RFP 12-14270 Amendment 00001.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE OF PAGES

1 7

2. AMENDMENT/MODIFICATION NO.

00001

3. EFFECTIVE DATE

05/16/2012

4. REQUISITION/PURCHASE REQ. NO.

5. PROJECT NO. (If applicable)

6. ISSUED BY CODE 3635 7. ADMINISTERED BY (If other than Item 6) CODE 3635

Centers for Disease Control and Prevention

Acquisition and Assistance Field Branch V

P O Box 18070 - 626 Cochrans Mill Road

Pittsburgh PA 15236-0070

Centers for Disease Control and Prevention

Acquisition and Assistance Field Branch V

P O Box 18070 - 626 Cochrans Mill Road

Pittsburgh PA 15236-0070

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

All Potential Offerors

X

9A. AMENDMENT OF SOLICITATION NO.

2012-N-14270

9B. DATED (See Item 11)

04/25/2012

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (See Item 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, X is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEGMENT

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 virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

N/A

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

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

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, X is required to sign this document and return 1 copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of this amendment is to provide answers to questions submitted in response to the solicitation. The answers are contained on continuation pages attached to this Standard Form 30. The

03:30 PM Local Time 05/25/12, due date of the solicitation is not extended by this amendment.

Responses remain due by 03:30 PM local time 05/25/12. See continuation pages for questions and answers.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME OF CONTRACTING OFFICER

Larry E. Guess

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY ___________________________________________

(Signature of Contracting Officer)

16C. DATE SIGNED

05/16/2012

NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE 30-105 Prescribed by GSA

FAR (48 CFR) 53.243

ITEM 10A.

2012-N-14270 00001

Solicitation 2012-N-14270 – Respiratory Protective Devices – On-Site Audit

Assistance - Questions and Answers

1. Question(s) –

What company is the incumbent contractor supporting the NPPTL auditing activity?

1.Answer(s) –

Under prior Solicitation No. 2005-N-01867 three (3) multiple award contracts were issued to successful offerors Brand Consulting Group, Incorporated under

Contract No. 200-2005-13364, ICS Laboratories, Incorporated under Contract

No. 200-2005-13365, and Orion Registrar, Incorporated under Contract No. 200-

2005-13366. In addition, three (3) competitively awarded Simplified

Acquisition Procedure actions were issued to Orion Registrar, Incorporated in

FY-2011.

2. Question (s) -

Page 43 of 63 Section (c) references “Cost Data Information.” Is this required as specified?

2. Answer (s) -

Specific cost or price information is to be provided for Attachments C, D, and E, for Example Tasks 1 and 2, and Training Task Order 0001. Provision

L.14 notes that specific sample task technical and cost proposals are to be submitted. These responses would be in addition to base contract business and technical proposal requirements. Training Task Order 0001 is to be proposed with a cost proposal. Cost Data Information of the type indicated on Page 43 of 63 is to be included for cost realism reviews. Specific example task or training task information, as indicated, would be requested for labor, materials and services, subcontracted items, travel, and other direct costs, for reasonableness and realism reviews.

For the base contract overall business/cost proposal, general information on labor rates, material and services pricing, subcontract procedures, travel polices, and other direct cost practices can be identified. This would be in addition to example task responses.

3. Question (s) -

Can Past Performance include prior contracts with NIOSH?

3 Answer (s) -

Yes.

4 Question (s) -

Page 47 of 63 Section M.1, A refers to “Auditing Experience” and auditor certification. In lieu of a list of recent audits, can we provide auditor certification with IRCA and/or RABQSA which requires a specified number of audits be conducted every 3 years?

4 Answer(s) -

No. Evidence of IRCA or RABQSA certification may be used to augment the list of recent audits; however, it will not be an acceptable substitute for this list.

5 Question (s) -

Is there an expectation that the Attachment F Contractor Performance Record

Form be used for Past Performance submitted? Or does NIOSH intend to use this form to judge contractor performance under this contract?

5 Answer (s) -

Attachment F is included in the solicitation for contractor performance evaluation under contract awards as indicated under Section G.8 Evaluation of

Contractor Performance (Service)(Jan 2000).

6. Question (s) -

Does NIOSH intend to utilize a system among organizations awarded this contract that takes into consideration previous visits to approval holder sites when an individual Task Order is awarded? (Note: There was a system under previous contracts that gave preference to a contractor who had been at a site once before but gave negative consideration to a contractor who had been to a site twice before). Or will all contractors awarded this contract be set back to “zero”?

6 Answer (s) -

Prior experience with a particular site will be taken into account during task order award. However, this will be limited to prior experience under the proposed contract; that is, experience on any previous contracts will be disregarded for this factor.

7 Question (s) -

Is it permissible to submit the proposal electronically?

7 Answer

Electronic proposal submission will not be considered by facsimile or electronic mail or other electronic method.

8 Question (s) -

Historically, how many audits were performed per year and which locations for the past 5 years?

8 Answer (s) -

As noted in the Scope and Requirements section of the Statement of Work, approximately fifty (50) audits are performed each year. The list of locations in the solicitation closely represents those which have been historically visited. This list changes at a slow pace; approximately two to three sites are added, removed, or changed each year.

9 Question (s) -

Please provide an electronic copy or link to the NIOSH Audit checklist and

SOP for conducting on-site compliance audits.

9 Answer (s) -

The latest version, in draft, of a standard operating procedure is enclosed.

There is no standard NIOSH audit checklist. Contractors/auditors will prepare their own work documents for their own use.

10 Question (s) -

What is the most current audit schedule?

10 Answer(s) -

A detailed list of sites to be included in task orders for the first year of the contract is not yet available. We anticipate that sites in Regions 1, 2, 3, 4, 7, 9, 10, and 12A will be included.

11 Question(s) -

Who is responsible for the MSHA joint audit notification letter, audit report, audit criteria/checklist, and corrective action/follow-up report?

11 Answer (s) -

Joint audits do not require the preparation of separate versions of these documents for MSHA. The contractor will add a carbon copy line to the NIOSH correspondence (including the following deliverables: Draft Audit

Announcement Letter and Audit Plan; Draft Audit Report) listing the appropriate MSHA official to be included in the distribution.

12 Question(s) -

42 CFR 84 cites MIL-STD-105 and MIL-STD-414. What is the purpose of MIL-STD-

1916 as referenced in Scope and Requirements?

12 Answer(s) -

42 CFR 84.41(b), 84.41(h), and 84.43(a) permit the use of MIL-STD-414 or an approved equivalent sampling procedure. NIOSH approves the use of alternative procedures if it judges that the quality system provides an appropriate level of quality assurance. MIL-STD-105D and MIL-STD-1916 are examples of equivalent procedures that are in use by approval holders.

13 Question(s) -

Request data on which sites are registered to ISO 9001 and which sites have

NIOSH approved company-specific quality systems in place.

13 Answer (s) -

Attachment B, List if Audit Locations, contains NIOSH sites. ISO 9001 registered sites are not available, and disclosure may not appropriate. The same NIOSH review process would apply whether ISO 9001 registered or not.

14 Question(s) -

Request data (i.e.: frequency and reasons for) on non-typical task orders generated as a result of special circumstances for the past five years.

14 Answer(s) -

One (1) non-typical task order has been generated in the past five years.

This was for a single site in China which was judged to need an immediate visit rather than waiting until the next task order that would be ordinarily generated for that region.

15 Question(s) -

Who is responsible for additional costs incurred if changes are requested by the Government after travel arrangements have been finalized? Who is responsible for additional costs incurred due to changes in site visit schedules or delays caused by the auditee such as access to key personnel or major quality issues? Who is responsible for additional costs incurred due to changes in airline (or other travel provider) schedules or severe weather conditions after travel arrangements have been finalized?

15 Answer(s) -

As noted in the Introduction/Background section of the Statement of Work, audits consist of audit initiation, audit planning, on-site visit and assessment, reporting, and nonconformance follow up activities. On-site compliance audit assistance contracts are for audit services to perform audit planning, on-site visits, and reporting, which will be the responsibility of the contractor.

Any necessary Government revised audit requirements would be implemented by bilateral task order modification. In addition, in accordance with FAR

52.249-8 Default, the contractor will not be liable for excess costs arising from causes beyond the control and without the fault or negligence of the contractor.

16 Question (s) -

To determine historical data and trends, request the frequency of Single

Award Contracts versus Multiple Award Contracts issued over the past five years

16 Answer(s) -

Single award task orders typically would only be used for meeting minimum total task order award requirements, or for training tasks involving return visits to NIOSH in Pittsburgh, Pennsylvania. It is anticipated the procedures established under Section H.3 Issuance of Task Orders, Paragraph C., Multiple

Award Contracts, will be followed with few exceptions, as was the practice under the prior multiple award solicitation and awards.

17 Question (s) -

To determine historical data and trends, request the frequency of and reasons for disputes in the issuance of task orders.

17 Answer(s) -

As noted in Answer 15. Above, revised audit requirements have been implemented by bilateral task order modification, and under FAR 52.249-8, contractors are not responsible for excess costs arising from causes beyond the control and without the fault or negligence of the contractor. Concerns or issues arising to the level of resolution under FAR 52.233-1, Disputes, were not encountered during the term of the previous multiple award contract.

18 Question(s) -

Request an example of an actual Task Order Request Package (TORP): Typical

TORP; Non-typical TORP (i.e.: special circumstances); Joint MSHA audit TORP.

18 Answer(s) -

Example Tasks 1 and 2 are illustrative of actual tasks which have been issued, or which could be anticipated to be issued. As noted in Question and

Answer 14, only one (1) non-typical task order was generated in the past five

(5) years. Typical task orders are pre-planned by region. Non-typical task orders would not differ from typical task orders, with the exception that an individual site may be issued independently, and not combined with other requirements within a region, as with pre-planned typical requirements. A joint MSHA audit task only differs by requiring coordination of the audit schedule with MSHA officials.

19 Question(s) -

Would a proposal be considered responsive if the offeror is otherwise qualified; however, limits its planned coverage of audit locations, to specialize in Regions 12 and 13, for example?

19 Answer (s) -

In the Award of Specific Tasks section of the Statement of Work, a pool of no more than three (3) contractors is indicated to be established. Section H.3, Issuance of Task Orders, Paragraph a., notes that the contractor shall be capable of providing the staff necessary to conduct the required work.

Successful offerors would be expected to cover all regions.

20 Question (s) -

With regards to NIOSH auditors, are their assignments made in order to facilitate translation where the primary language is not English?

20 Answer

No. NIOSH auditors do not maintain fluency in any language other than

English.

21 Question(s) -

Page 5 of the RFP, indicates that the contract will not require routine access to Government facilities or IT systems by the Contract. However, the

RFP lists specific IT requirements related to IT security and access. Please confirm whether access to HHS IT systems is required for this contract. Thank you.

21 Answer(s) -

Sections H.15, HHSAR 352.239-70, Standard for Security Configurations, H.16, HHSAR 352.239-71, Standard for Encryption Language, and H.17, HHSAR 352.239-

72, Security Requirements for Federal Information Technology Resources, are required agency clauses. These clauses would be applicable only if Government information technology facilities or systems would be involved in performance. As stated under Other of Page 5 of the solicitation, access to

Government information technology systems is not anticipated at this time.