B02_RFQ_AMENDMENT_959P0019Q0039_0001_7.25.19.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

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

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, 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 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 your 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 ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.

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

CHECK ONE 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.

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.

15C. DATE SIGNED

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

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

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

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

NSN 7540-01-152-8070

Previous edition unusable

959P0019Q00390001

Summary of Changes

Section C - Description/Specifications/Work Statement

C.1 BACKGROUND

The Pretrial Services Agency for the District of Columbia (PSA) is an independent federal entity within the Court Services and Offender Supervision Agency (CSOSA). PSA has served the Nation's Capital for more than 45 years. The Agency assists judicial officers in both the Superior Court for the District of Columbia and the United States District Court for the District of Columbia in formulating release recommendations and providing supervision and services to defendants awaiting trial, which reasonably assures that those on conditional release return to court and do not engage in criminal activities. PSA has been a leader in the D.C. criminal justice system and has been recognized nationally for its pretrial drug testing and innovative supervision and treatment programs.

PSA's Office of Forensic Toxicology Services (OFTS) performs urine drug testing for all defendants, adults, and juveniles in the pretrial status and drug courts; offenders on probation or parole; parents charged with abuse or neglect; and other tests as ordered by the Courts. OFTS collects over 250,000 specimens and performs approximately 2.6 million tests annually.

C.2 SCOPE OF WORK

The Contractor shall provide all reagents, calibrators, and controls required to test for synthetic cannabinoids and fentanyl in urine, and specified drugs in oral fluid using the homogeneous enzyme immunoassay (HEIA) reagents and associated calibrators and controls. The assays shall be compatible with the Beckman AU5810 clinical analyzer. The annual test volume for the synthetic cannabinoids is up to 240,000, up to 252,000 for fentanyl, and up to 28,350 for oral fluids.

C.2.1 Reagents, Calibrators, and Control Requirements

Immunoassay kits are medical devices and shall have clearance from the Food & Drug Administration (FDA) to be marketed.

The Contractor may provide medical devices designated as "Forensic Only" for oral fluid and synthetic cannabinoids reagents. The Contractor shall follow the registration and listing process specified by FDA. The manufacturer shall adhere to good manufacturing process (GMP) in the manufacture of the devices. Any mandatory recalls of the kits provided under this Contract and any other problems that require notifications to FDA shall be resolved as required by the FDA's current regulations. The Contractor shall notify the Contracting Specialist (CS), Contracting Officer's Representative (COR), and Laboratory Director via certified or overnight mail or via email of any recalls or FDA's notifications within two (2) working days of the event.

Except as provided herein, the reagents supplied throughout the term of this Contract shall be identical to the reagents offered by the Contractor and accepted by the Government at the time of Contract award. If during the course of this Contract, the manufacturer wishes to change or improve its reagents, the Contractor shall submit in writing to the CS, COR, and Laboratory Director the product modification for approval prior to its incorporation into the kits to be delivered. Any revalidations of the modified reagents shall be done by the Contractor at their expense and at a time acceptable to OFTS.

The Contractor shall provide an instrument parameter sheet. The materials provided shall be in volumes and packages, which are convenient and applicable to the throughput of OFTS and shall not result in the loss or unnecessary disposal of more than 5% of the working volume of the reagents. Reagent kits shall be available in low capacity (approximately 1,000 test/kit) and high capacity (3,500+ test/kit) sizes.

The reagents shall meet the current Substance Abuse & Mental Health Services Administration (SAMSHA) standards, OFTS's standard operating procedures, Department of Transportation (DOT) and Department of Defense (DOD) Standard Drug Testing Panel and Criteria for Reporting Drug Use in the Military Drug Testing Program cutoff guidelines.

C.2.2 Fentanyl

C.2.2.1 Salient Characteristics for Fentanyl Reagents

The Contractor shall provide fentanyl HEIA reagent kits for up to 252,000 tests annually including the calibrators, controls, and negative controls as per the below table. The reagent shall detect fentanyl at a 1.0 ng/mL cutoff or better. The following cutoff for urine specimens suspected of containing fentanyl or its analogues is currently desired by OFTS for the initial immunoassay test. The cross reactivity of the reagents to other analogues within the fentanyl group shall be 80% or greater.

ANALYTE CUTOFF LEVEL

Fentanyl 1 ng/mL

C.2.2.2 Salient Characteristics for Fentanyl Controls and Calibrators

The Contractor shall provide calibrators and control materials for the reagents, which shall meet SAMHSA's standards, OFTS's (as provided in this SOW), DOT's and DOD's standard cutoff values.

Calibrators and controls shall be in liquid form whenever possible. If liquid form is not available, then lyophilized may be provided.

Precision

Within Run C.V. 5% or less

Between Run C.V. 5% or less

Controls and calibrators shall be available no less than 5 mL or greater than 25 mL sizes (liquid).

Calibrators and Controls Desired Unit Volume

Calibrators (High, Medium, Low, Negative) 5 mL per vial

Controls (High, Low) 5 mL per vial

C.2.3 Oral Fluid

C.2.3.1 Salient Characteristics for Oral Fluid Reagents

The Contractor shall provide oral fluid HEIA reagent kits for up to 28,350 tests for 12 months including the calibrators, controls, and negatives controls as per the table below. The reagent shall detect the drugs listed at the cutoff levels in the table below. Reagents shall meet the current desired OFTS's cut off for the initial immunoassay test as given in the table below, SAMHSA's standards, DOT's and DOD's Standard Drug Testing Panel and Criteria for Reporting Drug Use in the Military Drug Testing Program cutoff guidelines.

ANALYTES CUTOFF LEVELS

Cocaine/Cocaine Metabolite (Benzoylecgonine) 20 ng/mL

Opiates (Morphine) 40 ng/mL

Phencyclidine (PCP) 10 ng/mL

Marijuana (THC) 4 ng/mL

Methadone 25 ng/mL

Alcohol/Ethanol 20 mg/mL

Oxycodone 40 ng/mL

Amphetamine 50 ng/mL

Methamphetamine 50 ng/mL

C.2.3.2 Salient Characteristics for Oral Fluid Controls and Calibrators

The Contractor shall provide calibrators and control materials for the reagents, which shall meet SAMHSA's standards, OFTS's, DOT's and DOD's standard cutoff values. The controls and calibrators shall be available in no less than 4 mL or greater than 25 mL (liquid). The calibrators and controls shall be in liquid form whenever possible. If liquid form is not available then lyophilized may be provided.

Lot numbers shall be good for six (6) months from the date of receipt. Calibrators and controls shall have a 30-day expiration of opened or reconstituted products.

Precision

Within Run C.V. 5% or less

Between Run C.V. 5% or less

Oral fluid matrix

Control values shall be at approximately 75% and 125% of the cut-off levels.

Calibrators and Controls Desired Unit Volume

Calibrators (High, Medium, Low, Negative) 4 mL per vial

Controls (Low, High) 40 mL per vial

PM Calibrators/Controls (High, Medium, Low, Negative) 10 mL per vial

Extraction Buffer 1 L per bottle

Synthetic negative oral fluid diluted with extraction buffer 500 mL per bottle

C.2.3.3 Specimen Collection Devices and Accessories for Oral Fluid Testing

The collection devices shall conform to the approved SAMHSA's standards and be FDA cleared single use collection device intended to collect oral fluid specimens. The collection device shall maintain the integrity of such specimen during transport and storage so it can be tested for the presences of the drug or their metabolites. The device shall provide a sealable, non-leaking container that maintains the integrity of the specimen during storage and transport. The device shall consist of components that ensure the pre-analytical drug and drug metabolite stability and not affect the composition of the drug and/or drug metabolites in the oral fluid specimen.

The device shall have accessories such as filter tubes and caps for specimen processing to maintain the integrity of the oral fluid specimens collected.

The device shall be suitable for a reliable and reproducible collection of 1 mL ± 10% of undiluted (neat) oral fluid. If the device contains a diluent (or other component, process, or method that modifies the volume of the testable specimen), the volume of the oral fluid collected shall be within 0.1 mL of the target volume, and the volume of diluents in the device shall be within 0.05 mL of the diluent's target volume.

The device shall allow the stability (recoverable concentrations ≥ 90% of the concentration at the time of collection) of the drugs and/or drug metabolites for one (1) week at room temperature and under intended storage and transport conditions.

The device shall allow recovering of ≥ 90% (but no more than 120%) of the drug and/or drug metabolite in the undiluted (neat) oral fluid at (or near) the test cutoff.

C.2.3.4 Additional Requirements for Oral Fluid Collection Devices

The Contractor shall provide on-site training on the collection and handling of the oral fluid specimens using the collection device.

C.2.3.5 Oral Fluid Validity Testing

The Contractor shall provide oral fluid specimens required for the validation testing on two (2) AU5810 analyzers.

C.2.4 Synthetic Cannabinoids

C.2.4.1 Salient Characteristics for Synthetic Cannabinoid Reagents

The Contractor shall provide synthetic cannabinoid HEIA reagent kits for up to 240,000 tests for 12 months including the calibrators, controls, and negative controls as per the below table. The reagents shall detect the following metabolites at a 10 ng/mL cutoff or better: AB-PINACA, ADB-PINACA, AB-FUBINACA, ADB-FUBINACA, AB-CHIMINACA, and their metabolites.

The following cutoffs for synthetic cannabinoid specimens are currently desired by OFTS for the initial immunoassay test.

ANALYTE CUTOFF LEVEL

Synthetic Cannabinoids 10.0 ng/mL

C.2.4.2 Salient Characteristics for Synthetic Cannabinoid Controls and Calibrators

The Contractor shall provide calibrators and control materials for the reagents, which shall meet SAMHSA's standards, OFTS's, DOT's and DOD's standard cutoff values.

The calibrators and controls shall be in liquid form whenever possible. If liquid form is not available then lyophilized may be provided. The controls and calibrators shall be available in no less than 5 mL or greater than 25 mL (liquid).

Precision

Within Run C.V. 5% or less

Between Run C.V. 5% or less

Sensitivity: at 96%

Specificity: 100%

Accuracy: 98-100%

The Contractor shall provide synthetic cannabinoids as three (3) calibrators and synthetic cannabinoids as three (3) control sets as outlined below.

Calibrators/Controls Desired Unit Volume

Calibrators (High, Medium, Low) 5 mL per vial

Controls (High, Low, Negative) 5 mL per vial

C.2.5 Specific Mandatory Tasks and Associated Deliverables

-The Contractor shall provide all initial on-site training for the proper techniques in specimen handling, preparation, and use on the existing AU5810 instruments for testing as needed within 15 days after Contract award or on a mutually agreed date with the Government. The Contractor shall provide on-site training on two (2) AU5810 and parameters that are compatible with the operation of the AU5810 and instruments for testing oral fluid. Training will be held at 90 K Street NE in Washington, DC.

-The Contractor shall provide technical support and troubleshooting help as needed. Technical support shall be provided for assay setup, validations, and correlation procedures. Technical support shall include assay trouble-shooting, establishing and clarifying test methods and assay upgrades. Technical support shall be available by telephone 24 hours per day, 7 days a week by local or toll-free number at no additional cost to the Government. The Contractor shall provide technical support for the assays via telephone and on-site when needed.

-The shelf life of unopened assay kits or components shall be at least 180 days from the date of delivery to OFTS. The shelf life of opened components or kits with broken container seals shall be at least 30 days. A Safety Data Sheet (SDS) shall accompany each reagent, calibrator, and control shipment.

-The Contractor shall deliver within 24 hours of receipt of notice reagents, calibrators and controls for the testing of the assay.

-The Contractor shall provide all equipment-specific consumable supplies, such as surfactants, and conditioning and cleaning solutions needed to perform the current volume of testing stated in Section C.2.

-The Contractor shall supply sufficient test tubes for the volume of testing per year.

Section J - List of Documents, Exhibits, and other Attachments

The following attachments are incorporated into this RFQ.

Description File Name

ATTACHMENT A PRICING TABLE

ATTACHMENT C QUOTERS' QUESTIONS &

GOVERNMENT'S RESPONSE

ATTACHMENT A: PRICING TABLE

Base Year: Contracting Line Item Number (CLIN) 0001

FENTANYL REAGENTS CALIBRATORS &

CONTROLS

QUANTITY UNIT PRICE TOTAL PRICE

Fentanyl, 1 ng/ml 32 KITS

Calibrators 1 ng/ml, 5 ml per vial 400 SETS Calibrator 2 ng/ml, 5 ml per vial 400 SETS Calibrator 3 ng/ml, 5 ml per vial 400 SETS Control sets, 10 ml per vial 600 SETS Negative Control sets, 10 ml per vial 100 SETS

SYNTHETIC CANNABINOID REAGENTS

CALIBRATORS & CONTROLS

QUANTITY UNIT

PRICE

TOTAL PRICE

Synthetic Cannabinoids HEIA Reagent Kits, 500 ml 240,000 SETS Synthetic Cannabinoids Calibrators, 10 ml volume 400 SETS Synthetic Cannabinoids Control Sets, 15 ml & 5 ml volume 600 SETS Negative Control sets, 10 ml 100 SETS

ORAL FLUID REAGENTS CALIBRATORS &

CONTROLS & ORAL SWABS COLLECTION KITS

QUANTITY UNIT PRICE TOTAL PRICE

Cocaine/Cocaine Metabolite (Benzoylecgonine), 20 ng/ml 4 KITS Opiates (Morphine), 40 ng/ml 4 KITS Phencyclidine (PCP), 10 ng/ml 4 KITS Marijuana (THC-COOH), 4 ng/ml 4 KITS Methadone, 25 ng/ml 4 KITS Alcohol/Ethanol, 20 mg/dl 4 KITS Oxycodone, 40 ng/ml 4 KITS Amphetamine, 50 ng/ml 4 KITS Methamphetamine, 50 ng/ml 4 KITS Calibrators (High, Medium, Low, Negative), 4 mL per vial 500 SETS Negative Control Set, 500 mL per vial 1 SETS Extraction Buffer, 1L per bottle 2 SETS Synthetic Negative Oral Fluid Diluted with Extraction Buffer, 500 mL per bottle

2 SETS

Quatisal Collection Devices, 8 BOXES of

500 DEVICES

Option Year 1: CLIN 1001

FENTANYL REAGENTS CALIBRATORS &

CONTROLS

QUANTITY UNIT PRICE TOTAL PRICE

Fentanyl, 1 ng/ml 32 KITS

Calibrators 1 ng/ml, 5 ml per vial 400 SETS Calibrator 2 ng/ml, 5 ml per vial 400 SETS Calibrator 3 ng/ml, 5 ml per vial 400 SETS Control sets, 10 ml per vial 600 SETS Negative Control sets, 10 ml per vial 100 SETS

SYNTHETIC CANNABINOID REAGENTS

CALIBRATORS & CONTROLS

QUANTITY UNIT

PRICE

TOTAL PRICE

Synthetic Cannabinoids HEIA Reagent Kits, 500 ml 240,000 SETS Synthetic Cannabinoids Calibrators, 10 ml volume 400 SETS Synthetic Cannabinoids Control Sets, 15 ml & 5 ml volume 600 SETS Negative Control sets, 10 ml 100 SETS

ORAL FLUID REAGENTS CALIBRATORS &

CONTROLS & ORAL SWABS COLLECTION KITS

Cocaine/Cocaine Metabolite (Benzoylecgonine), 20 ng/ml 4 KITS Opiates (Morphine), 40 ng/ml 4 KITS Phencyclidine (PCP), 10 ng/ml 4 KITS Marijuana (THC-COOH), 4 ng/ml 4 KITS Methadone, 25 ng/ml 4 KITS Alcohol/Ethanol, 20 mg/dl 4 KITS Oxycodone, 40 ng/ml 4 KITS Amphetamine, 50 ng/ml 4 KITS Methamphetamine, 50 ng/ml 4 KITS Calibrators (High, Medium, Low, Negative), 4 mL per vial 500 SETS Negative Control Set, 500 mL per vial 1 SETS Extraction Buffer, 1L per bottle 2 SETS Synthetic Negative Oral Fluid Diluted with Extraction Buffer, 500 mL per bottle

2 SETS

Quatisal Collection Devices, 8 BOXES of

Option Year 2: CLIN 2001

Calibrators 1 ng/ml, 5 ml per vial 400 SETS Calibrator 2 ng/ml, 5 ml per vial 400 SETS Calibrator 3 ng/ml, 5 ml per vial 400 SETS

QUANTITY UNIT PRICE TOTAL PRICE

Synthetic Cannabinoids HEIA Reagent Kits, 500 ml 240,000 Synthetic Cannabinoids Calibrators, 10 ml volume 400 SETS

Opiates (Morphine), 40 ng/ml 4 KITS Phencyclidine (PCP), 10 ng/ml 4 KITS Marijuana (THC-COOH), 4 ng/ml 4 KITS Methadone, 25 ng/ml 4 KITS Alcohol/Ethanol, 20 mg/dl 4 KITS Oxycodone, 40 ng/ml 4 KITS Amphetamine, 50 ng/ml 4 KITS Methamphetamine, 50 ng/ml 4 KITS Calibrators (High, Medium, Low, Negative), 4 mL per vial 500 SETS Negative Control Set, 500 mL per vial 1 SETS Extraction Buffer, 1L per bottle 2 SETS Synthetic Negative Oral Fluid Diluted with Extraction Buffer, 500 mL per bottle

2 SETS

Option Year 3: CLIN 3001

Calibrators 1 ng/ml, 5 ml per vial 400 SETS Calibrator 2 ng/ml, 5 ml per vial 400 SETS Calibrator 3 ng/ml, 5 ml per vial 400 SETS

QUANTITY UNIT PRICE TOTAL PRICE

Synthetic Cannabinoids HEIA Reagent Kits, 500 ml 240,000 Synthetic Cannabinoids Calibrators, 10 ml volume 400 SETS

Opiates (Morphine), 40 ng/ml 4 KITS Phencyclidine (PCP), 10 ng/ml 4 KITS Marijuana (THC-COOH), 4 ng/ml 4 KITS Methadone, 25 ng/ml 4 KITS Alcohol/Ethanol, 20 mg/dl 4 KITS Oxycodone, 40 ng/ml 4 KITS Amphetamine, 50 ng/ml 4 KITS Methamphetamine, 50 ng/ml 4 KITS Calibrators (High, Medium, Low, Negative), 4 mL per vial 500 SETS Negative Control Set, 500 mL per vial 1 SETS Extraction Buffer, 1L per bottle 2 SETS Synthetic Negative Oral Fluid Diluted with Extraction Buffer, 500 mL per bottle

2 SETS

Option Year 4: CLIN 4001

Calibrators 1 ng/ml, 5 ml per vial 400 SETS Calibrator 2 ng/ml, 5 ml per vial 400 SETS Calibrator 3 ng/ml, 5 ml per vial 400 SETS

QUANTITY UNIT PRICE TOTAL PRICE

Synthetic Cannabinoids HEIA Reagent Kits, 500 ml 240,000 Synthetic Cannabinoids Calibrators, 10 ml volume 400 SETS

Opiates (Morphine), 40 ng/ml 4 KITS Phencyclidine (PCP), 10 ng/ml 4 KITS Marijuana (THC-COOH), 4 ng/ml 4 KITS Methadone, 25 ng/ml 4 KITS Alcohol/Ethanol, 20 mg/dl 4 KITS Oxycodone, 40 ng/ml 4 KITS Amphetamine, 50 ng/ml 4 KITS Methamphetamine, 50 ng/ml 4 KITS Calibrators (High, Medium, Low, Negative), 4 mL per vial 500 SETS Negative Control Set, 500 mL per vial 1 SETS Extraction Buffer, 1L per bottle 2 SETS Synthetic Negative Oral Fluid Diluted with Extraction Buffer, 500 mL per bottle

2 SETS

CLIN 0001 Total Price for Base Period: $_________________________

CLIN 1001 Total Price for Option Year 1: $_________________________

CLIN 2001 Total Price for Option Year 2: $_________________________

CLIN 3001 Total Price for Option Year 3: $_________________________

CLIN 4001 Total Price for Option Year 4: $_________________________

Total Price for the Base & Four Option Years: $___________________________

# RFQ

Section

Page No.(s) Quoters’ Questions Government’s Response

1 C.2.1 8 The RFQ states: Immunoassay kits are medical devices and shall have clearance from the Food & Drug Administration (FDA) to be market.

Will you accept Forensic Use Only labeling for synthetic cannabinoids and oral fluid reagents?

Currently there is no FDA cleared synthetic cannabinoid or oral fluid reagents for the cutoffs specified in the RFQ. Forensic Use Only labeling is currently used by and meets the current Standard Operating procedures of OFTS and the DOD.

Yes. We will accept Forensic Use Only labeling for synthetic cannabinoids and oral fluid reagents. Please see Section C.2.1 in the request for quotation (RFQ).

2 C.2.3.1 &

Attachment A, Pricing

Table

54-58

The RFQ states: Marijuana (THC-COOH) 4 ng/mL Alcohol/Ethanol 20 mg/mL Is your intentions the following values?

-Marijuana (THC*) 4 ng/mL -Alcohol/Ethanol 20mg/dL *In oral fluid the parent drug THC is detected not the metabolite THC-COOH.

Yes. The values shall be:

-Marijuana (THC*) 4 ng/mL -Alcohol/Ethanol 20mg/dL Please see Section C.2.3.1 in the RFQ.

3 C.2.3.3 10 The RFQ states: The device shall allow the stability (recoverable concentrations ≥ 90% of the concentration at the time of collection) Since testing is not performed immediately after collection, is it your intention to state the following? The device shall allow the stability (recoverable concentrations ≥ 90% of the concentration at the time of initial analysis)

The statement is correct and it’s intended as written. The device shall allow the stability (recoverable concentrations ≥ 90% of the concentration at the time of collection) of the drugs and/or drug metabolites for one (1) week at room temperature and under intended storage and transport conditions.

The device shall allow recovering of ≥ 90% (but no more than 120%) of the drug and/or drug metabolite in the undiluted (neat) oral fluid at (or near) the test cutoff.

4 C.2.5 12 The RFQ states: The Contractor shall provide all equipment-specific consumable supplies, such as surfactants, and conditioning and cleaning solutions needed to perform the current volume of testing stated in Section C.2. Is this a requirement for this RFQ or is this already provided under another contract specific to the equipment?

The requirement is a part of this acquisition.

5 C.2.5 12 The RFQ states: The Contractor shall supply sufficient test tubes for the volume of testing per year. Is this a requirement for this RFQ or is this already provided under another contract specific to the equipment?

The requirement is a part of this acquisition.

6 Attachment A: Pricing

Table

54-58 What is the unit of measure represented on the pricing table for each item if not already

The units are in ‘sets’. For example, 400 sets of calibrators, 600 sets of controls, etc.

Please see the revised pricing table.

specified in the description or quantity? (For example: number of tests, number of kits?)

7 NA NA Is this bid all or none? Quoters shall provide a quotation in accordance with the RFQ.

8 C.2.1 7 Does the kit size have to be exact? We have small kits yielding 833 tests and large kits yielding 8330 tests.

The requirement is not for ‘exact kits’.

Please refer to Section C.2.1. The Government requires the larger volume kits to meet our testing capacity.

9 C.2.2.1 8 Will the Government accept different cut-offs, such as Methodone cut-off at 20ng/mL?

No. The Government will not accept different cut offs.

10 C.2.3.2 9 Is it a requirement that oral fluids have a 510(k)? No. It is not a requirement.

11 NA NA Does the RFQ require that Quoters submit a response for all three (3) items or can the response just be for one (1) item?

1) FENTANYL REAGENTS, CALIBRATORS

& CONTROLS

2) SYNTHETIC CANNABINOID

REAGENTS, CALIBRATORS & CONTROLS

3) ORAL FLUID REAGENTS,

CALIBRATORS & CONTROLS & ORAL

SWABS COLLECTION KITS

Please see the Government’s response to question #7.

12 C 9 If a manufacturer has 9 out of 10 of the requested oral fluid tests requested, plus additional available tests such as Buprenorphine and Benzodiazepines, would you accept an offer?

Please see the Government’s response to question #7.

13 C 11 How many oral fluid specimens are needed for validation?

A minimum of 20 specimens shall be validated for all the assays in this requirement.

14 M 35 Will you consider splitting this award to multiple vendors?

No. The Government will award a single firm fixed price Contract.

15 C 11 Since it is impossible to run oral fluids and urine samples simultaneously on the AU5810, do you have concerns for the process required to switch between oral fluids and urine fluids on the Beckman AU5810 analyzers?

The Government does not have any concerns.

QUESTIONS 7.25.19

QUESTIONS 7.25.19

1. Incorporate Attachment C, Quoters' questions and the Government's responses, into this RFQ.

2. Amend Sections C.2.1 and C.2.3.1. The changes to Section C are in bold print.

3. Include the unit "sets" in Attachment A, Pricing Table.

Please see the attachments. All other RFQ terms and conditions shall remain the same.

633 Indiana Ave, NW, Suite 1134 Washington, DC, 20004, US

AMD_ISSUING_OFFICE_LOCCODE: 959P00