B-3_Amd 0004 to S5121A21Q0003_AED Program Management Services.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as p rovid ed herein, all terms and cond itions o f th e document referenced in Item 9A o r 10 A, as hereto fore chang ed , remains un ch an ged and in full force and effect.

15A. NAME AND T IT LE OF SIGNER (T ype or print )

30-105-04EXCEP TION T O SF 30

AP PROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) P rescribed by GSA

FAR (48 CFR) 53.243

The purpose of A mendment 0004 to RFQ S5121A-21-Q-0003 for the Automated External Def ibrillator Program Management Services is:

1. To provide answ ers to questions received from industry.

2. To update the PWS by removing the "Mock Responses Exercise" sub-section and bullet under "Task 3: Provide AED Devices."

3. To change Task 5 to Task 4 under Part 5 and Specif ic Tasks due to an error in numbering.

4. To update the extended description of CLINs 0005, 1005, 2005, 3005 and 4005.

5. See the continuation page of the SF30 for thorough details of this A mendment.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 16

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

16C. DATE SIGNED

BY 18-May-2021

16B. UNITED STAT ES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Cont ract ing Officer)(Signat ure of person a ut horized t o sign)

8. NAME AND ADDRESS OF CONT RACT OR (No., St reet , County, Sta te and Zip Code) X S5121A21Q0003

X 9B. DATED (SEE IT EM 11)

07-Apr-2021

10B. DATED (SEE IT EM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS IT EM ONLY AP PLIES TO AMENDMENT S OF SOLICITAT IONS

X Th e ab ove n umbered solicitation is amend ed as set forth in Item 1 4. Th e hou r and date sp ecified for receipt o f Offer is extend ed , X is not extended.

Offer mu st ackn owled ge receipt of this amen dment p rior to the h our an d d ate specified in the solicitation or as amen ded b y o ne of the following method s:

(a) By completing Items 8 and 15 , and returnin g 1 co pies of the amen dment; (b ) By ackn owled ging receipt of this amen dment o n each copy of the o ffer sub mitted ;

o r (c) By separate letter o r teleg ram wh ich includ es a reference to th e so licitation and amend men t nu mbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtu e of this amen dment y ou desire to change an offer already su bmitted, su ch change may be made by teleg ram or letter, p rovid ed each telegram o r letter mak es reference to th e so licitation and this amen dment, an d is receiv ed prio r to the op en ing hou r and date sp ecified.

12. ACCOUNTING AND AP PROP RIATION DATA (If required)

13. THIS ITEM AP PLIES ONLY T O MODIFICATIONS OF CONT RACT S/ORDERS.

IT MODIFIES T HE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED P URSUANT T O: (Spec ify aut horit y) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN T HE

CONT RACT ORDER NO. IN ITEM 10A.

B. T HE ABOVE NUMBERED CO NTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office , appropria tion dat e, et c.) SET FORT H IN ITEM 14, PURSUANT TO T HE AUT HORITY OF FAR 43.103(B).

C. T HIS SU PP LEMENTAL AGREEMENT IS ENT ERED INTO PURSUANT TO AUT HORITY OF:

D. OT HER (Specify type of modificat ion and aut horit y)

E. IMP ORTANT: Contrac tor is not, is required t o sign this document and re turn copies to t he issuing office.

14. DESCRIP TION OF AMENDMENT/MODIFICATION (Organize d by UCF sec tion headings, inc luding solic ita tion/contrac t subject mat t er whe re feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If app licable)

6. ISSUED BY

3. EFFECTIVE DATE

18-May-2021

CODE

DCMA PROCUREM ENT CENTER S5121A

DCMA PROCUREM ENT CENTER (S5121A)

3901 A AVE BLDG 10500

FORT LEE VA 23801-1809

S5121A 7 . ADMINISTERED BY (If o ther than item 6)

4 . REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

S5121A21Q0003

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

AMENDMENT 0004

The purpose of Amendment 0004 to RFQ S5121A-21-Q-0003 for the AED Program Management Serevices is to provide the answers to the following questions received from industry:

Question 1: Should the pricing schedule worksheet be submitted in Excel format?

Answer 1: Refer to Tab B – Price under the Instructions for Quote Submission.

Question 2: In the Pricing Schedule, CLIN 0005, please clarify the reference to "Job." Is the quote intended to price training for 60 individual students?

Answer 2: The Unit of Measure “Job” is a class of up to 12 students, so for the Base Year we are asking for a price for 60 classes.

Question 3: Are the certifications and representations excluded from the page count for Tab B?

Answer 3: The certifications section is excluded from the page counts associated with TABs A & B.

Question 4: Are the amendments excluded from the page count for Tab B?

Answer 4: Amendments are excluded from the page count for TAB B.

Question 5: Is the compensation plan part of Tab A or Tab B? Is the compensation plan excluded from the page count for its respective section?

Answer 5: The compensation plan is not a part of TAB A or TAB B and thus not a part of the page counts for those TAB sections, but it is required.

Question 6: Per the Pricing Schedule, CLIN 0005:

CLIN Description Quantity Unit of Issue Unit Price ($) Amount ($)

0005 AED/CPR/FA Training 60 Job

Requests the contractor provide pricing for a quantity of 60 “jobs”.

Please clarify if the “unit of issue” is the same as the total number of training events or the number of students to be trained.

If it is related to the number of students to be trained, kindly provide a breakdown of the number of training events required and the number of attendees at each event. Example, would there be 30 training events with two

(2) students each or five (5) training events with twelve (12) students each?

Answer 6: Please see answer to Question 1.

Question 7: Will the government be issuing a revised pricing schedule?

Answer 7: The pricing schedule will remain the same, however the extended description within the training CLINs will be expanded to show the explanation or answer given for Question 1.

Question 8: Part 5 – Specific Tasks – Task 4 appears to be missing. The document jumps from Task 3: Provide AED devices to Task 5: Record Keeping.

Answer 8: This is a typo in that “Task 5: Record Keeping” was incorrectly labeled and should be “Task 4: Record Keeping. The information was updated within the PWS.

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

CLIN 0005

The CLIN extended description has changed from:

60 trainees (Approx)

To:

The Unit of Measure "Job" represents a class of up to 12 students.

CLIN 1005

This CLIN is an Optional CLIN that can be exercised, if needed, for up to 5 AED/CPR/FA Trainings within the Period of Performance for OY1.

This CLIN is an Optional CLIN that can be exercised, if needed, for up to 5 AED/CPR/FA Trainings within the Period of Performance for OY1. The Unit of Measure "Job" represents a class of up to 12 students.

CLIN 2005

60 trainees (Approx)

CLIN 3005

This CLIN is an Optional CLIN that can be exercised, if needed, for up to 5 AED/CPR/FA Trainings within the Period of Performance for OY3.

This CLIN is an Optional CLIN that can be exercised, if needed, for up to 5 AED/CPR/FA Trainings within the Period of Performance for OY3. The Unit of Measure "Job" represents a class of up to 12 students.

CLIN 4005

70 trainees (Approx)

The following have been modified:

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

Provide Automated External Defibrillator Support Services Defense Contract Management Agency (DCMA)

Part 1

General Information

1. GENERAL: This is a non-personal services contract for the Defense Contract Management Agency (DCMA) Automated External Defibrillator (AED) program. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government. The DCMA Safety and Occupational Health Office (TDSO) oversees the use of Automated External Defibrillators (AED) throughout the Agency. At present there are 92 locations with DCMA owned AEDs in place. Quantity and services to be verified annually based on DCMA mission need based in part of CMO re-location in relation to nearest Emergency Services provider.

1.1 Description of Services/Introduction: This program requires services and equipment (AED units and associated supplies specified in this PWS) be purchased from an outside source. The contractor shall provide AED program oversight, replace obsolete AED units (compatible program to existing), responder training, program supplies and other items/non-personal services necessary to maintain the AED program. These services shall include but are not limited to: development/validation of site specific AED protocols; AED units/cabinets (mounted), online unit maintenance tracking systems, onsite responder training, and consumables: Replacement batteries, pads, and response personal protective equipment. The contractor shall perform to the standards in this contract for AED placement locations within DCMA.

1.2 Background: The DCMA Safety and Occupational Health (SOH) office is responsible for assisting management with providing safe and healthy working conditions. As part of the current Collective Bargaining Agreement (CBA), DCMA is required to place AEDs where “deemed appropriate”. From 2005-2009 DCMA placed AEDs and sent trained volunteer responders to DCMA workplaces requesting an AED as participants in the program under the Federal Occupational Health (FOH) contract. In 2010, new placement requests were submitted based on local emergency response times to the location and the American Heart Association survivability guidelines.

1.3 Objectives: The objective of this requirement is to find an accredited contractor with the ability to provide services such as accredited recurring training and to obtain and maintain the equipment needed to sustain the Agency’s AED program. In meeting DCMA’s requirements the contractor shall:

a. Provide Medical Direction, Oversight, Prescription and maintenance for each DCMA AED (mounted)

b. Provide full program in 1.3.a. to existing Zolls AEDs currently in use at 20 of 92 DCMA locations.

c. Replace obsolete AED’s currently in the field (Attachment A) with Zolls or equal.

d. Track and maintain DCMA inventoried AED units, batteries and training dates.

e. Provide recurring American Heart Association, American Red Cross, Emergency University, EMS Safety

Services, Inc. or National Safety Council CPR/AED/FA training classes for DCMA sites.

f. Provide equipment placement instructions end-user use handbooks/guides, serviceability, inspection and operability checklists, program validations, supply order forms and training requests.

g. Maintain all warranted equipment items in serviceable condition.

h. Provide support for supplies and accessories (pads, batteries, display cabinets, signage).

i. Contractor shall have the ability to provide and sell new AEDs that are Zolls or equal.

j. Contractor shall be an authorized dealer or distributor for the Zolls or equal AEDs that they are providing under the resultant contract.

1.4 Scope:

1.4.1. The contractor shall provide products and services to sustain a comprehensive AED program at designated agency locations. Contractor shall provide AED’s equipped with a second set of electrode pads and a ready kit containing a bag mask, razor, gauze pads, scissors, nitrile gloves, and wipes.

1.4.2. The list of serviced locations with obsolete units, and delivery addresses are attached as Attachment A.

Contractor shall pay any originator related shipping costs.

1.4.3. Contractor shall provide CPR/AED/FA training to DCMA volunteer responders to be held in DCMA facilities. The contractor shall supply all necessary training materials to certify attendees that meet or exceed CPR/AED/FA American Heart Association, American Red Cross, Emergency University, EMS Safety Services, Inc., or National Safety Council guidelines, and shall issue each student a certification card.

1.4.4. DCMA will recruit for and advertise the availability of classes that the contractor shall provide to DCMA volunteer responders.

1.4.5. Records of CPR/AED/FA training and delivered supplies of AEDs shall be kept by contractor and shared with DCMA monthly.

1.4.6 DCMA will conduct periodic serviceability and operability checks/checklists of the placed AEDs in accordance with the contractor’s program. Site/Unit Checklists shall be turned into the DCMA AED Program manager monthly as proof of inspection.

1.5 Period of Performance: The period of performance will consist of one (1) Base Year and four (4) Option Years as outlined below:

Base Year 09/30/2021 – 09/29/2022

Option Year (1) 09/30/2022 – 09/29/2023

Option Year (2) 09/30/2023 – 09/29/2024

Option Year (3) 09/30/2024 – 09/29/2025

Option Year (4) 09/30/2025 – 09/29/2026

1.6 General Information

1.6.1 Quality Control: The contractor shall develop and maintain an effective quality control program (QCP) to ensure equipment and services are performed in accordance with this PWS. The Contractor will notify the Contracting Officer’s Representative (COR) when training and supplies are due by location. The government will conduct recurring serviceability checks on the installed units and report any deficiencies. Contract employees will be escorted into and while within all DCMA office spaces while performing under this contract.

1.6.2 Recognized Holidays: The contractor is not required to perform services on recognized federal holidays.

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

1.6.3 Hours of Operation: The contractor is responsible for conducting business, between the hours of 8:00 am. – 4:30pm (Eastern), Monday thru Friday, except Federal holidays, to perform tasks set-forth within this contract.

1.6.4 Place of Performance: At required DCMA locations listed in Attachment A, DCMA will provide and arrange for meeting spaces within its facility for all required training sessions to be performed by Contractor. DCMA will request contracror training dates and times NLT 30 days prior to training. The Contractor shall have capability to service DCMA locations at Attachment A.

1.6.5 Type of Contract: The government will award a Firm Fixed Price Contract.

1.6.6 Security Requirements: DCMA will notify contractor of any unique security or entry requirements to their sites for contractor training. If required, all contractor project team members shall submit security forms to DCMA for clearance and access badges (as required) to the facility. The contractor shall protect CUI (Controlled Unclassified Information) in accordance with DFARS Clause 252.204-7012 “Safeguarding Covered efense Infroamtion and Cyber Incident Reporting.”

1.6.6.1 Physical Security: N/A

1.6.7 Special Qualifications: N/A

1.6.8 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officer’s Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced.

Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.6.9 Contracting Officer Representative (COR):

The COR will review records to ensure the monthly checklist are completed and report any non-conformances to the Contracting Officer.

1.6.10 Key Personnel: The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate, who shall act for the contractor when the manager is absent, shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00am – 4:30pm, Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons.

1.6.11 Identification of Contractor Employees: N/A

1.6.12 Contractor Travel: N/A

1.6.13 Other Direct Costs: N/A

1.6.14 Data Rights: N/A

1.6.16 Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to, or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services, which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

1.6.17 Phase In/Phase Out Period: DCMA will provide Contractor with existing AED serial numbers and locations.

Contractor shall review and incorporate existing AED units into program.

1.6.18. Acceptance Criteria: Any discrepancies involving completion of project tasks or disagreement between CMS and the chosen contractor shall be referred to both organizations’ contracting offices for review and discussion.

PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

2.1.1. CONTRACTOR. A supplier or contractor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.5. DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

2.1.6. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.8. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.9. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.10. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privacy of contract with the subcontractor.

2.1.12. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.12. WORK WEEK. Monday through Friday, unless specified otherwise.

2.2. ACRONYMS:

ACOR Alternate Contracting Officer's Representative AED Automated External Defibrillator AFARS Army Federal Acquisition Regulation Supplement

AR Army Regulation CCE Contracting Center of Excellence CFR Code of Federal Regulations COR Contracting Officer Representative COTR Contracting Officer's Technical Representative COTS Commercial-Off-the-Shelf CUI Controlled Unclassified Information DA Department of the Army DCMA Defense Contract Management Agency DFARS Defense Federal Acquisition Regulation Supplement DMDC Defense Manpower Data Center DoD Department of Defense FAR Federal Acquisition Regulation KO Contracting Officer OSHA Occupational Safety and Health Administration OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs PIPO Phase In/Phase Out POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program SME Subject Matter Expert

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES: The contractor is responsible for providing all materials to complete the project. Unless specified in the contract, the Government will not provide any equipment.

All government purchased equipment under this contract is Government owned and will remain with DCMA during the entire performance of this contract

3.1. Services: The Government will provide: None

3.2 Facilities: The Government will provide: None

3.3 Utilities: The Government will provide: None

3.4 Equipment: The Government will provide: None

3.5 Materials: None

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: The Contractor shall furnish all supplies, equipment, and services required to perform work under this contract that are not listed under Part this PWS.

4.2. Materials: The Contractor shall provide all materials and supplies necessary to meet the requirements under this

PWS.

4.3. Equipment: The Contractor shall provide all equipment/machines necessary to meet the requirements under this

PWS.

4.4. Omissions: This contract may not cover all specified activities, steps, and procedures required to supply the contract product. In case of omission, the normal industry, state, or federal standards, practices, specifications, and/or guides shall prevail. In no instance shall an omission be reason to produce less than an acceptable product.

PART 5

SPECIFIC TASKS

Task 1: Provide Medical Direction, Oversight and Prescription

Contractor shall provide medical direction, oversight and prescription for each AED installed. Copies of medical prescriptions by location will be provided to the COR NLT 30 days after contract award.

Medical direction and oversight to include:

• Authorize the purchase of the AED(s)

• Provide medical consultation and expertise relating to the care and treatment of sudden cardiac arrests, cardiac emergencies and other medical emergencies

• Develop and/or approve protocols for the use of an AED and other medical equipment

• Act as a liaison between the early access defibrillation program site and the local Emergency Medical

Service (EMS) organization, and assist DCMA in responding on site and how to effectively activate DCMA local EMS response.

• Approve AED training program and ensure that rescuers are properly trained

• Review every event in which an AED is used

• Assistance in providing post-event reporting to the local or state EMS, and in analyzing data from your

AED to provide you with a thorough understanding of the event and DCMA program’s response

• Answer clinical questions about DCMA AED and DCMA AED program via telephone or email within 48 hours.

• Provide handling/disposition instructions when/if required

• Notify DCMA of potential updates/recalls from the AED manufacturer

• Prepare and submit invoices for devices and training provided

Task 2: Provide Required Training

Contractor shall provide:

CPR/AED/FA classes

• Up to 12 students each class (DCMA personnel only)

• CPR/AED/FA training sessions shall last no more than 4 ½ hours

• All course materials – booklets, videos, mannequins, AED trainers, etc. shall be provided by the contractor.

• Upon completion of the course contractor shall supply students with American Heart Association certification cards for CPR/AED/FA.

• Certification will be for two (2) years through the American Heart Association, American Red Cross or any

Nationally Recognized accreditation.

• Contractor shall provide COR with a list of personnel trained each month.

DCMA will provide:

• A means to display videos shown during training sessions.

• A location for conducting onsite training within DCMA workspaces.

• Room(s) will be a large conference area with ample floor space.

• Contractor a schedule of training dates at least 30 days in advance of class.

DCMA has the option to request/substitute like CPR/AED/FA training classes approved by contractor in the event schedule or location is not acceptable to the site. Contractor to verify instructor’s credentials prior to and receive copies of awarded cards to responders.

Task 3: Provide AED devices

AEDs shall be Zolls or equal:

ANSUAAMI DF3 9 -Automatic external defibrillators and remote-control defibrillators https://www.federalregister.gov/articles/2015/01/29/2015-01619/effective-date-of-requirement-for-premarket-approval-for-automated-external-defibrillator-systems#h-12

AEDs features and benefits shall include:

• Designed for use by lay responders

• Loud, clear voice instructions

• LCD screen intuitive to the lay responder and display to user what to do and how to do it, while providing visual CPR coaching

• Device shall consist of one piece adult pad pre-connected

• When in use, a clear, calm voice and visual indicators shall prompt the user from start to finish

• Continuous monitoring of the heart and will detect if the patient’s heartbeat recovers, to cancel the shock automatically

• Each AED shall be equipped with a battery pack and two sets of adult pads, which shall be replaced on or before the expiration date.

• Each AED shall be equipped/attached with a kit containing a bag mask; razor, gauze pads, scissors, nitrile gloves, and wipes.

• Each AED shall utilize consumer lithium camera batteries that are locally available.

DCMA will check the AEDs installed to see if they are in good working order and condition. DCMA will replace batteries and pads in accordance with manufacturer’s recommendations. If the AED experiences a malfunction the contractor shall resolve/replace the AED within 48 hours.

AEDs shall have self-tests performed by designated DCMA AED Coordinators at the frequency identified below:

Daily

• Power up AED

• Test software integrity

• Test basic operation of all electronic circuitry

• Test Battery integrity

Weekly Daily test plus:

• Advanced circuit and battery integrity testing

• Tests patient interface circuitry

• Check that training electrodes are connected

• Partial charge and discharge tests

• Document completion

Monthly Weekly test plus:

• Execute and document results of monthly serviceability/operability checklist(s).

Task 4: Record keeping

The Contractor shall submit to the COR a Monthly Progress Report via email that reflects the previous month’s effort that supports the monthly invoice submission. The Contractor shall submit the Monthly Progress Report to the COR on the 15th calendar day of each month or the next business day if the 15th occurs on a holiday or weekend. The COR and the Contractor will agree upon the content and format of the Monthly Progress Report if information is required other than described below. Monthly Progress Reports shall include, but not be limited to, the following elements:

• Report/Invoice Number (at a minimum the invoice must include the invoice number; date invoice was submitted; date service was conducted; type of service provided; location of service provided; cost for each service provided; contract number; and any remarks)

• Contract number and related task number;

• Date, location and cost of services provided;

• Prior month’s completed activities by task;

• Summaries of meetings including time, location, participants, and contact information;

• Areas of concentration for the upcoming month;

• Issues of concern that require CMS action;

• Any unresolved issues from the prior month, as well as the applicable timeline of submission and potential resolution;

• Identified risks including level of impact and mitigation strategy;

• Projected tasks/activities for the upcoming month; and,

• Report of any continuous quality/improvement activities and findings;

• Electronic copies of trainees sign in sheets, monthly inspections and/or replacement of equipment

Contractor shall keep all class rosters on file, provide the COR with a copy of the roster via email after each class with the expiration date of their CPR.

Performance Requirements Summery (PRS) Performance Objective (The Service required— usually a shall statement)

Standard Performance Threshold (This is the maximum error rate.

It could possibly be “Zero deviation from standard”)

Method of Surveillance

Incentives/ Disincentives

PRS # 1.

The contractor shall provide medical direction, oversight, and prescription

The contractor provides oversight and direction by ensuring trainers were properly certified; ensuring DCMA questions and concerns are addressed in a timely manner; notifying DCMA if there are updates and/or recalls on AED devices;

Zero deviation from standard

Random query Incentive:

Satisfactory Past Performance

Disincentive:

Unsatisfactory Past Performance

PRS # 2

The contractor shall provide required training.

The contractor provides training identified in the PWS and issues each attendee a certification card. The contractor provides a roster of employees trained, and expiration date of certification, NLT than the 3rd day of the month for the preceding month.

Roster received no later than the 5th day of the month for the preceding month.

Monthly review of rosters against invoices.

Incentive:

Satisfactory Past Performance

Disincentive:

Unsatisfactory

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

Standard Performance Threshold (This is the maximum error rate.

It could possibly be “Zero deviation from standard”)

Method of Surveillance

Incentives/ Disincentives

PRS # 3

The contractor shall provide new AEDs.

AEDs provided shall be Zolls or equal, delivered at the locations specified within Attachment A.

Devices and all support equipment received as invoiced.

COR will verify with organizational AED Coordinator upon receipt of each invoice.

As needed, verification with organizational

AED

Coordinators against invoice.

Payment will be withheld for any faulty or used AEDs delivered by or received from the contractor until DCMA is in receipt of new AEDs.

All charges associated with the faulty or used AEDs and return of same thereof will be paid by contractor.

Incentive:

Satisfactory Past Performance

Disincentive:

Unsatisfactory

PART 6

APPLICABLE PUBLICATIONS

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

6.1. The Contractor shall abide by all statutes, applicable regulations, publications, manuals, and federal policies, procedures including Cardiac Arrest Survival Act of 2015, HR 4152 and 21 CFR Section 870 – Cardiovascular Devices.

ANSUAAMI DF3 9 -Automatic external defibrillators and remote-control defibrillators https://www.federalregister.gov/articles/2015/01/29/2015-01619/effective-date-of-requirement-for-premarket-approval-for-automated-external-defibrillator-systems#h-12

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