9125-QE Managing Equipment in the Blood Bank Laboratory 10/9/2010 2:00 PM - 3:30 PM

Transcription

1 9125-QE Managing Equipment in the Blood Bank Laboratory 10/9/2010 2:00 PM - 3:30 PM

2 Event Outline Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010, 2:00 PM to 3:30 PM Presenters: Theresa Downs, Sheri Goertzen, Nancy Shotas Speaker Theresa Downs Sheri Goertzen Nancy Shotas Presentation Documentation Needed to Manage Your Equipment Challenges in Documentation of Equipment Maintenance

3 Event Faculty List Event Title: 9125-QE Managing Equipment in the Blood Bank Laboratory Event Date: Saturday, October 09, 2010 Event Time: 2:00 PM to 3:30 PM Director/Speaker Theresa Downs MT(ASCP)SBB, CQA(ASQ) UH2F225/Box East Medical Center Drive Ann Arbor, Michigan, N/A, (734) Disclosures: No Speaker Sheri Goertzen MT(ASCP)BB, CLS(CA) 1779 E. Muncie Ave. Fresno, CA, (559) Disclosures: No Speaker Nancy Shotas BS MT(ASCP)BB CQA(ASQ) Laboratory - Blood Bank 2701 W. 68th Street Chicago, IL, (773) NShotas@holycrosshospital.org Disclosures: No

4 Managing Equipment in the Blood Bank Laboratory: Part 1 Equipment Standards Theresa Downs, MT(ASCP)SBB, CQA(ASQ) Selection Computers Qualification Warming Devices Use AABB Equipment Standards Alarm systems Identification Storage devices Monitoring/ Maintenance Why Do We Do This? Ensure The validity of data The safety, potency and purity of blood products 1

5 Equipment Qualification Timeline Selection Assess available equipment Decide on equipment Qualification Install Operate Perform Calibration/ Maintenance Verify data integrity Maintain equipment Equipment Selection Define selection criteria Why the equipment is needed Intended use What is available out there (pros and cons) Check manufacturer s websites for documentation QC, maintenance, cost Which one will best meet needs Manufacturer track record Equipment Qualification Ensures the equipment works as intended Uses IQ, OQ and PQ 2

6 Installation Qualification Establishes the instrumentation was received as specified Documents the proper installation and operability according to manufacturer standards. Local codes Safety Plugs Space Temperature Humidity Operational Qualification The process of demonstrating that an instrument will function according to the manufacturer s operational specifications under normal laboratory conditions. Does the equipment operate per manufacturer s instructions? Can maintenance/qc be performed per instructions? Performance Qualification A testing procedure designed to test the analytical instrument s functional performance to factory published specifications. Performs per laboratory specifications Documents integrity of equipment Documents intended use 3

7 Use of equipment Follow manufacturer s instructions!!!! Unique identification Traceability Maintenance/repair records QC records ACME Laboratory Monitoring and Maintenance Use manufacturer s instructions to determine Type of checks Frequency Acceptance criteria Actions for unsatisfactory results 4

8 Calibration Before use After repair At defined intervals Safeguards to prevent adjustments to calibration Investigation and Follow-Up Assessment of blood products Quarantine until determination is made Assessment of donor eligibility and donor and patient t safety Remove equipment from service Investigate the malfunction Re-qualify when repaired Reporting when indicated Storage devices Proper capacity for intended product Temperature monitored 5

9 Alarm systems Set to activate before unacceptable conditions Initiates process for investigation and corrective action Blood warmers Equipped with temperature sensing device Detect malfunctions Prevent hemolysis and other damage Computer systems Records Downtime processes Compliance Support of management of system Unauthorized access 6

10 AABB Meeting: 2010 Managing Equipment in the Blood Bank Laboratory : Part 2 Documentation Needed to Manage Your Equipment Sheri Goertzen, MT(ASCP)BB, CLS Objective Describe the documentation needed for management of equipment. Will include: examples which will be shared and discussed. Did you know the 2 nd most frequent CAP deficiency for 2009 (11.05%) was GEN Document Control Equipment Lifecycle Birth Plan, Justification, Quotes, Purchase or Lease Agreement, Installation, Validation, Training Life Quality Control, Calibrations, Service Contracts, Maintenance, Corrective Actions, Repair Records Death Decontamination, Decommission, Disposal Records

11 Birth Plan Budget Justification Quotes Acquisition Records / Purchase Order Service Agreements / Contracts Qualification: Installation, Operational, Performance Validation (if used in a process) Training So where do we begin? How much is involved? Depends on what kind of equipment. Does it perform a simple vs. complicated process? Keep a file folder for each piece of equipment Start with the acquisition documents and operator/user manuals. Add the qualification and validation documents. Continue to add service & repair records over the life of the equipment. Can be a paper file, an electronic file, or a combination of both. Records must be promptly accessible to the users of the equipment.

12 Example: EQUIPMENT QUALIFICATION WORKSHEET NEW EQUIPMENT Equipment Name/Model: REQUALIFICATION / MONITORING ACME Plasma Freezer XYZ/123 Vendor: ACME Date Received: 04/27/10 Asset #: Description & Purpose of the Equipment: The ACME Plasma Freezer is a storage device intended for use by appropriately trained and qualified personnel in hospital/laboratory/clinical settings for the purpose of storing frozen plasma products in the Transfusion Service. Purpose of Qualification: Establish documented evidence that the ACME Plasma Freezer consistently, with a high degree of assurance, produces proper storage conditions. EQUIPMENT QUALIFICATION WORKSHEET (cont.) Qualification Activities: Installation Qualification (IQ) Performed By: Plant Services/Engineering Date: 04/27/10 Initial Electrical Check Performed By: Biomed Date: 04/27/10 Operational Qualification (OQ) Performed By: Plant Services/Engineering Date: 04/27/10-04/28/10 Performance Qualification (PQ) Performed By: Tony Tech, MT(ASCP) Date: 04/27/10-05/02/10 Risk Analysis Performed By: Susie Supervisor Date: 04/28/10 Safety Analysis Performed By: Tony Tech, MT(ASCP) Date: 04/28/10 Regulatory Analysis Performed By: Susie Supervisor Date: 04/28/10 EQUIPMENT QUALIFICATION WORKSHEET (cont.) Equipment Calibration(s) Requirements: Calibrate internal thermometer and graph using an NIST traceable digital thermometer. Equipment Maintenance Requirements: Alarm checks, battery replacement and cleaning Maintenance Frequencies: Quarterly: Alarm check, battery check. Annually and As Needed: Cleaning probe bottle, interior and exterior. To be performed By: Laboratory staff Maintenance Procedure(s): Refer to Equipment manual, section 7.1 Spare/Repair Parts List: Refer to Equipment Manual Equipment Cleaning Procedure: Refer to Equip. manual, section 7.3 Operating Procedures Written: Refer to Equipment Manual Troubleshooting Guide Written: Refer to Equipment Manual Basic Procedures for Monitoring and Control of the Operation: Refer to procedure Q0321. Personnel Training Documentation Completed: N/A (Attach All Qualification/Validation/Training Documentation)

13 EQUIPMENT QUALIFICATION WORKSHEET (cont.) Interpretation of Equipment Qualification/Validation: Suitable for its Intended Purpose? Y N Installed Properly? Y N Functioning as Intended? Y N Qualification/Validation Successful? Y N Added to Critical Equipment List? Y N Added to Equip. Operating Limits List? Y N Supervisor Review: Date: Medical Director Review: Date: Date Equipment Placed In Service: Validation Protocol: Equipment Equipment being validated: ACME Plasma Freezer Asset Number: Date of Purchase: 04/16/10 Received: 04/27/10 Purpose / Scope: What is the equipment supposed to do? Materials/Supplies /Equipment: Responsibilities Who is involved in this validation and what is each of their roles? Verify reliable storage of frozen plasma products. NIST traceable digital thermometer for calibration. Supervisor: write the procedure & this validation plan. Medical Director: approve the procedure and plan. Blood bank CLS: complete the validation testing. Supervisor: review the validation and write summary. Medical Director: review/approve the validation results. Supervisor: develop training documents/program for staff & document competency of all staff using the validation results. Validation Protocol: Equipment (cont.) Risk Analysis Is patient or product safety affected should this equipment fail? Safety Analysis Are there any related hazards with this equipment? Regulatory Analysis Are there changes in licensure, registration, proficiency testing or accreditation needed? High Moderate Low N/A Failure of the plasma freezer will result in loss of one storage unit for frozen products. The alarm would alert us before products are destroyed and products would be moved to backup storage. There are no identified chemical or safety hazards with the plasma freezer. There are no identified changes in regulatory needs with the acquisition of the plasma freezer.

14 Validation Protocol: Equipment (cont.) Procedure / Steps: Include an adequate number of variables to test the process Expected Results / Acceptance Criteria Clearly define an acceptable end result. Statistically valid number of samples How is the sample size determined? Normal & Abnormal samples Verify that the plasma freezer is able to maintain proper temperatures. Calibrate the internal thermometer and graph using an NIST traceable digital thermometer. Verify that internal thermometer readings and graph readings are consistent with NIST traceable thermometer readings. Perform alarm checks. Plasma freezer should maintain proper temperatures consistent with NIST traceable digital thermometer within 2 C for at least 24 consecutive hours. Graph chart should be consistent with upper NIST traceable thermometer readings within 2 C for at least 24 consecutive hours. Manual alarm checks should verify audible alarm functionality at temperatures at or above -19 C. Proper temperature maintained for 24 consecutive hours monitored using the min-max read-outs of the digital thermometer and graph chart. Manual alarm check (upper sensor and lower sensor) performed successfully at least once. Validation Protocol: Equipment (cont.) Plan approval: Signatures and Dates Documentation/ Data Failures must be tracked, evaluated and resolved. Documentation / Data sheets Investigation / Resolution Re-execution validation Supervisor: Date Medical Director: Date Performance Qualification performed by Tony Tech on 04/27/10 05/02/10. Included: 04/27/10:Adjusting internal thermometer readings to match NIST traceable digital thermometer@-29c. 04/27/10:Adjusted graph to match readings. 04/28/10:Fine adjustment of graph. 04/28/10:Performed upper sensor automatic & manual alarm check successfully (-19 C) 04/28/10:Engineering/ Plant Services adjusted defrost cycles to twice per and 16:30. 04/28/10:Engineering/ Plant Services installed digital thermometer probes through interior path. 04/29/10:Performed lower sensor manual alarm check unsuccessfully. Corrective action: contacted ACME Tech Support and received guidance on activating the lower sensor alarm settings (using service code: 5354). 04/29/10:ACME Tech Support recommended to have defrost cycles remain at factory setting (3 times/ day). 05/01/10:Performed lower sensor manual alarm check successfully (-19 C). Validation Protocol: Equipment (cont.) Validation Summary: Review & Approval of Validation Results: Signature and Date Training / Competency The ACME plasma freezer was able to maintain proper storage temp. for 24 consecutive hours based on the data derived from the temperature logs, digital thermometer readings and temperature chart. The manual alarm checks for both upper and lower sensors at -19 C were successful. The validation was successful and it is recommended that the frozen plasma products be transferred from the backup freezer to the new ACME plasma freezer. Notes: The defrost cycles observed so far had a high temp. of C, which was considered an outlier. ACME tech support was contacted. We will monitor the defrost log for 1 week and follow up. "This validation study has been reviewed and the performance of the equipment is considered acceptable for regular operational use Medical Director: Date Whenever Applicable - Develop training document(s) & document Competency of all staff performing the process or using the equipment.

15 Life Quality Control Calibrations Service Contracts Maintenance Corrective Actions Repair Records Equipment Management Documents Maintaining a list of all critical equipment helps in the control function of scheduling and performing functional and safety checks, calibrations, preventive maintenance, and repair. Control Number Sample: Critical Equipment List Equipment / Model Serial Number Manufacturer Purchase Date Blood Processor 1627 COBE 07/07/ Heat Block Marsters Clay Adams 06/14/01 Retire Date Tube Sealer ACS Terumo 02/01/ Blood Refrigerator Jewett 07/20/00 BBR Plasma Thawer DH L Helmer 10/23/ Sterile Connecting Terumo 04/03/96 Device SCD Echo Analyzer M00615 Immucor 04/27/ Immufuge II Baxter Dade 06/06/ Cellwasher Sorvall 03/01/86 04/03/09

16 Control Asset Number Sample: Equipment Operating Limits List Equipment / Model Temperature Humidity Alarm Operating Limits Operating Limits Y/N Automatic Shut Down Y/N Blood Processor 55 F to 85 F Not defined N N Heat Block Marsters Not defined Not defined N N Tube Sealer ACS152 Op. Instructions: Do not install in a very hot and humid place. N N Blood Refrigerator 80% at 31 C Y N 5 C to 32 C IB120 50% at 40 C Plasma Thawer DH8 5 C to 35 C Not defined Y N Sterile Connecting 10 C to 38 C 10% to 80% N N Device SCD Immufuge II Not defined Not defined N N Cellwasher UltraCW 5 C to 40 C Not defined N N Quality Control QC testing is performed to ensure the proper functioning of materials, equipment and methods. QC records provide evidence that the process was performed as intended and provide information needed to assess the quality of products and services. Calibrations / Maintenance CAP TRM.32000: There must be a routine plan or maintenance schedule available for checking the critical operating characteristics of all the instruments in use on a regular, periodic basis. The procedure and schedule must be, at a minimum, as thorough and as frequent as specified by the manufacturer.

17 Sample: Maintenance Checklist Any Hospital Anywhere, State Alarm Checks: Refrigerators, Platelet Incubator, Freezer, Water Bath MLA Pipettes - Accuracy RPM - Centrifuges Timers - Centrifuges & Irradiator Scales - Accuracy Stopwatch - Accuracy Calibrate Serologic Centrifuges J A N F E B M A R A P R M A Y J U N J U L A U G S E P O C T N O V D E C The Joint Commission When Preventive Maintenance is performed on a piece of equipment, the documentation needs to state specifically that Manufacturer s guidelines were followed in performing the required preventive maintenance. Good idea add this statement and a check box on your PM documents!

18 Sample: Corrective Action- Equipment Date/Time: Department: Equipment Name: Asset #: DESCRIPTION OF PROBLEM: Does this problem create a possible patient safety issue? No Yes If yes, describe investigation and action taken for resolution: Taken out of service by: Date/Time: Corrective Action- Equipment (cont.) Type of service required: IN-LAB Vendor Service Hospital Engineer Service call initiated to: Date/Time: Expected arrival Date/Time: Response by: Date/Time: Delayed TAT Process Required? No Yes If yes, initiated by: Date/Time: CORRECTIVE ACTION TAKEN: (include date/time of each action) Complete upon resolution of problem: Document Performance Criteria according to specific test protocol before reporting patient results: CALIBRATION Acceptable Not Required PATIENT SAFETY F/U Acceptable Not Required QUALITY CONTROL Acceptable Placed back in service by: Date/Time: Repair Records Repair records should be kept with each equipment s history file. Should include: In-House repair Service tech repair Help-Line / Remote repair Repair reports and Corrective Action sheets are important to maintain a chronological & comprehensive Equipment History Record.

19 Sample: Equipment History Record EQUIPMENT: Asset No.: Model No.: Serial No.: Date Purchased: Cost: Manufacturer: City: State: Zip: Telephone: Contact Person: Dealer: City: State: Zip: Telephone: Contact Person: Warranty: Expiration Date: Technical Representative: Telephone: SERVICE RECORD Date Comments Who contacted, action taken When there s just no more fixing that can be done Death Decontamination Decommission Disposal Records

20 Sorry there is a bit more involved in disposing of an old worn-out friend Sample: Asset Decommission Form Name of Supervisor: Department: Cost Center: Asset Name: Asset #: Serial Number: Begin by reviewing the manufacturer s recommendations for shut down, removal from service and/or disposal. Comments: Removal of all liquid reagents. Decontamination of external/accessible surfaces. Brief description of asset: Deletion of patient information to comply with HIPAA regulations. Deletion needs to be "destructive" enough to remove any patient information, but still allow for the equipment to be functional in the event of a sale to another buyer. Date Completed Sample: (cont.) Asset Decommission Form Plan for final disposition of asset: Notification to BioMed to remove the asset from the Safety Checks list & any Maintenance Agreements. Notification to Laboratory LIS System Administrator to deactivate any interfaces. Notification to stop any other service contracts on the asset. Referral to BioMed for disposition when determined appropriate. Notification to Accounting when the instruments are actually removed from the premises and require removal from the Laboratory Assets Lists. Technical Supervisor Final Check List: All related procedures/forms updated or changed. Removed from department asset list. CAP contacted to update equipment list. Date Completed

21 How long must we save these records? AABB Reference Std. 6.2C CAP TRM Years Equipment Qualification 5 Equipment Validation 5 Unique Identification of Equipment 5 Instrument Quality Control 5 Monitoring and Maintenance 5 Temperature Monitoring 5 Temperature Monitoring of Tissue (CAP) 10 Irradiation Dose Delivery 5 It s a good idea to save your equipment files for the life of the equipment plus a few more years. If records are maintained electronically, adequate backups should exist in case of system failure. Sample: QSE: Equipment Self-Assessment Checklist Records are maintained for each item of equipment contributing to the performance of examinations. These records include at least the following: YES NO Identity of the equipment; Manufacturer s name, type identification, and serial number or other unique identification; Manufacturer s contact person and telephone number, as appropriate; Date of receipt and date put into service; Current location, where appropriate;

22 Condition when received (e.g., new, used, or reconditioned); Manufacturer s instructions, if available, or reference to their retention; Equipment performance records that confirm the equipment s suitability for use; to include: copies of reports/certificates of all calibrations and/or verifications including dates, time and results, adjustments, the acceptance criteria and due date of the next calibration and/or verification, the frequency of checks carried out between maintenance / calibration, as appropriate YES NO Maintenance carried out and maintenance planned for the future; Damage to, or malfunction, modification, or repair of, the equipment; YES NO Predicted replacement date, if possible. Records are maintained, and readily available for the life span of the equipment or for any time period required by law or regulation. Up-to-date instructions on the use and maintenance of equipment (including any relevant manuals and directions for use provided by the manufacturer of the equipment) are readily available to laboratory personnel. Contact information Sheri Goertzen, MT(ASCP)BB, CLS Transfusion Service Children s Hospital Central California sgoertzen@childrenscentralcal.org

23 References: AABB Standards, 26 th Edition AABB Technical Manual, 16 th Edition AABB Assessment Tool, 11/01/09 CAP Checklist, 6/15/09 CLSI The KEY to Quality, 2007 CAP Audioconference Checklist Updates, 9/15/10

24 AABB Meeting: 2010 Managing Equipment in the Blood Bank Laboratory: Part 3 Challenges in Documentation of Equipment Maintenance Nancy M. Shotas, MT(ASCP)BB, CQA(ASQ) Objective Discuss challenges in documentation of equipment maintenance when other departments service Blood Bank equipment. Will include: when others are involved in the life cycle of BB equipment

25 Equipment Lifecycle Birth Plan, Justification, Quotes, Purchase or Lease Agreement, Installation, Validation, Training Life Quality Control, Calibrations, Service Contracts, Maintenance, Corrective Actions, Repair Records Death Decontamination, Decommission, Disposal Records Birth Plan Budget Justification Quotes Acquisition Records / Purchase Order Service Agreements / Contracts Qualification: Installation, Operational, Performance Validation (if used in a process) Training BIRTH

26 Birth Complications: Plan ex. Freezer You re not a refrigeration expert You know regulatory requirements! Possible action steps: - Incorporate help from inside expert - Chart options for review by biomed / inside expert (include specs the stuff you don t understand, they do!) - Get a signature to document decision! Birth Complications: Justification Hospital has no $$$ Administration says it s not a priority Possible action steps: - Letter from Maintenance - Medical Director involvement - Justify with increased TAT; patient care issues; extra $$$ if not replaced, including supply loss Birth Complications: Purchase o BEWARE!! - Your boss will handle it - Purchasing director will handle it o Have you outlined / have they asked about regulatory needs? o Are these needs being met? o Don t forget city/county/state requirements!

27 Birth Complications: Installation Who does what? Maintenance/ Biomed? Where will they document? Time line? Possible action steps: - What does your Quality Plan say to do? - YOU have to ensure all is done - YOU may have to create forms as needed Life Quality Control Calibrations Service Contracts Maintenance Corrective Actions Repair Records LIFE

28 Life: Who does what? Done by BB staff Done by in-house Maintenance Done by in-house Biomed Done by company service tech Documentation must be there! Life: BB staff Proper tools (ex. Calibrated thermometer, tachometer; correct range?) Proper operation of tools Schedule (that is followed) Initiative, knowledge, training Accountability You may need to be vigilante! Computerization of schedule may help (generates reminders) Documentation Hospital personnel Maintenance? Biomed? OTHER? Old /new staff do they understand what needs to be done? Lack of cross-trained maintenance staff Documentation - Copy of their form - Directly on your form IDEAL: BB has on line access to ALL documentation (maintenance; biomed)

29 Contracted service What is defined in contract? If you want/need more done, communicate BEFORE contract renewal Contracted services (ex. Biomed) come and go.you need to maintain continuity Reminder: Verification of service tech certification (pre-contract/include in contract) Documentation Life: Service Contracts What is covered? NOT covered? Service hours? Timeliness of service tech Skill level of service tech Ensure documentation Is QC OK before service tech leaves? Contract renewal: who s responsible? DON T LET CONTRACT LAPSE!! Hardships in Life Missing equipment a.k.a. death of unknown causes Additional equipment miraculously walks into your department Lab cleaners pre-inspection dumpster..leads to missing equipment

30 Death Decontamination Decommission Disposal Records DEATH Decontamination More than cleaning with H 2 O? Who will do this? Document

31 Decommission Biomed Accounting LIS Purchasing (ex. service contracts) Others? Do they KNOW what needs to be done? Document: disposal records! You will always be on the lookout..

32 for complete documentation of equipment life cycle Wait.. you started a new job, and in the cycle of life, we call that...inheritance! Inheritance Missing Documentation o Acquisition Records o Qualification o Installation o Etc. Now What????

33 Back to the Basics: Possible action steps Refer to quality program (QP), policies & SOPs Meets AABB standards? Other regulations? Yes begin to look for missing documentation. If not, you have another place to begin (Updating QP, SOPS) Ask first! (Possible action steps) Documentation in Record Storage? Purchasing Records? Maintenance Records? Biomed Records? Ask techs? Take action Document what you know Document what you don t know & why Requalify / revalidate? Use available historical data GOAL: Thorough and complete documentation, as per your QP, SOPs.

34 Ensure Why Do We Do This? Justification of decisions The validity of data The safety, potency and purity of blood products Regulatory Compliance!! FDA AABB CAP JCAHO OTHERS Your Quality Plan, defined processes, SOPs and forms are the backbone you need for good equipment maintenance and documentation! Must work together.follow what you have defined!

35 Remember With Good Equipment Maintenance and Documentation..what a wonderful world it will be!!! Contact information Nancy M. Shotas, MT(ASCP)BB, CQA(ASQ) Blood Bank (Transfusion Service) Holy Cross Hospital Chicago, IL Nshotas@holycrosshospital.org

36 Questions?