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Quality Procedures and Work Instructions

Manual

Revision Number: (1)

ISSUED TO: ____________________________________ MANUAL NO: __________________________________ REVISION NO: _________________________________ ISSUE DATE: ___________________________________ _______________________ ___________ President Date

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Quality Procedures and Work Instructions Manual

Section Page Date Revision ii. Table of Contents 1 of 4 0

Section Number Name Revision Date

i. Title Page ii. Table of Contents 1.0. Management Review 2.0 The Quality System 3.0. Contract Review 5.0. Document and Data Control 5.1 Document Preparation and Issue 5.2 Writing a Quality System Document 6.0. Purchasing 6.1 Approved Supplier Selection 6.2 Purchase Requisition Expenditure Authorization 6.3 Routine Purchase Request 6.4 Urgent Purchase Request 6.5 Standing Order Purchase 6.6 Petty Cash Purchase 6.7 Purchase Requisition Form Completion 6.8 Outstanding Order Progress 6.9 Using a Courier 6.10 Outside Work

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Section Number Name Revision Date 7.0. Control of Customer-Supplied Product 8.0. Product Identification and Traceability 9.0. Process Control 9.1 Special Processes 9.2 Emergency Call 9.3 Inspection 9.4 Risk Assessment of Patient Care Devices 9.5 Selecting Inspection and Preventive Maintenance Items 9.6 Inspection and Preventive Maintenance Scheduling 9.7 Transferring Equipment 9.8 Using the Equipment Management Software 9.9 Training Record Creation 9.10 Training Work Order Creation 9.11 Resource Allocation 9.12 Purchasing Advice 9.13 Equipment Evaluation

9.14 Soldering

10.0. Inspection and Testing 10.1 Incoming Goods Inspection

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11.0. Control of Inspection, Measuring,

and Test Equipment 12.0. Inspection and Test Status 12.1 Equipment Status Tag Completion 12.2 Incoming Work 12.3 Work Dispatch 13.0. Control of Nonconforming Product 13.1 Customer Complaints 14.0. Corrective and Preventive Action 14.1 Performance Reports 15.0. Handling, Storage, Packaging, Preservation, and Delivery 15.1 Stock Issue 15.2 Stock Control 15.3 Handling and Storage of Static-Sensitive Devices (SSDs) 15.4 Handling of Mercury 15.5 Handling of Contaminated Equipment

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16.0. Control of Quality Records 16.1 Computer Backup 16.2 Filing of Work Records 16.3 Medical Equipment Service Report Completion 16.4 Medical equipment Service Report and Equipment File Checking 16.5 Equipment File Completion 16.6 Part Record Creation 16.7 Project File Input 16.8 Work Order Completion 16.9 Project Work Order Input

17.0 Internal Quality Audits 17.1 Quality Assurance Program 17.2 Quality Assurance Indicators for Patient Care Devices 18.0. Training 19.0. Servicing 19.1 Maintenance of Medical Devices 19.2 Service Standards 20.0 Statistical Techniques

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Introduction

This document, Quality Procedures and Work Instructions, hereafter referred to as QPWI, contains or references all procedures and work instructions required to ensure the satisfactory operation of Legacy Biomedical (LEGACY BIOMEDICAL) quality system as described in our Quality System Manual. QPWI is divided into sections (1.0 to 20.0) corresponding to the ISO 9002 Standard entitled, Quality Systems –Model for Quality Assurance in Design, Development, Production, Installation, and Servicing, and LEGACY BIOMEDICAL’s Quality System Manual. Each section may contain a combination of procedures and work instructions. Procedures will detail the who, how, when, where, and why of a particular function or process undertaken by the organization and have a set structure (purpose, scope, references, definitions, procedure, and documentation). Work instructions are detailed step-by-step instructions that explain how to carry out a particular task. All procedures and work instructions are written in accordance with the “Writing a Quality System Document” procedure (see Section 5.2 of this document).

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Section Page Date Revision 1.0 Management Review 1 of 4 0

A. Purpose

This procedure describes the review of the suitability and effectiveness of LEGACY BIOMEDICAL’S quality system by management.

B. Scope

This procedure shall apply to any management review of any component of LEGACY BIOMEDICAL’S quality system.

C. References LEGACY BIOMEDICAL Quality System Manual Joint Commission for the Accreditation of Healthcare Organizations (TJC) Title 21 Code of Federal Regulations American Society for Healthcare Engineering D. Definitions See LEGACY BIOMEDICAL Quality System Manual E. Procedure 1. The need for a review

a. The need for a review of any component of the quality system may arise from one or more of the following sources:

i) LEGACY BIOMEDICAL staff.

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Any staff member may indicate problems with, or possible improvements to, the quality system procedures, work practices, work output, product performance, documentation, or records.



ii) Customers.

A customer, through a suggestion, comment, or complaint, may highlight a component of the quality system that requires review.

iii) Performance reports. Reports produced by performance analysis of work done may indicate areas of the quality system that should be reviewed.

iv) Internal and External Audits. Regular audits of the quality system may highlight components that need review.

b) Matters requiring review arising from any of the above sources shall be directed for

discussion and action, if necessary, to the Quality Assurance Council.

c) Information on such matters shall be provided to the Council through one of the Council members. Our staff members shall direct their comments to their Site Manager who sits on the Council. Council members shall then pass this information on to the Director, Quality Assurance, who shall include it on the agenda for the next Quality Assurance Council meeting.

d) The agenda for each meeting shall be made available to each Council member, with a copy placed on LEGACY BIOMEDICAL’ general bulletin board, no later than three days before each meeting.

2. Quality Assurance Council

a) The function of the Quality Assurance Council is to discuss, investigate, and resolve all matters affecting the quality system, the effectiveness of the quality system, the stability

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of the system in adapting to customer and business needs, and its compliance with the quality standard and quality system objectives.



b) This can include work practices, procedures, documentation, suppliers, complaints,

corrective and preventive actions, resource allocation, training, performance, and objectives. Its main purpose is to maintain and improve LEGACY BIOMEDICAL’ quality of service.

c) The Council consists of the Director, Quality Assurance, the Purchasing Manager, and

the Site Managers. Other staff members may be asked to attend, if appropriate, or may raise matters through an appropriate Council member.

d) The Director, Quality Assurance shall chair and may designate another member to take

minutes during the Council meetings. e) The Council shall meet every month but can meet more often if necessary.

f) The December Council meeting each year shall be used to review LEGACY

BIOMEDICAL’ performance over the previous 12 months and to formulate objectives for the next year.

g) The Council shall decide whether a matter placed on the meeting’s agenda requires

further action. 3. Responsibility for Review

a) Matters raised during a Quality Assurance Council meeting that require action shall be directed to the appropriate Council member who shall be responsible for investigating, responding to, and, if necessary, correcting the matter.

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b) Other procedures, such as “Document and data Control” (see Section 5.0), “Control of Nonconforming Product” (see Section 13.0), or “Corrective and Preventive Action” (see Section 14.0) may need to be invoked.



4. Records of Review

a) Minutes of the Quality Assurance Council meetings shall be taken as a record of all reviews undertaken.

b) The minutes shall be signed by the Director, Quality Assurance to authorize any actions

arising from the meeting.

c) The minutes of each meeting shall be circulated to all staff members, and copies of all minutes shall be kept for reference in the Quality Assurance Council meetings file in the Director, Quality Assurance’s office.

5. Verification of Action

a) Matters requiring action shall stay on subsequent Council meeting agendas until the Council is satisfied that the matter has been adequately resolved and that the proper corrective actions have been carried out.

b) Verification of action shall be confirmed by consulting the source of the review (i.e., staff

member or customer). This person shall be consulted to determine whether he or she is satisfied with the outcome of the review, measuring the success of the action from performance reports, or verification of the action through the next internal or external audit. This verification shall be recorded by the source of the review initialing the relevant entry in the Quality Assurance Council meeting minutes.

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F. Documentation

Documentation and Data Control Procedure (Section 5.0) Control of Nonconforming Product Procedure (Section 13.0) Corrective and Preventive Action Procedure (Section 14.0) Quality Assurance Council meetings file


Section Page Date Revision 2.0 The Quality System 1 of 5 0

A. Purpose

This procedure describes the establishment and maintenance of the quality system documentation required to meet the quality policy.

B. Scope

This procedure shall apply to any component of LEGACY BIOMEDICAL’ Quality system. These components include the Quality System Manual, quality procedures, and specific work instructions.

C. References LEGACY BIOMEDICAL’ Quality System Manual D. Definitions None E. Procedure 1. General

a) LEGACY BIOMEDICAL’ quality system has been established and shall be maintained in accordance with the requirements of ISO 9002. The quality system shall include the following elements:

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i) The Quality System Manual ii) QPWI ii) Nationally recognized standards iv) Third-party documentation v) Quality forms vi) Test specifications vii) Quality records viii) Management review of the quality system ix) Audits b) All quality documentation, including electronic data, shall be controlled as per the

“Document and Data Control” procedure (see Section 5.0), and all new documentation shall be logged and recorded as per the “Document Preparation and Issue” procedure (see Section 5.1). The format of all quality documents shall be as per the “Writing a Quality System Document” procedure (see Section 5.2). A complete list of all controlled quality system documentation, detailing current revision and distribution, is given in the documentation database.

c) All staff members are required to be aware of quality system requirements and to

implement those parts of the quality system that are applicable to them. d) The Quality Assurance Council shall ensure that the following steps take place:

i) The procedures developed comply with the objectives of the quality system and the requirements of ISO 9002.

ii) Those activities that should be subject to procedures have properly documented procedures and instructions written for them.

iii) The quality system and its documented procedures are effectively implemented. Refer to the “Management review” procedure (see Section 1.0).

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e) Regular audits, as described in the “Internal Quality Audits” procedure (see Section

17.0), shall ensure that the quality system procedures and instructions are being implemented in practice.

f) All staff should be aware of changes in technology, instrumentation, and techniques that

may bring an improvement in quality assurance. g) Whenever possible, a standard of acceptability will be defined for each aspect of

LEGACY BIOMEDICAL’ work that affects quality. This may be to a nationally recognized standard, a manufacturer’s specification, or a standard set by management.

h) All controls, processes, equipment, personnel, training, and other resources required to

achieve the required quality shall be identified and acquired. i) New processes, inspections, or tests shall be checked for compatibility with current

practice. Refer to the “Process Control” procedure (see Section 9.0) j) All records that verify that the requirements of the quality system are being met shall be

identified and maintained as per the “Control of Quality Records” procedure (see Section 16.0)

k) When changes are made to the structure of LEGACY BIOMEDICAL, the quality system

may need to be updated by agreement with the Director, Quality Assurance. 2. Production of Quality Plans

a) Quality plans are usually in the form of a reference to the appropriate documented procedures that form an integral part of our quality system. However, a quality plan may be produced for groups of products and services or individual products and services when:

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i) New processes, services, or products are developed; ii) A major improvement in a product or service is required; iii) Major changes in purchasing or subcontracting are made; and/or

iv) A major new assignment is undertaken or a proposal for a major project is prepared.

b) With regard to design and development work, a quality plan, known as a design plan,

shall be produced for each project. c) With major customers or with new types of work not undertaken before, the customer

shall be offered the opportunity to participate in the preparation of the quality plan. d) The quality plan needs to address the following issues: i) Assessment of current situation (e.g., existing production, competitors)

ii) Assessment of desired performance (e.g., customer requirements, competitor performance, market need)

iii) Assessment of tasks and processes necessary to reach desired performance iv) Resources required and staff responsible for these resources and carrying out

tasks v) Documents and other records that will be created and how they will be managed vi) Equipment required, if any vii) Costs of these resources and date when they will be required viii) Specification of measurements, tests and inspections for input, processes, and

final product ix) Specification of process control x) How satisfactory achievement of quality plan will be measured

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F. Documentation

LEGACY BIOMEDICAL’ Quality System Manual Document and Data Control Procedure (Section 5.0) Document Preparation and Issue Procedure (Section 5.1) Writing a Quality System Document Procedure (Section 5.2) Internal Quality Audits Procedure (Section 17.0) Process Control Procedure (Section 9.0) Control of Quality Records Procedure (Section 16.0) Quality Plan Cover Sheet Quality Plan File Project file

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Section Page Date Revision 3.0 Contract Review 1 of 6 0

A. Purpose

This procedure describes the process that ensures that contract requirements between LEGACY BIOMEDICAL and its customers are documented and understood and that the resources are available to fulfill the contract. It also details how records of the review are maintained.

B. Scope

This procedure shall apply to any repair, design, development, or service contract supplied by LEGACY BIOMEDICAL to its customers.

C. References LEGACY BIOMEDICAL Quality System Manual. D. Definitions None E. Procedure 1. Definition and Documentation of Requirements

a) All staff members are responsible for ensuring that requests from customers are correctly processed and recorded as described in this procedure. If a request is received directly by a staff member who is not familiar with the type of work requested, then he or she shall:

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i) Redirect the customer to a staff member who can process the request, or, if this is not possible,

ii) Record the basic details of the request (i.e., location, contact name, contact number) on a Medical Equipment Service Report (MESR) and pass that MESR on to the appropriate senior technician or Site Manager.

b) All maintenance, repair, installation, training, and commissioning work shall be initiated

by filling out an MESR. This MESR shall be processed as follows:

i) If the work is physically received, such as work being delivered to the depot receiving area, the “Incoming Work” work instruction (see Section 12.2) shall be followed.

ii) If the work request is received by telephone, mail, or in person, step no. 1 of the “MESR Completion” work instruction (see Section 16.3) shall be followed.

c) All design and manufacturing work shall be processed and recorded as per the “Design

Control” procedure (see Section 4.0)

d) A customer’s requirements shall be fully understood, any uncertainties clarified, and the contract or order documented before undertaking the work. This requires the following:

i) The customer shall define exactly what is required. For work received

accompanied by an Equipment Service Request (ESR), if the details conveyed on the ESR are unclear or conflict with any problems found, the customer shall be consulted to properly define the work request.

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ii) For work requests made by telephone and other relatively simple requests, the customer’s work details shall be recorded on an MESR and confirmed by summarizing the work done on the Equipment Status Tag attached to the work when returned to the customer. If the work is delivered to the customer personally, the work done shall be confirmed verbally.

iii) For more complex products and services, such as design and manufacturing, a

written specification from the customer shall be requested or the customer shall be aided by LEGACY BIOMEDICAL staff in the preparation of the specification. The specification shall be reviewed with the customer to ensure that it is accurate. This process is outlined in the “Design Control” procedure (see Section 4.0).

iv) Special delivery and packaging instructions, if requested, shall be recorded on the

“Equipment Status Tag”. v) Any cost to be incurred by the customer shall be clearly srated and understood by

the customer. vi) Contingencies affecting the cost or delivery schedule shall be identified, and the

customer shall be made aware of the effect on cost and delivery. vii) Contracts or orders shall be properly authorized by the customer.

2. Resource Requirements

a) Contracts and specifications shall be reviewed to ensure that the equipment, staff, and other resources required to carry out the work are available. This process is outlined in the “Resource Allocation” procedure (see Section 9.11) These resources may include the following:

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i) Personnel availability ii) Personnel capability iii) Personnel training requirements iv) Material availability v) Facilities and equipment availability vi) Facilities and equipment capabilities vii) Subcontractor requirements viii) Response time or delivery date requirements b) If deficiencies exist, these shall be discussed with the customer. c) Customers shall be advised of any likely delays in delivery of goods or services as soon

as possible after LEGACY BIOMEDICAL becomes aware that the delays are possible. d) For all major assignments and proposals prepared, such as design or manufacturing, a

plan is prepared that describes what will be done, when it will be done, and the resources it will require. This includes, if applicable, an estimate of the number of work-hours and the cost of materials required. Refer to the “Design Control” procedure (see Section 4.0).

e) If staff require training before they carry out an assignment, this shall be identified,

scheduled, and carried out before they work on the contract. 3. Use of Suppliers and Subcontractors

a) The procedures and policy set out in the “purchasing” procedure (see Section 6.0) shall be used to asses and select suppliers. If a supplier shall be involved in a contract undertaken by LEGACY BIOMEDICAL, it shall be confirmed that the supplier can carry out its requirements of the contract.

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b) If a subcontractor or supplier is making a key input to a customer contract, the supplier

shall be required to apply duplicate conditions to those required of LEGACY BIOMEDICAL by the customer.

c) For each supplier and subcontractor of quality-related inputs, there shall be a designated

contact in LEGACY BIOMEDICAL. This shall usually be the Site Manager that is using the output of the supplier. The Site Managers shall be provided with a copy of any contracts with suppliers relevant to their work.

4. Contract Changes

a) If any change occurs that has an effect on a contract (e.g., a delay), the staff member undertaking the work shall:

i) Advise and review with the customer how this change will affect the contract; ii) Obtain agreement from the customer for the change; iii) Document the change and customer notification and agreement on the applicable

MESR or project file as per the “MESR Completion” work instruction (see Section 16.3) and “Design Control” procedure (see Section 4.0), respectively; and

iv) Notify all appropriate staff of the changes.

b) When an agreement on a change cannot be satisfactorily reached with the customer, the staff member undertaking the work shall pass the negotiations on to the appropriate management member.

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5. Records

All records of contracts and contract reviews, such as ESR’s, MESR’s, and project files, shall be stored and maintained according to the record storage policy set out in the “Control of Quality Records” procedure (see Section 16.0)

F. Documentation

ESR MESR Equipment Status Tag Control of Quality Records Procedure (Section 16.0) Purchasing Procedure (Section 6.0) Design Control Procedure (Section 4.0) Resource Allocation Procedure (Section 9.11) MESR Completion Work Instruction (Section 16.3) Incoming Work Work Instruction (Section 12.2)

G. Appendix Figure 3.1 represents a diagram of the contract review processes.

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Section Page Date Revision 4.0 Design Control 1 of 1 0

LEGACY BIOMEDICAL is not engaged in design and development. If, at a future date LEGACY BIOMEDICAL engages in design and development, Policies and Procedures will be written at that time.

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Section Page Date Revision 5.0 Document and Data Control 1 of 8 0

A. Purpose This procedure describes the approval, issue, and modification of quality system documentation. B. Scope

This procedure shall apply to all quality system documentation used by LEGACY BIOMEDICAL. This documentation shall include the following: Externally supplied documents (e.g., third-party manuals, standards) Documentation written in-house (e.g., procedures, work instructions, design plans, contract

specifications, drawings, audit schedules) Computer software (e.g., work records, procedure generating programs, databases) Records (e.g., work records, audit reports, forms, purchasing data)

C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure 1. General

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a) All controlled documents shall be identified and listed in the documentation database. These documents shall be monitored and updated when necessary. Information in controlled documents can be reliably considered accurate and up to date.



b) Uncontrolled documents (i.e., not in the documentation database) may be held in

LEGACY BIOMEDICAL and referred to. However, before using information from an uncontrolled document for repair, design, or purchase, the information must be confirmed to be correct by contacting the supplier or originator of the document. Examples of uncontrolled documents include pamphlets, brochures, and catalogs.

2. Document Approval

a) All documents associated with the quality system shall be reviewed for accuracy and correctness.

b) The Quality Assurance Council is authorized to delegate the review and approval of

quality system documentation to selected personnel. These personnel and the documents they are authorized to approve are detailed in table 5.1.

c) The Quality Assurance Council shall approve the format of all quality documents,

including forms and software.

d) The reviewing and approving officer reviews the document to ensure that i) The document expresses the quality policy, ii) Suppliers and customers receive due consideration, and ii) The document is practicable.

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e) Where applicable, new documents shall have their status sheets signed by the appropriate approving officer before being released for use. For software, the accompanying manual’s status sheet shall be signed.



Table 5.1. Review and Approval

Review and Approval Document Type

Director, Quality Assurance Procedures and work instructions Forms Purchase data and specifications Contract specifications Quality plans Training schedules Quality Control Managers Standards Audit schedules Software Site Managers Third-party manuals In-house manuals In-house maintenance procedures Reference manuals Drawings

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f) Any staff member may make comment on the need for new documentation. These comments shall be directed to a Site Manager for review.

g) The procedure for the writing of new documentation is described in the “Writing a

Quality System Document” procedure (see Section 5.2). h) The control of quality records is as defined in the “Control of Quality Records” procedure

(see Section 16.0). 3. Document Issue and Distribution a) A list of all quality system documents is maintained in the documentation database.

Site Managers are responsible for recording documents in the database.

b) Depending on the type of document, the documentation database shall indicate for each document such information as the document number, title, revision, issue date, and distribution. The database shall also provide a label for each controlled document that uniquely identifies that document. The process of recording and issuing documentation is detailed in the “Document Preparation and Issue” procedure (see Section 5.1).

c) The Quality Control Managers shall check that the Site Managers prepares, issues, and

maintains documents in accordance with procedures.

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d) All revisions to a document shall be distributed to locations or individuals as listed in the documentation database.

e) Site Managers shall ensure that appropriate documentation is available at the required

locations. f) Controlled documents are issued only to staff who are authorized to receive them and

who have agreed to respect the confidentiality of these documents.



4. Document and Data Changes

a) Documents may be changed and updated in response to requests from customers, audits or reviews. The original authors of documents and data shall be responsible for the updating of documents.

b) Changes to documentation shall be reviewed for accuracy and correctness and approved

for adequacy by staff authorized by the Quality Assurance Council. This authorization is as detailed in paragraph 2(b) of this procedure.

c) Where applicable, changes to documents shall be reflected in the following ways:

i) On their status sheets, which shall be signed accordingly by the approving officer; ii) By a vertical line in the right-hand margin opposite the change; and iii) By a new issue number, which shall be allocated as per the “Document

Preparation and Issue” procedure (see Section 5.1).

d) Any staff member may comment on the need for changes to documentation. These comments shall be directed to their immediate supervisor for review with the applicable officers and action if agreed.

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e) Particular care shall be given to the effect of a change in a document on other related documents.

f) If, in reviewing a change to documentation, the approving officer believes that proposed

changes may have cost ramifications, a major effect on normal procedures, or an effect on other processes not under his/her supervision, then these changes shall be discussed with, and approved by the Quality Assurance Council.



g) The current issue status (revision) of all quality system documentation is recorded and

maintained in the documentation database. h) The documentation database indicates the location of all copies of documentation that

require reissue and produces this list on a document update sheet. This procedure also produces a record of the document updates (the document update sheet), which is maintained by the Director, Quality Assurance. A new document or an amendment shall be issued to all those locations or individuals named on this sheet.

i) Revised documents shall be given a new issue number, and the entire document shall be

reissued when more than half of the individual pages have been changed. j) Status sheets shall be updated to reflect the revision status of, and changes to,

documentation. k) Customers shall be advised of changes to documents normally issued to them and shall be

sent the revised copy if the document is a controlled document. If changes to a document will have a significant impact on the nature or quality of product or service, the customer shall be advised of the impact of these changes.

5. Removal of Obsolete Documents

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a) Documents that are obsolete shall be clearly stamped “Obsolete” or “Superseded” on

their cover. The document’s obsolete status shall be noted in the documentation database.



b) Site Managers shall ensure that obsolete documents are promptly removed. c) Quality Control Managers shall regularly conduct inspections to ensure that no

uncontrolled copies of documents are in use. d) Quality Control Managers shall maintain copies of all obsolete documentation for

reference, legal, and other purposes. e) The Quality Assurance Council shall monitor the use of documents and follow up any

misuse of documents as advised by the Quality Control Managers or others. It shall also monitor any corrective action arising from misuse of documents. Any outstanding corrective action that is more than two months old shall be referred to the Director, Quality Assurance.

6. Storage of Documents

a) All documents, including completed forms and other records, both computer based and hard copy, shall be stored so that they are easily retrieved. All controlled documents shall be recorded in the documentation database as outlined in the “Document Preparation and Issue” procedure (see Section 5.1) and the Documentation database User Manual.

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b) Computer records shall be backed up using the “Computer Backup” procedure (see Section 16.1), and backups shall be recorded in the computer backup file. Where possible, computer-based backup copies of documents shall be stored at a location remote from the location of the original file. Refer to the “Computer Backup” procedure (see Section 16.1) for the current storage location.

F. Documentation

Document Preparation and Issue Procedure (Section 5.1) Writing a Quality System Document Procedure (Section 5.2) Documentation Database Document Update Sheet Computer Backup Procedure (Section 16.1) Computer Backup File

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Section Page Date Revision 5.1 Document Preparation and Issue 1 of 8 0

A. Purpose This procedure describes the method of preparation and update of quality system documentation. B. Scope This procedure shall apply to all quality system documents used in LEGACY BIOMEDICAL. This

documentation shall include the following:

Externally supplied documents (e.g., third-party manuals, reference books, standards) Documentation written in-house (e.g., procedures, work instructions, contract specifications,

drawings, audit schedules) Computer software (e.g., work record programs, procedure- generating programs, databases) Records (e.g., work records, audit reports, forms, purchasing data)

C. References LEGACY BIOMEDICAL’ Quality System Manual

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D. Definitions None E. Procedure 1. General

a) Officers responsible for the review and approval of quality system documentation are as defined in the “Document and Data Control” procedure (see Section 5.0)



b) Each quality system document shall have a unique number assigned by the appropriate

responsible officer.

c) All quality system documentation shall be logged into the documentation database, providing information such as issue, storage location, etc. For instructions on using the documentation database, refer to Documentation Database User Manual.

2. Externally Supplied Documentation a) Installation, Operation, and Service Manuals.

Inspection, preventive maintenance, and repair will normally be carried out in accordance with the original manufacturer’s/supplier’s manuals and drawings (including, where applicable, authorized modifications). Newly received manuals shall be logged into the technical documentation section of the documentation database and marked with a label. This database holds the following information (information on label as indicated): i) Unique identification number ii) Device type

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iii) Manufacturer iv) Model number v) Document type vi) Storage location vii) Status viii) Revision ix) Issue date x) Date received xi) Notes



b) Technical Reference/Information

Technical data books and other reference material shall be logged onto the operational documentation section of the documentation database and marked with a label. This database holds the following information (information on label as indicated):

i) Unique identification number ii) Title iii) Author iv) Number – optional v) Document type vi) Storage location vii) Status viii) Revision ix) Issue date x) Date received xi) Notes

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3. In-House Documentation

a) All quality system documents written in-house, such as the Quality system manual, Quality Procedures and Work Instructions (QPWI), and customized inspection and preventive maintenance procedures, shall be logged into the operational documentation section of the documentation database and marked with a label. Each file shall have a status sheet as described in section 6 of this procedure. This database holds the following information (information on label as indicated):



i) Unique identification number ii) Title iii) Author iv) Number v) Document type vi) Storage location vii) Status viii) Revision ix) Issue date x) Date received xi) Notes b) Files All files compiled from the quality system documents, such as the training, contract

review, complaints, incomplete orders, and internal audit files shall be logged into the operational documentation section of the documentation database and marked with a label. This database holds the same information as in 3 a) above.

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c) Forms and labels All forms and labels used by the quality system shall be identified in the appendix of this

document (QPWI) and shall be identified by a number and a date of issue.

4. Drawings a) All drawings produced in-house shall be referenced appropriately (using a project

number, equipment control number, order number, etc.) Quality Procedures and Work Instructions Manual


b) All drawings produced in-house shall be kept with the relevant project or equipment file,

or service manual. c) Software masters of drawings produced by CAD packages shall be stored as indicated in

section 5 (below) of this procedure.

5. Software

a) Manufacturer-supplied or in-house software diskettes and their corresponding operation manuals related to customer or test equipment shall be logged into the technical database section of the documentation database and marked with a label. This database holds the same information as described in section 3 a) above.

b) Operational third-party or in-house software diskettes and their corresponding operation

manuals (Four Rivers, word processing programs, etc.) shall be logged into the operational database section of the documentation database and marked with a label. This database holds the same type of information as in section 3 a) above.

c) Master copies of in-house software files for procedures, manuals, or drawings produced

in house shall:

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i) be saved to a specific directory on LEGACY BIOMEDICAL’ Network Server as

shown in Table 2. ii) be uniquely identified by its file name as shown in Table 3. iii) in the case of individual project subdirectories, include a text file which shall list

all files located in the subdirectory, together with a brief description of the file contents.



iv) be backed up as per the “Computer Backup” work instruction (see Section 16.1).

6. Status Sheet

The status sheet shall be used whenever possible with in-house documentation to indicate the current issue status (i.e., revision number) of each page in the document. This allows changes to be made without the need for the entire document to be reissued.

7. Document Updating

If a change has to be made to a controlled document, whether on one page or throughout the document, the following procedure shall be followed: a) Using the document database, choose the appropriate area (technical or

operational) and select “Update Sheets” from the menu.

b) Conduct a search to identify all distributed copies of the document requiring an update.

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c) When satisfied with the search results, print out an update sheet.

d) Produce a new status sheet for the document that reflects the changes made and the new revision number. Make the appropriate number of copies of this status sheet as indicated by the update sheet.



e) Using the documentation database, update the revision information of each document copy affected by the change. As this is done for each document copy, check the box marked “COMP.” On the update sheet to record that this change has been made.

f) Locate each document copy, make the required change, and put in the new status

page. As this is done for each document copy, check the box marked “DOC” on the update sheet to record that this change has been made.

g) On completing all changes, sign and date the update sheet and send it to the

Director, Quality Assurance for storage in the document update file. F. Documentation

Document Control Procedure (Section 5.0) Documentation Database Computer Backup Work Instruction (Section 16.1) Documentation Database User Manual Document Update File

38



Table 2. Document Type Directory

Section Document Type Directory

General Quality System Manual, procedures, work instructions, forms, etc.

Electronic Design Drawings and manuals

Mechanical Design Drawings and manuals

Inspection and Preventive Maintenance (IPM) IPM procedures

Table 3. File Name Directory

39

Document Type File Name Structure File Name

Quality System Manual, procedures, work instructions, forms, etc.

Document No. File Name

Operator manuals Project No. File Name Service manuals Project No. File Name Drawings Project No. + drawing No. File Name Bill of Materials Project No. + bom extension File Name IPM procedures Procedure No. File Name


Section Page Date Revision 5.2 Writing a Quality System Document 1 of 14 0

A. Purpose This procedure describes the method of writing a quality system document. A documented quality

system encourages uniformity in processes, and it establishes a starting point for continuous improvement activity.

B. Scope This procedure shall apply to all quality system documentation written by the staff of LEGACY

BIOMEDICAL. C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions None

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E. Procedure 1. General

a) The procedure detailed in this document shall be used when preparing quality system documents such as the following:



i) Quality procedures ii) Work instructions iii) Inspection and preventive maintenance procedures iv) Manuals v) Files vi) Forms vii) Labels viii) Software

b) If this format is found to be inappropriate, it shall be brought to the attention of the Director, Quality Assurance. It is the Director, Quality Assurance’s responsibility to make changes to this procedure.

c) All quality system documents shall be entered into the documentation database in

accordance with the “Documentation Preparation and Issue” procedure (see Section 5.1).

41

d) Where quality documents become records, their storage and retention are as defined in

the “Control of Quality Records” procedure (see Section 16.0). 2. Quality Procedures

a) Quality procedures explain the how, who, why, when, and where of quality processes carried out by LEGACY BIOMEDICAL.



b) The Quality Assurance Council shall decide on the need for a new procedure, basing its

decision on the following factors:

i) The importance of the activity in the running of LEGACY BIOMEDICAL, particularly in its relation to customers and suppliers and the means of producing the goods or services produced and as required by ISO 9002.

ii) The need to clarify the exact process to be followed, particularly for production of goods and services and documentation of production.

iii) The infeasibility of modifying an existing procedure to incorporate new information. If possible, existing procedures shall be modified rather than developing new ones. However, making a procedure too lengthy can mean that it is subject to constant revision merely because its scope is too broad.

c) Procedures may be written in response to a number of events in the quality system:

42

i) Management review, audits, and customer complaints. Management review and audits are likely to indicate the need for new procedures or for substantial alteration of existing procedures. Customer complaints are usually an input to reviews, and these are a source of information about the need for procedures. Other inputs to this review process are identified customer, supplier, market, and legislative requirements.

ii) New products and services developed. Development of procedures is an integral part of the development of new products and services.

iii) Management and quality system changes. Management changes and other changes in the business can prompt the need for new procedures.

iv) Quality planning. A procedure is often one of the outcomes of a quality plan.



d) The Quality Assurance Council shall select the person responsible for writing and

implementing the procedure. Normally, this will be the person with functional control for the activity described in the procedure.

e) All quality procedures shall be filed in the QPWI. The master software file of this

document shall be stored and named as described in item 5 of the “Document Preparation and Issue” procedure (see Section 5.1).

f) Each quality procedure shall be given a title and unique number by the Director, Quality

Assurance. g) Each page of a quality procedure shall have a header showing its title and section

number.

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h) Each page of a quality procedure shall have a header showing its page number, total number of pages, revision number, and revision date.

i) Quality procedures shall have printed at the header a RED logo to differentiate controlled

copies from photocopies. j) Each quality procedure shall have the following format:

i) Purpose. Describes the essential and fundamental reason for the procedure’s existence.

ii) Scope. Briefly describes the area and application of the procedure. iii) References. Refers to information that may be useful to understand the procedure.

This can include glossaries. iv) Definitions. Define unique terms or language used in the procedure.



v) Procedure. Sets out a concise and objective way exactly what is to be done to

ensure that an activity is carried out to the quality standards required. Where possible, flowcharts shall be used to assist in explaining the procedure. Procedures are worded so that each action or process is described clearly; the inputs and outputs to each process or action are identified; the person or persons responsible for each action are identified; and an auditor can use the procedure to check whether the procedure is being followed.

vi) Documentation. Lists documentation referred to in the procedure. vii) Appendix. Includes information that serves only to provide help to the reader but

is not essential for understanding the procedure.

k) Once completed, a procedure’s correctness shall be confirmed by a staff member whose normal duties include the process described by the procedure.

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l) Before release for general use, the procedure shall be approved and reviewed as per the “Document and Data Control” procedure (see Section 5.0)

m) Changes to the QPWI and other documents due to the addition of a new procedure shall

be reflected in the relevant page status sheets. n) All staff affected by the procedure shall be briefed by the author about the intent and

content of the procedure. Training, if required, is provided by the author with the assistance of the Site Managers.



3. Work Instructions

a) Quality procedures are general documents that may not always provide detailed work instructions. Where it is necessary to supplement procedures, either to train new workers or to ensure that existing workers carry out the detailed requirements of the job, work instructions are written. Work instructions give a step-by-step account of how to carry out a task.

b) Site Managers shall decide on the need for a new work instruction. c) Site Managers shall select the person responsible for writing and implementing the work

instruction, Normally, this will be the person with functional control for the activity described in the work instruction.

45

d) All work instructions shall be filed in the QPWI. The master software file of this document shall be stored and named as described in item 5 of the “Document Preparation and Issue” procedure (see Section 5.1)

e) Each work instruction shall be given a title and unique number by the Director, Quality

Assurance. f) Each page of a work instruction shall have a header showing its title and section number. g) Included in the header of the work instruction shall be its page number, total number of

pages, revision number, and revision date.



h) Work instructions shall have printed at the header a BLUE logo to differentiate controlled copies from photocopies.

i) Each work instruction shall have the following format: i) A brief paragraph outlining the purpose of the work instruction.

ii) A numbered step-by-step instruction forming the body of the work instruction. iii) A list of documents related or referred to by the work instruction. iv) An appendix may be included to provide information that serves only to provide

help to the reader but is not essential for understanding the instruction.

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j) Once completed, a work instruction’s correctness shall be confirmed by a staff member whose normal duties include the task described.

k) Before release for general use, the work instruction shall be approved and reviewed as

per the “Document and Data Control” procedure (see Section 5.0). l) Changes to the QPWI and other documents due to the addition of a new work instruction

shall be reflected in the relevant page status sheets. m) All staff affected by the work instruction shall be briefed by the author about the intent

and content of the instruction. Training, if required, is provided by the author with the assistance of the Site Managers.



4. Inspection and Preventive Maintenance Procedures

a) IPM procedures are work instructions that specifically describe the tasks and methods involved in the inspection and/or preventive maintenance of individual types of equipment under the care of LEGACY BIOMEDICAL.

b) IPM procedures consist of those procedures published in the Maintenance Management

for Medical Equipment Manual published by the American Society for Healthcare Engineering and new and customized procedures developed by LEGACY BIOMEDICAL. All procedures shall be stored and named as described in item 5 of the “Document Preparation and Issue” procedure (see Section 5.0).

47

c) Site Managers shall determine the need for a new or customized IPM procedure. d) Site Managers shall select the person responsible for writing and implementing the IPM

procedure. Normally, this will be the person with the responsibility for maintaining the equipment involved.

e) Each IPM procedure shall be given a title and date-coded procedure number by the

appropriate Site Manager. This number and title shall be entered into the IPM Procedure Table of the database by the Director, Quality Assurance.

f) IPM procedures shall have a blue logo imprinted in the upper corner to differentiate

controlled copies from photocopies.



g) Each IPM procedure shall have the format provided by the current database.

h) Once completed, an IPM procedure’s correctness shall be confirmed by a staff member who is experienced with the subject device of the procedure.

i) Before release for general use, the procedure shall be reviewed and approved as per the

“Document and Data Control” procedure (see Section 5.0). j) Changes to the IPM Procedures Table in the database due to the addition of a new IPM

procedure shall be reflected in the appropriate page status sheets.

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k) All persons affected by the IPM procedure shall be briefed on the procedure by the author. Training, if required, is provided by the author with the assistance of the Site Manager.

5. Manuals

a) Manuals are written to explain the use, operation, or maintenance of products (hardware and software) developed by LEGACY BIOMEDICAL.

b) Site Managers shall decide on the need for a new manual.

c) Site Managers shall select the person responsible for writing and implementing the

manual. Normally, this will be the person with the responsibility for using, designing, manufacturing, or maintaining the equipment or software involved.



d) Once completed, a manual’s correctness shall be confirmed by a staff member whose

normal duties include the equipment or software associated with the manual. e) The master software file of the manual shall be stored and named as described in item 5

of the “Document Preparation and Issue” procedure (see Section 5.1). f) Before release for general use, the manual shall be reviewed and approved as per the

“Document and Data Control” procedure (see Section 5.0). g) All staff affected by the manual shall be briefed by the author. Training, if required, is

provided by the author with the assistance of the Site Manager.

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6. Files a) Files are used to collate reports, records, and other quality documentation. b) The LEGACY BIOMEDICAL Quality Assurance Council shall decide on the need for a new file.

c) Each file shall be given a title and unique number by the Director, Quality Assurance. d) Files shall be maintained by the officer named in the appendix of the “Control of Quality

Records” procedure (see Section 16.0).



7. Forms a) Forms are used as the basis for most quality records produced by LEGACY BIOMEDICAL. b) The LEGACY BIOMEDICAL Quality Assurance Council shall decide on the need for a new form.

50

c) The LEGACY BIOMEDICAL Quality Assurance Council shall select the person responsible for writing and implementing the form. Normally, this will be the person with functional control for the activity related to the form.

d) All quality forms shall be listed in the QPWI appendix. The master software file of these

forms shall be stored and named as described in item 5 of the “Document Preparation and Issue” procedure (see Section 5.1).

e) Each form shall be given a title and unique number by the Director, Quality Assurance.

This number shall be printed on the bottom of the form, along with its revision date, if possible.

f) Once completed, a form’s correctness shall be confirmed by a staff member whose

normal duties include the process affected by the form. g) Before release for general use, the form shall be reviewed and approved by the LEGACY

BIOMEDICAL Quality Assurance Council. h) Changes to the QPWI and other documents due to the addition of a new form shall be

reflected in the appropriate page status sheets.



i) All staff affected by the form shall be briefed by the author about the intent, completion, and use of the form. Training, if required, is provided by the author with the assistance of the Site Manager.

8. Labels

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a) Labels are used as the basis for traceability and/or status of goods and work within LEGACY BIOMEDICAL.

b) LEGACY BIOMEDICAL Quality Assurance Council shall decide on the need for a new

label. c) LEGACY BIOMEDICAL Quality Assurance Council shall select the person responsible

implementing the form. Normally, this will be the person with functional control for the activity related to the label.

d) Each label shall be given a title and unique number by the Director, Quality Assurance.

This number shall be printed on the bottom of the label, along with its revision date, if possible. This shall depend on the label’s size and use.

e) Once completed, a label’s correctness shall be confirmed by a staff member whose

normal duties include the process affected by the label. f) Before release for general use, the label shall be reviewed and approved by the LEGACY

BIOMEDICAL Quality Assurance Council. g) Changes to the QPWI and other documents due to the addition of a new label shall be

reflected in the appropriate page status sheets.

i) All staff affected by the label shall be briefed by the author about the intent, completion, and use of the form. Training, if required, is provided by the author with the assistance of the Site Manager.



9. Software

a) Software may be written by LEGACY BIOMEDICAL for record keeping, data interrogation, testing, or design.

b) The need for software may be initiated by

52

i) The Quality Assurance Council as a requirement of the quality system, ii) a customer as a request for work, and/or iii) a staff member as a work aid. c) The person assigned responsibility for writing and implementing the software will

depend on the origin and type of request for the software. Normally, this will be the person with functional control for the activity related to the software.

d) All software shall have an associated manual, written in accordance with paragraph 5 of

this procedure. e) The original file shall be stored and named as described in Section 5.0 of the “ Document

Preparation and Issue” procedure (see Section 5.1). The number and the current revision date shall be printed on any copies, together with any associated documentation.

f) Once completed, the software’s correctness shall be confirmed by a staff member whose

normal duties include the process affected by the software.


Section Page Date Revision

5.2 Writing a Quality System Document 14 of 14 0

g) Changes to the QPWI and other documents due to the addition of a new software shall be reflected in the appropriate page status sheets.

53

i) All staff affected by the software shall be briefed by the author about the intent, completion, and use of the software. Training, if required, is provided by the author with the assistance of the Site Manager.

F. Documentation

Document Preparation and Issue procedure (Section 5.1) Control of Quality Records procedure (Section 16.0) Document and Data Control procedure (Section 5.0)


Section Page Date Revision 6.0 Purchasing 1 of 5 0

A. Purpose

54

This procedure describes the purchasing methods used to ensure that purchased products conform to specified requirements.

B. Scope

This procedure shall apply to any goods or services purchased by LEGACY BIOMEDICAL to enable it to carry out its functions. The goods may be spare parts, test equipment, raw materials, etc. Services may include maintenance contracts or manufacturing work supplied by outside organizations.

C. References LEGACY BIOMEDICAL Quality System Manual. D. Definitions

Supplier. Any outside organization providing goods and/or services to LEGACY BIOMEDICAL. Subcontractor. Any outside organization carrying out work on behalf of LEGACY

BIOMEDICAL.

E. Procedure 1. General

Goods or services purchased by LEGACY BIOMEDICAL shall be initiated and processed by one of the following methods:



a) Routine purchase request (Section 6.3)

55

b) Urgent purchase request (Section 6.4) c) Standing order purchase (Sections 6.5 and 6.10) d) Petty cash purchase (Section 6.6)

2. Supplier and Subcontractor Evaluation

a) LEGACY BIOMEDICAL shall select suppliers and subcontractors on the basis of their ability to meet purchase or subcontract requirements, including quality requirements as per the “Approved Supplier Selection” procedure (See Section 6.1)

b) Selected suppliers and subcontractors shall be listed in the supplier section of the

LEGACY BIOMEDICAL database (known as the “supplier catalog”), where their acceptability and scope of product shall be identified as specified in the “Approved Supplier Selection” procedure (See Section 6.1).

c) Purchasing data shall be monitored by the Director, Purchasing to ensure that only

approved suppliers are used. 3. Purchasing Data

a) All purchasing documents shall contain clear and accurate descriptions of the item or service required.



56

b) Purchase requisitions shall only be raised on suppliers rated as acceptable (A) or conditionally acceptable (C) and whose scope of product is suitable as defined in the supplier catalog. An exception to this shall be if the requisition is to be raised on a new supplier. In this case, the new supplier shall be evaluated as per the “Approved Supplier Selection” procedure (See Section 6.1).

c) The person initiating a requisition is responsible for the accuracy of the data on the

requisition. d) A purchase requisition form shall be completed and processed as per the “Purchase

Requisition Form Completion” work instruction (See Section 6.7). e) Purchase requisitions completed by staff members shall be reviewed and approved by

their immediate supervisor. f) All purchase requisitions must be authorized as described in the “Purchase Requisition

Expenditure Authorization” procedure (See Section 6.2) before any commitment of expenditure.

4. Documentation Control and Progress

a) All officer(s) responsible for controlling purchase documentation shall be provided with a copy of the work instruction applicable to the purchase method used (See Sections 6.3, 6.4, 6.5, 6.6, or 6.10).

b) The Director, Purchasing shall be responsible for monitoring the progress of requisition

documentation and orders for conformance to promised delivery dates as per the “Outstanding Order Progress” work instruction (See Section 6.8).



5. Purchased Product Verification

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a) All purchased products received by LEGACY BIOMEDICAL shall be inspected to

confirm that the product conforms to the documentation and all other specifications issued. This process is detailed in the “Incoming Goods Inspection” procedure (See Section 10.1).

b) Where specified by the contract, clients or their representatives have the right to check

purchased products to verify they meet specified requirements. c) When a contract is reviewed (See “Contract Review” procedure, Section 3.0), customer

verification of purchased product shall only be included if required by the customer. d) The Director, Quality Assurance is responsible for arranging verification by a customer

and shall be contacted when this is required. e) LEGACY BIOMEDICAL staff members may visit the premises of its suppliers and

subcontractors to verify that products supplied meet specified requirements. The Director, Quality Assurance is responsible for arranging these inspections when deemed necessary by the Director, Purchasing or other officers of LEGACY BIOMEDICAL.

F. Documentation

Routine Purchase Request work instruction (Section 6.3) Urgent Purchase Request work instruction (Section 6.4) Standing Order Purchase work instruction Section 6.5) Petty Cash Purchase work instructions (Section 6.6) Outside Work work instruction (Section 6.10)



58

Approved Supplier Selection procedure (Section 6.1) Purchase Requisition Form Purchase Requisition Form Completion work instruction (Section 6.7) Purchase Requisition Expenditure Authorization procedure (Section 6.2) Outstanding Order Progress work instruction (Section 6.8) Incoming Goods Inspection procedure (Section 10.1) Contract Review procedure (Section 3.0)


Section Page Date Revision 6.1 Approved Supplier Selection 1 of 7 0

59

A. Purpose

This procedure describes the methods for ensuring that LEGACY BIOMEDICAL’ suppliers of goods and services are able to meet the required quality standards.

B. Scope

This procedure shall apply to all suppliers of goods and services purchased against purchase requisitions raised in LEGACY BIOMEDICAL.

C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure 1. General

a) A list of suppliers used by LEGACY BIOMEDICAL, detailing their approved scope of products or services and their current acceptability rating, shall be maintained in the supplier catalog section of the LEGACY BIOMEDICAL computer database. This procedure details the process for determining the approved scope of product or service and acceptability rating of each new supplier.

b) The Director, Purchasing shall be responsible for monitoring purchasing data to ensure

that only approved suppliers are used.


60


2. New Suppliers

a) When a purchase requisition is to be raised on a new supplier, the ability of the supplier to provide a suitable and quality product shall be evaluated by completing an Evaluation of Suppliers and Subcontractors Form. This form shall be completed by the person filling out the requisition and requires that the following information be given in the prepurchase evaluation section:

i) The product or range of products to be assessed. ii) The impact, if any, the product(s) will have on the final product.

iii) Whether the supplier or its products are certified to any recognized quality standards.

iv) Whether there is any reference, prior experience, or other information relevant to the products suitability and quality.

b) Upon completion of the Prepurchase Evaluation section, the Evaluation of Suppliers and

Subcontractors form shall be stapled to the accompanying purchase requisition and the requisition shall be processed as usual.

c) The Evaluation of Suppliers and Subcontractors form shall remain attached to the copy of

the purchase requisition in the Outstanding Requisition file while awaiting delivery of the goods.

d) Upon receipt of the goods, the goods shall be inspected by the Warehouse Clerk as per

the “Incoming Goods Inspection” work instruction (See Section 10.1), and the Director, Purchasing shall complete the incoming inspection section (delivery date, documentation, and packaging) of the Evaluation of Suppliers and Subcontractors form.


61


e) The goods and the Evaluation of Suppliers and Subcontractors form shall then be

forwarded to the requestor, who shall carry out a technical and quality evaluation of the goods. A summary of this inspection shall be completed in the Incoming Inspection section of the Evaluation of Suppliers and Subcontractors form.

f) If the performance of the supplier and the quality of goods are considered satisfactory,

the requestor shall indicate on the Evaluation of Suppliers and Subcontractors form that the supplier is recommended for approval in the supplier catalog.

g) The Evaluation of Suppliers and Subcontractors form shall then be forwarded to Director,

Quality Assurance for authorization and data entry into the supplier catalog. h) Suppliers new to LEGACY BIOMEDICAL shall initially be rated as acceptable (A),

conditionally acceptable (C), or unacceptable (X), depending on the outcome of the evaluation process. See item 5 for definitions of these ratings.

i) After data entry, the Evaluation of Suppliers and Subcontractors form and any other

associated information shall be filed in the Approved Supplier Selection file in the Quality Assurance department.

3. Supplier Catalog Data Entry

a) The acceptability and scope of product of all evaluated suppliers and subcontractors shall be identified in the company section of the LEGACY BIOMEDICAL computer database (known as the “company catalog”).


62


b) The format of this information shall be as follows: i) Suppliers and subcontractors shall be listed in the Purchasing, Vendors section.

ii) All relevant details, such as addresses, telephone numbers, and contact names, shall be entered and kept up to date.

iii) The Details tab shall be used to identify the acceptability rating and scope of the

product. iv) Additional concise comments may be added to assist in supplier or product

selection under the Details tab. 4. Supplier Performance Monitoring

a) Upon receipt of goods, the Director, Purchasing shall consider the performance of the supplier against the following criteria:

i) Were the goods delivered within the period promised? ii) Were the goods delivered with the correct documentation? iii) Were the goods shipped in a manner that ensured their arrival in an as-new

condition? iv) Were the goods supplied as described in the order?

v) Were the goods found acceptable as per the “Incoming Goods Inspection” work instruction (See Section 10.1)?


63


b) The Director, Purchasing, in cooperation with the originator, shall on each occasion of nonconformance, bring the matter to the attention of the supplier and note this on a copy of the purchase requisition.

c) When delivered to the originator of the requisition, the goods shall be inspected for

acceptability. Any nonconformances shall be processed as per the “Control of Nonconforming Product” procedure (See Section 13.0), and the nonconformance noted on the copy of the purchase requisition.

d) Upon completion of an order involving a nonconformance, copies of the requisition are to

be filed in the nonconforming received order file (in numerical order), in the Director, Purchasing’s office.

e) The nonconforming received order file shall be reviewed by the Director, Purchasing and

the Director, Quality Assurance every six months (December and July) or for a particular supplier at the request of either officer to establish the current rating of the supplier (See Section 5, below). Any changes to a supplier’s rating or scope of product shall be reflected in the supplier catalog. All documentation associated with the review shall be filed in the supplier deficiency reports file located in the Director, Purchasing’s office.

f) Following the six-month review, copies of the requisition held in the nonconforming

received order file shall be placed in the orders received file (in requisition number order) located in the Director, Purchasing’s office.

5. Supplier Ratings a) Suppliers are to be rated according to the following table:

64



Rating Explanation A Acceptable Supplier C Conditionally Acceptable Supplier X Unacceptable Supplier

b) “A” Rating. An “A” rating will be attributed to a supplier who consistently provides goods or services of an acceptable quality.

c) “C” Rating.

i) A “C” rating will be given to those suppliers who, in the opinion of the Director, Purchasing, fail to qualify for the “A” rating. The Director, Purchasing will discuss those areas of deficiency with the supplier so that corrective action can be undertaken. A summary of noted deficiencies shall be recorded on a supplier deficiency report and retained by the Director, Purchasing in the supplier deficiency report file for subsequent review of that supplier’s rating.

ii) Purchase requisitions may be raised on these suppliers. d) “X” Rating

i) An “X” rating is given to those suppliers who have failed to qualify for an A or C rating and who, in the opinion of the Director, Purchasing, are unable or unwilling to remedy significant supply deficiencies.

65



ii) Purchase requisitions may NOT be raised on these suppliers without approval by the Director, Purchasing.

iii) Before giving approval, the Director, Purchasing must audit the supplier’s supply

record and complete a supplier deficiency report form.

iv) When required, the Director, Purchasing or his or her representative will discuss those areas of deficiency with the supplier.

v) Copies of the supplier deficiency report form will be given to the company

concerned for agreement on corrective action. vi) Copies of all supplier deficiency reports shall be maintained by the Director,

Purchasing in the supplier deficiency reports file located in the Director’s office. F. Documentation

Evaluation of Suppliers and Contractors Form Incoming Goods Inspection Work Instruction (Section 10.1) Nonconforming received order file Approved supplier selection file Supplier Deficiency Report Supplier Deficiency Reports File

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Section Page Date Revision 6.2 Purchase Requisition Expenditure

Authorization 1 of X 0

A. Purpose This procedure describes the method of authorizing purchase requisition expenditures. B. Scope This procedure shall apply to purchase requisitions raised within LEGACY BIOMEDICAL. C. References

LEGACY BIOMEDICAL Quality System Manual

D. Definitions None E. Procedure

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Section Page Date Revision 6.3 Routine Purchase Request 1 of X 0

A. Purpose This procedure describes the method of making routine purchase requests. B. Scope This procedure shall apply to purchase requests raised within LEGACY BIOMEDICAL. C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure

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Section Page Date Revision 6.4 Urgent Purchase Request 1 of X 0

A. Purpose This procedure describes the method of making urgent purchase requests. B. Scope This procedure shall apply to urgent purchase requests raised within LEGACY BIOMEDICAL. C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure

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Section Page Date Revision 6.5 Standing Order Purchase 1 of X 0

A. Purpose

A standing order opens an account with an approved supplier to supply goods or services for a specified period. It is typically used when goods of low value are purchased frequently from one supplier. The standing order avoids the excessive use of petty cash and the payment of sales tax. The “Routine Purchase Request” procedure (See Section 6.3) is used to initiate a standing order.

B. Scope This procedure shall apply to standing order purchase requests raised within LEGACY BIOMEDICAL. C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure 1. The requestor shall do the following:

a) Complete the purchase requisition form as per the “Purchase Requisition Form Completion” work instruction (See Section 6.7).

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Section Page Date Revision 6.5 Standing Order Purchase 2 of X 0

b) If applicable, notes the requisition number on the Medical Equipment Service Report

associated with the purchase as a reference. c) Obtains the Director, Purchasing’s approval.

2. The Director, Purchasing will do the following:

a) Obtains expenditure authorization signature from the President LEGACY BIOMEDICAL for expenditures above _____________.

b) Places the order with the supplier by fax or phone and arranges delivery. Some services

may require goods to be forwarded to the supplier under cover of a Returned Goods Authorization.

c)

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Section Page Date Revision 6.6 Petty Cash Purchase 1 of X 0

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Section Page Date Revision 6.7 Purchase Requisition Form Completion 2 of X 0

73


Section Page Date Revision 6.8 Outstanding Order Progress 1 of X 0

74


Section Page Date Revision 6.9 Using a Courier 1 of X 0

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Section Page Date Revision 6.10 Outside Work 1 of X 0

A. Purpose

This procedure describes the method of engaging the services of suppliers (e.g., for repair of medical equipment).

B. Scope This procedure shall apply to obtaining services from suppliers outside LEGACY BIOMEDICAL. C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure

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Section Page Date Revision 7.0 Control of Customer-Supplied Product 1 of 4 0

A. Purpose This procedure describes the documentation, verification, and storage of items supplied by the customer. B. Scope This procedure shall apply to any item supplied to LEGACY BIOMEDICAL by its customers. C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure 1. Documentation

a) The customer-supplied product shall be identified and documented as described in the “Contract Review” procedure (See Section 3.0). The documentation shall provide:

77



i) a description of what is being received; ii) the customer’s name, contact information, and phone number; and iii) the purpose for which we received the product.

b) All customer-supplied product received by LEGACY BIOMEDICAL for acceptance,

installation, repair, inspection, or preventive maintenance shall be processed as incoming work as described in the “Incoming Work” work instructions (See Section 12.22). This will result in

i) a Medical Equipment Service Report being raised for this product, and

ii) an Equipment Status Tag being attached to the product for identification and tracking.

c) All customer-supplied product received by LEGACY BIOMEDICAL for design or

modification shall have a project file opened, and an Equipment Status Tag will be attached to it for identification and tracking.

2. Discrepancies Check

a) The Site Manager is responsible for ensuring that all customer-supplied product shall, upon arrival, be inspected for conformance to the items specified and agreed to by LEGACY BIOMEDICAL with the customer.

b) If the customer-supplied product does not conform to specification, or is unsuitable for

other reasons, it shall be processed as per the “ Control of Nonconforming Product” procedure (See Section 13.0).

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c) The customer shall immediately be informed of a nonconformance by the Site Manager, and a course of action shall be agreed upon.

d) The accompanying Medical Equipment Service Report or project file and Equipment

Status Tag shall be updated to reflect the discrepancies found, the action to be taken, and the current status.

3. Storage

a) While in the care of LEGACY BIOMEDICAL, the customer-supplied product shall be handled and stored as per the “Handling, Storage, Packaging, Preservation, and Delivery” procedure (See Section 15.0).

b) Customer-supplied product shall be identifiable by its accompanying Equipment Status

Tag. c) If a customer-supplied product is lost or damaged, the customer shall be informed by the

Site Manager. The details of the loss or damage shall be recorded on the accompanying Medical Equipment Service Report or project file.

d) In response to loss, damage, or nonconformance, a course of action shall be agreed upon

by the Site Manager and the customer, and the change in instructions shall be recorded on the Medical Equipment Service Report or project file.

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F. Documentation

Contract Review procedure (Section 3.0) Incoming Work work instruction (Section 12.2) Medical equipment Service report Equipment Status Tag Project File Handling, Storage, Packaging, Preservation, and Delivery procedure (Section 15.0) Control of Nonconforming Product procedure (Section 13.0)

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Section Page Date Revision 8.0 Product Identification and Traceability 1 of 3 0

A. Purpose This procedure describes the identification and, where specified, traceability of all items of product from

applicable drawings, specifications, or other documents during all stages of repair, inspection, preventive maintenance, production, testing, and installation.

B. Scope This procedure shall apply to items coming under the control of LEGACY BIOMEDICAL. C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure 1. The Director, Quality Assurance is responsible for setting the levels of identification.

2. Any unidentified item, such as customer equipment, parts, or materials, shall not be processed or used until identified and inspected for suitability for purpose. Any such item determined to be unsuitable shall be processed as per the “Control of Nonconforming Product” procedure (See Section 13.0).

3. The Director, Purchasing is responsible for identifying all incoming goods as described in the

“Incoming Goods Inspection” work instruction (See Section 10.1).

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4. All equipment entering LEGACY BIOMEDICAL for work shall be labeled with an Equipment Status Tag as per the “Incoming Work” work instruction (See Section 12.2) and shall be accompanied by a corresponding Medical Equipment Service Report.

5. The Site Manager is responsible for ensuring that all items are suitably identified as follows:

a) All incoming equipment identified as under contract and owned by a LEGACY BIOMEDICAL client shall be given a unique control number and labeled with the same control number as per the “Equipment File Completion” work instruction (See Section 16.5).

b) All incoming equipment not owned by the client (equipment for evaluation or on loan)

shall be labeled with an on-loan label as per the “Process Control” procedure (See Section 9.0). Verification of ownership and authorization to bill the client must be obtained prior to any work being performed on the device.

6. All nonstock parts and materials used on a job shall be identified on the Medical equipment

Service Report and shall be traceable back to the original supplier by the purchase order number or purchase requisition number as detailed in the “Medical Equipment Service Report Completion” work instruction (See Section 16.3).

7. All documents produced by LEGACY BIOMEDICAL, such as manuals and drawings, shall be

uniquely identified with a document or drawing number and stored in the document’s update file located in the Site Manager’s office so that they can be easily retrieved.

8. Documentation and Data identification shall be organized according to the policy set out in the

“Document and Data Control” procedure in Section 5.0 of LEGACY BIOMEDICAL’ Quality System Manual.

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F. Documentation

Control of Nonconforming Product procedure (Section 13.0) Incoming Goods Inspection work instruction (Section 10.1) Equipment Status Tag Incoming Work work instruction (Section 12.2) Medical Equipment Service Report Equipment File Completion work instruction (Section 16.5) Process Control procedure (Section 9.0) Project file Design Control procedure (Section 4.0) Medical Equipment Service Report Completion work instruction (Section 16.3) Document and Data Control procedure (Section 5.0)

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Section Page Date Revision 9.0 Process Control 1 of 11 0

A. Purpose

This procedure identifies the necessary quality procedures, work instructions, and test procedures to be used by LEGACY BIOMEDICAL for inspection and preventive maintenance (IPM) tasks, repairs, and projects.

B. Scope

This procedure shall apply to all Inspection and Preventive Maintenance (IPM) processes carried out by LEGACY BIOMEDICAL.

C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions MESR Medical Equipment Service Report IPM Inspection and Preventive Maintenance E. Procedure 1. General

a) All items of equipment in LEGACY BIOMEDICAL’ care shall have a pending work order number and associated MESR filled out as per the “Incoming Work” work instruction (See Section 12.2), and its current work and test status shall be identified by

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an Equipment Status Tag as per the “Inspection and Test Status” procedure (See Section 12.0). This will include LEGACY BIOMEDICAL’ own equipment.



b) All inspections, preventive maintenance, repairs, modifications, and work on project tasks shall be undertaken by staff meeting the qualifications, skill, and experience levels required by the position responsible for carrying out that task.

c) All repairs and project tasks shall be performed to the standards of good general practice.

This includes the identification and segregation of dismantled parts to facilitate accurate reassembly.

d) In the interests of personal hygiene and equipment safety, no food or drink may be

consumed in the workshops of LEGACY BIOMEDICAL, and all staff shall adhere to the infection control policy.

e) Wherever possible, work priorities shall be determined, recorded on the MESR, and

followed. If a change of priority is required, the Site Manager shall be notified. f) Site Managers shall monitor and act upon any work that fails to meet its scheduled

priority. g) All documents, manuals, drawings, and specifications shall be logged and filed by the

Multi-Vendor Site undertaking the work. h) All test equipment and tools used by LEGACY BIOMEDICAL’ staff must be in good

working order and have a current calibration label where appropriate (refer to the “Control of Inspection, Measuring, and Test Equipment” procedure, Section 11.0).

i) The equipment number of each item of calibrated equipment used shall be recorded on

the work’s MESR.

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j) All parts and supplies used in repairs, preventive maintenance, or projects shall be

obtained as described by the “Purchasing” procedure (See Section 6.0).



k) Spare parts shall be accessible from any Multi-Vendor Site as per the “Stock Issue” work

instruction (See Section 15.1) and shall be stocked and maintained in accordance with the “Stock Control” work instruction (See Section 15.2).

l) Where required by contract, parts shall be ordered to a relevant National standard or

manufacturer’s specification. m) All inspecting and testing of parts shall be carried out as described in the “Inspection and

Testing” procedure (See Section 10.0) n) All work done shall be carried out in conformance to the following: i) All relevant requirements of National Regulatory standards ii) All relevant requirements of Regional Governmental Regulatory standards

iii) All relevant requirements of local (Municipality, County, etc.) authorities relating to performance, safety, approval, testing, and licensing.

o) Details of work done, parts and materials used, and test results shall be recorded on the

associated MESR as per the “Medical equipment service report Completion” work instruction (See Section 16.3), and these records shall be kept for the period of time specified in the “Control of Quality Records” procedure (See Section 16.0).

p) In the case of fixed equipment or work done on site, all tests must be done before

returning the device to use and, again, records MUST be kept.

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q) All records and test results (MESR’s) shall be checked by the Site Manager as per the “Medical Equipment Service report and Equipment File Checking” work instruction (See Section 16.4).



r) Where any equipment, work, part, or material does not conform with the required

specification, tests, or inspections, the “Control of Nonconforming Product” procedure (See Section 13.0) shall be followed.

s) All equipment, parts, and materials in LEGACY BIOMEDICAL shall be stored during a

repair, maintenance, project task, or as stock in accordance with the “Handling, Storage, Packaging, Preservation, and Delivery” procedure (See Section 15.0).

t) Where equipment undergoing work in LEGACY BIOMEDICAL is to be stored for any

length of time, care shall be taken that the condition of the equipment does not deteriorate during its stay (e.g., batteries should be charged, reservoirs filled, surfaces cleaned).

u) In the case of software controlled equipment, great care must be taken to maintain the

integrity of the software. Backups of the software shall be made where possible. v) Any markings, dust, grease, etc. on the equipment’s surfaces that may have been incurred

during its stay in LEGACY BIOMEDICAL shall be removed, and the equipment shall be in a clean and tidy condition before return to the client.

w) Upon successful completion of work and final inspection and tests (See Section 9.3,

“Inspection”), equipment shall be forwarded to the customer as per the “Work Dispatch” work instruction (See Section 12.3).

x) During the course of their work, LEGACY BIOMEDICAL staff may be required to go to

several hospitals and departments and may have access to confidential information. All

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information received must be held in strict confidence and not be passed on to a third party without permission of the Vice President, LEGACY BIOMEDICAL.

y) Site Managers shall conduct regular monitoring of work and workmanship.



z) The Vice President, LEGACY BIOMEDICAL shall conduct regular monitoring of the work done by the Director, Quality Assurance and the Site Managers.

2. Installation

a) Where LEGACY BIOMEDICAL is to be involved in a large installation of equipment

(e.g., lasting more than two days), the Site Manager will ensure that this procedure is followed.

b) The Site Manager shall attend or call a preinstallation meeting. This meeting shall include

the Center’s staff undertaking the work, together with staff from the client’s departments, such as planning, engineering, etc., and from outside suppliers, if applicable. The Director, Quality Assurance and/or the Vice President LEGACY BIOMEDICAL may attend these meetings.

c) An installation file shall be created containing copies of specifications, plans, installation

drawings, etc. d) A time plan of LEGACY BIOMEDICAL’s involvement shall be agreed upon and

documented. e) Regular progress meetings must be held by the Site Manager and staff undertaking the

installation.

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f) Where LEGACY BIOMEDICAL staff are working with an outside supplier, the role of LEGACY BIOMEDICAL must be agreed upon in advance.

g) Commissioning and acceptance must always be carried out in conjunction with LEGACY

BIOMEDICAL. Records of these tests shall be maintained.



h) Before using the equipment on patients, the equipment shall be tested as per the

manufacturer’s manual or in-house test procedures (whichever is appropriate) and to the relevant National standards for electromedical equipment.

i) At the end of the installation, the Site Manager must ensure that the installation file is up-

to-date, complete, and filed appropriately. 3. Acceptance Test

a) Medical, surgical, and laboratory equipment that is purchased, evaluated, or on loan to a client’s facility and the client wants to include those devices into the Equipment Management Program must undergo acceptance testing by LEGACY BIOMEDICAL before use.

b) Equipment received for evaluation shall be processed in accordance with the “Equipment

Evaluation” work instruction (See Section 9.8). c) All equipment included in the contract between LEGACY BIOMEDICAL and its client

must be allocated a unique control number, a corresponding unique control number label, and a unique equipment file as per the “Equipment File Completion” work Instruction (See Section 16.5).

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d) Any equipment owned by the client’s facility and to be included in the equipment

management program but located in another facility for longer than six months shall be allocated a control number, a corresponding control number label, and an equipment file as per the "Equipment File Completion" work instruction (See Section 16.5).



e) Except as provided for in (d) above, all equipment not included in the equipment

management program (and not under contract with LEGACY BIOMEDICAL), but shall be used within the facility (e.g., on loan or on evaluation), at the request of the client, may be temporarily included in the Equipment management program. This equipment shall have an On-Loan label attached and completed with the following information:

i) Reason. The reason for the equipment to be in the client’s facility (e.g.,

evaluation, loan). ii) Department. The department in which the equipment will be used. iii) Valid Until. The date after which the acceptance tests are no longer valid.

For equipment being evaluated, this date will correspond to the end of the evaluation period.

iv) Number. The work order number associated with the equipment. f) All equipment selected for entry into the LEGACY BIOMEDICAL Equipment

Maintenance Program (See Section 9.3) and has a Risk Assessment number assigned must have an asset number allocated and be identified with an asset number sticker as per the “Equipment File

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Completion” work Instruction (See Section 16.5). g) The staff member undertaking the acceptance testing shall ensure that the equipment has

been supplied with full documentation and that its electrical safety and patient circuit classifications, if applicable, are identified. If applicable, these details shall be noted in the equipment file.

g) Before returning to use, the equipment shall be tested as per the manufacturer’s

instructions or LEGACY BIOMEDICAL test procedures (whichever is appropriate), and to the relevant ANSI standards for electromedical equipment.



4. Scheduled Inspections a) Inspections shall be carried out by LEGACY BIOMEDICAL on designated medical,

surgical, and laboratory equipment in accordance with schedules determined by the Site Manager utilizing the methodology of risk assessment (See Section 9.3).

b) Equipment designated for these inspections shall be determined by the Site Manager

based on the criteria established in Section 9.3, “Risk Assessment of Patient Care Devices”.

c) The procedure to be followed when carrying out inspections is described in the

“Inspection” work instruction (See Section 9.4). d) All work details of the inspections must be recorded either on a Medical Equipment

Service Report as per the “Medical Equipment Service Report Completion” work instruction (See Section 16.3) or on an equipment multiple work order sheet as per the

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“Equipment Work Order Completion” work instruction (See Section 16.8), whichever is most appropriate.

e) Any item of equipment failing an inspection must be repaired in accordance with the

procedure detailed in Section 6, below. 5. Preventive Maintenance a) Preventive maintenance shall be carried out by Legacy Biomedical, or a designated

outside supplier, on client’s equipment that has a high maintenance requirement and is included in the equipment management contract. The process for determining the need for preventive maintenance is described in the “Risk Assessment of Patient Care Devices” work instruction (See Section 9.3)



b) A preventive maintenance procedure for an item must be completed and approved by the

Site Manager with review by the Legacy Biomedical Quality Assurance Council. c) Preventive maintenance schedules shall be generated as per the “IPM Scheduling” work

instruction (See Section 9.5). d) The Site Manager is responsible for coordinating staff to undertake preventive

maintenance on the equipment under their control. e) The relevant procedure must be followed when performing preventive maintenance on an

item of equipment, and all work details and test results must be recorded on a Medical Equipment Service Report. This shall include testing to the applicable ANSI standards for medical devices.

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6. Repairs and Modifications a) Technicians shall be assigned individual repairs based on their respective training and

experience. b) Whenever possible and practical, a technician shall work on one repair at a time. c) Technicians shall attempt to meet the following objectives when undertaking a repair: i) Meet the client’s priority ii) Achieve a low cost for the repair iii) Achieve a high quality of repair



d) All parts and materials used to repair an item shall be identical or equivalent in both

specifications and quality to those replaced. e) A modification shall NOT be made to an item without the permission of the appropriate

Legacy Biomedical Corporate Director with consent from the client’s representative. f) Any modification so approved shall be fully documented in the item’s equipment file and

the applicable test and maintenance procedures and user and maintenance manuals shall be updated accordingly.

g) Before dispatch, the equipment shall be tested as per manufacturer’s manual, in-house

test procedure (whichever is appropriate), and to the relevant ANSI standards for electromedical equipment.

h) The Site Manager shall monitor the methods, efficiency, and effectiveness of the repairs

and modifications carried out by the technicians.

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7. Projects a) All requests for projects from customers shall be directed to the appropriate Site

Manager. b) Projects (design, modification, and/or fabrication) shall follow the “Design Control”

procedure (See Section 4.0)



F. Documentation

Medical Equipment Service Report Incoming Work work instruction (Section 12.2) Equipment Status Tag Inspection and Test Status Procedure (Section 12.0) Infection control Policy Inspection, Measuring, and Test Equipment procedure (Section 11.0) Purchasing Procedure (Section 6.0) Stock Issue work instruction (Section 15.1) Stock Control work instruction (Section 15.2) Inspection and Testing procedure (Section 10.0) Medical Equipment Service Report Completion work instruction (Section 16.3)

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Control of Quality Records Procedure (Section 16.0) Medical Equipment Service Report and Equipment File Checking work instruction (Section 16.4) Control of Nonconforming Product procedure (Section 13.0) Handling, Storage, Packaging, Preservation, and Delivery procedure (Section 15.0) Work Dispatch work instruction (Section 12.3) Equipment Evaluation procedure (Section 9.8) Equipment File Completion work instruction (Section 16.5) Inspection work instruction (Section 9.3) Equipment work order sheet Equipment Work Order Completion work instruction (Section 16.8) Selecting IPM Items work instruction (Section 9.4) IPM Scheduling work instruction (Section 9.5) Design Control procedure (Section 4.0)


Section Page Date Revision 9.1 Special Processes 1 of 2 0

A. Purpose

This procedure describes how Legacy Biomedical, Inc. undertakes processes that cannot be fully verified by subsequent inspection and testing, and where any deficiencies become obvious only after the product is in use.

B. Scope This procedure shall apply to special processes carried out in Legacy Biomedical, Inc. C. References Legacy Biomedical Quality System Manual D. Definitions

95

None E. Procedure 1. Where there are special processes that cannot be verified by subsequent inspection and testing,

and where any deficiencies become obvious only after the product is in use, Legacy Biomedical Staff must inform their Site Manager.

2. The Site Manager will issue a procedure detailing instructions for the special process. This

procedure shall be written as per the “Writing a Quality System Document” procedure (See Section 5.2).


Section Page Date Revision 9.1 Special Processes 2 of 2 0

3. This procedure shall be given a unique number and shall detail: a) the process involved, b) the sequence to be followed, c) the equipment to be used, and d) the workmanship standards to be met in completing the task or process. 4. The procedure shall be kept in the appropriate maintenance procedures file. 5. The Medical equipment Service Report or project file associated with the work on which the

process is being used shall be used to record all work and tests performed.

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6. Special processes shall be carried out by suitably qualified staff using qualified procedures and equipment so as to comply with the “Process Control” procedure (See Section 9.0).

7. All records associated with each process shall be maintained in accordance with the “Control of

Quality records’ procedure (See Section 16.0). F. Documentation

Writing a Quality System Document procedure (Section 5.2) Maintenance procedures file Medical Equipment Service Report Project file Process Control procedure (Section 9.0) Control of Quality Records procedure (Section 16.0)


Section Page Date Revision 9.2 Emergency Call 1 of 2 0

A. Purpose This procedure describes the method of providing emergency service.

B Scope

This procedure shall apply to all service that is required outside the Legacy Biomedical’ normal hours of operation.

C. References

LEGACY BIOMEDICAL Quality System Manual D. Definitions

97

None E. Procedure

1. All requests for service beyond the normal working hours of Legacy Biomedical shall be directed through Legacy Biomedical Corporate offices via either the LEGACY BIOMEDICAL web site or via telephone.

2. Legacy Biomedical Site Managers shall ensure that a technician shall be on-call via pager after

normal working hours.

3. Once a request for emergency service is received, the corporate Multi-Vendor Site shall page the technician on-call for his area. A notation of the time and date shall be recorded of any attempt to page.


Section Page Date Revision 9.2 Emergency Call 2 of 2 0

4. Response time for the technician on-call to contact corporate shall be less than thirty (30) minutes. Information about the client, hospital, department, and problem shall be forwarded to the on-call technician who shall then contact the client and inform them of his estimated arrival time at the location.

5. Unless emergency calls are covered in a contract with the client, all such calls shall be billed at

PREMIUM rates. All travel times to and from shall also be billed at these rates.

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Section Page Date Revision 9.3 Inspection 1 of 2 0

A. Purpose This procedure describes the method of inspection of medical equipment and systems.

B. Scope

This procedure shall apply to acceptance tests and scheduled inspections performed by LEGACY BIOMEDICAL personnel.

C. References LEGACY BIOMEDICAL Quality System Manual

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JCAHO Accreditation Manual for Healthcare Organizations ASHE Maintenance of Medical Equipment Manual Title 21 CFR D. Definitions

Acceptance Test. A detailed procedure used to verify the safety and performance of a device before

use, either after initial receipt (i.e., incoming inspection) or following major repairs, modifications, or overhaul.

Inspection. A procedure to check the physical integrity of a device and to ensure that it meets appropriate safety and performance requirements, including those of regulatory, licensing, and accrediting agencies, as well as those of the manufacturer and any special requirements of the client.


Section Page Date Revision 9.3 Inspection 2 of 2 0

E. Procedure

1. An acceptance test is performed on all newly purchased, rented, or loaned equipment, including devices to be evaluated by the client’s staff if said equipment is to be included in a contractual agreement between LEGACY BIOMEDICAL and the client. Conformance with purchase requisitions and manufacturer’s specifications shall be checked during these incoming inspections.

2. Following the acceptance tests, the Site Manager shall determine whether the equipment will

require scheduled inspections as described in section 9.4, “Risk Assessment of Patient Care

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Devices”, and if it will, an appropriate time interval and procedure are identified. This information shall be conveyed to the client for approval and inclusion in the contractual agreement.

3. The current scheduled inspection intervals shall be maintained in the equipment control system. 4. Procedures for acceptance tests and scheduled inspections are provided in the ASHE

Maintenance of medical equipment guidelines and shall conform with JCAHO and Federal standards. These procedures shall be revised when necessary by the LEGACY BIOMEDICAL Quality Assurance Council. If a new procedure is required, it shall be requested of the Quality Assurance Council.

F. Documentation

“Maintenance Management for Medical Equipment” American Society for Healthcare Engineering ECRI “Health Devices Inspection and Preventive Maintenance System.” Legacy Biomedical Quality System Manual


Section Page Date Revision 9.4 Risk Assessment of Patient Care

Devices 1 of 13 0 A. Purpose

This procedure establishes the methodology to assess the risks associated with use of patient care devices and to determine the service requirements that satisfy regulatory and accreditation standards.

B. Scope

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This procedure shall apply to all patient care devices to be entered into Legacy Biomedical’ Equipment Management Program or LEGACY BIOMEDICAL’ Year 2000 database.

C. References LEGACY BIOMEDICAL Quality System Manual

JCAHO Hospital Accreditation Standards (EC.1.8) D. Definitions

Patient care device Any device listed in the American Pharmacopoeia used in the treatment, diagnosis, and/or therapy of patients.

Equipment function The role the device plays in the care of the patient (i.e., Life

support, Therapeutic, Diagnostic, etc.)



Devices 2 of 13 0

Clinical Application The physical risk associated with the clinical application (i.e., Death, Injury, Mis-Diagnosis)

Maintenance requirements Level and frequency of preventive maintenance required as suggested by the manufacturer of the device or based upon the history of the device.

102

Likelihood of equipment failure How often a device fails based upon experience with the

device and its mean-time-between-failure (MTBF) Environmental Use The primary areas in which the device is to be used.

E. Procedure: 1) General

a) Patient care devices will be ranked by criteria to determine its placement in the LEGACY BIOMEDICAL equipment management program.

b) Devices placed in the criteria based equipment management program will be scheduled

for routine preventive maintenance.

c) At the discretion of the client, devices not meeting the criteria may be placed on the equipment management program for purposes of management.



Devices 3 of 13 0

2) Criteria

a) Criteria for placement of devices into the criteria based equipment management program

will consist of the following four areas:

i) Equipment Function

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The role the equipment plays in patient care. ii) Clinical Application

Considers the results to the patient or user in the event the equipment fails; the physical risk associated with the clinical application.

iii) Maintenance Requirements Maintenance requirements on equipment vary with the type of equipment. Some devices like ventilators, dialysis machines, and similar items require extensive maintenance. Mechanical, pneumatic, or hydraulic equipment requires routine alignment or calibration. Devices like physiological monitors and infusion pumps have average maintenance requirements and need only performance and safety inspections.

iv) Equipment Incident/Failure History This criteria will be evaluated by the Site Manager and the client’s representative on a scheduled basis to determine trends and requirements. Items on the criteria based equipment management program may be removed from the program if the history suggests that they do not pose a threat to quality patient care. Equipment not on the program but having a poor repair history may be placed on the program.



Devices 4 of 13 0 v) Environmental Use

Understanding that patient care devices, in general, are mobile, this category determines the PRIMARY area of use.

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b) There are four equipment categories whose intervals shall not be flexible, regardless of service history:

i) Equipment for direct life support, ii) Equipment with mandatory parts replacement at set intervals, iii) Equipment that delivers high levels of energy, and iv) Equipment with maintenance intervals subject to regulatory requirements.

c) Criteria Tables

Tables 1 through 5 shall be used to rank equipment for inclusion or exclusion in the criteria based equipment management program:



Devices 5 of 13 0 Table 1 Equipment Function

Equipment Function Numerical Ranking

Life Support Equipment 10

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Surgical and Intensive Care Devices 9

Surgical and Intensive Care Monitoring 8

Analytical Laboratory 7

Other Physiological Monitoring and Diagnostics

6

Physical Therapy and Treatment

5

Laboratory Accessories

4

Computer and Related Equipment

3

Patient Related and Other

2



Devices 6 of 13 0

Table 2 Clinical Applications

106

Clinical Application

Numerical Ranking

Patient Death 5

Patient or Operator Injury

4

Inappropriate Therapy or Misdiagnosis

3

Minimal Risk

2

No Significant Risk

1



Devices 7 of 13 0 Table 3 Maintenance Requirements

107

P.M. Frequency

Numerical Ranking

Monthly

8

Quarterly

7

Semi-Annually

6

Annually

5

Not Required

4


Section Page Date Revision

9.4 Risk Assessment of Patient Care Devices 8 of 13 0

Table 4 Likelihood of Failure

108

Mean time Between failure Numerical Ranking

Less than three months

8

Approximately six months

7

Approximately one year

6

Approximately three years

5

Greater than five years

4



Devices 9 of 13 0 Table 5 Environmental Use Classification

109

Primary Area of Equipment Use

Numerical Ranking

Anesthetizing Locations 8

Critical Care Areas

7

Wet Locations/Labs/Exam Areas

6

General Care Areas

5

Non-Patient Care Areas

4



Devices 10 of 13 0 3) Priority Description

110

All patient care devices shall be categorized according to the following priority of testing and degree

of risk: a) Priority I.

Equipment that scores 18 and above points on the criteria evaluation system. This equipment is given the highest priority for testing, calibration, and repair. Equipment in this group is tested on at least a semi-annual basis and is noted as “HIGH PRIORITY” in the database.

b) Priority II

Equipment that scores between and including 15 to 17 points on the criteria evaluation system. Every effort should be made to test, calibrate, and repair this equipment promptly, but only after Priority I equipment requirements have been completed. Equipment in this group is tested on at least a semi-annual basis and is noted as “MEDIUM PRIORITY” in the database.

c) Priority III

Equipment that scores between and including 12 to 14 points on the criteria evaluation system. Every effort should be made to test, calibrate, and repair this equipment promptly, but only after Priority I and II equipment requirements have been completed. Equipment in this group is tested on at least a semi-annual basis and is noted as “LOW PRIORITY” in the database.



Devices 11 of 13 0

d) Hazard Surveillance

111

Equipment that scores between and including 6 to 11 points on the criteria evaluation system. Devices in this category are placed on the equipment inventory, but are visually inspected on an annual basis during annual surveillance rounds.

e) Equipment Management Program Deletion

Equipment and devices that pose little risk and scores 5 or less points may be deleted from the equipment management program.

f) Priority Reclassification

In situations where it is desired to place equipment in a higher priority level than is indicated by the scoring formula, a recommendation must be made by the Client’s representative and approved by the Director, Quality Assurance. When it is desired to place equipment in a lower priority level than is indicated by the scoring guide, a recommendation must be made by the Client’s representative and approval must be obtained from the Director, Quality Assurance, Multi-Vendor Site Directors, Quality Assurance Council, and the Client’s Safety Committee.

End of Policy



Devices 12 of 13 0

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CLINICAL EQUIPMENT RISK ASSESSMENT EVALUATION FORM Model ID Number: ____________________ Manufacturer: ____________________________________ Nomenclature: ____________________________________ Model: _________________________ Version: __________________________ Evaluation Information:

Risk Category I: Equipment Function (E) Score: ____________ Risk Category II: Clinical Application (A) Score: ____________ Risk Category III: PM Requirement (P) Score: ____________ Risk Category IV: Likelihood of Failure (F) Score: ____________ Risk Category V: Environmental Use Area (U) Score: ____________ Evaluation Scoring: Total = E + A + [(P + F + U) / 3] Total Score: _____________



Devices 13 of 13 0

113

Inventory Classification Result: ______ Priority I (Score is in the 18 and above range) ______ Priority II (Score is in the 15 – 17 range) ______ Priority III (Score is in the 12 – 14 range) ______ Hazard Surveillance check only (Score is in the 6 – 11 range ) ______ Deleted from the Equipment Management Program Inventory (Score is 5 or less) Additional Comments: Approval and Responsibility:

Reviewed By: __________________________ Date:_________________

Approved By: ___________________________ Date: _____________________


Section Page Date Revision 9.5 Selecting IPM Items 1 of 2 0

114

A. Purpose This procedure describes the method of determining which equipment requires scheduled support in the form of inspection and/or preventive maintenance. B. Scope This procedure shall apply to all medical equipment in Legacy Biomedical’s equipment control system. C. References LEGACY BIOMEDICAL Quality System Manual ASHE Maintenance Management for Medical Equipment D. Definitions None E. Procedure

1. Following the initial acceptance test for a device being inserted into the Marconi Technology Management equipment control system, the Site Manager determines whether it will require scheduled inspection and/or preventive maintenance. All such determinations are made with the consent of the client’s representative.

2. The Clinical Equipment Risk Assessment Evaluation Form is used to document whether scheduled support is indicated for a given device model or equipment category, and if it is, what should be done, the appropriate support interval(s), and the responsible person and/or Multi-Vendor Site.


Section Page Date Revision 9.5 Selecting IPM Items 2 of 2 0

115

3. Instructions for the use of the Clinical equipment Risk Assessment Evaluation Form is included in Section 9.4 of this Manual. It shall be updated annually to reflect any change in the design in equipment use that effects scheduled support or when experience demonstrates that the equipment does or does not appear to deteriorate or fail in a predictable manner. F. Documentation LEGACY BIOMEDICAL Quality System Manual


Section Page Date Revision 9.6 IPM Scheduling 1 of 1 0

116

A. The Computerized Equipment Control Program used by Legacy Biomedical to control scheduling of inspection and preventive maintenance activities on specific equipment identified by the “Selecting IPM Items” work procedure (See Section 9.5). On the last working day of each month, each Site Manager shall schedule inspections and/or preventive maintenance activities using the equipment

control program.

B. Each Multi-Vendor Site shall have a copy of the user’s manual for the Equipment Control Program which details how to enter into the program and print out copies of each work order assigned to IPM’s.

C. Each Site Manager shall be responsible for manpower allocations assigned to work load under each manager’s jurisdiction. AT NO TIME shall an IPM be more than sixty (60) days overdue. Each month, the Site Manager shall make a determination of his manpower requirements and convey that information to the Legacy Biomedical Area Manager. If a determination is made that workload exceeds manpower, the Area Manager shall then have the responsibility of providing resources to accommodate these requirements whether it shall be temporarily transferring personnel from one location to another, or hiring additional personnel either temporary or permanent.


Section Page Date Revision 9.7 Transferring Equipment between

Multi-Vendor Sites 1 of 1 0

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Multi-Vendor Sites

From time to time, it may be necessary to transfer the control of an item from one Multi-Vendor Site another. This decision will usually be based on a review of the work commitment to the item by the Area Manager. When this transfer is required, the following procedure shall be followed: 1. Approval for the transfer shall occur only after discussion and agreement by the Area Manager. 2. All accessories, disposables and manuals necessary to operate the device must be passed on to

the receiving Multi-Vendor Site. 3. If the transfer is to be permanent, the LEGACY BIOMEDICAL Computerized Equipment

Management records shall be amended to reflect this transfer. 4. Packaging of the device shall conform with Section 15.0 “Handling, Storage, Packaging,

Preservation and Delivery” work instruction. 5. Shipping of the device shall be determined by the Area Manager. Depending upon the urgency of

the situation, it may be necessary to ship FEDEX, courier, or regular ground shipment.


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Section Page Date Revision 9.8 Using LEGACY BIOMEDICAL

Computerized Equipment Management Program

1 of 1 0

The LEGACY BIOMEDICAL Computerized Equipment Management Program is used for equipment inventory control, Inspection and Preventive Maintenance, Scheduling, and storage and analysis of data. The LEGACY BIOMEDICAL Equipment Management Program is password protected at various levels of entry. You will be informed of any restrictions and at what levels you will be able to access. Deletions of any records is prohibited unless at upper level management with the consent of the Director of Quality Assurance. You will be given an instruction manual and shown how to use the Equipment Management Program. You may be given the authority to correct factual errors (e.g., serial numbers, descriptions, locations, etc.) yourself. Any administrative errors (e.g., assignee, procedure code, etc.) you must discuss with your Site Manager. The integrity of the information contained within the LEGACY BIOMEDICAL Equipment Management Program is extremely important. It is subject to review by the Food and Drug Administration , JACHO, OSHA, Texas Department of Health, and any other regulatory agency that so chooses. While staff are encouraged to interact with the system, please take care when adding or changing data. Comments may be entered on work orders by technicians as an aid in explaining the history or status of equipment or work.

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Section Page Date Revision 9.9 Training Record Creation 1 of 5 0

A. Purpose This procedure describes the method for documenting and providing clinical staff with specialized training. B. Scope This procedure applies to all clinical staff training given by Legacy Biomedical. This includes practical

and theoretical training on the use, IPM, repair, clinical application, and safety of equipment. This procedure is not intended to cover spontaneous or informal talks by Legacy Biomedical’s staff to

its customers. C. References Legacy Biomedical Quality System Manual D. Definitions None E. Procedure 1. Identifying the Need for Clinical Staff Training a) It is the responsibility of the Site Managers to identify, manage, and initiate clinical staff

training.

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b) Clinical staff training needs may be identified in the following manner: i) A request from a clinical staff member. ii) Observation by Legacy Biomedical staff on the use and/or knowledge of a

particular skill, topic, or items of equipment. iii) Performance reports that highlight user errors or problems that may be rectified

by training and/or education. iv) Commissioning of new equipment. c) Once a training need has been identified, the Site Manager shall contact the Director of

Quality Assurance who shall delegate an officer to meet with the client’s representative to discuss training solutions. The following points shall be considered:

i) Is the training really required? ii) What should be the content of the training program? iii) What should be the format of the training program? iv) Who requires the training? v) Should this training be coordinated with other programs? vi) When should the training program be scheduled? d) The Director of Quality Assurance shall designate the officer(s) responsible for

documenting, organizing, and coordinating a particular training program. Only those officers with the appropriate skills or training shall be given this responsibility.

2. Identifying the Need for Biomedical Staff Training a) It is the responsibility of the Site Managers to identify, manage, and initiate biomedical

staff training.

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b) Biomedical staff training needs may be identified in the following ways: i) Observations by Legacy Biomedical staff on the use and/or knowledge of a

particular skill, topic, or item of equipment. ii) Performance reports that highlight maintenance errors or problems that may be

rectified by training and/or education. iii) Commissioning of new equipment. c) Once a training need has been identified, the Director of Quality Assurance shall assign a

staff member to organize the training. The following points shall be considered: i) Is the training really required? ii) What should be the content of the training program? iii) What should be the format of the training program? iv) Who requires the training? v) Should this training be coordinated with other programs? vi) When should the training be scheduled? d) The Director of Quality Assurance shall assign a staff member to be responsible for

documenting, organizing, and coordinating a particular training program. Only those officers with the appropriate skills or training shall be given this responsibility.

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3. Documenting a Training Program a) The level of documentation associated with a training program shall depend on the nature

of the training. For example, a unique instructional talk may have no notes associated with it, whereas a regular lecture may require structured notes to ensure continuity and consistency in the subject material.

b) All work associated with a customer training program shall have a Medical Equipment

Service Report filled out for it. This Service Report shall be given a Work Type designating “Training”, and an Action taken designating “User In-Service Given”.

c) Copies of any lecture notes, overheads, and handouts together with the Service Reports

and any other correspondence associated with the training program shall be lept and maintained in the training file associated with the Project Number.

4. Manufacturer’s Training Classes (Factory Locations) a) Occasionally, Legacy Biomedical may arrange to send employees to Factory Service

schools. These schools and the personnel sent to these shall be determined at the Corporate level and based upon the qualifications and possible retention of these employees. Many training programs may cost in the thousands of dollars. To ensure retention of those employees and to recoup some of the expenses involved should an employee decide to leave after attending one of these schools, the following policy will apply.

i) Any employee scheduled to attend a service school shall sign an agreement to

remain in the employ of Legacy Biomedical for a minimum of six months for every thousand dollars spent on his schooling. The time commences upon his completion of the course.

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ii) Should the employee elect to terminate his employment prior to the expiration of this agreement, he shall reimburse Legacy Biomedical at the rate of 75% of total

expenses for every six months left in his period. For example, if $2,000.00 was spent on his courses and he decided to leave after six months, he would have to reimburse Legacy Biomedical $750.00.

b) All training materials given to the employee are the property of Legacy Biomedical. He

may make copies if he so chooses, but all notes, books, handouts and overheads become the property of Karta. These shall be sent to the Director of Quality Assurance for inclusion in any training files for future use.

c) Within two weeks of the employees return, he must conduct an abbreviated training

session for the remainder of his peers. This is to ensure that even though he will be considered the primary contact repair person, there will be coverage in the event of illness or such.

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Section Page Date Revision 9.11 Resource Allocation 1 of 1 0

A. Purpose This procedure describes the method for allocating resources within Legacy Biomedical to meet the

requirements of its customers. B. Scope This procedure applies to all work undertaken by Legacy Biomedical. C. References Legacy Biomedical Quality System Manual D. Definitions None E. Procedures 1. Work Types a) For IPM, the available work can be classified as one of the following: i) Routine Work. Work that is received by routine requests by customers. ii) IPM Work. Due and overdue maintenance on equipment as planned maintenance. iii) “Emergency” work. Work that may be encountered during on-site visits,

extremely high-priority requests, etc.

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b) For design and development activities, all work is classified as either design or

modification.



2. Priorities a) The person assigned the work orders shall be aware of their priority and shall strive to

meet that priority. b) For all IPMs, the Site Managers are responsible for assigning work on a daily basis. The

priorities given to this work shall be assessed as follows: i) Customer’s Priority. This may be indicated on the Service Report, by some other

written instruction, or by verbal request. ii) Staff Availability. Work priorities may have to be adjusted so that experienced

staff may become available, or inexperienced staff needing training become available.

iii) Equipment Type or Customer. Life-Support equipment (e.g., defibrillators, heart- lung bypass units) and critical care areas (e.g., ICU, CCU, OR) will require greater priority. Also, certain types of equipment or customers may be delegated to particular staff members.

iv) Previous Experiences. The expectations of a customer or experience with previous work of a similar nature should be taken into account, particularly when the customer has not specified a priority.

v) Work Type. Those work types identified in section 1, above. c) The Site Managers are responsible for monitoring that all IPM defined priorities are met.

This is done by reviewing all current outstanding work on a weekly basis. The pending

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demand work orders and IPM reports generated by the Karta Equipment Management program shall be used as an aid to this review.

d) The aim of all activities shall be to complete all work in compliance with the customer’s

priorities.



3. Available Resources a) The following resources shall be considered when assigning priorities, together with the

possible courses of action when a lack of resources may cause delays: i) Staff. How many staff members are available? Note that when approving time off,

a minimum number of employees must be available during normal working hours. Consider: Is overtime an option? Are temporary staff available? Can the work be

subcontracted out? Are staff available from another Multi-Vendor Site? ii) Equipment. Is there sufficient and suitable test/calibration/repair/manufacturing

equipment available? Consider: Can equipment be borrowed or rented? Can equipment be brought in

from another Multi-Vendor Site? iii) Spare Parts and Materials. Is there a sufficient stock of suitable supplies

available? Consider: Is an alternate source available? Can another part be temporarily and

SAFELY substituted? iv) Facilities. Are there sufficient and suitable work areas available (e.g., Cleaning

areas, gas, electricity, water) Consider: Can temporary facilities be used? v) Training. Are there suitably trained staff available? Consider: Is it possible to arrange training? b) Any requirements for additional resources shall be brought to the attention of the Area

Manager who shall then, if deemed necessary, take up the request with the President of Legacy Biomedical.

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4. Delays The customer shall be informed verbally if work will not be completed within the customer’s expected or promised priority. In the case of repair and maintenance work, this notification shall be recorded in the Service Reports and in the Equipment Control Program. 5. Reviews a) Work priorities, delays, and outstanding work are discussed weekly with the BMET

Supervisors and the Site Managers. b) The Director of Quality Assurance shall monitor the overall performance and ability of

Legacy Biomedical in meeting the customer’s priorities and reacting to delays to these priorities. As an aid to this process, the following Utilities reports shall be used:

i) Pending Demand Work Orders ii) IPM Reports iii) Project Reports iv) Response to Assigned Priorities Performance Report v) Meeting Planned Maintenance Objectives Performance Report F. Documentation

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MESR Project Files Database Utilities Manual


Section Page Date Revision 9.12 Purchasing Advice 1 of 3 0

A. Purpose This procedure describes advising customer departments about the selection of medical or laboratory equipment to be purchased. B. Scope This procedure will apply to all formal requests for assistance in the selection of medical or related equipment received by LEGACY BIOMEDICAL staff. The procedure is not intended to cover informal

requests for information, except where the staff member considers it appropriate to invoke this procedure. C. References

LEGACY BIOMEDICAL Quality System Manual JCAHO Accreditation Manual for Healthcare Organizations Title 21 CFR

D. Definitions None E. Procedure

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1. It is the responsibility of the Site Managers or those delegated by them to investigate and recommend equipment in their area of expertise. This shall be done in consultation with the Director, Quality Assurance for equipment new to LEGACY BIOMEDICAL’ Client facilities with a purchase value of greater than $500.00. Quality Procedures and Work Instructions Manual


2. A copy of any report recommending equipment will be sent to the Director, Quality Assurance for information. These reports are to be retained for reference in the Equipment Purchase Recommendation file in the Director, Quality Assurance’s office. 3. At the time of the request or at a subsequent briefing, obtain as much information as possible relevant to the selection of the equipment to be recommended. Depending on the size and complexity of the equipment, be prepared to recommend additional discussions. This may require one or more meetings to establish a working specification. Two questionaires may be developed from these working specifications to be given to the Nursing staff and to the physician staff. 4. Involve all staff members who may have information and experience pertinent to the selection process. These questionaires will be tabulated and used as user specifications to compare against technical specifications provided by equipment manufacturers. These user specifications will be treated as confidential information. Any manufacturer’s specifications that do not meet these criteria will not be evaluated in clinical trials. 5. Once the tabulations are made and those manufacturers not meeting the selection criteria are eliminated, estimates of pricing shall be conducted of list prices ONLY. This information shall

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be conveyed to the client at which time a selection of three (minimum ) manufacturers will be made to undergo clinical evaluations. 6. LEGACY BIOMEDICAL personnel shall conduct an engineering evaluation of all equipment

submitted for evaluation. This evaluation shall consist of the following: a) Electrical safety evaluation b) Conformance to any applicable standards c) Applicability (Will it do what the medical staff wants it to do?)



d) Human Factors Engineering (Ease of operation, location of controls, buttons, etc) e) Maintainability (How difficult is it to maintain, any special parts needed, etc) f) Cost of ownership ( How much are the disposables, transducers, etc) 7. Any equipment failing the engineering evaluation shall be eliminated from any further evaluation. This information shall be conveyed to the client for approval. 8. LEGACY BIOMEDICAL personnel shall oversee the clinical evaluations and submit

questionaires to operator personnel concerning any shortcomings and/or advantages of equipment undergoing evaluation. 9. At the end of the clinical evaluations, all data shall be compiled and listed in the order of preference. Pricing shall then be negotiated with the manufacturers either by LEGACY

BIOMEDICAL or the client’s purchasing department.

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10. All data collected in any evaluation shall be entered in the LEGACY BIOMEDICAL database according to

manufacturer, model, pricing, any discrepancies, etc. 11. All medical equipment evaluations and recommendations shall be approved by the Director, Quality Assurance prior to a final report being released to the client. 12. ALL reports shall be considered confidential to LEGACY BIOMEDICAL and the customer

requesting the evaluation. Reports shall NOT be provided to commercial organizations without the approval of the President LEGACY BIOMEDICAL. F. Documentation Equipment Purchase Recommendation File


Section Page Date Revision 9.13 Equipment Evaluation 1 of x 0

A. Purpose

This procedure describes the method of evaluating medical devices for LEGACY BIOMEDICAL’s clients for their purchase.

B. Scope

This procedure shall apply to any request for an evaluation by a LEGACY BIOMEDICAL Client for any medical device being considered for purchase and will potentially fall within the purview of LEGACY BIOMEDICAL for maintenance.

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Section Page Date Revision 9.14 Soldering 1 of 3 0

A. Purpose This document describes the procedure for soldering to ensure consistency and quality of electronic construction and repair. B. Scope Soldering of electronic components, semiconductors, printed circuit boards (PCBs), connectors, cables, and assemblies. C. References

Operator’s manuals Manufacturer’s application notes

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D. Definitions None E. Procedure 1. Approved workshop tools. The following tools shall be used when soldering:

Pace Brand desoldering station Wellar Brand soldering stations located at work benches Portable soldering station Technician tools Antistatic kits



2. Standard of work a) In all cases, the PCBs and assemblies are to be handled with care. Components are generally low-cost items, whereas the PCB is expensive or not replaceable. b) The Pace brand desoldering station will melt solder and cool the surrounding area as the solder is removed. This is the preferred method for extracting devices. Another approved method is to carefully cut individual pins of a device, remove the device, and then remove the pins individually using the Wellar brand desoldering station. c) In general, a temperature of 316 degrees Centigrade for a maximum of 10 seconds is considered safe, and component damage will not occur.

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d) Precleaning of the PCB and the soldering bit before soldering is essential. e) Soldering sequence shall be as follows: i) Tin the soldering tip ii) Apply soldering iron tip to heat the joint. iii) Feed solder onto opposite side of the joint. iv) When the solder has melted and run around the joint, remove the solder and then the iron. f) Cleaning using a suitable cleaning solvent to remove residues from the joint. All soldering joints shall have flux and sharp points removed and inspected. g) Check joints for defects, voids, dry joints, and bridging.



3. Approved Brands of soldering tips: a) b) 4. Approved solder and flux: a) 60/40 tin/lead solder alloy shall be used for common electronics, and general-purpose work.

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b) _______________ Brand soldering cream shall be used for surface mount work, with liquid rosin flux. F. Documentation None


Section Page Date Revision 12.0 Inspection and Test Status 1 of 3 0

A. Purpose

This document describes the procedure for identifying the inspection and test status of work, supplies, parts, and materials in the care of Legacy Biomedical.

B. Scope This procedure shall apply to all work, supplies, parts, and materials while in LEGACY BIOMEDICAL. C. References

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LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure 1. All incoming supplies, parts, and materials shall be clearly identified, and their inspection status

shall be recorded as per the “Incoming Goods Inspection” procedure (See Section 10.1). 2. All work coming into LEGACY BIOMEDICAL shall have a) a unique work order number assigned to it; and b) an Equipment Status Tag attached, and the status recorded on this tag as per the

“Equipment Status Tag Completion” work instruction (SEE Section 12.2).



3. The Site Manager of the Multi-Vendor Site shall be responsible for the tagging of all incoming goods needing acceptance or repair as per the “Incoming Work” work instruction (See Section 12.2). 4. Each technician is responsible for tagging items handed into his or her care and for showing the

current status. 5. The Site Manager is responsible for ensuring that quarantined, rejected, or scrapped goods are

adequately tagged and segregated as per the “Control of Nonconforming Product” procedure (See Section 13.0).

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6. Projects shall be tracked and tagged as per the “Design Control” procedure (See Section 4.0). 7. Upon the successful completion of final inspection and testing and before dispatch, the

Equipment Status Tag must be signed and dated by the technician carrying out the work as ready for use.

8. Outgoing work shall be recorded as per the “Work Dispatch” work instruction (See Section

12.3). 9. A record of the work done and the final inspection and test results shall be recorded on the

accompanying Medical Equipment Service report and shall be referenced to the Equipment Status Tag by the work order number.

10. This procedure shall also apply to equipment owned or manufactured by Legacy Biomedical,

Inc.



F. Documentation

Incoming Goods Inspection procedure (Section 10.1) Equipment Status Tag Equipment Status Tag Completion work instruction (Section 12.1) Incoming Work work instruction (Section 12.2) Control of Nonconforming Product procedure (Section 13.0) Design Control procedure (Section 4.0)

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Medical Equipment Service Report (MESR) Work Dispatch work instruction (Section 12.3)


Section Page Date Revision 12.1 Equipment Status Tag Completion 1 of 2 0

The Equipment Status Tag is used to monitor an item’s status while undergoing work in the LEGACY

BIOMEDICAL Multi-Vendor Sites. An Equipment Status Tag will be attached to each job and shall be maintained by

the technician or technicians carrying out the work. The Equipment Status Tag shall be completed by entering the appropriate codes and data in the spaces provided as follows:

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1. Work Order Number. If no work order label is present, record the work order number printed on the associated Medical Equipment Service Report. 2. Control Number. If no work order label is present, record the control number of the equipment of the equipment related to the request. If no control number exists for the equipment, assign one as per the “Equipment File Completion” work instruction (See Section 16.5). 3. Status and Date. Record the current status of the work and the date the status was reached. A selection of codes are printed on the front of the card as follows:

Work in Progress – Work on this job has started Inspection – awaiting inspection Repair – awaiting repair Maintenance – awaiting maintenance Modification – awaiting modification Installation – awaiting installation Parts/Information – awaiting parts or information before work can continue Other – other (Specify status on the line next to the status box).

4. Ready for Use. The technician completing the job must record his or her signature and the date to

indicate that the request has been completed, the equipment has passed all final inspection and tests, and is ready to be returned to the user.


Section Page Date Revision 12.1 Equipment Status Tag Completion 2 of 2 0

5. Return To. Record the return location for the completed work. 6. Add brief comments on the work done if: a) the work done differs from the initial written request, and/or

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b) the work request was verbal and was not summarized on a work order label. This then allows confirmation of the work request.

7. The Equipment Status Tag shall remain affixed on the equipment for further processing by the Site Manager. Other Relevant Documentation

Equipment Status Tag Incoming Work work instruction (Section 12.2) Inspection and Test Status procedure (Section 12.0)


Section Page Date Revision 12.2 Incoming Work 1 of 1 0

When equipment enters a LEGACY BIOMEDICAL Multi-Vendor Site, A Medical Equipment Service

Report MESR) and an Equipment Status Tag must be initiated. This is usually done by the Site Manager, but may be done on occasion by other staff. The procedure for the completion of the MESR and an Equipment Status Tag is described as follows:

141

1. Obtain a blank MESR and an Equipment Status Tag. 2. Enter ALL pertinent data into the LEGACY BIOMEDICAL Medical Equipment Maintenance

Database. a) If this equipment is new to the LEGACY BIOMEDICAL database i) Create a new asset account, with all data fields necessary for billing purposes (i.e., account codes, locations , etc). ii) Create a work order for Acceptance Testing b) Create a work order for work to be performed c) Attach the work order form to the MESR d) The equipment shall then be forwarded with its MESR to the appropriate technician for

servicing. 3. It shall be the responsibility of the Site Manager to ensure that at no time will any device remain in a receiving area more than 2 hours without being processed into the KARTA MED Database and a work order created for it.


Section Page Date Revision 12.3 Work Dispatch 1 of 1 0

A. Purpose This procedure describes the method of returning equipment to the customer upon completion of

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inspection, Preventive maintenance, and/or repair. B. Scope This procedure shall apply to all equipment supported by LEGACY BIOMEDICAL. C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure


Section Page Date Revision 13.0 Control of Nonconforming Product 1 of 5 0

A. Purpose This procedure describes the controls for ensuring that any nonconforming equipment is identified,

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removed from use, and repaired or disposed of. B. Scope This procedure shall apply to all products for which LEGACY BIOMEDICAL has service

responsibilities. C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure 1. Identification a) All LEGACY BIOMEDICAL staff are responsible for the quality of their own work and

for identifying nonconformances in their work. b) If unacceptable equipment or parts are received or found, or a complaint is received about

an installation, repair, maintenance, or project, the Site Manager must be informed.



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c) The Site Manager is responsible for monitoring all work done and to ensure that staff have the training, information, and resources required to identify nonconformances.

d) Once identified, a nonconforming product shall be removed from further processing. e) Upon receipt of any complaint from a customer, the “Customer Complaints” procedure

(See Section 13.1) must be followed. If a piece of equipment is the subject of the complaint, it must be processed as described in this procedure.

2. Isolation a) The Site Manager is responsible for ensuring that nonconforming product is isolated from

further processing. b) Nonconforming product shall be clearly identified as such on its associated Equipment

Status Tag. c) An area shall be set aside in each section in which nonconfroming product shall be held

while awaiting further action. 3. Recording a) The current status and nonconforming details of a nonconforming product shall be

recorded on its associated Equipment Status Tag and Medical Equipment Service Report, Purchase Requisition or project file.



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b) Associated documentation reflecting inspections or actions, such as a GRA form, complaints, and scrap notes, for a nonconforming product shall be attached to the Medical Equipment Service Report, purchase requisition, or the project file.

c) The Site Manager is responsible for maintaining these records. 4. Disposal Once isolated, nonconforming product shall be processed in one of the following ways: a) Any faulty spare parts or materials shall be isolated, recorded, and processed as per the

“Inspection and Testing” procedure (See Section 10.0). If the recording or resourcing of the part will result in a delay to the expected work schedule, the customer shall be notified of the delay. A record of this notification shall be made on the work’s Medical Equipment Service Report.

b) Items received by LEGACY BIOMEDICAL for repair and which are subsequently

determined to be unrepairable, shall be processed as follows: i) Their Equipment Status Tag’s shall be clearly marked “unrepairable.” ii) Their owner shall be informed by an “Equipment replacement Memorandum” and

provided with an “Asset Disposal form”. iii) When LEGACY BIOMEDICAL receives the completed “Asset Disposal Form”

from the owner, the item’s history shall be annotated in the LEGACY BIOMEDICAL’s Equipment Management Program and P.M. scheduling shall be discontinued.



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c) If, for a manufactured or repaired item, the installation or maintenance is found

unacceptable to the customer, then a remake/repair shall be initiated as follows: i) The Site Manager responsible for the item will arrange with the customer for a

suitable time for retrieval to LEGACY BIOMEDICAL. If the customer wishes to continue using the item until remake/repairs can be affected or to forego any remake/repairs altogether, and if, in the opinion of the Site Manager, continued use of the item is acceptable, then a concession shall be granted; and

ii) A Medical Equipment service Report and Equipment Status Tag shall be raised as

per normal for the remake/repair. The work required section shall highlight the details of the reported nonconformance.

iii) The Medical Equipment Service Report shall remain active until the job has been

recalled and the unsatisfactory goods replaced/rectified. The Site Manager shall be responsible for monitoring the progress of all recalls associated with work under their control.

F. Documentation

Equipment Status Tag Inspection and Testing procedure (Section 10.0) Medical Equipment Service Report Equipment Replacement Memorandum Asset Disposal Form Customer Complaints procedure (Section 13.1)


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G. Appendix Figure 13.1 presents a diagram of the control of nonconforming product process.


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Section Page Date Revision 13.1 Customer Complaints 1 of 3 0

A. Purpose This document describes the procedure to be undertaken upon receipt of a customer complaint. B. Scope

This procedure shall apply to any complaint received from a customer regarding the services provided by LEGACY BIOMEDICAL.

C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure 1. It is the responsibility of any staff member of LEGACY BIOMEDICAL receiving a complaint to

inform his or her supervisor immediately. 2. It is the responsibility of the appropriate Multi-Vendor Site Supervisor to ensure that complaints

are documented and followed up as described in this procedure. 3. The Director, Quality Assurance shall be made aware of all complaints and subsequent proposed

actions.

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4. All complaints shall be logged by initiating a Medical Equipment Service Report as per the

“Medical Equipment service report Completion” work instruction (See Section 16.3). Any associated correspondence concerning the complaint shall be attached to the Medical equipment service report.

5. A complaint shall be given a priority of 3 (“THIS WEEK”). 6. The Site Manager shall inform the Director, Quality Assurance of the complaint. If considered

appropriate, the complaint shall be treated as a nonconformance and acted upon in accordance with the “Control of Nonconforming Product” procedure (See Section 13.0).

7. If corrective action is required, then this shall be implemented as per the “Corrective and

Preventive Action” procedure (See Section 14.0). 8. Only when the corrective action is certified by the Director, Quality Assurance to be satisfactory

will the complaint procedure be closed. 9. A copy of the completed Medical Equipment Service Report and any associated correspondence

shall be sent to the Director, Quality Assurance for filing in the complaints file and entry in the complaint log at the front of the complaints file. The Director, Quality Assurance shall record the details of the Medical Equipment Service Report in the LEGACY BIOMEDICAL Equipment Management Program and raise the complaint at the next LEGACY BIOMEDICAL Quality Assurance Council Meeting. The current status of the complaint shall be recorded and maintained in the complaints file by the Director, Quality Assurance.

10. If the complaint is not resolved within thirty (30) days, the Director, Quality Assurance will

personally take charge of the situation.

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F. Documentation

Medical Equipment Service Report Medical Equipment Service Report Completion work instruction (Section 16.3) Control of Nonconforming Product procedure (Section 13.0) Corrective and Preventive Action Procedure (Section 14.0) Complaints file Complaint log

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Section Page Date Revision 16.1 Computer Backup 1 of 2 0

A. Purpose

This procedure describes the method of backing up LEGACY BIOMEDICAL computer files. It Applies specific guidelines for maintaining integrity and security of the database in case of mechanical or electrical failure.

B. Scope

This procedure shall apply to all LEGACY BIOMEDICAL projects and back office databases on NT04 server used for this purpose.

C. References LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure

The Director, Research and Database Design of LEGACY BIOMEDICAL shall have the primary responsibility for ensuring that LEGACY BIOMEDICAL maintains an effective procedure for backups of the database. The LEGACY BIOMEDICAL Quality Assurance Council shall monitor the Director, Research and Database Design in this function. Appropriate staff shall be assigned responsibility to provide assistance in determining policies for specific parts.

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Section Page Date Revision 16.1 Computer Backup 2 of 2 0

1. Full backups shall be performed on scheduled intervals for maximum reliability and security of the database.

2. Backups shall be performed on a daily basis. The entire NT04 server containing the database and

project folders shall be backed up using Backup Exec. These tapes may be rotated on a biweekly basis. Two sets of four tapes will be used for this procedure.

3. Weekend backups will occur for the entire server and rotation shall occur on a monthly basis. 4. End of month backups shall occur and be stored indefinitely in an appropriate off site location. 5. Backups are a critical systems maintenance task and are often the final recourse after a total

systems failure or disaster. 6. A complete and recent set of backups for each system should be kept off-site. 7. A hard-copy summary of how to create and restore a backup for a given system must be filed

with easy access for systems staff. 8. Tapes must be clearly labeled with the current date of the backup and a sequence number. 9. A copy of the backup script should be kept on floppy disk and stored as a hard copy. 10. Backup media and devices are to be taken into consideration with new equipment purchases. 11. Backup devices are to be cleaned and maintained are per the manufacturer instructions. 12. The backup material is to be kept in a location separate from the original system to protect it

from the same hazards.

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13. Media degeneration implies that files should be copied to fresh media as the manufacturer recommends.


Section Page Date Revision 17.1 Quality Assurance Program 1 of 4 0

A. Purpose Quality Assurance (QA) is a comprehensive, on-going assessment of Legacy Biomedical, Inc. (LEGACY BIOMEDICAL) services, responsibilities, and methods of operation that will help assure quality patient care for our client’s medical facilities. This quality assurance plan is intended to identify problems or potential problems concerning the safe and effective use of patient care equipment, the acquisition of appropriate new equipment, and to provide methods for evaluating and solving any of these problems for our clients.

This Quality Assurance Program acknowledges the importance of sustaining the high quality of patient services provided by our client medical facilities. Quality is defined as the accomplishment of achievable, feasible, patient-care and management goals. Assurance means to inspire confidence by providing objective evidence of effective and efficient performance.

Authority:

The LEGACY BIOMEDICAL Administration and Governing Board have authorized the Director Quality Assurance to manage, monitor, evaluate and change, as necessary, the Quality Assurance Plan.

Quality Assurance Coordinator:

A Quality Assurance Coordinator shall be appointed to each Regional Multi-Vendor Site location. This position shall report to the Legacy Biomedical, Inc (LEGACY BIOMEDICAL) Quality Assurance Director. The Quality Assurance Coordinator shall have the same authority as the Regional Site Manager in order to make changes to assure the quality of work being performed.

The Quality Assurance Coordinator shall coordinate the review of service histories, overdue equipment inspections, investigations of safety issues or equipment-related incidents, and will summarize QA and

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safety activities for the Karta Quality Assurance Committee and the Client Hospital’s Quality Assurance and Safety Committees.



B. Scope The objectives of quality assurance for LEGACY BIOMEDICAL are:

1. To review equipment maintenance operations and to review any equipment or technology issues

that may impact quality of patient care. 2. To define a system for resolving identified problems. 3. To communicate with our client’s departments, such as Quality Assurance, Risk Management,

and Safety Committees to investigate and resolve problems. C. References LEGACY BIOMEDICAL Quality System Manual Title 21 CFR JCAHO Accreditation Manual for Healthcare Organizations D. Definitions None E. Procedure

The QA Coordinator shall examine summaries of service histories quarterly for each client, involving other LEGACY BIOMEDICAL personnel, as needed, to investigate and resolve QA issues. A summary of these equipment-related issues will be presented to the client’s Safety Committee. QA activities

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specific to the Multi-Vendor Site will be summarized in a monthly Report to the Director of Quality Assurance.

1. Identification. Problems or potential problems will come to the QA Coordinator’s attention

from the following sources:



a) On-going quality assurance monitoring of repair and performance assurance functions. b) On-going quality assurance review of consultation functions (incident investigations,

safety issues, etc.) c) Multi-Vendor Site Departmental meetings. d) Comments/complaints from clinical departments. e) Reports of various client’s committees (Safety & Disaster Planning, Risk Management &

Loss Control) f) Monitoring of Equipment Hazard Alerts. g) Electrical Safety Issues.

2. Analysis of cause and scope of problems

Identified problems will be assessed on their potential impact on patient care and a determination of developing trends.

3. Resolution of problems and implementation of corrective actions.

a) Implementation of corrective actions for problems identified by on-going monitoring of repair and performance assurance functions will be the responsibility of the BMET Supervisors.

b) Implementation of corrective actions for Hazard Alerts will be the responsibility of the Quality Assurance Coordinator.

c) Implementation of corrective action for all other problems will be the responsibility of the Site Manager.

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4. Monitoring, Evaluation, and Documentation of results.

a) Each quarter, the Karta QA Coordinator will review patient care equipment service activities and will monitor the following indicators:

i) Service calls in which NO PROBLEM was found or OPERATOR ERROR was

indicated. Also, service reports of DAMAGED equipment will be reviewed.



ii) Repeat Service Calls on the same device or repeated calls indicating a

developing trend. iii) Hazard Alerts on patient care equipment. iv) Safety Issues or Incidents.

b) An action plan will be developed to address the issues raised. c) Verification of the results of corrective action plans will be determined by a follow-up

review. d) Reports summarizing the quality assurance indicators listed above will be issued to all

applicable LEGACY BIOMEDICAL personnel and to the client’s Quality Assurance Committee for review, discussion, and action as needed.

e) The Multi-Vendor Site Quality Assurance activities shall be reviewed by the Karta Quality Assurance Committee each quarter with regard to:

i) Impact on patient care ii) Effectiveness of monitoring and reporting mechanisms iii) Resolving equipment-related safety issues and incidents.

f) Every 30 days, the QA Coordinator shall also review the 90-day overdue scheduled maintenance inspections and coordinate with the Site Manager and the Regional Director of the Multi-Vendor Sites to minimize this QA indicator.

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Section Page Date Revision 17.2 Quality Assurance Indicators for

Patient Care devices 1 of 5 0

I. Compliance Measurements A. Unweighted Compliance Number of items in compliance with PM schedule by number of items on inventory B. Compliance weighted by Risk Perceived risk vs compliance II. Count of Inspections Performed A. Relative number of inspections Number of inspections completed vs number assigned B. Equipment not located Percentage of total inspections scheduled

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C. Equipment in use Percentage of total inspections scheduled D. Other reasons Lack of time, test equipment, higher demand for work



Patient Care devices 2 of 5 0 E. Inspections Failed Measurement of value of inspections F. Compilation of failures Identifies types of failures (i.e., component, calibration, calibration drift, etc.) G. Lack of failures

Documentation of lack of failures of particular class of equipment could justify extended intervals

H. Downtime Most critical for hospitals – loss of revenues III. Documentation A. Presence or absence of documentation

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Missing documents? B. Quality of completed documents Accuracy and completeness



Patient Care devices 3 of 5 0 C. Compliance with required procedures Degree to which work was properly performed IV. Specific Equipment Failures V. Number of Repairs A. Average time per repair Time spent on repairs/number completed repairs B. Average time per repair for specific types of equipment Pinpoints problems associated with equipment types (training, device design, etc.) VI. Downtime due to repairs VII. Repair turnaround time

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A. Classification by repair times Indication of changes in workload, training, parts inventory, etc. B. Mean time to repair Device problems, training?



Patient Care devices 4 of 5 0 C. Response time Time between receipt of service call vs time tech arrives at site VIII. Repeat repairs IX. Repair Types

Equipment failure (electronic), equipment failure (mechanical), equipment failure (unknown), operator error, and no problem found.

X. Repairs delayed due to parts orders XI. Downtime associated with parts orders XII. Complaints

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A. Classification by type of complaint Response time, equipment downtime, courtesy, inability to meet deadlines, other B. Frequency of complaints C. Response to complaints



Patient Care devices 5 of 5 0 XIII. User-related problems A. Number of user errors B. Percentage of user errors associated with high risk devices C. Number of repairs caused by user misuse or abuse D. Frequency of repairs caused by user errors E. Frequency of similar user errors on same shifts on same unit XIV. User Instruction Time XV. Customer Surveys XVI. Technical competence

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A. Educational background B. Certification C. Continuing education

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Section Page Date Revision 19.1 Maintenance of Medical Devices 1 of 4 0

A. Purpose

This procedure outlines the intent of the LEGACY BIOMEDICAL Quality System to assure that servicing is correctly performed and verified according to manufacturer’s specified requirements such that the serviced device is suitable for the intended use and that service information is collected and analyzed to help correct any quality issues

B. Scope

All Legacy Biomedical, Inc. (LEGACY BIOMEDICAL) Multi-Vendor Sites will manage and document the repairs, electrical safety testing, performance assurance testing, and preventive maintenance of all patient care equipment under contract with Karta’s client medical facilities. This service will include after-hours service support for emergency situations as well as a periodic quality assurance review of patient care equipment for service-related anomalies and equipment-related safety issues.

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C. References ASHE Maintenance Management for Medical Equipment JACHO Accreditation Manual for Healthcare Organizations D. Definitions None E. Procedure

1. Inventory of Patient Care Devices

a) All patient care devices included under contract between LEGACY BIOMEDICAL and a client will be inventoried and ranked by criteria to determine its placement in the LEGACY BIOMEDICAL equipment management program.



b) Equipment placed in the criteria based equipment management program shall be inspected for electrical safety and performance tested and documented on a work order form.

c) A unique barcode tag will be affixed to the device and all pertinent data shall be recorded

and entered into the equipment management program.

d) All patient care devices placed into the criteria based equipment management program shall be scheduled for periodic preventive maintenance.

e) Patient care devices not meeting the criteria for the equipment management program may

still be placed into the program at the client’s wishes.

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2. Preventive Maintenance/Performance Assurance Testing

a) Frequency of Inspection

Each patient care device shall be evaluated upon entry into the database as determined by the Preventive Maintenance (PM) Evaluation Score Sheet. Clinical and service experience with the type of instrument as well as manufacturer recommendations will be considered in establishing the maintenance schedule for this device. The Client hospital’s clinical departments may request re-evaluation of any medical device’s inspection program based upon their own quality improvement efforts.

b) Nature of Inspection

i) Specific procedures for accomplishing testing of patient care devices shall be determined by the manufacturer’s instructions, industry standards, and recommended practices such as:



ANSI/AAMI – Standards and Recommended Practices JACHO – Accreditation Manual for Hospitals NFPA – Health Care Facilities Code (NFPA 99) NEC – National Electrical Code

ii) In general, PM instructions will be listed on PM work orders. Complete

procedures will be listed in the Karta PM manual as well as in equipment service manuals.

iii) A visual inspection shall be performed to determine that the instrument is mechanically intact, properly assembled and free of extraneous materials.

iv) An Electrical Safety Inspection shall be conducted on each device (in accordance with NFPA 99) included in the equipment management program at a frequency determined by the JCAHO risk based management system.

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v) The instrument shall be operated with a known input, where appropriate, and its output and the functional status of its control observed. The values of all instrument parameters related to patient care shall be within tolerances specified by the manufacturer of each instrument.

vi) Minor maintenance such as lubrication, replacement of bulbs, filters; etc. shall be performed at the time of inspection.

c) Documentation of Inspection

i) A tag or sticker shall be affixed to the instrument in a prominent location. The tag or sticker shall display the date of inspection and the initials of the inspector.

ii) The PM work order will be completed and entered into the computerized equipment maintenance system.



d) Failure to Meet Inspection Criteria

i) In the event that any instrument shall be shown to be unsafe or to not operate according to manufacturer’s specifications, it shall be removed from service and a work order generated to track the repair of the instrument. Before the device is removed from the area, the responsible charge person MUST sign a copy of the work order. A reasonable effort must be made to supply a replacement device during the time repairs are to take place. Trained personnel shall perform all repairs and the inspection process MUST be repeated before the instrument is returned to service.

3. Repairs

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a) LEGACY BIOMEDICAL service personnel will respond to requests for service according to the following priority:

i) Emergency repairs, safety issues. ii) 90-day overdue PM’s. iii) Routine service requests. iv) Performance Assurance/ Preventive Maintenance Inspections. v) Special projects (as assigned by Branch Manager)

b) After-hours Emergency Service on Mission Critical Patient Care Equipment

LEGACY BIOMEDICAL service personnel will provide after-hours coverage for true equipment emergency situations when the Multi-Vendor Site is closed on weekday evenings (4:30 PM – 8:00 am) and on a 24-hour basis on weekends and major Karta holidays. NOTE: If written into the contract with client hospital, the Multi-Vendor Site will maintain two shifts to cover emergency situations and to be able to access critical equipment for maintenance.

c) All service work will be documented on Work Order Forms and this documentation will

be maintained in the computerized Equipment Maintenance System.


Section Page Date Revision 19.2 Service Standards 1 of 4 0

A. Purpose

This procedure establishes the minimum criteria for “turn-around” times and warranty repairs on medical devices worked on by LEGACY BIOMEDICAL personnel.

B. Scope This procedure applies to all devices worked on by Legacy Biomedical, Inc personnel. C. References

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LEGACY BIOMEDICAL Quality System Manual D. Definitions None E. Procedure 1. Initial Assessment of Repair Work - Legacy Biomedical Multi-Vendor Sites a) All work arriving at a LEGACY BIOMEDICAL Multi-Vendor Site shall be processed in

accordance with the “Incoming Work” work instruction (See Section 12.2). All work as detailed in these instructions shall be processed within two (2) hours of its arrival within a LEGACY BIOMEDICAL facility. Special notations of any priorities assigned by the client shall be noted on the work order.

b) All work shall be assigned to a designated technician who shall perform an initial

assessment of the device(s). Dependent upon the complexity of the device, this assessment should be completed within 2 hours of receipt by the technician.



c) Any discrepancies noted shall be processed in accordance with “ Control of

Nonconforming Product” work instruction (See Section 13.0). Any delays in repairing the device(s) (i.e., workload, parts, information) shall be conveyed to the appropriate Site Manager who in turn, will report these delays to the appropriate client. This information shall also be entered into the LEGACY BIOMEDICAL Database and noted on the Equipment Status Tag.

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d) All equipment designated as delayed shall be flagged in the LEGACY BIOMEDICAL Database and weekly reports generated showing all delayed equipment. The Site Manager shall act upon these reports and attempt to expedite any equipment remaining in the Multi-Vendor Site longer than three (3) working days. All clients shall be informed of any further delays and given an estimated time the equipment can be returned.

e) If the device is designated “critical”, the Site Manager should attempt to assist the client

in locating replacement equipment for the duration of the repairs. Unless written into a service contract, any charges for rentals will be billed directly to the client. A LEGACY BIOMEDICAL technician shall inspect, inventory and test the device prior to its use in the client’s facilities (See Section 9.3 “Inspection” work instruction).

2. Initial Assessment of Repair Work – At Client’s Facilities a) Upon arrival at a client’s facility, a LEGACY BIOMEDICAL technician shall perform an

initial assessment of any repair work needed to bring a device back into operation. Depending upon the complexity of the equipment, this assessment shall take no longer than two hours of his/her arrival at the client’s facility.

b) If the device is deemed critical (O.R., I.C.U., etc, equipment), the LEGACY

BIOMEDICAL technician shall notify the client and the applicable LEGACY BIOMEDICAL Site Manager of the time it would take him to repair the device.



c) Working with the client’s representative, the LEGACY BIOMEDICAL technician shall

attempt to locate similar devices within the client’s facility to substitute for the defective device. This is of critical importance if the estimated repair time exceeds two hours.

d) If no similar devices are located within the client’s facilities, the LEGACY

BIOMEDICAL technician shall notify the LEGACY BIOMEDICAL Site Manager who shall work with the client’s representative to obtain either loaner or rental equipment.

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Any charges stemming from this shall be billed direct to the client, unless covered under contract.

e) If replacement equipment is found, the LEGACY BIOMEDICAL technician should

confer with the client’s representative and inform him of the repair problems (i.e., repair parts, information, supplies). Depending upon size, complexity, etc, the LEGACY BIOMEDICAL technician may elect to remove the device from its location and return with it to his/her Multi-Vendor Site for repair. The device shall be logged in and an Equipment Status Tag shall be attached to the device according to the “Incoming Work” work instruction (See Section 12.2).

3. All repairs effected by LEGACY BIOMEDICAL shall carry a warranty of ninety (90) days parts

and labor provided that the device failed for the exact same reason as the original problem. In the case of equipment which have repetitive malfunctions but no problems can be found, the LEGACY BIOMEDICAL

technician shall: a) Contact the applicable Site Manager and arrange to procure loaner equipment with the

consent of the client’s representative. b) The equipment in question should be taken to the applicable Multi-Vendor Site and

stressed to attempt a failure (i.e., application of heat, vibration, etc.). Overnight “burn-in” would be appropriate in such cases.



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c) If no problems still can not be found, the technician should question the operator(s) of the

equipment to determine exactly what s/he did to cause the problem. An attempt to duplicate the exact circumstances shall take place. If still no problem can be found, the device shall be returned and the service report shall be annotated as "No problem found".

d) Consistent problems with like equipment where no problems can be found shall be

reported through the reporting mechanism the client has established (i.e., Risk Management, Q.A. Committee, Safety Committee).