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FBO DAILY - FEDBIZOPPS ISSUE OF DECEMBER 20, 2014 FBO #4774
DOCUMENT

Q -- Prescott ANATOMIC PATHOLOGY SERVICES - Attachment

Notice Date

12/18/2014
 

Notice Type

Attachment
 

NAICS

621111 — Offices of Physicians (except Mental Health Specialists)
 

Contracting Office

Department of Veterans Affairs;VISN/18PHX;777 E. Missouri, Suite 300;Phoenix AZ 85014
 

ZIP Code

85014
 

Solicitation Number

VA25815N0156
 

Response Due

12/22/2014
 

Archive Date

3/22/2015
 

Point of Contact

Michael Lane
 

Small Business Set-Aside

Total Small Business
 

Description

Please provide an e-mail indicating your interest for this project to Michael.Lane3@va.gov PERFORMANCE WORK STATEMENT The purpose of this PWS is to procure anatomic pathology services from a qualified Reference Laboratory (hereafter Contractor) for the Northern Arizona VA Health Care System (hereafter NAVAHCS) on an as-needed basis. The tissue specimens will be obtained in order to determine a veteran's risk of cancer or other histopathologic and cytological anomalies, as determined by specimen slide analysis by a board certified pathologist. In accordance with VHA Handbook 11006.01 Transmittal Sheet, the VHA Handbook is issued to provide procedures for the administration, accreditation, staffing and functioning of clinical and anatomic pathology laboratories in the Department of Veterans Affairs facilities. NAVAHCS does not have an anatomic pathology department, and the clinical pathology laboratory department must be under the directorship and guidance of a qualified, licensed consulting pathologist. This consulting pathologist must ensure the laboratory director responsibilities are discharged as cited in 42 CFR 493.1445. NAVAHCS is in need of a service that will provide a licensed consulting pathologist for the role of Laboratory Director, surgical specimen processing with interpretation, and cytological specimen processing with interpretation. Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide reference laboratory services to the NAVAHCS described herein. Reference laboratory services include, but are not limited to: specimen preparation and storage; transportation of clinical laboratory specimens, microbiology cultures, and stocks; performance of analytical testing; reporting of analytical test results; and consultative services. The Contractor must be CLIA certified and confirm that they are a covered entity. A Business Associate Agreement is required. In accordance with Appendix A, Handbook 6500.6 Checklist block 6 and 7, the C&A requirements apply to this requirement, and Security Accreditation Package is required. There is sensitive information to protect. I.Specimen Testing A.The Contractor shall pick up, process, embed, stain, cut, and coverslip the specimens, provide pathological analysis, and report findings in a reasonable time frame. Note: The Contractor must offer the Technical Component separately from the Professional Component on both their test menu and the bill of charges. Note: Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change. Note: Any new test(s) not listed must be added to the contract through modification by the Contracting Officer (CORs and Government facility representatives do not have this authority) prior to specimen being tested. B.The Contractor shall embed, stain, cut, and coverslip the specimens; and then return the specimen to the NAVAHCS for pathological analysis by VA pathologists upon request. This could be called a "block and stain" service for anatomic pathology specimens should a special circumstances arise. 1.The specimen cassettes (yellow and green) will be identified by sequential case numbers assigned by the Laboratory staff at the NAVAHCS. Completed and processed slides will be return from the Contractor with the same case numbers. 2.Upon receipt of yellow cassette tissue specimens, the Contractor shall embed, perform a Hematoxylin & eosin stain (H&E), perform a single cut of the specimen, and affix it to a slide with a coverslip. 3.Upon receipt of green cassette biopsy specimens, the Contractor shall embed and stain the specimen. Then two cuts shall be made; one shallow and one deeper, according the proper processing of CPT code 88305 - Technical Component. Both cuts shall be affixed to a microscope slide and coverslipped. Note: The Professional Component - the reading and analysis of the microscope slides by a board-certified pathologist - shall be performed by VA staff. During an "as needed" event this service is not required of the Contractor. The Contractor must offer the Technical Component separately from the Professional Component on both their test menu and the bill of charges. Note: Contractor shall notify the Contracting Officer and each Government facility of any test information modifications no later than two weeks prior to the implementation date of the test change. Note: Any new test(s) not listed must be added to the contract through modification by the Contracting Officer (CORs and Government facility representatives do not have this authority) prior to specimen being tested. C.All Contractor testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the COR or designee. D.The Contractor shall ensure the accurate and timely performance of laboratory testing services on the biomedical materials. II Laboratory Directorship Clinical Laboratory Management Services: The contractor will provide 4 to 8 hours of professional services per week. Routine work hours for the NAVAHCS are 7:00 am to 4:30 pm Monday through Friday, except for Federal Holidays. Contractor must be available, on site, within 30 minutes for emergency consults or inspections that may occur. (a)Provide clinical and technical consultation as requested by NAVAHCS Laboratory staff. (b)Attend Laboratory staff meetings and other medical staff meetings as deemed necessary. (c)Provide monthly quality assurance review or as requested by the Contracting Officer's Technical Representative. (d)Be actively involved in the design, implementation and oversight of the quality management system in the laboratory. Provide monthly review of quality control records and review of proficiency testing results. (e)Provide direction and consultation in Transfusion Medicine as necessary to maintain FDA and CAP accreditation or as requested by the Contracting Officer's Technical Representative. (f)Provide availability of consultation on a 24/7 basis, either by telephone, fax, email or in person. Contractor will provide a monthly schedule with name and telephone number of the on call pathologist. (g)Involvement and consultation in the selection of equipment and methodology used for laboratory testing. (h)All services performed must be in compliance with JC, FDA and CAP requirements. (i)Must be able to interact positively with VA patients, providers and NAVAHCS employees. (j)Will meet appointment and credentialing standards of the Medical Center's Professional Standards Boards for full privileging in clinical pathology services. (k)Will be qualified and trained as demonstrated by Certification of the American Board of Pathology. (l)Will participate in the AFIP and/or CAP Anatomical Pathology surveys as defined by the Pathology & Laboratory Medicine Service in central office. (m)Laboratory Medical Directorship will be provided and duties as delineated in the CAP guidelines. (n)The Contractor will provide input to any Peer Review or Process Review required by the Joint Commission on Accreditation of Healthcare Organizations directly relating to a patient treatment or incident resulting from actions taken as a result of the consultation or report. (o)VA may evaluate the quality of professional and administrative services provided but will retain no control over medical and professional aspects of services rendered (e.g., professional judgments, and diagnosis for specific medical treatment). The Chief of Staff or designee, will monitor patient care via the peer review process and the quality of direct patient care delivered by the Contractor. III.Specimen Preparation and Storage for Reference Testing Specimens A.Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory. B.Contractor shall be responsible for storing specimens in such a manner to insure the integrity of the specimen. IV.Transportation Services for Reference Testing Specimens A.Contractor shall provide transportation of primarily biomedical materials that include patient specimens, originating from the NAVAHCS and destined to their contracted reference laboratory facility. These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained. 1.Note: The NAVAHCS will not employ use of their own courier services for this contract. B.Routine transportation services shall occur a minimum of once per day: 1.New specimens shall be picked up from the NAVAHCS no later than 5:30 pm each business day, Monday through Friday, not including government holidays. 2.There are no conditions for Emergency Transportation. C.Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor's laboratory. These supplies shall include, but may not be limited to: 1.Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor's laboratory. 2.Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates. 3.Test request forms. V.Specimen Retention A.All anatomic pathology materials (e.g., histology blocks, slides or other diagnostic material) generated by the VA shall be returned within 2 days after final diagnosis is reported. VI.Reporting of Results A.The results of testing shall be reported within the prescribed turnaround times provided by the Contractor as part of the test information (defined in Section B3.III.A.12). B.The Anatomic & Pathology report must be issued as an electronic final copy. The Contractor shall deliver reports electronically preferably though a Veterans Administration VISTA HL7 interface. Contractor must provide IT support for current and/or future connectivity to VISTA. C. Accessibility to NAVAHCS reports must be available via web based programs at any time. D.Each test report shall, at minimum, include the following information: 1.Patient's full name 2.Patient's identification number, e.g. social security number (SSN) 3.Physician's name (if supplied) 4.Government laboratory accession number (if supplied) 5.Submitting facility name 6.Submitting facility account number 7.Test(s) ordered 8.Date/time of specimen collection 9.Collection site 10.Brief patient history that is provided 11.Date/time test completed 12.Test result 13.CPT code 14.SNOMED code 15.Reference laboratory accession number if applicable 16.Name and address of testing laboratory 17.Any other information the laboratory has that may indicate a questionable validity of test results. 18.Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing. VII.Customer Service A.Contractor shall provide customer service that is accessible by telephone service Monday through Friday, 8:00 am - 6:00 pm Arizona Time, in order to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract. B.Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period: 1.Telephone Inquiries - Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government's minimum time expectation for meeting this service. a.Specimen Collection 1.Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call. 2.Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within ½ hour of the initial call. b.Testing 1.Inquiries regarding the status of pending orders shall be addressed at the time of the initial call. 2.Esoteric inquiries when information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call. c.Technical Expertise 1.Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call. 2.Result interpretation inquiries shall be addressed within four business hours of initial call. 3.Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call. d.Account follow-up 1.Information general in nature yet specific to the account, e.g. test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call. C.The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc. VIII.Consultative Services/Utilization Reports A.Contractor shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation. B.Contractor shall provide a statistical analysis of the Government facilities' workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities on mechanisms to reduce their costs. C.Contractor shall provide a cumulative workload summary report of tests performed. The summary must include the test name/description, monthly test volume, year-to-date test volume, unit test cost, monthly test expenditures and year-to date test expenditures. 1.A copy of the report shall be delivered electronically to the Contracting Officer, Lead COR, and each Government facility COR by the 10th of the month following the close of the reporting month. 2.All reports shall be submitted in electronic spreadsheet format. SPECIAL CONTRACT REQUIREMENTS I. Services A.The services specified herein may be changed by written modification to this contract. The VA Contracting Officer will prepare the modification (reference FAR clause 52.212-4(c), Changes) and, prior to becoming effective, shall be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. B.This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor's employee(s). Contractor personnel are not subject to the supervision and control of a Government officer or employee. Rather, contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare provider who furnishes services under this contract is subject to Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance. C.The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered. D.Contractor is required to maintain medical liability insurance for the duration of this contract. Medical Liability insurance must cover the provider(s) for services in all states where services are rendered by the provider. Contractor must indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance. E.Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract. F.Contractor shall not, under any circumstances, furnish reports directly to patients. II. Term of Contract The period of performance for this contract is five (5) years; one (1) base year and four (4) option years. The contractor shall perform no services after September 30th of each year until the contracting officer authorizes such services in writing. Availability of Funds during a Continuing Resolution: At the beginning of each new fiscal year (October 1st) the federal government or parts thereof may be operating under a Continuing Resolution and only be funded for a limited period of time rather than for the entire fiscal year. If, at any time, funds for this contract are provided under a Continuing Resolution (CR), funds will only be available for performance under this contract up to and including the expiration date of the CR, and any extension thereof. The Government's obligation for performance of this contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this contract beyond the expiration date of the CR, and any extension thereof, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability. III. Federal Holidays Contractor is not required to provide transportation of specimens on federal holidays. The 10 holidays observed by the Federal Government are: New Year's Day (January 1st), Martin Luther King's Birthday (3rd Monday in January), Presidents' Day (3rd Monday in February), Memorial Day (last Monday in May), Independence Day (July 4th), Labor Day (1st Monday in September), Columbus Day (2nd Monday in October), Veterans Day (November 11), Thanksgiving Day (4th Thursday in November), Christmas Day (December 25th) and any other day specifically declared by the President of the United States to be a national holiday. When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies. IV.Qualifications/Requirements of Laboratory & Contractor Personnel A. Laboratory 1.The Contractor must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The Contractor must maintain valid certifications during the entire performance period of this contract. 2.Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this solicitation. In addition, as these documents are reissued or re-awarded, the awarded Contractor must supply a copy to the Contracting Officer's Representative assigned to each Government facility. 3.Contractor must notify immediately the Contracting Officer's Representative (COR) at each of the Government facilities in writing, upon its loss of any required certification, accreditation or licensure. 4.Contractor shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention. B.Personnel 1.Contractor shall ensure all testing and supervisory personnel at the reference laboratory assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, or other accrediting organizations' and State standards. 2.Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification. 3.Any new requirements for mandatory education and/or competency reassessment, which occur during the contract period, must be completed by the individual contractor employee(s) within VA established timeframes. 4.Contractor couriers entering any Government facility shall prominently display a contractor-issued identification badge. V.HIPAA Compliance Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). The Contractor shall prove to the NAVAHCS that they are identified as healthcare providers and that the PHI is being disclosed and/or used for treatment. BAA is required for Contractor Services. VI. Information Technology Security Requirements Contractor must adhere to, and understand, the IT security requirements for certification and accreditation (authorization) (C&A) of the contractor system. See VA Handbook 6500.0, Certification and Accreditation. Contractor performance will be monitored for timely submission of deliverables, compliance with personnel screening requirements, maintenance of secure system configurations and participation in annual IT Federal Information Security Management Act (FISMA) assessments to ensure compliance with FISMA requirements. VII. Designation of Contract Representatives The S & D Ancillary Testing Coordinator at the NAVAHCS, Eliza Carnley MLS (ASCP)cm, will be designated as the Lead Contracting Officer Representative (COR) to represent the Contracting Officer in furnishing guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. The extent and limitations of the COR designation will be provided in the COR Delegation Memo. VIII. Contract Performance Monitoring A.Monitoring of contractor's performance shall be demonstrated through clinical and administrative record reviews. COR will be responsible for verifying contract compliance. Contracting Officer's Representative(s) (COR) will designate appropriate VA personnel to monitor services through one or a combination of the following mechanisms: 1.Departments being served will monitor Contractor performance to ensure that services called for in the contract have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer. 2.Documentation of services performed will be reviewed prior to certifying payment. The COR will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services actually provided. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided. 3.Departments being served, through the COR(s), will provide a written statement annually to the Contracting Officer to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary evaluation will be submitted 45 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable). IX. Quality Assurance Monitoring A.Contractor shall maintain a Quality Assurance Program related to Reference Laboratory services covered under this contract. B. Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the NAVAHCS. This program must minimally address the quality aspects representative to the testing process, i.e. pre-analytical, analytical and post-analytical variables and include a description of monitoring and evaluation activities. There must be a mutually agreed upon procedure for responding to issues, problems and/or concerns identified by the Government with details as to whom and in what timeframe the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event. The contractor will meet or communicate with the NAVAHCS staff for process review and improvement of contract performance on an as needed basis. TaskIDIndicatorStandardAcceptable Quality LevelMethod of SurveillanceIncentive Clinical and Professional Standards 1Maintains patient privacy/confidentialityZero breaches of privacy.100%100% InspectionPast Performance 2Maintains appropriate licensure/certification/ credentialing requirementsMandatory prior to performance100%100% InspectionPast Performance 3 On site visits during Laboratory Director absence. During scheduled coverage for laboratory director an onsite visit must occur once per week. Must be available on call 100%100% InspectionPast Performance 4Adheres to a maximum 14 day turnaround time for final reports. Delays must be communicated to VA Medical Center 100%Periodic InspectionPast Performance 5Diagnostic testing: written test results provided to the authorizing VA medical center. Upon completion of processing, testing and interpretation reports must be available within 48 hours.95%Random SamplingPast Performance 6Lost, missing or mislabeled specimen and/or reportsZero errors 100%Periodic SamplingPast Performance C. Copies of licensure/certifications are also required to be submitted upon request by the VA. D. If the contractor believes there are excusable circumstances, the contractor shall inform the Contracting Officer and the Lead COR. Excusable circumstances may result in adjustment of the disincentives established in the Performance Matrix based upon the Contracting Officer's Determination and Findings.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25815N0156/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-15-N-0156 VA258-15-N-0156.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1780080&FileName=VA258-15-N-0156-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1780080&FileName=VA258-15-N-0156-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Prescott VA;500 Hwy 89N;Prescott, Arizona

Zip Code: 86313
 

Record

SN03600413-W 20141220/141218235200-74086ef7838f9546179ff015c9676ad4 (fbodaily.com)
 

Source

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

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