M00263-15-R-0008-0001_Amendment_drug_kits_solicitation.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to post the question and answ ers and the follow ing:

1. Update the Statement of w ork - added the delivery locations

2. Updated section L Instruction to address closing date and time for question submission.

With exception to w hat is being updated via the amendment no other changes are incorperated and the closing date and time remain the same.

POC: SSgt Angel D. Rodriguez, Contract Specialist 843-228-2407

1. CONTRACT ID CODE PAGE OF PAGES

J 1 13

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

16C. DATE SIGNED

BY 14-Jul-2015

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X M00263-15-R-0008

X 9B. DATED (SEE ITEM 11)

26-Jun-2015

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

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 Offer is extended, X is not extended.

Offer 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 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 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)

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 ITEM 10A.

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, is required to sign this document and return copies to the issuing office.

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

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

14-Jul-2015

CODE

REGIONAL CONTRACTING OFFICE

ATTN: SSGT ANGEL D. RODRIGUEZ

PO BOX 5069 MCRD/ERR

PARRIS ISLAND SC 29905

M00263 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

M00263-15-R-0008

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:

QUESTION AND ANSWERS

QUESTIONS GOVERNMENT RESPONSE

1. When is the deadline to submit questions? 1. Section L of the solicitation has been updated and is provided in this amendment to address the deadline for questions.

2. Who is your current vendor providing you with the Drug Test Kits?

2. The current support is being provided on an

IDIQ type contract (M00263-11-D-0010) with

Redwood Toxicology Laboratory Inc.

3. How satisfied are you with your current vendor and their turnaround time to get you the product?

3. The Government requires the source to ship the testing kits IAW section C.6.4.3 of the Statement of

Work. As also stated in each CLIN description.

4. How much are you paying per Drug Test Kits? 4. As specified on the current contract the unit price for the drug testing kit is $1.60 per

5. How many drug tests were processed in 2014?

2015?

5. In FY14 we purchased $65,250 in total

In FY15 we purchased, so far, $46,800

6. What is the anticipated start date of this contract? 6. As specified in CLIN 0001 (Base Year) the period of performance to start services will be 30

September 2015. Orders will be placed upon the needs of the requesting activity.

7. Our company is looking to respond to this request and would like to know the address’s the orders would be shipping to? I realize these will be going to multiple locations.

7. All locations have been identified and incorporated into the Statement of Work in section

C.8.4 Delivery Addresses.

8. Under C.6.4.3 Technical Support section, letter

b. you state that contractor must offer expert witness testimony and support for any unforseen legal issues. How many times has there been a need for expert witness testimony in 2013? 2014? So far

2015?

8. To date there has not been a need for an expert witness. The contractor must have the capability to support if such need woulr arise.

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

DESCRIPTION OF REQUIREMENT

Description of Requirement

Marine Corps Recruiting Command

Drug Test Kits

C.1.0 Background

The Marine Corps Recruiting Command (MCRC) has a requirement for non-instrumental, single-use instant drug test kits. These kits are used at the Military Entrance Processing Station (MEPS) to screen poolees/applicants as they go through the enlistment process. This is a commercial item that may require modifications of a type customarily available in the commercial marketplace, or minor modifications of a type not customarily available in the commercial marketplace made to meet Federal Government requirements.

C.2.0 Scope

The scope of this requirement is to provide drug test kits, as needed, to each of the six (6) Marine Corps Districts

(MCDs), by issuance of a Delivery Order. Delivery of drug test kits will be to eight (8) Recruiting Stations (RS) within each MCD. The Delivery Orders are typically issued on a quarterly basis. The Contractor shall provide all materials, equipment, personnel, and facilities necessary to manufacture, produce and deliver the drug test kits. The delivery address for the location will be identified on each order issued.

C.3.0 Requirements Point of Contacts

C.3.1 Government Point of Contact for Marine Corps Recruiting Command (MCRC):

Jessica I. Quinones

Contract Specialist

Marine Corps Recruiting Command (G-4)

3280 Russell Rd, 2nd Floor

Quantico, VA 22134

Phone: 703-432-9348

Email: jessica.quinones@marines.usmc.mil

C.3.2 Contractor Point of Contact: The Contractor shall establish a single management point of contact to accomplish the administrative, managerial, and financial aspects of this Indefinite Delivery Requirements contract, and to serve as the primary interface with the Government POC and the Contracting Office.

C.4.0 Place of Performance

The place of performance will be at the contractor’s facility.

C.5.0 Requirement

C.5.1 The required drug test kits shall test urine for the following drugs, at the specified cutoff levels:

1. Marijuana (THC) at 50ng./mL

2. Cocaine (COC) at 150 ng./mL

3. Methamphetamine (METH) at 500 ng./mL

4. Amphetamine (AMP) at 500 ng./mL

5. Opiates (OPI) at 300 ng/mL mailto:jessica.quinones@marines.usmc.mil

C.5.2 The drug test kits shall test, at a minimum, for the drugs listed above at the specified cutoff levels. The drug test kits may include testing of additional drugs with cutoff levels at or above current industry standards. All drug assays shall be contained in a single test cup.

C.5.3 The cup shall also include a built-in validity/adulteration test and a built-in temperature strip and screw on lid.

C.5.4 Estimated Quantities. Provided in the table below are the estimated quantities for each MCD.

DISTRICT

BASE

YEAR OY1 OY2 OY3 OY4 TOTAL

1MCD 10,500 12,000 13,500 14,000 14,000 64,000

4MCD 7,100 7,100 7,100 7,100 7,100 35,500

6MCD 8,400 10,400 12,400 14,400 16,400 62,000

8MCD 11,000 12,975 14,950 16,925 18,900 74,750

9MCD 11,700 11,700 11,700 11,700 11,700 58,500

12MCD 13,875 12,900 12,780 12,900 12,900 65,355

TOTAL 62,575 67,075 72,430 77,025 81,000 360,105

C.6.0 Specifications

C.6.1 TEST FEATURES

C.6.1.1 The drug test kits shall be designed to allow test results to be easily photocopied.

C.6.1.2 The product shall be a one-step, all inclusive test kit for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine and also have built-in validity/adulteration testing.

C.6.1.3 The test shall not require any pre-treatment of the urine sample prior to testing and must be non-instrument based, free of plumbing and electrical systems, with an ease of use based on practical portable field application and use. No pipettes, droppers, patches, or other devices/materials shall be required for operation and use.

C.6.1.4 The test shall be able to be stored at room temperature, with a minimum shelf life of 12 months from date of delivery.

C.6.1.5 The test and test results shall be clear and easy to read visually.

C.6.1.6 The test cup shall be able to run standing upright and shall not require tilting or inverting the cup upside down to run the test.

C.6.1.7 The test time to completion for read, once operator begins the test, shall not exceed five (5) minutes, but test results shall remain stable for up to one (1) hour.

C.6.1.8 The test cup shall have a screw on lid, and be a one-step, all inclusive cup requiring no additional keys or devices for the specimen to interact with test material.

C.6.2 ACCURACY AND RELIABILITY

C.6.2.1 The drug assays at the specified cutoff levels shall be approved by the US Food and Drug Administration

(FDA) for commercial distribution as a medical device with an active 510(K) notification document.

C.6.2.2 The test product shall be manufactured to be “negative specific.”

C.6.2.3 The assays shall have been proficiency tested by the College of American Pathologists and subsequently published on their product/method Master List indicating that products meet the proficiency testing requirements.

C.6.3 QUALITY CONTROL

C.6.3.1 The Contractor shall have a specialized internal quality control test which provides guaranteed quality product for each lot produced.

C.6.3.2 The device shall provide an easily-read internal control test which indicates that the device is functioning properly.

C.6.3.3 Device test results shall not be openly visible to the donor (i.e. the area of the test results should remain covered until the test administrator is ready to read the results and the donor cannot remove the cover without clear evidence of tampering).

C.6.3.4 The assay test strips within the device shall be encapsulated and protected from donor tampering.

C.6.3.5 Tamper-evident security seals shall be provided for each device to ensure that the cup has not been reopened once the specimen has been submitted, and to allow the specimen to be sent to a laboratory for further GC/MS confirmation if desired or needed. The seals shall provide surface and space for written data related to the specimen collection and donor and operator information, if needed.

C.6.3.6 The Contractor shall supply a legally defensible drug test results from incorporating a photocopy template to allow actual test results to be copied and kept on record along with related donor information, if needed.

C.6.4 TRAINING AND SUPPORT

C.6.4.1 Contractor shall have current training systems in place via:

a. Online web-based training; or

b. Product-specific user manual supported by DVD/CD training materials, delivered to each delivery location on the first Delivery Order.

This training shall be provided, if needed, at the written request of the Contracting Officer.

C.6.4.2 Customer Service Support

a. The Contractor shall provide Customer Service support available via telephone during the standard operating hours of 8:00 AM to 8:00 PM, Eastern Standard Time (EST). This Customer Service support will include answering questions about the product’s features and functionality.

C.6.4.3 Technical Support

a. The Contractor shall provide access to technical and toxicology specialists for any specialized questions, as needed.

b. The Contractor shall offer expert witness testimony and support for any unforeseen legal issues, should they ever arise.

C.7.0 Delivery

The Contractor shall deliver the drug testing kits in accordance with each Delivery Order. Shipping addresses and a

Point of Contact will be listed for each delivery location on the Delivery Order. Delivery shall be 10 days After

Receipt of Order (ARO).

C.8.0 Deliverables

C.8.1 The Contractor shall deliver drug test kits in the quantities specified in each individual Delivery Order.

C.8.2 The Contractor shall provide in every box a separate packing list which reflects the Delivery Order number and the quantity of drug test kits included.

C.8.3 The Contractor shall provide to the Government POC via email prior to invoice submission in Wide Area

Work Flow (WAWF); a document, that shows the Government receipt of drug test kits delivered to each location.

The Government POC is Mrs. Jessica Quinones, email: Jessica.Quinones@marines.usmc.mil.

C.8.4 Delivery Addresses st

DISTRICT RS SHIPPING ADDRESSES

RS Albany

1 Buffington Street

Watervliet Arsenal

Watervliet, NY 12189

RS Buffalo

100 Corporate Parkway

Amherst, NY 14226

RS Harrisburg

Bldg 54, Bay 5, DDC

New Cumberland, PA 17070

RS New Jersey

Naval Weapons Station Earle

201 Route 34 South, Bldg C-38

Colts Neck, NJ 07722

RS New York

605 Stewart Avenue

Garden City, NY 11530

RS Pittsburgh

1000 Liverty Avenue, Room 1816

Wm S. Moorehead Federal Building

Pittsburgh, PA 15222

RS Portsmouth

755 Banfield Road

Portsmouth, NH 03801

RS Springfield

700 Eagle Drive

Bldg 3103, Suite 143

Chicopee, MA 01022 mailto:Jessica.Quinones@marines.usmc.mil th

RS Baltimore

1334 Ashton Road

Hanover, MD 21076

RS Cleveland

7261 Engle Road, Suite 110

Middleburg Heights, OH 44130-3479

RS Charleston

3198 Rt. 60

Ona, WV 25545

RS Detroit

580 Kirts Blvd, Suite 307

Troy, MI 48084

RS Frederick

5112 Pegasus Ct., Suite B

Frederick, MD 21704

RS Louisville

600 Martin Luther King Jr. Place, Rm 221

Louisville, KY 40202-2269

RS Raleigh

5000 Falls of Neuse Road, Ste 404

Raleigh, NC 27609

RS Richmond

9210 Arboretum Parkway, Suite 220

Richmond, VA 23236-3472

RS Atlanta

4855 Peachtree Industrial Blvd Suite 225

Norcross, GA 30092

RS Montgomery

2350 Fairlane Dr. Suite 120

Montgomery, AL 36116

RS Nashville

2519 Perimeter Place Drive

Nashville, TN 37214-3681

RS Baton Rouge

5555 Hilton Ave, Suite 103

Baton Rouge, LA 70808-2597

RS Columbia

9600 Two Notch Rd., Suite 17

Columbia, SC 29223

RS Jacksonville

3728 Phillips HWY Suite 229

Jacksonville, FL 32207

RS Orlando

5886 South Semoran Blvd.

Orlando, FL 32822

RS Ft. Lauderdale

7820 Peters Rd. Suite E-109

Plantation, FL 33324

RS Albuquerque

5338 Montgomery Blvd NE, Suite 300

Albuquerque, NM 87109

RS Dallas

1331 N Plano Rd

Richardson, TX 75081

RS Denver

225 E. 16 th

Ave, Suite 500

Denver, CO 80203

RS Fort Worth

3313 W. Pioneer Pkwy

Pantego, TX 76133

RS Houston

701 San Jacinto St.

U.S. Customhouse, Rm 225

Houston, TX 77002-3622

RS Oklahoma City

301 NW 6

th

St., Suite 211

Oklahoma City, OK 73102

RS Phoenix

One North First St., Suite 302

Phoenix, AZ 85004

RS San Antonio

8700 Tesoro Drive, Suite 275

San Antonio, TX 78217

RS Chicago

2400 E. Devon Avenue

Des Plaines, IL 60018

RS Des Moines

7105 NW 70th Avenue

Camp Dodge Bldg S-72

Johnston, IA 50131

RS Indianapolis

9152 Kent Avenue

Bldg 401, Suite B7

Indianapolis, IN 46216

RS Kansas City

10302 NW Prairie View Road

Kansas City, MO 64153

RS Lansing

315 West Allegan Street

Lansing, MI 48911

RS Milwaukee

11050 West Liberty Drive

Suite 110

Milwaukee, WI 53224

RS St Louis

1222 Spruce Street

St Louis, MO 63103

RS Twin Cities

1 Federal Drive, Room G473

Ft Snelling, MN 55111

RS San Diego

16644 West Bernardo Dr STE 440

San Diego CA 92127

RS Orange

1921 E. Alton Ave. Ste 150

Santa Anna, CA 92075

RS Los Angeles, USMC

6230 Van Nuys Blvd, Suite 3005

Van Nuys, CA 91401

RS Sacramento

4090 Truxel Rd

Sacramento, CA 95834

RS San Francisco

546 Vernon Ave, Suite 215

Mountain View, CA 94043

RS Portland

100 SW Main St Ste 600

Portland, OR 97204

RS Salt Lake City

309 W. 2880 S.

Salt Lake City, UT 84115

RS Seattle

4735 E. Marginal Way S Federal Center #1238

Seattle, WA 98134

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

The following have been modified:

ADDENDUM TO FAR 52.212-1

ADDENDUM TO 52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (JULY 2013)

L.1. Procurement Approach

This procurement is being conducted pursuant to FAR Part 12 and Subpart 13.5. The incorporated provisions and clauses listed in the solicitation are those in effect through Federal Acquisition Circular 2005-82 Effective 7 May

2015 and DFARS Publication Current to DPN 20150602 Effective 2 June 2015 Edition.

Definitions can be obtained at the following web-site www.acquisition.gov. The government intends to issue one (1) firm fixed , Indefinite Delivery Requirements contract for the purchase of drug testing kits. The Service

Contract Act is not applicable pursuant to FAR Part 22.1003-4 (C)(1)(iii).

L.1.1 NAICS CODE

Interested parties shall have this solicitations’ NAICS code 334516 Analytical Laboratory Instrument

Manufacturing, Size Standard in Employees 500 listed on their respective SAM.GOV

(https://www.sam.gov/portal/public/SAM) profile prior to award being made.

L.2. CLOSING DATE/TIME

The closing date for quote submission is 26 July 2015 at 10:00 AM EST. Offers received after this date and time will be deemed ineligible for award. Quotes shall be submitted by one of the following methods:

L.2.1. QUOTE/PROPOSAL SUBMISSION

Electronic submission of the written quote is authorized. Email or fax quotes to the points of contact below. If faxing, contact the Government POC prior to faxing to ensure the quote was received and legible. The written submission must arrive by the stated deadline in order for a quote to be considered complete and to be evaluated. Failure of any portion of the quote to arrive by the stated deadline will result in rejection of the entire quotation.

E-mail to: angel.d.rodriguez@usmc.mil; Phone: (843)228-2407; Fax: (843)228-2163

USPS: Regional Contracting Office

Attn: SSgt Angel D. Rodriguez

P. O. Box 5069

Parris Island, SC 29906-5069

FED-EX or UPS: Regional Contracting Office

Attn: SSgt Angel D. Rodriguez

Bldg. 159 Corregidor

Parris Island, SC 29905

L.2.2 CLOSING DATE AND TIME FOR QUESTION SUBMISSION

If you should have any questions regarding the solicitation please submit your questions in writing no later than July 13, 2015 no later than (10:00 AM EST) to Staff Sergeant Angel D. Rodriguez.

You may submit your written questions via email to the following addresses; angel.d.rodriguez@usmc.mil.

NOTE: ANY QUESTIONS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED,

AND WILL NOT BE ADDRESSED.

L.3. Offerors must provide their technical quote with no company identifying information on any page except the first page. Failure to follow this instruction may result in rejection of your quote.

L.3.1. The following information/items shall be submitted with the quote:

1. Technical capabilities information to include literature and/or pictures.

2. Completed Offerors Representations and Certifications in accordance with FAR 52.212-3 Alt 1 if not registered in SAMS.

3. Provide Offerors Tax Identification number and Cage Code.

4. Installation and Delivery Date ARO (After Receipt of Order) http://www.acquisition.gov/ mailto:angel.d.rodriguez@usmc.mil

5. Complete and signed the DD 1449 (Blocks 30a, 30b, and 30c); with company’s information (1st page of this RFQ).

6. Warranty information to include warranty claim process, if applicable.

7. All offers shall provide three (3) current and relevant references. A current reference is an order within the last 36 months. A relevant reference is an order of approximately the same size and complexity.

Include POC, contract number and contract amount.

(End of Summary of Changes)