Al-Amiri Clinical Laboratories Department Policies ... · Ministry of Health ةـحــصلا...

Al-Amiri Clinical Laboratories Department

Policies Education & Training

General Policies

Group (A)

Laboratory Management Policies

Lecturer: Dr Naheda Alkazemi

Ministry of Health

وزارة الصــحـة

Al-Amiri Hospital األمــيـري المســتشفى

DEPARTMENT OF CLINICAL LABORATORIES

.

Page 1 of 7

ORGANIZATION OF THE LABORATORY DEPARTMENT POLICY Effective Date: 01/05/2001 Rev. Date: 01/12/2017

Title: Organization of the Laboratory Department Policy

Policy Owner: Laboratory Department

Policy Code: C-LAB-001

Section Location: Laboratory Units

Effective Date: 01/05/2001

Applies To: Laboratory Department Staff Revision Date:01/12/2017

Approval(s):

Signature/Date:

Note(s): No Changes

Ministry of Health




.

Page 2 of 7


1. Purpose

1.1. The purpose of this policy is to define the organization of the Al Amiri laboratory department.

2. Policy Statement(s) 2.1. The department of clinical laboratories consists of units and sections based on

defined services as illustrated in the department organization chart (refer to attachment 8.1).

2.2. The director of the laboratory and the chief technologists are ministerial decrees with defined qualification and responsibilities. They have ultimate responsibilities for both the hospital as well as PHC laboratories.

2.3. The laboratory director delegates some of his/her responsibilities to the heads of units who are medically qualified according to the unit requirements and activities.

2.4. The chief technologist delegates some of his/her responsibilities to the seniors in charge of the units and sections.

2.5. The department has assigned councils, committees and offices to ensure the implementation of standardized practice with optimum quality and safety.

2.6. The department has assigned officers for quality, safety, inventory and information technology who are supervising, monitoring and training the staff on relevant standardized practices.

3. Responsibility

3.1. Laboratory Director Responsibilities

3.1.1. Preparing the operational policy for the laboratory. 3.1.2. Implementing training programs for the medical staff and ensuring good

work flow. 3.1.3. Preparing and implementing the general policies in accordance to the

ministry’s general plans. 3.1.4. Giving consultation services in his/her field of specialty. 3.1.5. Approving annual requirements for the entire department including

manpower, equipment, reagents etc… 3.1.6. Approving the annual performance evaluation for all laboratory staff. 3.1.7. Approving the recommendations of staff promotions. 3.1.8. Maintaining communication between laboratory and hospital

administration as well as with other administrative hospital departments.

Ministry of Health




.

Page 3 of 7


3.2. Chief Technologist Responsibilities

3.2.1. Coordinating the laboratory operations. 3.2.2. Conducting and generating orientations for new employees. 3.2.3. Preparing and implementing training programs for scientists and technical

staff. 3.2.4. Organizing the duty roster and annual leaves for the technologists and

scientists. 3.2.5. Preparing the operational policies along with the head of the department

and heads of the units. 3.2.6. Performing the evaluation of the technologists and scientists along with

the heads of the units. 3.2.7. Suggesting and recommending promotions for the technologists and

scientists.

3.3. Primary Healthcare Laboratories Office- The responsibility of the office is to ensure good communication and supervision.

3.4. Training Office-

3.4.1. Responsible for the orientation of new technical staff. 3.4.2. Ensures continuous training for all staff.

4. Definition(s)

Laboratory Director- the laboratory director is technically and administratively responsible for the department.

Chief Technologist: is the technologist responsible for all managerial function.

Head of the Unit: a highly qualified medical doctor in his/her specialty and has

technical and administrative responsibilities in the unit as delegated by the laboratory director.

Senior Technologist: a technologist assigned to supervise, organize and ensure

smooth flow of work done by the technologist in the unit.

5. Equipment/Form(s) Required (Not Applicable)

Ministry of Health




.

Page 4 of 7


6. Procedure

6.1. Administration

6.1.1. Laboratory Director 6.1.2. Chief Technologist

6.2. Units of the laboratory

6.2.1. There are four units in the laboratory

6.2.1.1. Clinical Chemistry 6.2.1.2. Hematology 6.2.1.3. Microbiology 6.2.1.4. Histopathology

6.3. Department Council

6.3.1. Members include-

6.3.1.1. Laboratory director 6.3.1.2. Chief technologist 6.3.1.3. Head of the units 6.3.1.4. Senior technologist of each unit 6.3.1.5. Quality and safety officers 6.3.1.6. The supervisor of the reception and outpatient offices 6.3.1.7. The supervisor of the training office 6.3.1.8. The supervisor of the primary healthcare laboratories

6.3.2. Committees

6.3.2.1. Safety Committee 6.3.2.2. Blood Transfusion Committee 6.3.2.3. Accreditation Team Committee 6.3.2.4. Laboratory Utilization Committee 6.3.2.5. Laboratory Council Committee 6.3.2.6. Point of Care Committee

Ministry of Health




.

Page 5 of 7


6.3.3. Sections and Officers

6.3.3.1. There are five sections to ensure the quality of the laboratory services to the patients under acceptable safety measures-

6.3.3.1.1. Reception and outpatient section- lead by a senior technologist whom supervises the work in the laboratory reception and outpatient phlebotomy and result distribution.

6.3.3.1.2. Primary healthcare laboratories officer- chaired by a senior technologist responsible for the laboratories located at various polyclinics which belong to the Capital Health Area.

6.3.3.1.3. Quality officer 6.3.3.1.4. Safety officer- representative delegated as the officer for

each unit. 6.3.3.1.5. Training section

6.3.4. Staff

6.3.4.1. Clinicians- having qualifications in laboratory science 6.3.4.2. Technologists and technicians 6.3.4.3. Phlebotomists 6.3.4.4. Secretaries and Clerks 6.3.4.5. Auxiliary Staff- porters, messengers and domestic helpers

7. Reference(s)

7.1. Laboratory Administration Policy, MOH Kuwait

8. Attachment(s)

8.1. Al Amiri Laboratory Layout 8.2. Al Amiri Laboratory Organization Chart

Ministry of Health




.

Page 6 of 7


8.1 Al Amiri Laboratory Layout

Ministry of Health




.

Page 7 of 7


8.2 Al Amiri Laboratory Organization Chart

Ministry of Health




.

Page 1 of 5

WORKING HOURS POLICY Effective Date: 01/05/2001 Rev. Date: 01/12/2017

Title: Working Hours Policy


Policy Code:C-LAB-003



Applies To: Laboratory Department Staff

Revision Date:01/12/2017

Approval(s):

Signature/Date:

Note(s): Minor Changes

Ministry of Health




.

Page 2 of 5


1. Purpose 1.1. The purpose of this policy is to define the working hours for all laboratory

personnel.

2. Policy Statement(s) 2.1. The laboratory is following the regulations set by the MOH and Civil Service

Commission for doctors, technologist and technicians working hours, duties and leaves

2.2. The extended hours service (overtime) is arranged locally according to the work requirements and needs. These hours follow the regulations placed by the MOH.

3. Responsibility

3.1. Units’ heads and seniors shall prepare monthly duty rosters and work assignments for the staff in advance and submit them to the head of department and chief technologist for approval.

3.2. Head of department and chief technologist shall ensure the implementation and abidance of the working staff to the working hours and duties. They shall approve all the duty rosters and submit them to the hospital director.

4. Definition(s)

Working Days- Sunday to Thursday from 7:00 AM to 2:00 PM.

Duty hours- Any shift outside regular working hours on official workdays. This

includes all afternoon shifts; night shifts and weekends or holidays. Overtime- Extended working hours from 4:00 PM till 8:00 PM from Sunday to Wednesday.

5. Equipment/Form(s) Required 5.1. Annual leave form (2 forms) 5.2. Casual leave form 5.3. Sick leave form 5.4. Day-off form 5.5. Permission request form 5.6. Official mission form-Any course, workshop or task outside of the Laboratory 5.7. Employer’s statement of return to work form (2 forms)

Ministry of Health




.

Page 3 of 5


6. Procedure

6.1. Attendance

6.1.1. Working days

6.1.1.1. Working hours for technologists (abides by the regulations set by the Laboratory Service Department in the MOH). Refer to attachment 8.1 for a detailed work hour schedule.

6.1.2. Break time- the break time shall be half an hour during regular working hours. During duty hours, the break shall be taken when there is no work and there shall be at least one technician present inside the laboratory at all times.

6.1.3. Leaves

6.1.3.1. Annual leave- the application shall be submitted at least one month prior to the actual day of the leave.

6.1.3.2. Special leave- any leave given with either full salary, half salary or no salary abiding by the MOH regulations.

6.1.3.2.1. Maternity leave 6.1.3.2.2. Family care leave 6.1.3.2.3. Continued education leave

6.1.3.3. Hajj leave- this leave is permissible once during the whole

employment period according to MOH regulations. 6.1.3.4. Sick leave- the sick leave shall be informed to the unit senior prior

to the shift, and shall be accompanied with the official sick leave document upon returning to work.

7. Reference(s)

7.1. Laboratory Service Department, MOH

Ministry of Health




.

Page 4 of 5


8. Attachment(s)

8.1. Work hour schedule 8.2. Annual leave form (2 forms)* 8.3. Casual leave form* 8.4. Sick leave form* 8.5. Day-off form* 8.6. Permission request form* 8.7. Employer’s statement of return to work form (2 forms)*

*All forms are located in the ‘Forms Folder’

Ministry of Health




.

Page 5 of 5


8.1 Work Hour Schedule

Unit Shift Time Begins Time Ending

Work Days

Biochemistry, Hematology,

Microbiology, Reception

Morning Shift 7:00 AM 2:00 PM

Afternoon Shift 2:00 PM 8:00 PM

Night Shift 8:00 PM 7:00 AM Outpatient Laboratory

Department Morning Shift 7:00 AM 2:00 PM

Histopathology Morning Shift 7:00 AM 2:00 PM

Extended Hours

2:00 PM 8:00 PM

Laboratory Clinicians Morning Shift 7:00 AM 2:00 PM

Doctors Morning Shift 7:30 AM 2:00 PM

Weekends and Holidays

Biochemistry, Hematology,

Microbiology, Reception

Morning Shift 7:00 AM 2:00 PM

Afternoon Shift 2:00 PM 8:00 PM Night Shift 8:00 PM 7:00 AM

Histopathology On-Call for the whole day

Laboratory Clinicians On-Call for the whole day

Outpatient Laboratory Department

Closed

Overtime

Outpatient Laboratory Department

Afternoon Shift 4:30 PM 8:30 PM

Ministry of Health




.

Page 1 of 7

CONTINUOUS PROFESSIONAL DEVELOPMENT POLICY Effective Date: 01/05/2001 Rev. Date: 01/12/2017

Title: Continuous Professional Development Policy







Approval(s):

Signature/Date:


Ministry of Health




.

Page 2 of 7


1. Purpose

1.1. The purpose of this policy is to

1.1.1. Ensure unit laboratory staffs are aware and up-to-date with current laboratory practices, quality control and laboratory safety.

1.1.2. Provide continuous medical education through in-house as well as outside training activities for all laboratory staff.

2. Policy Statement(s)

2.1. Al Amiri Hospital is recognized by KIMS (Kuwait Institute for Medical

Specialization) as a teaching and training medical facility. 2.2. Continuous professional education and developments are essential

requirements for technical staff and unit doctors to improve their scientific basic knowledge and to cope with the new developments in technical, practical, managerial and scientific fields. It is a document for staff quality improvement and a tool to overcome the defects in basic knowledge of some of the working staffs. Different opportunities for learning and enhancements are available.

3. Responsibility

3.1. All doctors and staff of the unit have to participate and are given opportunities to learn more and enhance their knowledge of the profession.

4. Definition(s)

(Not Applicable)

5. Equipment/Form(s) Required

5.1. Training program of the unit and training documents. 5.2. Schedule of lectures, scientific meetings and journal club. 5.3. Letters for participation in conferences, workshops and seminars. 5.4. Certificates of staff attendance and participation. 5.5. Documents of attendance of quality and accreditation lectures. 5.6. Staff competency evaluation form

Ministry of Health




.

Page 3 of 7


6. Procedure

6.1. Laboratory

6.1.1. Scheduled timings shall be assigned to each unit in the laboratory for educational material to be given as a part of the continuous professional development (CPD).

6.1.2. Scheduled timings for safety and risk management lectures shall be arranged and given by the safety officers.

6.1.3. Workshops organized by the laboratory administration are given to laboratory staff.

6.1.4. Participation in conferences organized by the ministry according to technologist or doctor specialty.

6.1.5. Scheduled lectures for the training doctors in the Kuwait board. 6.1.6. Mandatory training programs for new employees cover both scientific and

safety aspects.

6.2. Biochemistry

6.2.1. Unit Doctors

6.2.1.1. Weekly Journal club meetings within the unit are held according to a schedule.

6.2.1.2. Journal and scientific meetings of KGCB (Kuwait Group of Clinical Biochemists) are held monthly.

6.2.1.3. Journal Club of Pathology department at the Faculty of Medicine are held on Mondays.

6.2.1.4. Weekly medical department clinical meetings are held when the subject is related to clinical chemistry.

6.2.1.5. National conferences and International conferences are given. 6.2.1.6. The head of the unit is a clinical tutor and site coordinator in the

Kuwait Board for Clinical Chemistry and Metabolic Medicine program under KIMS.

6.2.1.7. Participation in online training and CME activities.

6.2.2. Unit Staff

6.2.2.1. A weekly meeting is held by the unit to discuss some scientific and management topics focusing on safety and quality issues.

Ministry of Health




.

Page 4 of 7


6.2.2.2. Lectures and presentations given by the hospital quality and accreditation office team cover quality, accreditation, risk management, patient safety, and incident reporting topics.

6.2.2.3. Occasional external presenters hold lectures to discuss topics about infection control and offer training dealing with emerging outbreaks and emergencies.

6.2.2.4. All technologists participate in the completion and update of the unit’s SOP and in giving presentations dealing with scientific topics.

6.2.2.5. The technologists who are members in the KGCB are encouraged to attend the journal clubs and scientific meetings held by the group.

6.2.2.6. Monthly clinical chemistry courses/training taught by the laboratory administration department are attended by two selected technologists.

6.2.2.7. Training program including lectures, demos and bench training are given to newly-joined staff as well as the other staff in the unit.

6.2.2.8. The senior technologists participate in the practical training of allied health students, public authority students, hospital nursing team and technologists working in the peripheral clinic laboratories.

6.3. Hematology

6.3.1. Hematologists in the Unit attend conferences and symposia including national conferences held by the Faculty of Medicine and KIMS as well as international conferences.

6.3.2. The Hematology Journal Club is held weekly in the laboratory meeting room and is attended by all hematologists.

6.3.3. Medical department clinical meetings are conducted on a weekly basis with presentations given by hematologists.

6.3.4. Training is conduced for the Kuwait Board hematology candidates whom are involved in all unit activities on a weekly basis.

6.3.5. He 1st Monday of every month a whole day teaching session is scheduled for all hematology doctors in the Kuwait board at the FOM.

6.3.6. An average minimum of 50 CME credits is required annually by KIMS. 6.4. Microbiology

6.4.1. Training

6.4.1.1. All personnel receive direct and detailed training for the

performance of all duties and tasks that they perform. 6.4.1.2. Newly appointed technologists undergo a special training program.

Initially the technologists spend one week in each section in the

Ministry of Health




.

Page 5 of 7


Microbiology unit to familiarize themselves with the work performed in the respective unit.

6.4.1.3. Competency assessments is conducted and recorded for all components of the employee’s training and functional responsibilities upon completion of initial training (refer to the form folder).

6.4.1.4. Competency shall be assessed every three months during the first year of employment, and an annual assessment or evaluation is performed starting from the second year.

6.4.1.5. Competency assessments should assure that the staff maintains their competency to perform test procedures and report results promptly, accurately and proficiently.

6.4.1.6. Competency assessments must compare employee performance against a documented standard and clearly verify competency or lack of competency for each evaluated task.

6.4.1.7. In-service training programs including lectures and seminars are presented by microbiologist clinicians and/or technologists at least once a week.

6.4.2. Evaluation

6.4.2.1. Direct observations of routine patient test performance, including patient preparation, if applicable.

6.4.2.2. Specimen handling, processing, and testing. 6.4.2.3. Monitoring the recording and reporting of test results. 6.4.2.4. Review of intermediate test results or worksheets, quality control

records, proficiency testing results, and preventive maintenance records.

6.4.2.5. Direct observation of performance of instrument maintenance and function checks.

6.4.2.6. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples.

6.4.2.7. Assessment of problem solving skills.

6.4.3. Personnel Responsible

6.4.3.1. A clinical laboratory continuing education program that is adequate to meet the needs of all personnel shall be documented, and evidence of ongoing adherence by all laboratory personnel must be readily available. This documentation includes scheduling information such as how frequently personnel shall attend a given course, the type of

Ministry of Health




.

Page 6 of 7


courses required, and the number of educational sessions personnel are required to attend over a given period.

6.4.3.2. Senior technologists are participating in the training of allied health students, Public Authority students, and technologists working in the peripheral clinic laboratories.

6.4.3.3. Doctors and technologists are encouraged to attend workshops, conferences and other medical activities arranged by Ministry of Health & Faculty of Medicine, or companies.

6.4.3.4. Clinical meetings (Medical, Surgical and Pediatrics): Clinical Microbiologists attend and take part when infectious disease related topics are presented and discussed. Microbiologists take active part in infection control meetings.

6.4.3.5. Accreditation Meetings: Senior in charge of microbiology laboratory attend accreditation meeting. It is held at least once per month to discuss accreditation standards.

6.4.3.6. Monthly Microbiology Meetings, Kuwait: Topics associated with clinical problems, case reports, etc. are presented (in rotation) by microbiologists. This helps in updating the clinical and technical knowledge of the microbiologists and technologists.

6.4.3.7. Microbiologists are involved in the Kuwait Board of Microbiology training programs and in teaching undergraduate and postgraduate students.

6.5. Histopathology

6.5.1. Technologists

6.5.1.1. Histopathology unit technologists shall perform a rotation through the different sections of the unit.

6.5.1.2. Monthly meeting shall be held with technologists to discuss safety and quality control topics.

6.5.1.3. Lectures are held every two weeks for continuous educational development regarding the skills and scientific aspects in the unit.

6.5.1.4. Technologists shall attend lectures and presentations given by the hospital quality and accreditation office discussing-

6.5.1.4.1. Quality 6.5.1.4.2. Accreditation 6.5.1.4.3. Risk management 6.5.1.4.4. Patient safety 6.5.1.4.5. Incident Reports

Ministry of Health




.

Page 7 of 7


6.5.1.5. Technologists shall attend courses, conferences and workshops held by the Ministry of Health.

6.5.2. Pathologists

6.5.2.1. Unit pathologists shall attend local and national conferences held by the faculty of medicine and KIMS.

6.5.2.2. The Journal club is held monthly in the histopathology unit. 6.5.2.3. Gastroenterology clinical meetings are conducted once every two

weeks with gastroenterologists. 6.5.2.4. Training is conducted for the Kuwait board histopathology doctors.

They are involved in all activities of the unit and they have a teaching day which is conduced weekly on Tuesdays.

6.5.2.5. The surgical unit conducts an MDT meeting twice a month on Tuesday, the cases are provided by surgeons and the pathologist in charge attends and presents the pathologic findings.

7. Reference(s)

7.1. Laboratory Administration Policy, MOH Kuwait

8. Attachment(s)

8.1. Staff Competency Evaluation Form*


Ministry of Health




.

Page 1 of 4

LABORATORY UTILIZATION POLICY Effective Date: 01/05/2001 Rev. Date: 01/12/2017

Title: Laboratory Utilization Policy







Approval(s):

Signature/Date:

Note(s): No Changes

Ministry of Health




.

Page 2 of 4


1. Purpose 1.1. The purpose of this policy is to describe the policies and processes for the

proper utilization of laboratory diagnostics.

2. Policy Statement(s) 2.1. Approximately 90% of modern day clinical treatment decisions are based on

diagnostics. 2.2. Imaging and laboratory studies generate the vast majority of all data

transactions in a hospital. The growing complexity of diagnostic studies and the frequency in which they are ordered makes it essential that an organized and sound program of diagnostic utilization be developed to ensure patients receive quality testing in a safe, effective and efficient manner. Improving educational opportunities to enhance provider knowledge of the latest clinical evidence concerning diagnostic utilization is essential.

3. Responsibility 3.1. Laboratory leadership shall organize tools to review, improve and maintain

proper utilization of laboratory diagnostics. These tools can be through special multidisciplinary committees (e.g. Laboratory Utilization Committee (LUC) ,Blood transfusion committee, Point of Care Testing Committee), educational workshops, enhancement and implementation of electronics that help detecting improper utilization of laboratory diagnostics. Laboratory leadership shall also approve and recommend adoption of appropriateness criteria, guidelines, protocols, and algorithms to improve standardization and minimize variation of diagnostics used for specified patients and physicians.

4. Definition(s)

(Not Applicable)

5. Equipment/Form(s) Required (Not Applicable)

6. Procedure

6.1. Laboratory leaders shall establish multidisciplinary committees through the

following steps-

6.1.1. Assign laboratory chair persons for the committee. 6.1.2. State the purpose and objectives of the committee.

Ministry of Health




.

Page 3 of 4


6.1.3. Send letters to the hospital director with the purpose of the committee to assign multidisciplinary members and approve it.

6.1.4. Review and approve the meeting minutes with recommendations and actions to be implemented.

6.1.5. Support the committee progress and achievements via decision making and provide resource.

6.2. Laboratory leaders shall delegate chairs of laboratory services and senior technologists in charge to-

6.2.1. Review the statistics of laboratory tests and detect significant improper overutilization of any laboratory tests and raise these statistics with evidence of improper utilization to the concerned committee for proper actions.

6.2.2. Write regulatory policies for appropriate laboratory tests ordering based on guidelines and evidence based medicine and submit them to the concerned multidisciplinary committee for discussions and approval.

6.2.3. Implement policies for special laboratory tests to be ordered only by the laboratory pathologist based on the results of provisional laboratory screening tests, relevant clinical data and frequency of requesting (e.g. Thrombophilia screen, Hb electrophoresis, Vitamin D testing, HbA1C in monitoring of diabetic control etc…).

6.3. The aim of the laboratory utilization committee-

6.3.1. This committee reviews and makes determinations regarding the safe and effective use of laboratory tests in optimizing patient treatment and outcomes.

6.3.2. The main aim of the committee is to aid Amiri laboratory department to provide a service with high standards; and review the quality of service.

6.3.3. It is chaired by a doctor from the lab and the members by representatives from each unit in lab, medical department, surgical department, pediatric department, intensive care department, casualty department, primary care, nursing department and medical record department.

6.4. Functions and Scope of the laboratory utilization committee-

6.4.1. Serve in an advisory capacity to the hospital and medical staff, in all matters pertaining to the use of diagnostics in relation to the diseases treated.

6.4.2. Establish a framework for the selection of diagnostic testing based on criteria, which encompasses the clinical evidence supporting the particular test, the risks associated (sentinel events), value-based practice.

Ministry of Health




.

Page 4 of 4


6.4.3. Approve and recommend adoption of appropriateness criteria, guidelines, protocols, and algorithms to improve standardization and minimize variation of diagnostics used for specified patients and physicians.

6.4.4. Prevent unnecessary and costly duplication of laboratory testing. 6.4.5. Make recommendations to optimize appropriate ordering, collecting,

labeling, testing, and reporting (including timely availability of results) of laboratory tests.

6.4.6. Promote the multidisciplinary correlation of various testing modalities and studies to achieve a consistent diagnostic assessment in which a provider can optimize an effective treatment plan.

6.4.7. Foster the development and support of cross-disciplinary services. 6.4.8. Monitor implementation of the written policies and procedures and make

recommendations for improvement.

7. Reference(s)

7.1. Utilization Management in the Clinical Laboratory: An Introduction and Overview , K. Lewandrowski et al. 2017.

8. Attachment(s)

(Not Applicable)

Ministry of Health




.

Page 1 of 5

EQUIPMENT AND SUPPLIES POLICY Effective Date: 01/05/2001 Rev. Date: 01/12/2017

Title: Equipment and Supplies Policy







Approval(s):

Signature/Date:


Ministry of Health




.

Page 2 of 5


1. Purpose 1.1. The purpose of this policy is to

1.1.1. Provide directions for processes and procedures to be used for selection

and evaluation of laboratory equipment. 1.1.2. Specify the laboratory supplies policy including orders, installation,

inventory, and scrapping.

2. Policy Statement(s) 2.1. The laboratory director has established and maintained processes and

procedures for the selection and evaluation of laboratory equipment.

3. Responsibility

3.1. Laboratory leadership has designated the heads of units and unit seniors for the selection, and evaluation of the equipment related to their units. Designated staff members are assigned by the unit head and senior for calibration, maintenance, operation, troubleshooting, service and repair, and decommissioning of equipment. The laboratory may collaborate with its partners, clients, and their relevant operational departments in the execution of this following established processes and procedures that govern laboratory equipment.

4. Definition(s)

Equipment- includes any machines used in the laboratory for pre-analytical (e.g. centrifuges, fridges, autoclaves, fume hoods), analytical (e.g. auto-analyzers, other instruments used for analysis of patient specimens), and safety equipment (e.g. autoclaves for safe biohazard waste disposal).

Selection- the process of selecting equipment according to the list of features which may include input from the appropriate clinical staff and medical staff, needs assessments, review of literature, clinical trials, feedback from clients, cost effectiveness, service provided by the vendor, workplace health and safety standards, environmental effect(s), specifications, and regional impact.

Evaluation- the process of determining the equipment performance using certain experiments and comparing them with the manufacturer claims and the acceptable performance.

Biweekly Order- an order requested every 2 weeks monthly.

Ministry of Health




.

Page 3 of 5


Special Order- an order requested outside the regular schedule.


5.1. Equipment selection and purchase documents 5.2. Instrument installation form 5.3. Procedure manual and CD and standard operating procedures for the machine 5.4. Maintenance records from engineers 5.5. Equipment log registers and repair records 5.6. Equipment decommissioning form provided by the biomedical department. 5.7. Medical equipment Voucher 5.8. Equipment performance assessment form

6. Procedure

6.1. Equipment

6.1.1. Selection of the laboratory equipments depends on the spectrum of the order; the laboratory leadership is responsible for selection of equipments that are specified for the work place only, other equipments which are ordered for other laboratories too the selection process is the responsibility of the specialized committees and director of the administration of laboratory services.

6.1.2. The laboratory director or the delegated head of unit shall determine the specifications required according to the purpose of the equipment used.

6.1.3. The equipment order and specifications shall be sent to the director of the laboratory services administration for further processing and shall be sent to the engineering department for approval regarding sufficient spacing and electrical load limitations as per the requirements from the Ministry of Health.

6.1.4. Following the approval of the equipment order, a copy of the approval letter is received by the Amiri laboratory director.

6.1.5. The equipment shall be installed in the assigned laboratory by the engineers of the responsible company within the time interval stated in the contract.

6.1.6. The biomedical department in the hospital shall be involved in the supervision, approval and documentation of the installation process and maintenance contract.

6.1.7. After the installation of the equipment along with all requirements (electrical, water, waste, and LIS interface), a period of familiarization including staff training by the company’s application managers and engineers shall be performed.

Ministry of Health




.

Page 4 of 5


6.1.8. Preparation of the standard operating procedures and work instructions, maintenance procedures and log book shall be done for all new equipment.

6.1.9. The laboratory unit senior shall order the required reagents and consumables for the equipment and maintain a file containing all the related documents (the approval letter, installation documents, and a copy of the contract and report of the equipment’s evaluation data when done).

6.1.10. After verification and acceptance of equipment performance, the equipment can be used in the routine analysis of patient specimens with continuous monitoring of its long term performance with the different QC programs (internal, national, and external; refer to the quality control policy [C-LAB-013]).

6.1.11. Scrapping of equipment is performed by the biomedical department in the Capital Health Area according to their policy.

6.1.12. In case of dysfunctional equipment, the decision for scrapping of that equipment is taken by the senior technologist, the head of the unit, and the laboratory director. A special form shall be sent to the biomedical department and the service contract of the equipment shall be terminated immediately.

6.1.13. Equipment shall be assessed quarterly as per ministry regulations via a form sent by the ministry of health. The laboratory assesses the equipment according to performance, maintenance, and functionality.

6.2. Supplies

6.2.1. Biweekly Orders- An order form shall be filled by the senior technologist of each unit in the laboratory then checked and signed by the chief technologist before sending it to the central medical store (CMS).

6.2.2. The senior technologists shall determine their laboratory unit’s needs in term of minimum and maximum supply requirement for the upcoming two weeks.

6.2.3. The supply order shall be arranged through the hospital laboratory store technician.

6.2.4. Usually the supply from the medical stores is received in the morning. Then immediately distributed to the laboratory sections on the same day according to their requests.

6.2.5. General items for the laboratory are kept in the hospital laboratory store and issued weekly.

Ministry of Health




.

Page 5 of 5


6.3. Special Order

6.3.1. Any special orders requested shall be submitted with their specifications by the head of the unit and raised to laboratory administration department through the laboratory director.

6.4. Inventory

6.4.1. The inventory is performed by the biomedical department in the Capital Health Area according to their policy.

6.5. Each unit shall consist of the following-

6.5.1. Laboratory storage rooms (room temperature) 6.5.2. Cold room (+4oC) 6.5.3. Storage facility for flammable and explosive material 6.5.4. Storage facility for poisonous/hazardous material

7. Reference(s) 7.1. Laboratory Administration Policy, MOH Kuwait

8. Attachment(s)

8.1. Instrument installation form* 8.2. Equipment performance assessment report*


Ministry of Health




.

Page 1 of 3

LABORATORY INFORMATION SYSTEMS MANAGEMENT POLICY Effective Date: 01/05/2001 Rev. Date: 01/12/2017

Title: Laboratory Information Systems Management Policy







Approval(s):

Signature/Date:

Note(s): No Changes

Ministry of Health




.

Page 2 of 3


1. Purpose

1.1. The purpose of this policy is to define the different laboratory information systems and ensure their integrity and confidentiality.

2. Policy Statement(s)

2.1. Laboratory leadership have established and maintained processes and procedures for managing written and electronic information systems both internally and externally.

2.2. Receiving and distributing written and electronic information as well as maintaining the confidentiality of patient related information are documented.

2.3. Laboratory Information System (LIS) is used for patient data bases, requested investigations, reporting, quality control records, statistics, specimens auditing, referral service and archiving of patient reports.

2.3.1. Confidentiality of patient related information is maintained through defined staff access rights.

2.3.2. The main server and its backup are available to allow maximum retention and retrieval of patient related information and reports.

3. Responsibility

3.1. Laboratory leadership shall designate individuals to be responsible for the organization and implementation of external and internal communications and documentation.

3.2. All laboratory personnel have a responsibility to follow the established processes and procedures that govern the integrity and confidentiality of all types of information.

4. Definition(s) Histovision– A highly specialized information system used in the histopathology unit.


5.1. LIS Program 5.2. Computers 5.3. Network (within the laboratory and through the hospital internet) 5.4. Laboratory manuals

Ministry of Health




.

Page 3 of 3


6. Procedure

6.1. Different information systems are available in the laboratory department to support the service including-

6.1.1. Manuals 6.1.2. Reporting systems 6.1.3. Communication systems 6.1.4. Quality management systems 6.1.5. External review systems

6.2. Laboratory Information System (LIS)

6.2.1. All units in the Al Amiri hospital laboratory departments have the CareWorks LIS installed and implemented except for the histopathology unit which uses the Histovision electronic system.

6.2.2. The LIS is extended to the wards and casualties (male, female and pediatric). The LIS at these locations is limited to ‘read and print’ results.

6.2.3. All LIS data is protected on a backup server.

6.3. LIS Information Confidentiality

6.3.1. Each laboratory user has a unique username and password to with defined access rights.

6.3.2. Each laboratory user has limited access to their unit’s information on the LIS in modifying patient data.

6.3.3. The laboratory director and chief technologist have full access to the LIS. 6.3.4. To access laboratory authorized reports in the wards and the casualty,

users must have a password to log into the system via the internet. 6.3.5. The senior technologist and some nominated laboratory staff are the only

users with rights to correct patient demographic data.

6.4. Meetings with the LIS company representatives are held every six months to update the system, discuss any problems, and any potential upgrades in the LIS system according to the requirements of the laboratory.

7. Reference(s)

7.1. Laboratory Information Management System , WHO

8. Attachment(s) (Not Applicable)

Ministry of Health




.

Page 1 of 11

RETENTION AND STORAGE OF SAMPLES/ARCHIVING POLICY Effective Date: 01/05/2001 Rev. Date: 01/12/2017

Title: Retention and Storage of Samples/Archiving Policy






Revision Date: 01/12/2017

Approval(s):

Signature/Date:

Note(s): Major Changes

Ministry of Health




.

Page 2 of 11


1. Purpose

1.1. The purpose of this policy is to describe the policies and procedures for the retention of laboratory records and materials in the laboratory.

2. Policy Statement(s) 2.1. Laboratory Records and materials are retained for periods mandated by

government regulations, accreditation requirements, and the Administration of Laboratory Services' policies.

2.2. Records and materials shall be kept and preserved in a suitable environment that maintains integrity, prevents damage or destruction, and facilitates retrieval for the defined retention period.

2.3. Archiving and good record keeping means that records must be-

2.3.1. Accurate- documenting all the significant steps done in the blood bank. 2.3.2. Retrievable- allowing retrieval of information in timely manner. 2.3.3. Confidential- protected from unauthorized access. 2.3.4. Safe- protected from being destroyed e.g. by fire.

3. Responsibility

3.1. It is the responsibility of the head of unit and senior technologist in charge to ensure proper retention and storage of record and materials within the unit and specify their safe accessible locations.

3.2. Technologists who are assigned in different sections of the unit shall participate and be fully aware about the location of relevant records or when to dispose materials after the specified storage time.

4. Definition(s)

(Not Applicable)


5.1. Refrigerator 5.2. Cupboard/ storage cabinet 5.3. Files and logbooks 5.4. All pertinent records 5.5. Computer /LIS

Ministry of Health




.

Page 3 of 11


6. Procedure

6.1. Biochemistry

6.1.1. All patients' records are retained and secured in the LIS by password for each doctor and technologists according to defined access and rights for a certain period of time. A back-up server is available to maintain a copy of the data. Through the software, patient records can be retrieved by searching using one of the following criteria-

6.1.1.1. CID of the patient 6.1.1.2. File number of the patient 6.1.1.3. Date and location

6.1.2. Tables containing the recommended retention time, location and responsibilities for records and materials in the Biochemistry unit are depicted in the attachment section.

6.2. Hematology

6.2.1. Laboratory

6.2.1.1. Record keeping is computerized for all tests done at Al Amiri laboratory.

6.2.1.2. Manual record keeping is also available for-

6.2.1.2.1. Bone marrow examination 6.2.1.2.2. Hb. Analysis 6.2.1.2.3. G6PD, reticulocytes count & sickling test 6.2.1.2.4. ESR 6.2.1.2.5. Pre-transfusion testing. 6.2.1.2.6. Tests sent out to other laboratories in Kuwait (i.e. KCCC,

FOM, and KCBB)

6.2.1.3. Blood Bank

6.2.1.3.1. The record keeping system in the blood bank is both manual and electronic.

6.2.1.3.2. Record Retention Time (Preservation)-

6.2.1.3.2.1. Patient records: minimum 5 years

Ministry of Health




.

Page 4 of 11


6.2.1.3.2.2. QC records: minimum 2 years

6.2.1.4. Transfusion Reactions: minimum 5 years

6.3. Microbiology

6.3.1. Laboratories shall retain records and/or materials for a period of time when required for patient care, education, quality improvement, and other needs. Irrespective of the period of retention, the sample storing reservoir should be big enough for the storage of all required samples as well as permits easy access for review.

6.4. Histopathology

6.4.1. Filing reports and slides- The department will store slides and tissue

blocks on specimens received for 15 years. These are archival items for future review in case of change in condition of patient disease or emergency of new diagnostic tools. The original reports are stored in the department and are available upon request by the physician.

7. Reference(s)

7.1. Ministry of Health Retention Policy of Specimens and Documents 2016 7.2. CLIA – Clinical Laboratory Improvement Amendments (US) 7.3. CAP - College of American Pathologists 7.4. OAML- Ontario Association of Medical Laboratories 7.5. MOHLTC- Ministry of Health and Long-term Care, Ontario 7.6. OLA – Ontario Laboratory Accreditation(Quality Management Program-

Laboratory Services) version 3 8. Attachment(s)

8.1 Retention Periods and Location of Laboratory Records

Ministry of Health




.

Page 5 of 11


8.1 Retention Periods and Location of Laboratory Records

General Laboratory Records

Retention Time Retention Location

Responsibility

Laboratory Records

Analytical Incident Reports

2 Years Various Subsections Staff Assigned to the Subsection, Quality Control Officer

Result Communication Records

1 Year Logbook and LIS Staff

Daily Patient Logs 1 Year LIS

Laboratory Worksheet/Work List

2 Years LIS

Instrument Maintenance Records

Life of Instrument Plus 2 Years

Quality Control Section Instrument Logs

Unit Senior Technologist, QC Officer

Method Manuals /Electronic Copy

Life of Instrument Hard Copy- on the Shelves in the Quality Control Section. Electronic Copy-on the Computers Inside the Laboratory, inside the Doctor’s rooms and in the Unit Senior Technologist’s Room.

Method Verification Records

Life of Instrument Inside the Instrument Documentation File in the Unit Senior Technologist’s Room.

Patient Test Results Hard Copy- 2 Years Electronic Copy- 10 Years

Electronic Copy-LIS and Back-Up Server

Accession Records 10 Years LIS and Back-Up Server

Ministry of Health




.

Page 6 of 11


Endorsement Records 1 Month Quality Control Data Filing Area and Each Unit Section

Consultation Records 1 Year

SOP (Obsolete) 2 Years Quality Improvement Records

Training, Qualifications and Competency

3 Years Past Last Day of Employment

Computer, Hard Copies

Head of Unit- for Unit Doctors Senior Technologist- Technical Staff

Records of External Inspections, Self and Peer Assessments

3 years Head of Unit and Unit Senior Technologist

Method/ Process Validation Records

Life of Instrument Instrument folder and Hard Copies With Unit Senior Technologist

Annual Review of Policies, Processes and Procedures

2 years Head of Unit, Unit Senior, Hard Copies are Available in related location

Register of Referred Specimen/Patient Records for Referred Tests

10 years Scanned Copies on the LIS in the Send-Out Section

Equipment Calibration Records (e.g. Thermometers, Machines, Pipettes)

2 years Quality Control Data Filing Area

Quality Control Officer

Specimen Rejection Log 3 Months Quality Control Data Filing Area and Quality Control Computer Database


Management Review Policies

2 Years

Software Application Validation Records

Life of Instrument

Quality Control (Internal, National, and International) Records

2 Years Quality Control Data Filing Area and Computer, External Data Drive

Ministry of Health




.

Page 7 of 11


[Levey-Jennings, Cumulative Summaries, Quality Control Corrective Actions etc…]

Containing all Quality Control Reports

Safety Records

Waste Disposal Record Current Year Plus 2 Years

Safety Data Filing Area

Safety Officer

Material Safety Data Sheet (MSDS/SDS)

Life of Instrument Plus 2 years

Safety Data Filing Area

Safety Officer

Inspection Round Checklist

2 Years Safety Data Filing Area

Safety Officer

Proficiency Testing Materials

Proficiency Testing Materials

Until Final Participant Results are Received

Refrigerator or Freezer


Clinical Chemistry Laboratory

Serum/Plasma or EDTA Plasma/CSF/Body Fluids (Except Urine)

7-10 Days Refrigerator (2-8oC)

Section Staff

Aliquots of 24-Hour Urine (2-8oC)

7-10 Days Cold Room (2-8oC)

Section Staff

Electrophoresis and Immunofixation Prints

3 Years Electrophoresis Report Book

Section Staff

Random Urine 7-10 Days Refrigerator (2-8oC)

Section Staff

Stone Samples 10 Years Quality Control Sample Filing Area

Section Staff

Stone Analysis and MMS Reports

10 Years Stone Analyzer Computer

Section Staff

Hematology Laboratory

Hematology Laboratory Patient Results for Special Tests

5 Years Refer to Unit SOP Section Staff

Bone Marrow Reports 20 Years Refer to Unit SOP Section Staff Special Tests Logbook 3 Years Refer to Unit SOP Section Staff

Specimen for Complete Blood Count (CBC)

48 Hours Refer to Unit SOP Section Staff

Peripheral Blood Smear 7 Days Refer to Unit SOP Section Staff Bone Marrow Smears 10 Years Refer to Unit SOP Section Staff

Bone Marrow Reports 10 Years Minimum

Refer to Unit SOP Section Staff

Ministry of Health




.

Page 8 of 11


Specimen for Coagulation 48 Hours After Release of Report


Specimen for Special Coagulation

4 Months Refer to Unit SOP Section Staff

Specimen for Blood Group

7 Days Refer to Unit SOP Section Staff

Positive Serum for Antibodies

1 Year Refer to Unit SOP Section Staff

Blood Bank

All Donor and Recipient Records


Records of Employee Signatures and Initials


Records of Permanently Deferred Donors

Indefinitely Refer to Unit SOP Section Staff

Specimens from Blood Donor Units and Recipients

7 Days Post Transfusion


Patient Records 10 Years Refer to Unit SOP Section Staff Quality Control Records 5 Years Refer to Unit SOP Section Staff

Microbiology Laboratory

Specimens

Culture and Sensitivity (Except Sterile Sites)

Until Testing is Complete

Refrigerator (2-8oC)

Section Staff

Culture and Sensitivity (Sterile Sites)

7 Days After Testing is Complete

Room Temperature Section Staff

Urine for Urinalysis Until Testing is Complete


Culture Plates Until Final Report is Released


Smears Routine Microbiology Slides

7 Days Room Temperature Section Staff

Gram Negative Diplococci Smears-Male Urethral (Negative Culture)

1 Year Room Temperature Section Staff

Positive Smears From Sterile Sites (Negative Culture)

1 Year Room Temperature Section Staff

Ministry of Health




.

Page 9 of 11


AFB Smears 1 Year (Negatives and Positives)


Albert’s Stain 1 Year (Negatives and Positives)


Isolates (Storage Temperature Dependent on Organism)

Isolates From MOH Notifiable Positive Cultures

Keep Viable Until the Final Report is Received From the Referral Laboratory

Section Staff

Sterile Site Isolates of Potential Pathogenic Significance

1 Month After Reporting

Freezer (-70oC)

Section Staff

MRSA/VRE/PDR Gram Negative

3 Months Freezer (-70oC)

Section Staff

Serology

Serum for Serology (Other Than Syphilis)

One Month For All Specimens


Section Staff

Positive Serum for TPHA, VDRL, RPR

6 Months Refrigerator (2-8oC)

Section Staff

Parasitology

Specimen Blood/.Serum If Positive-6

Months Freezer (-20oC)

Section Staff

Stool for Microscopy Until Results Released For All Specimens Positive Cryptosporidium For 3 Months


Freezer (-20oC)

Section Staff

Virology

Specimen

Blood If Negative, Keep Up To 3 Months If Positive, Keep Up To 6 Months Positive Samples for HIV Will Be Kept Forever

Freezer (-20oC)

Freezer (-20oC)

Section Staff

Ministry of Health




.

Page 10 of 11


Stool Samples for Polio If Negative, Keep Up To 1 Year If Positive, Must Be Discarded By The WHO

Freezer (-20oC)

Freezer (-20oC)

Section Staff

Samples For Measles, Rubella, Influenza, Corona

If Negative, Keep Up To 1 Year If Positive, Must Be Discarded By The WHO

Freezer (-20oC)

Freezer (-20oC)

Section Staff

Other Samples If Negative, Keep Up To 3 Months If Positive, Keep All For Up To 6 Months

Freezer (-20oC)

Freezer (-20oC)

Section Staff

Mycology

Specimen Keep Up To 6 Weeks For Mucormycosis, Keep Up To 6 weeks

Freezer (-70oC)

Room Temperature

Section Staff

Cultures Keep Plates Until Final Reports Are Released


Histopathology Laboratory

Surgical Pathology Wet Tissue 2 Weeks After

Final Report Safe Cabinet (Once

the Cabinet is Full, the Older Ones Are Kept in the Histopathology Store in Basement 2)

Section Staff

Paraffin Blocks 10 Years Block Cabinet (Once the Cabinet is Full, the Older Ones Are Kept in the Histopathology Store in Basement 2)

Section Staff

Ministry of Health




.

Page 11 of 11


Slides 10 Years Slides Cabinet (Once the Cabinet is Full, the Older Ones Are Kept in the Histopathology Store in Basement 2)

Section Staff

Reports 10 Years Patient Report File and Computer

Section Staff

Cytology


Section Staff

Non-Forensic Autopsy

Wet Tissue 3 Months After Final Report

Safe Cabinet (Once the Cabinet is Full, the Older Ones Are Kept in the Histopathology Store in Basement 2)

Section Staff

Paraffin Blocks 10 Years Block Cabinet (Once

the Cabinet is Full, the Older Ones Are Kept in the Histopathology Store in Basement 2)

Section Staff

Slides 10 Years Slides Cabinet (Once the Cabinet is Full, the Older Ones Are Kept in the Histopathology Store in Basement 2)

Section Staff


Section Staff

Forensic Autopsy

Wet Stock Tissue Indefinitely Refer to Unit SOP Section Staff Paraffin Blocks Indefinitely Refer to Unit SOP Section Staff

Slides Indefinitely Refer to Unit SOP Section Staff Reports Indefinitely Refer to Unit SOP Section Staff

Gross Photographs/Negatives


Accession Log Indefinitely Refer to Unit SOP Section Staff

Body Fluids and Tissue for Toxicology

1 Year Refer to Unit SOP Section Staff

Representative Tissue Suitable for DNA Analysis


Al-Amiri Clinical Laboratories Department Policies ... · Ministry of Health ةـحــصلا...

Documents

Transcript of Al-Amiri Clinical Laboratories Department Policies ... · Ministry of Health ةـحــصلا...