent upon project conditions and support in country quality assurance programs by training laboratory and non-laboratory staff on HIV rapid testing, implementation of a proficiency testing program and quality assurance.

Support external quality assessments —which are variable and contingent upon project conditions and perform retesting of specimens tested in GAP countries.

Support HIV surveillance —which is variable and contingent upon project conditions and prevention with focus on national reference laboratories to establish standardized protocols, provide QA/QC, and continuing diagnostic training.

Perform laboratory assessments —which is variable and contingent upon project conditions technology transfer, training and support to countries participating in the GAP initiative.

Core Hours: Each individual service requires 40 hours per week in accordance with the core duty hours.

Hours Beyond Core Hours: Each individual service requires 20 hours beyond core.

Period of Performance: July 1, 2015-June 30, 2016

Place of Performance: Atlanta, GA Point of Contact upon arrival: TBD

Domestic Travel: N/A

Bachelor degree in Laboratory Sciences

Formal laboratory training in Biology, Chemistry and Laboratory science.

Minimum of three years’ work experience in public health laboratory.

Teleworking: This service is eligible for teleworking no more than 2 days per the week. The following external keyboard, monitor, mouse, multi-function printer/scanner/fax, expansion docking bar, key fob, telephone handse, and Blackberry (data only), as applicable.

Service Requirement 5:

Perform HIV molecular diagnostic tests using dried blood spots (DBS), plasma or serum.

Perform DNA sequencing, HIV genotyping and epidemiologic linkage investigation.

Participate in quality control and proficiency testing programs to assure quality of testing in PEPFAR-supported countries.

Conduct training activities at headquarters and PEPFAR-supported countries inclusive of early infant diagnosis and viral load and other molecular test.

Conduct HIV drug resistance genotyping.

Evaluate new molecular technologies including point-of-care assays.

Perform as laboratory consultant, working in collaboration with GAP professional staff, for all laboratory-related aspects of DGHA programmatic activities at headquarters and in PEPFAR-supported countries (Asia, Central America, Caribbean, Central Asia, South Africa, Africa ) List out the PEPFAR supported countries.

Perform as technical expert for laboratory science, including technical expertise/advice, training and performing laboratory testing to support the Ministry of Health staff, CDC DGHA staff in PEPFAR-supported countries, cooperative agreement and implementing partners, and laboratory suppliers and manufacturers.

Provide technical assistance to laboratory scientists in PEPFAR-supported countries.

Prepare documents and manuscripts in support of the DGHA laboratory efforts to strengthen the services of PEPFAR, PEPFAR-related programs, and international laboratory networks.

Contribute to the development standard operation procedures and protocols for HIV laboratory operational research activities.

Participate in laboratory maintenance activities and quality assurance activities.

Observe and comply with biosafety regulations.

Conduct clinical Lab Improvement Amendments (CLIA) and College of American Pathologist (CAP) stated requirements.

Assist in updating procedures and policies for maintenance of College of American Pathologist (CAP) accreditation.

Evaluate molecular platforms and assays.

Core Hours: The service requires 40 hours per week in accordance with the core duty hours.

Hours Beyond Core Hours: This service requires 20 hours beyond core.

Period of Performance: July 1, 2015-June 30, 2016

Place of Performance: Atlanta, GA Point of Contact upon arrival: TBD

Domestic Travel: N/A.

Bachelors degree in biology, microbiology or other laboratory-related disciplines

Minimum of 5 years experience

Minimum of 5 years experience conducting laboratory operational research requiring working knowledge of good laboratory practice.

Minimum of 5 years experienceproviding technical assistance to international laboratory scientists in limited resource settings.

Teleworking: This service is eligible for teleworking no more than 2 day per the week. The following external keyboard, monitor, mouse, multi-function printer/scanner/fax, expansion docking bar, key fob, telephone handset, and Blackberry (data only).

Service Requirements 6-7:

Research and compile data for national level assessments on the performance of HIV rapid testing, supply chain management challenges and laboratory capacity.

Use research results and data to develop recommendations for strengthening HIV RT training, testers and sites certification programs, use of practical quality assurance tools such as dried tube specimens

(DTS) and standardized logbook, new kit lot verification and post-market surveillance.

Develop a national framework to integrate QI efforts for HIV rapid testing with testing in other program areas (e.g. TB and Malaria).

Provide input to revise existing national HIV rapid testing training curricula to incorporate key QA activities and develop activities designed to strengthen national certifying authorities for HIV rapid testing.

Work to strengthen national reference laboratory (NRL) capacity to perform new lot verification by establishing specimen repository, validating methods and developing procedures and documentation system.

Develop strategies and work plans for long-term follow up and sustainability to monitor performance of testing sites and to document best practices with participating countries.

Prepare and deliver written or oral reports to a variety of individuals and groups in both formal and informal settings.

Provide input to CDC-HQ and in-country Monitoring and Evaluation (M&E) teams who will then provide support to MOH develop M&E plan and metrics to monitor and evaluate impact of RTQII RTQII” HIV rapid testing Quality Improvement Initiative” to be implemented jointly by CDC and USAID.

Provide technical services as needed utilizing data collection techniques and qualitative data analysis

Core Hours: This service requires 40 hours per week in accordance with core duty hours. Note: If a service has domestic or international travel they must work 8 hours per day or 40 hours per week during trips.

Hours beyond Core Hours: Each individual service requires 20 hours beyond core.

Place of Performance: Atlanta, GA Point of Contact upon arrival: TBD

Period of Performance: July 1, 2015-June 30, 2016

Domestic Travel: N/A.

12 years of advanced laboratory and public health programmatic experience.

Minimum of five years’ work experience in public health or research laboratory

Master Degree in Laboratory Sciences

Minimum of 7 years of advanced laboratory and public health programmatic experience.

Minimum of 5 years’ work experience in public health or research laboratory

Minimum of 5 years of formal laboratory training in Biology, Chemistry and Laboratory science that require working knowledge of good laboratory practice

Minimum of 3 years experience working with Ministries of Health in developing countries

Minimum of 3 years experience in providing technical assistance to international laboratory scientists

Minimum of 5 years experience and/or training in the data collection techniques and qualitative data analysis.

Teleworking: This service is eligible for teleworking no more than 2 days per the week. The following Government Furnished Equipment is available for contractor’s use, as applicable: CDC issued Laptop computer, MS Lync headset device, and key fob.

Maternal and Child Health Branch

Service Requirement 1:

Perform as lead technical advisor for Preventing Mother to Child Transmission (PMTCT) program in Uganda; provide input on scale-up strategy, review and revise training materials, and guide program evaluation

Perform as PMTCT point of contact for Uganda, Sierra Leone, Botswana and/or other countries as assigned.

Perform as lead technical expert for Early Infant Diagnosis (EID) and infant feeding issues, collaborating between the field, laboratory, programmatic liaisons, inter-agency partners; and country-specific TA.

Perform as CDC’s PMTCT representative at regional and global meetings regarding PMTCT scale up and implementation activities

Collaborate across branches to determine program synergies that may be capitalized upon.

Collaborate with Laboratory and Child Survival subgroups of the IATT (Interagency Task Team) on multiple projects including guidance documents and papers.

Serve as the branch liaison for issues related to infant and young child feeding and attend meetings related to these activities.

Mentor junior colleagues, fellows, interns and students working with the PMTCT Team in evaluation methodology, program support, and project management.

Participate in PMTCT/Peds technical work groups providing technical advice and guidance on PMTCT/Pediatric activity implementation.

Develop, produce, and submit abstracts, posters, and scientific articles informed from PMTCT/Pediatric activity implementation when applicable.

Perform as Lead and coordinate revision of a toolkit of Early Infant Diagnosis (EID) resources, including a training package for clinical workers, job aids, Information, education and communication (IEC)/Patient handout materials, and a DBS sample collection instruction video.

Lead program evaluation design and implementation including: protocol writing, Associate Director for Science (ADS) approval, data collection, data analysis, and results dissemination, and preparation for publication.

Direct ongoing projects as a Principal Investigator or collaborator in applicable countries (Asia, Central America, Caribbean, Central Asia, South Africa, Africa) for: “HIV incidence in pregnancy,” “Infant Feeding for PMTCT”, “Pima Phase III POC CD4 Evaluation,” and “Uganda EID assessment”, and analyze data and provide related reports as applicable.

Review protocols related to PMTCT and/or pediatric treatment for scientific merit, soundness of epidemiologic methods, data analysis plan, and impact assessment

Present 1-2 HIV-related Conferences annually to present accepted materials and/or keep up-to-date on the most recent evidence being presented related to core duties.

Core Hours: This service requires 20 hours per week in non-travel status and 40 hours per week in travel status in accordance with core duty hours.

Hours Beyond Core Hours: N/A

Period of Performance: July 1, 2015 – June 30, 2016

Place of Performance: Atlanta, GA Point of contact upon arrival: TBD

Domestic Travel: N/A.

Masters in Public Health

Minimum of 6 years experience working in international prevention of mother-to-Child HIV

Transmission and/or pediatric HIV treatment programs within the Public Health arena.

Minimum of 4 years training and/or experience in HIV/AIDS care and treatment to perform the services as outlined.

Clinical training includes successful completion of medical rotation leading to a Physician Assistant degree from an accredited program, certification by the National Commission for Certification of

Physician Assistants, and maintenance of an active medical license.

Completion of 50 category 1 continuing medical education (CME) annually with at least 20 of these

CME hours focused in HIV and/or maternal and child health.

Must be possess physical requirements necessary to perform services as outlined.

Minimum of 4 years experience conducting lab diagnostics for early infant diagnosis.

Teleworking: This service is eligible for teleworking no more than 2 days per the week. The following Government Furnished Equipment is available for contractor’s use, as applicable: CDC issued Laptop computer, MS Lync headset device, and key fob.

Special Notice: At any time any service within this task order PWS may no longer be required and a modification will be issued reflecting the removal of this particular service.

Return of Government Furnished Equipment: All equipment is to be returned to CDC upon completion of the award.

Telework Notification: Services already approved for teleworking within this task order are permitted to telework during instances for which CDC Facilities (i.e. natural disaster, water main break, etc.) are closed but teleworking is authorized/encouraged. Services not authorized for telework may or may not be authorized for “Situational Telework”. As such please reference each individual service for details.

Please note that services should not be provided for what so ever in the event that Atlanta CDC Offices are closed for business.

Government Furnished Property:

The Government will provide contractor personnel with an office environment typically provided to Government personnel that includes workstations, facsimile, telephones, and computers with access to the Internet and local area network (LAN). Government will issue a blackberry, printer, and laptop if deemed necessary to complete the requirements of the task order.

Core Hours of Operations for all services herein:

Monday – Friday, 8a.m.-4:30 pm excluding federal holidays (listed below) and weekends. The work day shall consist of 8 duty hours with a 30 minute lunch. The start and end times may be adjusted by assignment area, as deemed necessary to accommodate required support in the respective organization, as long as the 8 duty hours a day are met. Start times for all positions must occur between 7:00 a.m. and 9:00 a.m. The normal 8 duty hours shall be calculated from the start time agreed upon between the contractor and each individual contractor employee.

Federal Holidays

New Years Day Labor Day Martin Luther King’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Independence Day Christmas Day

***Any other day determined to be a federal holiday by executive order.***

Clearances as required for all services herein:

Work under this task order is unclassified; however, all CDC individuals are required to undergo a National Agency Check and Inquiries (NACI) investigation, fingerprinting, and acquire a user ID for security-clearance work at CDC campuses. If necessary, the contractor will be required to provide clearances for personnel requiring access to Government computers and workstations.

Performance Requirements Summary

In general, the deliverables completed by the Contractor will be evaluated in terms of how well the requirements of the contract are satisfied. The Contracting Officer’s Representative (COR) will utilize Validated User Customer Complaints to ensure there is a match between actual and expected performances. If there are discrepancies, a Contract Discrepancy Report will be used to communicate these performance concerns to the Contractor, and follow through to ensure performance gaps are closed.

Task/Deliv erable

Performanc e

Standard/In dicator

Acceptable Quality Levels Surveillance

Method

Incentives

Each

Individual

Service as outlined within

PWS.

Timeliness and/or

Quality

All services will be provided for as outlined within the applicable

PWS and in accordance with the contact/task order terms and conditions. Services will be conducted and completed within program established timelines established.

No unresolved Contract

Discrepancy Reports for any individual service during any individual calendar month.

Validated

User

Customer

Complaints

Vendor’s failure to resolve CDR within

PGO established timeframe will result in a failure to performance service succesfully in the

Contractor’s

Performance and

Reporting System

(CPARS).