V15 SOW IV Room Training and Certification .pdf

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Statement of Work VISN 15 IV Room Certification & Personnel Training

PART I – GENERAL INFORMATION

a. Introduction. This requirement is for testing and certification of all the VA Heartland Health Care Network (VISN 15) facilities’ primary engineering controls (PECs) and clean rooms used for preparation of compounded sterile preparations (CSPs). PECs include biological safety cabinets (BSCs), laminar airflow workbenches (LAFWs), compounding aseptic containment isolators (CACIs), compounding aseptic isolators (CAIs) and Isolators. Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797> (<797>), USP Chapter <800> (<800>), or current guidelines. This requirement also includes personnel training, evaluation and requalification to compound CSPs in accordance with <797>, <800>, or current guidelines.

b. Background. VISN 15 is pursuing a VISN-wide contract for standardized testing criteria appropriate for all PECs used pursuant to current <797> and <800> standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2006.

Although <797> states that certification procedures “or an equivalent” of those outlined in CAG-003-2006 shall be performed, Veterans Affairs (VA) will be requiring that CAG- 003-2006 be used in lieu of any other “equivalent” procedures that may exist.

Depending on the period of performance and option year(s), testing procedures shall be maintained in compliance with all current applicable USP standards.

The USP establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of CSPs. The Joint Commission (TJC) Accreditation Manual for Home Care, effective January 13, 2018, established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards.

VISN 15 facilities have either upgraded/constructed or are in the process of upgrading/constructing compounding spaces to continuously meet <797> and <800> standards. As such, VISN 15 requires contractors to adjust quantity, and perhaps types, of services to meet the changing needs of the facilities as upgrades and construction are completed. Adjustments are included in the Independent Government Cost Estimates (IGCEs) to reflect planned work and changing needs in the contract year they are expected.

Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA CNBT certified testing individual no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

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PART II: SPECIAL WORK REQUIREMENTS

All vendors used to conduct primary and secondary engineering controls certifications/assessments must be registered with CETA.

a. PEC Testing and Certification. The contractor shall test and certify each PEC according to <797> and <800> using certification procedures from the CETA Certification Guides for Sterile Compounding Facilities (CAG-003-2006 and CAG-002- 2006).

All PECs must:

1. Be certified to meet ISO Class 5 or better

2. Maintain unidirectional airflow

3. Be supplied by HEPA filtered air

The list of tests, depending on CETA and manufacturer guidance for the type of PEC, includes, but is not limited to:

1. HEPA filter leak test

2. Induction leak/back-streaming test

3. Cabinet leak test

4. In-flow velocity test to include exhaust airflow volume rate

5. Dynamic airflow smoke pattern test

6. Total airborne particle testing

7. Viable microbial air testing

8. Viable microbial surface testing

LAFWs, Integrated Vertical Laminar Flow Zones (IVLFZs), and BSCs must be tested and certified according to CETA CAG-003-2006 guidelines and to manufacturer’s specifications. Horizontal laminar flow cabinets shall be certified according to The Institute of Environmental Sciences (IEST) RP-CC-002 Testing Laminar Air Flow Devices and Induction Leak/Back-streaming Test and IEST-RP-CC034 HEPA Filter Leak Test.

Certifications for Class II Biological Safety Cabinets (BSCs) must be accomplished in accordance with the most current National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II (laminar flow) Biosafety Cabinetry.

The contractor shall use a National Institute of Standards and Technology (NIST) traceable or comparable calibrated piece of equipment (calibrated within past 12 months) to perform all testing and provide copies of the calibration tests to the POCs upon request.

The contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and back-streaming test. Any failures shall be reported directly to the identified site POCs as soon as practicable. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify

P a g e 4 | 14 technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified POC as soon as immediately.

Restricted Access Barrier Systems (CAIs, CACIs, and isolators (e.g. PECs with a controlled workspace, transfer devices, access devices, and a decontamination system) must be certified according to CETA CAG-002-2006 and CAG-003-2006 guidelines and to manufacturer’s specifications. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified point(s) of contact (POCs) immediately.

Hazardous compounding PEC certification is required for:

1. Negative pressure hoods

2. Isolators

3. PECs where robotic enclosure is used inside of the PEC

The contractor shall test and certify each hazardous PEC to the manufacturer’s specifications. Tests shall include:

1. Face velocity test

2. Airflow smoke pattern test

3. Low flow alarm test

If the hazardous PEC has an air flow monitor (AFM) or controller (AFC), the contractor shall confirm the unit is calibrated and operating within +/-10% of actual velocity. If it is not calibrated appropriately the contractor shall calibrate the AFM or AFC. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to calculate the face velocity.

The contractor shall report each individual face velocity reading and the average of those readings, a pass/fail grade for the airflow smoke pattern test and a pass/fail grade for the low flow alarm test. Any failures shall be reported directly to the POC(s) as soon as practicable.

For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

1. Company name and phone number

2. Unit model and serial number

3. Report number reflecting the room certification

4. Certification date

5. Recertification date

6. Sash height (for fume hoods)

7. Technician signature

b. Clean Room Certification. All classified areas must be tested and certified in accordance to ISO 14644-1 Classifications of Air Cleanliness, CETA CAG-003-2006 and CETA CAG-009-00 specifications. The contractor will provide comprehensive

P a g e 5 | 14 cleanroom testing and certification services with frequency required by most current <797> and <800>. Test equipment used for certification will be clean, in good working order and 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 facility POC for all calibrated test equipment. USP Compliance Testing for Cleanrooms and Controlled Environment certification will include, but is not limited to, the following:

1. Air velocity and volume

2. Air exchange rate

3. Room pressure differential

4. Leak testing of HEPA filters

5. Temperature, relative humidity measurements

6. Lighting measurement

7. Sound level measurement

8. Electrical leakage and ground circuit resistance and polarity tests

9. Pass-through chamber air quality

10. Pass-through HEPA filter leak test (where present)

11. Total airborne particle testing

12. Viable microbial air testing

13. Viable microbial surface testing

c. Air Changes Per Hour (ACPH). The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug (HD) storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate ACPH for each buffer room, ante room, Containment Segregated Compounding Area (C-SCA), and HD storage room and include their findings in the report. In the event a room does not meet <797> or <800> requirements for ACPH the identified site POC(s) shall be informed immediately.

d. Pressure Requirements. The contractor shall include in their report differential pressure readings from each buffer/ante room to surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per <797> or <800>. The contractor shall report all pressures to an accuracy of 0.001 inch water column (3 decimal places). Pressure differentials will be reflected on a report showing the sketch of the room(s).

e. Total Airborne Particles. The contractor shall perform total airborne particle testing under dynamic operating conditions every 6 months. The contractor shall derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 standard.

The volume sampled at each location shall be at least 2 liters, with a minimum sampling time at each location of 1 minute. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:

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1. ISO Class 5: not more than 3,520 particles 0.5 µm and larger size per cubic meter of air for any area primary engineering control.

2. ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per cubic meter of air for any buffer area or hazardous compounding ante room.

3. ISO Class 8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any non-hazardous compounding ante room.

f. Microbial Air Monitoring.

1. The contractor shall perform viable air sampling every 6 months for fungi and bacteria using an impaction device in all classified areas during dynamic operating conditions.

2. A sufficient volume of air (1,000 liters or more) shall be tested at each location in order to maximize sensitivity. Samples of less than 1,000 liters will not be acceptable.

3. A general microbiological growth media that supports the growth of bacteria and fungi must be used (e.g. trypticase soy agar (TSA)). Alternately, malt extract agar (MEA) or sabouraud dextrose agar (SDA) can be used for sampling of fungi.

4. Samples will be incubated at the temperature and duration specified in <797>.

5. The contractor must be willing and able to supply, upon request, the certificates of analysis (COAs) verifying the media meets the expected growth promotion, pH, and sterilizing requirements of <797>.

g. Microbial Surface Monitoring.

1. The contractor shall perform viable surface sampling every month for fungi and bacteria.

2. A general microbiological growth media that supports the growth of bacteria and fungi and supplemented with neutralizing additives (e.g., lecithin and polysorbate

80) to neutralize the effects of any residual disinfecting agents must be used (e.g.

TSA). Alternately, MEA or SDA can be used for sampling of fungi.

3. Samples will be incubated at the temperature and duration specified in <797>.

4. Surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected. Sampled surfaces are to include:

a) The interior of the PEC and the equipment contained in it

b) Staging or work area(s) near the PEC

c) Frequently touched surfaces

d) Pass-through chamber(s)

h. Environmental Wipe Sampling. The contractor will perform environmental wipe sampling for HD surface residue every 6 months, or more frequently as needed to verify containment, for those facilities that perform HD compounding and opt in for this testing.

The kits used to complete wipe sampling must be verified prior to use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs from surface types found in the sample area(s). The contractor must be able to test for the following:

1. Cyclophosphamide

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2. Ifosfamide

3. Methotrexate

4. Fluorouracil

5. Platinum-containing drugs

6. Additional Drugs

i. Additional drugs may be requested based upon identified need per site.

ii. Upon identified need, the applicable site will work directly with the contractor where additional cost will be clarified and agreed upon by both parties prior to testing.

Surface wipe sampling may include the following areas:

1. Interior of PEC and equipment contained in it.

2. Pass-through chambers

3. Surfaces in staging or work areas near PEC

4. Areas adjacent to PECs (e.g. floors directly under C-PEC, staging, and dispensing area)

5. Areas immediately outside the HD buffer room or C-SCA

6. Patient administration areas

i. Report Requirements. All of the following information shall be included in the report for clean room certification. Pass/Fail notifications should be included on a per-test basis where applicable:

1. Executive summary or summary of findings to include:

a. Room Certification Pass/Fail

b. Hood Certification Pass/Fail

c. Viable Air Sampling Pass/Fail

d. Viable Surface Sampling Pass/Fail

e. Specific deficiencies by location (room and/or hood), if identified

2. Room number and/or location

3. Room type (e.g. oncology prep room)

4. Standards used to test room

5. List of equipment utilized to include make, model, serial number, and calibration date

6. Room air changes per hour (The ACPH from HVAC, ACPH contributed from the

PEC, and the total ACPH)

7. Pressure differentials

8. Indication when dynamic operating conditions were used

9. Total airborne particle counts, action level for target ISO level

10. Action levels for ISO area tested

11. Total room area and volume

12. Date of next required certification

13. Type of PEC certified

14. Serial number of the PEC certified

15. Date and time samples collected and particle counts tested

16. Technician collecting the samples

17. COAs of media used

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18. Viable sample results (CFUs), action level for target ISO level

19. Viable sample results graph showing trends over time

20. Genus identification of bacterial and/or fungal isolates

21. Highly pathogenic microorganism isolates highlighted in the report notes

22. Room sketch (location of supply/exhaust diffusers, equipment, room dimensions)

23. Sketch identifying location of each viable particle and surface samples obtained

24. Location of positive HD wipe sample results

25. Room humidity and temp

j. Report Distribution. The contractor will immediately notify the POCs with any results indicating failure. A formalized written report including all required aspects specified in this SOW will be provided in a timely manner with receipt no more than 14 days from certification evaluation. All completed reports will be provided via email to the POCs and Report Distribution Lists. See PART IV: GENERAL ADMINSTRATION section of this document for identification and email addresses of POCs and Report Distribution Lists. Contractor will be notified by facilities of any updates to identified points of contact on an as needed basis.

k. Testing Frequency.

1. Certification procedures for PEC and room defined in CETA CAG-003-2006 and CETA CAG-009-00 shall be performed by a CETA CNBT certified testing individual no less than every 6 months, whenever the PEC or room is relocated or altered, when major service to the sterile compounding facility is performed, or to assess corrective actions associated with prior failed testing results. More frequent testing may be required should USP standards change during the performance period or option year(s).

2. Viable surface sampling will be completed every month, or more frequently if required to assess corrective actions associated with prior failed results. More frequent testing may be required should USP standards change during the performance period or option year(s).

3. Viable airborne particle sampling will be completed every 6 months, or more frequently if required to assess corrective actions associated with prior failed testing results. More frequent testing may be required should USP standards change during the performance period or option year(s).

4. Environmental wipe sampling for HD residue will be performed every 6 months, or more frequently if required to verify containment for those facilities who opt to perform this testing as part of their HD sterile compounding quality assurance activities.

l. Estimated Service Needs. See VISN 15 IV Room/Hood/Training Services Estimate – Summary of Service Qtys worksheet for estimated quantities of services needed for each facility over the contract period.

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PART III: SPECIAL CONSIDERATIONS

a. Contractor Furnished Materials.

1. All materials and tools to complete the work identified.

2. Contractor to ensure all staff that perform on-site testing arrive wearing non-shedding clothing.

3. All equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and introduces minimal microorganisms into the clean environments being tested. All equipment will be wiped/cleaned prior to taking into clean testing environments.

b. Government Furnished Materials and Services.

1. The Government will provide all necessary personnel protective equipment (PPE) required for contractors on site.

2. The Government will provide oversight and verification of contractor personnel completion of donning of PPE and hand hygiene prior to testing/sampling.

3. The Government will, on rare occasion, provide office or meeting space to discuss test results, projects, or plans.

4. May also provide desk phone service as needed.

c. Qualifications/References. VISN 15 is seeking a qualified contractor that meets the following specifications:

1. Provide three references showing the completion of at least 3 jobs of similar size and scope at other hospital facilities with at least one of those facilities being a VA Medical Center. Reference information is to include: Hospital/Medical Center name, POC name, email address and phone number.

2. All certifications must be signed by an NSF 49 certified technician. A copy of NSF 49 certifications must be attached to the bid documentation for any technicians that will be performing work at the facility.

3. All cleanroom performance testing must be supervised by a technician with CETA CNBT certification. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility.

4. Provide AIHA accredited laboratory certification for all <797> viable sampling analysis. Certification must be attached with bid documentation.

5. Provide copy of clean room certification report for evaluation.

6. If required, contractor (employees performing services at the facility) will attain

VA clearance (e.g. attend VA training, identification card)

d. Security Requirements. There are no security requirements required for this work, as samples are retrieved by the contractor and a test report is received in return.

e. Additional Considerations. The contractor (or Representative) shall contact the facility identified POC(s) to schedule work and prior to the beginning of work.

Scheduling of work will be at the direction of facility identified POC(s) to ensure services are incorporated into current facility certification cycles.

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Local facility COR(s) will provide the contractor with additional facility specific procedures which include: check in and check out procedures; contractor badging requirements; parking procedures; and any additional facility specific procedures. The contractor will be expected to adhere to those procedures. If a contractor is willing to perform services after 4:00pm (CST) this service must be included within the bid pricing as no extra charge. The ability to perform work after hours is not required; however, preferences will be given to contractors that offer flexible work hours.

f. Invoicing. Payment will be made monthly in arrears, invoices will be prepared by the

Contractor, and submitted through Tungsten Network (formerly known as OB10) http://www.tungstennetwork.com/us/en/. A properly prepared invoice shall contain:

1. Invoice number and date

2. Contractor’s name and address

3. Accurate purchase order number

4. Supply or service provided

5. Period supply or service provided

6. Total amount due

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PART IV: GENERAL ADMINISTRATION

a. Points of Contact (POCs). The contractor will contact the POC to schedule the work to be completed; upon arrival, the contractor will contact the POC. The POC will escort the contractor to the appropriate area and monitor the work being done. Upon completion of the work, the POC will escort the contractor out of the area.

Facility Name E-Mail Address VISN 15 589 Kansas City, MO Sarah.Hwang2@va.gov VISN 15 589A4 Columbia, MO Danielle.Field@va.gov

Second Contact TBD VISN 15 589A5 Topeka, KS Ryan.Province@va.gov

Clint.Freeman@va.gov VISN 15 589A6 Leavenworth, KS Ryan.Province@va.gov

Debra.Reynolds2@va.gov VISN 15 589A7 Wichita, KS Steven.Williams3@va.gov

Anna.Johnson1@va.gov VISN 15 657 St. Louis, MO J. Cochran James.Preston3@va.gov

Denise.Crannage@va.gov VISN 15 657A0 St. Louis, MO J. Barracks James.Preston3@va.gov

Denise.Crannage@va.gov VISN 15 657A4 Poplar Bluff, MO Kasey.Tubb@va.gov VISN 15 657A5 Marion, IL Lindsay.Oliveira@va.gov

Shyannon.McFarland@va.gov VISN 15 657GJ Evansville IN Nick.Ratcliffe@va.gov

John.Hays@va.gov

b. Report Distribution Lists

VISN 15 589 Kansas City, MO vhakanpharmacysupervisors@va.gov VISN 15 589A4 Columbia, MO VHACMOPHARMEnvironmentalControlTests@va.gov VISN 15 589A5 Topeka, KS EKHCSPharmacyManagement@va.gov VISN 15 589A6 Leavenworth, KS EKHCSPharmacyManagement@va.gov VISN 15 589A7 Wichita, KS vhawiccspcertification@va.gov VISN 15 657 St. Louis, MO J.

Cochran

STLCSPG@va.gov

VISN 15 657A0 St. Louis, MO J.

Barracks

STLCSPG@va.gov

VISN 15 657A4 Poplar Bluff, MO TBD VISN 15 657A5 Marion, IL VHAMRNCSPCERTIFICATION@va.gov VISN 15 657GJ Evansville IN VHAMRNCSPCERTIFICATION@va.gov

c. Contracting Officers of Record (CORs).

VISN 15 589 Kansas City, MO Jonathan.Corbett@va.gov

VISN 15 589A4 Columbia, MO Carlton.Foust@va.gov

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VISN 15 589A5 Topeka, KS David.Holland2@va.gov

VISN 15 589A6 Leavenworth, KS David.Holland2@va.gov VISN 15 589A7 Wichita, KS Marguerite.Fortin@va.gov

VISN 15 657 St. Louis, MO J. Cochran Jeffery.Bauman2@va.gov VISN 15 657A0 St. Louis, MO J. Barracks Donna.Richardson@va.gov VISN 15 657A4 Poplar Bluff, MO Anita.Hinkle@va.gov VISN 15 657A5 Marion, IL Rhonda.Epperley@va.gov VISN 15 657GJ Evansville IN Kimberly.Mickus@va.gov

d. Places of Performance.

Facility Name Address VISN 15 589 Kansas City, MO 4801 E. Linwood Blvd. Kansas City, MO 64128 VISN 15 589A4 Columbia, MO 800 Hospital Drive Columbia, MO 65201 VISN 15 589A5 Topeka, KS 2200 SW Gage Blvd. Topeka, KS 66622 VISN 15 589A6 Leavenworth, KS 4101 4th St. Trafficway Leavenworth, KS 66048 VISN 15 589A7 Wichita, KS 5500 E. Kellogg Drive Wichita, KS 67218 VISN 15 657 St. Louis, MO J. Cochran 915 N. Grand Blvd. St. Louis, MO 63106 VISN 15 657A0 St. Louis, MO J. Barracks 1 Jefferson Barracks Dr. St. Louis, MO 63125 VISN 15 657A4 Poplar Bluff, MO 1500 N. Westwood Blvd. Poplar Bluff, MO 63901 VISN 15 657A5 Marion, IL 2401 West Main Street Marion, IL 62959 VISN 15 657GJ Evansville IN 6211 East Waterford Blvd. Evansville, IN 47715

e. Period of Performance. See Block 3 of SF1449 plus 4 option years.

f. Contract Administration Data. All contract administration functions will be retained by the Department of Veterans Affairs. The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract.

The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

g. Non-Personal Services. This is a non-personal services contract. Personnel rendering services under this contract 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. The Government shall not exercise any supervision or control over the contract service providers performing services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

h. Hours of Operations.

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1. Business hours: Monday through Friday, 8:00 a.m. – 4:30 p.m.

2. National Holidays: The holidays observed by the Federal Government are:

New Year’s Day;

Martin Luther King’s Birthday;

Presidents Day;

Memorial Day;

Independence Day;

Labor Day;

Columbus Day;

Veterans Day;

Thanksgiving;

Christmas; and Any other observed Federal holiday.

i. Contract Performance Monitoring. The COR(s) may perform surveillance of services by any of the methods listed below:

1. Observing actual performance

2. Inspecting the services to determine whether the performance meets the performance standards

3. Review of any other appropriate records

4. When unacceptable performance occurs, the POC shall inform the Contractor and the Contracting Officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case, the POC shall document the discussion and place it in the POC file. When the POC determines that formal written communication is required, the POC shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor program manager.

The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor must present this corrective action plan to the POC. The Government shall review the Contractor corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer.

5. Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer representative(s); The Government shall periodically evaluate the Contractor performance by appointing a POC to monitor performance to ensure services are received. The Government representative(s) shall evaluate the Contractor performance through inspections of observations, inspection of services or any other form of documentation and all complaints from VA personnel. The

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Government may inspect as each task is completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates.

The Government Contracting Officer shall make final determination of the validity of customer complaint(s).

6. If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.

7. Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.

j. Contract Security. The C&A requirements do not apply, and a Security Accreditation

Package is not required. Also, no BAA is required.