SOLICITATION NOTICE
H -- College of American Pathologists Laboratory Accreditation
- Notice Date
- 8/20/2010
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Center for Health Care Contracting, ATTN: MCAA C BLDG 4197, 2107 17TH Street, Fort Sam Houston, TX 78234-5015
- ZIP Code
- 78234-5015
- Solicitation Number
- W81K0410R0014
- Response Due
- 8/31/2010
- Archive Date
- 10/30/2010
- Point of Contact
- Anush Collins, 210-295-4456
- E-Mail Address
-
Center for Health Care Contracting
(anush.collins@amedd.army.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- PERFORMANCE WORK STATEMENT C1. SCOPE OF WORK C1.1. GENERAL. The contractor shall provide services required for laboratory compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA; 42 CFR Part 493) and its subsequent amendments. All laboratories must meet or exceed the conditions and standards to be certified to perform testing of human specimens. The desired outcome is the professional accreditation of laboratories performing testing on human specimens for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings, and the assessment of the testing performance of each laboratory through analysis of proficiency testing surveys. The accreditation and proficiency testing programs must be provided by one contractor as part of a comprehensive, integrated program to minimize administrative requirements and ensure coordinated actions between the accreditation agency and the proficiency testing provider. The coordination of these two functions is critical in the assessment of the laboratorys overall performance and the quality of service provided to patients and the expeditious implementation of corrective actions when a condition of non-compliance or unsatisfactory performance exists. C.1.2. LABORATORY ACCREDITATION C.1.2.1 The contractor shall provide and maintain an accreditation program approved by the Centers for Medicare and Medicaid Services (CMS) to meet the requirements as stated in 42 CFR Part 493, Subpart E - Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program. CMS approval may not exceed 6 years. Reports/notifications specified in Subpart E normally provided to the Department of Health and Human Services/CMS will be provided to the Army Associate Director, CCLM or Army Program Manager, CCLM. C.1.2.1.2. The laboratories to be accredited during the base year of the contract will be the list of accredited laboratories for option year 4 (1 Jan 06-31 Dec 06) of the current contract DADA10-02-C-0004. A listing of the current laboratories accredited for the fourth option year of the referenced contract will be provided by the contractor for verification by the COR as part of the Request for Proposal. Laboratories to be accredited by the contractor during the option years of the contract will carry over from calendar year to calendar year unless the contractor is notified by the COR. Additions or deletions due to openings or closings of laboratories may occur during each calendar year and during the life of the contract. The contractor shall be able to accommodate the changes, as required. All revisions (i.e., deletions or additions) to the listing of laboratories to be accredited must have COR approval prior to processing. C.1.2.1.3. The contractor shall provide annual inspections utilizing published standards, and checklists or other supporting materials to validate and/or verify the laboratorys performance, including oversight and monitoring of its pre-analytical, analytical, and post-analytical testing processes, laboratory director and personnel qualifications, facilities, and resources, quality control, and quality assurance activity. The contractor must be approved to inspect all clinical and anatomic pathology disciplines (specialties and subspecialties) within a laboratory to avoid the need and cost for multiple inspections. C.1.2.1.4. For laboratories achieving accreditation, the contractors accreditation program shall meet or exceed Joint Commission on Accreditation of Healthcare Organizations (JCAHO) accreditation standards and be granted deeming status by JCAHO. Deeming status means that if a laboratory is accredited by the CAP that JCAHO accepts this determination (unless unusual circumstances exist such as an excessive number of deficiency citations) and does not reinspect the laboratory when they are surveying/accrediting a medical treatment facility. C.1.2.1.5. The contractor shall inspect and/or evaluate each laboratory within the continental United States (CONUS) and outside the continental United States (OCONUS) annually. The contractor shall provide an on-site inspection every two years on or near the anniversary date of the initial on-site inspection to ensure each facility complies with CLIA. During the intervening year, the contractor shall supply the laboratories with materials and complete instructions for performing an interim self-inspection. C.1.2.1.6. To aid in the control of accreditation inspection costs, the contractor, to the maximum extent possible, will inspect all Army laboratories on an installation/post during a single travel period to the installation/post. Likewise, all Army laboratories in Europe and Korea will be inspected during a single travel period to those respective geographic areas. C.1.2.1.7. The contractor must also evaluate and act on complaints reported to the accrediting agency by patients, medical staff and other customers. Off-cycle on-site inspection to evaluate a laboratorys performance as it relates to a complaint will be conducted as necessary. The contractor will notify the COR at least 24 to 48 hours prior to conducting an inspection. An official report of the inspection and the resultant accreditation determination will be sent to the Laboratory Director or designee within 120 days of the inspection. A contractor inspection report for each inspected laboratory will be furnished to the (use for correspondence only) Army Program Manager, Center for Clinical Laboratory Medicine (CCLM), AFIP/ZD, 6825 16th Street NW, Bldg 54, Room G0134, Washington, DC 20306-6000 within 120 days of the inspection. C.1.2.1.8. When laboratory services include the specialties/subspecialties of cytology, histopathology, oral pathology, radiobioassay, histocompatibility, clinical cytogenetics, or transfusion services and blood banking, the team leader shall be a board certified pathologist. C.1.2.2. The contractor shall provide all materials, labor, lodging, meals, transportation and professional expertise required to conduct inspections of laboratories located within the CONUS and overseas OCONUS for accreditation purposes. All costs associated with the accreditation inspection process will be borne by the contractor as part of accreditation program charge, with the exception of international airfare travel to OCONUS laboratories. Travel to OCONUS laboratories (international airfare only) will be funded by the government at cost as an additional charge to the normal accreditation program charge for a laboratory. The government will not pay for business-class or first-class travel. For OCONUS inspections, the contractor shall appoint a team leader with no geographical limit on place of origin of travel. All other team members, as required, shall be appointed by the contractor from a group of qualified volunteer peer reviewers located within the geographical area of the laboratory to be surveyed. If it becomes necessary for the contractor to send additional team members from the CONUS, the contractor must obtain approval from the COR for Clinical Laboratory Medicine (CCLM). The contractor shall coordinate with the laboratory director or manager of the inspected laboratory and comply with security requirements needed to grant members of the inspection team access to the military installations and inspection sites. C.1.2.2.1. Accreditation inspection teams for Army laboratories will not be drawn from other Army laboratories or, to the maximum extent possible, from other DoD Service laboratories (i.e., Air Force and Navy laboratories). C.1.2.3. On-Site Pre-Inspection Preparation: For on-site inspections, the contractor shall provide a pre-inspection package 6 10 months prior to an on-site inspection. The contractor shall provide the pre-inspection packet to the Laboratory Director or laboratory-designated point of contact of the laboratory to be inspected and shall include all information, instructions and forms related to the inspection and a questionnaire used to define the size, complexity and scope of services of the lab being inspected so that appropriate inspection teams may be assembled to match the makeup of the lab being inspected. The laboratory shall receive the pre-inspection package from the accreditation organization. The facility to be inspected will complete the questionnaire and return it to the contractor in accordance with instructions provided in the pre-inspection package. C.1.2.3.1. On-Site Inspection: The contractors inspection teams shall inspect the laboratories using the pre-supplied materials. The same inspection standards shall be applied to both CONUS and OCONUS laboratories. At the termination of an on-site inspection, the contractor shall provide a copy of all deficiencies noted during the inspection to the Laboratory Director or designee prior to the teams departure from the facility being inspected. The contractor shall have a process to monitor the correction of deficiencies. C.1.2.3.2. On-Site Post Inspection: An official report of the accreditation inspection shall be sent to the Laboratory Director or designee along with an accreditation letter and certificate within 120 days of the inspection. A contractor inspection report for each inspected laboratory shall be furnish to the (use for correspondence only) Army Program Manager, AFIP/ZD, 6825 16th Street NW, Bldg 54, Room G0134, Washington, DC 20306-6000 within 120 days of the inspection. C.1.2.3.3. Interim Year Self Inspection: The contractor shall furnish each facility a self inspection package that includes the necessary materials for self evaluation and a deficiency summary report and verification form to note deficiencies and corrective actions. Each facility will complete the inspection and shall return the self-evaluation forms to the contractor according to the instructions provided by the contractor in the self-inspection package. C.1.2.4. Special function laboratories or decentralized laboratories operated independently from the main laboratory of a medical military treatment facility shall be charged a separate accreditation fee and will be inspected at the same time as the main laboratory. A comprehensive, multi-specialty laboratory with constituent operations in several locations will be considered a single, cohesive laboratory provided there is no duplication of services. C.1.2.5. The contractor shall provide a process for CCLM to electronically access all inspection reports for all laboratories. The contractor shall provide a printed and/or electronic monthly accreditation report outlining the sites inspected each month of the calendar year. This report shall list, at a minimum, the accreditation agencys ID number for each laboratory, the DoD Clinical Laboratory Improvement Program certificate number, the accredited laboratorys name, and the effective date of the accreditation. C.1.2.5.1. The contractor shall provide printed and/or electronic administrative reports allowing the CCLM to track accreditation-related information. Reports shall be provided periodically as scheduled/requested by the CCLM. Reports provided must include, but are not limited to: - a site key showing by laboratory, the accreditation organizations identification number, the laboratorys name and address, and the laboratorys point of contact and phone number - accreditation report updates showing by laboratory, the accreditation organizations identification number, the DoD CLIP certificate number, the inspection anniversary date, the date of last inspection, the accreditation fee (and information related to calculation of that fee), and the airfare cost (estimated and actual) for OCONUS sites - inspection checklist performance overview by specialty (inclusive of all laboratories; to include comparative statistics) - inspection checklist performance overview by laboratory - inspection performance statistics by laboratory by specialty - deficiency listing by laboratory - deficiency listing overview question (inclusive of all laboratories) C.1.3 PROFICIENCY TESTING (PT) SURVEYS C.1.3.1. The contractor shall provide a proficiency testing program approved by the Centers for Medicare and Medicaid Services (CMS) to meet the requirements as stated in 42 CFR Part 493, Subpart I Proficiency Testing Programs for Nonwaived Testing to the enrolled laboratories each calendar year. Reports/notifications specified in Subpart I normally provided to the Department of Health and Human Services/CMS will be provided to the Army Associate Director, CCLM or Army Program Manager, CCLM. C.1.3.1.1. The contractor shall furnish proficiency testing challenges for analytes regulated by CMS and stated in 42 CFR Part 493, Subpart I Proficiency Testing Programs for Nonwaived Testing. The program must include regulated analytes and tests for all specialties and subspecialties in the clinical laboratory and anatomic pathology. The program shall include analytes and tests for non-regulated analytes for all specialties and subspecialties that are performed in the clinical laboratory and anatomic pathology services of the enrolled laboratories. The contractor shall provide proficiency test surveys to cover the analytes/tests performed in the laboratories. C.1.3.1.2. The contractor shall provide samples that mimic actual patient samples. The contractor shall ensure the samples are stable within the timeframe for analysis by the participating laboratories. C.1.3.1.3. The contractor shall provide survey kits containing specimens and instructions to each laboratory enrolled in the PT program. The proficiency testing program shall, for regulated analytes, comply with the requirements as stated in 42 CFR Part 493, Subpart I Proficiency Testing Programs for Nonwaived Testing. For each event, the survey kits shall be shipped to the participating laboratories. The shipping schedule for each survey event shall conform to dates established by the contractor for each calendar year. A listing of survey shipping dates shall be provided to all laboratories that have purchased/subscribed to any of its proficiency testing materials at the beginning of the calendar year proficiency testing cycle. C.1.3.1.4. The contractor shall provide preprinted order forms and catalogs listing all available surveys to each participating laboratory no later than 3 months prior to the start of the new calendar year. The annual renewal of proficiency testing survey orders for all laboratories will be received, processed, consolidated, and submitted to the contractor by the COR. The contractor shall allow for revisions of orders throughout the calendar year. All revisions (i.e., additions, deletions, or substitutions) to survey orders must have COR approval prior to processing. C.1.3.1.5. The contractor must have provisions in place for replacement of surveys lost in transit or received but unable to be tested, e.g., due to shipping delays and degradation of the contained specimens or broken specimen vials/containers, etc. The replacement of surveys shall be at the contractors expense. If a charge to replace a survey kit is considered necessary by the contractor, the contractor shall seek approval from the COR before additional costs are charged due to replacement of surveys. If a survey is discontinued, the contractor shall credit the government for those costs. If a survey is otherwise unavailable at the time of scheduled shipment, the contractor may either backorder the survey or credit the Army. C.1.3.1.6. The contractor shall incur all regular shipping costs associated with PT samples sent to CONUS and OCONUS laboratories. Some surveys may contain hazardous materials and may require special permits and additional charges. Materials shipped to APO AA, AE, or AP addresses via the U.S. Postal Service shall, at a minimum, be sent first class. Surveys containing specimens especially susceptible to degradation during shipment (e.g., liquid whole blood specimens, specimens containing non-stabilized cells, etc.) shall be shipped to OCONUS laboratories by air freight. Shipment of such surveys by air freight must be pre-approved by the COR. The contractor shall comply with all applicable packaging, shipping and notification requirements contained in the Code of Federal Regulations, the Domestic Mail Manual, the International Air Transport Association Dangerous Goods Regulations, and 42 CFR Part 72 Interstate Shipment of Etiologic Agents. C.1.3.1.7. The contractor shall provide electronic submission of proficiency testing results during the result reporting timeframe as specified within the instructions contained with the proficiency testing material. Laboratories must submit the results after an analysis of the proficiency testing materials are performed by the laboratory. C.1.3.1.8. The contractor shall evaluate the submitted results and provide an electronic and printed evaluation report to each survey participant within 60 days of the closeout date for submission of the results. These evaluation reports shall include the value reported, the method used, and a comparison with the referee/peer laboratory results. The evaluation printed reports shall be forwarded to each applicable laboratory using the addresses provided during enrollment. The contractor shall provide the U.S. Army Laboratory Consultant, CCLM, and the Regional Medical Command Laboratory Consultant (for laboratories within their respective regions) access to reports for all laboratories. The contractor shall provide an efficient, simplified process for CCLM to electronically access original proficiency testing result evaluations for all laboratories. C.1.3.1.9. The contractor shall notify the U.S. Army Laboratory Consultant and Army Program Manager, CCLM of a laboratorys unsatisfactory performance via printed and/or electronic means. The contractor shall provide the Army Program Manager, CCLM with monthly reports of all unsuccessful proficiency test results. In addition, the contractor shall provide PT data for all laboratories at least quarterly. Access to all data shall be through printed and/or electronic means. C.1.3.1.10. The contractor shall provide administrative reports allowing the CCLM to track proficiency testing-related information. Reports shall be provided periodically as scheduled/requested by the CCLM and shall include, but are not limited to: - proficiency testing performance overview by laboratory - proficiency testing performance statistics by laboratory by survey event - exception report by analyte by laboratory (provided quarterly) - exceptions by subspecialty/analyte by survey event (with laboratory ID number provided) - exceptions by laboratory by subspecialty/analyte by survey event - analyte performance by laboratory by survey event - subspecialty performance overview (inclusive of all laboratories; to include comparative statistics) C.1.4. CUMULATIVE MANAGEMENT REPORTS C.1.4.1 The contractor shall distribute cumulative management reports with one copy to each of the participating laboratories at the address listed for each facility and consolidated copies to (use for correspondence only): Armed Forces Institute of Pathology/AFIP-ZD Attn: Army Element Manager Center for Clinical Laboratory Medicine (CCLM) 6825 16th Street NW, Bldg 54, Rm G134 Washington, DC 20306-6000 C.1.5 INVOICING C.1.5.1 Services shall be billed quarterly, i.e., for Jan Mar, Apr Jun, Jul Sep, and Oct Dec of each calendar year. Invoice charges shall be billed separately against the appropriate contract CLIN. An itemized listing of charges for each CLIN number shall be provided to the COR quarterly. C.2. CONTRACTOR VERIFICATION SYSTEM C.1.2.1. The contractor shall ensure compliance with the provisions set forth below. For purposes of this clause, the Government will designate a Trusted Agent (TA), and the contractor shall designate a Facility Security Officer (FSO), for this contract. The Government reserves the right to amend or supplement these provisions pursuant to the Changes clause in the contract. C.1.2.2. In-processing Requirements. Contract service providers are prohibited from performing services under this contract absent compliance with the in-processing requirements set forth below. C.1.2.3. The FSO shall provide the following information to the TA for input into the DEERS/RAPIDS System for every contract service provider: C.1.2.4. Last Name C.1.2.5. First Name C.1.2.6. Middle Name C.1.2.7. Social Security Number C.1.2.8 Date of Birth C.1.2.9. E-mail Address (may be either the e-mail address of the incoming contract service provider or the FSO). C.1.2.10. The incoming contract service provider must have an Army Knowledge Online (AKO) account in order to submit the application. AKO registration may be accessed using https://www.us.army.mil C.1.2.11. The DEERS/RAPIDS Systems will send a notice to the e-mail address provided containing the incoming contract service providers user ID and password. In the event the e-mail message is sent to the FSO, the FSO shall notify the incoming contract service provider of the user ID and password. C.1.2.12. The incoming contract service provider shall log into the DEERS/RAPIDS System and submit an application for acceptance into the System, using the use ID and password provided. C.1.2.13. The application will be accepted, returned, or rejected by the TA. Notice as to whether the application has been accepted, returned, or rejected will be provided to the contract service provider via e-mail, normally within 48 hours after submission. If the application is returned or rejected, the contract service provider shall contact the TA and comply with the TAs guidance to attempt to correct and resolve the issues. C.1.2.14. Upon approval of the application, the incoming contract service provider will receive an e-mail stating the CAC application was approved and to proceed to the Verifying Office (VO) with two photo IDs to obtain a Common Access Card (CAC). For CAC issuance, a DD Form 2842 must be completed and taken by the contract service provider with two forms of picture ID. The e-mail will contain a URL to download the form. Acceptable forms of ID are: Drivers License, Social Security Card, Military ID, Contractor Company ID with picture and expiration date, VISA charge card with picture imprinted, and passport. C.1.2.15. Revalidation Requirements. The TA is required to revalidate all contract service providers in the DEERS/RAPIDS System every 6 months. In the event revalidation is denied, the CAC credentials shall be revoked and the Card will not be useable to login. C.1.2.16. Out-processing Requirements. When a contract service providers performance under this contract ceases, the contractor or FSO shall provide written notice to the TA. The TA will remove the contract service provider from the DEERS/RAPIDS System. The contractor shall also ensure the contract service providers CAC is turned in to the Government IAW the out-processing procedures set forth by the contracting officer. C.3. DEPARTMENT OF THE ARMY ANNUAL CONTRACTOR MANPOWER REPORTING SYSTEM C.3.1 Standard. The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower (including subcontractor manpower) required for performance of this contract. The contractor is required to completely fill in all the information in the format using the following web address https://contractormanpower.army.pentagon.mil. The required information includes: (1) Contracting Office, Contracting Officer, Contracting Officers Technical Representative; (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor name, address, phone number, e-mail address, identity of contractor employee entering data; (5) Estimated direct labor hours (including sub-contractors); (6) Estimated direct labor dollars paid this reporting period (including sub-contractors); (7) Total payments (including sub-contractors); (8) Predominant Federal Service Code (FSC) reflecting services provided by contractor (and separate predominant FSC for each sub-contractor if different); (9) Estimated data collection cost; (10) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the contractor with its UIC for the purposes of reporting this information); (11) Locations where contractor and sub-contractors perform the work (specified by zip code in the United States and nearest city, country, when in an overseas location, using standardized nomenclature provided on website); (12) Presence of deployment or contingency contract language; and (13) Number of contractor and sub-contractor employees deployed in theater this reporting period (by country). As part of its submission, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period will be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. Contractors may use a direct XML data transfer to the database server or fill in the fields on the website. The XML direct transfer is a format for transferring files from a contractors system to the secure web site without the need for separate data entries for each required data element at the web site. The specific formats for the XML direct transfer may be downloaded from the web site.* End of Performance Work Statement
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- Place of Performance
- Address: Center for Health Care Contracting ATTN: MCAA C BLDG 4197, 2107 17TH Street Fort Sam Houston TX
- Zip Code: 78234-5015
- Zip Code: 78234-5015
- Record
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