L.E.M. Laboratories Standards

L.E.M. LABORATORIES STANDARDS

A.ORGANISATION AND QUALITY MANAGEMENT SYSTEMS

SECTION A

A1 Professional Direction

A1.1

----L.E.M Laboratory is directed by

Herzel Ben Hur M.D, Consultant Gynecological Oncologist (Assaf Harofeh Medical CenterIsrael)

Tal Ben Hur Advocat. Zion Maimon, Administrator

COMPANY PROFILE

LEM Ltd. was established in 2002 and is situated in SciencePark, Nes Ziona.

The company supplies Laboratory and Diagnostic services in the field of Cytology and Immunohistochemistry to General health Services, Private companies, Insurance Companies, Private Institutions and the Defence Ministry.

Licence Definition: Laboratory Services and Diagnostics

Address: Einstein 14 Street, Nes Ziona

Telephone:08-9380770

Fax; 08-9389783

The management desires to acquire excellence in a completive field and therefore has obtained Quality Assurance according to ISO 9001 and CAP American colledge of pathologist accreditation

A1.2

The laboratory aims to operate in conformity with CPA Uropean standards

A1.3

Personnel have the resources to perform the their duties
No pressure is applied to the processes for commercial or financialgain
Users confidentiality is maintained. Computers are secure, specimens are delivered by LEM couriers and results are delivered back to users by courier or Fax. See Section D for details
Arrangements are in place to maintain confidentiality of reports See Section D

A4.1Management flow charts are in place See Section B

b.General Manager:Herzel Ben Hur and Tal Ben Hur

Deputy General Manager:Zion Maimon

Laboratory Manager:Zion Mainon

Medical manager: Prof. Elimelech Okon

Medical Manager:Dr. Herbert Merhdat (Pap & Thin prep)

Accounting:Ofra Azoulai

Supervisor of Paps:Sharon Ben Dor

Primary Screeners:Rela Herivan (Pap & Thin prep)

Tanya Fink (Pap & Thin prep)

Hana Gil (Pap & Thin prep)

Lynne Katz

Ana Lachmonov

Dr Ignatt. Schwarz ( Pap & Thin Prep )

Dr. Herhert Merhdat (Pap & Thin Prep)

Dr. Julia Strenov

Slava Landau

Secondary Screeners:Dr. Herbert Merhdat

Rela Herivan

Tanya Fink

Hana Gil

Pathologist (Abnormalities)Dr Herbert Merhdat

A2 Needs and requirements of users

A2.1 The laboratory has a policy of meeting users needs by direct consultation with the users by phone and a yearly questionnaire

A2.2 Management formally reviews users needs by questionnarre each year and in between on an ad hoc basis by speaking with them

A2.3Has a quality policy detailed in the laboratory ISO document 9000:2000

The quality policy in regard to users records the following:

Information for patients
Collection of specimen
Issue of preliminary tests, process and final examination (noting the person authorized to release the diagnosis)
Customer complaints
Procedure for rectification of results
A procedure for yearly review of the above parameters

A3 Quality Policy

A3.1

a. The laboratory and its staff are committed to achieving The CAP Standard for Pap smears

b. This achieved by all processes in the system of processing the Pap Test ( Sections E, F, G), including the monitoring results (Section H)

c. Staff are required to be familiar with the quality manual and to follow the relevant documented procedures for each part of the process.

d. Staff are committed to good professional practice and this is achieved by attending continuing education programs

e. Staff are aware of the relevant Occupational Health and Safety Regulation

f. Staff are required to comply with the relevant Israeli environmental regulations

g Staff are committed to continuing compliance with CPA (Uropean) accreditation standards

A3.2

The quality policy manual is signed by the Laboratory Manager
The quality policy manual us available to be read ansd is implemented by staff throughout the laboratory
The quality policy manual is reviewed for its effectiveness annually

A4Quality Management

A4.1 There is a quality management System in place. Documentation ISO9001:2000

Section4

Quality Management System, Quality Manual

1. Objective

Creation of a system of regulations and objectives for Quality Management within the organization, according to the requirements of the Israeli Standards ISO 9001:2000

2. Definition

2.1 Organizational structure, Responsibility, Regulations, procedures and personnel to enforce the service quality system.

3. Applicable Documents

3.1 Israeli Standard ISO 9001:2000 section 4.1, 4.2.1, 4.2.2

4. Method

Quality Manual:

Company Activities are described and detailed

The Quality System of the Company comprises three main sections:

Marketing

Acquisitions

Service.

The processes carried out in each of the sections are documented and summarized in the Management Summary.

Relations between the sections are documented in the Relations Diagram – Appendix 4/1-01.

4.4 This manual contains written instructions and regulations including all the necessary activities and process characteristics in order to ensure the quality requirements of the client, from the price quotation through to the supply of service to the client.

4.5 Documentation requirements

Obligatory Regulations are defined in the Quality Assurance Regulations according to

ISO9001:2000.

4.5.1 Document Control – Regulation No. 5.

4.5.2 Control of Records – Regulation No. 6

4.5.3 Internal Audits - Regulation No. 19

4.5.4 Non-conforming product Control – Regulation No. 22

4.5.5 Corrective Action – Regulation No. 25

4.5.6 Preventive Action – Regulation No. 26

4.6 Laws and Standards

4.6.1 Regulations for National Health (Medical Laboratories) 1977, revised 1994.

4.6.2 Regulations and Instructions- Ministry of Health.

5. Responsibility

The Quality Assurance Manager is responsible for carrying out this regulation.

6. Attachments

Attachment 4/1-01 – Relations Diagram.

7. Review and Revision

This regulation will be reviewed at least once a year and the review will be documented.

4.2Roles responsibilities and authority of all staff are defined in A1.4 of

This document

4.3

a. The laboratory has in place plans for setting Quality objectives. This is achieved with the laboratory executive working together. The laboratory executive consists of General Managers, Medical manager and Laboratory Manager

b.The Laboratory Manager is responsible for the preparation of the Quality Manual

c. The Quality manager is Zion Mainon

d.Zion Mainon and Tal Ben Hur are responsible maintaining and updating all documents

e.Zion Mainon is responsible for the maintenance of all quality records

f.Zion Mainon is responsible for control of clinical material

g.Zion Mainon and Tal ben hur are responsible for conducting the yearly management review process

A5 Quality objectives and plans

5.1

a. The laboratory has an established quality policy in the form of ISO 9001 2000. The laboratory has a laboratory procedure manual which is used to maintain the quality objectives. This is reviewed annually.

A6Quality Manual

6.1The laboratory Quality Manual is in place in the form of an ISO 9001

2000

document

6.2The quality manual includes:

a. A quality policy ISO 9001-2000Section 4.5

b. A Quality Management system as described in the ISO 9001-2000

Section 4

c.Organisational chart

An outline of the structure of the documentation used for the management of resources

Section B,Cand D see pages

Section E,F and G see pages

Section Hsee pages

A7Quality manager

A7.1The Quality manager is Zion Maimon, Laboratory Manager

A7.2The Quality Manager and Tal Ben Hur meet once a month to discuss quality issues and this is minuted .

A7.3The Quality Manager is responsible for ensuring that;

the quality system is implemented and maintained.
Reporting to management that the quality system is functioning and is effective. This done at the monthly meetings between Tal Ben Hur and the Quality Manager.
The laboratory manager is aware of the needs of the users by the annual questionnaire and personal contact with users. Such contact is documented for action at the next monthly meeting

Document Control

From ISO9001 – 2000 document

Objective

Definition of controlled documentation of the Company and the manner it is executed.

2. Definition

Controlled documentation includes the technical work regulations that have to be updated and organized according to this manual.

3. Applicable Documents

Israeli Standard ISO 9001:2000, section 4.2.3.

4. Method

4.1 Control of documentation and information

4.1.1 This section is applicable to all persons in the Company and the aim is to define the

structure of the documenting system.

4.1.2 The Company manager is responsible for giving instructions to all personnel.

4.1.3 The Quality Assurance Manager is responsible for approval of quality control regulations applicable to each section.

4.1.4 Document quality control will be as follows:

4.1.4.1 Documents will be present and available in the required places.

4.1.4.2 Each document will be approved and signed by the company manager.

4.1.4.3 Documents will be distributed to all required levels.

4.1.4.4 Documents will be updated according to the latest version, and dated.

4.1.4.5 Documents will be comprehensible and acceptable to all users.

4.1.4.6 Documents that are out of date will be destroyed.

4.1.4.7 Every update and change to a form will be approved by the Company manager and documented by the Quality Assurance manager. Changes made to technical forms,regulations, working instructions and other controlled documents (listed in Regulation 6 (section 4.1) , must be noted on the appropriate form, stating the nature of the change,

date and name of the Quality Assurance manager.

4.1.5 Updates: The original version of an updated form will be stored by the Quality Assurance manager, and marked cancelled.

4.1.6 Updated documents will be distributed only after approval by the Quality Assurance manager. They will be distributed according to a distribution list compiled by the Quality Assurance manager.

4.1.7 Examples of documents requiring Document control:

Specifications, sample receipt standards, company regulations, work regulations, quality egulations, corrective actions, price quotations to customers, external documents like: Department of Health regulations, catalogues, supplier specifications, ISO standards.

4.2 Method of numbering documents:

4.2.1 The numbering system for Quality Assurance regulations matches the sectional numbering in

the ISO 9001:2000 Standard.

4.2.2 Method for numbering forms: XX / YY – ZZ

↓ ↓ ↓

version serial regulation

Documents are approved and authorised by TAL Ben Hur prior to issue
Documents have a unique identifier, date of issue, a revision version and a total number of pages. See the following page for list.

Form No. / Subject / Update / Date of Update / No. of Pages
4/1-01 / Interaction Diagram / 02 / 10.03 / 2
5/1-01 / Format Quality Regulations / 02 / 10.03 / 1
7/1-01 / General Manager’s emphasis for Quality / 03 / 12.03 / 1
7/2-01 / Summary of Management Survey / 02 / 10.03 / 2
7/3-01 / Findings of Management Survey / 02 / 10.03 / 2
8/1-01 / Annual Instruction Program / 02 / 10.03 / 1
8/2-01 / Authorization and Training / 02 / 10.03 / 1
9/1-01 / Diagram of PAPS examination process / 04 / 06.04 / 1
9/2-01 / Diagram of Pathological Examination process / 02 / 10.03 / 1
12/1-01 / Supplier Authorization Questionnaire / 02 / 10.03 / 1
12/2-01 / Form for Non-conformity of Supplier/Product / 05 / 08.04 / 1
13/1-01 / Work Procedure for Cutters / 02 / 10.03 / 1
13/2-01 / Procedures for receiving Histology Samples / 05 / 05.05 / 1
13/3-01 / Procedures for receiving PAP samples / 05 / 05.05 / 1
13/4-01 / List of Forms / 02 / 10.03 / 1
13/9-01 / Directions for Maintaining Laboratory Equipment / 02 / 10.03 / 1
13-01/10 / Fax Message / 05 / 08.04 / 1
13-01/11 / Procedure for Removal of Slide from Laboratory / 05 / 08.04 / 2
13-01/12 / Procedure for marking Pathology samples / 05 / 05.05 / 1
13-01/13 / Procedure for marking PAP samples / 05 / 08.04 / 1
13-01/14 / Work procedure for Accountant / 05 / 08.04 / 1
13-01/15 / Protocol for Pathological Staining / 05 / 08.04 / 1
13-01/16 / Protocol for PAP staining / 05 / 08.04 / 1
13-01/17 / Form for Unmatched samples and corrective action / 05 / 08.04 / 1
13-01/18 / Procedure for operation of Thin PAP machine / 05 / 05.05 / 1
18/1-01 / Customer Satisfaction Questionnaire / 05 / 05.05 / 1
19/1-01 / Internal Audit Report / 02 / 10.03 / 20
19/2-01 / Quality Auditing Program / 02 / 10.03 / 1
20/1-01 / Internal Inspection / 02 / 10.03 / 1
23/1-01 / Data Collection Form / 02 / 10.03 / 1
24/1-01 / Form for Attaining Quality Objectives / 02 / 10.03 / 1
25/1-01 / Form for non-conformity / 02 / 10.03 / 1

All documents have a unique identifier documented (see list above)
All documents are legible, and retrievable. They also have the identifier on the document
Documents are reviewed annually and updated as required

A8.2Only the current documents are available out of date documents are archived.

A8.3The laboratory adheres to current Israeli legislation, regulations and guidelines on the retention of documents

A9.1The laboratory has in place a procedure for the controlling of records

All documents are kept on computer, paper records are scanned onto CD.
The records stored on computer are secured by a computer security system
The CD's are stored in the Pap processing room. These are duplicated to another disc twice weekly and stored off-site
All duplicate downloaded record are kept indefinitely in off-site storage
All external documentation is on computer and the paper copy is removed by an external security firm,who shared and dispose of the material securely.
Quality records are available from the laboratory to demonstrate compliance to the operation of quality management. These records are kept in the laboratory Manager’s office
. Pap smear flow chart identifies the processes and the paper work generated during this process enables the reconstruction of the process

A10CONTROL OF CLINICAL MATERIAL

10.1 a.Procedures are in operation for the identification and indexing (see A8)

For security procedures see A9.1b
For retention of documents see A9.2c
For storage and retrieval of documentation see A9.2 d
Pap smear slides are not disposed of, see 10.2

10.2 All slides are kept as per Israeli regulations for a minimum of 25 years

10.3

Quality Management System, Quality Manual

1. Objective

Creation of a system of regulations and objectives for Quality Management within the organization, according to the requirements of the Israeli Standards ISO 9001:2000

2. Definition

2.1 Organizational structure, Responsibility, Regulations, procedures and personnel to enforce the service quality system.

3. Applicable Documents

3.1 Israeli Standard ISO 9001:2000 section 4.1, 4.2.1, 4.2.2

4. Method

Quality Manual:

Company Activities are described and detailed

The Quality System of the Company comprises three main sections:

Marketing

Acquisitions

Service.

The processes carried out in each of the sections are documented and summarized in the Management Summary.

Relations between the sections are documented in the Relations Diagram – Appendix 4/1-01.

4.5 Documentation requirements

Obligatory Regulations are defined in the Quality Assurance Regulations according to

ISO 9001:2000.

4.5.1 Document Control – Regulation No. 5.

4.5.2 Control of Records – Regulation No. 6

4.5.3 Internal Audits - Regulation No. 19

4.5.4 Non-conforming product Control – Regulation No. 22

4.5.5 Corrective Action – Regulation No. 25

4.5.6 Preventive Action – Regulation No. 26

4.6 Laws and Standards

4.6.1 Regulations for National Health (Medical Laboratories) 1977, revised 1994.

4.6.2 Regulations and Instructions- Ministry of Health.

5. Responsibility

The Quality Assurance Manager is responsible for carrying out this regulation.

6. Attachments

Attachment 4/1-01 – Relations Diagram.

7. Review and Revision

This regulation will be reviewed at least once a year and the review will be documented.

4.6 Organizational structure

A.6

______

B PERSONNEL 31 August 2010

B 1. PROFESSIONAL DIRECTION

B1.1

L.E.M Laboratory aims to have appropriate numbers of fully qualified staff at all times and who are committed to providing the highest qualified service.

Name: Herberd Mehrdad MD. Specialist in Pathology and Cytologist*

Languages: English, Hebrew, Persian fluently

Part-time Consultant Cytopathologist L.E.M 2002 until present

Place of Work (current): AssafHarofeh MedicalCenter, Tel Beer Yaacov, Israel

Department: Pathology

A. EDUCATION

PERIOD OF NAME OF SUBJECT DEGREE OR DATE

STUDY UNIVERSITY PROFFESSIONAL AWARDED

LICENSE

19863-1969 NationalUniv. M.D 1969

Teheran, Iran

1990 Consultant Pathologist AssafHarofehMedicalCenter

B. MEMBERSHIP IN PROFESSIONAL SOCIETIES

YEAR SOCIETY

1983- To Present Israel Pathology Association Israel

1983- To Present International Assoc. of Pathology

1998- To Present International Assoc. of Urologic Cytology and Pathology

1998- To Present Israel Assoc. for the study of the liver

1999- To Present Israel Assoc. for the study of the breast.

1990 16th International Tutorial on Clinical Cytology, Vienna, Austria

2002- To Present ConsultantCytopthologistAssafHarofehMedicalCenter

And part time consultant Cytopathologist L.E.M UK Laboratiries

Dr. Julia Stranov, Senior Cytopathologist

B1.1 THE LABORATORY IS DIRECTED BY

PROFESSOR ELIMELECH OKON M.D, CONSULTANT PATHOLOGIST *

a) 1971 Awarded M.D, HadassaMedicalSchool of Medicine Jerusalem.

1976 Specialization certificate in Pathology, Hadassa Medical Center Jerusalem.

1977 Postdoctoral training period in Surgical Pathology, St.BartholomewsHospital, London, England.

1977 Postgraduate visitor in the Pathology Department, St. Marks Hospital, London, England

1988 Visiting Professor, Mallory Institute Pathology and Department of Pathology, BostonUniversity. Boston, USA.

1996 Visiting Professor Mallory Institue, Boston University, school of Medicine Boston. US

1996- To present Head Department of Pathology, Rabin Medical Center, Beilinson Campus, Petach Tiqva, Israel.

b. 1997- To present Clinical Professor in Pathology, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.

1998- To present Chairman, Central Research Authority,

RabinMedicalCenter, Beilinson Campus, Petah Tikva, Israel.

1996- To present is Chairman at RabinMedicalCenter for all Scientifing meetings, teaching and training masters and specialist physicians in pathology.

1996- To present is heading weekly staff meetings in the Department of Pathology.

2004- To present heading bi- weekly the staff meetings in L.E.M. All problematic cases are presented to Professor Okon.

B 1.2Consultant on site

L.E.M LABORATORY STANDARDS

B PERSONNEL 31 August 2010

B 2.1 Staffing

Pathologists

Name:Muralee Dharan, M.B.B.S., M.D., M.I.A.C.*

Languages: English, Hebrew, Indian fluently

Part-time Consultant Cytopathologist L.E.M UK – 2004 until present

ACADEMIC DEGREES

Medical Degree:MedicalCollege, Trivandrum (1969-74)

University of Kerala, India

1974-1975 Housemanship (general)

1975-1980 Senior Housemanship (in Med)

Speciality BoardPart I - May 1985

examination:Part II - May 1990

Speciality Board Certification, Pathology - Israel Health Ministry 27-10-1991, University of Tel Aviv

ACADEMIC APPOINTMENTS

2004 Clinical lecturer in Pathology, Faculty of Medicine, Technion, Israel Institute

of Technology, Haifa, Israel ( renewed 01/03/04 )

2000 Lecturer in Pathology, Faculty of Medicine, Technion, Israel Institute of Technology, Haifa, Israel

1993Clinical Instructor, RappaportSchool of Medicine, Technion, Haifa, Israel

1991Post-Graduate Instructor, RappaportSchool of Medicine, Technion, Haifa, Israel

PROFESSIONAL EXPERIENCE

1993Head Cytopathology Unit, HaemekMedicalCenter, Afula

1991Senior Pathologist, Ha EmekMedicalCenter, Afula.

1987-1990Residency in Pathology, Ha EmekMedicalCenter, Afula.

6/1985-12/1987Forensic Pathology (army service), L. Grinberg Forensic

Institute, Tel-Aviv

1982-1985Residency in Pathology, HaemekMedicalCenter, Afula

RESEARCH INTERESTS

Tumor Pathology, Molecular Aspects

TEACHING EXPERIENCE

Since 1991General Pathology (neoplasia), Graduate medical students, Rappaport

School of Medicine, Haifa

Special Pathology – Biliary tract

Since 1991General Pathology (neoplasia), TouroCollege

Special Pathology – Biliary tract

MEMBERSHIP IN PROFESSIONAL SOCIETIES

1.Member of Israel Medical Association

2.Member of Israel Pathologists Association

3.Member of Israel Cytologists Association

4.Member of InternationalAcademy of Cytology (MIAC)

5.Member of the New YorkAcademy of Sciences

6. Member of European Society of Analytical Cellular Pathology

7. Member of the InternationalAcademy of Pathology

HONORS

Certificate of merit for the outstanding doctor, 1987, HaemekMedicalCenter, on the 75th Anniversary of Kupat Holim (Israel Health Federation).

BASIC SCIENCE RESEARCH

2005 – Dr. MACHULA YELNA ( post-graduate in Gynecology and Obstetrics ):

Cytologic changes in PAP-smears in women with Lichen Sclerosus.

ACTIVE PARTICIPATION IN MEDICAL SEMINARS

1.3rd Conference of the European Society for Analytical Cellular Pathology,

Grenoble, France 16-20 May, 1994.