LSJ_1226684.pdf

Last Modified: May 18, 2016 Page 1 of 9

TMPLT 2016.06-028

OAGS Template and Instruction for a General Services Administration Federal Supply Schedule Limited Source Justification

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

U.S. Food and Drug Administration (FDA) Office of Acquisition and Grants Services (OAGS)

b. Sponsoring organization.

Center for Devices and Radiological Health (CDRH)

Office of the Center Director (OCD)

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Greg Shaw

ii. Mailing address: 10903 New Hampshire Avenue, Silver Spring, MD 20993

iii. E-mail address: gregory.shaw@fda.hhs.gov

iv. Telephone number: 301-796- 7040

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

Template

The objective of this requirement is to provide the Office of the Center Director (OCD) with a vehicle (Blanket Purchase Agreement) to provide Quality Management Training for CDRH staff.

The training shall include examination preparations, and examination for American Society for Quality (ASQ) quality management certifications.

Last Modified: May 18, 2016 Page 2 of 9

b. Project background.

The CDRH’s Office of the Center Director (OCD) provides vision, leadership, and strategic direction for the Center, including both the regulation of medical devices and radiation-emitting products and Center-level management, planning, and evaluation systems to ensure optimal utilization of personnel, budgetary, and financial resources.

The CDRH Strategic Priorities have included Quality Management as one of the Center’s initiatives sponsored by the CDRH OCD’s Quality Management Program in direct support of one of the CDRH’s strategic objectives (Promote a Culture of Quality and Organizational Excellence) for the Center’s staff.

Quality and excellence require the Center to engage in continuous improvement through leaning and improving processes to better serve all the CDRH’s customers—internal and external—reducing unnecessary burdens and increasing quality and predictability. In order to achieve these goals, the Center requires that staff be trained and certified in quality management. CDRH is seeking a vendor to provide training in Quality Management, consisting of both preparation and examination for quality management certifications. All training must be in compliance with the quality standards addressed in the Quality Body of Knowledge (QBOK)

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title.

Quality Management Training and Lean Six Sigma Certifications

b. Project Description.

This requirement is to provide the Office of the Center Director with a vehicle to provide quality management training for Center staff. CDRH OCD requires contractor support to provide training, examination preparations, and examination for several quality management certifications.

The contractor shall provide training, training materials, course related question banks, examination preparation, and examinations related to respective quality management courses.

Training must be on-site and instructor-led.

In addition to training materials, certification examination must be provided for all certifications below:

Certified Quality Auditor (CQA) Certified Six Sigma Yellow Belt (CSSYB) Certified Six Sigma Green Belt(CSSGB) Certified Six Sigma Black Belt (CSSBB).)

Last Modified: May 18, 2016 Page 3 of 9

Requirement type.

Support services (non-R&D)

Supplies/equipment

Information Technology (IT)

Other: Training Services

Type of action.

New requirement

Follow-on

Other:

Proposed contract/order type.

Firm-fixed-price

Time and materials

Indefinite delivery:

Other: Blanket Purchase Agreement (BPA)

Completion Form

Term Form

Acquisition identification number.

CDRH-20-C-0072

c. Total estimated dollar value and performance/delivery period.

The total estimated value of all Call Orders issued under the BPA, including the base and option periods, is $5,000,000.00. The estimated value of the initial Call Order is $100,000.00.

The term of the BPA shall be for a twelve-month base with four additional twelve-month option periods. The dates of performance are:

Base: July 24, 2020 through July 23, 2021.

Option 1: July 24, 2021 through July 23, 2022.

Option 2: July 24, 2022 through July 23, 2023.

Option 3: July 24, 2023 through July 23, 2024.

Option 4: July 24, 2024 through July 23, 2025.

Last Modified: May 18, 2016 Page 4 of 9

4. The authority and supporting rationale (see FAR 8.405-6(a)(1)(i); (b)(1)) and, if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

a. Acquisition authority.

This acquisition is conducted under the authority of the Multiple Award Schedule Program. In accordance with Federal Acquisition Regulation (FAR) 8.405-6(a), consideration of schedule contractors will be restricted to fewer than the number required at FAR 8.405-1, FAR 8.405-2, FAR 8.405-3 (i.e., fewer than three FSS contractors). FAR 8.405-6 (a)(1)(i), for a proposed order or BPA with an estimated value exceeding the micro-purchase threshold not placed or established in accordance with the procedures in FAR 8.405-1, FAR 8.405-2, or FAR 8.405-3, the only circumstances that may justify the actions are-

(A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays;

(B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

(C) In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited-sources procedures.

This acquisition is conducted under the authority of the Multiple Award Schedule Program. In accordance with FAR 8.405-6(b), consideration of schedule contractors will be restricted only to the item peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer.

b. Demonstration of the proposed contractor(s) unique qualifications to provide the required supply or service.

Name and address of the proposed contractor(s).

American Society for Quality (ASQ)-(GS-02F-0126S) 600 N Plankinton Ave Milwaukee, WI 53203-2914 www.asq.org

Nature of the acquisition and proposed contractor(s) unique qualifications.

D The CDRH 2016-2017 Strategic Priorities established a goal to Promote a Culture of Quality and Organizational Excellence throughout CDRH. Under this initiative, CDRH developed and then began implementing our Quality Management Framework. However, while a QMS provides some level of confidence about its products and services, a culture focused on

Last Modified: May 18, 2016 Page 5 of 9 quality and customer service is needed to truly achieve organizational excellence. A key measure of excellence for CDRH is to have systems and procedures in place to be eligible for ISO 9001 certification, which sets out the criteria for a quality management system and is the only standard in the family that can be certified. The ISO 9001 standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement.

CDRH, due to its mission of interacting with organizations around the world to assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation emitting products, must establish and maintain the highest level of quality excellence.

Therefore, CDRH leadership determined that to achieve the highest level of quality, that is accepted around the world, Its QMS program must have quality certifications that are accepted by all organizations, whether Federal, State, Military, Civilian, or International.

CDRH found that the quality certifications from the American Society for Quality (ASQ) are the only certifications that meet its Strategic Priorities and have established the ASQ certifications a mandatory part of its quality program.

The American Society for Quality (ASQ ) is the sole proprietor of the ASQ certifications and is the only company allowed to train for and award the certifications. No other company can provide the specific training necessary to meet the ASQ standards and therefore, cannot meet the needs of CDRH.

The issue of the solicitation and award under limited sources conditions, represents the method most beneficial to the Government to meet its minimum needs and to achieve its mission critical goals.

5. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

Since (a) GSA has already determined the prices of the supplies and services under FSS contracts, including rates for services offered at fixed hourly rates, to be fair and reasonable; and (b) by placing an order against a schedule contract using the procedures in FAR 8.405-1, the ordering activity CO has concluded that the order represents the best value (see FAR 2.101) and results in the lowest overall price alternative, the determination shall cite:

i. Whether any additional discounts will be sought before placing an order (see FAR 8.405-4);

ii. The type of pricing information, if any, that will be obtained from the schedule contractor(s) in relation to seeking additional discounts; and

iii. The extent of the price evaluation anticipated in order to determine that the total price is reasonable – see FAR 8.405-2(d).

Last Modified: May 18, 2016 Page 6 of 9

The Market Research conducted by the Government evaluated whether there are sources that can meet the requirements as outlined in the Statement of Work and provide the continuity of vision and strategic direction required for the training. The Government determined that there are no other sources that can provide the required level of training necessary to achieve ASQ LSS certification. Due to the International acceptance of the ASQ certifications, which aligns with the CDRH mission of ensuring the safety and quality of medical and health related devices within the U.S., including those originating in foreign countries, the CDRH leadership has determined that LSS certifications from ASQ is the standard for CDRH quality personnel.

Therefore, the FDA recommends that this requirement is awarded to the American Society for Quality as the contactor that provides the best value to the Government.

6. Description of the market research conducted among schedule holders and the results, or a statement of the reasons market research was not conducted.

The focus of this market research is to ascertain the availability of companies that are capable of providing quality management training, onsite at the FDA White Oak campus, and online. The training must include training materials, examination preparations, and examination for several quality management certifications. The certifications must be recognized and accepted in the U.S.

and internationally. Specifically, the training must provide for the following certifications:

Certified Quality Auditor (CQA) Certified Six Sigma Yellow Belt (CSSYB) Certified Six Sigma Green Belt (CSSGB) Certified Six Sigma Black Belt (CSSBB)

The research included a review of GSA schedule contracts. This research did not include issuing a request for information (RFI), contacting the companies, or contacting any other agency that may have experience with the companies.

A. GSA Schedule Contracts

A search conducted for NAICS 611430 on GSA eLibray returned 944 contract holders on GSA Multiple Award Schedule (MAS) Professional Services Training.

B. Listed below are a few of the contract holders for NAICS 611430.

Company Contact Socioeconomic Status American Society for Quality, Inc.

600 N Plankinton Ave Milwaukee, WI 53203-2914

GS-02F-0126S

414-272-8575 E-Mail: mkern@asq.org Web Address: http://www.asq.org/

OTSB

Alliance Training and Consulting 12706 Cedar Leawood, KS 66209-1872

GS-10F-0560N

913-385-5515 E-Mail: dmask@alliancetac.com Web Address:

http://https://alliancetac.com

VOSB

Beacon Training Services Inc.

1229 Mohawk Trail Richardson, TX 75080-3924

GS-02F-0185P

(972) 404-0069 diana@beacontraining.com WOSB

Last Modified: May 18, 2016 Page 7 of 9

Center for Creative Leadership Inc. 1 Leadership Pl Greensboro, NC 27410-9427

GS-02F-0077T

(336) 286-4195 loomisc@ccl.org

OTSB

American Society for Training and Development, Inc.

1640 King St Ste 300 Alexandria, VA 22314-2743

GS-00F-188GA

703-683-8100 E-Mail: Jabbess@td.org Web Address: http://www.td.org OTSB

Based upon the market research, it is found that there are several sources capable of providing Lean Six Sigma training, however, none of the companies can provide training to the level required to receive certification by ASQ. Due to the International acceptance of the ASQ certifications, which aligns with the CDRH mission of ensuring the safety and quality of medical and health related devices within the U.S., including those originating in foreign countries, the CDRH leadership has determined that LSS certifications from ASQ is the standard for CDRH quality personnel.

The American Society for Quality (ASQ ) is the sole proprietor of the ASQ certifications and is the only company allowed to train for and award the certifications. No other company can provide the specific training necessary to meet the ASQ standards and therefore, cannot meet the needs of CDRH.

7. Any other facts supporting the justification.

NONE

8. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

a) Removal of barriers to competition.

Thorough market research was conducted by the Government to determine that full and open competition was not feasible given the current availability of the market to meet the requirements. Ongoing market research will continue to assess whether other sources become available. Any subsequent acquisitions will undergo thorough market research before any decision is made about available sources.

b) Listing of sources, if any, that expressed an interest, in writing, in the acquisition.

No formal communication was conducted. Market research resulted communication with Management Concepts, Partnership for Public Service, and ASQ.

9. Program office certification.

Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for limited sources) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

Last Modified: May 18, 2016 Page 8 of 9

Signature:____________________________________

Karina Kuhn COR/Requiring Activity POC

Signature:____________________________________

Kyle Roberts COR/POC Immediate Supervisor

10. Contracting Officer Certification.

This is to certify that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

Signature:____________________________________

Anthony S. Wimbush Contracting Officer

11. Division Director and Head of the Contracting Activity signature(s).

Signature:____________________________________

Vidya Vish Division Director

Signature:____________________________________

Karina Kuhn -S Digitally signed by Karina Kuhn -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Karina Kuhn -S, 0.9.2342.19200300.100.1.1=2000226608 Date: 2020.07.02 12:28:48 -04'00'

Salim K. Roberts - S

Digitally signed by Salim K.

Roberts -S Date: 2020.07.02 12:41:24 -04'00'

Nancy Collazo Braier -

Signature:_S___________________________________ Nancy Collazo Braier

Head of the Sponsoring Program Office

Digitally signed by Nancy Collazo Braier -S Date: 2020.07.10 12:40:08 -04'00'

Anthony S.

Wimbush -S

Digitally signed by Anthony S. Wimbush -S Date: 2020.07.13

18:41:07 -04'00'

Leonard D. Grant Head of the Contracting Activity

Last Modified: May 18, 2016 Page 9 of 9

12. Competition Advocate signature.

Signature:____________________________________

Jim Sigg Competition Advocate