Self Assessment Tool for Healthcare Organizations

7/31/2019 Self Assessment Tool for Healthcare Organizations

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LEADERSHIP AND QUALITY IMPROVEMENT

Documentation Implementation

Quality Paradigms training & consulting, inc. 1-800-430-5504

ISO 9000 is an international standard

that helps you build a system for managing the quality of care

provided at your facility.

The standard gives requirements for a quality system that must be met. Your

application of the standards should reflect the mission and values of your

organization; beginning with a succinct quality policy statement, all facets of

the quality management system focus on that goal and drive it to reality.

This is a system of documented procedures that are useful and up to date,

indexed for ready accessibility.

What is important to your organization?

YOU decide.

YOU voice a vision.

YOU make it happen-

with a quality management system to make quality dreams reality

and keep them that way!!


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Quality Paradigms training & consulting, inc. 1-800-430-5504 i

INSTRUCTIONS FOR COMPLETING THE ISO 9001Self Assessment Tool For Healthcare Organizations

PerspectiveTake the perspective of people who do the daily work within the healthcare organization, rather thanwhat management wants or leadership says. In other words, be as objective as possible about thecurrent reality.

ScoringRespond to each statement with a percentage of readiness corresponding to one of the followingphrases that best describes how well your organization performs with respect to that statement.

For statements related to DOCUMENTATION(prefixed by a D on the Score Sheets), use thesephrases:

20% - There has been discussion about the need for documentation. Alternatively, do not know.

40% - Rough drafts or outdated versions exist but are not used.

60% - Documentation exists, but it is superficial or is seen as insufficient or not useful.

80% - Documentation exists and is generally useful, but it is not always kept up to date.

100% - Relevant documentation is available, complete, useful and up to date.

For statements related to IMPLEMENTATION(prefixed by an I on the Score Sheets), use thesephrases:

20% - There has been discussion about the need for this. Alternatively, do not know.

40% - Applies to limited parts of the organization.

60% - Widespread awareness, but not done on a consistent basis across the organization.

80% - Consistently done in major parts of the organization, done sporadically in other parts.

100% - The norm for all major parts of the organization.

For the purpose of this tool, the ISO 9001 Standard has been broken into three parts. The first part is entitled,

Leadership & Quality Improvement; the second entitled, Quality System Infrastructureand the third entitled,Process Management in Quality Organizations. At the end of each section you will find Score Sheets for thatsection. The Score Sheets are self-explanatory. The last page of the tool is a Final Scoring Sheet. Tally up theresults from the Section Score Sheets and place them in the appropriate column of the Final Score Sheet. Dividethe total number by 20 and you will have your organizational percentage of readiness in obtaining ISO 9001

Certification.

NOTE: In some cases all of the questions will not apply to your organization. If this is the case, simply add thenumber of scores that you did answer in a specific section and divide that number by the total number of ques-tions answered.

We hope that you find this tool useful as you consider adding ISO 9001 to your current management system inorder to bring about continuous quality improvement.


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4.1 Management Responsibility

4.1.1 Quality Policy

LD1. A written quality policy signed by Executive

Management is published and maintained.

LD2. Copies of the quality policy are made availableto employees.

LD3. Employees can state the intent and elementsof the quality policy.

LD4. Procedures exist to ensure that new employ-ees are oriented to the quality policy.

LD5. Quality concerns are reviewed and addressedin accordance with the quality policy.

LD7. All personnel have written job descriptions with

responsibility and authority for quality clearly speci-fied.

LD8. There is a current written and approved orga-nizational chart in place.

LD10.Specific authority is delegated to identify andrecord quality nonconformances?

LD11. Specific authority is assigned for review ofnonconformances to determine what corrective andpreventive action is necessary.

LD12. Specific authority for initiating solutions throughdesignated channels is documented.

LD6.Responsibilities and authorities for all personnelare clearly defined and documented.

4.1.2 Organization4.1.2.1 Responsibility and Authority

LD9. Authority delegated to personnel to identifyand record quality nonconformance, initiate andverify corrective action, and control furtheractivities.

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4.2 Quality System

QI1. A documented quality systems manual assures

that stated policies and objectives for service qualityperformance have been established. It is sufficientlyspecific to guide personnel on What, Who, When,Where, Why and How.

QI2. A quality systems manual is implemented anddescribes the organizations procedural infrastruc-ture which in turn acts as a road map to guide andnavigate users to the applicable quality system pro-cedures and protocols which drive organizational

wide quality and performance.

QI3. The quality system documentation is easilyunderstood by all personnel who have a need to useit.

QI4. There is a written plan of care, clinical pathway,nursing plan, quality plan (how the requirements forquality will be met), etc. for each patient, service de-livery activity or project engaged in.

QI5. Personnel use, carry-out and follow the plansof care, clinical pathways, nursing plans, quality plans(how the requirements for quality will be met) whenappropriate to ensure that quality objectives and clini-cal outcome expectations are met.

QI6. Personnel throughout the organization areaware of policies, procedures, protocols and instruc-tions, know where to get them..

QI7. Personnel understand policies, procedures, pro-tocols and instructions and use them to obtain mea-surable outcomes.

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QI8. Written procedures address how to plan, sched-

ule, document, and follow-up on internal quality au-dits of the entire quality system.

QI9. Internal quality auditing personnel exist; auditsare conducted at defined intervals; improvements arerecommended; action is taken; if necessary changesto the quality system are made and the effectivity ofsuch changes is verified.

QI10. The results of all internal audits are documented

and reported to management.QI11. Management reviews the results of the inter-nal quality audits during its annual management re-view and makes a determination as to the continuingsuitability and effectiveness of the documented qualitysystem in order to continue to meet patient / cus-

tomer defined needs and expectations.

4.14 Corrective Action (4.14.2)

QI12. Procedures exist for implementing correctiveactions in order to eliminate the causesof noncon-forming service delivery and/or poor patient care.

QI13. Procedures exist which define the effective han-dling of customer / patient complaints; investigationof the causesof such complaints, determine the cor-rective actions needed to eliminate the causes ofcustomer / patient complaints; define controls nec-essary to ensure that corrective action taken is ef-fective.

QI14. Corrective action procedures not only deal ef-fectively with problems in the present and near term,but the records indicate that procedures have beenuseful in driving continuous quality improvement.

QI15. Records indicate that corrective actions havebeen brought to managements attention for use dur-ing Management Review in order to evaluate thecontinued suitability and effectiveness of the QualitySystem.

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4.17 Internal Quality Audits


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4.14 Preventive Action (4.14.3)

QI16. Procedures exist for implementing preventive

actions in order to eliminate the potential causesofnonconforming service delivery and/or poor patientcare.

QI17. Procedures define what sources of organiza-tional data and other outcome measures will be usedto detect, analyze and eliminate potential causesofnonconforming service delivery and/or poor patientcare.

QI18. Records indicate that appropriate steps aretaken to deal effectively with potentialproblems re-quiring preventive action.

QI19. Personnel initiate preventive action and en-sure that the preventive measures taken were effec-tive.

QI20. Records indicate that preventive actions havebeen brought to managements attention for use dur-ing the annual evaluation of the effectiveness of the

overall quality system.

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4.16 Control of Quality Records

QI21. Procedures exist to guide the organization inidentifying, collecting, filing, indexing, storing, main-tenance, retaining and disposing of Quality Records.

QI22. Procedures outline how records are held in

confidence and are stored to minimize deteriorationand allow ready retrieval.

QI23. The quality records system works well and fa-cilitates information retrieval for root cause analysiswhether initiated by patient / customer complaints orprocess control difficulties.

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4.20 Statistical Techniques

QI24. Procedures exist to guide the organization in

the application of statistical techniques. Statisticaltechniques are used to: control and measure servicedelivery quality; measure and collect data regardingmeasurable clinical outcomes; assist in identifyingproblems associated with poor organizational perfor-mance.

QI25. Records and employee actions indicate a wide-spread understanding and use of statistical data col-lection tools to track and record organizational per-formance and measure outcomes.

QI26. Perato charts and/or other statistical techniquesare used to identify and track quality / service deliv-ery problems in order to identify root causes of thoseproblems and report the same to management.

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4.1 Management Responsibility LD1 _____LD2 _____LD4 _____LD6 _____LD7 _____LD8 _____LD12 _____LD13 _____LD16 _____LD17 _____LD19 _____

D Score _____

LD3 _____LD5 _____LD9 _____LD10 _____LD11 _____LD14 _____LD15 _____LD18 _____LD20 _____LD21 _____

I Score _____

D Score + I Score =

Total SectionScore

SectionAverageScore

Divide the SectionScore by 21

=

4.2 Quality System

QI1 _____QI3 _____QI4 _____

D Score _____

QI2 _____QI5 _____QI6 _____QI7 _____

I Score _____

D Score + I Score =

Total SectionScore

SectionAverageScore


=


QI8 _____QI10 _____

D Score _____

QI9 _____QI11 _____

I Score _____

D Score + I Score =Total Section

Score

SectionAverageScore


=

Section Scoring Sheet #1

Leadership and Quality Improvement

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4.14 Corrective & Preventive Action


QI12 _____Qi13 _____QI16 _____QI17 _____

D Score _____

QI14 _____QI15 _____QI18 _____QI19 _____QI20 _____

I Score _____

D Score + I Score =

Total SectionScore

Section

AverageScore


=


QI24 _____QI26 _____

D Score _____

Q25 _____

I Score _____

D Score + I Score =

Total SectionScore

SectionAverageScore


=

Leadership and Quality Improvement

8



Score

SectionAverageScore


=

QI21 _____QI22 _____

D Score _____

Q23 _____

I Score _____


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QUALITY SYSTEM INFRASTRUCTURE

4.5 Document & Data Control

TX1. Procedures describe a control mechanism

which ensures that all documents (policies, proce-dures, protocols, instructions, forms etc.) are con-trolled.

TX2. Procedures, protocols, instructions, forms, etc.are approved by authorized personnel prior to issue.

TX3. Documents of external origin such as accredi-tation standards, FDA, DEA, State HD Regulations,HCFA, etc. are controlled to ensure that the latestversions / revisions are available to personnel who

need the documents.

TX4. Current revisions of policies, procedures, pro-tocols, instructions, forms etc. are readily availableand in use by all personnel.

TX5. A master list of documents / forms identifyingthe current revision status of policies, procedures,protocols, instructions, forms etc. is available to pre-clude the use of invalid and/or obsolete documents.

TX6. Invalid and/or obsolete policies, procedures, pro-tocols, instructions, forms etc. are promptly removedfrom all points of use and replaced with updated re-visions.

TX7. Obsolete policies, procedures, protocols, in-structions, forms etc. retained for knowledge-preser-vation purposes are suitably identified.

TX8. Changes and revisions to policies, procedures,protocols, instructions, forms etc. are reviewed and

approved by the same functionas those who per-formed the original review and approval.

TX9. Procedures describe a method for safeguard-ing computer data. Appropriate backup proceduresexist. Computer process management control soft-ware systems such as Meditech are safeguardedand protected to ensure confidentiality.

TX10. Records indicate that computer backups oc-cur on a regular basis. Backups are safeguarded.

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4.7 Customer Supplied Product

TX11. Procedures are available which describe the

protocol for verification, storage, identification, record-ing and maintaining patient valuables, dentures,medications, clothing and other items which the or-ganization will be required to control while the pa-tient is under the healthcare organizations control.

TX12. Personnel understand the protocols for thecontrol of patient owned items. Items are rarely lost,damaged or misused.

TX13. Organizational wide procedures / protocols de-scribe the process of identifying critical medical prod-ucts (e.g. pharmaceuticals, blood, medical devices,etc.) purchased by the hospital and used in provid-ing patient care.

TX14. Procedures and/or protocols exist describingthe process of identifying patients / newbornsthroughout the healthcare delivery process.

TX15. Identification and traceability records indicatea high degree of traceability and identification con-trols. Such records are available in a timely manner.

TX16. Critical medical product (meds, blood, medi-cal devices, etc.) are identified in such a manner thatpositive recall of such products can be accomplishedeasily.

4.12 Inspection and Test Status

(Assessment, Examination and Test Status)TX17. Procedures / protocols exist which describethe assessment / examination status of the patient

or their tests.

TX18. Assessment, examinations and test statusprocedures, protocols work well. There are noknown instances of assessments and/or tests whichwere not conducted as ordered. Little time is wastedbecause of confusion over test results.

4.8 Product Identification & Traceability(Patient Identification Protocols / Medical ProductTraceability)

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TX19. Procedures exist to ensure that medical sup-

plies which do not conform to specified requirementsare prevented from inadvertent use.

TX20. Procedures exist which ensure that servicedelivery which does not meet policy/procedure re-quirements is identified and corrective action takento prevent recurrence.

TX21. There is no indication from review of medicalrecords or customer complaints that known noncon-forming service occurred nor were any nonconform-

ing medical products/supplies released or found inuse.

TX22. Procedures exist that cover the formal reviewand disposition of nonconforming service and/or medi-cal products/supplies.

TX23. Records of all nonconforming service and/ormedical products/supplies are kept and are available.

TX24. Observations and discussions with employeesindicate that procedures and/or protocols for a formalreview and disposition of nonconforming service/medical equipment/products/supplies is consistentlyfollowed and that corrective actions taken continueto meet the needs of patients/customers and theoverall organization.

4.11 Inspection Measuring and Test Equipment


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TX25. Procedures exist which document how assess-

ment, examination, measuring and test equipment isidentified, maintained and calibrated to ensure thatmeasurement uncertainty is known.

TX26. Procedures indicate the appropriate actions tobe taken whenever equipment is found to be out ofcalibration.

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4.13 Control of Nonconforming Product(Control of Nonconforming Service)


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4.11 Inspection Measuring and Test Equipment

TX27. Records are available and maintained by Bio-medical/Lab, etc. which indicate the dates and re-sults of all calibrations within specified periods of time.Records indicate the actions taken when equipmentwas found to be out of acceptable ranges.

TX28. Centralized calibration records and labels onequipment indicate that calibration intervals are con-sistently on schedule and few instances of equip-ment out of calibration are noted.

TX29. Every instance of equipment out of calibra-tion had a careful investigation of potential negativeclinical effects. Effective remedial action was ob-served to be taken to prevent reccurance.

4.18 Training

TX30. Procedures are established to identify all train-ing needs of personnel whose jobs effect servicequality.

TX31. Records of training needs and training receivedare readily available.

TX32. Training records indicate that analysis of train-ing needs are kept up to date and training, licensure,credentials, and qualifications are current.

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4.5 Document and Data Control TX1 _____TX2 _____TX5 _____TX9 _____

D Score _____

TX3 _____TX4 _____TX6 _____TX7 _____TX8 _____TX10 _____

I Score _____

D Score + I Score =

Total SectionScore

SectionAverageScore

Divide the SectionScore by 10 =

TX11 _____

D Score _____

TX12 _____

I Score _____


Score

SectionAverageScore


=

TX13 _____TX14 _____

D Score _____

TX15 _____TX16 _____

I Score _____


Score

SectionAverageScore



Quality System Infrastructure


4.8 Product Identification & Traceability(Patient Identification / Medical Product Traceability)

4.12 Inspection and Test Status(Assessment and Test Status)

D Score + I Score =

Total SectionScore

SectionAverage Score


=

TX18 _____

I Score _____

TX17 _____

I Score _____

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4.13 Control of Nonconforming Product

(Control of Nonconforming Service) TX19 _____TX20 _____TX22 _____TX23 _____

D Score _____

TX21 _____TX24 _____

I Score _____


Score

SectionAverageScore


D Score + I Score =

Total SectionScore

SectionAverageScore


=

TX30 _____TX31 _____

D Score _____

TX32 _____

I Score _____

D Score + I Score =

Total SectionScore

Section

AverageScore



Quality System Infrastructure

4.11 Control of Inspection, Measuring and

Test Equipment

4.18 Training

TX25 _____TX26 _____TX27 _____

D Score _____

TX28 _____TX29 _____

I Score _____

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4.3 Contract Review(Contracts, Orders and/or Consents)

PM1. Written procedures exist for reviewing all or-

ders, consents, contracts or customer questions toassure adequate definition of customer / patient re-quirements; the ability to satisfy these requirements;and methods to resolve differences and difficulties.

PM2. Procedures for reviewing customer orders arefollowed consistently, and records are maintained todemonstrate compliance, including names of review-ers if specified.

4.4 DESIGN CONTROL4.4.2 Design and Development Planning4.4.3 Organization and Technical Interfaces

PM3. Procedures covering the generation of plansof care, nursing plans and clinical pathways exist.

PM4. Plans for designing and developing plans ofcare, nursing plans, clinical pathways and other ac-tivities are generated and followed, or updated asnecessary.

PM5. Organizational and technical interfaces be-tween different functions within the healthcare orga-nization that have input into the design plans aredefined.

PM6. Information regarding the design is docu-mented, transmitted and regularly reviewed.

4.4.4 Design Input

PM7. Procedures are available describing and guid-

ing staff as to what, where, when and how care is tobe provided to the patient during the delivery of care.Clinical care input requirements are identified, docu-mented and reviewed for adequacy.

PM8. Care plan input requirement documents are onfile and easily accessible.

PM9. Documents and records indicate that proce-dures for reviewing input requirements are consis-tently followed.

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PROCESS MANAGEMENT INQUALITY ORGANIZATIONS

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4.4.5 Design Output

PM10. Procedures describe how the clinical inputrequirements are transformed into Clinical Care out-puts (the ensuing results are the plan of care, nurs-ing plans, clinical pathways, etc. that become the ISO9001 design output requirements)

PM11. Documentation of design outputs (plan of care,nursing plans, clinical pathways, etc.) is maintainedand easily accessible.

PM12. A review of design outputs, change notices,customer complaints and internal audit reports indi-cate consistent adherence to organizational stan-

dards for design output (plan of care, nursing plans,clinical pathways, etc.).

4.4.6 Design Review

PM13. At appropriate stages of designing plans ofcare, nursing plans, clinical pathways or other de-sign activities, formal documented reviews of the de-sign are conducted.

PM14. Records of design reviews are maintained and

demonstrate effective service designs.

4.4.7 Design Verification

PM15. Planning, staffing ,and conducting design veri-fication is described in formalized procedures.

PM16. Results of design verification activities are kepton file and readily accessible.

PM17. Results of design verification activities anddesign verification records confirm that verification

procedures are followed consistently.

4.4.8 Design Validation

PM18. Procedures exist which define methods of en-suring that plans of care, clinical pathways and otherdesign activities are verified as meeting the patients

/ physicians defined needs.

PM19. Care Plans are validated as meeting the pa-tients needs prior to the patients discharge.

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4.4.9 Design Change

PM20. Written procedures are available coveringchanges to nursing plans and plans of care , includ-

ing: identification, documentation, review and ap-proval.

PM21. Procedures for handling such changes arefollowed consistently, and there are few instances ofproblems caused by lack of control over nursing plan

/ plan of care changes.


4.6 Purchasing

PM22. Procedures exist which describe how sub-contractors/vendors are selected/deselected.

Records are maintained which identify acceptablesubcontractors / vendors .

PM23. Purchase orders are consistently issued tosubcontractors / vendors whose name appears onthe list of those acceptable.

4.6.3 Purchasing Data

PM24. Procedures are available to assure that pur-chasing documents adequately describe products /

services being ordered. Procedures describe howthese documents are reviewed and approved priorto release.

PM25 There are few changes to purchase orderswhich were caused by incomplete and inaccurate in-formation on the original order.

4.9 Process Control

PM26. Documented procedures describe how toidentify, plan, document, implement and control all

processes that directly affect quality.

PM27. Current process descriptions and guidancedocuments are readily available to all who have needof them.

PM28. Controlled conditions exist for ensuring that processesfollow prescribed regulatory requirements; that environmen-tal conditions are within defined limits. Processes such asinfection Control (BBP) are effective and followed. Utilitiesmanagement carries out equipment maintenance and PM.

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4.10 Inspection & Testing(Receiving Inspection of Medical Supplies/Equipment and

Assessment, Examination of Patients/Lab/Pathology)

PM29. Procedures describe the protocols surround-ing PAT, admissions of patients, receiving inspectionsand verifications of purchased medical supplies uponreceipt.

PM30. Records are available of pre-admission test-

ing, admission of patients and examination of pre-admission test results upon or prior to admissions .

PM31. The pre-admission assessments / tests andthe records to be established are detailed in the poli-cies, procedures, protocols, instructions, etc.

PM32. Procedures detail the requirements for verifi-cation and inspection of medical supplies during re-ceiving / incoming inspection.

PM33. Procedures / nursing plans of care describewhat assessments / examinations must be conducted.

PM34. Records indicate what assessments, exami-nations and/or tests have been carried out.

PM35. Physician orders indicate which examinations/tests / lab work are to be conducted for patients.

PM36. Records indicate what physician ordered tests/labs, examinations have been carried out and when.

4.10.2 In-Process Inspection and Testing(Assessment, Examinations of Patients/Lab/Pathology)

PM37. Procedures covering assessment, examina-

tion and testing are described either in policy manu-als or in separate documentation.

PM38. Inpatient/outpatient records of assessments,examinations and tests are readily available.


PM39. A combination of clinical process controls andphysician ordered testing effectively catches mostclinical problems close to the source, and few prob-lems occur or are detected at or after final discharge.

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4.10.3 Final Inspection and Testing

PM40. Procedures for final patient assessment/ex-

amination and testing prior to discharge are main-tained and are available.

PM41. Final assessment/examination and testrecords are readily available.

PM42. Results of the final discharge assessment/ex-aminations are documented and assure that the pa-tient understands what they are required to do to pre-vent readmission.

4.15 Handling, Storage, Packaging, Preservationand Delivery.

PM43. Procedures to prevent damage or deteriora-tion of materials/patients/supplies during handling,storage, packaging and delivery are available. (i.e.Pharmacy, Lab, Blood Bank, Patient Handling, etc.)

PM44. Records are maintained to demonstrate thatthe procedures are effective.


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4.19 Servicing

PM45. Where applicable, procedures exist toensure that customer/patient follow-up visitsare completed as scheduled by the physician.

PM46. Records of follow-up visits are main-tained. Schedules are made and service pro-vided with positive patient outcomes in mind.

PM47. Follow-up visit procedures are effectiveat preventing service quality problems andcreating positive patient outcomes.

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PM26 _____

I Score _____

4.3 Contract Review

(Review of Contracts, Orders & Consents) PM1 _____

D Score _____

PM2 _____

I Score _____

D Score + I Score =

Total SectionScore

SectionAverageScore



Score

SectionAverageScore


=

PM22 _____PM24 _____

D Score _____

PM23 _____PM25 _____

I Score _____


Score

SectionAverageScore



Process Management in Quality Organizations

4.4 Design Control

4.6 Purchasing

4.9 Process Control


Score



PM27 _____PM28 _____

I Score _____

PM3 _____

PM5 _____PM7 _____PM8 _____

D Score _____

PM10 _____PM11 _____PM13 _____PM15 _____PM18 _____PM20 _____

PM4 _____

PM6 _____PM9 _____PM12 _____PM14 _____PM16 _____PM17 _____PM19 _____PM21 _____

I Score _____

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PM45 _____PM46 _____

I Score _____

D Score + I Score =

Total SectionScore

SectionAverage

Score


=

PM43 _____

D Score _____

PM44 _____

I Score _____

D Score + I Score =

Total SectionScore

SectionAverageScore



Process Management in Quality Organizations

4.10 Inspection & Testing

(Receiving/Assessment of Patients/Lab/Pathology)

4.15 Handling, Storage, Packaging,Preservation & Delivery

4.19 Servicing

D Score + I Score =

Total SectionScore


Divide the Section

Score by 3=

PM47 _____

I Score _____

PM29 _____

PM31 _____PM32 _____PM37 _____PM40 _____

D Score _____

PM30 _____

PM33 _____PM34 _____PM35 _____PM36 _____PM38 _____PM39 _____PM41 _____PM42 _____

I Score _____

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FINAL SCORING STEET

SCORE SHEET #1-

LEADERSHIP& QUALITY IMPROVEMENT4.1 Management Responsibility

4.2 Quality System



4.14 Corrective & Preventive Action


SCORE SHEET #2-

QUALITY SYSTEM INFRASTRUCTURE4.5 Document & Data Control


4.8 Product Identification & Traceability

4.12 Inspection & Test Status

4.13 Control of Nonconforming Product

4.11 Inspection Measuring & Test Equipment

4.18 Training

SCORE SHEET #3-PROCESS MANAGEMENT IN QUALITYORGANIZATIONS

4.3 Contract Review

4.4 Design Control

4.6 Purchasing

4.9 Process Control

4.10 Inspection & Testing

4.15 Handling, Storage, Packaging,

Preservation & Delivery

4.19 Servicing

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SECTION AVERAGE

SCORE

ADD COLUMNS ABOVE & ENTER HERE

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________________

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DIVIDE TOTAL SCORE BY 20This Score Represents Your % of Readiness ForISO 9001 Certification.

%

.

.

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