QOPI Certification Participation Guide
Contents
1. Target foreach module should be met 2 If target for certain modules is not met confirm that all eligible charts for that module have been abstracted 3 After confirming that all targets are met for each module and if not met that all eligible charts have been abstracted then confirm minimum unique chart requirements are met 4 If below the minimum unique chart requirements you are allowed to add additional charts of patients that qualify for core or symptom with cases with any invasive malignancy in the allowable range 2 1 7 DETERMININGFTES AT YOUR PRACTICE Full Time Equivalent FTE is the ratio of the total number of clinical hours during a period part time full time contracted with the number of working hours in that period or the proportion of time a medical oncologist or hematologist provides clinical care relative to a full time schedule The ratio units are FTE units or equivalent employees working full time one FTE equals one employee working full time For example You have three clinicians and they work 50 hours 40 hours and 10 hours per week totaling 100 hours Assuming a full time employee works 40 hours per week your full time equivalent calculation is 100 hours divided by 40 hours or 2 5 FTE American Society of Clinical Oncology Page4 QOPI Certification Participation Guide Spring 2015 Table 2 1 Target Chart Numbers Medical Hematologist Oncologist Clinical FTEs pep ar Target Number of Charts2. in 2014 the QOPI Certification program adopted a 75 threshold score A complete list of the QOPI Certification designated measures including their specifications scoring thresholds and the overall scoring methodology are found n the Appendix 11 1 QOPI DATA COLLECTION ROUND DETAILS The pathway to the QOPI Certification Programi participation in a QOPI data collection round n accordance with the QOPI methodology A practice mustfirst meet the QOPI Certification measures scoring requirements 75 to be eligible to apply for QOPI Certification The QOPI data collection which includes a retrospective chart review is currently offered twice each year in the spring and in the fall Practice staff identifies cases as specified by the QOPI methodology and abstract data from paper medical records and or electronic health records EHR A detailed QOPI User Manual 8 available in the QOPI System to assist practice staff n appropriately selecting charts for review and successfully completing the chart abstraction Al data are submitted using a secure online Web based application Work is now underway to facilitate the electronic transfer of QOPI data from EHR systems to the QOPI System but is unavailable at this time The QOPI measures are organized into a required core set and disease and domain specific modules Practices seeking Certification select and submit chart data for each QOPI module 5 that includes a measure designa
3. Certification term American Society of Clinical Oncology Page 23 QOPI Certification Participation Guide Spring 2015 15 QOPI CERTIFICATION LEGAL POLICIES AND PROCEDURES All Policies can be requested by writing to qopicertification asco org or at the ASCO website Www asco org 15 1 INFORMATION AND DATA REIFASED FROM THE QOPI CERTIFICATION PROGRAM ASCO will not release any information or performance data without the specific request of the participant However with practice opt in ASCO will transfer a practice s certification status to health plans or other entities selected by that practice Complete details regarding information being sent will be included at the time of opt in American Society of Clinical Oncology Page 24 QOPI Certification Participation Guide Spring 2015 16 POLICY SUMMARIES The section describes QOPI Certification policies 16 1 QOPI CERTIFICATION SCORE WAIVER REVIEW e Practices that did not achieve the QOPI Certification scoring requirement can request that the QOPI Certification Oversight Council review the scoring decision e Reception of a waiver is based on a finding that unique characteristics of a practice unfairly disadvantaged the practice s performance relative to specific QOPI measures impacting their overall score e Requests must be received within 10 days of receiving quality scores 16 2 REPEAT ON SITE SURVEY POLICY Following review ofa practice s QOPI Certification Application a
4. as soon as possible to ensure thatelectronic ordering systems integrate allof these elements If the information cannot be captured in the electronic system it should be documented within the patient record Drug Preparation 6 A second person a practitioner r or other r pers onnel approve d by the practice institution to prepare or administer r chemotherapy independently verifies each orde r for chemotherapy before pre parathion including confirming TQmt roam gt Two patient identifiers Drug names Drug dose Drug volume Route of adminstration Rate of administration The cakultion for dosing including the variables used in this cakuhtion Treatment cyck and day of cyck 7 Chemotherapy drugs are labeled immediately upon preparation including at minimum TOnMOADp Patient s full name and a second patient identifer e g medical record number DOB Full generic drug name Drug administration route Total dose to be given Total volume required to administer this dosage Date of admmnstration Date and time of preparation Date and time of expration when not for mmedate use Immediate use must be defined by institutional policy state and federal regulations e g use within 2 hours Practices institutions are not expected to be in full compliance with this standard if they currently have electronic systems that are unable to meet these labeling requirements Appropriate changes should be impl
5. chemotherapy are written and signed by licensed independent practitioners who are determined to be qualified by the practice institution according to the practice s institution s policies procedures and or guidelines Chemotherapy drugs oral or parenteral are prepared by a pharmacist pharmacy technician or nurse determined to be qualified according to the practice s polces procedures and or guidelines Only qualified physiians physician assistants advanced practice nurses or registered nurses admnister chemotherapy The practice institution has a comprehensive educational program for new staff adminsterng chemotherapy including a competency assessment or the practce mstiution uses an establshed educational program regarding chemotherapy admmnstration that ends n competency assessment Education and competency assessment regarding Chemotherapy admmnstration mcldes al routes of admmnstration used in the practice mstitution site e g parenteral oral intrathecal intraperitoneal mtravascular and safe handing of hazardous chemotherapy agents An example of an established educational program is the ONS Chemotherapy and Biotherapy Course The practice mnstitution has astandard mechanism for montormg chemotherapy adminstration competency at specifed ntervakb Annualcompetency reassessment is recommended There must be atkast one clinical staff member who mamtamns current certification n bask lfe support on site dur
6. e Provide resources to communicate your practice s QOPI certification to your patients and the local community This guide provides detailed instructions to practices entering the QOPI Certification Program For information regarding QOPI QOPI data abstraction or other documentation related to the QOPI Certification Program go to http qopi asc 0 org American Society of Clinical Oncology Pagel QOPI Certification Participation Guide Spring 2015 2 ELIGIBILITY FOR QOPI CERTIFICATION This section describes the QOPI Certification and the steps required for a practice to achieve Certification 2 1 PRACTICE DEFINITION QCP awards QOPI Certification to practices rather than individual office sites Practices are expected to come into Certification with all of their office sites However QCP may grant exceptions to this rule for special circumstances Practices that would like to participate with less than all of their office sites should contact the QOPI Certification help desk for more information Practices that want to test the certification waters are allowed to come in with a pioneer site Practices applying for Certification using a pioneer site should intend to certify the practice as a whole in future years Sites coming into Certification separately should discuss with QCP staff how to merge any existing certified practice sites in the QOPI database so they can apply for Certification as a whole at a later date For Certifica
7. outcome e g self or immediate family member_ employed by a direct competitor of the practice of the review or 3 Any other relationship with the practice that would cast considerable doubt on his or her ability to provide an objective review as determined by the Certification Program If a disqualifying relationship is identified an alternate reviewer and or an alternate surveyor will be named by the Certification Program QCP reserves the right to determine if the noted conflict of interest meets the program threshold 14 1 SCHEDULING THE ON SITE VISIT The on site surveyor will contact the practice to schedule the on site survey date The visit must take place within two to eight weeks from the first contact with the On site surveyor Once a mutual date has been decided and the surveyor has notified the certification team the Certification Team sends a confirmation email to you Once the date is agreed upon it cannot be changed without penalty If the practice changes the initial agreed upon date it will be required to bear the cost associated with the travel fees surveyor stipends etc that occur because of the change Please be advised that a QOPI Certification staff member may accompany the on site surveyor for quality assurance or other purposes 14 2 ON SITE SURVEY AGENDA The surveyor s goal is to review your practice s agreement with the 20 ASCO ONS Chemotherapy Safety Standards using a patient tracer method thro
8. per Module Target Total Number of Charts for QOPI Koa 120 m 160 a 170 a 200 Certification five modules P PE 2 1 8 WHEN TO PARTICIPATE IN QOPI Practices must apply for Certification after participating in the QOPI chart abstraction Recertifying practices should participate in QOPTI chart abstraction at least 9 months prior to certification expiration Practices that have not completed QOPI data abstraction and have concerns about timelines are encouraged to contact QCP staff at qopicertification asco org Detailed information on QOPI collection requirements can be found on the QOPI website at http qopi asco org American Society of Clinical Oncology Page5S QOPI Certification Participation Guide Spring 2015 3 QOPI CERTIFICATION PROCESS OVERVIEW This section describes the processes required to initiate and achieve QOPI Certification 3 1 PROCESS FOR NEW AND RECERTIFYING PRACTICES At the time of application practices are asked to identify a main contact person This person will be responsible for all steps of the Certification process and will receive all important information regarding the status of their application At the QOPI Certification application Webpage http qopi asco org LOG_IN htm practices can complete the QOPI Certification practice application submit appropriate fees and complete the Site Assessment Questionnaire Practice completes and submits QOPI Certification applicatio
9. site survey QCP staff randomly selects the sites to be visited Practices with more than five office locations are required tohave multiple sites visited with additional site fees For practices that have one or more sites located more than 250 road miles from the next closest site as measured by the shortest route between such sites QCP may divide the practice into regions The practice will consult QCP regarding the appropriate manner of applying for QCP but QCP has the sole discretion to establish the geographic regions Regardless of whether a large multi site practice is divided into geographic regions or permitted to apply for Certification under a single application QCP may assess additional fees to cover the cost of the on site surveys and travel related costs if sites being surveyed are separated by more than a one hour driving distance Examples include 1 A multi site practice with one or more sites serving a large number of patients measured by whether the site services more than an average of 30 infusion visits in one day and or has greater than seven 7 FTE medical or hematology oncologists may be required to submit additional fees to cover on site surveys of these high volume practice sites 2 Anoncology practice with greater than three 3 campus infusion centers may be subject to additional fees to cover expenses associated with extended visits 3 An oncology practice that has a separate specialty office may be s
10. to do the review and will not have access to previous review materials 6 1 COST OF REPEATED ON SITESURVEY If an additional site visit is required to demonstrate practice improvement the practice will bear the cost Practices may appeal Certification decisions using a structured appeals process The policy for appeals will be sent to a practice upon request American Society of Clinical Oncology Page 10 QOPI Certification Participation Guide Spring 2015 7 FINALREVIEW QOPI Certification Committee Reviewers including community and academic oncologists and oncology professionals evaluate the on site survey report and any responses and determine whether to award QOPI Certification American Society of Clinical Oncology Page11 QOPI Certification Participation Guide Spring 2015 8 QOPI CERTIFICATION AWARD Certification is awarded when a practice is deemed to have met QCP s standards The award indicates that by achieving QOPI Certification or Recertification a practice has participated in the QOPI Certification process and met or exceeded a benchmark score on measures that compared the quality of its care against national standards The practice has then undergone an on site review and peer review by a select team of oncology professionals such as physicians and nurses at least once every three years 8 1 CERTIFICATION TERM QOPI Certification has a three year term starting at the time when the practice achieves QOPI Cert
11. 5 QOPI CERTIFICATION LEGAL POLICIES AND PROCEDURES 24 15 1 Information and Data Released from the QOPI Certification Program 24 16 POLICY SUMMARIES wees ssccesssceocasszauessesscossevensenveawissesseavsosdesassessussessoadeesues 25 16 1 QOPI Certification Score Waiver Review ccccccssececeeeseeeeeeceeaeeeeeaaes 25 16 2 Repeat On Site Survey Policy cic ccsedeecsececcserveioeaseadaetetyaadd ettaadvreates 25 16 3 QOPI Certification Appeals Process ssuscsivsicaiesseiceucunus eee 25 16 4 Conflict of Interest Polic y for QOPI Certification Appeals and Revocation26 16 5 QCP Policy for the Extension of Practice s Final Deadline 0 ee 26 16 6 Practice Mergers And Transactions Policy eeeeeeeeeeseeneneneneaeeeeeeeeeeees 26 16 7 QOPI Certification Program Revocation Procedure cssseseeceeeeeeeeeees 26 16 8 Appropriate Use Protocol and User Access Protocol ccssessseseeeeeeeeeees 27 16 9 Webinars Consultations and Certification Help Desk ec ceeeeeeeeeee 27 16 0 COntaCt US errian E E A A a Aa 28 APPENDIX A SCORED QOPI MEASURES esessssssesesssssesoessssscsseesssoeossssssoee A 1 APPENDIXB QOPI 2015 CERTIFICATION STANDARDS 1 20 B 1 APPENDIXC QCP ON SITE REVIEW A DAY IN THE LIFE 00 C 1 American Society of Clinical Oncology Spring 2015 Pageiv QOPI Certification Participation Guide Spring 2015 LIST OF TABLES TABLE 4 1 TARGET CHART N
12. ASURES sesondsnsanccnsondincandencanvewneeaseneteseuseus cna kaeenceustencansdaseadacencencsacaaseatoarins 15 11 1 QOPI Data Collection Round Details ccsssssssssssssssssssscsesssssssssssesssssssssn 15 11 2 Sampling Requirements for QOPI Certification eee eeeeeeseeeeeeeeeeeees 16 11 3 Multi Site Practice Sample ccsccietecettcieceetesni ee 16 11 4 Certification Reports and Scoring eiccccasiaccacceccoccaexsscassacsdacsaccarsecizelectaernceeas 16 11 5 Final Certification Report esesessesseseseserererssstrssrsrsrererrereeeeresssssssrererereeee 17 11 6 Re certifying Practices One Time Pass on Certification Scoring 17 12 SITE SELF ASSESSMENT QUESTIONNAIRE ccsssccccssssssceeesssseeees 18 13 DETERMINING SURVEY SITES AND ADDITIONAL FEEG 19 American Society of Clinical Oncology Pageiii QOPI Certification Participation Guide 14 CONFLICT OF INTEREST SCREENG cssssssssssssssssesssssscessssscossenees 20 14 1 Scheduling the On Site Visit o1icciceschcccdd Gcediceecedvatentactevicutectectentaetacteataxdes 20 14 2 On Site Survey Agenda eseseesseeerererersrrrsrrrsrsrsrrererertertressessressrerereene 20 14 3 Practice Preparation for the On Site Survey eesseseesereerrireesesrsessrerrreree 21 14 4 Exit Summary of Findings eeeseeessseseseserrersrsssssrsrerrrrerertererssssssrerrrerrreene 21 14 5 The On Site Survey Report and Response Timeline soceneccceeeeeeereeeeee 22 1
13. FLICT OF INTERES T POLICY FOR QOPI CERTIFICATION APPEALS AND REVOCATION Consistent with the ASCO Conflict of Interest Policy this Policy Implementation provides mechanisms for minimizing potential conflicts of interest through each phase of the QOPI Certification and Appeals Process 16 5 QCP POLICY FOR THE EXTENSION OF PRACTICE S FINAL DEADLINE QCP recognizes and appreciates that achieving Certification s time consuming and requires the commitment of scarce practice resources For this reason practices are given a full year from their Certification Pending date to complete the requirements to achieve Certification QCP will only grant extensions to meet the requirements for Certification when an unforeseen and uncontrollable act of nature occurs within 60 days of the end of the practice s Certification Pending period Staffing and personnel changes are not grounds for an extension QCP strongly recommends that all practices complete the requirements for Certification at their earliest opportunity Requesting an Extension New Practices seeking an extension must make a formal request in writing to qopicertification asco org The request must include information regarding the basis for the extension Extensions will be granted at the sole discretion of QCP and will be for a maximum of 30 days Practices requesting an extension will be assessed a 250 administrative fee 16 6 PRACTICE MERGERS AND TRANSACTIONS POLICY Significant practice trans
14. OCP QOPI Certification Program Quality In SSS QOPI Certification Participation Guide Spring 2015 June 1 to September 12 QOPI Certification Participation Guide Spring 2015 Copyright 2015 American Society of Clinical Oncology ASCO All rights reserved Note QOPI is a registered name of ASCO American Society of Clinical Oncology Page ii QOPI Certification Participation Guide Spring 2015 TABLE OF CONTENTS 1 INTRO DUC THON riscontaissecvscneisinnacsienecawaioastusdannaivustnadanveasustacqastaceastarracucencoacts 1 2 ELIGIBILITY FOR QOPI CERTIFICATION c ssssssssssssssssesssseesssesseseeees 2 21 Pra tice TDG TiO sisisi sissa anaE ES EEEE 2 2 1 1 Designation of QOPI Certification c ccccccscecesesesesssseseeessssesteeeeen 2 2 1 2 Large Multi Site Practices oecscsiseresirsesisirssseserverrersesesesee 3 2 1 3 Practices that Do Not Provide InfusionServices 0 cesseeeeeeees 3 2 1 4 Participation in QOPI Chart Data Abstraction eee 3 2 1 5 QOPI Certification Quality Scoring Threshold seeseeseeeeseessesss 4 2 1 6 Target Chart Requirements cccicsticsecesauectcoiesnouauenunayatetteneaeeaues 4 2 1 7 Determining FTEs at Your Practice eeeeeeeeeeeeererererererrrerrres 4 2 1 8 When to Participate in QOPI A niente eeabaies 5 3 QOPI CERTIFICATION PROCESS OVER VIEW sscscsssssssssssesssseeees 6 3 1 Process for New and Recertifying Practices eeeess
15. QOPI for information on how to precede at qopi asco org The QOPI sampling methodology requires that practices identify their eligible most recently seen patients and proceed backwards in time to a maximum of 6 months to achieve the required sample size The complete methodology and eligibility criteria are included in the QOPI User Manual 11 3 MULTI SITE PRACTICE SAMPLING Large multi site practices within 250 miles of each other may elect to sample as one practice or with all of the practice sites expected to participate in Certification Practices with more than 25 sites are required to participate as geographic regions For additional information on practice sampling refer to Practice Definition in the QOPI User Manual The entire practice must participate in QOPI n the way that best represents the whole practice Multi site practices can do this in two ways with differing sample size requirements The first option involves puling one sample across the multiple office sites within the practice The second involves a distinct chart pull at each office site Practices can select whichever methodology is most feasible and appropriate for their quality improvement goals 11 4 CERTIFICATION REPORTS AND SCORING Interim Certification Report This report is available one week prior to the close of the collection round and shows the practice office depending on sampling approach performance on the 26 American Society of Clinical Onc
16. Report OSR is written and submitted to the QCP staff by the Surveyor for review approximately one week The OSR is finalized by the QCP staff and sent to the QCP Committee member for final review approximately 2 3 weeks The final OSR is sent to the practice with instructions a Response Plan and Document Submission guide will be attached to the email for submitting a Response Plan or action plan which is then sent to the QCP staff at qopicertification asco org within 10 business days from the day you receive the final OSR The Response Plan will be reviewed by the QCP staff for clarity accuracy and within your timeline for certification recertification with an email sent to you within 3 business days with approval to move forward with the plan If the Response Plan requires any change or modification the QCP staff will include this feedback in an email to you within 3 business days A modified Response Plan will need to be re submitted to the QCP staff within 3 business days for final approval The practice works on the requirements and the corresponding document submission see Response Plan and Document Submission guide for instructions and submits all documents to databank to meet the final document submission timeline as outlined in the OSR When all required documents have been submitted to Databank they will be summarized within 10 business days for completeness and accuracy as specified in the OSR and sent to the ori
17. To be eligible for the QOPI Certification Program a practice must participate in the QOPI spring 2015 collection and meet or exceed the Certification scoring threshold The practice must submit data for the core measures and five modules required for Certification The required modules are e Care at the End of Life e Symptom Toxicity Management e Breast Cancer e Colorectal Cancer e Non Small Cell Lung Cancer American Society of Clinical Oncology Page3 QOPI Certification Participation Guide Spring 2015 2 1 5 QOPI CERTIFICATION QUALITY SCORING THRESHOLD The QOPI Certification Report provides the practice score on the 26 designated measures and the overall quality score The Overall Quality Score is an aggregate score based on these 26 certification measures within the required modules designated for QOPI Certification Note The practice must meet or exceed a 75 Overall Quality Score 2 1 6 TARGET CHART REQUIREMENTS Practices must follow the QOPI sampling methodology and meet the target chart requirements for their practice size and applicable modules If all charts from all medical oncologist and hematologist oncologists from all office locations were not included in the pool from which charts were sampled an attestation form must be completed when applying for Certification to justify why exclusion does not compromise the validity of the abstraction from an assessment standpoint Specifically the following apply 1
18. ULTATIONS AND CERTIFICATION HELP DES K ASCO provides a variety of resources for QOPI Certification education and information regarding QOPI Certification processes These programs include e QCP Resource Library coming soon American Society of Clinical Oncology Page 27 QOPI Certification Participation Guide Spring 2015 e Monthly webinar presentations e One on One Standards Review via appointment e Standards Interview for review readiness The QOPI Certification Help Desk is available for participants from 9 00 am 5 00 pm EST QCP staff can be contacted by emailing qopicertification asco org calling 571 483 1669 For questions regarding account set up in the QOPI web based application or data abstraction contact the QOPI Help Desk at gopi asco org or 571 483 1660 16 10 CONTACTUS For more information please contact gopic ertific ation asco org For information on QOPI registration participation or measures please contact gopi asco org American Society of Clinical Oncology Page 28 QOPI Certification Participation Guide Spring 2015 APPENDIX A SCORED QOPI MEASURES Table A 1 QOPI Spring 2015 Summary of Measures Pathology report confirming malignancy 1 Core 2 Staging documented within one month of first office visit NQF Endorsed 0386 adapted Core 3 Pain assessed by second office visit NQF Endorsed 0383 384 adapted Core 4a Pain intensity quantified by second office visit includes documentation o
19. UMBERG 0ccceeececeeecae eee eeeeeeeeeeeeeeaeeeeeeeeeeeeecaeeeeaeeeceeeeeeeaeeseaaeeeqags 5 TABLE 16 1 QOPI CERTIFICATION PROGRAM LEVELS OF CERTIFICATION 0ccceccseecesceaeseeseueeees 23 TABLE A 1 QOPI SPRING 2015 SUMMARY OF MEASURES 0scceeceeseeeeeseeceeeaeecaeceaeeeeseneeenees A 1 TABLE A 2 COMMON DEFINITIONS FOR CHEMOTHERAPY ADMINISTRATION SAFETY STANDARDG A 4 TABLE C 1 QCP ON SITE REVIEW ACTIVITIES ccccccccccceeceeceeeeeeeeeeeeeeeeeeceeeeaeeeeseseeeaeeeaesgeeeaees C 1 American Society of Clinical Oncology Pagev QOPI Certification Participation Guide Spring 2015 1 INTRODUCTION The QOPI Certification Program builds upon the success of the American Society of Clinical Oncology s ASCO Quality Oncology Practice Initiative QOPI QOPI Certification is conducted by the QOPI Certification Program QCP a Vrgnia limited lability company wholly owned by ASCO QOPI Certification demonstrates a commitment to excellence and ongoing quality improvement in the hematology oncology outpatient practice The goals of the QOPI Certification program are to e Promote the highest quality cancer care as defined by the clinician experts e Provide a trusted solution to satisfy external demand for quality activities e Reduce multiple assessment and improvement programs or requirements for your practice including health plan programs e Provide a three year designation of QOPI Certification status
20. actices Interview wil be scheduled to determine practice specific implementation of the standards The purpose of the interview is twofold e To verify standard submission to confirm readiness for the QOPI Certification Program On Site Review Process e To provide you an opportunity to speak directly with QOPI Certification Staff regarding your standard submission and on site review readiness 4 3 2 CHART VERIFICATION INTERVIEW New and Re Certifying Practices Interview wil be scheduled to determine practice specific abstraction methods of the required measures for the QOPI Certification Quality Score The purpose of the interview i two fold e To verify chart selection methodology for QOPI participation toconfirm eligibility for the QOPI Certification Program e To provide you an opportunity to speak directly with QOPI Staff regarding your experience with and suggestions for the program American Society of Clinical Oncology Page8 QOPI Certification Participation Guide Spring 2015 5 QOPI CERTIFICATION PENDING STATUS Once a practice has submitted the complete Certification application and initial program materials the practice will be awarded QOPI Certification Pending status Practices are granted Pending Status upon receipt of the supporting documentation standards 1 15 and 18 and randomly selected charts from spring 2015 The practice is labeled as having achieved QOPI Certification Pending indicating they have ach
21. actions such as mergers must be reported to the QCP within thirty 30 business days We do not automatically transfer Certification to new owners or practices that have merged QCP will assist you in determining whether the sites that were QOPI Certified will retain their certified status following the merger pursuant to QCP s policies Failure to notify us of major changes to your organization can result in a loss of certification 16 7 QOPI CERTIFICATION PROGRAM REVOCATION PROCEDURE To continue to ensure that our standards are met the Certification Program has adopted revocation procedures that allow the Certification Programto investigate complaints concerning a Certified Practice Each practice investigated under the Procedures s provided with due process including written notice and opportunity for a hearing The basis for revocation of Certification under these Procedures includes the following American Society of Clinical Oncology Page 26 QOPI Certification Participation Guide Spring 2015 e Final conviction or admission of a crime by a Certified Practice or any member thereof that s related to the delivery of quality oncology care e A final finding or admission of gross negligence or willful misconduct by a Certified Practice or any member thereof that is related to the delivery of quality oncology care e Fraud or misrepresentation by a Certified Practice or any member thereof in the application or maintenance of QOPI Certifi
22. alliative to non curative Core 11 Chemotherapy intent discussion with patient documented SP Number of chemotherapy cycles documented Core Chemotherapy planning completed appropriately defect free measure 9 10 and 12 Core Performance status documented prior to initiating non curative chemotherapy regimen Test Measure Core 13al Chemotherapy administered to patients with metastatic solid tumor with performance status of 3 4 or undocumented Lower Score Better Test Measure Top 5 Core 13a2 PET CT or radionuclide bone scan within 3 months after diagnosis of early stage prostate cancer with low risk of metastases Lower Score Better Test Measure Top 5 Core 13orall Documented plan for oral chemotherapy defect free measure 13oralla 13oralle Test Measure Core 13oralla Documented plan for oral chemotherapy dose Test Measure American Society of Clinical Oncology PageA 2 QOPI Certification Participation Guide Spring 2015 isc oie ee ee ieee Core Core Core Core Core 13orallb 13orallc 13oralld 13oralle Documented plan for oral chemotherapy administration schedule days of treatment rest and planned duration Test Measure Documented plan for oral chemotherapy lab and toxicity monitoring Test Measure Documented plan for oral chemotherapy frequency of office visits contacts Test Measure Documented plan for oral chemotherapy provided to patient prior to st
23. art of therapy Test Measure Oral chemotherapy education provided prior to the start of therapy defect free measure 13oral2a 13oral2g Test Measure Oral chemotherapy education provided prior to the start of therapy safe handling Test Measure Oral chemotherapy education provided prior to the start of therapy indications Test Measure Oral chemotherapy education provided prior to the start of therapy schedule and start date Test Measure Oral chemotherapy education provided prior to the start of therapy missed doses Test Measure Oral chemotherapy education provided prior to the start of therapy food and drug interactions Test Measure Oral chemotherapy education provided prior to the start of therapy side effects and toxicities Test Measure Oral chemotherapy education provided prior to the start of therapy clinic contact instructions Test Measure American Society of Clinical Oncology PageA 3 QOPI Certification Participation Guide Spring 2015 ss err eee erie Core 13o0ral3 Oral chemotherapy monitored on visit contact following start of therapy defect free measure 13oral3a 13o0ral3e Test Measure Core 13oral3a Oral chemotherapy monitored on visit contact following start of therapy start date documented Test Measure Table A 2 Common Definitions for Chemotherapy Administration Safety Standards Che mothe rapy All antineoplastic agents used to treat cancer given through oral and pare
24. atient care areas and a staffmember familiar with the EMR paper chart is needed to assist in locating needed items Review and or discussion of policies and procedures for the 20 QCP standards Review of pharmacy and nursing personnel records licensure orientation traming etc 1 hour 10 15 minutes each Interview of 2 3 nurses who administer chemotherapy Additional interviews of the nurse educator and administrative staff may be requested Interviews will occur ata mutually convenient time in a private area away from the patient care area One nurse is interviewed ata time Interview of personnel who prepare chemotherapy and or dispense oral chemotherapy when applicable 1 hour Reviewer in quiet space alone to review notes 30 minutes to hour Summary and discussion practices may invite whomever they wish to attend e On site review observations e Timeline for follow up American Society of Clinical Oncology Page C 1
25. cation and e Breach by a Certified Practice or any member thereof of the Practice s Participation Agreement including but not limited to failure to adhere to the QOPI Certification Participation Guide QCP s Logo Use Guidelines QCP s License Terms and Conditions QOPI Certification Participation Agreement and other related policies 16 8 APPROPRIATE USE PROTOCOL AND USER ACCESS PROTOCOL In accordance with the Health Information Portability and Accountability Act of 1996 HIPAA and the Health Information Technology for Economic and Clinical Health HITECH Act the American Society for Clinical Oncology ASCO and the QOPI Certification Program have adopted Privacy and Security Policies to ensure the security of Protected Health Information PHI including but not limited to Electronic Protected Health Information EPHI and Paper Protected Health Information PPHI acquired from physician practices who participate in the Quality Oncology Practice Initiative QOPI and the QOPI Certification Program All members of ASCO s workforce including staff are obligated to comply with these Policies Refer to Documentation Guides e Chart Submission Guide e Response Plan and Documentation Submission Guide e Standards Documentation Submission Guide If a practice has any questions regarding these policies and procedures or would like to receive a copy of the written procedures please email gopicertification asco org 16 9 WEBINARS CONS
26. cond re Certification date for the currently Certified practice after the transaction A particular site is not entitled to hold itself as QOPI Certified simply by virtue of its affiliation with a particular practice That site must be included in the Certification assessment of the applicant practice including but not limited to being subject to potential survey QOPI Certification Program staff must be notified of any such transaction within 30 days of its being finalized Transaction is intended to capture significant corporate changes such as sale of a practice merger of one or more practices and or split of a practice into two or more separate entities For questions about your practice network and sites please contact QCP staff at qopicertification asco org American Society of Clinical Oncology Page 14 QOPI Certification Participation Guide Spring 2015 11 MEASURES ASCO oncologist members lead the QOPI Certification Program including developing measures and standards and performance thresholds Other stakeholders including patient advocates non oncologist clinicians private payer representatives and government agencies serve as advisors in their development Al QOPI Certification Measures are pilot tested and used in previous reporting periods as quality improvement measures QOPI Certification Program performance thresholds are based on statistical analyses of performance during preceding reporting periods
27. d Health DHHS publication No 2004 165 2004 Occupational Safety and Health Administration OSHA technical manual 1995 Polovich M et al Pittsburgh PA Oncology Nursing Society 2009 US Phannacopeia Convention Rockville MD 2008 Education training and competency validation for chemotherapy administration must necessarily include this aspect of practice Organizations should focus on a culture of safety because of the relationship between patient and health care worker safety Friese CR et al BMJ Qual Saf 2011 Polovich M Clark PC Oncology Nursing Fomm 2012 American Society of Clinical Oncology PageB 6 QOPI Certification Participation Guide Spring 2015 APPENDIX C QCP ON SITE REVIEW A DAY IN THE LIFE Table C 1 presents proposed time estimates for QCP On Site Review activities Table C 1 QCP On Site Review Activities 20 30 minutes Introductions brief tour of facility overview 1 2 hours depending on the flow of the Review of chemotherapy orders and chemotherapy infusion room and the observation of chemotherapy order checking timing of chemotherapy preparation Observation of chemotherapy preparation and labeling Observation of double check of prepared chemotherapy 2 4 hours Review of chart documentation for two patients receiving IV chemotherapy and two patients receiving oral chemotherapy on site reviewer will select records to review If possible this review should occur in an area away from the pharmacy or p
28. e surveyor how to access them online Many practices find that creating a binder with policies specific to the 20 ASCO ONS safety standards saves time during the review day Please inform practice staff they may be selected for observation and that participation is mandatory to continue with the on site survey process Note We randomly choose the patients to follow It is part of our process to ask the patient s permission first If the practice does not provide infusion services on site please contact the QOPI Certification Helpdesk before applying Because the potential for bias in such situations is real and significant practice staff refusal to participate in the on site survey process is grounds for certification failure 14 4 EXIT SUMMARY OF FINDINGS The Surveyor will provide the practice with a prelimmary overview of the findings for each of the 20 ASCO ONS Safety Standards A brief review of each standard with observations and findings will be conducted The exit summary provides the practice with an opportunity to clarify the American Society of Clinical Oncology Page21 QOPI Certification Participation Guide Spring 2015 standards and the surveyor s observations at the practice s discretion invite team members y including those who may benefit from the discussion of the findings The exit summary takes approximately 30 45 minutes 14 5 THE ON SITESURVEY REPORT AND RES PONSE TIMELINE The On Site Survey
29. ed using full generic name s and follow Jomt Commission standards regarding abbreviations Brand nanes should be included in orders only where there are multiple products or when including the brand nane otherwise assists in identif ying a unique drug formulation 5 Complete orde rs must include Patient s full name and a second patient identifier e g medical record number DOB Date Dagnoss Regimen name and cyck number Protocol name and number f applcabk Approprate critera to treat e g based on reevant laboratory results and toxicites Allergies Reference to the methodology of the dose cakuhtion or standard practice equations e g QmM OO gt American Society of Clinical Oncology PageB 2 QOPI Certification Participation Guide Spring 2015 calculation of creatinine clearance 20 ASE a Z Height weight and any other varabks used to cakuhte the dose Dosage Doses do not include trailing zeros use a kading zero for doses lt 1 mg Route and rate f applicable of administration Length of nfusion if applcabk Supportive care treatments appropriate for the regimen ncudng pre medtations hydration growth factors and hypersenstiviy medications Sequence of drug admmnstration if applcabk Practices institutions are not expected to be in full compliance with this standard if they currently have electronic ordering systems that prevent compliance Appropriate changes should be implemented
30. emented as soon as possible to ensure that electronic labels integrate all of these elements American Society of Clinical Oncology PageB 3 QOPI Certification Participation Guide Spring 2015 8 Practice s institutions that administer intrathecal medication maintain policies specifying that intrathecal medication will A Not be prepared during preparation of any other agents B Be stored once prepared in an sohted contamer or bcation wih aunquely dentifabe intrathecal mediation hbel C Bedelvered to the patent only wth other medication intended for admnstration into the CNS Chemotherapy Administration 9 Before chemotherapy administration A A practitioner who is admmistering the chemotherapy confirms with the patient his her panned treatment prior to eachcyck B At East two practitioners or personnel approved by the practice mnstitution to prepare or administer chemotherapy verify the accuracy of 1 Drug name 2 Drug dose 3 Drug volume 4 Rate of administration 5 Route of administration 6 Expiration dates times if applicable expiration date time is not required if for immediate use Inmediate use must be defined by institutional policy state and federal regulations e g use within 2 hours 7 Appearance and physical mtegrity of the drugs 8 Rate set on infusion pump when utilized C A practitioner who is administering the chemotherapy documents that the verification in B was done D At Fast two individua
31. f no pain NQF Endorsed 0384 adapted Core 5 Plan of care for moderate severe pain documented NQF Endorsed 0383 0384 adapted Core Pain addressed appropriately defect free measure 3 4a and 5 NQF Endorsed 0383 adapted Pain intensity quantified on either of the two most recent office visits NQF Endorsed 0383 0384 adapted Plan of care for moderate severe pain documented on either of the two most recent office visits NQF Endorsed 0383 0384 adapted NQF Endorsed 0383 0384 adapted Pain addressed appropriately by second office visit and during most recent office visits defect free measure 6 and 6d NQF Endorsed 0383 0384 adapted Core Pain assessed on either of the two most recent office visits NQF Endorsed 0383 0384 adapted Pain addressed appropriately on either of the two most recent office visits defect free measure 6a 6b and 6c American Society of Clinical Oncology PageA 1 QOPI Certification Participation Guide Spring 2015 i eee ee ecciae Core 7 Effectiveness of narcotic assessed on visit following prescription Core Constipation assessed at time of narcotic prescription or following visit Core Documented plan for chemotherapy including doses route and time intervals Core 10 Chemotherapy intent curative vs non curative Add timing within documented before or within two weeks after 60 days prior or two administration weeks after to intent question and changed p
32. ginal QCP Committee member for final review and approval within 10 business days When the practice submits the required documentation the QCP staff will review and summarize the information If there is additional information needed the QCP staff emails or calls the practice with further instructions regarding document submission Once all documents have been submitted the summary of the final documents are sent to the original QCP Committee member for final review and approval within 10 business days American Society of Clinical Oncology Page 22 QOPI Certification Participation Guide Spring 2015 e When the QCP Committee member approves the document submission certification is awarded and the practice notified within 5 business days of having attained QOPI Certification Table 14 1 QOPI Certification Program Levels of Certification QOPI CERTIFICATION PROGRAM LEVELS OF CERTIFICATION AND TERMS QOPI Certification Applied for QCP and Until QOPI Certification is Pending submitted initial awarded or expires within 12 14 documentation months if QOPI Certification is not achieved QOPI Certification 1 Met or exceeded QOPI For three years or until renewal Certification Measure scoring as long as Certification requirements in one or more maintenance requirements are QOPI rounds met 2 Met QOPI Site Assessment safety standards 3 Participated in QOPI abstraction at least once per year during three year
33. have a process to track cumulative doses of chemotherapy agent s associate d with a risk of cumulative toxicity The practice institution maintain a plan for ongoing and regime n specific assessment of e ach patient s oral chemotherapy adhere nce and toxicity The policy includes at minimum patient assessment for adherence and toxicity at each clinical encounter at the practice mstitution as well as a plan for clinical staff to address s any issue s identified Patient Consent and Education American Society of Clinical Oncology PageB 5 QOPI Certification Participation Guide Spring 2015 20 Before initiation of a chemotherapy regime n each patient is give n written and or electronic information including at mmimum Information regarding his her diagnosis Goak of therapy Planned duration of chemotherapy drugs and scheduk Information on possbe short and long term adverse effects including wmnfertilty risks Regimen or drug specific risks or symptoms that requre notification and emergency contact information including 1 How to contact the practice or organization 2 Symptoms that should trigger a call 3 Who should be caled in specific circumstances onc ologst or other provider F Phn for montormg andfolow up mcluuding appomtments with the practitioners or laboratory testing Patient education materials should be appropriate for the patient s reading levelNiteracy and patient caregiver understand ing Documentati
34. hich must be addressed before Certification can be awarded New Practices have up to one year from their Certification Pending date to meet all requirements for Certification Note Recertifying Practices have up until one month before their term ends to meet all requirements American Society of Clinical Oncology Page9 QOPI Certification Participation Guide Spring 2015 6 REPEAT PRACTICE SITE SURVEY Following review of a practice s QOPI Certification Application and completion of the on site survey the QOPI Certification Program QCP may in its sole discretion determine that an additional on site survey 8 necessary to evaluate the applicant practice s qualification for QOPI Certification QCP may require an additional on site survey f there is discord between the practice s reported adherence to one or more policies and procedures relating to QCP standards and the Certification Surveyors observations during the initial on site survey or if QCP otherwise determines that further personal observation is needed to assess the practice s qualifications for Certification e Certification Surveyors and Committee Reviewers determine is a second review is necessary e QCP Staff will contact the practice to review the on site survey report and identified requirements within four weeks e QCP Staff will determine the date of the new review and timelines for responses due prior to the on site review e A new surveyor will be assigned
35. ieved the threshold quality score and are actively pursuing certification New Practices have one year from the designation of Certification Pending status to meet all requirements for Certification 5 1 QOPI RE CERTIFICATION AND PENDING STATUS Recertifying practices have up until their current term to achieve QOPI Re Certification The Recertification Pending Status is an internal marker indicating that the recertifying practice has achieved the threshold quality score submitted a completed application and is actively pursuing re certification While new practices have one year from the designation of Certification Pending status to meet all requirements for Certification Re certifymg Practices must participate in the process early enough to achieve Re Certification by the end of the current three year certification Extensions on certification terms cannot exceed three months and the practice must demonstrate hardship to QCP s satisfaction When a practice is granted re certification it extends the current Certification date an additional three years 5 2 QCPON SITESURVEY e The practice on site survey s scheduled when Pending Status has been achieved All practices Re Certifying and New must participate in an on site survey Surveys are scheduled two to eight weeks from pending depending on surveyor availability and practice readiness e Upon completion of the scheduled survey the practice receives a report detailing any requirements w
36. ification status Recertifymg Practices will maintain their original certification date and a subsequent three year term then added to the original date American Society of Clinical Oncology Page 12 QOPI Certification Participation Guide Spring 2015 9 MAINTAINING CERTIFICATION STATUS To maintain QOPI Certification status all QOPI Certified Practices must participate in QOPI chart abstraction by submitting data for at least all core measures plus one module of their choice once per year based on the Certification date For example f a practice s certified in April 2015 it must participate n QOPI to maintain a certified status n fall 2015 or spring 2016 If the practice does not participate in QOPI chart abstraction once per year they will receive a warning notice After one warning notice has been sent the practice must participate in the next QOPI chart abstraction process or the practice will lose their Certification status There is no need to register or apply for maintenance the QOPI Certification team tracks participation Additionally there i no scoring requirement for maintenance rounds While the requirement s only one module practices are encouraged to abstract modules that enhance their quality initiatives and to try modules that are not specific to the certification modules Recertifying Practices are encouraged to apply 9 12 months prior to their current term end date Figure 1 QOPI Certificat
37. ion Applicant Timeline American Society of Clinical Oncology Page 13 QOPI Certification Participation Guide Spring 2015 10 PRACTICE TRANSACTIONS The QOPI Certification Program i for outpatient hematology oncology or medical oncology adult practices For purposes of the QOPI Certification Program a practice 8 a group of oncologists that share a common business address and tax identification number or key features such as unified policies and procedures that are implemented consistently across the practice QOPI Certification i practice specific and non transferable In the event a practice undergoes a re organization or other significant transaction QCP will have the discretion to determine whether one or more of the post transaction entities may continue to be entitled to QOPI Certification Pending or QOPI Certification status Practices have the option of bringing the newly acquired site or affiliate into certification by participating in the entire application process prior to the end of the three year term for Certified sites or Practices can opt to have that practice site designated as non certified and when applying for re certification incorporating that practiced site into the data abstraction and application process Note QCP requires that sites coming into Certification separately and the existing Certified sites must apply for Certification as a whole ata later date and that this must occur no later than the se
38. k in the presence of patient verify the patient dentification using at kast two dentifers e g medical record number DOB 10 Extravasation management procedure s are define d and align with current literature and guide lines A Antidote order sets and B Antidotes are accessbk Monitoring and Assessment 11 The practice institution maintains protocols for responses to life threatening eemergencies including eescalation of patient support be yond basic life support It is recommended that emergency protocols are reviewed annually 12 On each clinical visit or day of treatment during Chemotherapy administration staff A Assessand document clinical status and or performance status B Document vital signs and weight C Verify alerges previous reactions and treatment rehted toxicities American Society of Clinical Oncology Page B 4 QOPI Certification Participation Guide Spring 2015 13 14 15 16 17 18 19 D Assess and document psychosocial concerns and need for support taking action when ndr ated This standard applies to all clinical encounters including each inpatient day practitioner visits and chemotherapy administration visits but notlaboratory or administrative visits For the purpose of Certification section C k known allergies and section D psychosocial assessment do notneed to be assessed more than once per week I e during multi day treatments At each clinical eenco
39. logy Page6 QOPI Certification Participation Guide Spring 2015 awarded Recertification Recertifying practices are encouraged to participate in QOPI data abstraction prior to applying to avoid a lapse in certification if they do not meet the scoring requirement Recertifying Practices should apply and submit payment early nn the application round in order to meet all recertification deadlines American Society of Clinical Oncology Page7 QOPI Certification Participation Guide Spring 2015 4 SUBMITTING DOCUMENTATION This section describes the process and procedures to follow when submitting supporting documentation for QOPI Certification 4 1 STANDARDS Practice submits supporting documentation for three selected Certification program standards Practices can refer to the Standards Documentation Submission Manual QCP Staff will provide the selected standards and guidance on the types of documentation required to support compliance with the standards 4 2 CHART MEASURES VALIDATION e Practice submits supporting documentation for three Charts from spring 2015 QOPI Practices can refer to the Chart Documentation Submission Manual e Charts are randomly selected by QCP staff from the charts submitted for QOPI data abstraction Staff will use the selected practice ID to identify the charts QOPI Certification Staff will evaluate submitted materials 4 3 REQUIRED INTERVIEWS 4 3 1 STANDARDS COMPLIANCE INTERVIEW New and Re Certifying Pr
40. n which includes the following steps 1 Review the QOPI Certification report and confirm that the QOPI Certification scoring requirements were met 2 Confirm that they participated in QOPI data abstraction with the same sites that will be included on the QOPI Certification application Sign the QOPI Certification Practice Agreement 4 Completes practice specific demographic information Submits the QOPI Certification Site Assessment Questionnaire online attesting that they comply with 20 certification program standards which are based on the ASCO ONS Safe Administration of Chemotherapy Standards Please see QOPI Certification Site Assessment section for additional details about the questionnaire 6 Submit payment based on practice size online wires payment or mails a check The payment must be postmarked one week after the completion of the application and questionnaire 3 2 ALTERNATE RE CERTIFYING PRACTICE APPLICATION PATHWAY Recertifying Practices should participate at least nine months prior to certification expiration Practices that have not completed QOPI data abstraction and risk expiration before the next QOPI round may in some circumstances be allowed to apply complete the QOPI Certification Steps 3 through 6 above and proceed through the on site review process after which they will participate in QOPI data abstraction as required to obtain the threshold quality score before being American Society of Clinical Onco
41. nd completion of the on site survey the QOPI Certification Program QCP may in its sole discretion determine that an additional on site survey is necessary to evaluate the applicant practice s qualification for QOPI Certification QCP may in accordance with the procedures set forth in this policy require an additional on site survey if there is discordance between the practice s reported adherence to one or more policies and procedures relating to QCP standards and the Certification Surveyor s observations during the initial on site survey or if QCP otherwise determines that further personal observation is needed to assess the practice s qualifications for Certification e QCP staff shall notify the applicant practice that a repeated survey is required within eight 8 weeks of completion of the survey report for the prior survey e QCP will appoint a different Certification Surveyor to perform the repeated survey consistent with the procedures in the Conflict of Interest Policy Implementation for QOPI Certification Waiver Appeals and Revocation e The practice shall bear the cost of repeated survey 16 3 QOPI CERTIFICATION APPEALS PROCESS Practices that apply for but do not achieve QOPI Certification may appeal the decision to deny Certification in accordance with the terms of the QOPI Certification Appeals Process American Society of Clinical Oncology Page25 QOPI Certification Participation Guide Spring 2015 16 4 CON
42. ng chemotherapy admmnstration in the health care settng Certification should be froma nationally accredited course Clinical staff includes staff involved in patient care RNs MDs NPs etc Chemotherapy Planning Chart Documentation Standards 2 Before the first administration of a newchemotherapy regime n chart documentation available to the practice institution includes A B Ke Pathologic confirmation or verification of initial diagnosis If original pathology report is unobtainable note of explanation is in chart or a reference to primary source pathology This standard does not imply the need to re biopsy if notclinically necessary Intal cancerstage or current cancer status Cancer stage is defined at diagnosi Cancer status includes a current description of the patient s disease since dia gnosis staging if relevant e g recurrence metastases Compkte medical history and physical exammation thatincludes at mnimum height weight pregnancy screenng when applcabk andassessment of organ American Society of Clinical Oncology PageB 1 QOPI Certification Participation Guide Spring 2015 specific function asapproprute for the panned regimen Example of assessment of organ specific functionas appropriate forthe planned regimen patient plan for cisplatin requires pretreatment assessment of kidney function Presence or absence of alerges and history of other hypersensitivity reactions Documentation of paten
43. nteral routes or other routes as specified in the standard Types mclude targeted agents alkylating agents antimetabolites plant alkaloids and terpenods topoisomerase mbhiitors antitumor antibiotics monoclonal antibodes and bobgics and related agents Hormonal therapies are not included in the defintion of chemotherapy for the standards One or more chemotherapeutic agents used alone or n combmation in a welldefined protocol generally administered cyclically Practitioner Licensed independent practitioner including physicians advanced practice nurses nurse practitioner or clinical nei nurse specialist and or physician assistants as determined by state law All chemotherapy treatment settings inpatient and outpatient Adhe re nce The degree or extent of conformity to the provider s recommendations about day to day treatment with respect to timing dosing and frequency Clinical encounter Clinical encounters include eachinpatient day practitioner vists and chemotherapy administration vits but not laboratory or administrative vists American Society of Clinical Oncology PageA 4 QOPI Certification Participation Guide Spring 2015 APPENDIX B QOPI 2015 CERTIFICATION STANDARDS 1 20 Staffing Related Standards 1 The practice institution has policies s procedure s and or guideline s for verification of training and continuing education for clinical staff A E F G Orders for parenteral and oral
44. ology Page 16 QOPI Certification Participation Guide Spring 2015 Certification designated measures The reportis released during collection to allow practices time to investigate potential abstraction errors and make corrections prior to the close of the round Once the round closes the database s locked and changes cannot be made Itis important to review data as it is entered throughout the collection period 11 5 FINAL CERTIFICATION REPORT This report s available after the close of the collection round and shows the practice office s depending on sampling approach performance on the 26 Certification designated measures The final report indicates if the scoring requirements have been met If the overall quality score has been met the target number of charts per module abstracted or alleligible charts f targets cannot be met the minimum unique chart requirement was met the QOPI sampling approach followed then the practice may be eligible apply for Certification 11 6 RE CERTIFYING PRACTICES ONE TIME PASS ON CERTIFICATION SCORING If the re certifying practice s performance on the 26 Certification designated measures does not meet scoring requirements on the initial try the practice is allowed to participate in the next round following the same process as outlined above If the final report indicates that scoring requirements have been met on this subsequent round and all other requirements have been met the practice will not l
45. on should include patient f feedback reflecting understanding and engagement ee Note Informed consent for chemotherapy must be document ed prior to initiation of a chemotherapy regimen The consent process should follow appropriate professional and legal guidelines For more information and sample forms see http www asco org conse nt All standards are from Neuss MN Jacobson JO Polovch M Pobvich M et ak 2013 Updated American Sockty of Clinical Oncobgy Oncology Nursing Society Chemotherapy Administration Safety Standards Including Standards for the Safe Administration and Management of Oral Chemotherapy J Oncol Pract 2013 95s 13s The current version of these consensus standards reflects modifications that are intended to extend the standards to address the safe use of oral chemotherapeutic agents The American Society of Clinical Oncology Oncology Nursing Society ASCO ONS standards are intended to reflect current thinking on best practices and as such are intended to be a living document future modifications are expected Although the ASCO ONS standards were not developed to address this issue ASCO and ONS endorse the safe handling of chemotherapy agents Published guidelines define the expectations for organizations and health care workers related to the use of safe handling precautions American Society of Health System Phamacists Am J Health Syst Pham 63 1172 1193 2006 National Institute for Occupational Safety an
46. ose its certification status If the overall quality score i not met on both collection rounds then the practice loses its certification status and is allowed to apply after a subsequent score again shows eligibility American Society of Clinical Oncology Page17 QOPI Certification Participation Guide Spring 2015 12 SITE SELF ASSESSMENT QUESTIONNAIRE The QOPI Certification Program includes an assessment of a practices concordance with 20 program standards based on the ASCO ONS Chemotherapy Safety Standards QCP s Site Assessment includes an evaluation of the responses and information submitted by the practice A practice must pass the QOPI Site Assessment to achieve QOPI Certification Practices are asked to attest to their compliance with the 20 selected standards using the structured online QOPI Certification Site Assessment Questionnaire Although there is the option of selecting No on the Site Assessment Questionnaire a practice must be able to answer in the affirmative to all 20 standards within the timeframe specified for achieving Certification one year from the date of Certification Pending status If you check No be certain that the practice will be able to provide proof of compliance for this standard within the specified time frame American Society of Clinical Oncology Page18 QOPI Certification Participation Guide Spring 2015 13 DETERMINING SURVEY SITES AND ADDITIONAL FEES All practices receive an on
47. sessececeeeeeeeeeeeeeeeee 6 3 2 Alternate Re Certifying Practice Application Pathway eee 6 4 SUBMITTING DOCUMENTATION sssscsssssssssssssssssssscesssssessssssssesssseess 8 Al Standards eccriene a eho he cc E E ayo tices 8 4 2 Chart Measures Validation cccccccccsseecceeesceeceseeeceeeesececuaeeeeeeecessuees 8 4 3 R quited INErvVieWS iasssiesoianasianasoiasiarisaiaisasgaiisis ei aeaieie 8 4 3 1 Standards Compliance Interview eeeeseeeeeeeeereeeresrsssesrrererrrrrrres 8 4 3 2 Chart Verification Interview v2 22 22czeazeczsaceazsazscceccencpncsnacecpncsneescuaedects 8 5 QOPI CERTIFICATION PENDING STATUS sesssssesssssssoeossssssosessssssoosesse 9 5 1 QOPI Re Certification and Pending Status s 2ccczccecrzezessactaacaccepzeewietennnigyeass 9 35 2 QCP On Site SU VEY aaora enaa i a aaaea 9 6 REPEAT PRACTICE SITE SURVEY scsccsssssssssssesssssssssssssessssssessoeees 10 6 1 Cost of Repeated On Site Survey s eeeeeseesesessssssrererererertrsessrssssrereerereee 10 7 FINAL REVIEW a sasstssisecteescosescstceasaenessinnssaciucsacetesacesisecsuet acces tasttseasitscesecodass 11 8 QOPI CERTIFICATION AWARD cssccsssssssssscccssssseccsssssssssssessenees 12 Bel Cettifi ation Verne ciiise sheaves eia nE aAa ESETE 12 9 MAINTAINING CERTIFICATION STATUS sccscsssssseescssscssseeeessees 13 10 PRACTICE TRANSACTIONS ivisscasccsscteatsosssssaiactsosvsssasvodsrsnsisstnesistsainoterassies 14 11 ME
48. t s comprehension regarding chemotherapy regimens and associated medications including information regarding disease H Assessment regarding psychosocial concerns and need for support with action taken when indicated Documentation of psychosocial concerns may include copy of distress depression or anxiety screening formin the chart patient self report of distress depression or QT anxiety or chartdocumentation regarding patientcoping adjustment depression distress anxiety emotional status family supportand care giving coping style cultural back ground and socioeconomic status I The chemotherapy treatment phn nclding atmnimum chemotherapy drugs doses anticipated duration and goak of therapy J For oral chemotherapy the frequency of office vsits and monitoring that is approprute for the ndwidual and the antneophstc agent and is defned n the treatment phn General Chemotherapy Practice Standards 3 The practice institution maintain a policy for how informed consent is obtained d and documented for chemotherapy The practice institution may provide options for consent e g use of chart documentation of patient consentor a signed patient consentform that allow for variation among practitioners in the practice nstitution Chemotherapy Order Standards 4 Order forms inclusively list all chemotherapy agents in the regime n and their individual dosing parameters All medications within the order set are list
49. t site must be included in the Certification assessment of the applicant s practice including but not limited to being subject to potential survey Only practice sites that are subject to the full QOPI Certification review process may be deemed as being QOPI Certified 2 1 2 LARGE MULTI SITEPRACTICES A large multi site practice may submit a single Certification application where each site of the practice 8 located within a geographic distance of 250 road miles from at least one other site of the practice as measured by the shortest route between such sites For practices that have one or more sites located more than 250 road miles from the next closest site as measured by the shortest route between such sites QCP may divide the practice into regions The practice should consult QCP regarding the appropriate manner of applying for Certification but QCP retains sole discretion to establish the geographic regions 2 1 3 PRACTICESTHAT DO NOTPROVIDE INFUSIONSER VICES A practice that does not administer chemotherapy on site or refers a majority of their patients to unaffiliated infusion centers may come into Certification by demonstrating a sufficient relationship with one or more unaffiliated infusion center s to which t generally refers its patients Practices which do not provide infusion services should contact the QOPI Certification helpdesk to determine their eligibility 2 1 4 PARTICIPATIONIN QOPI CHART DATA ABSTRACTION
50. ted for Certification applicable to the practice s patient population refer to the QOPI User Manual in the QOPI System QOPI Certification designated measures are Clearly noted for each module QOPI measures marked as quality improvement measures are reported to participating practices but not included in QOPI Certification scoring calculations American Society of Clinical Oncology Page15 QOPI Certification Participation Guide Spring 2015 11 2 SAMPLING REQUIREMENTS FOR QOPI CERTIFICATION Certification designated measures are included n the QOPI Core Sympton Toxicity management End of life Breast cancer Colon rectal cancer and Non Small Cell Lung cancer modules Refer to the QOPI User Manual in the QOPI System All modules that are applicable to the practice s patient population must be selected and completed for that practice to be eligible for Certification For example f a practice treats breast cancer patients only the breast cancer sympton toxicity management and care at End of life modules are required Practice selection of appropriate modules and sampling will be verified upon application to the QOPI Certification Program Deviation from this methodology s grounds for denying the initial designation of QOPI Certification Pending The QOPI sample sizes per module are described in detail below and in Figure 1 in the QOPI User Manual Smaller practices which are notable to meet the chart requirements should contact
51. tion purposes the defining feature of a practice is the use of the same policies and procedures across alloffice sites Certification of a practice is only meaningful if standards apply to all sites Loosely affiliated organizations with multiple office sites that do not operate under the same policies and procedures at all office sites will be required to come into Certification separately To become QOPI Certified as a practice an applicant must demonstrate to QCP s satisfaction that all of its office sites are functionally integrated Staffs that rotate across all sites identifying a centralized person or entity as being in charge of implementing policies quality across all sites and the use of a common EMR and operation under a single tax ID number are all indicators of functional integration Oncologists or oncology groups that have unique practice arrangements but would like to apply for Certification should contact QCP staff to discuss Certification participation Only practice sites that provide hematology oncology or medical oncology care are eligible to apply for QOPI Certification 2 1 1 DESIGNATION OF QOPI CERTIFICATION Designation of QOPI Certification Applies Only to Participating Practice Sites A site is not allowed to present itself as QOPI Certified because of its affiliation with other QOPI Certified American Society of Clinical Oncology Page2 QOPI Certification Participation Guide Spring 2015 entities Tha
52. ubject to additional on site survey visits requiring additional fees if the specialty practice extends beyond general medical oncology infusions such as intraperitoneal or intra thoracic In addition QCP reserves the right to assess additional fees to cover any unexpected and significant costs associated with conducting on site surveys Refer to the Cost section for Certification on the QCP Website or consult with the QCP staff at qopicertification asco org American Society of Clinical Oncology Page 19 QOPI Certification Participation Guide Spring 2015 14 CONFLICT OF INTEREST SCREENS QCP will assign a primary committee reviewer and two alternates to review the certification application and responses to requirements before awarding certification QCP staff will assign an on site surveyor who will visit your practice The on site survey s will be conducted by a certified oncology nurse You wil receive an email informing you of the revewer s name and the onsite surveyor s name and will be asked to notify the Certification Program within five 5 business days by email to confirm that you do do not consider this surveyor or reviewer to have a disqualifying relationship with your practice The disqualifying relatonship criteria may be defined as 1 A substantial personal or professional relationship with the practice e g self or immediate family member employed by the practice 2 An appreciable financial interest in the
53. ugh American Society of Clinical Oncology Page 20 QOPI Certification Participation Guide Spring 2015 e Review of Medical Record documentation e Review of policies procedures and guidelines e Observation of Chemotherapy Preparation e Observation of Chemotherapy Administration e Interview two three RN s and an Administrator Educator 14 3 PRACTICE PREPARATION FOR THE ON SITESURVEY 1 Ensure that someone who is familiar with the practice s EHR system if applicable will be available to spend approximately 1 4 hours with the surveyor on the day of the site visit to review records and find standards elements within medical records Surveyors are not allowed to access EHR system without staff present 2 If chemotherapy is prepared mixed by an off site pharmacy or at another location please let the reviewer know during the scheduling process The practice will need to make arrangements for the surveyor to observe chemotherapy being prepared 3 Ensure the availability of a conference room or quiet area for the day to allow the surveyor to review patient records and other associated documents 4 Provide the surveyor with access to the practice s policy procedure manual for each site if there is only one site then provide one policy binder The policies that correspond to the 20 ASCO ONS safety standards must be readily accessible to the on site surveyor if the policies are only available online have someone available to show th
54. unterr staff re vie w the patient s current me dictations including overr the counterr medications and complementary and alternative therapies s Any change in the patient s medications prompts are view for drug drug interactions This standard applies to allclinical encounters including each inpatient day practitioner visit and chemotherapy administration visits but notlaboratory or administrative visits For the purpose of Certification standard 12 does not need to be assessed more than once per week ie durng mulkiday treatments The practice institution maintain referral resource s for psychosocial and other supportive care Services The practice institution eestablishes a procedure for documentation and follow up for patients who miss office visits and or scheduled chemotherapy treatments The practice institution has policies and procedures that identify A A process to provide 24 7 trag to a practitioner e g on call practitioner emergency department for care of toxicities B If an oncobgy LIP does not provide intial trage a mechanism to provide oncobgy consultation must be available 24 7 C This should include a policy to define how to transfer a patient to a center with oncology expertise if needed Practices in rurallow population areas should consult with QCP staff in unable to comply with the standard Toxicity assessment documentation is available for planning subsequent treatment cycles The practice institution
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