Quality Management Program

Transcription

1 Quality Management Prgram Barbara Parsns, MA MT (ASCP) Patricia Wachter, MA CT/HT (ASCP) Date Adpted 8/12/2009 Signature Dr. J. Brks Jacksn (signature n file) Review Date Revisin Date Signature

2 Objective/Purpse The gal f the Quality Management Prgram (QMP) is t establish leadership structure thrughut the path f quality wrkflw that enables Jhns Hpkins Hspital t prvide high quality labratry services. Jhns Hpkins QMP is designed t prmte quality and patient safety thrugh risk reductin and cntinuus prcess imprvement. This includes develpment f a prgram that prvides fr the cntinuus mnitring and evaluatin f patient care activities within the in cllabratin with Jhns Hpkins Medicine fr the purpse f imprving utcmes. Labratry perfrmance is evaluated in pursuit f these gals. The Quality Management Prgram is designed t cmmunicate the detail and relatinship f the s Quality Initiatives as they relate t the larger institutin. Quality management is the cntinuing prcess whereby the labratry ensures quality, maintains cmpliance with applicable laws, regulatins and institutinal plicies, and purses quality imprvement activities. This QMP prvides fr cntinuus crss-functinal and departmental mnitring and evaluatin f patient care activities within the Jhns Hpkins and Jhns Hpkins Medicine. Mnitring includes pre-analytic, analytic, and pst analytic prcesses. The fcuses n quality and patient safety. Each labratry/divisin is respnsible fr scheduling and hlding infrmatinal meetings in rder t review quality imprvement initiatives, patient safety activities, dcumentatin quality and ther clinical matters f the lab area. Cmmittee invlvement in hspital wide quality cmmittees, as specified in the hspital Medical Staff Bylaws, demnstrates integratin and cllabratin f labratry and hspital thrugh the labratry quality management structure. Selected members f the participate in cmmittees as either permanent r ad hc members. Other selected members f the department wrk with clinical departments t slve prblems, imprve systems, r fulfill specific strategic initiatives. Key cmmittees within The include the Labratry Advisry, Perfrmance Imprvement, Pathlgy Administrative Team, Cmpliance, Credentials, Educatin Advisry, Pathlgy Data Systems Steering, Human Resurces and Outreach Testing Cmmittees. The fllwing sectins utline the framewrk frm which the perates. SECTION I Labratry Persnnel and Hierarchy/Structure The Labratry Directr in Chief, Deputy Directrs, Divisin Directrs and Administratrs/Managers, versee the management f quality and patient safety within the. The clinical labratries/divisins are rganized int 7 administrative grups, each managed by an Administratr r Manager wh reprts t his/her Lab Directrs/Administratrs. Each divisin is lead by a Labratry Directr designee fr that discipline. The duties are delineated by the Labratry Directr in Chief. 2

3 Chief f Service/The Labratry Directr in Chief is respnsible fr the verall peratin and administratin f the, including emplyment f persnnel wh are cmpetent t perfrm test prcedures, recrd and reprt test results prmptly, accurately, and prficiently, and fr ensuring cmpliance with the applicable regulatins. He/she directs the implementatin f a safe labratry envirnment in cmpliance with gd labratry practice and applicable regulatins. The Labratry Directr in Chief, appinted by the Medical Bard, is invlved in the design, implementatin and versight f the Quality Management System (QMS) and the Quality Management Prgram (QMP). Jhns Hpkins Directr in Chief annually reviews the QMS and the QMP. The Labratry Directr in Chief reprts prgress and summaries f Safety, Quality Imprvement and Cmpliance Strategies in the Annual Planning Meeting t Jhns Hpkins Medicine Senir Management. (See Appendix A fr Directr duties) The Labratry Directr in Chief delegates respnsibility t Deputy Directrs, Lab Directrs and Lab Managers fr the peratin and administratin f their Clinical and Anatmic Labratries. The Labratry Directr in Chief is ultimately respnsible fr verseeing the design and implementatin f quality imprvement activities within the that are bth intra and interdepartmental in apprach. He/she is additinally respnsible fr the quality f the in vitr labratry and pathlgy testing perfrmed fr patient care in the Hspital. The Labratry Directr in Chief may delegate the perfrmance f such activities t the Physician Advisr and will ensure these respnsibilities are met. The Labratry Directr in Chief delegates respnsibility fr crdinating risk management and perfrmance imprvement activities t the Physician Advisr. The Physician Advisr is a qualified prfessinal with apprpriate clinical training and experience whse respnsibilities include the implementatin, crdinatin and maintenance f the quality imprvement (QI) prgram within the department. He/she versees the design and implementatin f quality imprvement and patient safety activities and ensures integratin f QI activities with ther hspital departments. The Physician Advisr represents the at Clinical Quality Imprvement Cmmittee meetings and reviews perfrmance measurements, reprts f ccurrence, and ther identified indicatrs t determine if a quality r patient safety issue requires further peer review. As set frth in the Medical Staff Bylaws the duties f the Physician Advisr are: Chair Departmental Quality Imprvement Cmmittee Serve n the Department Credentials Cmmittee Serve n the Hspital Clinical Quality Imprvement Cmmittee Crdinate patient safety and quality imprvement activities including, as apprpriate, quality assurance/quality imprvement, medical staff mnitring functins, credentialing, medical recrd dcumentatin, drug usage evaluatin, infectin cntrl, surgical and invasive prcedures reviews, bld usage evaluatin, utilizatin reviews and utilizatin f critical pathways. Manage department risk management activities Mnitr department cmpliance with regulatry requirements Regularly reprt t Labratry Directr in Chief cncerning activities and issues pertaining t areas f respnsibility as utlined abve 3

4 Identify a designee t serve during absences Other respnsibilities as defined by the Labratry Directr in Chief Labratry Directr Designees are qualified prfessinals with apprpriate clinical training and experience and are respnsible fr the clinical and technical directin f patient care prvided by their labratry discipline. The qualified designees apprve and r review discipline specific Quality Plans (QP) develped by the Labratry Managers, Labratry Supervisrs, Quality Assurance Technlgist and r Lead Technlgists. Quality mnitrs are als reviewed and apprved n an annual basis in cnjunctin with the Supervisrs, Quality Assurance Technlgists and r Lead Technlgist. Quality mnitrs may be develped as needed if an issue is discvered r reprted. Labratry Directr Designees reprt t hspital and r department cmmittees as required r necessary. Other duties include: Apprve/review the quality assurance prgram in their labratry divisin. Define the labratry s perfrmance criteria fr quality cntrl, prficiency testing and reprting f results Apprve plicies and prcedures n a regular basis Oversee assay develpment and evaluatin, equipment selectin, referral f testing Ensure regulatry cmpliance, technical educatin and cmpetency f labratry staff Dcument review f prficiency testing by signing attestatin statements and survey results Prvide educatin prgrams, planning, research and develpment apprpriate t the needs f the labratry Department Administratrs / Labratry Managers f each area are qualified prfessinals with apprpriate educatin and experience; in cnjunctin with the Labratry Directr in Chief, Lab Directrs and Administratrs, they are respnsible fr the administrative and technical directin f labratry services prvided by their labratry r labratries. The administratrs and r managers ensure the develpment f an apprpriate quality assurance plan and assist in the selectin f QI mnitrs. They determine hw quality and safety infrmatin is cmmunicated t the staff and encurage staff t reprt quality and safety cncerns. Their shared respnsibilities include: Budgetary and financial management Quality assurance, risk management and safety Prgram develpment and business planning Staff cmpetencies, educatin and training Materials and equipment management Facility design and maintenance Supervisr, QA Technlgist r Technical Specialist, in cnjunctin with Labratry Directrs and Labratry Managers define the QI mnitrs fr the year and prepare and review the QA mnitring reprts and/r annual quality summaries. They cllect data, reprt department measures t the 4

5 Pathlgy PIC, prepare any ther summaries required by the department and participate in interdepartmental perfrmance imprvement activities, as needed. Additinally, they perfrm the fllwing duties: Review mnthly quality cntrl (QC) dcuments, and dcumentatin f any prblems. Review prficiency testing results. Ensure that PT samples are tested in the same manner as patient samples Ensure that all PT failures are identified, investigated, crrected and dcumented. Slve interdepartmental Quality Assurance (QA) and Patient Care prblems. The Supervisr, Quality Assurance Technlgist r Technical Specialist is respnsible fr establishing a system fr identifying, crrecting and dcumenting internal and external department prblems. The Supervisr, Quality Assurance Technlgist r Technical Specialist dcuments prblem slving methds and preventive actins taken. Ensures perfrmance imprvement activities are executed per departmental plan. Implement and maintain a cmprehensive emplyee rientatin, training and cmpetency prgram. May perfrm annual persnnel perfrmance evaluatins. Ensure plicy and prcedure manuals are current and fllwed by staff. The Faculty Labratry Directrs may designate the Supervisrs, Quality Assurance Technlgists r Technical Specialists as the authrized reviewer f unchanged plicies. Lead Medical Technlgist Slve quality assurance prblems within their areas f expertise Review mnthly preventive maintenance (PM) dcumentatin and bring prblems t the supervisr s attentin. Review varius cmputer generated reprts t assure that dcumented prblems have been handled crrectly. Review abnrmalities, utliers, r ther prblems with quality cntrl lgs, preventive maintenance lgs r ther reprting frmats assigned fr review. Implement established plicies and prcedures fr the area. Cmmunicate and reslve issues that arise between shifts Assist in writing and implementing plicies and prcedures. Bench Technlgist/Technicians Ensure that daily quality cntrl is within expected ranges befre prceeding with patient samples. Refer any unreslved prblems t lead technlgist r supervisr Identify pprtunities fr imprvement, dcumenting prblems arising n each shift Perfrm ther functins as defined within their jb descriptin 5

6 SECTION II Quality Infrastructure Key crss-functinal, departmental and interdepartmental cmmittees: JHH is respnsible fr prviding in vitr diagnstic services thrugh its Pathlgy and Labratry Medicine services. Additinally the Department is respnsible fr the quality f patient care labratry and pathlgy services perfrmed by all units prviding infrmatin fr patient care decisin-making. It has versight respnsibility fr Pint f Care Testing perfrmed by nnlabratry persnnel. The Office f CQI Prgrams within the perfrms the task f mnitring CQI activities/regulatry cmpliance f all patient care testing areas. The Department f Pathlgy participates in a variety f departmental and interdepartmental quality assurance imprvement plans and initiatives. Cllabrating with ther hspital departments is pursued in rder t imprve patient health utcmes. The Quality Imprvement Cuncil (QIC) is a crss-functinal hspital cmmittee that meets mnthly. The Assistant Directr f Quality Management represents the n the JHH QIC. The cuncil is the frum where safety, service and quality imprvement leaders acrss the institutin discuss related issues, set annual quality imprvement pririties, and mnitr prgress tward these pririties. The cuncil reprts its prgress t the Trustees via the Bard f Trustees Quality Imprvement Cmmittee. The hspital Clinical Quality Imprvement Cmmittee (CQIC) is a crss-functinal cmmittee that meets mnthly. Members are cmprised f departmental Physician Advisrs wh review identified perfrmance measurements, plicies and ther quality, utilizatin r risk management issues. The Physician Advisr represents the n the CQIC and reprts pertinent infrmatin t the department. The cmmittee assesses and makes recmmendatins related t intra and interdepartmental prblems in quality assessment/quality imprvement, risk management and utilizatin management. Imprvement f patient care is addressed thrugh review, discussin and supprt f departmental quality imprvement prgrams. The Labratry Advisry Cmmittee (LAC) is a crss-functinal cmmittee and meets mnthly. The Deputy Directr fr Clinical Affairs chairs the LAC and the members are cmprised f physicians, residents, nursing administratin, pharmacy, labratry directrs and administratrs. As laid ut by the Medical Bylaws the cmmittee: Assists in the educatin f physicians and ther staff n the apprpriate use f labratry services 6

7 Prvides recmmendatins t the Medical Bard and Hspital Administratin regarding imprvement f pathlgy and labratry services and their utilizatin. Advises the n the scpe, availability, and relevance f labratry services, including selectin f reference labratry services. Peridically reviews reprts pertaining t clinical department assessment f labratry services in terms f factrs such as quality, timeliness and respnsiveness t prblems and inquires Participates in the develpment and interpretatin f quality assessment studies dealing with the apprpriateness f test rdering the effectiveness f test utilizatin and interpretatin, and crrelatin with quality imprvement activities in the clinical departments Advises the regarding written and electrnic cmmunicatins t medical, nursing, and ther hspital staff Receives relevant infrmatin frm perating divisins and central administratin if the Evaluates all critical pathways, rder sets, and similar materials cncerned with Pathlgy and Labratry Medicine tests and prcedures Serves as a resurce fr infrmatin r cnsultatins fr Jhns Hpkins Medicine institutinal Review Bards and requesting investigatrs regarding Pathlgy and Labratry issues Mnitrs and develp plicies regarding the activities f sales representatives fr labratry diagnstics and in vitr devices within the Hspital The Surgical and Invasive Prcedure Review Cmmittee (SIPRC) is a crss-functinal cmmittee that meets at least quarterly. Members are cmprised f physician representatives frm each divisin f Anatmic Pathlgy, Dermatpathlgy and Eye Pathlgy. Representatives f anatmic pathlgy administratin, nursing administratin, clinical departments r divisins and quality imprvement wh evaluate cases that meet specific criteria fr review are als members. A list f cases reviewed and findings are presented semiannually t apprpriate Chiefs f Service and t the Vice President fr Medical Affairs. Duties and respnsibilities: Evaluate cases with the fllwing prperties: Cases in which the final diagnsis differs frm the pre-perative diagnsis r frm the diagnsis made frm frzen sectin, and/r cytpathlgy Cases in which the riginal pathlgical diagnsis has been changed Cases in with specific diagnses selected fr peridic reviews f specific perative and invasive prcedures Surgical cases perated n at JHH fllwing tissue diagnsis made elsewhere, fr which pertinent slides have nt been reviewed by JHH pathlgists prir t the peratin at JHH Autpsy cases in which the pst-mrtem diagnsis differs significantly frm the perterminal diagnsis Each f the abve cases fund t merit review will a written reprt generated that will include dcumentatin and explanatin f any event in questin and any respnse frm the attending physician. The reprt will be submitted t the apprpriate Physician Advisrs fr departmental review and actin. Prvide a list f cases reviewed and the findings semiannually t the apprpriate Chiefs f Service and t the Vice President fr Medical affairs. 7

8 Reprt t the Clinical Quality Imprvement Cmmittee any identified systemic prblems requiring institutinal r multidisciplinary alerts r actin The Transfusin Practices Cmmittee is a crss-functinal cmmittee that meets quarterly. Members are cmprised f Directr, Assciate Directr, Labratry Manager and QA Specialist f the Transfusin Divisin f the, medical directr and manager f HATS divisin, Department f Pathlgy Physician Advisr, Pathlgy Data System (PDS) Lab Directr, Assistant Directr f Quality Management and physician and nurse representatives f clinical departments. Members review the practices related t the administratin f bld and bld cmpnents, review and apprve surces f bld and bld cmpnents and serve as a frum fr discussin f transfusin practices. Duties and respnsibilities: Review the practices relating t administratin f bld and bld cmpnents within the hspital Review the verall institutinal utilizatin f bld prducts by type f cmpnent Advise clinical departmental Quality Imprvement Cmmittees and ther s n bld and bld cmpnent utilizatin. This shall include review f departmental transfusin mnitring activities Prvide versight f prcesses that ensure prmpt review, and dcumentatin as indicated fr actual r suspected untward events, including reprted transfusin reactins, pst-transfusin infectins, r events assciated with actual r ptential patient harm as identified by the Risk Management Department r ther bdies cncerned with patient safety issues. Review and apprve surces f bld and bld cmpnents Review and evaluate new bld cmpnents r services fr pssible additins t the Bld Bank inventry and Hemapheresis and Transfusin Supprt (HATS) divisin Serve as a frum fr discussin f transfusin practices and bld dnatin activities. Develp and update every tw years, and as needed, the Jhns Hpkins Transfusin Guidelines The Pathlgy Perfrmance Imprvement Cmmittee (PIC) a cmmittee within the Department f Pathlgy meets mnthly (at least 10 times per year). As defined in the Medical Staff Bylaws, each clinical department f the Hspital shall schedule and hld meetings in rder t review quality imprvement initiatives, patient safety activities, dcumentatin quality and ther clinical matters f the department. The Physician Advisr and Assistant Directr f Quality Management c-chair the cmmittee and the members are cmprised f the finance Directr r designee, Administratr fr Operatins, Labratry Directrs, Faculty, Lab Managers, QA Specialists/Technlgists and ther individuals upn request. The cmmittee facilitates the department QI plans, decides which prcesses and utcmes shuld be mnitred, reviews results f data cllectin, assesses the effectiveness f actins and makes recmmendatins fr imprvement. Prgress reprts and summaries f QI initiatives are reprted mnthly t the Labratry Directr in Chief and Deputy Directr and annually t the hspital QIC. 8

9 The cmmittee is respnsible fr: Planning the prgram t assess and imprve the quality f patient care functins f the Department Facilitate the plan and design f functins in the Department t identify areas f ptential imprvement thrugh the use f perfrmance measures Decide which prcesses and utcmes shuld be mnitred. Emphasis is placed n thse aspects f care, which are high risk, high vlume and/r prblem prne and where the pprtunity exists t imprve care Review the results f data cllectin. Other surces f data may include but are nt limited t reprts f ccurrence, physician cmplaints, autpsy reprts, medical recrds, amended pathlgy reprts, prficiency reprts, and ther supprt service Dcument actins taken t facilitate reslutins f identified prblems and imprve quality f patient care Redesign and assess effectiveness f actins taken and dcument imprvement in care and/r services Identify and priritize issues that need mre fcused data and analysis Crdinate the cmmunicatin f quality related infrmatin t pertinent individuals thrughut the Department Maintain cnfidentiality f all quality f care and risk management infrmatin. This infrmatin is prtected frm discvery under Maryland Anntated Cde Review findings frm the fllwing cmmittees r departments and make recmmendatins as relevant: Infectin Cntrl Quality Cuncil Labratry Advisry Transfusin Practices Regulatry Cmpliance Cmmittee Risk Management Safety Patient Relatins Service Perfrmance Imprvement Cmmittee Clinical Perfrmance imprvement Cmmittee Surgical and invasive Prcedure Review Cmmittee Subcmmittees/wrking grups f the departmental PIC Quality Assurance Wrk Grup, a subcmmittee f PIC, meets mnthly. The meeting is chaired by the s Office f Cntinuus Quality Imprvement (CQI) and attended by the Physician Advisr, and labratry QA persnnel fr each divisin. Significant patient safety events, ther patient safety matters and prcess imprvement activities are discussed. Any items needing further investigatin are brught t the mnthly PIC. 9

10 The Pathlgy Data Systems (PDS) Steering Cmmittee, a Pathlgy Quality Team within the that meets every ther week. The cmmittee is chaired by the Pathlgy Systems Manager and cmprised f the Directr and Manager f the PDS/Infrmatics Divisin, the Department Administratr, Finance Directr, Managers f majr labratry Divisins, and ther individuals upn request. The Cmmittee reprts t the Directr f the thrugh the Pathlgy Operating Grup (POG), and t the Administratr f the Department directly and thrugh the Pathlgy Administrative Team (PAT). The cmmittee is respnsible fr: Advising the Department's executive and administrative leadership n matters relating t the Department's and t Jhns Hpkins Medicine's "labratry infrmatin system" (LIS) patientcare, administrative, and billing functins. Reviewing current peratinal prblems with LIS services fr the Institutins and fr Jhns Hpkins Medicine, it advises n a brad range f LIS-related plicies and prcedures, it assists with strategic and shrt-term planning fr LIS services, and it reviews and makes recmmendatins regarding internal and external requests fr new r additinal LIS services. Interdisciplinary Phlebtmy Cmmittee, a Pathlgy Quality Team within the that meets peridically. The meeting is chaired by the Physician Advisr and the Cre Lab Manager. Membership is cmprised f representatives frm Pathlgy, Hspital QI, Nursing, Vascular Access Team (VAT), Huse staff and Outpatient Services. The cmmittee develps service expectatins, reviews patient safety events, advises n safe/efficient/timely phlebtmy practices and addresses challenges n an inpatient and utpatient level. Prgress reprts and summaries f Phlebtmy imprvement initiatives are reprted mnthly t the Labratry Directr in Chief and t the Labratry Advisry Cmmittee (LAC). The s Office f Cntinuus Quality Imprvement (CQI), under the directin f the Assistant Directr f Quality Management, is respnsible fr: Onging mnitring f quality imprvement and regulatry cmpliance Interface and crdinate with regulatry agencies Maintenance f an updates regulatry cmpliance database Review Patient safety Net (PSN) and ther reprts f ccurrence Crdinate safety investigatins and crrective actin plans Prvide versight and guidance fr Quality Imprvement and Safety activities Quality Imprvement (QI) Teams are frmed when prblems r pprtunities fr new r imprved services r prcesses are identified. Representatives f the department participate n these whenever apprpriate. The department can initiate a team if any pprtunity is identified. 10

11 SECTION III Divisin Quality Plans The maintains a strng cmmitment t quality and patient safety. Emplyees are encuraged t discuss quality and safety cncerns with their supervisr and r quality assurance specialist. Each divisin quality plan is designed with this in mind. It is the respnsibility f management and all labratry persnnel t d the right thing, all the time, fr the patient. Each labratry divisin maintains a discipline specific quality imprvement plan t mnitr and trend the quality and apprpriateness f services. Divisin quality plans shuld utline a prcess fr identifying current and freseeable custmer needs using the 5 Key quality system cmpnents, planning (rganizatin), teamwrk (persnnel), mnitring (assessment), imprvement (PI) and review (rganizatin). Quality plans generate a prcess fr effective, team-based decisin making, sustaining nging mnitring f peratinal prcess and custmer satisfactin, identifying prcess prblems, implementing apprpriate prcess imprvement and practicing nging quality reviews. The fcus is imprved patient safety and increased quality utcmes. This is accmplished thrugh nging prgrams designed t assess, measure, imprve and mnitr imprvement f care prvided by the in cnjunctin with clinical users, and thers in the Health Care Organizatin. The gal f these plans is t ensure prcesses that systematically measure areas needing imprvement, and develp prgrams apprpriate t enhance perfrmance in ptimum utilizatin f health care resurces, and patient health utcmes. Plan Elements: Quality System Essentials Each divisin and r lab area fllws the utline f the Quality System Essentials (QSE) fr their specific quality plan. The QSEs are defined in the Quality Management System and in a general Quality Plan template/aide designed fr lab area use. Key Quality Indicatrs The Labratry Directr in Chief, the Clinical & Financial Administratr fr Pathlgy and the Assistant Directr fr Quality Imprvement, tgether with safety, service and quality imprvement leaders acrss the institutin align the key indicatrs with the Quality Imprvement Plan fr the hspital. The Key quality indicatrs are selected n an annual basis and are cnsistent with the patient centered gals f the Jhns Hpkins Health System (Safe Care, Evidence-based/Effective Care, Efficient/Timely Care and Patient Centered Care), CAP and ther accreditatin agencies patient safety gals. key quality indicatr selectin is discussed at the QA wrkgrup meeting. The Department selects indicatrs that measure the perfrmance f prcesses in the path f wrkflw. Quality indicatrs are bservatins, statistics, r ther data that typify and measure the perfrmance f a prcess. The quality indicatrs are selected t facilitate and implement strategies t align with the Hspital strategic gals f clinical, service, fiscal and infrastructure. The selected indicatrs are applied t 11

12 issues relevant t imprvement f pathlgy and labratry services. Once the indicatrs are chsen they are presented at PIC fr final review. (See Appendix B fr indicatrs) The CAP patient safety gals incrprated int each quality plan are: Imprve patient and sample identificatin Imprve the verificatin and cmmunicatin f life threatening r life altering infrmatin regarding: Malignancies HIV and ther infectins Cytgenetic abnrmalities Critical results Imprve the identificatin, cmmunicatin and crrectin f errrs Imprve crdinatin f the labratry patient safety rle within healthcare rganizatins RELATED DOCUMENTS: Quality Management System Medical Bylaws ARTICLE XXII MEDICAL BOARD REFERENCES: GP26-A2 Applicatin f a Quality System Mdel fr Labratry Services; Apprved Guideline (2003), 2 nd Editin. NCCLS Valenstein, P. (Editr) Quality Management in Clinical Labratries: Prmting Patient Safety Thrugh Risk Reductin and Cntinuus Imprvement. Nrthfield, Illinis: Cllege f American Pathlgists;

13 APPENDIX A As set frth by CLIA the Labratry Directr in Chief and each Labratry Directr designee must Ensure quality services in all aspects f test perfrmance Ensure that testing systems develped and used fr each f the tests perfrmed in the labratry prvide quality labratry services fr all aspects f test perfrmance, which includes the pre-analytic, analytic and pst-analytic phases f testing; Ensure that the physical plant and envirnmental cnditins f the labratry are apprpriate fr the testing perfrmed and prvide a safe envirnment in which emplyees are prtected frm physical, chemical and bilgical hazards; Ensure that the test methdlgies selected have the capability f prviding the quality f results required fr patient car; verificatin prcedures used are adequate t determine the accuracy, precisin, and ther pertinent perfrmance characteristics f the methd; and labratry persnnel perfrming the test methds as required fr accurate and reliable results Ensure that the labratry is enrlled in HHS apprved prficiency testing prgram fr the testing perfrmed and that the prficiency testing samples are tested as required under subpart H f the Federal Register; the results are returned within the timeframes established by the PT prgram. All prficiency testing reprts received are reviewed by the apprpriate staff t evaluate the labratry s perfrmance and t identify any prblems that require crrective actin; and an apprved crrective actin plan is fllwed when any prficiency testing results are fund t be unacceptable r unsatisfactry Ensure that the quality cntrl; quality assessment prgrams are established and maintained t assure the quality f labratry services prvided and t identify failures in quality as they ccur Ensure the establishment and maintenance f acceptable levels f analytical perfrmance fr each test system Ensure that all necessary remedial actins are taken and dcumented whenever significant deviatins frm the labratry s established perfrmance specificatins are identified, and that patient test results are reprted nly when the system is functining prperly Ensure that reprts f test results include pertinent infrmatin required fr interpretatins Ensure that cnsultatin is available t the labratry s clients n matters relating t the quality f the test results reprted and their interpretatin cncerning specific patient cnditins Emply a sufficient number f labratry persnnel with the apprpriate educatin and either experience r training t prvide apprpriate cnsultatin, prperly supervise and accurately perfrm tests and reprt test results in accrdance with the persnnel respnsibilities described by CLIA Ensure that prir t testing patient s specimens, all persnnel have the apprpriate educatin and experience, receive the apprpriate training fr the type and cmplexity f the services ffered, and have demnstrated that they can perfrm all testing peratins reliably t prvide and reprt accurate results 13

14 APPENDIX A (cntinued) Ensure that plicies and prcedures are established fr mnitring individuals wh cnduct preanalytical, analytical, and pst-analytical phases f testing t assure that they are cmpetent and maintain their cmpetency t prcess specimens, perfrm test prcedures and reprt test results prmptly and prficiently, ad whenever necessary, identify needs fr remedial training r cntinuing educatin t imprve skills Ensure that an apprved prcedure manual is available t all persnnel respnsible fr any aspect f the testing prcess Specify in writing, the respnsibilities and duties f each cnsultant and each persn engaged in the perfrmance f the pre-analytic, analytic and pst-analytic phases f testing, that identifies which examinatins and prcedures each individual is authrized t perfrm, whether supervisin is required fr specimen prcessing, test perfrmance r results reprting, and whether cnsultant r directr review is required prir t reprting patient results. 14

15 APPENDIX B FY10 Safety Dashbard Measures fr JHH Clinical Divisins FY10 Measure and Definitin SAFE/OUTCOMES Patient ID Defects Definitin: #mislabeled/unlabeled Specimens (phlebtmy cllected) SAFE/OUTCOMES Hand Hygiene Definitin: % Pathlgy staff and faculty cmpliance (direct patient care respnsibilities) EVIDENCE-BASED/PROCESS Assessment/reductin f HAC ( never event ) Definitin: #Acute Hemlytic Bld Transfusins EFFICIENT/TIMELY Breast Bipsy TAT Definitin: % f rutine cases reprted within 24 hurs EFFICIENT/TIMELY Imprve availability f APTT fr Heparin Prtcl Patients; Pathlgy phlebtmy drawn specimens Definitin: Cllectin time t results available; TAT 120 min. PATIENT CENTERED CARE In Patient all areas, Outreach Phlebtmy Patient Satisfactin, Overall Definitin: 550 building, Nel-2, GSS, WM; quarterly survey Baseline Metric (e.g. previus year number, rate, r percentage) Achievement Target in FY10 (number, rate, percentage) Gal: Imprvement r Maintenance 4/year < 4/year Imprvement >90% >90% Maintenance 0 0 Maintenance TAT = <90% TAT = >90% Imprvement TAT 120 min 65 th percentile (IP) 45 th percentile (OP) TAT < 120 min >90% cmpliance 70 th percentile (IP) 50 th percentile (OP) Imprvement Imprvement 15