Loren Data's SAM Daily™

FBO DAILY ISSUE OF MARCH 28, 2009 FBO #2679
SOURCES SOUGHT

Q -- LABORATORY TESTING

Notice Date

3/26/2009
 

Notice Type

Sources Sought
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
 

ZIP Code

20892-5480
 

Solicitation Number

NIHCL20009034
 

Archive Date

4/25/2009
 

Point of Contact

India E. Payne,, Phone: 301-496-4848
 

E-Mail Address

ipayne@nih.gov
 

Small Business Set-Aside

N/A
 

Description

The National Institutes of Health, Clinical Center is conducting a market survey/sources sought so help determine the availability and technical capability of qualified Small Businesses, Veteran-Owned Small Businesses, Service Disabilities Veteran-Owned Small Businesses and/or HUBZONE Small Businesses who are manufacturers of the products described below and are capable of serving the needs mentioned below. According to FAR 19.102(f)(f)(1)(2), manufacturer is defined as acquired is the concern which,…”the manufacturer of the end item being acquired is the concern which, with its own forces, transforms in organic or organic substance including raw materials and/or miscellaneous parts components in such end items. A concern purchases items and packages them into a kit is considered to be a non-manufacturer Small Business… “The applicable NAICS code is 621511-500 employees. Any firm who is a Small Business that manufacturers the above noted products requested must identify themselves as such when responding to this market survey. All firms responding to this market survey must identify their firm’s size and type of business (e.g. small business, service disabled, HUBZONE, 8(a), etc. and whether or not they are the manufacturers as defined by FAR 19.102 (f)(f)(1)(2) or dealer or distributor of these kinds of products. This information will assist the government in determine in accordance with FAR Acquisition Regulation (FAR) 19.502(b) and (c) whether or not this procurement will be set aside for any of the programs described above. This market survey/sources sought announcement is not a request for proposals and the Government is not committed to award a contract pursuant to the announcement. The information from the market research is for planning purposes only and will only assist the Government in planning its acquisition strategy. This is strictly market research and the Government will not entertain questions concerning the market research. The Government will not pay any cost incurred into the preparation of information for responding to this market survey. The National Institutes of Health (NIH) is a 234-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 process and report approximately one million test results per year. Because of the unique research role of the NIH, there is also a need for outside clinical laboratory test services to support and augment in-house capabilities. Off-site laboratory services support ongoing clinical research and clinical trials through the performance of unique or unusual tests. Because of the research focus, each sample requires a high degree of methodological and reference range uniformity to ensure consistency over time. Historically, the off-site laboratory services have performed approximately 28,000 tests per year. PURPOSE The purpose of this contract is to establish a mechanism for obtaining laboratory services. This contract will provide service to the multiple Institutes of the National Institutes of Health through a central site 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, laboratory services should be provided by a Contractor who has the capability to furnish all laboratory tests listed in Section B in a timely manner. It is imperative that changes in reference ranges and methodologies be limited during the length of the contract, because the laboratory results will be used in clinical trials. It is expected that most of the tests will be performed directly by the Contractor, however, some may (must?) be distributed to sub-contractor laboratories, if approved or requested by the Department of Laboratory Medicine COTR. CONTRACT TASKS TO BE PERFORMED Independently and not as an agent of the Government, the Contractor 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 Contractor shall perform the laboratory tests as specified in Section B with their estimated quantities. 1.The following requirements shall be accomplished by the Contractor in relation to the items listed in Section B. a)The contractor will provide adequate information regarding specimen collection requirements including volumes and containers. Written catalogs, interpretation manuals and on-line computer assistance or web sites for proper specimen collection and test methodologies will be provided. b)Specimens shall be picked up at the NIH, in Building 10, Room 2C-324, at least once per day, Monday through Friday at 5pm or later, and at other designated locations on the NIH, Bethesda, Maryland campus. Specimens will also be picked up on Saturdays and holidays before 3pm, if needed. c)The Contractor will be responsible for packing and marking all specimens for shipping. The contractor will be responsible for managing the shipping process from sample receipt through the receipt by the Contractor at the off-site location. All samples need to be shipped and received by the contractor’s off-site lab at least within 24 hours of day that they are received into the lab at the Clinical Center. The Contractor will bear all costs for postage, handling and delivery fees. d)DLM will provide a work area and the Contractor will furnish on-site personnel, equipment, materials and computers to ensure the prompt communication of test results and to facilitate the movement of samples between the Clinical Center and the Contract facility. The training of on-site personnel must be facilitated by contractor to perform primary responsibilities. e)All specimen containers shall be provided by the Contractor as well as the containers that will be used to pack the specimens. The contractor will also supply any dry ice or cool packs to maintain proper temperatures for shipping. f)The Contractor shall use the “Specimen Logs” which are produced by the Department of Laboratory Medicine’s computer. The specimen log lists all of the specimens that are being sent out at a certain time. It lists the accession number of the specimen, the patient’s name, hospital number, and the test(s) requested. No other paperwork shall be required to accompany the specimens contained in Section B. The contractor will also assist in any questions from DLM or the users of DLM about specimen requirements for those tests that will be sent to the contractor. g)The contractor would have to supply evidence of high quality compatibility with Soft Computer System (SCC). Data security confidentiality must be demonstrated. h)The contractor will assume all costs for building the interface into the Soft Computer System (SCC) if a new interface is requested. i)The Contractor will provide a remote terminal and will accession the test requests into the off-site Contractor’s computer system. The Contractor will transmit the test requests from SOFT LIS to the Contract laboratory LIS. Manual entry for the test not interfaced will be performed by contract personnel. (Dr. Remaley added ‘The contractor will also be responsible for developing and or paying a subcontractor to develop any software for transmission of laboratory results into SOFT LIS.) j)The Contractor shall provide data entry of all test results into the Department of Laboratory Medicine’s computer. The turn-around time for test results will be based on contractor standards and methodologies. The Contractor will transmit results data from the Contractor LIS to SOFT LIS and perform manual entry for tests not interfaced. Each electronic result file must contain a comment that indicates the name and address of the laboratory performing the test. Corrected reports files must be annotated as “corrected” and contain the previous result and date the test was performed. The SOFT LIS interface for the referral laboratory must be built and the Contractor must be able to demonstrate that the system is ready for “live” implementation upon award of the contract. Award of this contract requires that the contract laboratory have a prior successful interface with other Soft client laboratories. Technical information regarding this electronic system for management of laboratory date can be obtained from Soft Computer Consultants, www.softcomputer.com, 5400 Tech Data Drive, Clearwater, Florida 33760. The phone number is 1-800-763-8522. Computer hardware and software systems utilized by the Contract Laboratory must be compatible with SOFT technology. k)The Contractor shall list the % of tests in Section B that they would perform at their facility and the % of tests that would be sent to off-site facilities. l)The Contractor shall specify the handling fee charge when sending specimens to an off-site facility. m)The Contractor shall package all specimens for shipment in the Department of Laboratory Medicine. The Contractor will verify that the Specimen Logs are correct, and that the specimens are ready for pickup. n)Hard copies of reports are not required if all data is contained in the electronic data file transfer including interpretative data (and any extensive comments) pertaining to test results. However, if requested, one (1) hard copy of the test report must be provided to the Department of Laboratory Medicine within three (3) days of request. Hard copies of reports are required for test reports that contain extensive interpretations (if the report is not transmitted in its entirety). All test reports must include the name and address of the contract laboratory or sub-contractor laboratory at which it was performed. o)The Contractor shall provide strong technical advice and expert consultation services 24/7. The Contractor shall provide updates 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 Contractor must also provide copies of their methods when requested by DLM. p)The Contractor and all sub-contractors shall provide thirty (30) days advance written notice (from the date the written information is received by the Department of Laboratory Medicine to the effective date) of any changes which will be made in methodologies, reference ranges, reagents or procedures. However, no changes will be permitted unless written approval is received in advance from the Contracting Officer. An administrative charge $250.00 for each occurrence will be charged for failure to give the required 30-day notice, and when the changes are made prior to receiving the written approval from the Contracting Officer. The $250.00 administrative charge shall be deducted from the weekly invoices. q)The Contractor shall have laboratory certification consistent with Clinical Laboratory Improvement Act (CLIA) 1968 and CLIA 1988, to perform these laboratory services. The current copy of the CLIA certification should be submitted with the response to this proposed contract. The contractor shall provide annually copies of certificates as evidence of CLIA certification and inspection by accrediting agencies. This contract requires the operation of a system of patient records. Thus, the Privacy Act requirements are applicable. The Contractor and its employees are subject to criminal penalties for violations of the ACT (5 U.S.C. 552a(I)). Hence, the Contractor shall assure that its employees abide by prescribed rules of the Privacy Act. r)The Contractor would supply discounted prices for other NIH sites that would take into account DLM volume. s)The escalation fee of all contract tests would not exceed 2% each year. t)The Contractor shall perform essentially all of the tests listed in Section B at one facility in one location. If the contractor does not provide the test on-site, or if the Department of Laboratory Medicine personnel request that a specific test be performed at an alternate laboratory, the contractor will forward the specimen to the appropriate referral lab in the appropriate container and provide test results to the Department of Laboratory Medicine. The laboratory’s name and address that performed the test must appear on the test report in the electronic file transfer and on the hard copy if requested. u)The Contractor will ensure that the alternate laboratory is certified in accordance with CLIA. v)The Contractor will be responsible for fulfilling IT security training annually. w)The Contractor shall verbally notify and provide a faxed copy of all alert limits, panic value reports and corrected reports to Department of Laboratory Medicine personnel and to the on-site contract personnel within one hour of discovery. During duty hours, the on-site contract personnel will notify the requesting physician. Alert limit values and corrected reports will be followed up with a hard copy of the report. x)The Contractor will provide prompt Customer Service and on-site personnel will act as a liaison with the Reference Lab. The on-site personnel will provide prompt response to inquiries regarding test requirements to NIH patient care providers on a Monday through Friday basis. On-site personnel will respond within one hour to requests for the retrieval of information on patient results. Client Services and the ability to consult with experts at the Contract lab must be available to NIH requestors via toll free telephone 24 hours per day, seven days a week. The Contractor shall perform an audit every six months (DLM website, http://intranet.cc.nih.gov/dlm) so that volume increases can be identified. A decision to bring tests in-house based on increasing volumes would not be met with any penalty. Equally, tests would be added to the contract with the expectation of receiving a discount. NOTE: In the event that the Government requires additional tests for the NIH community due to changing research requirements, it is expected that the Contractor will provide the same discounts for any new tests listed in their catalog without modification to the contract. The contractor will review the contract to include tests with volume of 100 or greater into the contract at the stated contract price. B.The government shall provide the Contractor with the following: (1)A specimen log listing all the tests requested and the corresponding specimens available. (2)Computer security/training by NIH ISSO. C.The representative(s) of the Contractor shall resolve any problems such as, but not limited to, QNS samples, wrong type of specimen, and/or improperly collected sample with a member of the Department of Laboratory Medicine. The Contractor should properly store any received samples for at least a 14-day period to allow for reruns or add on tests. It is expected that the Contractor has an on-going quality assurance process to identify missing specimens and incomplete testing. The Contractor shall meet at regular intervals (as frequently as monthly) with the Contracting Officer’s Technical Representative (COTR) and members of the senior staff of the Department of Laboratory Medicine to monitor the performance of the Contractor and to resolve any problems. The Contractor will provide continuing education opportunities via free attendance at sponsored seminars and teleconferences. The Contractor will provide professional consultation to provide assistance with the interpretation of test results, selection of tests, and preferred methods of analysis. There will be opportunity for collaborative projects. The Contractor will provide assistance with method development and validation by providing samples to be used in the validation process. The Department of Laboratory Medicine shall be permitted to send up to 25 blind control samples per month free of charge to monitor any assay suspected as being questionable by the Department of Laboratory Medicine. The Contractor’s quality control record and turnaround report for any analyte shall be available to the Department of Laboratory Medicine for review upon request. Initial review that all data has been entered is done by contract employees. The Department of Laboratory Medicine will review the Contractor’s data entry results by means of a computer generated “master log.” An “incomplete test list” provided by the computer will be used to monitor the timeliness of data entry and to ensure that the turnaround times are being met. TECHNICAL REPORTING REQUIREMENTS The Contractor shall submit the following acceptable deliverables/reports in accordance with the Statement of Work. These deliverables/reports shall be delivered to the individuals specified in Section F in the quantities specified. 1.All lab test results will be received via the SOFT LIS interface on a regular and continual basis. If the interface is not operational, the Contractor will provide to the Department of Laboratory Medicine one (1) hard copy with all applicable NIH patient numbers for all laboratory test results within a 24-hour period. Once the interface is operational, the Contractor will enter all results into the computer in units specified by the Department of Laboratory Medicine. 2.If requested for any reason, one (1) hard copy of the test report must be provided to the Department of Laboratory Medicine within three (3) days of request. 3.Provide a written report to the COTR with at least a 30-day advance written notice about any forthcoming changes in methodology, procedure, reference ranges and/or reagents. If no changes, a report will still be required with a “no change” statement. 4.Provide a written notice to the Department of Laboratory Medicine for each test delay and the cause when the specified turnaround time will be exceeded by more than three (3) working days. 5.Provide thirty (30) days advance written notice (from the date the written information is received by the Department of Laboratory Medicine to the effective date) of any changes which will be made in methodologies, reference ranges, reagents procedures, or alternate testing facilities. 6.Hard copy of all laboratory tests results as required shall contain all of the following information: NIH patient hospital number NIH patient name Date of birth NIH accession number Date and time sample collected from the patient Date and time logged in by Contractor Date and time report received at NIH Name and address of laboratory that performs the test The test value with appropriate units Reference range The interpretation of test results if applicable 7.Contractor will retain Clinical Center samples for up to one month after receipt. 8.The monthly report delivered to the COTR shall list all tests that pass through the contractor’s laboratory, whether they are performed at the contractor’s lab or forwarded to another lab for testing. The report should be composed of the client’s account #, the test code, the test name, the CPT code, the list fee, the client fee, the MTD charges, the MTD volumes, the YTD charges, and the YTD volumes. This summary report should reach the COTR within seven (7) days after the month has ended. 9.For any on-site employees, the following reports for compliance with control of infectious diseases in Federal facilities will be required: •An initial report within 30 days of initiation of the new contract which includes the itemized compliance by each on-site worker for a history of immunization or immunity for measles, varicella and Hepatitis B vaccine; attendance at Universal Precautions training; annual TB screening and evaluation and documentation of the potential exposure to M. tuberculosis. •Semi-annual reports to the Hospital Epidemiology Service shall include itemized compliance by each employee for the factors listed in the initial repot as well as a summary compliance report with the inclusion of TB surveillance activities. •As new employees are hired, an itemized compliance report must be submitted to the Hospital Epidemiology Service within 30 days of beginning employment. •Contractors must notify the Hospital Epidemiology Service immediately for any contract employee identified with suspected or active pulmonary or laryngeal tuberculosis or a PPD skin test conversion. 10.All on-site employees must show written documentation of attendance at Clinical Center orientation and any other NIH training that is necessary for contractors. The contractor will provide written documentation of the competency assessment of technical skills as well as written documentation of the employee’s ability to meet Clinical Center competencies. Copies of employee performance evaluations must be available upon request. 11.Annually provide copies of certificates as evidence of CLIA certification and inspection of accrediting agencies. Guarantee that alternative testing sites used by Contractor are CLIA certified. INVOICE SUBMISSION AND PAYMENT Weekly invoices itemizing the type of tests, the date of the tests, the patient name and test costs will be submitted to the Department of Laboratory Medicine purchasing agent and the administrative officer. Invoices will delineate contract vs non-contract charges. Summary page will outline contract vs non-contract charges. All payments will be made by government purchase card. REPORTING AND DELIVERY REQUIREMENTS The contractor shall submit to the COTR the following items in the quantities and in accordance with the schedules specified: ITEMQUANTITYDUE DATE 1. A report itemizing all tests One Within 7 days after requested and costs each month.the end of each month 2. A report itemizing all tests OneWithin 7 days after requested and costs year to datethe end of each month 3.A set of invoices from the OneAt least once a month billing officeto the Department of Laboratory Medicine (DLM) for payment by purchase card. 4.Notification of reference rangeOneAt least 30 days in or methodology changeadvance of effective date 5.Provide personnel (two full-time As needed employees on site); supplies; all Equipment (specimen refrigerator/freezer), services for transport or specimens, Supply cabinet, fax machine, printer, furniture (ie, desk) EVALUATION/AWARD CRITERIA The Contracting Officer and evaluation panel will select for purposes of award the best overall proposal based primarily upon technical merit with cost and other factors considered as appropriate. In determining the best overall proposal, the following minimum qualifications will be considered: 1.TECHNICAL PROPOSAL – An objective technical evaluation will be performed on each offeror’s technical proposal based solely on the information furnished and not on previous knowledge or associations. a. An objective price analysis will be performed on each offeror’s price proposal including all options. Any proposed prompt payment discounts or credits will also be evaluated. For details on how each offerors price will be evaluated see the price evaluation section. b. The Offeror receiving this award must be accredited by the College of American Pathologists or show evidence of certification with equivalent standards and be eligible to obtain Federal contracts. The quality of testing will be evaluated based on the qualifications of the technical and directorial staff and the diversity of the test menu. The quality of testing will also be judged on whether state-of-the art test methodologies and instrumentation exists, the capability of interfacing with SOFT (SCC) Laboratory Information System, (ordering and reporting) and the capability to provide extensive data on test performance upon request. c. The Offeror shall provide the best turn-around-times available based on industry standards and methodologies and have to meet the clinical needs of DLM. Reporting of these results must be electronically transmitted by Contractor’s Laboratory Information System (LIS) to the DLM SOFT LIS. This interface must be built and tested prior to final acceptance by the Government. The Contractor will be responsible for any cost related to the initial building or maintenance of the interface. Consideration will also be given to the % of testing that will be performed at on-site facility and the % of testing that will be sent off-site. d. The Offeror shall provide client services that will include customer services via telephone 24 hours a day, seven days a week, support for specimen handling and a dependable courier service with option of weekend pickup at no additional cost with delivery to the testing lab by at least 5:00am local time the following calendar day. e. The offeror shall provide support for test interpretations through the use of consultations with doctoral experts, interpretive guides, extensive data on reference ranges and test performance and parallel testing of specimens when there are methodology changes. f. The offeror shall provide support to the Department of Laboratory Medicine operations by giving assistance with method validation and evaluation, new test development, and offer continuing education programs. Within one (1) year after the contractor has developed a new test, the contractor when requested shall assist the NIH Clinical Center laboratory in the development of this new test for use in the NIH Clinical Center laboratory. g. 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. h. Past Performance/Prior Experience Past Performance Past performance will be evaluated from a business and technical standpoint to determine the relative merits of the proposal. The performance of the contractor on earlier work for the Government or the private sector will be a very significant indicator of how well the contractor can be expected to perform the required services in the future. The information presented by the contractor together with that available from sources within the Government will provide the information for this portion of the technical evaluation. References from labs with a similar lab set-up are requested at time of submission. The Offeror’s past performance will be evaluated after determination of the competitive range of the proposals. Only those offerors included in the competitive range will be evaluated. 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. 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. 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. Past performance will be scored, and the Government’s conclusions about overall quality of the Offeror’s past performance will be highly influential in determining the relative merits of the offer’s proposal and in selecting the offeror, whose proposal is considered most advantageous to the Government. 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. 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. 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. 2.GENERAL RELATIONSHIP – TECHNICAL MERIT VERSUS COST In the relationship of technical merit versus cost, offerors are advised that overall cost of contract performance will not be considered as controlling. However, in the event evaluations result in substantially equal technical proposals, overall cost will be a major factor in selection of a proposal for award. In the event evaluations result in acceptable technical proposals with a significant difference in technical weighting, overall cost will be considered but will not be major in making a determination as to which proposal offers the greatest value and is most advantageous to the Government. The vendor‘s response shall also include any other specific and relevant information related to the requirements of this project that will enable the Government to determine the capabilities of the company to perform the specialized requirements described in the synopsis. Interested organizations must demonstrate and document in any response submitted, to this market survey extensive with and the ability to perform all of the specialized requirements elsewhere described. This notice is a market survey and is for information and planning purposes only and does not commit the Government to any contractual agreement. THIS IS NOT A REQUEST FOR PROPOSALS. The Government will not award a Purchase Order or contract based upon Vendor responses to this announcement. The Government shall not assume any costs for preparing or submitting any information in response to the survey of the Government’s use of the information. Any proprietary information should be clearly identified as “proprietary information.” Vendors must send written capability responses by April 10, 2009 to the Contract Specialist as the following address National Institutes of Health, 9000 Rockville Pike, Bethesda Maryland 20892, Building 10 Room 2C537C. For any questions, please contact India Payne 301-496-4848.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=3997fa3d7e4383589330000ce2cb47f5&tab=core&_cview=1)
 

Place of Performance

Address: Department of Laboratory Medicine,National Institutes of health 9000 Rockville Pike, Bethesda, Maryland 20892 Bldg 10 Room 2C306, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN01778472-W 20090328/090326215907-3997fa3d7e4383589330000ce2cb47f5 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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