STATE OF DELAWARE DELAWARE HEALTH AND SOCIAL SERVICES DIVISION OF MANAGEMENT SERVICES 1901 N. DuPont Highway New Castle, DE 19720 REQUEST FOR PROPOSAL NO. PSCO-868 FOR CLINIC AND LONG TERM CARE FACILITY LABORATORY SERVICES FOR THE DIVISION OF PUBLIC HEALTH DELAWARE HEALTH AND SOCIAL SERVICES 417 FEDERAL STREET JESSE COOPER BUILDING DOVER, DE 19901 Deposit Waived Performance Bond Waived Date Due: July 30, 2009 11:00 A.M. LOCAL TIME A mandatory pre-bid meeting will be held on June 18, 2009 at 10:00 a.m. at Delaware Health and Social Services, Herman M. Holloway Sr. Campus, Procurement Branch, Main Administration Building, South Loop, First Floor Conference Room #198, 1901 North DuPont Highway, New Castle, DE 19720. "All Bidders Who Wish To Bid On This Proposal Must Be Present, On Time, At The Mandatory Pre-Bid Meeting. No Proposals Will Be Accepted From Bidders Who Either Did Not Attend The Mandatory Pre-Bid Meeting Or Who Are More Than Fifteen (15) Minutes Late." REQUEST FOR PROPOSAL #PSCO-868 Bids for Clinic and Long Term Care Facility Laboratory Services for the Division of Public Health, Delaware Health and Social Services, 417 Federal Street, Jesse Cooper Building, Dover, DE 19901 will be received by the Delaware Health and Social Services, Herman M. Holloway Sr. Campus, Procurement Branch, Main Administration Building, South Loop, Second Floor, Room #259, 1901 North DuPont Highway, New Castle, Delaware 19720, until 11:00 a.m. local time July 30, 2009. At which time the proposals will be opened and read. A mandatory pre-bid meeting will be held on June 18, 2009 at 10:00 a.m. at Delaware Health and Social Services, Herman M. Holloway Sr. Campus, Procurement Branch, Main Administration Building, 1901 North DuPont Highway, South Loop, First Floor Conference Room #198, New Castle, DE 19720. For further information, please contact Armon Martin at (302) 744-4780. In the event that state offices are closed on the day of the pre-bid meeting due to a State of Emergency declared by the Governor of Delaware, the pre-bid meeting will be cancelled or postponed. The status of the pre-bid meeting will be posted to the RFP website as soon as possible at www.dhss.delaware.gov/dhss/rfp/dhssrfp.htm. If the pre-bid meeting is cancelled, written questions will be accepted, in lieu of the pre-bid meeting, in accordance with the instructions presented in Section VI. D. of this document. If the pre-bid meeting is postponed, the new date and time will be posted to the RFP website. All RFP-PSCOs can be obtained online at www.dhss.delaware.gov/dhss/rfp/dhssrfp.htm A brief “Letter of Interest” must be submitted with your proposal. Specifications and administration procedures may be obtained at the above office or phone (302) 255-9290. NOTE TO VENDORS: Your proposal must include the forms in Appendices A, B ,C and D signed and all information on the forms complete. "All Bidders Who Wish To Bid On This Proposal Must Be Present, On Time, At The Mandatory Pre-Bid Meeting. No Proposals Will Be Accepted From Bidders Who Either Did Not Attend The Mandatory Pre-Bid Meeting Or Who Are More Than Fifteen (15) Minutes Late." NOTIFICATION TO BIDDERS Bidder shall list all contracts awarded to it or its predecessor firm(s) by the State of Delaware; during the last three years, by State Department, Division, Contact Person (with address/phone number), period of performance and amount. The Evaluation/Selection Review Committee will consider these Additional references and may contact each of these sources. Information regarding bidder performance gathered from these sources may be included in the Committee's deliberations and factored in the final scoring of the bid. Failure to list any contract as required by this paragraph may be grounds for immediate rejection of the bid." There will be a ninety (90) day period during which the agency may extend the contract period for renewal if needed. If a bidder wishes to request a debriefing, they must submit a formal letter to the Procurement Administrator, Delaware Health and Social Services, Main Administration Building, Second Floor, South Loop, 1901 North DuPont Highway, Herman M. Holloway Sr., Health and Social Services Campus, New Castle, Delaware 19720, within ten (10) days after receipt of “Notice of Award”. The letter must specify reasons for the request. If you do not intend to submit a bid you are asked to return the face sheet with “NO BID” stated on the front with your company’s name, address and signature. IMPORTANT: ALL PROPOSALS MUST HAVE OUR RFP NUMBER (PSC868) ON THE OUTSIDE ENVELOPE. IF THIS NUMBER IS OMITTED YOUR PROPOSAL WILL IMMEDIATELY BE REJECTED. FOR FURTHER BIDDING INFORMATION PLEASE CONTACT: SANDRA SKELLEY DELAWARE HEALTH AND SOCIAL SERVICES PROCUREMENT BRANCH MAIN BLD-2ND FLOOR –ROOM #259 1901 NORTH DUPONT HIGHWAY HERMAN M. HOLLOWAY SR. HEALTH AND SOCIAL SERVICES CAMPUS NEW CASTLE, DELAWARE 19720 PHONE: (302) 255-9290 IMPORTANT: DELIVERY INSTRUCTIONS IT IS THE RESPONSIBILITY OF THE BIDDER TO ENSURE THAT THE PROPOSAL HAS BEEN RECEIVED BY THE DEPARTMENT OF HEALTH AND SOCIAL SERVICES BY THE DEADLINE. REQUEST FOR PROPOSAL FOR CLINIC AND LONG TERM CARE FACILITY LABORATORY SERVICES FOR DELAWARE DIVISION OF PUBLIC HEALTH Availability of Funds Funds are available for the selected vendor to provide services in the area of Clinic and Long Term Care Facility Lab Services. The Contract is for a 36-month period with renewal possible for up to two additional years contingent on funding availability and task performance. Pre-Bid Meeting A mandatory pre-bid meeting will be required. The meeting will be June 18, 2009 at 10:00am at the following location. Delaware Health and Social Services Herman Holloway, Sr. Social Services Campus Main Administration Building, 1st Floor, Room 198 1901 N. Dupont Highway, New Castle, DE 19720 All bidders who wish to bid on this proposal must be present on time at the mandatory pre-bid meeting. No proposals will be accepted from agencies that either did not attend the mandatory Pre-Bid Meeting or who are MORE than 15 minutes late. Bidders may ask clarifying questions regarding this request for proposal at the pre bid meeting. Responses to questions posed at the pre-bid meeting will be distributed to bidders attending the pre-bid meeting. A Letter of Interest must be submitted by potential vendors at the October 8, 2008, Pre-Bid Meeting. Further Information Inquiries regarding this RFP should be addressed to: Armon Martin Division of Public Health Jesse Cooper Bldg. 417 Federal Street Dover, DE 19901 Tel: (302) 744-4780 FAX: (302) 739-3313 Email: armon.martin@state.de.us Restrictions on Communications with State Staff From the issue date of this RFP until a contractor is selected and the selection is announced, bidders are NOT allowed to contact any Division of Public Health staff, except those specified in this RFP, regarding this procurement. Contact between contractors and Kathleen Russell is restricted to emailed or faxed questions concerning this proposal. Questions must be submitted in writing and will be addressed in writing. Questions are due by June 15, 2009 and will be addressed at the pre-bid meeting. The complete list of questions and their answers will be released via e-mail or fax to the vendors that submitted any questions or attended the pre-bid meeting. The complete list of questions and their answers will also be posted on the Internet at http://www.dhss.delaware.gov/dhss/rfp/dhssrfp.htm REQUEST FOR PROPOSAL FOR CLINIC AND LONG TERM CARE FACILITY LABORATORY SERVICES FOR DELAWARE DIVISION OF PUBLIC HEALTH RFP Table of Contents Page TIME TABLE 8 INTRODUCTION 9 SCOPE OF SERVICES 9 Part A – Clinic Test Specifications 10-15 Monthly Invoice 12 Medicaid & Medicare Assistance 13 Cost Per Test 13 Statistics 13 Part B – Christiana Care HIV Community Program 15 PART C – Lead Program & Clinic Test Specifications 16 PART D – Long Term Care Specifications 17-21 Monthly Invoice 19 Cost Per Test 19 Statistics 20 Services 21 SPECIAL TERMS AND CONDITIONS 22 Length of Contract 22 Subcontractors 22 Training and Review 22 Funding Disclaimer Clause 23 Quality Assurance 23 Reserved Rights 23 Termination Conditions 24 Contract Monitoring 24 Payment 25 W-9 Submission 25 FORMAT AND CONTENT OF RESPONSE 25 Bidders Signature Form 25 Title Page 26 Table of Contents 26 Qualification and Experience 26 Bidder References 26 Proposed Methodology and Work Plan 27 Statement of Compliance 27 Standard Contract 27 BUDGET 27 GENERAL INSTRUCTIONS FOR SUBMISSION OF PROPOSAL 28 Number of Copies Required 28 Closing Date 28 Notification of Acceptance 28 Questions 29 Amendments to Proposals 29 Proposals Become State Property 29 Non-Interference Clause 29 Investigation of Grantee’s Qualifications 29 RFP and Final Contract 30 Proposal and Final Contract 30 Cost of Proposal Preparation 30 Proposed Timetable 30 Confidentiality and Debriefing 30 SELECTION PROCESS 31 Proposal Evaluation Criteria 31 Project Costs and Proposed Scope of Service 32 ATTACHMENT A (BID SHEETS FOR CLINIC AND LONG TERM CARE FACILITY LABORATORY SERVICES) 33 ATTACHMENT B (TEST SUMMARY) 36 ATTACHMENT C (Number of Tests Performed in 2007 for All Clinics Combined and Long Term Care Facilities) 42 ATTACHMENT D (Northern Health Services Clinic Addresses) 54 ATTACHMENT E (Southern Health Services Clinic Addresses) 55 ATTACHMENT F (Christiana Care Community Program Addresses) 56 ATTACHMENT G (Delaware Public Health Laboratory Address) 57 ATTACHMENT H (Long Term Care Facility Addresses) 58 ATTACHMENT I (DPH Program Reporting Requirements) 59 APPENDIX A (BIDDERS SIGNATURE FORM) 64 APPENDIX B (CERTIFICATION SHEET) 66 APPENDIX C (STATEMENTS OF COMPLIANCE FORM) 70 APPENDIX D (Office of Minority and Women Business 72 Enterprise Self-Certification Tracking form) APPENDIX E (DHSS Contract Boilerplate) 75 REQUEST FOR PROPOSAL FOR CLINIC AND LONG TERM CARE FACILITY LABORATORY SERVICES FOR DELAWARE DIVISION OF PUBLIC HEALTH TIME TABLE Posting on Department of Health and May 25, 2009 & June 1, 2009 Social Services Request for Proposal Website Deadline for submission of all questions June 15, 2009 Written responses faxed or emailed to bidders On or before July 2, 2009 Pre-bid meeting at Delaware Health and June 18, 2009 at 10:00 AM Social Services Herman Holloway, Sr. Social Services Campus Main Administration Building, 1st Floor, Room 198, 1901 N. Dupont Highway, New Castle, DE 19720 Bid Opening July 30, 2009 at 11:00 AM Review and Evaluation of Bids July 31, 2009 – September 3, 2009 Contract Award Notice (Tentative) September 4, 2009 Contract Negotiations Complete October 2, 2009 Laboratory Services begin November 16, 2009 NOTE: A “Letter of Interest” MUST be submitted by potential vendors at the bid meeting. REQUEST FOR PROPOSAL FOR CLINIC AND LONG TERM CARE FACILITY LABORATORY SERVICES FOR DELAWARE DIVISION OF PUBLIC HEALTH l. INTRODUCTION A. Background The mission of the Division of Public Health is to protect and enhance the health of the people of Delaware. The Division accomplishes it mission by: * working together with others; * addressing issues that affect the health of Delawareans; * keeping track of the State’s health; * promoting positive lifestyles; * promoting the availability of health services. The accomplishment of this mission will facilitate the Division in realizing its vision of creating an environment in which people in Delaware can reach their full potential for a healthy life. B. Project Goals The Delaware Department of Health and Social Services, Division of Public Health, requests bids from qualified testing laboratories for the purpose of clinical testing services and providing test results to clinics and Long Term Care Facilities. The primary emphasis and concern of this proposal is to provide timely, accurate, and reliable lab tests for clients at various state clinics and patients at Long Term Care Facilities. The award will be made as an entire package. No fragmentation of award will be made. Vendor must bid on the entire proposal. ll. SCOPE OF SERVICES All components listed in this section are mandatory. A. CLINIC TEST SPECIFICATIONS – PART A The successful contractor shall: 1. Provide specimen containers and supplies, preparation, handling, and testing of all specimens collected for testing, unless otherwise noted in this contract, and assure pick up of the specimen collections from Public Health sites on a daily basis. On Fridays and before holidays, specimen collections will be required by 3:30 PM. Clinics recognize the following holidays: New Year’s Day, Martin Luther King, Jr. Day, Presidents’ Day, Good Friday, Memorial Day, Independence Day, Labor Day, Columbus Day, Election Day, Veterans’ Day, Thanksgiving Day, Day after Thanksgiving Day and Christmas Day. 2. Provide detailed description of courier services that will be used to obtain specimens at all sites. 3. Furnish supply items which are defined as all items determined necessary to provide specimens. Note: Required inventory maintenance is defined as an initial supply sufficient to sustain operations plus a 30-day inventory based on test count per site. 4. Provide chemistry/test request form with only Public Health tests listed and with pre-printed clinic account number on form for clinic use. A preferred feature is the use of on-line, printable lab forms for completion by Public Health staff to send with specimens. 5. Provide 24-hour turn around time after specimen pickup for the following tests: a. Therapeutic drug monitoring b. White blood count and CBC with and/or without Differential c. Serum pregnancy test 6. Provide routine testing results within 48 hours after specimen pickup. 7. Send final culture reports to the clinic site within 80 hours of pickup. 8. Report results for each clinic by teleprinter. A minimum of one teleprinter per site is required with the exception of the Kent County Health Unit which requires two (2) teleprinters. Vendor will provide A. CLINIC TEST SPECIFICATIONS – PART A, continued teleprinters, telephone lines, and pay monthly charges. Vendor will also provide Clinic staff with online access to test results. 9. Test Results a. Establish and maintain a control number on each client and specimen. b. Issue a written report to the appropriate authorized individuals following completion of the tests. The data report shall contain at least: * The date(s) of collection of the samples, and the date reported * The clinic’s name and account number * The condition of the specimen as received - was it acceptable or not acceptable. * The results of each test requested * High and low flags * Normal values and values expected * The client’s name, date of birth, social security number and account number. 10. Provide proof of liability insurance in case of injury 11. Provide a copy of the current CLIA lab certificate 12. Possess a license to do business in the State of Delaware, a copy of which will be provided to the Division should a contract be awarded. 13. Invoice client’s insurance company directly (i.e., Medicare, Medicaid, private insurance company). Contractor will accept payment in full from insurance claims, and consider amount received as full payment for tests and services rendered. Contractor will bill the Division of Public Health only for client services not covered by insurance. Verification must be provided to the Division for rejected insurance claims. 14. Provide each clinic site with a comprehensive clinical reference guide to include general information and services, specimen A. CLINIC TEST SPECIFICATIONS – PART A, continued collection, preparation and handling, guide to completing test request forms, profiles, and billing and insurance information. 15. Report all notifiable diseases and conditions within 48 hours of recognition, except as otherwise noted, to the appropriate DPH surveillance office as required by the Delaware Regulations, Administrative Code, Title 16, 4202 Control of Communicable and Other Diseases. For additional reporting details and the current list of notifiable diseases and conditions, please refer to http://regulations.delaware.gov/AdminCode/title16/4000/4200/420 2.shtml 16. Assure HIPAA compliant management of in-patient and clinic client data and laboratory test results. Vendor will demonstrate that they have tested electronic protected health information (ePHI) policies and procedures in place, as well as, encryption mechanisms, authentication methods, database security, and so forth. The successful vendor will complete the DHSS Business Associates Agreement as part of the annual contract. (See Appendix E, Contract Boilerplate). 17. MONTHLY INVOICE Invoice the Division of Public Health for services rendered on clients not covered by insurance programs, Medicare, Medicaid, private insurance, for the tests performed at the rates bid on for this contract. Should clients qualify for coverage under federal programs, or produce proper insurance cards within the allowable time frames as allowed by insurance carrier, bidder will re-bill the insurance carrier and issue a credit to the Division of Public Health for services charged. Invoice will show test performed, patient name, assession number, cost per test. Invoice will be by clinic number, and consolidated on a cover sheet. Under no circumstances should the vendor bill the client for services covered by the contract. The vendor will bill the Division of Public Health using the appropriate account code which exists on every lab form that leaves the respective clinics. The vendor should not bill Public Health clients. A. CLINIC TEST SPECIFICATIONS – PART A, continued 18. DELAWARE MEDICAL ASSISTANCE PROGRAM and MEDICARE ASSISTANCE The Division of Public Health will assist contractor in acquiring Medicaid Managed Care, Medicaid and Medicare numbers for clients covered by the contracts. 19. COST PER TEST The vendor will stipulate the following when bidding on this contract: a. Bidder will use bid sheet for Clinic Laboratory Services attached in Attachment A. Bidder should fill out the cost per test, and show the discount to be applied to all other tests not listed as being billed to the Division of Public Health. b. A current list of tests now being done in the clinics is attached, see Attachment B. Bidder may be required to do additional tests from those listed. Should other tests be required, the rate listed in the rate schedule, less the flat rate discount will apply. Please refer to Attachment C for the Division’s test volume in 2007. c. Bidder will submit as part of the bid package a professional fee schedule as established by the bidder. A flat rate discount will be applied to all tests not covered under bid that are being billed to Public Health. 20. COMMUNITY HEALTH SERVICES, NORTHERN AND SOUTHERN HEALTH SERVICES CLINC SITE STATISTICS (See Attachments D and E) Each month the selected Contractor must provide the Delaware Division of Public Health with: * a clinic-by-clinic summary report of all tests performed during the previous month; * an all clinics combined report; * a Northern Health Services clinics report; and * a Southern Health Services clinics report. Statistics must be received within 30 days of the end of each monthly cycle. A. CLINIC TEST SPECIFICATIONS – PART A, continued Monthly statistics shall be mailed to: Division of Public Health ATTN: Planning & Budget Coordination Support Services Jesse Cooper Building, 1st Floor 417 Federal Street Dover, DE 19901 Northern Health Services (New Castle County sites) ATTN: County Health Administrator Limestone Building, 3 rd Floor 2055 Limestone Road Wilmington, DE 19808 Southern Health Services (Kent and Sussex Counties) ATTN: County Health Administrator Georgetown State Service Center 544 S. Bedford Street Georgetown, DE 19947 NOTE: The DPHL should receive the Monthly and Annual reports for All Clinics Combined only. Please see Attachment G. a. At a minimum, the monthly clinic-by-clinic summary must include: * The number of tests performed at each clinic, by test * The total cost at each clinic, and how the costs were billed (i.e., Medicaid, Medicare, private insurance) and total amount billed to the Division of Public Health. b. The monthly combined Southern Health Services (Kent and Sussex clinic sites) and a separate combined Northern Health Services (New Castle and Wilmington clinic sites) must include: * The number of tests performed at each clinic, by test * The total cost at each clinic, and how the costs were billed (i.e., Medicaid, Medicare, private insurance) and total amount billed to the Division of Public Health. A. CLINIC TEST SPECIFICATIONS – PART A, continued c. The selected vendor will also provide fiscal year-end reports clinic- by-clinic and by Northern Health Services (NHS) and Southern Health Services (SHS). NHS and SHS sites are listed in Attachments D and E. d. A monthly PAP test report by test site is required showing the number of specimens tested by Bethesda System 2001 classification results, inadequate, and other. Public Health requires names of clients with abnormal results by test site for case tracking. Therefore, to appropriately identify the client both client name and date of birth are required fields. e. All Pap test results will be completed and reported by Bethesda System 2001 classification methodology within 10 working days. Abnormal Paps will be reported by phone and teleprinter. A monthly report will be printed by clinic, for each class of Pap tests done. Report should include client name, account number, date of birth, and test result. A report for the monthly rejection rate and reason for the rejection is also required. 21. REPORTING REQUIREMENTS See ATTACHMENT I for complete reporting requirements. 22. VENDOR LABORATORY ACCESS FOR PUBLIC HEALTH CLIENTS Public Health reserves the right to send Public Health clients to the vendor’s respective lab(s) for specimen draws in the event that the client proves to be a difficult draw. B. CHRISTIANA CARE COMMUNITY PROGRAM - PART B The Community Program at Christiana Care offers HIV medical care and social work services for patients living with HIV/AIDS in Kent and Sussex counties. In addition to meeting the criteria under CLINIC TEST SPECIFICATIONS – PART A for the HIV Community Program, the contractor will provide a phlebotomist for the Georgetown Wellness Clinic at Stockley Center in Georgetown and Kent Wellness Clinic at Delaware Hospital for the Chronically Ill in Smyrna eight (8) hours on a weekly basis for each clinic. Times will be provided by the clinic. Please refer to Attachment F for report mailing addresses. C. LEAD PROGRAM AND CLINIC TEST SPECIFICATIONS – PART C The Department of Health and Social Services, Division of Public Health (DPH) is committed to assuring the identification of those children who will benefit from lead poisoning screening and to assuring that they receive the medical services they need. Although most clients now receive blood-lead testing services through their primary health care provider, the uninsured or underinsured clients may use DPH as a resource for blood-lead testing until they are engaged with a permanent health care provider. DPH assures that all children under the age of six (6) years are provided with the opportunity to receive a blood lead test. Since all clients may not have a medical home or the ability to get to a public health clinic for blood draws, a minimum of two (2) patient service centers per county (New Castle, Kent and Sussex) are required. NOTE: One of the New Castle County sites must be in the City of Wilmington. The contractor will be required to draw a venipuncture blood sample. The blood draw will be sent to the Division of Public Health State Laboratory, 30 Sunnyside Rd., Smyrna, Delaware via the contractor’s Courier Service. The contractor will invoice the Division of Public Health for the blood draw. The bidder will use the Bid Sheet for CLINIC LABORATORY SERVICES to indicate the cost of blood draws to be charged to the Division of Public Health. The Bidder will use the Bid Sheet for CLINIC LABORATORY SERVICES to indicate the cost of confirmation blood lead testing to be charged in the event this service is requested by the Division of Public Health. A. The blood draw will be a venipuncture. B. Two empty vacutainers from each new lot number (#) will be provided to the Public Health State Laboratory for quality control purposes. C. The only vacutainer acceptable will have EDTA as the anti- coagulant. D. The blood draw will be ordered by Public Health clinic staff or private providers. Contractor will complete Public Health LIMS Test requisition form which can be found at http://www.dhss.delaware.gov/dhss/dph/lab/files/testreq.pdf or http://www.dhss.delaware.gov/dhss/dph/lab/labs.html E. and submit it with the sample to the Delaware Public Health State Lab in Smyrna, DE. F. The vendor will provide paper and online access to lead reports to the Delaware Division of Public Health Lead Program Manager and clinic staff. Report format will include client name, sex, age, date of birth; gender, address, phone, physician’s name and number; collection sample type; test results; date of collection; date of receipt; and date of report; ordering provider data including name, address, phone, and contact person. G. Monthly statistics shall be mailed to: Lead Program ATTN: Program Director Health Systems Protection Jesse Cooper Building, 2nd Floor 417 Federal Street Dover, DE 19901 D. LONG TERM CARE LAB TESTING – PART D The successful contractor shall: 1. Provide a phlebotomist to meet Long Term Care facilities needs. Regularly scheduled draws to be specified by Long Term Care facilities management for Emily P. Bissell (EPBH), Governor Bacon Health Center (GBHC), and Delaware Hospital for the Chronically Ill (DHCI) facilities. 2. Utilize pathologists that are members of the College of American Pathologists or other appropriate accrediting body. Prior to phlebotomist making first draw, the successful bidder will provide documentation to Long Term Care Facility management staff. 3. Provide specimen containers and supplies, chemistry test/request form, preparation, and label specimens. 4. Provide stat testing 24 hours a day, 7 days a week, on a call coverage basis. All stat testing will be performed by vendor. a. Vendor must respond within one hour of the call. b. Stat test result requires a four-hour test result reporting time. 5. Provide routine testing results within 24 hours after specimen pickup. 6. Send preliminary cultures reports in 80 hours from pick up for blood, fungal and any “problem” cultures, with final reports to follow upon completion. 7. Report results by teleprinter and online for each Long Term Care Facility. One teleprinter will be provided for each nursing care unit. Vendor will provide teleprinter, telephone line, and pay monthly charges. 8. Test Results a. Establish and maintain a control number on each client and specimen. b. Issue a written report to the appropriate authorized individuals following completion of the tests. c. Telephone critical/panic values to the appropriate nursing unit on day shift or the nursing supervisor on off-shifts as soon as the results are confirmed, with a hard copy faxed to the clinic site. d. Provide a monthly infection surveillance summary report for each Long Term Care Facility. The report shall contain at least: * Date(s) of collection of the samples, and the date reported * Long Term Care facility’s name and account number * Condition of the specimen as received - was it acceptable or not acceptable? * Results of each test requested * High and low flags * Normal values and expected values * Client’s name, date of birth, social security number and account number * Nursing unit and room number D. LONG TERM CARE LAB TESTING – PART D, continued 9. Provide annual antibiogram showing percentage of each bacteria species resistant and susceptible to different antibiotics. 10. Provide proof of liability insurance in case of injury. 11. Possess a license to do business in the State of Delaware, a copy of which will be provided to the Division should a contract be awarded. 12. Provide each Long Term Care Facility site’s nursing unit, nursing supervisor's office and nursing administrative office with a comprehensive clinical reference guide which will include the bidder’s general information and services; specimen collection, preparation and handling procedures; and its guide for how to complete test request forms, profiles, and billing and insurance information. 13. Provide phone numbers, pager and cellular numbers of at least two or more company representatives that will be able to answer questions concerning tests, turn-around times, or billing questions relative to the lab services contract. 14. MONTHLY INVOICE Provide Monthly invoice which will include client name, social security number, test performed, test number, cost of test, and all pertinent information necessary to convert data into UB92 Billing Information Invoice. 15. DELAWARE MEDICAL ASSISTANCE PROGRAM and MEDICARE ASSISTANCE Long Term Care Facilities will provide the successful bidder with Medicaid Managed Care, Medicaid, and Medicare numbers for clients covered by the contract. 16. COST PER TEST The prospective contractor will: D. LONG TERM CARE LAB TESTING – PART D, continued a. Use the bid sheet for Long Term Care Facilities attached in Attachment A. Bidder should fill out the cost per test, and show the discount to be applied to all other tests not listed if billed to the Division of Public Health, Long Term Care Facilities. b. Submit a professional fee schedule as established by the bidder as part of the bid package. A flat rate discount will be applied to all tests not covered under bid that are being billed to Long Term Care Facilities. 17. LONG TERM CARE STATISTICS Selected contractor must provide a monthly summary of tests performed during the month by each Long Term Care Facility to the Delaware Division of Public Health and each Long Term Care Facility. Statistics must be received within 30 days of the end of each monthly cycle. Refer to Attachment H. Monthly statistics will be mailed to: Delaware Division of Public Health ATTN: Support Services Planning & Budget Coordination 417 Federal Street Dover, DE 19902 Governor Bacon Health Center P.O. Box 559 Delaware City, DE 19706 Emily P. Bissell Hospital 3000 Newport Gap Pike Wilmington, DE 19808-2300 Delaware Hospital for the Chronically Ill 30 Sunnyside Road Smyrna, DE 19977 At a minimum the summary must include: a. Number of tests performed at each Long Term Care Facility, by test number. D. LONG TERM CARE LAB TESTING – PART D, continued b. Total cost of tests at each Long Term Care Facility, to whom the costs were billed (i.e., Medicaid Managed Care, Medicaid, Medicare, private insurance), and total, combined dollar amount billed to Long Term Care Facilities. 18. Services The successful contractor will ensure that all Vendor’s staff members including phlebotomists and couriers comply with: a. DHSS Long Term Care residential facilities Patient Abuse Law (16 Del. C., section 1131, et seq.) and the Rules and Regulations Governing Delaware’s Patient Abuse Law; http://regulations.delaware.gov/AdminCode/title16/3000/ 3201.shtml b. all Medicaid and/or Medicare-certified Long Term Care facilities and Intermediate Care Facilities for Mental Retardation (ICF/MR) federal regulations (42 CFR) and State Operations Manual for such facilities; and c. all applicable HIPAA regulations. Any contractual employee having contact with residents will be required to supply a copy of and the vendor will also be required to have on file a copy of the Service Letter check of the employee's employment history with current and previous employers. The purpose of the check will be to identify any misconduct by the employee in the areas of violence, threats of violence, abuse and/or neglect. The employee will also be required to authorize the vendor to have on file an Adult Abuse Registry check and a Child Abuse Registry check. All contractual employees having contact with residents will be required to attend a training session regarding resident Abuse, Neglect, Mistreatment, Misappropriation of Property or Significant injury. The training session will be conducted at the appropriate facility by facility staff. Before beginning work at a facility all contractual employees must present documented evidence of a recent Mantoux tuberculin skin test (PPD). lll. SPECIAL TERMS AND CONDITIONS A. Length of Contract Contract term is 36 months with the possibility of renewal for up to two additional years contingent on funding and additional needs to be addressed. B. Subcontractors The use of subcontractors will be permitted for this project. If the vendor plans to use a subcontractor, this information must be specified in the proposal, with an identification of the proposed subcontractor, the service(s) to be provided, and the subcontractor’s qualifications to provide such service(s). Subcontractors must be CLIA certified. Copies of the Subcontractor’s certification must be provided to the agency prior to the contract award. For example, some tests may require outside consultation. Or due to advanced technology, specific tests may be performed at an outside lab to obtain proper results for the client. The vendor will advise clients when such actions are required. Also, STAT testing may be performed by subcontractors providing the subcontractor selected by the successful vendor is CLIA-certified and a copy of the certification is on file. Subcontractors will be held to the same requirements as the primary contractor. The contract with the primary contractor will bind sub or co- contractors to the primary contractor by the terms, specifications, and standards of the RFP. All such terms, specifications, and standards shall preserve and protect the rights of the agency under the RFP and any subsequent proposals and contracts with respect to the services performed by the sub or co-contractor, so that the sub or co-contractor will not prejudice such rights. Nothing in the RFP shall create any contractual relation between any sub or co-contractor and the agency. The proposed subcontractors must be approved by the Division of Public Health. C. Training and Review Within 30 days of contract execution, the representative will visit each clinic site and each Long Term Care Facility site for distribution of “User Friendly” comprehensive clinical reference guides. Following the initial visit, the representative will make visits every three months for updates of manual, quality assurance issues and procedures for tests (specimen collection manual). Representative must be available to sites to resolve quality assurance issues. Vendor will be required to provide in-service training on ICD-9/ICD-10 codes and other service related problems, including forms and Medicaid issues, as required, by each Clinic or Long Term Care facility. D. Funding Disclaimer Clause Delaware Health and Social Services reserves the right to reject or accept any bid or portion thereof, as may be necessary to meet the Department’s funding limitations and processing constraints. The Department reserves the right to terminate any contractual agreement upon fifteen (15) calendar days written notice in the event the state determines that state or federal funds are no longer available to continue said contractual agreement. E. Quality Assurance 1. Contractor must provide testing and specimen rejection policy as it relates to each test identified in the contract. 2. On a six (6) month basis, the contractor will identify, by clinic site and Long Term Care Facility site, the number and reason of test types rejected. 3. Contractor must meet all applicable CLIA amendment regulations, and provide a copy of the current CLIA lab certificate. 4. Contractor must be able to provide testing which will provide accuracy to a confidence level according to the Centers for Medicare and Medicaid Services (CMS). 5. Contractor must define its continuous Quality Improvement program including, but not be limited to, the procedures, frequency, percentage, and sample selection criteria. Contractor must participate in each Long Term Care facility’s Quality Assurance Improvement Panel program according to that facility’s plan. F. Reserved Rights Notwithstanding anything to the contrary, the Department reserves the right to: * Reject any and all proposals received in response to this RFP; * Select a proposal other than the one with the lowest cost; * Waive or modify any information, irregularities, or inconsistencies in proposals received; * Negotiate as to any aspect of the proposal with the bidder and negotiate with more than one bidder at a time; * If negotiations fail to result in an agreement within two (2) weeks, the Department may terminate negotiations and select the most responsive bidder, prepare and release a new RFP, or take such other action as the Department may deem appropriate. E. Termination Conditions The Department may terminate the contract resulting from this RFP at any time that the vendor fails to carry out its provisions or to make substantial progress under the terms specified in this RFP and the resulting proposal. Prior to taking the appropriate action as described in the contract, the Department will provide the vendor with thirty (30) days notice of conditions endangering performance. If after such notice the vendor fails to remedy the conditions contained in the notice, the Department shall issue the vendor an order to stop work immediately and deliver all work and work in progress to the State. The Department shall be obligated only for those services rendered and accepted prior to the date of notice of termination. The Contract may be terminated in whole or part: a) by the Department upon five (5) calendar days written notice for cause or documented unsatisfactory performance, b) by the Department upon fifteen (15) calendar days written notice of the loss of funding or reduction of funding for the stated Contractor services, c) by either party without cause upon thirty (30) calendar days written notice to the other Party, unless a longer period is specified. F. Contractor Monitoring The contractor may be monitored/evaluated on-site on a regular basis by representatives from the Division of Public Health. Failure of the contractor to cooperate with the monitoring/evaluation process or to resolve any problem(s) identified in the monitoring/evaluation may be cause for termination of the contract. G. Payment: The agencies or school districts involved will authorize and process for payment each invoice within thirty (30) days after the date of receipt. The contractor or vendor must accept full payment by procurement (credit) card and or conventional check and/or other electronic means at the State’s option, without imposing any additional fees, costs or conditions. H. W-9 Information Submission Effective January 5, 2009, a new vendor process and use of the new Delaware Substitute Form W-9 will be implemented by the Delaware Division of Accounting. With the development of the new Delaware Substitute Form W-9, state organizations will no longer be responsible for collecting the Form W-9 from vendors. The vendor will have the capability of submitting the required Form W-9 electronically and directly to the Delaware Division of Accounting for approval. The vendors will submit their Form W-9 by accessing this website, http://accounting.delaware.gov/. The vendor will complete the secure form, read the affirmation, and submit the form by clicking the “Submit” button. Delaware Division of Accounting staff will review the submitted form for accuracy, completeness, and standardization. Once all the requirements are met, the form will be uploaded to the vendor file and approved. The vendor is then able to be paid for services provided. For those vendors that do not have internet access, a printable version of the Delaware Substitute Form W-9 can be faxed or mailed to the vendor. Upon completion, the vendor will then fax or mail the form directly to the vendor staff at the Delaware Division of Accounting. All vendor requests, additions and changes, will come directly from the vendor. Questions for vendors who do not have internet access , contact vendor staff at (302) 734-6827. This applies only to the successful bidder and should be done when successful contract negotiations are completed. It is not a required to be done as part of the submission of the bidder’s proposal. lV. FORMAT AND CONTENT OF RESPONSE Proposals shall contain the following information, adhering to the order as shown: A. Bidder’s Signature Form This form, found in the Appendix A, must be completed and signed by the bidder’s authorized representative. B. Title Page The Title page shall include: 1) the RFP subject; 2) the name of the applicant; 3) the applicant’s full address; 4) the applicant’s telephone number; 5) the name and title of the designated contact person; and 6) bid opening date (due date: July 30, 2009 at 11:00am). C. Table of Contents The Table of Contents shall include a clear and complete identification of information presented by section and page number. D. Confidential Information The following items, if required in response to this RFP, are to be included in a separate section of your proposal and marked as confidential. These items are: 1) any financial information relating to the company or organization (not the RFP pricing or budget); 2) Resumes; 3) Organization Charts. E. Qualifications and Experience This section shall contain sufficient information to demonstrate experience and staff expertise to carry out the project. A statement must be included that the vendor either has or certifies he/she will secure a Delaware Business License prior to initiation of the project. Attach articles of incorporation and IRS certification of tax exempt status if applicable. The specific individuals who will work on this project must be identified, along with the nature and extent of their involvement. The qualifications of these individuals shall be presented (in resumes or other formats). If conducting this project will require hiring of one or more individuals who are not currently employed by the bidding organization, applications shall provide detailed job descriptions, including required qualifications and experience. If subcontractors are to be used, the proposal shall also contain similar information regarding each subcontractor. F. Bidder References The names and phone numbers of at least three (3) organizations/agencies for whom the vendor carried out a similar project must be included. If no similar project has been conducted, others requiring comparable skills can be used. Bidder shall list all contracts awarded to it or its predecessor firm(s) by the State of Delaware; during the last three years, by State Department, Division, Contact Person (with address/phone number), period of performance and amount. The Evaluation/Selection Review Committee will consider these additional references and may contact each of these sources. Information regarding bidder performance gathered from these sources may be included in the Committee’s deliberations and factored in the final scoring of the bid. Failure to list any contract as required by this paragraph may be grounds for immediate rejection of the bid. G. Proposed Methodology and Work Plan This section shall describe in detail the approach that will be taken to carry out the activities described in the Scope of Services section of this RFP. Specific completion dates for the various tasks must be shown. The workplan shall outline specific objectives, activities and strategies, and resources. H. Statements of Compliance The bidder must include statements that the applicant agency complies with all Federal and Delaware laws and regulations pertaining to equal opportunity and affirmative action. In addition, compliance must be assured in regard to Federal and Delaware laws and regulations relating to confidentiality and individual and family privacy in health care delivery and in the collection and reporting of data. (See Appendix C) I. Standard Contract Appendix E is a copy of the standard boilerplate contract for the State of Delaware, Delaware of Health and Social Services, Division of Public Health. This boilerplate will be the one used for any contract resulting from this Request for Proposal. If a bidder has an objection to any contract provisions or the RFP and its procurement provisions, objections shall be stated in the Transmittal Letter of the bidder’s proposal. V. BUDGET Vendor will submit the Bid Sheet for Clinic Laboratory Services and the Bid Sheet for Long Term Care Facilities, in lieu of a line item budget, describing the cost per test. Modifications to the budget after the award must be approved by the Division of Public Health. Applicants shall also describe any factors that may have an impact on the cost and should suggest a payment schedule contingent upon completion of the various tasks. VI. GENERAL INSTRUCTIONS FOR SUBMISSION OF PROPOSALS A. Number of Copies Required Two (2) original CDs (Each Labeled as “Original”) and six (6) CD copies (Each labeled as “Copy”). In addition, any required confidential financial or audit information relating to the company and not specifically to the proposal may be copied separately to three (3) additional CDs (Each labeled “Corporate Confidential Information”). All CD files shall be in PDF and Microsoft Word formats. Additional file formats (i.e. .xls, .mpp) may be required as requested. It is the responsibility of the bidder to ensure all submitted CDs are machine readable, virus free and are otherwise error-free. CDs (or their component files) not in this condition may be cause for the vendor to be disqualified from bidding. Bidders will no longer be required to make hard copies. The responses to this RFP shall be submitted to: Mrs. Sandra Skelley, Procurement Administrator Division of Management Services Delaware Health and Social Services Main Administration Building Second Floor, Room 259 1901 North duPont Highway New Castle, DE 19720 B. Closing Date All responses must be received no later than July 30, 2009 at 11:00 a.m. Later submission will be cause for disqualification. C. Notification of Acceptance Notification of the Department's intent to enter into contract negotiations will be made in writing to all bidders. D. Questions All questions concerning this Request for Proposal must be in writing and can be either mailed, faxed. or emailed to: Kathleen Russell, Division of Public Health, Georgetown State Service Center, Room 1102, 544 S. Bedford Street, Georgetown, DE 19947. Fax number: (302) 854-2856. E- mail: Armon.martin@state.de.us Deadline for submission of all questions is June 15, 2009. Written responses will be faxed or emailed to bidders no later than July 2, 2009. Please include your fax number and/or your email address with your request. E. Amendments to Proposals Amendments to proposals will not be accepted after the deadline for proposal submission has passed. The State reserves the right at any time to request clarification and/or further technical information from any or all applicants submitting proposals. F. Proposals Become State Property All proposals become the property of the State of Delaware and will not be returned to the bidders. The State will not divulge the specific contents of any proposal to the extent that the applicant(s) identity(ies) would be disclosed. This information is privileged and confidential. G. Non-Interference Clause The awarding of this contract and all aspects of the awarded bidders contractual obligations, projects, literature, books, manuals, and any other relevant materials and work will automatically become property of the State of Delaware. The awarded bidder will not in any manner interfere or retain any information in relationship to the contractual obligations of said contract, at the time of the award or in the future tense. H. Investigation of Grantee’s Qualifications The Delaware Health and Social Services may make such investigation as it deems necessary to determine the ability of the bidder to furnish the required services, and the bidder shall furnish such data as the Department may request for this purpose. I. RFP and Final Contract The contents of the RFP will be incorporated into the final contract and will become binding upon the successful bidder. If the bidder is unwilling to comply with any of the requirements, terms, and conditions of the RFP, objections must be clearly stated in the proposal. Objections will be considered and may be subject to negotiation at the discretion of the state. J. Proposal and Final Contract The contents of each proposal will be considered binding on the bidder and subject to subsequent contract confirmation if selected. The contents of the successful proposal will be included by reference in the resulting contract. All prices, terms, and conditions contained in the proposal will remain fixed and valid for one (1) year after proposal due date. K. Cost of Proposal Preparation All costs for proposal preparation will be borne by the bidder. L. Proposed Timetable The Department’s proposed schedule for reviewing proposals is outlined as follows: Activity _________ Date Bid Opening July 30, 2009 at 11:00 AM Selection Process Begins July 31, 2009 Vendor Selection (tentative) September 4, 2009 Project Begins November 16, 2009 M. Confidentiality and Debriefing The Procurement Administrator shall examine the proposal to determine the validity of any written requests for nondisclosure of trade secrets and other proprietary data identified in conjunction with the Attorney General’s Office. After award of the contract, all responses, documents, and materials submitted by the offeror pertaining to this RFP will be considered public information and will be made available for inspection, unless otherwise determined by the Director of Purchasing, under the laws of the State of Delaware. All data, documentation, and innovations developed as a result of these contractual services shall become the property of the State of Delaware. Based upon the public nature of these Professional Services (RFP) Proposals an offeror must inform the state in writing, of the exact materials in the offer which CANNOT be made a part of the public record in accordance with Delaware’s Freedom of Information Act, Title 29, Chapter 100 of the Delaware Code. If a bidder wishes to request a debriefing, he must submit a formal letter to the Procurement Administrator, Herman M. Holloway Campus, Delaware Health and Social Services Main Building, 2nd Floor, Room 259, 1901 N. duPont Highway, New Castle, Delaware 19720 within 10 days after receipt of Notice of Award. The letter must specify reasons for the request. VII. SELECTION PROCESS All proposals submitted in response to this RFP will be reviewed by an evaluation team composed of representatives of the Division of Public Health, Delaware Health and Social Services, and others as may be deemed appropriate by the Department. Each proposal will be independently reviewed and rated against review criteria. Selection will be based upon the recommendations of the review committee. A. Proposal Evaluation Criteria The vendor will be selected through open competition and based on the review of proposals submitted in response to this request for proposals. A technical review panel will review all proposals utilizing the following criteria. A maximum of 100 points is possible. Category Weight Meets mandatory RFP provisions Pass/Fail Understanding of the requirements and ability to provide the service. 30 1. Qualifications of vendor 10 a. Current CLIA certification b. References with contact information c. Demonstrates capacity to deliver services 2. Inclusion of all requested elements 10 a. Submission of required forms b. Report formats 3. Available resources 10 a. Number and location of Patient Service Centers Methodology Proposed 35 1. Services proposed fit needs as expressed in RFP 15 a. Invoicing procedures b. Reporting schedule 2. Proposed activities follow a logical sequence 10 3. Time line for trainings 10 Cost proposal 35 1. Bid Sheets 20 2. Professional Fee Schedule 15 Upon selection of a vendor, a Division of Public Health representative will enter into negotiations with the bidder to establish a contract. B. Project Costs and Proposed Scope of Service The Department reserves the right to award this project to a bidder other than the one with the lowest cost or to decide not to fund this project at all. Cost will be balanced against the score received by each bidder in the rating process. The State of Delaware reserves the right to reject, as technically unqualified, proposals that are unrealistically low if, in the judgment of the evaluation team, a lack of sufficient budgeted resources would jeopardize project success. ATTACHMENT A BID SHEETS FOR CLINIC LABORATORY TESTS AND LONG TERM CARE FACILITIES Bid Sheet for CLINIC LABORATORY SERVICES State of Delaware – Division of Public Health Bid Form for CLINIC LABORATORY SERVICES Contract #_____________ Name of Bidder: _________________________________________ Mailing Address: _________________________________________ Mailing Address: _________________________________________ City, State, Zip: _______________________________________ Below are the tests in which Public Health requests a firm price per test. These prices will be valid for the duration of the contract. TEST COST Per TEST Blood Lead (Pediatric) __________ Comprehensive Metabolic Panel + 8 AC __________ Metabolic Panel (13) Comprehensive ____ Comp Blood Count with Differential Platelet ____ Comp Blood Count, Diff (SP. PLATE) __________ Glucose – Fasting ____ Glucose, Plasma ____ HBV Prevac Profile ____ HBV XI – Vac follow up ____ Helper T-Lymphocytes Marker CD4 __________ Hepatitis A Antibody Igm ____ Hepatitis C Virus Antibody __________ Hepatitis Panel ____ HIV-1 RNA by PCR, Quantitative ____ HIV-1 Ultrasens ____ HIV-1 Western Blot __________ In pouch TV ____ ____ Lipid Panel and Chol/HDL ratio ____ Pap Smear ____ Pap Smear – Thin Prep Reflex High Risk HPV (ASC-US) ____ Phlebotomy – Single Draw __________ Poc Kit, HSV2 Rapid Test ____ Pregnancy, hCG Beta Subunit, QUAL, Serum ____ Prolactin __________ TB Panel(delete) ____ Testosterone – Free & Total ____ Thyroid Panel with TSH __ ____ T-Lymphocyte Helper/Suppressor ____ Toxoplasma – IGG +IGM ____ Urinalysis – Routine __________ Yeast Culture ____ Estradiol, Adult __________ Hepatic Function Panel __________ Hemoglobinopathy Evaluation (Hgb electophoresis & partial CDC) __________ Thin Prep with High Risk HPV (over age 30 years) __________ Secondary Amenorrhea Panel (FSH, LH, prolactin, thyroid panel) __________ PSOC panel (estradiol & testosterone) __________ Hemoglobin A1C __________ Bid Sheet for LONG TERM CARE FACILITIES State of Delaware – Division of Public Health Bid Form for LONG TERM CARE FACILITIES CONTRACT #___________ Name of Bidder: _______________________________________________ Mailing Address: _______________________________________________ Mailing Address: _______________________________________________ City, State, Zip: _______________________________________________ Below are the tests in which Public Health requests a firm price per test. These prices will be valid for the duration of the contract. TEST COST Per TEST Albumin, Serum CBC With Differential/Platlets Basic Metabolic Panel (BMP) _____________ Digoxin _____________ Electrolytes (NA, K, Cl, CO2) _____________ Hemoglobin A1C Hepatitis Panel _____________ Lipid Panel _____________ Magnesium _____________ Metabolic Panel, 8 Basic Metabolic Panel, 14 Comprehensive Blood Urea Nitrogen; Bun ________ Creatinine, serum ________ Electrolyte panel ________ Occult Blood, Stool Phlebotomy – Single Draw Phosphorous _____________ Potassium _____________ Prealbumin Prostate Specific Antigen (PSA) _____________ Prothrombin Time with INR Thyroid Panel with TSH _____________ T4 & T3 _____________ Urinalysis, Complete Urinalysis, Routine Urine Culture, Routine ATTACHMENT B TEST SUMMARY TEST DESCRIPTION Amylase, Serum Synonyms AML Specimen Serum Complete Blood Count (CBC) With Differential Synonyms CBC Specimen Whole blood Differential count, hematocrit; hemoglobin, mean corpuscular volume (MCV); mean corpuscular hemoglobin (MCH); mean corpuscular hemoglobin concentration (MCHC); percentage and absolute counts; platelet count; red cell count; white blood cell count Comprehensive Metabolic Panel + 8 AC Glucose, Serum Uric Acid, Serum BUN Creatinine, Serum BUN/Creatinine Ratio Sodium, Serum Potassium, Serum Chloride, Serum Calcium, Serum Phosphorus, Serum Protein, Total, Serum Albumin, Serum Globulin, Total A/G Ratio Bilirubin, Total Alkaline Phosphatase, Serum LDH AST (SGOT) ALT (SGPT) GGT Iron, Serum Cholesterol, Total Triglycerides Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Synonyms FSH and LH; LH and FSH; Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) Specimen Serum Test Includes Follicle-stimulating hormone (FSH) and luteinizing hormone (LH) Genotype HIV Genotype Genotype with Virtual Phenotype HIV Genotype + Virtual Phenotype Genotype HIV-1 Genotyping for drug resistance to PRI and RTI TEST DESCRIPTION Glucose, Serum Synonyms Blood Sugar; Glu Specimen Serum Gynecologic Pap Smear, 1 Slide Synonyms Cervical/Vaginal Smear; Genital Cytology; Papanicolaou Smear; Vaginal Cytology Gynecologic Pap Smear, Liquid-Based Preparation Synonyms Mono-Layer Pap Smear; Pap Smear, Gynecologic; ThinPrep, Pap Test System Helper T-Lymphocyte Marker CD4 Specimen Whole Blood CBC; absolute CD4+ (helper/inducer); absolute lymph count; percentage of CD4+ Hemoglobin (hgb) Solubility Synonyms Hb S; Hemoglobin S; Sickle Cell Preparation; Sickle Cell Solubility Test; Sickle Cell Test; Sickledex TM, Sickle Prep Hepatitis A Antibody, IgM Synonyms Antibody to Hepatitis A Virus, IgM; Anti-HAV, IgM; HAVAb, IgM Specimen Serum or plasma Hepatitis C Virus Antibody Synonyms Antibody to Hepatitis C, Anti-HCV Specimen Serum or plasma Hepatitis Panel Synonyms HP Specimen Serum or plasma Hepatitis A antibody, total; hepatitis B core antibody, total; hepatitis B surface antibody, hepatitis B surface antigen; hepatitis C virus antibody Hepatitis Profile X (HBV) Prevaccination Profile Synonyms HBV Prevaccination (Profile X) Specimen Serum or plasma Antibody to B surface antigen (anti-HBs); B surface antigen (HbsAg); antibody to B core antigen, IgM (anti-HBc, Igm); antibody to B core antigen (anti-HBc); interpretation TEST DESCRIPTION Human Chorionic Gonadotropin (hCG), Beta Subunit, Qualitative, Serum Synonyms Beta Subunit, hCG; hCG, Beta Subunit, Qual, Serum; Pregnancy Test, Serum Specimen Serum Human Chorionic Gonadotropin (hCG) Quantitative Human Immunodeficiency Virus 1 (HIV01) RNA, Quantitative Synonyms HIV-1 Plasma Viremia; HIV-1 RNA by PCR, Quantitative Specimen Blood plasma, CSF Serial monitor report TEST DESCRIPTION In Pouch TV Lead, Blood (Pediatric) Synonyms Pb blood Specimen Whole blood Lipid Panel and Chol/HDL Ratio Specimen Serum Cholesterol, Total Triglycerides HDL Cholesterol VLDL Cholesterol Cal LDL Cholesterol Cal T. Chol/HDL Ratio Metabolic Panel (13), Comprehensive Synonyms CMP13; Comprehensive Metabolic Panel Specimen Serum Albumin; albumin/globulin (A/G) ratio (calculation); alkaline phosphates; aspartate aminotransferase (AST); bilirubin, total; BUN; BUN/creatinine ratio (calculation); calcium; carbon dioxide, total; chloride; creatinine; globulin, total (calculation); glucose; potassium; protein, total; sodium Poc Kit, HSV2 Rapid Test Prolactin Specimen Serum TB Panel Creatinine, glucose, serum, uric acid, serum, BUN, Ca++, serum, Phosphorus, Serum, Protein, Total, Serum, Cholesterol, Total, Albumin, serum, bilirubin, total alkaline phosphatose, serum, LDH, AST,ALT,GGT TEST DESCRIPTION Testosterone, Free (Direct), Serum (With Total Testosterone) Synonyms Free Testosterone (Direct) and Total, Serum; Testosterone, Free/Tot/Direct Specimen Serum Total testosterone Thyroid Panel With TSH Synonyms Thyroid Profile B Specimen Serum Free thyroxine index (FTI); thyroid hormone binding ratio (t3 uptake); thyroid- stimulating hormone (TSH), high sensitivity; thyroxine (t4) Urinalysis, Routine (With Microscopic Examination on Positives) Synonyms Routine Urinalysis; UA, Routine Specimen Urine (random) Color, appearance, specific gravity, pH, protein, glucose, ketones, occult blood, leukocyte esterase, nitrite, bilirubin, and urobilinogen. These tests are done on all routine urinalysis ordered and if protein; leukocyte, occult blood nitrite, and turbidity are all negative a microscopic is not performed; just the above parameters are reported out. Yeast Culture ATTACHMENT C NUMBER OF TESTS PERFORMED IN 2007 FOR ALL CLINICS COMBINED AND ALL LONG TERM CARE FACILITIES COMBINED State of Delaware – Division of Public Health Number of Clinic Tests Performed in 2007 All Clinics Combined Test Name Volume CHOLESTEROL,TOTAL 4669 GGT 4016 LDH, TOTAL 4016 COMP METAB PNL 4010 URIC ACID 4010 PHOSPHORUS,INORGANIC 4009 TPPT W/RFX HPV 2508 TRIGLYCERIDES 1180 HDL-CHOLESTEROL 1172 CBC (DIFF/PLT) 1128 LYMPH SUBSET 5PNL 916 HIV-1 RNA QN PCR ULT 698 CYTO,THINPREP PAP 541 MISC\OTHER TESTS 508 PATH REVIEW, LIQ PAP 459 HPV HR 344 GLUCOSE, SERUM 335 DRAW FEE, PSC SPEC. 233 HIV-1 RNA,QUANT PCR 225 TSH 157 HCG, SERUM, QUAL 113 LEAD (B) 106 CYTOPATH, GYN 1 99 T-4 (THYROXINE) 87 T-3 UPTAKE 82 HEP B SURF AG W/CONF 61 HEP B SURFACE AB QL 60 HEP B CORE AB, TOTAL 57 HEP C AB 54 AST 52 ALT 52 BILIRUBIN, TOTAL 50 ALKALINE PHOSPHATASE 50 HEP A AB, TOTAL 47 HIV-1 GENOTYPING PRI 45 HIV-1 GENOTYPING RTI 45 PROTEIN, TOTAL 43 HEP B CORE IGM 42 CALCIUM 42 CREATININE 39 UREA NITROGEN (BUN) 39 TESTOSTERONE F&T 35 HEP A IGM AB 34 URINALYSIS SCREEN 33 TOXO IGG AB 32 TOXO IGM EIA 31 PROLACTIN 30 HIV-1 PR/RT DNA SEQ 26 State of Delaware – Division of Public Health Number of Clinic Tests Performed in 2007 All Clinics Combined, continued Test Name Volume HEMOGLOBINOPATHY 24 FSH 18 PATH REVIEW 18 HEMOGLOBIN A1C 16 HEPATIC FUNC PNL 16 LUTEINIZING HORMONE 14 LIPASE 13 AMYLASE 13 IV-PATH, G&M, TC, 1 SP 10 IV-PATH, G&M, PC, 1 SP 10 HCV RNA BY PCR, QT 8 HEPTIMAX (TM) 1 PRO TIME WITH INR 1 ALBUMIN 1 Total 36783 State of Delaware – Division of Public Health Number of Clinic Tests Performed in 2007 All Long Term Care Facilities Combined Total number of tests (test codes = 342 tests / Total volume (sum of all) = 23,848 tests. Test Code Test Name Sum Of CY2007 205 ACETONE (B) 1 213 IMMUNOFIX (U) 8 223 ALBUMIN 229 231 ALK PHOS ISOENZYMES 1 234 ALKALINE PHOSPHATASE 10 235 A-1-ANTITRYPSIN 1 236 AMIKACIN 3 237 AFP, TUMOR (CHIRON) 12 243 AMYLASE 20 249 ANA W/RFX 15 255 ANTI-DSDNA AB, EIA 5 259 MITOCHONDRIAL W/REFL 1 263 SMOOTH MUSC RFX/TIT 2 285 BILIRUBIN,DIRECT 3 287 BILIRUBIN, TOTAL 2 294 UREA NITROGEN (BUN) 188 303 CALCIUM 11 306 CALCIUM, IONIZED 4 310 CARBON DIOXIDE 1 311 CAROTENE 2 318 CATECHOLAMINES, FRAC 1 326 CERULOPLASMIN 1 329 CARBAMAZEPINE, TOTAL 58 330 CHLORIDE 1 334 CHOLESTEROL,TOTAL 400 347 FACTOR VIII ACTIVITY 1 351 COMPLEMENT C3C 3 353 COMPLEMENT C4C 3 361 COOMBS, DIRECT 2 367 CORTISOL, TOTAL 8 368 CHLORIDE, 24 HOUR UR 1 374 CK, TOTAL 21 375 CREATININE 194 381 CREATININE (U) 1 389 CULTURE, BLOOD 61 394 CULTURE, THROAT 22 395 CULTURE, ROUTINE UR 667 396 HCG, TOTAL (U) QL 1 403 CMV IGG AB, EIA 1 410 DHEA,PL,RIA 1 415 DIFF CT, MANUAL 25 418 DIGOXIN 81 427 ERYTHROPOIETIN 2 443 ALCOHOL, ETHYL (B) 1 449 FATTY ACIDS, FREE 1 457 FERRITIN 189 466 FOLATE,SERUM 145 467 FOLATE, RBC 1 470 FSH 3 482 GGT 5 483 GLUCOSE, SERUM 57 484 GLUCOSE, PLASMA 7 496 HEMOGLOBIN A1C 501 497 GRAM STAIN 21 498 HEP B SURF AG W/CONF 44 499 HEP B SURFACE AB QL 11 500 G-6-PD (B) 1 501 HEP B CORE AB, TOTAL 4 502 HAPTOGLOBIN 4 508 HEP A AB, TOTAL 3 509 HEMATOCRIT 255 510 HEMOGLOBIN (B) 262 512 HEP A IGM AB 32 521 HGH 1 539 IMMUNOGLOBULIN A 4 543 IMMUNOGLOBULIN G 3 545 IMMUNOGLOBULIN M 3 549 IMMUNOFIXATION 11 555 HEP BE AG 2 571 IRON, TOTAL 7 593 LDH, TOTAL 6 606 LIPASE 13 608 HDL-CHOLESTEROL 400 613 LITHIUM 55 615 LUTEINIZING HORMONE 2 622 MAGNESIUM 64 660 MYOGLOBIN 1 673 OCCULT BLD, FECES 1 355 677 OSMOLALITY 21 678 OSMOLALITY (U) 5 681 OVA AND PARASITE 3 689 CULTURE, VIRUS 7 690 CHLAMYDIA CULTURE 1 706 ROTAVIRUS AG DETECT. 1 708 PHENOBARBITAL 65 713 PHENYTOIN 338 718 PHOSPHATE (AS PHOS.) 47 723 PLATELET COUNT 33 733 POTASSIUM 58 734 POTASSIUM, 24 HOUR UR 1 746 PROLACTIN 3 747 PROTEIN ELECTRO. 28 750 PROTEIN ELECTRO. (U) 3 751 PRIMIDONE 25 754 PROTEIN, TOTAL 8 757 TP 24HR W/ CREAT 9 763 PTT, ACTIVATED 42 793 RETICULOCYTE CELL CT 56 795 AB SCR RFX ID/TITER 1 799 RPR MONITOR W/REFL 40 809 SED RATE BY MOD WEST 134 822 AST 56 823 ALT 56 836 SODIUM 3 838 SODIUM, 24 HOUR UR 1 852 BET-2-MICRO,SR 2 859 T-3, TOTAL 13 861 T-3 UPTAKE 181 866 T-4, FREE 90 867 T-4 (THYROXINE) 285 873 TESTOSTERONE, TOTAL 4 878 THEOPHYLLINE 9 891 TRANSFERRIN 24 896 TRIGLYCERIDES 403 899 TSH 486 905 URIC ACID 26 916 VALPROIC ACID 296 917 VANCOMYCIN 2 927 VITAMIN B12 155 931 VITAMIN E 1 937 WBC 30 967 T-3, REVERSE 1 978 CEA 21 1715 TP RAND UR W/ CREAT 7 1759 HEMOGRAM/PLT 477 2179 DRUG SCR 10-20 + 0 2649 CULT.HERPES W/TYPING 1 3020 UA,COMP W/RFL CULTURE 153 3021 CULT,UR,CATH COLLECT 96 3189 PHENYTOIN, FREE 26 3190 SPECIFIC GRAVITY (U) 3 3259 DRAW FEE, PSC SPEC. 10 3260 HOUSE CALL & DRAW 3957 3679 TOXO IGG AB 1 3812 PICK UP FEES, STAT 0 3930 FECAL LEUKOCYTE STN 2 3960 T.VAGINALIS CULTURE 1 3967 FECAL FAT, QUAL 2 3968 CULT,YEAST W/DIR KOH 1 4021 ESTRADIOL 1 4112 FTA-ABS 1 4407 C.DIFFICILE CULTURE 1 4418 RHEUMATOID FACTOR 13 4420 CRP 27 4446 CULTURE,AEROB/ANAER 4 4456 DIFFERENTIAL CT (B) 2 4469 ANAEROBIC CULT. W/GS 7 4475 CULTURE, CAMPYLOBAC. 11 4477 CULTURE, EAR, EXT. 1 4480 CULTURE, EYE, EXT. 207 4482 CULTURE,NP/NASAL 77 4550 CULTURE, AEROBIC BAC 401 4553 CULT,FUNGUS,OTHER 3 4554 CULTURE, AFB 3 4556 CULTURE,SPUTUM/LOWER RESP 42 4558 CULTURE, GENITAL 20 4605 CULT,FUNGUS,SKIN 8 4662 CARDIOLIPIN IGG AB 1 4663 CARDIOLIPIN IGM AB 1 4729 VITAMIN D, 1-25 3 4847 PREALBUMIN 307 4848 HEP B CORE IGM 36 5233 HIV-1 AB BY WBA 3 5363 PROSTATE SPECIFIC AG 64 5463 UA, COMPLETE 261 5489 RFL-MICR(INC) 156 5509 AMMONIA (P) 26 5704 COMP C3C4 3 6399 CBC (DIFF/PLT) 1290 6449 *HIV-1 SCR(REFL) 17 6517 MICROALB/CREAT RATIO 51 6635 COMP DRUG,(U) 1 6646 LYME AB-WB CONFIRM 1 7008 HEMOGRAM 2 7079 LUPUS ANTICOAG W/RFL 4 7286 BILIRUBIN,FRAC. 1 7352 CARDIOLP G/M/A 1 7573 IRON, TOTAL, & IBC 153 7577 GLOB,TOT W A/G RATIO 1 7832 SJOGREN'S ANTIBODIES 1 7846 PINWORM ID, 2 SPEC 1 7909 UA, REFLEX 206 7943 CREATININE CLEARANCE 10 8293 DIRECT LDL 5 8340 FRUCTOSAMINE 34 8347 POTASSIUM RAND UR 1 8360 LYMPH SUBSET 5PNL 42 8369 HEP B DNA 3 8396 HCG, SERUM, QUANT 2 8435 HCG, SERUM, QUAL 0 8459 CREATININE, RAND UR 1 8467 RSV AG,EIA 1 8472 HEP C AB 49 8477 GLUCOSE, GEST. SCR. 1 8525 PROTEIN ELECTRO. 2 8563 UA, MICROSCOPIC 2 8579 VANCOMYCIN,TR 21 8659 D-DIMER 1 8794 OCCULT BLD, FECES 3 1 8801 SCREEN FOR S. AUREUS 208 8812 CYCLOSP TR FPIA 3 8821 TTG IGA 3 8837 PTH,INTACT & CALCIUM 30 8847 PRO TIME WITH INR 680 10019 CULTURE,SALM/SHIG 11 10073 HCV RNA QUANT.TMA 1 10124 CARDIO CRP 5 10157 PSA, MEDICARE 1 10165 BASIC METAB PNL 1023 10231 COMP METAB PNL 710 10237 GC DNA, PCR 1 10238 CHLAMYDIA/GC DNA,PCR 1 10256 HEPATIC FUNC PNL 272 10314 RENAL FUNC PNL 37 10537 PLASMA RENIN ACTIV 1 10600 CMV DNA,QT,PCR 1 10662 MYCOPHENOLIC ACID, S 1 11015 SURFACE LIGHT CHAINS 2 11173 CCP AB IGG 6 11228 GLIADIN IGA 1 11234 KAPPA/LAMBDA W/RATIO 1 11290 FECAL IMMUNOCHEM 3 11293 FECAL IMMUNOCHEM MED 9 11320 PROTEIN, TOTAL 1 14600 CHROM, HEMATOLOGIC 1 14962 METANPH.24 HR URINE 1 15061 KAPPA LIGHT CHAIN,FREE 1 15111 PHOSPHOLIPID NEUT 1 15126 D TEST 116 15142 LEVETIRACETAM 68 15544 NORWALK LIKE VIRUS 3 16101 JAKE MUTATION PLASMA 3 16102 *JAK2 MUTATION CELL 1 17181 ALDOSTERONE,LC/MS/MS 1 17303 CHLAMYDIA SDA 1 17304 NG SDA 1 17305 CT/NG SDA 5 17306 VIT D 25OH LC/MS/MS 18 19728 HIV1/2 AB SCR W/RFLS 13 19791 DRVVT 1:1 MIX 1 20253 CBC (DIFF/PLT)W/SMEAR RVW 1 29256 CA125 1 29407 H.PYLORI IGG AB 4 29421 DRUG SCR 10 + ETOH 1 29891 SED RATE MANUAL WEST 1 30509 VDRL, SERUM 1 31348 PSA FREE & TOTAL 2 31789 HOMOCYSTEINE,CARDIO 2 34181 HBV DNA PCR, QUAL 1 34205 HIV-1 RNA,QUANT PCR 12 34220 HIV-1 RNA QN PCR ULT 31 34388 BASIC METAB PNL W/O CA 14 34392 ELECTROLYTE PANEL 238 34429 T-3, FREE 3 34856 MISC-ATHENA 1 34857 MISC-ATHENA 1 35436 LIPOPROTEIN ELEC 1 35441 OCCULT BLD, 1 123 35489 HEMOGLOBINOPATHY 5 35645 HCV RNA BY PCR, QT 16 35945 CULT, RAPID FLU A&B 9 36126 RPR(DX)REFL FTA 33 36127 TSH W/REFL FT4 50 36170 TESTOSTERONE, FR&TOT 3 36189 CARDIOLP SC/RF 1 36203 RPR TITER 1 36209 ANA TITER&PATTERN 5 36423 CORTISOL FREE 3 36504 HEP A AB,W/REFL IGM 2 36559 HCV RNA BY PCR,QL 8 36573 LUPUS ANTICOAG HEX 3 36637 OXCARBAZEPINE 3 36721 AMIODARONE 8 37056 ANTIHISTONE AB 1 37077 CORTISOL, FREE-TOTAL 6 37092 ANTI-DSDNA,RFX,TITER 1 37129 VRE SCREEN 21 37212 C DIFF TOXIN A&B 57 37386 BRAIN NATRI. PEPTIDE 36 37419 ANTIBODY PANEL X 1 1 37498 ENA,SCL 70,SSA,SSB 1 37811 HCV GENOTYPE LIPA 1 38914 ANCA SCREEN 1 1AE ORG ID 1 130 1AE1 WOUND SUSC-1 129 1AE2 WOUND SUSC-2 63 1AE3 WOUND SUSC-3 14 1AE4 WOUND SUSC-4 3 1AE5 WOUND SUSC-5 1 1BD ORG ID 1 42 1BD1 SUSC-1 41 1CU2 SUSC-2 15 1CU3 SUSC-3 4 1CU4 SUSC-4 1 1EY ORG ID 1 123 1EY1 SUSC-1 77 1EY2 SUSC-2 11 1FID FUNGAL ISOLATE ID 2 1FUC ORG ID 1 3 1GE ORG ID 1 4 1GE1 SUSC-1 3 1IC1 SUSC-1 7 1ID1 SUSC-1 1 1NA ORG ID 1 30 1NA1 SUSC-1 30 1SA ORG ID 1 86 1SC1 STOOL SUSC-1 1 1SP ORG ID 1 20 1SP1 SUSC-1 20 1SP2 SUSC-2 2 1UR ORG ID 1 332 1UR1 URINE SUSC-1 340 1UR2 URINE SUSC-2 39 1UR3 URINE SUSC-3 9 1UR4 URINE SUSC-4 1 1YSC ORG ID 1 1 2AC ORG ID 2 1 2AE ORG ID 2 64 2CU ORG ID 2 15 2EY ORG ID 2 21 2FO ORG ID 2 1 2ID ORG ID 2 1 2SA ORG ID 2 1 2SP ORG ID 2 2 2UR ORG ID 2 43 3AE ORG ID 3 22 3CU ORG ID 3 4 3EY ORG ID 3 4 3UR ORG ID 3 9 4AE ORG ID 4 3 4CU ORG ID 4 1 5AE ORG ID 5 2 CU1P PRESUMPTIVE ID 1 M 11 CU2P PRESUMPTIVE ID 2 M 8 CU3P PRESUMPTIVE ID 3 M 1 CU4P PRESUMPTIVE ID 4 M 1 UR1P PRESUMPTIVE ID 1 M 112 UR2P PRESUMPTIVE ID 2 M 2 UR2P PRESUMPTIVE ID 2 M 3 UR2P PRESUMPTIVE ID 2 M 6 UR3P PRESUMPTIVE ID 3 M 5 UR4P PRESUMPTIVE ID 4 M 3 ATTACHMENT D Northern Health Services Clinic Addresses APPOQUINIMINK STATE SERVICE CENTER PORTER PUBLIC HEALTH UNIT 120 Silverlake Road Porter State Service Center Middletown, DE 19709 509 West 8th Street Wilmington, DE 19801 NORTHEAST PUBLIC HEALTH UNIT MIDDLETOWN PUBLIC HEALTH Northeast State Service Center UNIT 1624 Jessup Street 215 North Broad Street Wilmington, DE 19802 Middletown, DE 19709 HUDSON PUBLIC HEALTH UNIT Hudson State Service Center 501 Ogletown Road Newark, DE 19711 A suffix after the account name is used to identify the accounts. SRH = Sexual and Reproductive Health TB = Tuberculosis AH = Adult Health PN = Prenatal CH = Child Health WC = Wellness Clinic ATTACHMENT E Southern Health Services Clinic Addresses KENT PUBLIC HEALTH UNIT MILFORD PUBLIC HEALTH UNIT Williams State Service Center 11-13 N. Church Street Milford 805 River Road Milford, DE 19963 Dover, DE 19901 SEAFORD PUBLIC HEALTH UNIT Pyle Health Unit Shipley State Service Center Pyle State Service Center 350 Virginia Avenue Rt. 2 Box 281-1 Seaford, DE 19973 Omar-Roxana Road Frankford, DE 19945 SUSSEX COUNTY HEALTH UNIT Georgetown State Service Center 544 S. Bedford Street Georgetown, DE 19947 And One Non-Public Health Site Address DELAWARE STATE UNIVERSITY 1200 N. DuPont Highway Dover, DE 19901 A suffix after the account name is used to identify the accounts. SRH = Sexual and Reproductive Health TB = Tuberculosis AH = Adult Health PN = Prenatal CH = Child Health WC = Wellness Clinic ATTACHMENT F Christiana Care Community Program Addresses (HIV/AIDS Medical Services) Christiana Care HIV Community Program (Georgetown Wellness Clinic) Stockley Campus 26351 Patriots Way 102 Lloyd Lane Georgetown, DE 19947 Christiana Care HIV Community Program (Kent Wellness Clinic) Delaware Hospital for the Chronically Ill (DHCI) Campus 100 Sunnyside Road Smyrna, De 19977 ATTACHMENT G Delaware Public Health Laboratory Address Delaware Public Health Laboratory (DPHL) 30 Sunnyside Road Smyrna, DE 19977 NOTE: DPHL should receive the Monthly and Annual reports for All Clinics Combined only. ATTACHMENT H Long Term Care Facility Addresses EMILY P. BISSELL HOSPITAL 85 Operating Beds 3000 Newport Gap Pike Licensed as both Skilled Wilmington, DE 19808-2300 Nursing Facility & Intermediate Care Facility GOVERNOR BACON HEALTH CENTER 90 Operating Beds P.O. Box 559 Intermediate Care Facility Delaware City, DE 19706 DELAWARE HOSPITAL FOR THE CHRONICALLY ILL 30 Sunnyside Road 230 Operating Beds Smyrna, DE 19977 Skilled Nursing Facility & Intermediate Care Facility ATTACHMENT I DIVISION OF PUBLIC HEALTH (DPH) PROGRAM REPORTING REQUIREMENTS DPH Laboratory Report Matrix Report Name Send To Frequency Mode Format Clinic-by-Clinic Summary Division of Public Health ATTN: Planning & Budget Coordination Support Services Jesse Cooper Building, 1st Floor 417 Federal Street Dover, DE 19901 Northern Health Services (New Castle County sites) ATTN: County Health Administrator Limestone Building, 3 rd Floor 2055 Limestone Road Wilmington, DE 19808 Southern Health Services (Kent and Sussex Counties) ATTN: County Health Administrator Georgetown State Service Center 544 S. Bedford Street Georgetown, DE 19947 Monthly and Annual Paper and/or electronic attachment See page 15 All Northern Health Services (NHS) All Clinics Report All Tests by Volume, and All Tests by Cost Northern Health Services (New Castle County sites) ATTN: County Health Administrator Limestone Building, 3 rd Floor 2055 Limestone Road Wilmington, DE 19808 Monthly and Annual Paper and/or electronic attachment See page 43 Southern Health Services (SHS) All Clinics Report All Tests by Volume, and All Tests by Cost Southern Health Services (Kent and Sussex Counties) ATTN: County Health Administrator Georgetown State Service Center 544 S. Bedford Street Georgetown, DE 19947 Monthly and Annual Paper and/or electronic attachment See page 43 Long Term Care Summary Report See Attachment H Monthly and Annual Paper and/or electronic attachment See page 20 Lead Program Report Attn: Lead Program Director Division of Public Health 417 Federal Street Dover, DE 19901 Monthly and Annual Paper and/or electronic attachment See page 17 DPH Laboratory Report Matrix, continued Report Name Send To Frequency Mode Format Family Planning Annual Report (FPAR) Cervical Cancer Screening Activities Attn: Family Planning Director Division of Public Health 417 Federal Street Dover, DE 19901 Phone: (302) 741-2985 FAX: (302) 741-2995 Norman Clendaniel Norman.clendaniel@state.de.us 1/1 to 3/31 by 4/30 4/1 to 6/30 by 7/31 7/1 to 9/30 by 10/31 1/1 to 12/31 by 1/31 Paper and/or electronic attachment See page 55 Family Planning Annual Report (FPAR) Unduplicated Number of Family Planning Users Tested for Chlamydia by Age and Gender Attn: Family Planning Director Division of Public Health 417 Federal Street Dover, DE 19901 Phone: (302) 741-2985 FAX: (302) 741-2995 Norman Clendaniel Norman.clendaniel@state.de.us 1/1 to 3/31 by 4/30 4/1 to 6/30 by 7/31 7/1 to 9/30 by 10/31 1/1 to 12/31 by 1/31 Paper and/or electronic attachment See page 55 Family Planning Annual Report (FPAR) Number of Gonorrhea, Syphilis, and HIV Tests Attn: Family Planning Director Division of Public Health 417 Federal Street Dover, DE 19901 Phone: (302) 741-2985 FAX: (302) 741-2995 Norman Clendaniel Norman.clendaniel@state.de.us 1/1 to 3/31 by 4/30 4/1 to 6/30 by 7/31 7/1 to 9/30 by 10/31 1/1 to 12/31 by 1/31 Paper and/or electronic attachment See page 56 Laboratory Monthly Report Attn: STD Director, 540. S. duPont Hwy Suite 12 Room 200L Dover, DE 19901 Phone: (302) 744-1063 FAX: (302) 739-2548 Cathy Mosley Cathy.Mosley@state.de.us Monthly Electronic Attachment See page 56 Division of Public Health Program-Specific Reports I. Family Planning Reports-Cervical Cancer Screening Activities Cervical Cancer Screening Activities SCREENING ACTIVITY Number of Users or Number of Tests (a) 1 Unduplicated number of users who obtained a Pap test 2 Number of Pap tests performed 3 Number of Pap tests with an ASC or higher result 4 Number of Pap tests with an HSIL or higher result Date Submitted: Reporting Period: or Quarter: January 1, 200______ through December 31, 200______ __________________ through _____________________ (Month/day/year) (Month/day/year) II. Family Planning Reports – Chlamydia Tests Unduplicated Number of Users Tested for Chlamydia by Age and Gender Age Group (Years) Number of users Female Users (a) Male Users (b) 1 Under 15 2 15–17 3 18–19 4 20–24 5 25 and over 6 Total Users (sum rows 1 to 5) Date Submitted: Reporting Period: or Quarter: January 1, 200______ through December 31, 200______ __________________ through _____________________ (Month/day/year) (Month/day/year) II. Family Planning Reports – Number of Gonorrhea, Syphilis, and HIV Tests Number of Gonorrhea, Syphilis, and HIV Tests Test Type Number of Tests Total Tests (Sum Cols A + B) (c) Female (a) Male (b) 1 Gonorrhea 2 Syphilis 3 HIV – All confidential tests 4 HIV – Positive confidential tests 5 HIV – Anonymous tests III. Sexually Transmitted Diseases Laboratory Monthly Report for Sexually Transmitted Diseases (Provide in Excel Spreadsheet) Date of Collection Specimen Number Patient Name Patient ID number Site Name Laboratory Service Service Code Payee Amount Charged 11/28/07 Sample entry 12345 Doe, Jane 6789 KCHU- STD Thin prep XXX DPH $XYZ.00 APPENDIX A BIDDERS SIGNATURE FORM DELAWARE HEALTH AND SOCIAL SERVICES REQUEST FOR PROPOSAL BIDDERS SIGNATURE FORM NAME OF BIDDER: SIGNATURE OF AUTHORIZED PERSON: TYPE IN NAME OF AUTHORIZED PERSON: TITLE OF AUTHORIZED PERSON: STREET NAME AND NUMBER: CITY, STATE, & ZIP CODE: CONTACT PERSON: TELEPHONE NUMBER: FAX NUMBER: DATE: BIDDER’S FEDERAL EMPLOYERS IDENTIFICATION NUMBER: DELIVERY DAYS/COMPLETION TIME: F.O.B.: TERMS: THE FOLLOWING MUST BE COMPLETED BY THE VENDOR: AS CONSIDERATION FOR THE AWARD AND EXECUTION BY THE DEPARTMENT OF HEALTH AND SOCIAL SERVICES OF THIS CONTRACT, THE (COMPANY NAME) HEREBY GRANTS, CONVEYS, SELLS, ASSIGNS, AND TRANSFERS TO THE STATE OF DELAWARE ALL OF ITS RIGHTS, TITLE AND INTEREST IN AND TO ALL KNOWN OR UNKNOWN CAUSES OF ACTION IT PRESENTLY HAS OR MAY NOW HEREAFTER ACQUIRE UNDER THE ANTITRUST LAWS OF THE UNITED STATES AND THE STATE OF DELAWARE, RELATING THE PARTICULAR GOODS OR SERVICES PURCHASED OR ACQUIRED BY THE DELAWARE HEALTH AND SOCIAL SERVICES DEPARTMENT, PURSUANT TO THIS CONTRACT. APPENDIX B CERTIFICATION SHEET DELAWARE HEALTH AND SOCIAL SERVICES REQUEST FOR PROPOSAL CERTIFICATION SHEET As the official representative for the proposer, I certify on behalf of the agency that: a. They are a regular dealer in the services being procured. b. They have the ability to fulfill all requirements specified for development within this RFP. c. They have independently determined their prices. d. They are accurately representing their type of business and affiliations. e. They will secure a Delaware Business License. f. They have acknowledged that no contingency fees have been paid to obtain award of this contract. g. The Prices in this offer have been arrived at independently, without consultation, communication, or agreement, for the purpose of restricting competition, as to any matter relating to such prices with any other contractor or with any competitor; h. Unless otherwise required by Law, the prices which have been quoted in this offer have not been knowingly disclosed by the contractor and prior to the award in the case of a negotiated procurement, directly or indirectly to any other contractor or to any competitor; and i. No attempt has been made or will be made by the contractor in part to other persons or firm to submit or not to submit an offer for the purpose of restricting competition. j. They have not employed or retained any company or person (other than a full-time bona fide employee working solely for the contractor) to solicit or secure this contract, and they have not paid or agreed to pay any company or person (other than a full-time bona fide employee working solely for the contractor) any fee, commission percentage or brokerage fee contingent upon or resulting from the award of this contract. k. They (check one) operate ___an individual; _____a Partnership ____a non- profit (501 C-3) organization; _____a not-for-profit organization; or _____for profit corporation, incorporated under the laws of the State of ____________________. l. The referenced offerer has neither directly or indirectly entered into any agreement, participated in any collusion or otherwise taken any action in restraint of free competitive bidding in connection with this bid submitted this date to Delaware Health and Social Services. m. The referenced bidder agrees that the signed delivery of this bid represents the bidder’s acceptance of the terms and conditions of this invitation to bid including all Specifications and special provisions. n. They (check one): _______are; ______are not owned or controlled by a parent company. If owned or controlled by a parent company, enter name and address of parent company: __________________________________________ __________________________________________ __________________________________________ __________________________________________ Violations and Penalties: Each contract entered into by an agency for professional services shall contain a prohibition against contingency fees as follows: 1. The firm offering professional services swears that it has not employed or retained any company or person working primarily for the firm offering professional services, to solicit or secure this agreement by improperly influencing the agency or any of its employees in the professional service procurement process. 2. The firm offering the professional services has not paid or agreed to pay any person, company, corporation, individual or firm other than a bona fide employee working primarily for the firm offering professional services, any fee, commission, percentage, gift, or any other consideration contingent upon or resulting from the award or making of this agreement; and 3. For the violation of this provision, the agency shall have the right to terminate the agreement without liability and at its discretion, to deduct from the contract price, or otherwise recover the full amount of such fee, commission, percentage, gift or consideration. The following conditions are understood and agreed to: a. No charges, other than those specified in the cost proposal, are to be levied upon the State as a result of a contract. b. The State will have exclusive ownership of all products of this contract unless mutually agreed to in writing at the time a binding contract is executed. Date Signature & Title of Official Representative Type Name of Official Representative APPENDIX C STATEMENTS OF COMPLIANCE FORM DELAWARE HEALTH AND SOCIAL SERVICES REQUEST FOR PROPOSAL STATEMENTS OF COMPLIANCE FORM As the official representative for the contractor, I certify on behalf of the agency that (Company Name) will comply with all Federal and Delaware laws and regulations pertaining to equal employment opportunity and affirmative action. In addition, compliance will be assured in regard to Federal and Delaware laws and regulations relating to confidentiality and individual and family privacy in the collection and reporting of data. Authorized Signature: Title: Date: APPENDIX D OFFICE OF MINORITY AND WOMEN BUSINESS ENTERPRISE SELF- CERTIFICATION TRACKING FORM OFFICE OF MINORITY AND WOMEN BUSINESS ENTERPRISE SELF- CERTIFICATION TRACKING FORM IF YOUR FIRM WISHES TO BE CONSIDERED FOR ONE OF THE CLASSIFICATIONS LISTED BELOW, THIS PAGE MUST BE SIGNED, NOTARIZED AND RETURNED WITH YOUR PROPOSAL. COMPANY NAME_____________________________________________________ NAME OF AUTHORIZED REPRESENTATIVE (Please print) ______________________________________________________________________ SIGNATURE___________________________________________________________ COMPANY ADDRESS___________________________________________________ TELEPHONE #_________________________________________________________ FAX #_________________________________________________________________ EMAIL ADDRESS_______________________________________________________ FEDERAL EI# __________________________________________________________ STATE OF DE BUSINESS LIC#____________________________________________ Note: Signature of the authorized representative must be of an individual who legally may enter his/her organization into a formal contract with the State of Delaware, Delaware Health and Social Services. Organization Classifications (Please circle) Women Business Enterprise (WBE) Yes/No Minority Business Enterprise (MBE) Yes/No Please check one---Corporation ______ Partnership_______Individual _______ ________________________________________________________________________ For appropriate certification (WBE), (MBE), (DBE) please apply to Office of Minority and Women Business Enterprise Phone # (302) 739-4206 L. Jay Burks, Executive Director Fax# (302) 739-1965 Certification #____________ Certifying Agency____________ http://www.state.de.us/omwbe SWORN TO AND SUBSCRIBED BEFORE ME THIS ______________DAY OF ___________20________ NOTARY PUBLIC_________________________MY COMMISION EXPIRES ____________________ CITY OF ___________________________COUNTY OF _________________STATE OF__________________ Definitions The following definitions are from the State Office of Minority and Women Business Enterprise. Women Owned Business Enterprise (WBE): At least 51% is owned by women, or in the case of a publicly owned enterprise, a business enterprise in which at least 51% of the voting stock is owned by women; or any business enterprise that is approved or certified as such for purposes of participation in contracts subject to women-owned business enterprise requirements involving federal programs and federal funds. Minority Business Enterprise (MBE): At least 51% is owned by minority group members; or in the case of a publicly owned enterprise, a business enterprise in which at least 51% of the voting stock is owned by minority group members; or any business enterprise that is approved or certified as such for purposes of participation in contracts subjects to minority business enterprises requirements involving federal programs and federal funds. Corporation: An artificial legal entity treated as an individual, having rights and liabilities distinct from those of the persons of its members, and vested with the capacity to transact business, within the limits of the powers granted by law to the entity. Partnership: An agreement under which two or more persons agree to carry on a business, sharing in the profit or losses, but each liable for losses to the extent of his or her personal assets. Individual: Self-explanatory For certification in one of above, the bidder must contract: L. Jay Burks Office of Minority and Women Business Enterprise (302) 739-4206 Fax (302) 739-5561 APPENDIX E Contract Boilerplate DELAWARE HEALTH AND SOCIAL SERVICES DPH CONTRACT # _______ BETWEEN THE DIVISION OF PUBLIC HEALTH, DELAWARE DEPARTMENT OF HEALTH & SOCIAL SERVICES, AND [Contractor] FOR [TYPE OF SERVICE] A. Introduction 1. This contract is entered into between the Delaware Department of Health and Social Services (the Department), Division of ______________ (Division) and _______________________ (the Contractor). 2. The Contract shall commence on __________________ and terminate on _____________ unless specifically extended by an amendment, signed by all parties to the Contract. Time is of the essence. (Effective contract start date is subject to the provisions of Paragraph C. 1. of this Agreement.) B. Administrative Requirements 1. Contractor recognizes that it is operating as an independent Contractor and that it is liable for any and all losses, penalties, damages, expenses, attorney's fees, judgments, and/or settlements incurred by reason of injury to or death of any and all persons, or injury to any and all property, of any nature, arising out of the Contractor's negligent performance under this Contract, and particularly without limiting the foregoing, caused by, resulting from, or arising out of any act of omission on the part of the Contractor in their negligent performance under this Contract. 2. The Contractor shall maintain such insurance as will protect against claims under Worker’s Compensation Act and from any other claims for damages for personal injury, including death, which may arise from operations under this Contract. The Contractor is an independent contractor and is not an employee of the State. 3. During the term of this Contract, the Contractor shall, at its own expense, carry insurance with minimum coverage limits as follows: a) Comprehensive General Liability $1,000,000 and b) Medical/Professional Liability $1,000,000/ $3,000,000 or c) Misc. Errors and Omissions $1,000,000/$3,000,000 or d) Product Liability $1,000,000/$3,000,000 All contractors must carry (a) and at least one of (b), (c), or (d), depending on the type of service or product being delivered. If the contractual service requires the transportation of Departmental clients or staff, the contractor shall, in addition to the above coverage, secure at its own expense the following coverage: e) Automotive Liability (Bodily Injury) $100,000/$300,000 f) Automotive Property Damage (to others) $ 25,000 4. Not withstanding the information contained above, the Contractor shall indemnify and hold harmless the State of Delaware, the Department and the Division from contingent liability to others for damages because of bodily injury, including death, that may result from the Contractor’s negligent performance under this Contract, and any other liability for damages for which the Contractor is required to indemnify the State, the Department and the Division under any provision of this Contract. 5. The policies required under Paragraph B. 3. must be written to include Comprehensive General Liability coverage, including Bodily Injury and Property damage insurance to protect against claims arising from the performance of the Contractor and the contractor's subcontractors under this Contract and Medical/Professional Liability coverage when applicable. 6. The Contractor shall provide a Certificate of Insurance as proof that the Contractor has the required insurance. The certificate shall identify the Department and the Division as the “Certificate Holder” and shall be valid for the contract’s period of performance as detailed in Paragraph A. 2. 7. The Contractor acknowledges and accepts full responsibility for securing and maintaining all licenses and permits, including the Delaware business license, as applicable and required by law, to engage in business and provide the goods and/or services to be acquired under the terms of this Contract. The Contractor acknowledges and is aware that Delaware law provides for significant penalties associated with the conduct of business without the appropriate license. 8. The Contractor agrees to comply with all State and Federal licensing standards and all other applicable standards as required to provide services under this Contract, to assure the quality of services provided under this Contract. The Contractor shall immediately notify the Department in writing of any change in the status of any accreditations, licenses or certifications in any jurisdiction in which they provide services or conduct business. If this change in status regards the fact that its accreditation, licensure, or certification is suspended, revoked, or otherwise impaired in any jurisdiction, the Contractor understands that such action may be grounds for termination of the Contract. a) If a contractor is under the regulation of any Department entity and has been assessed Civil Money Penalties (CMPs), or a court has entered a civil judgment against a Contractor or vendor in a case in which DHSS or its agencies was a party, the Contractor or vendor is excluded from other DHSS contractual opportunities or is at risk of contract termination in whole, or in part, until penalties are paid in full or the entity is participating in a corrective action plan approved by the Department. A corrective action plan must be submitted in writing and must respond to findings of non-compliance with Federal, State, and Department requirements. Corrective action plans must include timeframes for correcting deficiencies and must be approved, in writing, by the Department. The Contractor will be afforded a thirty (30) day period to cure non-compliance with Section 8(a). If, in the sole judgment of the Department, the Contractor has not made satisfactory progress in curing the infraction(s) within the aforementioned thirty (30) days, then the Department may immediately terminate any and/or all active contracts. 9. Contractor agrees to comply with all the terms, requirements and provisions of the Civil Rights Act of 1964, the Rehabilitation Act of 1973 and any other federal, state, local or any other anti discriminatory act, law, statute, regulation or policy along with all amendments and revision of these laws, in the performance of this Contract and will not discriminate against any applicant or employee or service recipient because of race, creed, religion, age, sex, color, national or ethnic origin, disability or any other unlawful discriminatory basis or criteria. 10. The Contractor agrees to provide to the Divisional Contract Manager, on an annual basis, if requested, information regarding its client population served under this Contract by race, color, national origin or disability. 11. This Contract may be terminated in whole or part: a) by the Department upon five (5) calendar days written notice for cause or documented unsatisfactory performance, b) by the Department upon fifteen (15) calendar days written notice of the loss of funding or reduction of funding for the stated Contractor services as described in Appendix B, c) by either party without cause upon thirty (30) calendar days written notice to the other Party, unless a longer period is specified in Appendix A. In the event of termination, all finished or unfinished documents, data, studies, surveys, drawings, models, maps, photographs, and reports or other material prepared by Contractor under this contract shall, at the option of the Department, become the property of the Department. In the event of termination, the Contractor, upon receiving the termination notice, shall immediately cease work and refrain from purchasing contract related items unless otherwise instructed by the Department. The Contractor shall be entitled to receive reasonable compensation as determined by the Department in its sole discretion for any satisfactory work completed on such documents and other materials that are usable to the Department. Whether such work is satisfactory and usable is determined by the Department in its sole discretion. Should the Contractor cease conducting business, become insolvent, make a general assignment for the benefit of creditors, suffer or permit the appointment of a receiver for its business or assets, or shall avail itself of, or become subject to any proceeding under the Federal Bankruptcy Act or any other statute of any state relating to insolvency or protection of the rights of creditors, then at the option of the Department, this Contract shall terminate and be of no further force and effect. Contractor shall notify the Department immediately of such events. 12. Any notice required or permitted under this Contract shall be effective upon receipt and may be hand delivered with receipt requested or by registered or certified mail with return receipt requested to the addresses listed below. Either Party may change its address for notices and official formal correspondence upon five (5) days written notice to the other. To the Division at: Division of Public Health 417 Federal Street Dover, DE 19901 Attn: Support Services Section To the Contractor at: ________________________________________ ________________________________________ ________________________________________ 13. In the event of amendments to current Federal or State laws which nullify any term(s) or provision(s) of this Contract, the remainder of the Contract will remain unaffected. 14. This Contract shall not be altered, changed, modified or amended except by written consent of all Parties to the Contract. 15. The Contractor shall not enter into any subcontract for any portion of the services covered by this Contract without obtaining prior written approval of the Department. Any such subcontract shall be subject to all the conditions and provisions of this Contract. The approval requirements of this paragraph do not extend to the purchase of articles, supplies, equipment, rentals, leases and other day-to-day operational expenses in support of staff or facilities providing the services covered by this Contract. 16. This entire Contract between the Contractor and the Department is composed of these several pages and the attached Appendix ___. 17. This Contract shall be interpreted and any disputes resolved according to the Laws of the State of Delaware. Except as may be otherwise provided in this contract, all claims, counterclaims, disputes and other matters in question between the Department and Contractor arising out of or relating to this Contract or the breach thereof will be decided by arbitration if the parties hereto mutually agree, or in a court of competent jurisdiction within the State of Delaware. 18. In the event Contractor is successful in an action under the antitrust laws of the United States and/or the State of Delaware against a vendor, supplier, subcontractor, or other party who provides particular goods or services to the Contractor that impact the budget for this Contract, Contractor agrees to reimburse the State of Delaware, Department of Health and Social Services for the pro-rata portion of the damages awarded that are attributable to the goods or services used by the Contractor to fulfill the requirements of this Contract. In the event Contractor refuses or neglects after reasonable written notice by the Department to bring such antitrust action, Contractor shall be deemed to have assigned such action to the Department. 19. Contractor covenants that it presently has no interest and shall not acquire any interests, direct or indirect, that would conflict in any manner or degree with the performance of this Contract. Contractor further covenants that in the performance of this contract, it shall not employ any person having such interest. 20. Contractor covenants that it has not employed or retained any company or person who is working primarily for the Contractor, to solicit or secure this agreement, by improperly influencing the Department or any of its employees in any professional procurement process; and, the Contractor has not paid or agreed to pay any person, company, corporation, individual or firm, other than a bona fide employee working primarily for the Contractor, any fee, commission, percentage, gift or any other consideration contingent upon or resulting from the award or making of this agreement. For the violation of this provision, the Department shall have the right to terminate the agreement without liability and, at its discretion, to deduct from the contract price, or otherwise recover, the full amount of such fee, commission, percentage, gift or consideration. 21. The Department shall have the unrestricted authority to publish, disclose, distribute and otherwise use, in whole or in part, any reports, data, or other materials prepared under this Contract. Contractor shall have no right to copyright any material produced in whole or in part under this Contract. Upon the request of the Department, the Contractor shall execute additional documents as are required to assure the transfer of such copyrights to the Department. If the use of any services or deliverables is prohibited by court action based on a U.S. patent or copyright infringement claim, Contractor shall, at its own expense, buy for the Department the right to continue using the services or deliverables or modify or replace the product with no material loss in use, at the option of the Department. 22. Contractor agrees that no information obtained pursuant to this Contract may be released in any form except in compliance with applicable laws and policies on the confidentiality of information and except as necessary for the proper discharge of the Contractor’s obligations under this Contract. 23. Waiver of any default shall not be deemed to be a waiver of any subsequent default. Waiver or breach of any provision of this Contract shall not be deemed to be a waiver of any other or subsequent breach and shall not be construed to be a modification of the terms of the Contract unless stated to be such in writing, signed by authorized representatives of all parties and attached to the original Contract. 24. If the amount of this contract listed in Paragraph C2 is over $25,000, the Contractor, by their signature in Section E, is representing that the Firm and/or its Principals, along with its subcontractors and assignees under this agreement, are not currently subject to either suspension or debarment from Procurement and Non-Procurement activities by the Federal Government. C. Financial Requirements 1. The rights and obligations of each Party to this Contract are not effective and no Party is bound by the terms of this contract unless, and until, a validly executed Purchase Order is approved by the Secretary of Finance and received by Contractor, if required by the State of Delaware Budget and Accounting Manual, and all policies and procedures of the Department of Finance have been met. The obligations of the Department under this Contract are expressly limited to the amount of any approved Purchase Order. The State will not be liable for expenditures made or services delivered prior to Contractor's receipt of the Purchase Order. 2. Total payments under this Contract shall not exceed $ ______ in accordance with the budget presented in Appendix ___. Payment will be made upon receipt of an itemized invoice from the Contractor in accordance with the payment schedule, if any. The contractor or vendor must accept full payment by procurement (credit) card and or conventional check and/or other electronic means at the State’s option, without imposing any additional fees, costs or conditions. Contractor is responsible for costs incurred in excess of the total cost of this Contract and the Department is not responsible for such costs. 3. The Contractor is solely responsible for the payment of all amounts due to all subcontractors and suppliers of goods, materials or services which may have been acquired by or provided to the Contractor in the performance of this contract. The Department is not responsible for the payment of such subcontractors or suppliers. 4. The Contractor shall not assign the Contract or any portion thereof without prior written approval of the Department and subject to such conditions and revisions as the Department may deem necessary. No such approval by the Department of any assignment shall be deemed to provide for the incurrence of any obligations of the Department in addition to the total agreed upon price of the Contract. 5. Contractor shall maintain books, records, documents and other evidence directly pertinent to performance under this Contract in accordance with generally accepted accounting principles and practices. Contractor shall also maintain the financial information and data used by Contractor in the preparation of support of its bid or proposal. Contractor shall retain this information for a period of five (5) years from the date services were rendered by the Contractor. Records involving matters in litigation shall be retained for one (1) year following the termination of such litigation. The Department shall have access to such books, records, documents, and other evidence for the purpose of inspection, auditing, and copying during normal business hours of the Contractor after giving reasonable notice. Contractor will provide facilities for such access and inspection. 6. The Contractor agrees that any submission by or on behalf of the Contractor of any claim for payment by the Department shall constitute certification by the Contractor that the services or items for which payment is claimed were actually rendered by the Contractor or its agents, and that all information submitted in support of the claims is true, accurate, and complete. 7. The cost of any Contract audit disallowances resulting from the examination of the Contractor's financial records will be borne by the Contractor. Reimbursement to the Department for disallowances shall be drawn from the Contractor's own resources and not charged to Contract costs or cost pools indirectly charging Contract costs. 8. When the Department desires any addition or deletion to the deliverables or a change in the services to be provided under this Contract, it shall so notify the Contractor. The Department will develop a Contract Amendment authorizing said change. The Amendment shall state whether the change shall cause an alteration in the price or time required by the Contractor for any aspect of its performance under the Contract. Pricing of changes shall be consistent with those prices or costs established within this Contract. Such amendment shall not be effective until executed by all Parties pursuant to Paragraph B.14. D. Miscellaneous Requirements 1. If applicable, the Contractor agrees to adhere to the requirements of DHSS Policy Memorandum # 46, (PM # 46, effective 3/11/05), and divisional procedures regarding the reporting and investigation of suspected abuse, neglect, mistreatment, misappropriation of property and significant injury of residents/clients receiving services, including providing testimony at any administrative proceedings arising from such investigations. The policy and procedures are included as Appendix ___ to this Contract. It is understood that adherence to this policy includes the development of appropriate procedures to implement the policy and ensuring staff receive appropriate training on the policy requirements. The Contractor’s procedures must include the position(s) responsible for the PM46 process in the provider agency. Documentation of staff training on PM46 must be maintained by the Contractor. 2. The Contractor, including its parent company and its subsidiaries, and any subcontractor, including its parent company and subsidiaries, agree to comply with the provisions of 29 Del. Code, Chapter 58: “Laws Regulating the Conduct of Officers and Employees of the State,” and in particular with Section 5805 (d): “Post Employment Restrictions.” 3. When required by Law, Contractor shall conduct child abuse and adult abuse registry checks and obtain service letters in accordance with 19 Del. Code Section 708; and 11 Del. Code, Sections 8563 and 8564. Contractor shall not employ individuals with adverse registry findings in the performance of this contract. 4. If applicable, the Contractor agrees to adhere to the requirements of DHSS Policy Memorandum # 40, and divisional procedures regarding conducting criminal background checks and handling adverse findings of the criminal background checks. This policy and procedure are included as Appendix ___ to this Contract. It is understood that adherence to this policy includes the development of appropriate procedures to implement the policy and ensuring staff receive appropriate training on the policy requirements. The Contractor’s procedures must include the title of the position(s) responsible for the PM40 process in the contractor’s agency. 5. If applicable, the Contractor agrees to adhere to the requirements of DHSS Policy Memorandum # 36 (PM #36, effective 9/24/2008), and divisional procedures regarding minimal requirements of contractors who are engaging in a contractual agreement to develop community based residential arrangements for those individuals served by Divisions within DHSS. This policy and procedure are included as Appendix ____ to this Contract. It is understood that adherence to this policy includes individuals/entities that enter into a contractual arrangement (contractors) with the DHSS/Division to develop a community based residential home(s) and apartment(s). Contractors shall be responsible for their subcontractors’ adherence with this policy and related protocol(s) established by the applicable Division. 6. All Department campuses are tobacco-free. Contractors, their employees and sub- contractors are prohibited from using any tobacco products while on Department property. This prohibition extends to personal vehicles parked in Department parking lots. E. Authorized Signatures: For the Contractor: For the Department: _______________________ __________________________ Signature Rita M. Landgraf Secretary Name (please print) _______________________ ________________ Title Date _____________ For the Division: Date __________________________ Karyl T. Rattay, MD, MS, FAAP, FACPM Director ________________ Date APPENDIX A DIVISION OF PUBLIC HEALTH REQUIREMENTS 1. Funds received and expended under the contract must be recorded so as to permit the Division to audit and account for all contract expenditures in conformity with the terms, conditions, and provisions of this contract, and with all pertinent federal and state laws and regulations. The Division retains the right to approve this accounting system. 2. The Contractor shall recognize that no extra contractual services are approved unless specifically authorized in writing by the Division. Further, the Contractor shall recognize that any and all services performed outside the scope covered by this Contract and attached budgets will be deemed by the Division to be gratuitous and not subject to any financial reimbursement. 3. All products are expected to be free of misspellings and typos, as well as punctuation, grammatical and design errors. Acronyms should be avoided; when used, they should be spelled out on first reference with the acronym in parentheses after that reference. For example, 'Division of Public Health (DPH)' on first reference. 4. No part of any funds under this contract shall be used to pay the salary or expenses of any contractor or agent acting for the contractor, to engage in any activity (lobbying) designed to influence legislation or appropriations pending before the State Legislature and/or Congress. 5. The contractor agrees that, if defunding occurs, all equipment purchased with Division funds for $1,000.00 or more and a useful life expectancy of one (1) year, will be returned to the Division within thirty (30) days. 6. Contractors receiving Federal funds must comply with all the requirements of the Federal Office of Management and Budget (OMB) Circular A-133, Audits of State, Local Governments, and Non-profit Organizations. APPENDIX B SERVICE AND BUDGET DESCRIPTION 1. Contractor: _ ________________ Address: _ ____________________________ __ ________________________ Phone __________________________________________________ E.I. No.: _____________________________________________________ 2. Division:__ ____________________________________________ 3. Service:__ __________________________ ________ _________________________ ______________________________________________________________________ 4. Total Payment shall not exceed _________. 5. Payment(s) will be made upon presentation of invoice(s) with supporting documentation that verifies the completed, acceptable deliverable(s). Invoice must contain period of service, Vendor Invoice Number, Vendor EI Number, Contract Number, DPH Purchase Order Number and itemized description of the services provided to coincide with the contract deliverables. (See also Paragraph C.2. of the contract) 6. Source of Contract Funding: _____ Federal Funds (CFDA#__________ ) _____ State Funds _____ Other Funds _____ Combination of Funds APPENDIX C BUSINESS ASSOCIATE AGREEMENT This Business Associate Agreement (“Agreement”), effective as of the _______day of __________________, 200__, is entered into by and between _________________, (“Covered Entity”) and ________________ (“Business Associate”) WHEREAS, in conjunction with the provision of certain healthcare services, Covered Entity receives and creates certain individually identifiable heath information (“Protected Health Information”) the creation, transmission, disclosure and dissemination of which must be protected as confidential information; WHEREAS, in conjunction with the provision of certain healthcare services to Covered Entity under an agreement dated the _________ day of _________________, _______, (“Original Contract”) Business Associate has access to and is involved in the creation, transmission, disclosure and dissemination of such Protected Health Information. WHEREAS, the Covered Entity and Business Associate wish to comply with the provisions of 45 C.F.R. §160.101 et seq. (“Privacy Regulations”) and 45 C.F.R. §164.308 et seq. (“Security Regulations”) regarding the appropriate use and disclosure of Protected Health Information; NOW THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Covered Entity and Business Associate hereby agree as follows: 1. Definitions. The terms used in this Business Associate Agreement (“Agreement”) shall have the same meaning as those terms are used in HIPAA, 45 CFR § 160 et seq. and 45 CFR § 164.308 et seq. 2. Permitted uses and Disclosures of Protected Health Information. Business Associate will not use or further disclose any Protected Health Information except in the provision of services to Covered Entity as specifically authorized under the Original Contract, including without limitation any use or disclosure which would violate the provisions of the Privacy Regulations. Notwithstanding the foregoing, Business Associate may use and disclose Protected Health Information to provide data aggregation services related to the healthcare operations of Covered Entity. Business Associate may also use and disclose Protected Health Information in the proper management and administration of Business Associate and to carry out its legal responsibilities, provided that the use and disclosure is either required by law or Business Associate obtains reasonable assurances from the person to whom the information is disclosed that it will be held confidentially and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person and the person notifies Business Associate of any instances of which it is aware in which the confidentiality of information has been breached. 3. Responsibilities of Business Associate. Business Associate will: (a) Not use or further disclose Protected Health Information other than as permitted or required by the Original Contract or as required by law, including without limitation, the Privacy Regulations and any applicable State law; (b) Use appropriate safeguards to prevent use or disclosure of Protected Health Information other than as provided for in the Original Contract; (c) Implement administrative, physical, and technical safeguards that reasonably protect the confidentiality, integrity, and availability of the electronic protected health information that it creates, receives, maintains, or transmits on behalf of the Covered Entity. (d) Report to Covered Entity any use or disclosure of Protected Health Information not provided for in the Original Contract of which it becomes aware; (e) Ensure that any agents, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by Business Associate on behalf of, the Covered Entity agrees to the same restrictions and conditions that apply to Business Associate with respect to Protected Health Information. Further any agent or subcontractor must agree to implement reasonable and appropriate safeguards to protect electronic protected health information. (f) Make available for inspection and copying Protected Health Information to an individual about such individual in accordance with 45 C.F.R § 164.524; (g) Make available Protected Health Information to an individual about such individual for amendment and incorporate any amendments to Protected Health Information in accordance with 45 C.F.R. § 164.526; (h) Make available Protected Health Information required to provide an accounting of disclosures in accordance with 45 C.F.R. §164.528; (i) Make its internal practices, books, and records relating to the use an disclosure of Protected Health Information received from, or created or received by Business Associate on behalf of, Covered Entity available to the Secretary of HHS to whom the authority involved has been delegated for purposes of determining the Covered Entity’s compliance with privacy Regulations; and (j) At termination of the Original Contract, if feasible, return all Protected Health Information received from, or created or received by Business Associate on behalf of, Covered Entity that Business Associates still maintains in any form and retain no copies of such Protected Health information or, if return is not feasible, extend the protections of the Original Contract and this Agreement to the information and limit further uses and disclosures to those purposes that make the return of the protected Health Information infeasible. Business Associate Agreement Date: 03/11/2005 4. Other Arrangements (a) If a business associate is required by law to perform a function or activity on behalf of a covered entity or to provide a service described in the definition of business associate as specified in §160.103 of this subchapter to a covered entity, the covered entity may permit the business associate to create, receive, maintain or transmit electronic protected health information on its behalf to the extent necessary to comply with the legal mandate without meeting the requirements of (a) (2) (1) of §164.314, provided that the covered entity attempts in good faith to obtain satisfactory assurances as required by paragraph (a)(2)(ii)(A) of §164.314, and documents the attempt and the reasons that these assurances cannot be obtained. (b) The covered entity may omit from its other arrangements authorization of the termination of the contract by the covered entity, as required by paragraph (a)(2)(i)(D) of §164.314 if such authorization is inconsistent with the statutory obligations of the covered entity or its business associate. 5. Termination of Agreement. This Agreement and the Original Contract may be terminated by Covered Entity if Covered Entity determines that Business Associate has violated a material term of this Agreement. The provisions of Paragraphs 1 and 2 hereof shall survive any termination of this Agreement and/or the Original Contract. 6. Miscellaneous. This Agreement contains the final and entire agreement of the parties and supersedes all prior and/or contemporaneous understandings and may not be modified or amended unless such modification is in writing and signed by both parties and their successors, administrators and permitted assigns. All personal pronouns used in this Agreement whether used in masculine, feminine or neuter gender, shall include all other genders, the singular shall include the plural, and vice versa. Titles of Paragraphs are utilized for convenience only and neither limit nor amplify the provisions of this Agreement itself. If any provision of this Agreement or the application thereof to any person or circumstance shall be invalid or unenforceable to any extent, the reminder of this affected thereby and shall be enforced to the greatest extent permitted by law. IN WITNESS WHEREOF, the parties hereto have executed this Agreement to be effective as of the day and year first above written. COVERED ENTITY: BUSINESS ASSOCIATE: By: __________________________ By: __________________________ Print Name: ___________________ Print Name: ___________________ Title:_________________________ Title: _________________________ Business Associate Agreement Date: 03/11/2005 The entities must enter into a memorandum of understanding with the business associate that contains terms that accomplish the objectives of paragraph (a) (2)(i) of section §164.314 or if other law contains requirements applicable to the business associate that accomplish the objectives of paragraph (a)(2)(i) of section §164.314 Business Associate Agreement Date: 03/11/2005 1 69 92