PSA-14-R-000012_-_Amendment_No._0003_(FBO).pdf

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 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.

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

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.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

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)

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

959P

Brad D. Nelson

Project: Immunoassay Reagents and Instrumentation

"Please refer to page two (2) for specifics."

Pretrial Services Agency for the District of Columbia Procurement Office 633 Indiana Avenue, NW, Suite 1120 Washington, DC 20004

PSA-14-R-000012

1 10

05/09/2014

04/21/2014

Brad D. Nelson Digitally signed by Brad D. Nelson DN: cn=Brad D. Nelson, o=Office of Finance and Administration, ou=Pretrial Services Agency for the District of Columbia, email=brad.nelson@psa.gov, c=US Date: 2014.05.02 15:26:39 -04'00'

05/09/2014

PSA-14-R-000012, Amendment No. 0003

Immunoassay Reagents and Instrumentation

The Government hereby amends the solicitation to answer the below questions:

Question #1:

The introduction is for LC/MS extraction materials and set aside for small business. Will this be for small business or is the bid amended?

Government Response:

The small business set-aside requirement was removed via amendment 0002 (dated 05/07/2014).

Question #2:

The estimated monthly test volumes add up to 2.1M tests annually. What accounts for the additional 0.5M tests?

Please see the below:

ASSAY ESTIMATED ANNUAL VOLUME

COCAINE 460,000

OPIATES 390,000

HEROIN METABOLITE (6ACETYL MORPHINE 60,000

THC 420,000

METHADONE 110,000

ETHANOL 160,000

EtG 160,000

AMPHETAMINES 160,000

CREATININE 425,000

TOTAL 2,345000

Question #3:

If new analyzers are not required by the incumbent vendor, why can’t all vendors offer refurbished instrumentation?

The equipment is only required to be new condition upon initial installation. This requirement provides the incumbent a significant financial advantage. Immunoanalyzers have an average life of greater than 10 years, if properly maintained and serviced. Requiring new equipment every 5 years would increase the cost of testing without any additional benefits to the agency.

The analyzers are provided by the vendor as a tool to perform the immunoassay drug testing. If the specifications for both the analyzers and the reagents are met, would a refurbished analyzer be acceptable as long as the equipment is reliable and parts and service are available? Many county, state and federal bids do not require new equipment to be supplied with the purchase of immunoassays, rather that they meet the throughput and reliability specifications. Examples are

US Probation and Pretrial, State of Missouri Department of Corrections, Wyoming State

Chemical Testing, and Cuyahoga County Probation.

All prospective vendors including the incumbent, if they chose to bid, will be required to provide new instrumentation to be installed at the beginning of the contract. PSA is a high volume laboratory working under with very tight turnaround time requirements and a need for minimal downtime. Based on our many years of experience chemistry analyzers start to show an increase in service calls in their fourth and fifth years of use.

Question #4:

What is multiple reagent configurations supported? Why is QC data is stored on board the analyzer, rather than the LIS?

Multiple reagent configurations mean that more than one reagent bottle for the same analyte can be placed on the analyzer so the analyzer can switch over to the reserve reagent when the primary reagent bottle is empty. Our market research showed that 3 of 3 high speed chemistry analyzers had this feature.

Question #5:

What is the timeframe for completion of the interface after installation?

We expect that work can begin on the analyzer to LIS interface within one month of the contract award. Work on the interface must be substantially completed by the time the analyzers are installed and performance validated so final performance checks can be conducted to insure data integrity. PSA is prepared to provide software developer assistance to the vendor (section

D.2.1.2).

Question #6:

Why are racks required for 3,000 specimens when the average daily workload is less than 2,000 specimens, based on the monthly volume of 33,000 specimens (20 working days/month)?

PSA is requiring enough analyzer sample racks for 3000 specimens so that in the event of analyzer downtime specimen processing can continue.

Question #7:

Why are 45,000 test tubes being required monthly when the average volume is about 33,000 specimens?

Because we perform a repeat test on each positive specimen and 26% of our specimens are positive the 33,000 specimens require 42,000 tubes. We also need to allow for calibrations and control specimens.

Question #8:

Why is the agency’s (D.C. Pretrial) approval required before shipping improved products? If the improvement has been accepted by FDA, we do not maintain old inventory after it’s been depleted. We will notify the agency and assist with validations of changed products.

A new product may not meet PSA’s specifications as put forth in the contract. PSA reserves the right to reject any substitutions. Any substitutions shall be negotiated with the PSA Contracting

Officer and the Contracting Officer’s Technical Representative.

Question #9

Why are kit sizes restricted to no more than 5,000 tests? We can supply alternate sizes to meet this requirement, but high volume laboratories prefer larger kit sizes. In fact, the agency currently purchases PCP large kits from Microgenics that provide approximately 6,000 tests.

We are deleting from section D.2.2.4, Reagent kits shall be available in low capacity (approx.

1,000 test/kit) and high capacity (3,500+test/kit) sizes. Any individual bottle of reagent, which would be prepared for use at one time, may not include materials for more than 5,000 tests.

Question #10

The bid states that the reagents must meet SAMHSA guidelines, yet the Opiate cut-off listed is

300ng/mL, whereas the SAMHSA Opiate cut-off is 2,000ng/mL. Could you please elaborate?

We are revising this section to read: Reagents must meet current PSA cut off for the initial immunoassay test as given in the table below in order to support the Agency mission. The following cutoffs for urine specimens are currently used by the OFTS for the initial immunoassay test:

Cocaine Metabolite (Benzoylecgonine) 150 ng/ml

Opiates (Morphine) 300 ng/ml

Heroin Metabolite (6Acetyl Morphine) 10 ng/ml

Marijuana (THCCOOH) 50 ng/ml

Methadone 300 ng/ml

Ethanol 20 mg/dl

Ethyl Glucuronide (EtG) 500 ng/ml

Amphetamines (Amphetamine) 500 ng/ml

Creatinine 20 mg/dl

Question #11

Some analyzer consumables are hazardous, i.e. wash solutions and must be shipped ground, which may take > 72 hours. Is this acceptable, as it is shipping restrictions, not the ability to fulfill the order?

We agree that this is too restrictive and are replacing the requirement from delivered within 72 hours of receipt of an order to shipped within 72 hours of receipt of an order.

Question #12

Are there any criteria for the one in-house educational training session per year? Is it re-training for additional personnel or continuing education on any topic?

The content of the training sessions can be negotiated between the vendor and the PSA

Contracting Officer or the Contracting Officer’s Representative. Content can be training or retraining of new and existing personnel on analyzer operation or maintenance or of a more general nature such as emerging trends in drug use.

Question #13

Please elaborate on the pre-award survey. Is this an opportunity for the vendor to evaluate the data management system prior to installation?

Yes, PSA will allow prospective vendors to conduct a pre-award survey and evaluate the LIS.

Of course whoever is awarded the contract will be welcome to conduct a post-award survey as well.

Question #14

Please elaborate on your required validation studies. Toxicology labs have different requirements, depending on their certification(s).

PSA requires at a minimum the standards for immunoassay validation studies documented in

SWGTOX Doc 003, Revision 1, Published May 20, 2013. If the vendor offers additional testing to comply with internal company policies we will be happy to accept that test data too.

Question #15

Why would 100ng of benzoylecgonine have to be detected at 150ng cut-off on the immunoassay? This implies that immunoassay must detect the cocaine metabolite at

>100%. Most commercial immunoassays have antibodies against benzoylecognine and therefore it is detected at 100% or 150ng, using a 150ng cut-off.

4.1.4 and 4.1.5, 4.2.4+4.2.5, 4.3.4+4.3.5, 4.4.5+4.4.6, 4.5.5+4.5.6, 4.6.5+4.6.6, 4.7.4+4.7.5, 4.8.4+4.8.5, 4.9.4+4.9.5, We agree the wording is unclear. The wording is revised as follows:

4.1 Cocaine (Benzoylecgonine): The sensitivity and specificity of the assay should provide sufficient reactivity with Benzoylecgonine such that actual human physiological specimens which contain 150 ng/ml of Benzoylecgonine as determined by GCMS would show an apparent concentration of 150±15 ng/ml Cocaine Metabolite by the immunoassay procedure. While Benzoylecgonine is the principal analyte for urinary cocaine detection, sensitivity to the presence of other Cocaine metabolites is desired.

4.2 Opiates: Recognizing that physiologic urine specimens from opiate abuse may contain other secondary metabolites, the assay must detect Morphine or Codeine when present at a concentration of 300 ng/mL of urine. The sensitivity and specificity of the assay should provide sufficient reactivity with Morphine such that actual human physiological specimens which contain 300 ng/ml of Morphine as determined by GCMS would show an apparent concentration of 300±30 ng/ml Opiates by the immunoassay procedure. Sensitivity to the presence of other Opiates and their metabolites is desired.

4.3 Heroin Metabolite (6-Acetyl Morphine) The sensitivity and specificity of the assay should provide sufficient reactivity with 6-Acetyl Morphine such that actual human physiological specimens which contain 10 ng/ml of 6-Acetyl Morphine as determined by

GCMS would show an apparent concentration of 10±2 ng/ml Heroin Metabolite by the immunoassay procedure.

4.4 Cannabinoids (Marijuana): The sensitivity and specificity of the assay should provide sufficient reactivity with Cannabinoids such that actual human physiological specimens which contain 50 ng/ml of the marijuana metabolite THCCOOH as determined by GCMS would show an apparent concentration of 50±5 ng/ml Cannabinoids by the immunoassay procedure. While THCCOOH is the principal analyte for urinary Cannabinoid detection, sensitivity to the presence of other Cannabinoid metabolites is desired.

4.5 Methadone: The sensitivity and specificity of the assay should provide sufficient reactivity with Methadone such that actual human physiological specimens which contain

300 ng/ml of Methadone as determined by GCMS would show an apparent concentration of 300±30 ng/ml Methadone by the immunoassay procedure.

4.6 Amphetamines: The sensitivity and specificity of the assay should provide sufficient reactivity with Amphetamine and Methamphetamine such that actual human physiological specimens which contain 500 ng/ml of Amphetamine or Methamphetamine as determined by GCMS would show an apparent concentration of 500±50 ng/ml amphetamines by the immunoassay procedure.

4.7 Ethanol: The sensitivity and specificity of the assay should provide sufficient reactivity with Ethanol such that actual human physiological specimens which contain 20 mg/dl of

Ethanol as determined by headspace GC would show an apparent concentration of 20±2 mg/dl Ethanol by the reagent.

4.8 Ethyl Glucuronide (EtG): The sensitivity and specificity of the assay should provide sufficient reactivity with Ethyl Glucuronide such that actual human physiological specimens which contain 500 ng/ml of Ethyl Glucuronide as determined by a LCMS reference method would show an apparent concentration of 500±50 ng/ml Ethyl

Glucuronide by the immunoassay procedure.

4.9 Creatinine: The sensitivity and specificity of the assay should provide sufficient reactivity with Creatinine such that actual human physiological specimens which contain 20 mg/dl of Creatinine as determined by a reference method would show an apparent concentration of 20±2 mg/dl Creatinine by the procedure.

Question #16

Why is a new immunoassay’s performance being only compared to the existing immunoassay for accuracy of being positive or negative, rather than against a gold standard method such GC or

LC/MS?

We have already compared our existing immunoassays to GCMS for accuracy. If the new immunoassay shows the same performance we have confidence it is as accurate as the current immunoassays. If the vendor wishes to submit accuracy data comparing their immunoassay to

GCMS or LCMS we will consider the information in our evaluation.

Question #17

Why is the QC for 6-Acetyl Morphine not following the SAMHSA guidelines of 75% and 125% of the cut-off?

This was incorrect but we will accept the wider limits. Currently we use controls for 6-

Acetylmorphine with target values of 7.5 ng/ml and 12.5 ng/ml. PSA prefers to use reagent and control materials that can match those targets.

Question #18

Why is Creatinine QC +/- 25% of the cut-off? SAMHSA guidelines are specific to include controls in the normal (>20mg/dL), diluted (2-19.9) and substituted (0- 2)range.

We are not a workplace drug testing laboratory although we use control materials which fit

SAMHSA definitions of normal, dilute, and substituted. There can be serious consequences for persons who submit diluted or substituted specimens. Our quality control levels were chosen to closely monitor the accuracy of the creatinine assay at the 20 mg/dL decision point to best fit the agency’s mission. A zero creatinine control is also used.

Question #19

Can the Request for Proposal (RFP) due date be extended?

Another extension is not probable at this time. The RFP was extended to May 16, 2014 via amendment no. 0001 (dated May 2, 2014).

Question #20

In section E.2.2.2 INSTRUCTIONS FOR PREPARING THE PRICE VOLUME, the bid states, “Section 2.1.2 addresses required initial training for six (6) individuals. As a separate part of its price proposal, offeror’s shall include pricing for travel, lodging, and ground transportation from

Washington DC to the training location for the six government officials to attend the training.”

Is the Pretrial Services Agency, looking to itemize the value associated with training for an internal procedure or is the Pretrial Services Agency looking to know the costs for training so that the Pretrial Services Agency can pay for travel, lodging, and ground transportation directly

(and not by the chosen vendor)?

The intent of this requirement is to allow PSA to review the proposed costs associated with the travel, lodging, and ground transportation and compare those proposed costs to what it would cost the Government if PSA were to pay for those costs directly. If it is determined that significant savings to the Government can be realized by paying these costs directly, then the

Government would exclude the contractor’s proposed transportation costs from the award total.

Question #21

Replacing a floor model analyzer within 24 hours can be difficult when shipping by truck is required. Can this timeline be revised?

The timeline is amended to reflect that analyzers must be restored to service within 96 hours.

Question #22

Quality Assurance Surveillance Plan on page 33. For the template, can you provide us with a list of the minimum deliverables? Can you please provide an example of the completed form?

Attachment II (Quality Assurance Surveillance Plan) is hereby DELETED. I it also DELETED from the Solicitation Provisions (Attachment E).

-------------------------------------------------Nothing Follows-----------------------------------------------