Reference Clinical Laboratory Services for the National Institute on Aging Clinical Unit

Notice Type: Presolicitation Notice

Posted Date: 09-OCT-18

Office Address: Department of Health and Human Services; National Institutes of Health; National Institute on Drug Abuse; 6001 Executive BoulevardRoom 4211, MSC 9559 Bethesda MD 20892-9559

Subject: Reference Clinical Laboratory Services for the National Institute on Aging Clinical Unit

Classification Code: R - Professional, administrative, and management support services

Solicitation Number: HHS-NIH-NIDA-(AG)-PSOL-18-492

Contact: Andrea McGee, Contract Specialist, Phone 3014802449, Email [email protected]

Setaside: N/AN/A

Place of Performance (address): 3001 S. Hanover StreetBaltimore, MD

Place of Performance (zipcode): 21225

Place of Performance Country: US

Description: Department of Health and Human Services

National Institutes of Health

National Institute on Drug Abuse

PRE-SOLICITATION NOTICE OF INTENT NON-COMPETITIVE INTRODUCTION PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT ACTION.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), intends to negotiate and award a contract for reference clinical laboratory services.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 621511 with a Size Standard of $32.5 dollars.

REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) 05-100 October 5, 2018.

STATUTORY AUTHORITY

This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1.

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source.

DESCRIPTION OF REQUIREMENT

Purpose and Objectives The purpose of this acquisition is to obtain reference clinical laboratory services for the NIA clinical unit located at Medstar Harbor Hospital in Baltimore, Maryland.

PROJECT REQUIREMENTS The Contractor shall be responsible for performing pre-analytic processing, analysis, and result interpretation for clinical and anatomical pathology specimens as requested by the NIA Clinical Unit physicians. Services shall include the transportation of clinical laboratory specimens to the contractor's laboratory(ies) if off-site from the NIA Clinical Unit (including providing the shipping/pickup containers), the performance of analytical testing as defined by the Contractor's reference test manual, the reporting of analytical test results and consultative services as required to assimilate the full scope of its laboratory operations to the ordering facility.

Specific Requirements: * Specimen Pick-up: The NIA clinical unit staff will send reference specimens to the laboratory on a daily basis. Lab services are not required on New Year's Day, Independence Day, Thanksgiving Day, and Christmas Day. * Turnaround Time (TAT): Laboratory shall deliver or transmit results of a routine nature (general routine chemistries) to NIA within specified timeframe (to be determined upon award). Some lab results to be provided to NIA on the same day the specimen is received by the Laboratory's testing facility. The Laboratory shall make reasonable efforts to transmit or deliver results of tests performed on specimens of a special nature (special chemistries, tissues, etc.) to NIA within the times set forth in Laboratory's then current turn-around-time schedule. * Specimen Collection and Handling Requirements - Price list must indicate whether test demographic information is available upon request in either hardcopy or electronic format, listing any e-mail addresses or web links necessary to obtain the Requirements. * Sample Preparation: Each ordering ac tivity will prepare (collect and handle) and package laboratory specimens in accordance with the requirements defined in the Contractor's commercial specimen collection guide. The packaging and transportation procedures must be of a quality that ensures the integrity of the specimen throughout the shipment process. * Proper tracking of specimen: Tra cking must be maintained from the initial pickup/shipping of the specimens from the ordering activity throughout the testing process at the Contractor's laboratory. * Consultation: Laboratory staff shall be available to consult with NIA in person or by telephone during normal Laboratory working hours to discuss laboratory procedures and to provide the status of test results. The Contractor shall provide telephone number(s) and contact personnel to be used by the ordering activity to address questions regarding their commercial services. The Contractor shall include names and telephone numbers of technical directors and pathologists available for consultation. * Testing: The testing methodology and reference ranges for a test must be defined in the laboratory user manual. The Contractor shall advise facility of any changes in methodology, procedure, reference ranges and any new tests introduced no later than two weeks prior to test change implementation. In the event that the Contractor discontinues and/or substitutes a new test, the Contractor shall notify the NIA Project Officer prior to the intended change. Any such change may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the Project Officer. All clinical reference laboratory testing shall be executed in accordance with standard industry practices. All test methods shall be FDA approved. Any non-FDA approved method being performed shall have a documented validation plan. Upon request the validation plan and validation results shall be made available. Test Result Reporting: A report is defined as a final copy of laboratory testing results. This report shall be received by remote terminal where applicable. If results are previously telephoned, the report must include the name of the individual notified of the results. Each test report shall include all information as required by Regulatory Agency Requirements. Contractor shall provide test results via one of the following methods: 1. In-person 2. Fax transm ission 3. The contractor sha ll provide laboratory results by the below methods: a) Access to the Contractor's computer system by the ordering facility, i. e. web-site, installation of software on the Government computer, installation of Contractor hardware with required software; b) Inter-connectivity between Contractor computer system and Government comp uter system, i.e. results are automatically transmitted from the Contractor computer directly into the Government computer system without human intervention (i.e. HL7 Transfer). c) Ensure electronic transmission and te chnical details of security settings provided by NIA. d) Lab results are available electronically and provide ability to generate reports. All completed and/or partial test results shall be reported to the ordering activity within awarded Turnaround Time (TAT), except where specified. Contractor shall provide all required hardware and software (including installation) and related consumable supplies to support the transmission of electronic data for each ordering activity at no additional charge. Any necessary "additional required connections" shall be the responsibility of the contractor. All equipment, software and hardware remain the property of the contractor. * Critical Tests: The Contractor shall immediately telephone the NIA physician or requesting Clinician to report Critical Value or test result that may indicate a life-threatening condition. Appropriate notification information will be provided at the time of task order award. * Procedure Guidance: The Contractor sh all make available either through its electronic catalog or upon request the following information: o Specimen collection and handling requirements o Test reference intervals adjusted for ages, sex, o r race, when required o Test specific sensitivity, specificity, and interferences, when required o Result code (electronic transmissions only) o Test critical values, if any o Location of test performan ce by test name (i.e. name of primary laboratory, name of separate branch division of primary lab, name and address of secondary/subcontracted laboratory must be cited) * Documentation: The Contractor shall ensure that all required documentation is, at a m inimum, timely, legible, and accurate. Contract personnel shall indicate responsibility for the content and accuracy of all prepared and transcribed reports. The Contractor shall have a system in place to identify the personnel performing the test analysis. * Retentio n of Specimens: Upon completion of the testing, the Contractor shall retain all specimens as required by regulatory agencies. * Utilization Reports: The Contractor, upon request, shall provide to each ordering activity at a minimum, the utilization reports customarily provided to commercial customers. The report shall at minimum identify the test code, test name, YTD volumes, unit cost, YTD expenditures, and turnaround times. * Price List: The price list shall include Medicare allowable costs. * Contract Quality Assurance/ Quality Control: The Contractor fac ilities, test methodologies (defined as the principle of the method), validation studies, and quality control information may be examined by representatives of the Government at any time during the life of the contract. The Contractor shall comply with all applicable OSHA, Fed eral, State, laws, and regulations as required for performing the type of services required. * HIPAA Compliance: The contractor shal l be a "covered entity" under the Health and Portability and Accountability Act of 1996 (HIPAA) and agree to comply with the requi rements thereof, as well as all other applicable laws and regulations pertaining to patient privacy.

* Licensing and Accreditation: Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation will be considered. The Contractor must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare and Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency with deemed status from the Centers for Medicare and Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as 02b - Statement of Work RFP-797-FSS-04-0001-R23 mandated by federal and state statues. The Contractor must maintain valid certifications throughout the performance period of this contract. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America prior to contract award. In addition, the Contractor shall be responsible for providing a written guarantee or evidence that all subcontractors have appropriate licensure and accreditation to perform tests that the primary contractor cannot perform prior to contract award. The Contractor shall maintain current accreditation and notify the Contracting Officer of any lapse in state license, CLIA certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses/certificates to the Contracting Officer before expiration. Immediate (within 24 hours) notification must be given to ordering activity upon adverse action by a regulatory agency.

* Malpractice Liability Insurance: Malpractice liability insurance shall b e by a commercial insurance company in the business of providing the required insurance coverage of not less than $1,000,000.00 per occurrence. The Contractor shall provide a copy of the Medical Malpractice Insurance Certificate before award of the contract. The Contractor shall notify the contracting officer in writing of any malpractice investigation or licensure or certification suspension which concerns the Contractor or any employees, within 24 hours of notification of an investigation or suspension.

ANTICIPATED PERIOD OF PERFORMANCE The anticipated period of performance is from November 5, 2018 through December 31, 2019 with four (4) option year periods.

CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice.

Responses to this notice must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.

Respondents that believe that they are manufacturers or authorized resellers of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order.

In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by October 24, 2018 12:00pm eastern standard time and must reference number HHS-NIH-NIDA-(AG)-PSOL-18-492.

Responses must be submitted electronically to Andrea McGee [email protected] and must reference the solicitation number HHS-NIH-NIDA-(AG)-PSOL-18-492 on your electronic request. FAX requests are not accepted.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."

Link/URL: https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA-(AG)-PSOL-18-492/listing.html