SOURCES SOUGHT
99 -- SOURCES SOUGHT: Clinical Laboratory Services
- Notice Date
- 10/13/2022 1:56:34 PM
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95023Q00005
- Response Due
- 10/28/2022 8:00:00 AM
- Point of Contact
- Hashim Dasti, Phone: 3014025139, Karen Mahon, Phone: 3014357479
- E-Mail Address
-
hashim.dasti@nih.gov, karen.mahon@nih.gov
(hashim.dasti@nih.gov, karen.mahon@nih.gov)
- Description
- This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement, to determine the method of acquisition, and availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality.� It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract.� Responses will not be considered as proposals or quotes.� No award will be made as a result of this notice.� The Government will NOT be responsible for any costs incurred by the respondents to this notice.� This notice is strictly for research and information purposes only. Small businesses are encouraged to respond. Background:� The National Institute on Aging (NIA) Intramural Research Program (IRP) Clinical Research Core (CRC) seeks to elucidate normative values and separate normal aging findings from disease states in aging in an effort to prolong disease-free states with age. The CRC serves as an infrastructure to facilitate the creation and development of therapeutic targets for the treatment of age-related disease across the NIA IRP.� The CRC performs research in various protocol studies that have direct clinical applications to human aging and disease states.� NIA recruits voluntary participants to take part in the various research protocol studies performed by the CRC staff.� The NIA CRC requires reference clinical laboratory services that provide tests results of participant specimens, some required with a short turnaround time.� The lab results must be provided with a short turnaround time because the test results determine which research tests may be performed safely on the participants.� For some research tests, the lab tests are taken and results provided on the same day.� The lab results become official documentation of the participant�s medical record. Purpose and Objectives: The purpose of this requirement is to obtain reference clinical laboratory services. The contractor shall provide all resources necessary to accomplish the tasks and deliverables described below. 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. 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 activity 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: Tracking 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. 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: In-person Fax transmission The vendor will provide laboratory results by the below methods: 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; Inter-connectivity between Contractor computer system and Government computer system, i.e. results are automatically transmitted from the Contractor computer directly into the Government computer system without human intervention (i.e. HL7 Transfer). Ensure electronic transmission and technical details of security settings provided by NIA. 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 shall make available either through its electronic catalog or upon request the following information: Specimen collection and handling requirements Test reference intervals adjusted for ages, sex, or race, when required Test specific sensitivity, specificity, and interferences, when required Result code (electronic transmissions only) Test critical values, if any Location of test performance 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 minimum, 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. Retention 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 should include Medicare allowable costs. Contract Quality Assurance/ Quality Control: The Contractor facilities, 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, Federal, State, laws, and regulations as required for performing the type of services required. HIPAA Compliance: Incumbent acknowledges it is a �covered entity� under the Health and Portability and Accountability Act of 1996 (HIPAA) and agree to comply with the requirements 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 be 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 required base period of performance is January 1, 2023 through December 31, 2023, plus four (4) option years. Other important considerations: Key Personnel: Contract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR).� Information System Security Plan: The Contractor must ensure that any and all contractor systems which hold or may hold personally identifiable or confidential information are secure. Please see the attached Information Systems Security Addendum for specific requirements. Data Rights: The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided, including clinical laboratory test results. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer.� In addition, it includes any additional deliverables required by contract change. The definition of �unlimited rights� is contained in Federal Acquisition Regulation (FAR) 27.401, �Definitions.� FAR clause 52.227-14, �Rights in Data-General,� will be incorporated by reference and made a part of this contract/order. Confidentiality of Information & Protection of Personally Identifiable Information: The Contractor must be fully compliant with the Health and Portability and Accountability Act of 1996 (HIPPA). Additionally, the Contractor must protect confidential information associated with this requirement. Confidential Information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization. The Contractor will have access to confidential and personally identifiable information regarding clinical research participants in the process of performing this requirement. Confidential Information or records must not be disclosed by the Contractor without written authorization from the Contracting Officer. Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor must consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately.� Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents� technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2� x 11� paper size, with 1� top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein.� A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit.� The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer.� Facsimile responses are NOT accepted. The response must be submitted to Hashim Dasti, Contract Specialist, at e-mail address hashim.dasti@nih.gov. The response must be received on or before October 28, 2022 at 11AM Eastern Time. Disclaimer and Important Notes:� This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization�s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/62d64c80bec544bc8ccada77e848a9e9/view)
- Place of Performance
- Address: Brooklyn, MD 21225, USA
- Zip Code: 21225
- Country: USA
- Zip Code: 21225
- Record
- SN06493332-F 20221015/221013230105 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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