Description
This is a sources sought notice only. The purpose of this sources sought notice is to gain market knowledge of potential businesses to provide (see possible description of services and qualification requirements below.) The applicable NAICS Code is 621511, with a small business size standard of $32.5 M. If a solicitation is issued, it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from this response. Responses to this sources sought notice is not a request to be added to a prospective source list or to receive a copy of the solicitation. Information received as a result of this notice will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This notice does not represent a commitment by the Government to pay for costs incurred in the preparation and submission of information or any other costs incurred as a response to this announcement. All businesses currently providing this service are encouraged to reply, as responses will be used by the Government to make determinations about for the appropriate set-aside. No solicitation is currently available at this time. After review of the responses to this sources sought announcement, a synopsis and/or solicitation announcement may be published at a later time. The duration of the services is anticipated to be required for three (3) months. If your firm is currently providing this service, please respond to this Sources Sought notice by Friday, April 20, 2018 at 12 Noon Pacific time. Responses must include: (1) Business Name, GSA contract number (if applicable), or other contract number (2) DUNS (3) Point of Contact Name, Phone Number, and E-mail Address (4) Business Size SMALL or LARGE (5) Type of Business SERVICE DISABLED VETERAN OWNED, VETERAN OWNED, 8A, HUBZone, WOMEN-OWNED etc. (6) Description of your firm s capability in providing these types of services (Include relevant past performance/ contract number and point of contact for services provided) VIP Registration - Veterans First Contracting Program and the VA Rule of Two (Kingdomware v. United States) 38 U.S.C. 8127 - 8128: Service-disabled veteran owned small business (SDVOSB) or Veteran owned small business (VOSB) concern must be registered and verified in VA's Vendor Information Pages (VIP) database at www.vip.vetbiz.gov to be eligible for award as a SDVOSB or VOSB if/when a solicitation is issued for this requirement as a SDVOSB or VOSB set aside. Possible Requirements Contractor shall provide laboratory services to include slides and specimen pickup, transport of specimens to its laboratory and pre-analytic processing as defined in its Laboratory Testing Manual; performing tests for Urinary, Pulmonary, FNA, Body Fluids, GI, Other Anatomic Pathology cases, and GYN cases in support of the San Francisco VA Medical Center,  herein referred as the VAMC, located in San Francisco, CA including analysis, reporting, consultation and results interpretation. After the sample is collected, received in the Anatomic pathology laboratory, the container is labeled with patient name, accession number along with the completed requisition form with two patient identifiers, and type of tests. Make sure it has the correct patient name/identifiers, accession number and proper tests for each request. The tests requested from the laboratory Screen, stain and read GYNs Prep all body fluids of (Urinary, Pulmonary, Body Fluids, GI, other Anatomic Pathology cases) (concentrating, making smears ( 1 PAP, 1 MGG, 1 Thin Prep) CSF ( 1 cytospin, MGG) Staining FNA slides (PAP stain / MGG stain) cell block for (Urinary, Pulmonary, FNA, Body Fluids, GI and other Anatomic Pathology cases) The tests results from the laboratory will be reviewed by Attending Pathologists to finalize diagnosis for VA patients. Place of Performance: Services shall be provided at the contractor s location Pricing Instructions: The total cost shall base on number of tests (slides and specimens) submit to the laboratory for processing including the courier service cost provides by vendor. The tests are submitted to be performed by outside laboratory and accurate results mean increased satisfaction and more effective for our Veteran s care. The VA pathologists evaluate the tissue and determine the best type of testing and amount of tissue available to processing. The total monthly cost depends on number of specimens received within the pathology laboratory which is average 463 cases for a three-month period. The Contractor shall propose the following cytology tests type. Description of Tests (Stains/ Specimens) Estimated Qty. Stain and read GYN case 70-80 cases Prep fluids (concentrating, making smears (1 PAP, 1 MGG, 1 Thin Prep) 180-193 cases CSF ( 1 cytospin, MGG) 3-5 cases Staining FNA slides (PAP stain / MGG stain) 70-85 cases Cell Block 90-100 cases Courier Service - Expect one daily pickup and one daily delivery. 60-65 trips Total for this three months performance period including courier service 1. SCOPE OF WORK 1. 1 Contractor shall provide courier services to pick up and transport specimens to its laboratory; preanalytic processing as defined in its laboratory user s manual; analysis, reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation. Changes can be in volume of tests and test menu. The contractor shall provide the following services: 1.1.2. Provide all necessary supplies, not limited to the following: Requisition forms Special instructions Current list of tests with reference ranges and specimen requirements Specimen carriers All forms, including Chain of Custody forms Special media or tubes for viral samples All supplies for special tests (e.g., but not limited to, viral studies) 1.1.3 Provide specimen pick up courier services as defined in the contract. 1.1.4 Transport samples in such a manner as to ensure the integrity of the specimen. 1.1.5 Contractor shall supply any special preservatives required for specimen preservation. 1.1.6 Analyze samples. 1.1.7 Routine test results shall be reported within 1 to 2 days of specimen testing. 1.1.9 Consult with Laboratory on test results by telephone as needed. 1.1.10 Provide VAMC Laboratories with a means of communication to permit immediate inquiry regarding the status of pending tests. 1.1.11 Billing is on a monthly basis and shall begin the first day of the month and include the last day of the month. 2. LICENSING AND ACCREDITATION. 2.1. Contractor shall have all licenses, permits, accreditation and certificates required by law. 2.1.1. Contractor shall be accredited by the College of American Pathologists (CAP). 2.1.2. Contractor shall be accredited by Centers for Prevention and Disease Control (CDC) under CLIA if contractor is engaged in interstate commerce. 2.1.3 Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified cytotechnologist. 3. CHANGES. 3.1. Any proposed subcontractor changes from what is proposed under this contract must have prior approval by the Contracting Officer (CO). Contractor shall be responsible for assuring all subcontractors have appropriate licensure and accreditation to perform tests that the contractor cannot perform. Contractor shall notify the CO and the Contracting Officer s Representative (COR) of any change of subcontract laboratory. Any change shall be submitted to the CO for review and approval. 3.2. If it is deemed that the removal of the test from the test menu is required, due to any changes by the contractor, then it will be communicated by the CO, COR or designee. 3.3. The VA may need to add test to the test list during the contract term without contract modification. This may be due to a change or discontinued test previously done by another laboratory. Requests may be made for pricing, specimen requirements and methodology. The CO, COR or designee will make the final decision on the appropriateness of moving the test to the contractor. 4. PROCEDURE GUIDANCE 4.1. The Contractor shall not introduce new medical procedures and services for specimens provided by VA without prior recommendation to, and approval of, the COR, or authorized laboratory representative. 4.1.1. The Contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy (per all applicable regulatory agency [RA] guidelines). The standard deviation and daily control records are to be available for review upon request by the Contracting Officer or contracting officer s representative. 4.1.2. The Contractor shall perform repeat tests at no charge to the government if the results do not, in the government requesting physician's opinion; fit the clinical picture of the patient. When requesting these tests, the government requesting physician or representative will explain the conditions of the patient or any discrepancies observed. Repeat tests shall be the same test originally ordered. 4.1.3. The Contractor shall notify the VA COR or designee of instances in which, in the professional judgment of the Contractor, the patient requires services or tests, which were not originally requested. 4.1.4. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government. 4.1.5. Contractor shall fill out and maintain for specimens the VA provided test request form necessary to meet clinical and administrative requirements of VA at no additional expense to the government. 4.1.6. The Contractor shall contact the VA COR to coordinate the furnishing and delivery of specimen collection and transportation supplies. 5. SPECIMEN PICK-UP TIMES. 5.1. Routine. Contractor must be located within a geographical area which enables sufficient courier transportation and processing time for slides to be delivered by 9:00 am the following day except on Saturday and Sunday. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA COR but not less than once daily or as requested by COR or POC at SFVA Anatomic Pathology. The VA COR or designee shall notify the Contractor during weekends (if not already scheduled) and federal holidays, via telephone, when a pick-up courier is required. 6. TEST RESULTS. 6.1. Routine. The Contractor shall provide routine test results to the ordering VA facility within 1 to 2 days following test completion, except when specimens are picked up the day before a weekend or holiday (in which case the results will be provided the following business day). 6.2. Telephone Consultation. The Contractor shall consult with the VA COR, requesting Clinician or designee at the VAMC by telephone as needed. 6.3. The Contractor shall immediately telephone the respective VA COR; requesting Clinician or designee to report Critical Values or test result that may indicate a life threatening condition. 6.4. Reporting of Results. A report is defined as a printed final copy in duplicate of laboratory testing results. If results are telephoned, the report must include the name of the individual notified of the results. Each test report shall at minimum indicate the following information: -Patient's name and/or identification code (Social Security number if provided) -Physician's name (if supplied) - Facility Name -Patient's location (clinical/ward), (if supplied) -Date/time specimen received in Reference Lab -Test ordered -Date/time of specimen collection (when available) -Date test completed -Test result -Flag abnormals -Reference range -Toxic and/or therapeutic range where applicable -Testing laboratory specimen number -Name of testing laboratory (contractor and/or subcontractor) -Type of specimen -Any additional comments related to test provided by submitting labs. -Any other information the laboratory has that may indicate a questionable validity of test results. -Unsatisfactory specimen shall be reported with regard to its unsuitability for testing. SLIDES. 7.1 The Contractor shall return representative cytology slides, etc., for quality control review if requested. Quality control slides shall represent duplicate copies original slides prepared by the Contractor from permanent tissue blocks. The Contractor shall provide quality control slides to the participating VAMC or clinics at the same time the contractor submits the final reports. 7.2 The Contractor shall prepare additional blocks and slides, in quantities specified by the participating VAMC for review by pathologists. 7.2.1 For malignant cases, the Contractor shall call results to the submitting VAMC, and prepare paraffin blocks and slides review by the Joint Pathology Center (JPC) or other Government Pathology Organization (GPO). 7.2.2. For benign cases, the Contractor shall prepare slides for review by participating VA. 8. STORAGE OF SPECIMENS. 8.1 The Contractor shall store all specimens as required by regulatory agencies (RA) 8.1.1 Upon request by the VA COR or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA. All the specimens and slides need to be submitted to VAMC after the testing. 9. TEST SAMPLES. 9.1 Upon provision of sample slides by the government, the Contractor shall provide interpretation of sample slides. The slides may include all types of fluids, FNA s, gynecology and non-gynecology cytology slides or specimens. 10. MONTHLY TESTS SUMMARY. 10.1 The Contractor shall provide to each VA a cumulative (year-to-date) and monthly report of all tests received during the month and for all outstanding results. The report will also include turn around statistics, cost per test (including any additional charges) and specimen or testing issues. 11. SERVICE. 11.1 The contractor shall provide telephone number(s) and contact person to be used by the VA facilities to make specimen problem inquiries and problem solving at all times including weekends and holidays. 11.1.2 The contractor shall include names and telephone numbers of technical Directors and Pathologists available for consultation. 11.2. Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency (RA). 11.3 Contractor shall assign a specific local account representative to each VA facility. 11.4 Contractor shall advise facility of any changes in methodology, procedure, reference ranges, delays in testing, and any new tests introduced within a timely manner and prior to changes are made. 11.5 In the event that the contractor changes the assay procedure of a critically important component of an assay (e.g., and antibody, purified antigen, etc.), the contractor shall notify the VA COR prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged or be improved when desirable for all tests. All new tests shall have CPT codes and LIONC coding. Changes in the assay materials or procedure 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 CO/COR. 11.5.1. If it is deemed that the removal of the test from the test menu is required, due to any changes by the contractor, then it will be communicated by the CO, COR or designee. 12. TELECOMMUNICATIONS. 12.1 Telecommunications Linkage. Each VA shall receive transmission of the results to a teleprinter located at the hospital site. Any necessary connection/devices shall be the responsibility of the contractor (including one commercial phone line for terminal/datafax connection if required). The transmission of all the completed and/or partial test results shall arrive at the hospital within published TAT except where specified. The contractor is responsible for all supplies required for transmission of test results. 12.2 The teleprinter system (all elements of the transmission path including the transmitter and associated receivers) must be able to: (1) Print multipart copies of the laboratory reports, minimum of two copies. (2) Provide format of the copies equal to the current facilities format. (3) Provide remote teleprinter motor on and off. (4) Operate in a "normal" medical center-operating environment without additional expense for air conditioning, humidity control, or noise suppression. (5) Reprint a report at the local VA laboratory. 12.3 The contractor shall: (1) Be responsible for preventive and as-needed maintenance on the teleprinter, PC and all associated devices; (2) Have the responsibility to train medical center personnel in routine operations (loading and unloading paper, ribbon changes, test and reset); and (3) Provide a validation service (fax or telephone) in the event of transmission or printer degradation. 13. TESTING METHODOLOGY & REFERENCE. 13.1 Testing methodology and reference ranges for a test must be defined in the laboratory user manual. 14. CONTRACTOR PERSONNEL. 14.1 The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. Technologist, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology acceptable to the United States Surgeons General must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction; and shall have provided pathology services a minimum of 24 months within the past 36 months and pathology consultation services a minimum of 36 months within the past 48 months. 14.2 The Contractor shall maintain current licenses and certificates and provide copies of such to VA upon reasonable written request. 15. CONTRACT QUALITY ASSURANCE/QUALITY CONTROL. 15.1 To ensure proper handling and test performance, the contractor shall provide the following updated information upon request during the life of contract: 15.1.1 For quality purposes, tests routinely performed in duplicate should be indicated. 15.1.2 Indication of average monthly volume of specified tests in the Schedule that the laboratory performs. 15.1.3 Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs. 15.1.4 Proficiency testing data shall include a list of tests outside of the acceptable range for past 2 years. 15.1.5 Contractor shall provide address of processing sites under contract, including subcontracted testing location sites. 15.1.6 The contractor(s) facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the government upon prior written notice and during normal business hours during the life of the contract. 16. HOURS OF OPERATION. 16.1. Normal Hours of Operation. The Contractor shall perform the services required under this contract 8 to 10 hours a day, 5 days a week, 12 months of the year. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA COR. 17. RECORDS. 17.1 The Contractor shall be responsible for creating, maintaining and disposing of only those government required records that are specifically cited in the work statement or required by the provisions of a mandatory directive listed in section (d) Applicable Publications and Forms. If requested by the VA COR, the Contractor shall provide the original record, or a reproducible copy of any such record, promptly of receipt of the written request. 18. PATIENT LISTS. 18.1 The Contractor shall treat patient lists, no matter how developed, as privileged information. Lists and/or names of patients shall not be disclosed to or revealed in any way for any use outside the participating VAMC without prior written permission by the VA COR or Chief of the Medical Staff. 19. RELEASE OF MEDICAL INFORMATION. 19.1 The Contractor shall not release any medical information obtained during the course of this contract to anyone outside the VA, unless authorized in writing by the VA COR and the patient, as required by applicable law. 20. COLLEGE OF AMERICAN PATHOLOGISTS (CAP). 20.1 All testing facilities providing laboratory services under the contract must possess a valid state license, CLIA license and full accreditation from the College of American Pathologists (CAP). Contractor shall provide evidence of such accreditation upon receipt of a written request. 21. PROFESSIONAL LIABILITY INSURANCE. 21.1 Professional liability insurance shall be by a commercial insurance company in the business of providing the required insurance coverage. The Contractor shall provide a copy of the Insurance Certificate upon receipt of a written request. 22. SAFETY. 22.1 The Contractor shall comply with all applicable OSHA, Federal, State, laws, and regulations as required for performing the type of services required. 23. END OF CONTRACT PERFORMANCE. 23.1 At the end of the period of contract performance, the participating medical treatment facility will notify the Contractor. 24. GENERAL DEFINITIONS. Critical Value. A test result that requires evaluation by a physician or other health care provider as soon as verified. Failure to take appropriate action as a result of a critical value might cause harm or undue suffering for a patient. A list of critical values is to be made available to each VA facility upon request. Paraffin Block. A tissue specimen that has been embedded in paraffin wax that the sections can be cut for histologic examination. Reference or Referral Laboratory. The contract laboratory that provides testing, and examination of specimens provided by the medical treatment facility. Reference Value. A range of test values expected for a designated population of individuals. Slides. Glass surface containing biological material to be analyzed. Specimen. A body fluid or tissue sample removed for medical examination and analytical testing. Cytology Specimen. A sample or part of an organ or tissue removed during surgery for medical examination and analytical testing. Tests. Diagnostic assays to evaluate a patient's physiological condition. Routine Test - A test that is usually performed at high volume in which the result is required in 24 hours generally. TAT - The length of elapsed time between pick-up or dispatch of specimen from the contractor s laboratory until the receipt of the completed printed/ electronically transmitted report back in the lab. Special handling - Unusual circumstances may dictate the need for a specimen to be picked up, run out of sequence at a special time, or reported within a shorter than usual time. Overflow - A test usually performed in the VAMC lab, which might be referred to the contractor s laboratory in case of instrument breakdown or other circumstances interfering with the VAMC s ability to analyze the specimens. Proficiency Testing - An assessment of the accuracy of testing by a laboratory based on the analysis of an unknown specimen analyzed by a large number of other labs. The proficiency survey is conducted by an organization or agency authorized by the Department of Health and Human Services to do so. 27. SAMPLE PREPARATION. 27.1 Each VA facility will provide laboratory specimens prepared according to the contractor's laboratory specimens according to industry standards. Contractor shall supply any special preservatives required for specimen preservation.