PROG ID: POCNBK3A STATE OF ALABAMA DATE: 02/24/09 DEPARTMENT OF FINANCE DIVISION OF PURCHASING CONTRACT NOTICE OF AWARD ANALYZATION OF PAP SMEARS CONTRACT T-NUMBER....... : T151 USAGE.......... : AGENCY TERM CONTRACT PERIOD......... : JANUARY 18, 2005 TO JANUARY 17, 2010 SOLICITATION NO : 2149130 CONTRACT BUYER...... : BERNIE ARANT BUYER PHONE.. : (334) 242-4201 PURCHASING NUMBER......... : (334) 242-7250 FAX NUMBER... : (334) 242-4419 DATE PRINTED. : 02/24/09 DIVISION OF PURCHASING CONTRACT NOTICE OF AWARD TERMS AND CONDITIONS PAGE: 2 FAMILIARIZE YOURSELF WITH THIS CONTRACT AND THE TERMS AND CONDITIONS REGARDING THE RESPONSIBILITIES OF THE STATE AND THE VENDORS. * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * IT IS THE RESPONSIBILITY OF THE ORDERING AGENCY TO MAKE SURE THAT * * ALL OF THE INFORMATION SUBMITTED ON THEIR REQUISITION IS CORRECT. * * ALWAYS BE SURE TO RECHECK YOUR COMMODITY NUMBERS. AS SOON AS YOUR * * PURCHASE ORDER ARRIVES, CHECK IT FOR ACCURACY. IF THERE ARE ANY * * DISCREPANCIES, PLEASE NOTIFY THE VENDOR FIRST, THEN CONTACT THE * * BUYER LISTED ON THE FRONT OF THIS CONTRACT AS SOON AS POSSIBLE. * * IN MOST INSTANCES, PROBLEMS CAN BE CORRECTED. * * * * COMPLAINTS MUST BE DOCUMENTED & SUBMITTED TO THE BUYER IN WRITING.* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ALABAMA DEPARTMENT OF PUBLIC HEALTH (ADPH) 2005 PAP SMEAR BID I. GENERAL REQUIREMENTS: THE LABORATORY MUST PROVIDE EVIDENCE OF THE FOLLOWING: * CERTIFICATION BY CLIA (CLINICAL LABORATORY IMPROVEMENT AMENDMENTS) AND PROVIDE A SUMMARY REPROT OF THE MOST RECENT CLIA INSPECTION UPON REQUEST. * CERTIFICATION/ACCREDITATION BY THE COLLEGE OF AMERICAN PATHOLOGISTS (CAP). * A DESCRIPTION OF THE CONTRACTOR'S ORGANIZATION, INCLUDING ORGANIZATIONAL CHART, LABORATORY FACILITIES, QUALITY CONTROL PROGRAM, AND DOCUMENTED EXPERIENCE IN THE PROCESSING, INTREPRETATION, AND REPORTING OF A MINIMUM OF 60,000 OR MORE GYNECOLOGICAL PAP SMEAR CASES DURING EACH OF THE PAST THREE DIVISION OF PURCHASING CONTRACT NOTICE OF AWARD TERMS AND CONDITIONS PAGE: 3 YEARS. * HAVE ON ITS STAFF A BOARD CERTIFIED PATHOLOGIST WITH TRAINING AND CURRENT EXPERIENCE IN CYTOPATHOLOGY, PREFERABLY WITH MEMBERSHIP IN THE AMERICAL SOCIETY OF CYTOLOGY, WHO WILL: * PERSONNALLY REVIEW ALL ABNORMAL PAP SMEARS, PLUS 10% OR MORE SLIDES INTERPRETED AS NEGATIVE, MAKE CYTOLOGICAL JUDGEMENT OF FINDINGS, AND SIGN ALL SPECIMEN REPORTS REVIEWED. * THE LABORATORY'S CYTOTECHNOLOGISTS ARE GRADUATES OF AN ACCREDITED SCHOOL OF CYTOTECHNOLOGY AND ARE REGISTERED THROUGH EXAMINATION EITHER BY THE AMERICAN SOCIETY OF CLINICAL PATHOLOGISTS OR THE INTERNATIONAL ACADEMY OF CYTOLOGY. * LABORATORY MUST USE THE 2001 BETHESDA CLASSIFICATION SYSTEM OF REPORTING CYTOLOGY TEST RESULTS. ANY DEVIATION FROM THE BETHESDA SYSTEM LANGUAGE AND TERMINOLOGY MUST BE MUTUALLY AGREED UPON IN ADVANCE. AN EXCEPTION IS FOLLOW UP RECOMMENDATION - LAB SHALL STATE "FOLLOW UP PER ADPH PROTOCOL" ON ALL SPECIMENS REQUIRING FOLLOW UP. * LABORATORY MUST INDICATE EXPERIENCE IN PROVIDING LIQUID-BASED CERVICAL CANCER AND HPV TESTING TO INCLUDE A DESCRIPTION OF THE TESTING METHODOLOGY USED FOR THE LIQUID-BASED PAP TEST AND HPV (E.G. NUMBER OF YEARS EXPERIENCE, NUMBER OF TESTS PERFORMED ANNUALLY, ETC.) * ASSURANCE OF THE AVAILABILITY FOR ADPH AGENCY STAFF TO CONSULT LABORATORY PERSONNEL, PREFERABLY A CYTOPATHOLOGIST OR SUPERVISING CYTOTECHNOLOGIST, DURING NORMAL BUSINESS HOURS REGARDING PAP SMEAR RESULTS AND MANAGEMENT. * THE LABORATORY'S ANNUAL RATES FOR THE FOLLOWING: ASC-US, ASC-H, LSIL, HSIL, AGC, CIN AND UNSATISFACTORY FOR THE PAST THREE YEARS. * THE LABORATORY MUST HAVE A COMPUTER SYSTEM WHICH PRODUCES ALL CYTOLOGY REPORTS, MONTHLY STATISTICAL DATA AND ITEMIZED BILLING BY CLINICAL SITE; IT MUST PROVIDE FOR THE PROPER ACCESSION OF DIVISION OF PURCHASING CONTRACT NOTICE OF AWARD TERMS AND CONDITIONS PAGE: 4 SPECIMENS AS THEY ARE RECEIVED FROM CLINICS STATEWIDE, AND FOR THEIR ORDERLY HANDLING, PREPARATION, STAINING, ETC. THE LABORATORY MUST PROVIDE MATERIALS AND SUPPLIES FOR THESE ANALYTICAL PROCEDURES. * THE PROCESS CLINICS WILL NEED TO FOLLOW IN PREPARING SPECIMENS AND GETTING THEM TO THE LABORATORY (E.G. COLLECTION DEVICES, MAILERS, COURIER SERVICES, ETC.) * THE LABORATORY'S POLICIES AND PRODEDURES FOR THE PROCESSING AND STORAGE OF SPECIMENTS. * A DESCRIPTION OF TURNAROUND TIME AND METHODS FOR REPORTING THE RESULTS OF THE PAP AND HPV TESTS TO PROVIDERS. * A PLAN FOR PROVIDING ONSITE ORIENTATION ON SPECIMEN COLLECTION, SPECIMEN PACKAGING, TRANSPORT AND OTHER ISSUES RELATED TO PROVIDING LIQUID-BASED CERVICAL CYTOLOGY AND HPV TESTS, AND FOR ON-GOING TRAINING AND INFORMATION FOR CLINIC STAFF PARTICIPATING IN THE PROJECT. * THE TYPES OF REPORTS, INCLUDING TEST RESULTS AND STATISTICAL REPORTS, THAT WILL BE PROVIDED TO CLINICS IN THE PROJECT. SAMPLES OF REPORTS TO INCLUDE INDIVIDUAL CLIENT TEST RESULTS, STATISTICAL REPORTS, AND ANY ADDITIONAL REPORTS SUCH AS SUMMARIES OF CLIENTS WITH ABNORMAL TEST RESULTS SHOULD BE INCLUDED WITH THE PROPOSAL. THE FREQUENCY OF STATISTICAL REPORTS AND THE ABILITY OF THE LABORATORY TO PRODUCE ANY SPECIAL REPORTS SHOULD ALSO BE ADDRESSED. * AGREEMENT TO AN ONSITE VISIT TO THE LABORATORY BY REPRESENTATIVES OF THE AGENCY, INCLUDING COVERAGE OF EXPENSES; INCLUDES MAXIMUM OF TWO PEOPLE EVERY TWO YEARS. * CURRENT LIABILITY INSURANCE COVERAGE. * THE DATE BY WHICH THE SERVICES REQUIRED BY THE AGENCY WILL BE AVAILABLE AND AN EXPLANATION OF THE TIMEFRAME REQUIRED FOR START-UP IF SERVICES ARE NOT AVAILABLE BY DECEMBER 31, 2004. DIVISION OF PURCHASING CONTRACT NOTICE OF AWARD TERMS AND CONDITIONS PAGE: 5 II. SERVICE SPECIFICATIONS: * LABORATORY MUST USE THE FDA APPROVED THINPREP PAP TEST LIQUID BASED PAP SMEAR MANUFACTURERED BY CYTYC CORPORATION. A UNIT PRICE PER THINPREP PAP TEST MUST BE INCLUDED IN THIS PROPOSAL. * LABORATORY MUST USE THE FDA APPROVED HPV REFLEX - HYBRID CAPTURE II TEST FOR HIGH RISK TYPING MANUFACTURERED BY DIGENE. THE LABORATORY MUST BE ABLE TO PERFORM HPV TESTING ON THE SAME SAMPLE SUBMITTED FOR THE INITIAL LIQUID-BASED PAP TEST. ALL SMEARS WITH AN ASC-US RESULT WILL AUTOMATICALLY HAVE AN HPV TYPING PERFORMED ON THE SAME SPECIMEN. A UNIT PRICE PER HPV TEST MUST BE INCLUDED IN THIS PROPOSAL. * ONLY ONE FEE (UNIT PRICE) WILL BE CHARGED PER SPECIMEN; NO ADDITIONAL FEE CAN BE CHARGED SUCH AS FOR RE-EXAMINATION OF ABNORMAL SPECIMEN BY PATHOLOGIST. * ADPH PREFERS THE LABORATORY INFORMATION SYSTEM (LIS) TO INTERFACE WITH AGENCY SOFTWARE, I.E., SYSWARE/POWERLAB. A DESCRIPTION OF THE COMPUTER SOFTWARE MUST BE INCLUDED IN THIS PROPOSAL. * QUALITY ASSURANCE: A) LABORATORY MUST HAVE IN PLACE A WELL-DEFINED, DOCUMENTED, CONTINUOUS INTERNAL AS WELL AS EXTERNAL QUALITY CONTROL PROGRAM, WHICH INCLUDES THE RE-EXAMINATION BY PATHOLOGISTS OR QUALIFIED SUPERVISORS OF AT LEAST TEN PERCENT (10%) OF ALL SLIDES INTERPRETED AS NEGATIVE. ALL SPECIMENS DIAGNOSED AS EITHER UNSATISFACTORY OR ABNORMAL MUST BE REVIEWED, APPROVED AND SIGNED BY THE LABORATORY PATHOLOGIST. SUBSTATINTIATING DATA MUST BE AVAILABLE UPON REQUEST AT REASONABLE INTERVALS. B) LABORATORY MUST RETAIN IN ITS FILE A COPY OF ALL PAP SMEAR SLIDES AND REPORTS FOR MINIMUM OF FIVE YEARS ON ALL NEGATIVE SLIDES. SLIDES ON ABNORMAL SPECIMENS SHALL BE KEPT DIVISION OF PURCHASING CONTRACT NOTICE OF AWARD TERMS AND CONDITIONS PAGE: 6 INDEFINITELY TO PROVIDE CORRELATION OPPORTUNITIES WITH THE CYTOLOGY AND HISTOLOGY FINDINGS GENERATED IN FOLLOW-UP EVALUATIONS. * THE LABORATORY MUST COMPLETE ALL TASKS INVOLVING THE PROCESSING, INTERPRETATION, CLINIC REPORT PREPARATION, AND RETURN OF REPORTS TO THEIR RESPECTIVE ORIGINATING CLINICS WITHIN TEN (10) WORKING DAYS OF THE RECEIPT OF RAW SPECIMENS IN LABORATORY. IN ADDITION TO THE MAILED REPORTS ON ALL SPECIMENS, SPECIMENS INTERPRETED AS REQUIRING IMMEDIATE ATTENTION (E.G., HSIL), WILL BE REPORTED TO THE CLINIC NURSE BY TELEPHONE OR CONFIRMED FAX ON THE DAY OF DIAGNOSIS. * SUPPLIES/FORMS: THE LABORATORY WILL BE RESPONSIBLE FOR ALL PAP SMEAR SPECIMENS REACHING ITS FACILITY. THIS WILL INCLUDE THE LABORATORY FURNISHING TO CLINIC SITES STATEWIDE ALL SUPPLIES NECESSARY TO COLLECT AND TRANSPORT THE SPECIMENS FROM THE CLINIC SITES TO THE LABORATORY. NOTE: THE LABORATORY MUST FURNISH A SAMPLE COLLECTION KIT AND LABORATORY REQUISITION FORM WITH THIS PROPOSAL. * DATA: LABORATORY WILL PROVIDE DATA REPORTS AS SPECIFIED BY THE DEPARTMENT SUCH AS: A) THE OVERALL RATES OF ASC-US, LSIL, HSIL, AGC, CIN AND UNSATISFACTORY RESULTS B) A QUARTERLY CLINIC SITE LIST BY PATIENT NAME, PATIENT ID NUMBER, PROGRAM FROM WHICH SPECIMEN WAS OBTAINED (FAMILY PLANNING, BREAST AND CERVICAL CANCER PROGRAM, MATERNITY, ETC.), DATE SPECIMEN RECEIVED, DATE RESULTS REPORTED, PROVIDER NAME OR NUMBER ON ALL PATIENTS WITH ABNORMAL FINDINGS. C) A MONTHLY REPORT THAT ADDRESSES WHICH PATIENTS AT AN INDIVIDUAL SITE REQUIRE FOLLOW-UP DUE TO ABNORMAL FINDINGS. D) A SEMI-ANNUAL AND ANNUAL REPORT THAT REFLECTS THE TOTAL PAP SMEARS BY AGE, RACE, AND DIAGNOSIS BY CLINIC SITE, COUNTY, AND STATE TOTALS. E) A QUARTERLY REPORT THAT ADDRESSES UNDUPLICATED PATIENT BY DIVISION OF PURCHASING CONTRACT NOTICE OF AWARD TERMS AND CONDITIONS PAGE: 7 DIAGNOSIS, CLINIC SITE AND PROVIDER F) A QUARTERLY REPORT THAT GIVES THE TOTAL NUMBER OF UNSATISFACTORY PAP TESTS BY CLINIC SITE AND PROVIDER G) AN ANNUAL REPORT THAT GIVES THE TOTAL NUMBER OF PAP TESTS BY CLINIC SITE, BY PROVIDER AND THE TOTAL NUMBER OF UNSATISFACTORY PAP TESTS * PAYMENT: A) SUBMIT REIMBURSEMENT VOUCHERS IN A FORMAT SPECIFIED BY THE BUREAU OF FAMILY HEALTH SERVICES, 201 MONROE STREET, RSA TOWER, SUITE 1350, MONTGOMERY, ALABAMA 36130-3017 ONCE EACH MONTH INCLUDING PATIENT NAME (INITIAL + SURNAME) AND HEALTH DEPARTMENT PATIENT IDENTIFICATION NUMBER OF EACH PATIENT INCLUDED IN BILLING FOR THAT MONTH. B) SUBMIT INVOICES TO THE BUREAU OF FAMILY HEALTH SERVICES, 201 MONROE STREET, RSA TOWER, SUITE 1350, MONTGOMERY, ALABAMA 36130-3017, ON THE TOTAL NUMBER OF PAP SMEAR SPECIMENS ANALYZED. * REFERENCES: IT WOULD BEHOOVE THE VENDOR TO FURNISH A LIST OF THE AGECNIES/ PRIVATE BUSINESSES AND CONTACT PERSONS FOR WHOM SIMILAR WORK HAS BEEN DONE. SOLICITATION NUMBER : 2149130 PURPOSE: ESTABLISH A CONTRACT FOR THE ANALYSIS OF PAP SMEARS TO BE USED BY THE STATE OF ALABAMA AND MAY BE USED BY LOCAL GOVERNMENTAL AGENCIES, WHICH IS OPTIONAL. CONTRACT PERIOD: ESTABLISH A 12 MONTH CONTRACT WITH AN OPTION TO EXTEND FOR A SECOND, AND THIRD 12 MONTH PERIOD WITH THE SAME PRICING, TERMS AND CONDITIONS. THE SECOND AND THIRD 12 MONTH PERIOD, IF AGREED BY BOTH PARTIES, DIVISION OF PURCHASING CONTRACT NOTICE OF AWARD TERMS AND CONDITIONS PAGE: 8 WOULD BEGIN THE DAY AFTER THE FIRST OR SECOND 12 MONTH PERIOD EXPIRES. ANY SUCCESSIVE EXTENSION MUST HAVE WRITTEN APPROVAL OF BOTH THE STATE AND VENDOR NO LATER THAN 30 DAYS PRIOR TO EXPIRATION OF THE PREVIOUS 12 MONTH PERIOD. ORDERING PROCESS: PURCHASES FOR STATE AGENCIES WILL BE MADE BY CONTRACT RELEASE ORDERS SHOWING SPECIFIC SHIPPING INFORMATION. CITIES, COUNTIES, SCHOOL SYSTEMS AND OTHER POLITICAL SUBDIVISIONS WILL BE RESPONSIBLE FOR ISSUING THEIR OWN PURCHASE ORDERS DIRECTLY TO THE VENDOR. DIVISION OF PURCHASING CONTRACT NOTICE OF AWARD CONTRACT VENDORS PAGE: 9 CONTRACT VENDOR NUMBER CONTACT PERSON TERMS AND NUMBER NAME AND ADDRESS PHONE NUMBERS/FAX DELIVERY 4008311 200267816-00 JAMES T. SHEEDER NET MARLBOROUGH HOLDINGS LLC D/B/A 412-373-8300 30 DAYS ARO PENNSYLVANIA CYTOLOGY SERVICES 800-344-1026 SUITE 1700 PARKWAY BLDG 339 OLD HAYMAKER ROAD MONROEVILLE PA 15146 412-373-7027 DIVISION OF PURCHASING CONTRACT NOTICE OF AWARD COMMODITY LISTING PAGE: 10 CONTRACT COMMODITY NUMBER UNIT PRICE VENDOR # TERMS NUMBER/LINE # COMMODITY DESCRIPTION MEASURE NAME 4008311 00002 961-48-087544 13.95000 200267816-00 NET SLIDE MARLBOROUGH HOLDINGS LLC D/B/A PAP SMEAR, CYTOPATHOLOGICAL ANALYSIS PENNSYLVANIA CYTOLOGY SERVICES OF LIQUID BASED CYTOLOGY(THINPREP) FOR THE DETECTION OF CANCER, AND OTHER ABNOMALITIES AS PER SPECIFICATION NO APS-151. 4008311 00003 961-48-089350 35.95000 200267816-00 NET EA MARLBOROUGH HOLDINGS LLC D/B/A HPV, ALL ASC-US SMEARS WILL HAVE HIGH PENNSYLVANIA CYTOLOGY SERVICES RISK HPV DNA TESTING PERFORMED USING DIGENE'S HYBRID CAPTURE 2 TECHNOLOGY. / DIVISION OF PURCHASING CONTRACT NOTICE OF AWARD * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * IF YOU NEED ASSISTANCE CONCERNING THIS CONTRACT, PLEASE CONTACT THE BUYER LISTED ON THE COVER PAGE. * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * THIS CONTRACT CONTAINS 11 PAGES.