SOW mutation analysis 012511.pdf

STATEMENT OF WORK

MUTATION ANALYSIS OFF-SITE LABORATORY TESTING

BACKGROUND

The National Institutes of Health (NIH) is a 240-bed biomedical research hospital with an active outpatient component. The Department of Laboratory Medicine processes standard and specialized laboratory tests at the Clinical Center. The laboratories housed within the Clinical Center analyze and report approximately 1.8 million test results per year. Because of the unique research role of the NIH, there is also a need for outside clinical laboratory services to run very low volume but necessary testing to support and augment in-house capabilities. Specifically, there is a need for mutation analysis testing of a large number of genes. Off-site mutation analysis testing services would provide support for ongoing clinical research and clinical trials through the performance of unique genetic tests. Because of the research focus, each sample requires a high degree of methodological uniformity to ensure consistency over time.

PURPOSE

The purpose of this contract is to establish a mechanism for obtaining mutation analysis laboratory services. This contract will provide service to the multiple Institutes maintaining a clinical research program within the National Institutes of Health through central local management in the Department of Laboratory Medicine of the Clinical Center. To ensure the continuity and uniformity required for long term clinical studies, and to maximize the efficient use of patient specimens and the Department of

Laboratory Medicine’s resources, mutation analysis testing should be provided by an Offeror who has the capability to furnish requested tests within a mutually agreeable timeframe. It is imperative that changes in methodologies be limited during the length of the contract, because the mutation analysis results will be used in clinical trials. It has been determined that it is most advantageous to the

Government to award multiple Indefinite Delivery, Indefinite Quantity (IDIQ) contracts to offerors who can perform at least >= 80% of required tests listed in any of the three attached schedules. Offerors may choose from either one or all of the lists titled: “Mutation Analysis Schedule I”, “Mutation Analysis

Schedule II”, “Mutation Analysis Schedule III.” Each proposal will be evaluated competitively and independently of the aggregate lists. Each offeror is instructed to clearly identify the schedule list

(example: Mutation Analysis Schedule I) for which they are offering a proposal, and submit their most advantageous pricing arrangements. The successful offeror will be determined on the >=80 % performance criteria, the technical/mandatory requirements, and fair and reasonable pricing.

OFFEROR QUALIFICATIONS

Independently, and not as agent of the Government, the Offeror shall furnish all the necessary services, qualified personnel, supplies, materials, equipment and facilities not otherwise provided by the

Government as needed to perform the work set forth below:

A. The Offeror shall demonstrate capability to perform mutation analysis testing for the battery of tests listed in at least one of the independent schedules. Offerors may submit a proposal to one or all three of the schedules listed. These schedules include annual volume estimates for each test. In its proposal, the Offeror shall list the types of tests it can perform at its facility and which tests would be evaluated at another reference laboratory. It is preferable for all tests to be performed at one facility without the use of subcontractors. Offerors shall be able to demonstrate that they can perform >=80% of tests required on the test schedule they choose to offer a proposal. The market research conducted could not identify any small businesses that can perform >=80% of the mutation analysis testing outlined in each of the three schedules.

B. This Contract requires the operation of a system of patient records. Thus, the Privacy Act requirements are applicable. The Offeror and its employees are subject to criminal penalties for violations of the Act (5 U.S.C. 552a (I)). Hence, the Offeror shall assure that its employees abide by prescribed rules of the Privacy Act.

C. The Offeror will accept whole blood or other non-fixed tissue samples for DNA (or RNA) extraction performed at the Contract laboratory site.

MANDATORY REQUIREMENTS

A. The Offeror shall demonstrate that >=80% of tests on the test schedule they select to bid on can be performed at the Offeror’s on-site laboratory. Of those tests, there must be availability of sequencing of the entire coding region of all listed genes on each list that the Offeror chooses to bid.

B. The Offeror shall have laboratory certification consistent with Clinical Laboratory Improvement

Act (CLIA) 1968 and CLIA 1988, to perform these mutation analysis tests. The current copy of the CLIA certification should be submitted with the response to this proposed contract. The

Offeror shall provide annually copies of certificates as evidence of CLIA certification and inspection by accrediting agencies. If subcontractors are utilized, the Offeror shall submit the subcontractor’s laboratory certificates as evidence of CLIA compliance.

C. The Offeror shall provide strong technical advice relative to the interpretation of data and expert consultation services during their normal operating schedule. This includes the availability of at least one staff member who is board certified by the American Board of

Medical Genetics and/or the American Board of Genetic Counseling. In its proposal, the Offeror shall include resumes of its staff to confirm it meets this requirement. The Offeror shall provide updates to the NIH Clinical Center’s Department of Laboratory Medicine (DLM) on new technology. The contact laboratory must have the capability to participate in collaborative projects involving senior personnel at the contract laboratory and the Department of Laboratory

Medicine. The Offeror must also provide copies of their methods when requested by DLM.

LAB SPECIMEN COLLECTION AND RESULTS REPORTING REQUIREMENTS

A. All requests for mutation analysis testing and transmission of specimens for testing will originate from the NIH Clinical Center’s Department of Laboratory Medicine (DLM). Physician orders will be forwarded to the DLM via the hospital’s electronic order system, and then interfaced with the SoftLab system.

B. It is desirable for the Offeror to provide a remote terminal that will allow the test accessioning of requests from the hospital’s SoftLab system directly into the off-site Offeror’s computer system. The SoftLab system is a commercially-available information system to manage laboratory data (www.softcomputer.com). The interface from the Offeror’s Lab information

System to the SoftLab system will be via secure VPN connection. (Specifics regarding electronic interfacing requirements are addressed in the information technology section). In its proposal, the Offeror must clearly identify the method used by their laboratory to report the results.

C. The Offeror will provide adequate information regarding specimen collection requirements including volumes and specific collection tubes. Written catalogs, interpretation manuals and on-line computer assistance or web sites for proper specimen collection and test methodologies will be provided by the Offeror.

D. The Offeror shall ensure that specimens shall be picked up at the NIH’s Bethesda Maryland campus in Bldg 10, Room 2C-324, once per day, Monday through Friday at 3pm or later. The

Offeror shall describe in its proposal whether courier service or shipment via Federal Express will be utilized for transportation to the Offeror’s laboratory. The NIH DLM will package all specimens for shipment. The Government will supply all shipping containers and dry ice or cool packs to maintain proper temperatures for shipping.

E. The Government will utilize the SoftLab system to track all orders and results, in addition, a separate “Specimen” log may be developed, listing all of the specimens that are to be sent to the Contract laboratory. Once patient information is in its possession, the Offeror shall ensure adherence to Privacy Act and confidentiality.

F. Electronic results reporting in a secure environment is mandatory for this contract. Facsimile transmission is not an acceptable form of test result transfer from the contract laboratory to the

NIH. Acceptable forms of secure transmission include: 1. Via VPN directly from the Offeror’s information system to the NIH’s SoftLab system; or 2. Via secure email and file transfer. The NIH

Secure Email and File Transfer Service are available as a free service to Contractors who do business with the NIH. Further information is available at https://secureemail.nih.gov/bds/Main.do. The Contractor shall specify its proposed method of results in its proposal. Results must be transmitted directly to the CC DLM, not to the individual practitioner who orders the test.

http://www.softcomputer.com/ https://secureemail.nih.gov/bds/Main.do

G. Results reporting by the Offeror must include the following fields: patient medical record number, patient last name, patient middle name, patient first name, date of birth, gender, visit/billing number, research protocol number, CRIS order number, SoftLab order number, ordering physician, ordering NIH institute (i.e. NCI, NICHD, etc.), test name, test code, order date, processes date, result date, result, and result comments.

H. Once the patient data is in its possession, the Offeror shall ensure compliance with confidentiality and Privacy Act requirements. Each electronic result file must contain a comment that indicates the name and address of the laboratory performing the test. Corrected report files must be annotated as “corrected” and contain the previous result, the revised result, and the date each test was performed.

I. Turnaround times for lab results must be included in the proposal for each mutation analysis performed by the Offeror.

J. If hard copy reports are requested by the DLM, the Offeror must provide reports within 3 days of the request.

K. The DLM shall resolve any problems such as QNS (quantity not sufficient) samples, wrong type of specimen or improperly collected sample by notifying the Offeror verbally or in writing upon discovery of any testing issues or deficiencies. The Offeror shall properly store any received sample for up to one month after receipt to allow for reruns or add-on tests.

L. The Offeror shall provide at least thirty (30) days advance written notification of any changes which will be made in methodologies, reference ranges, reagents or procedures. The thirty day timeline is calculated from the time the written notification is received by the CC Department of

Laboratory Medicine to the effective date of the change. However, all changes must be submitted in writing and no changes will be permitted unless written approval is submitted by the Contracting Officer. The Offeror shall notify the DLM Lab Manager or the Chief

Technologist of the DLM Accessioning Section of all proposed changes.

M. The Offeror will provide prompt customer service via telephone in support of their testing during the Contract laboratory’s normal business hours, Monday through Friday. All calls will be returned the same day of the initial call by the NIH. The Offeror will include all contact phone numbers and operating hours in its proposal.

QUALITY ASSURANCE

A. The Offeror shall have an on-going quality assurance process to ensure the integrity of its lab results. The Offeror shall identify incomplete testing and/or missing specimens within 2 days of receipt from the DLM NIH Laboratory, and notify the DLM Accessioning Section of the error.

B. The Offeror’s quality control record and turnaround time report for any analyte shall be available to the Department of Laboratory Medicine for review upon request.

C. The Department of Laboratory Medicine will review the Offeror’s data entry results for accuracy and timeliness on a regular basis.

D. The Offeror shall be responsible for the quality and timeliness of reporting of its subcontracted work.

E. The Offeror shall meet in person or via teleconference quarterly with the Contracting Officer’s

Technical Representative (COTR) and members of the senior staff of the Department of

Laboratory Medicine for performance assessment and resolution of any problem areas.

GOVERNMENT RESPONSIBILITIES

A. The Government shall provide the Offeror with a specimen log with each shipment, which lists all tests requested and the corresponding specimens in the shipment. Specimen logs will record the date/time of pick up as well as the name and title of the person sending the test from the NIH. Since these specimens have patient identifiers, compliance with HIPAA Privacy disclosure documents is mandatory. DLM shall also track the date/time of test receipt by the Contract laboratory and the name of the person who received the specimen. The NIH will maintain these specimen logs, and retain records for 3 years.

B. The Government will fund the shipping containers and delivery costs associated with sending specimens to the Offeror’s laboratory. Specimens will be shipped according to the specifications of the vendor.

C. If a sample is improperly collected, or a specimen is damaged upon delivery, the NIH CC Department of Laboratory Medicine will pay for the procurement and shipment of the new sample/specimen.

D. Any applicable computer training will be provided by the Government. HHS policy requires contractors/subcontractors to receive security and privacy training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements.

INFORMATION TECHNOLOGY ISSUES

A. INTERFACE REQUIREMENTS

1. Electronic interface between the Government’s SoftLab system and the Contractor’s laboratory information systems is highly preferable to enable real-time transmission of specimen testing requests and facilitate timely results reporting. Additionally, electronic interface enhances patient safety by ensuring laboratory results are directly uploaded to the patient’s electronic medical record. The ability of the offeror to provide electronic interfaces and/or electronic results reporting shall be rated as an important element when awarding this contract.

2. If the Contractor chooses to select an electronic interface with the NIH SoftLab Computer System, the Contractor will assume all costs for building the interface. The contractor will also be responsible for developing or paying a subcontractor to develop any software for transmission of laboratory results into the SOFT Laboratory Information System. Computer hardware and software systems utilized by the Contractor shall be compatible with SOFT technology. Technical information regarding this electronic system for management of laboratory data can be obtained from Soft Computer Consultants, www.softcomputer.com, 5400 Tech Data Drive, Clearwater, FL 33760. The phone number is 1-800-763-8522.

B. SECURITY REQUIREMENTS

1. Systems that interconnect, exchange or share sensitive information need to meet the OMB A-130 requirement that “written management authorization (often in the form of a Memorandum of Understand or Agreement), be obtained prior to connecting with other systems and/or sharing sensitive data/information. The written authorization shall detail the rules of behavior and controls must be maintained by the interconnecting systems.” To meet this requirement, a System Interconnection Security Agreement and Memorandum of Understanding focused on protecting the data exchanged and the information technology assets of both parties is required.

2. The offeror shall prepare a detailed narrative explaining the specific plans for each of the security requirements listed below:

1.1 The Contractor shall provide a Draft Information Systems Security Plan and

Personally Identifiable Indicators (PII) Security plan to assure compliance with the Health Insurance Portability and Accountability Act (HIPAA).

1.2 NIH and Contract Staff accessing government IT systems remotely must use two-factor authentication. If the contractor does not utilize government servers to facilitate electronic interfacing, two-factor authentication is not required for systems access. Please describe how this requirement will be met.

1.3 NIH requires use of a VPN access to remotely access a server. Additionally persons accessing the server from a remote location must log in with a named account.

Please identify how the Contractor shall satisfy this requirement.

1.4 Please provide documentation of Contractor employee training related to IT security, PII, Personal Health Information (PHI) and sensitive data, HIPAA compliance and remote access security.

1.5 NIH is required to follow NIST System Security Configuration Standards for FISMA C & A documentation. Please provide mapping of system security configuration controls written to the NIST 800-53, Rev 3 standards.

http://www.softcomputer.com/

INVOICE AND PAYMENT PROVISIONS

A. The NIH Department of Laboratory Medicine will facilitate the payment of Offeror invoices which shall be submitted monthly by the Offeror in accordance with the guidelines delineated in a separate attachment.

B. Invoices must clearly identify the Contract number, invoice date, unique invoice number, type of test, the date the result was transmitted to the NIH Department of Laboratory Medicine, patient name, NIH protocol number, ordering NIH Institute (i.e. NCI, NICHD, etc.), and ordering physician. To expedite payment, invoices should be sorted by the ordering NIH Institute.

Invoices which do not contain all of these elements will be rejected for payment until a proper invoice is submitted.

EVALUATION /AWARD CRITERIA

Proposals will be evaluated in accordance with the factors listed below. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. In any case, the

Government reserves the right to make an award to that offeror whose proposal provides the best overall value to the Government. All offerors must meet the mandatory criteria, in section titled

Mandatory Requirements. Any offeror not meeting the required specifications shall be excluded from further evaluation.

A. Technical Proposal (50%): An objective technical evaluation will be performed on each offeror’s proposal based solely on the information furnished.

1. The quality of testing will be evaluated based on the ability of the offeror to show the availability of sequencing the entire coding region of each gene listed. It will also be judged on whether state-of-the art test methodologies and instrumentation exists, and the capability to provide extensive data on test performance upon request.

2. The percentage of testing performed on site by the Contract Laboratory. The Government has stipulated that the offeror must provide >=80% of the tests listed on the test schedule at their laboratories to be considered for this contract. Offerors who can provide 90%-100% of the tests on the schedule on which they choose to bid, without the use of subcontractors, will be more favorably considered that those who can provide a range of tests between

80%-90% of the total.

3. The technical expertise of the technical and directorial staff will be evaluated by examining resumes and biographies provided in the offeror’s proposal.

4. Evidence of how NIH IT security requirements specified in the statement or work will be supported by the offeror. This includes, but is not limited to, protection of Personally

Identifiable Indicators (PII), Personal Health Information (PHI) and sensitive data, and a description of how the results will be transmitted electronically to the NIH CC Department of Laboratory Medicine. Proposals which offer an interface from the Contractor’s laboratory via VPN to the NIH Softlab system will receive a higher rating than those which offer a PDF results transmission via secure email.

5. The offeror shall delineate the turn-around-times for tests to be processed , analyzed and reported in terms of routine and time-sensitive tests.

6. The offeror shall delineate the capability to provide test interpretations through the use of consultations with doctoral experts, interpretive guides, extensive data on test performance and parallel testing of specimens when there are methodology changes.

7. The offeror shall submit documentation of the experience with testing for clinical research and use of advanced test methodologies that provide optional data for research protocols, including any evidence of the ability to generate a database for human patient lab testing.

B. Past Performance (25%)

Past performance will be evaluated from a business and technical standpoint to determine the relative merits of the proposal. The performance of the offeror on earlier work for the Government or the private sector will be a significant indicator of how well the offeror can be expected to perform the required services in the future. The information presented by the offeror together with that available from sources within the Government will provide the information for this portion of the technical evaluation. References from client labs with a similar need for mutation analysis testing shall be included with the Offeror’s proposal.

1. The Government will evaluate the quality of the Offeror’s past performance based on information obtained from references provided by the offeror, as well as other relevant past performance information obtained from other sources known to the Government.

2. Evaluation of past performance will be a subjective assessment based on a consideration of all relevant facts and circumstances. It will not be based on absolute standards of acceptable performance. The Government is seeking to determine whether the offeror has consistently demonstrated a commitment to customer satisfaction and timely delivery of services at fair and reasonable prices.

3. The assessment of the Offeror’s past performance will be used as a means of evaluating the relative capability of the offeror and the other competitors. Thus, an offeror with the exceptional record of past performance may receive a more favorable evaluation than another whose record is acceptable even though both may have acceptable technical proposals.

4. By past performance, the Government means the offeror’s record of conforming to specifications and to standards of good workmanship; the offeror’s record of forecasting and controlling costs; the offeror’s adherence to contract schedules, including the administrative aspects of performance; the offeror’s reputations for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror’s business-like concern for the interest of the customer.

5. The Government will consider the number and severity of an offeror’s problems, the effectiveness of corrective actions taken, the offeror’s overall work record, and the age and relevance or past performance information.

6. The lack of a performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror.

C. Cost: (25%)

1. An objective price analysis will be performed on each offeror’s price proposal for each test listed, including all options. Any proposed prompt payment discounts or credits will also be evaluated.

2. In the relationship of technical merit versus cost, offerors are advised that overall cost of contract performance will not be considered as controlling.