womack army medical center, fort bragg, nc

Womack Army Medical Center, Fort Bragg, NC

“Committed to Those We Serve”

Quality System Essentials

• Quality Control – provides feedback to operational staff about the state of the process that is in progress.– Acceptable – continue with process– Unacceptable – stop until a problem is resolved

• Quality Assurance – activities that are not tied to the actual performance of the process.– Retrospective review and evaluation of operational

performance

• Quality Management – interrelated processes in the context of the organization– Leadership role in commitment to quality– Encompasses the quality systems approach


• Documents and Records• Organization• Personnel• Equipment• Purchasing and Inventory• Process Control• Information Management• Occurrence Management• Internal and External Assessment• Process Improvement• Customer Service• Facilities and Safety


• Quality Management as an Evolving Science– The principles and tools in use today will

change as research provides new knowledge of organizational behavior, as technology provides new solutions, and as the field of laboratory medicine presents new challenges

» AABB Technical Manual – 15th ed


• Submitted monthly by section supervisors• Summary of their QA activities

– QC/QC reviews– Preventive Maintenance– Timed activities

• Weekly, monthly, quarterly, semi-annual, annual

– Corrective actions taken

• Reviewed by Quality Manager• Reviewed by section’s Medical Director• Which QSE does this address??

QSE ToolsMonthly QA Checklists

QUALITY ASSURANCE CHECKLIST

MONTH:___________ YEAR:_______ QA Coordinator:_________________

Weekly Review By/Date




Monthly Review By/Date

Review of Hematology Quality Control Charts

Spun Hematocrit Sickle-Chex 15 Minute ESR 60 Minute ESR Retic QC Chart Fertility QC Chart FDP QC Chart Atlas Level 1 Atlas Level 2 Kova-Trol Level 1 Kova-Trol Level 3 Corrective Action Control Logs Parrallel Testing Logs Review of Hematology Maintenance Charts Microscopre Maintenance Refrig/Freezer Temperature STA-1 Daily STA-1 Weekly STA-2 Daily STA-2 Weekly Centrifuge Maintenance LH 750-1 LH 750-2 Clinitek Maintenance Nikon Maintenance Eye Wash Check Microhematocrit MIdasII Maintenance-Stainer ESR Maintenance Log


Document Control

• Document Control Standard Operating Procedure (SOP)– Standard format for SOPs and Forms– Matches up with items on the control logs– Only the current version in use

• Document Control Logs– Location, version, reviews

• Forms Control Logs

• What QSE does this represent?

WOMACK ARMY MEDICAL CENTER DEPARTMENT OF PATHOLOGY

FORT BRAGG, NC 28310

Copy MCXC-PA-QM 14 January 2008

STANDARD OPERATING PROCEDURE

DOCUMENT CONTROL I. PURPOSE: To establish a uniform system of document control throughout the

Department of Pathology and Outlying Clinics. This system will provide a more organized tracer system for location of policies and procedures. This will ensure the most up to date version is in place at all locations.

II. PRINCIPLE: The laboratory document management system has been implemented to

ensure that all documents in use are written in the approved formats, reflect the current version, and are reviewed and approved by the appropriate individuals in a timely manner. Generally, procedures are reviewed by the Quality Manager and forwarded to the laboratory manager and the responsible pathologist for signature.

III. APPLICABILITY: This procedure is applicable to all Department of Pathology and

Outlying Clinic personnel who read, write, or review standard operating procedures (SOP) and policies for their respective laboratories.

IV. PROCEDURE: A. Procedures/Policies Control

1. Prior to implementation, all policies and procedures require approval by the medical director of the respective section and the laboratory manager.

2. Personnel affected by the policy/procedure and any revisions thereafter will read and acknowledge their understanding by signature and date. Procedure version or revision will be designated by the date in the header.

3. Policies and procedures will be managed and distributed to the appropriate locations by the proponent. The proponent will be designated in the header of the SOP following the department designation –PA.

4. The proponent (section supervisor) of the SOP will maintain a control log of all procedures and policies that they are responsible for. When more than one copy of the SOP is required, the first copy will remain with the proponent.

Copy Number Location SOP Name

Last Revision Review Review Review Review

1Safety SOP

Manual General Laboratory Safety 25 Jan 07 22 Feb 07 25 Jun 07 22 Jan 08 2 Hematology3 STAT4 Histology5 Clark HC6 Joel HC7 Robinson HC8 BDC

9Laboratory

(Phlebotomy)

1Safety SOP

Manual Chemical Hygiene Plan 25 Jan 07 22 Feb 07 25 Jun 07 22 Jan 082 Hematology3 STAT4 Histology5 Clark HC6 Joel HC7 Robinson HC8 BDC

9Laboratory

(Phlebotomy)

Updated: 19 Jul 20042-Jul-07CPT Tonia Urick, 71A, MS

Section: Safety (Admin.)

Updated: 22 Jan 2008Joanna Horne, MT, ASCP

WOMACK ARMY MEDICAL CENTERDEPARTMENT OF PATHOLOGY

FORT BRAGG, NC 28310Hematology Section

QUALITY ASSURANCE CHECKLIST

HEM FORM 39December 12, 2007

Body of Form

LIS Form # Form Date Form Name Associated SOP(s)

1 May 9, 2006 Computer/Printer Maintenance Computer/Printer Maintenance2 May 9, 2006 Specimen Master Log Review Checksheet Result Review and Error Procedure3 May 10, 2006 Corrective Action Report Result Review and Error Procedure4 May 25, 2006 Action Needed Form Result Review and Error Procedure5 May 11, 2006 Automated Patient Result Verification Result Review and Error Procedure

7 May 27, 2006 CHCS Training Checklist CHCS Training SOP


Forms Control Log


Audit Tool

• Audit schedule – annual– Cross reference monthly QA Checklist to make sure

original documents reflect the items listed on the QA Checklist

– Spot check document control accuracy– Annual/Semi annual Competency audit– Quality Control records and corrective action

documentation– Phlebotomy Area – Patient identifiers, safety, HIPAA

• Unannounced audits – based on observation• Which QSE does this address?

Quality System EssentialsQuality Management Audits

YEARLY AUDIT SCHEDULE

JANUARY

Chemistry – QC Audit 1st shift

SOP updates

FEBRUARY

Hematology – QC Audit 1st shift SOP updates

MARCH

Stat Lab – QC Audits

APRIL Microbiology –

QC & QM (weekly) Audits

MAY

Outlying Clinics – QC & QM (weekly) Audits, Document Control Forms

JUNE

Hematology – QM (weekly) Review, Document Control Forms

JULY

Chemistry – QA (weekly) Review Document Control Forms

AUGUST

Stat Lab –

QA (weekly) Review Safety SOP Review

SEPTEMBER SOP / Action Comparison

(SOP matches practice)

OCTOBER Bi-Annual Review of QM

Yearly Planning Calendar – (proficiency testing not on survey)

NOVEMBER

Phlebotomy Room Observation / Audit

DECEMBER CAF Review –

All departments


Occurrence Management

• DA4106 (Incident report)– Log item and resolution– Interdepartmental

• Lab generated• Generated Outside Dept of Pathology

• Quality Management report– Internal to Department of Pathology– Errors caught prior to release of results

• What QSE does this represent?

Quality Monitoring Report

Location

Date

- Patient Safety or Quality Issue/Concern

Description of Occurrence (Include person identifying error): ____More on Back Specimen Saved for further investigation? __Yes __No Specimen Recollected? __Yes __No Amended Report? (If so, must be attached)__Yes __No POC for amended report ______________ This Form Completed By:

Corrective Action and Suggestions for Improvement (Include steps taken):

____More on Back

TYPE OF ERROR (Check all that apply) Pre-Analytic Errors Analytic Errors

Order Error Method/assay error

Order missed Instrument problem

Wrong test ordered Faulty reagent/standard/etc

Test ordered on wrong patient Incorrect/expired calibration

Cancellation error Technical Error

Other order error Misinterpretation/misidentifcation

Specimen collection Error Dilution/pipetting error

Specimen mislabeled/unlabeled Calculation error

Wrong container or tube Run accepted-QC out of range

Wrong patient drawn Result accepted-outside linear limits

Delay in collection Sample mix-up

No initials/date/time for collection Transcription/Entry Error

Specimen not received in lab Other

Specimen contaminated with fluids Post-Analytic Errors

Processing Error Delay in reporting

Delay in testing/sending to other site STAT/Critical not called/documented

Specimen lost Other

Courier delay

Other BB entry/issue/processing Error


BB Errors

Transcription Entry errors

Quality Monitoring Report Log

Specimen Collection Errors

Pre-Analytic Errors

Technical Errors

Post-Analytic ErrorsAnalytic Errors

Post-Analytic Errors

Method/ Assay Errors

Order ErrorsProcessing

Errors

Date Section Description of error


Proficiency Testing

• Is your testing process in control?– Measuring system– Technical competence– Clerical

• Investigation of failed proficiency testing– Use a comprehensive form– Determine root cause– Prove you can obtain the correct result

• What QSE does this address?

D e pa rtm en t o f P a th o lo gy1 D ec 07

Laboratory ManagerLTC Linda Guthrie

Decentralized LaboratoriesVera Claude

Accreditation oversight

Laboratory NCOICMSG Larry Reyes

SecretaryLynn Salley

Point of Care CoordinatorJackie Vennero

Quality AssuranceJoanna Horne

QI CoordinatorRobin Wein

SupplyMary Martin-Mitchell

SGT Carpenter Anthony

Office of the Chief


ChiefMAJ Branch

Transcription

Civilian SupervisorWalter Thornton

NCOIC CytologySGT Delena Roper

CytologyMedical Director

CPT Foster

HistologyCivilian Supervisor

Mona Wheat

AutopsyMedical Director

MAJ Branch

Anatomic Pathology


ChiefMAJ Charles Scott

Laboratory NCOICMSG Larry Reyes

OIC Clinical PathologyVACAN T

NCOIC Clinical PathologySFC Cassandra Maxw ell

MicrobiologyVacant

HematologyRhonda Tucker

ChemistryBonnie McGrady

STAT LabLinda Thompson

Shipping, Receiving, HIVShanika, Reeves

Outpatient CollectionsShanika Reeves

Pathology Support

Clinical Pathology

BSL SupervisorPatricia Dempsey

OIC BSLCPT Krishnasw amy


BioSafety Laboratory


OIC Blood Donor CenterMAJ Jason Corley

Medical DirectorMAJ John Schaber

Quality AssuranceTransfusion Medicine

Karen Royster

Civilian SupervisorVacant

NCOIC Blood Donor CenterSGT Isom, Cherise

Blood Donor Center


Medical DirectorMAJ John Schaber

OIC Blood Donor CenterCPT Jason Corley

Quality AssuranceTransfusion Medicine

Karen Royster

Civilian SupervisorShannon Grovenger

Transfusion Services

Transfusion Medicine

ChiefDepartment of Pathology

COL Bradley Harper

Which QSE is addressed?


Personnel

• Gains and Losses• New Employee Orientation

– Learning methods• AV- Audiovisual• V- Verbal• R-Review of Documents• I-In service

• Training• Competency assessment

– 6 month– Annual

ACTIONS

Leadership Introductions

Tour & Staff Introductions Lockers

Supply Room

Admin/Reception

Break Room

Location of SOP’s/Policies & Regulations.

Safety Manual

QA Manual

CHCS Manual

MSDS/ Hazardous Material Storage Location

DEPARTMENT POLICIES Hours

Leave

Personal Items/GOVT property Security

Essential Employees/ Inclement weather

Telecommunication/ Internet usage:

Directories/Paging/Roster sites

Hospital Parking Policy

Location & use of Emergency Red Power Outlets

PERFORMANCE Job Description

Performance standards

Personal conduct

Rating Scheme

Initiate Competency Assess. File -6pt folder

CHCS ACCESS

System Administrator (Laboratory)

Register for AKO Account

Register for WAMC Badge and Network access (WAMC form 25-1U)

SAFETY Fire Alarm Code (Bldg B. zone 06-07)

RACE/PASS

Evacuation rally point -(Back loading dock)

Fire alarm/ extinguisher locations

Emergency eye wash/showers

MSDS/HAZMAT storage

Code Responses (Yel, Blue, Orange, Purple, Silver, Pink, Red, Gold, Green)

Personal Protective Equipment usage

Needle Stick Procedures-Packets

Safety Accident Procedures- Packets

Use of ABC cart system

Isolation Techniques/ Ward rounds

TRAINING HIPAA online training

Anti-terrorism training

Hospital Orientation Scheduled

COMPETENCY METHOD LEVEL VERIFICATION

10. Observance of Lab Safety policies.

11. Oversees MLT training and ensures students meet accreditation standards.

12. Ensures staff is trained in all areas of the Chemical Hygiene Plan and EPP.

Verification Method Codes: Competency Level:C-Course/Class Presentation O-Observe Daily Workflow M-Mock Survey/Drill E-Exceeds ExpectationsD-Demonstration S-Self Assessment W-Written Example S-SatisfactoryG-Group Discussion/Case Study V-Verbalizes Knowledge Q-QI Monitor N-Needs ImprovementNA-Not Applicable I-In-service R-Review of Paperwork/QC/SOP

The above named employee is competent to perform the assessed skills on the Competency Assessment – Section Supervisor without/with listed exceptions. If any exceptions are listed, attach a separate sheet of paper listing the exceptions and plans for remediation.____________________________________ __________________________________________Signature Date Lab Manager Signature Date


QI MonitorLOG #7

SUBJECT POC OPENED FREQUENCY CLOSED

Microbiology Blood Culture Contamination Rate

Ms. Dempsey Jan 07 Monthly

ESTABLISHED THRESHOLD <3%

2007JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

Total # of Sticks

320

338 338

331 305 303 314 303 282 273

#Contaminates

12 6 13 5 9 5 16 11 10 9

% Cont 3.8% 1.8% 3.8% 1.6% 3.0% 1.7% 5.1% 3.6% 3.5% 3.3%

0.00%

1.00%

2.00%

3.00%

4.00%

5.00%

6.00%

JAN FEB MARCH APRIL MAY JUNE JULY AUG SEPT OCT NOV DEC

% Cont

Which QSE is addressed?


Integration into QI Program/Minutes

• QI Worksheet– Broken down by QSE– Submitted monthly

• By section supervisors• One week prior to QI meeting• Collated by Quality Manager

– Presented at QI meeting– Submitted as the QSE attachment to the minutes

WOMACK ARMY MEDICAL CENTER DEPARTMENT OF PATHOLOGY

FORT BRAGG, NC 28310

Quality Improvement Report Form

I. The report below is submitted by the _____________________ section for inclusion in the minutes for the (month) __________________QI meeting. II. Old Business QI Monitors/Issues:

TITLE: QA LOG #: (Circle one) Sentinel Indicator New Issue Old Issue

FINDINGS: CONCLUSION: RECOMMENDATION: ACTION: EVALUATION:

III. New Business A. Personnel 1. Gain/Losses:

2. Training Completions:

Individual ___________________ Completely Trained for __________________ 3. Competency Assessments:

Individual _____________________ Assessed for __________________ 4. Continuing Education Report (see attached attendance roster)

Class _________________________ Instructor______________________

B. Equipment 1. Demonstrations 2. Validations 3. Issues C. Purchasing and Inventory 1. Supply Issues 2. Contracts D. Process Control 1. Proficiency Testing Survey ____________# Responses____________#Acceptable______________ 2. Monthly QAP QA report form submitted Y N 3. SOP Updates E. Documents and Records -archived/updated/document control F. Information Management -Upgrades/downtime/issues G. Occurrence Management - DA4106 H. Assessments 1. Point of Care Testing report 2. Internal/External I. Process Improvement 1. Utilization Review item(s) a. TAT reports, etc b. Workload 2. New Tests in evaluation 3. Teams/Committee activity J. Customer Service and Satisfaction 1. Complaints – physicians, patients, staff 2. Satisfaction Surveys K. Facilities and Safety 1. Infection Control report 2. Safety Report Comments: ________________________________________________________ _________________________________ Section Supervisor


The Final Product

• QSE attachment to Department of Pathology monthly QI minutes

• All 12 QSEs addressed during QI meeting• Opportunity for discussions

– Add/correct items

• Laboratory Director and Laboratory manager as well as staff are aware of all quality activities at that snapshot in time