Al-Amiri Clinical Laboratories Department Policies Education ......Within run Imprecision- a pool of...

Al-Amiri Clinical Laboratories Department

Policies Education & Training

General Policies

Group (C)

Laboratory Safety & Quality Policies

Lecturer: Dr Naheda Alkazemi

Ministry of Health

وزارة الصــحـة

Al-Amiri Hospital األمــيـري المســتشفى

DEPARTMENT OF CLINICAL LABORATORIES

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SAFETY AND RISK MANAGEMENT POLICY Effective Date: 01/05/2001 Rev. Date: 01/12/2017

Title: Safety and Risk Management Policy

Policy Owner: Laboratory Department

Policy Code: C-LAB-006

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): Minor Changes

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1. Purpose

1.1. The purpose of this policy is to

1.1.1. Ensure a healthy and safe working environement and to protect both the staff and their surrounding environment from hazardous materials.

1.1.2. Orient and train all laboratory personnel on safe work practice and procedures in compliance with established hospital policies.

1.1.3. Prevent the spread of infection, physical injury, and illness through exposure to chemicals that maybe present.

2. Policy Statement(s)

2.1. Safe laboratory practice and safe environment are essential requirements and

are the responsibility of laboratory leadership, safety committee and all laboratory staff.

2.2. The laboratory has a Safety Committee with a safety officer from each laboratory unit participating as a member. It is headed by a Microbiology physician and under the laboratory director for resources and supplies approval and documentation of safety policies and procedures.

2.3. Incidents related to staff safety are documented and managed through procedures involving the cooperation of safety officers, head of safety committee, preventive medicine department staff and emergency department.

3. Responsibility

3.1. The unit safety officer is responsible primarily in making personal safety inspections to discover and correct unsafe practices in the laboratory.

3.2. The unit safety officer is accountable to the senior technologist and the head of the unit.

3.3. The safety officer is trained on safety through regular lectures and demonstrations by the head of the safety committee.

3.4. All working staff must adhere to the basic safety rules for their own protection and show awareness of safe practice and proper and immediate response to safety incidents. They receive a copy of the Laboratory Safety Manual upon employment in the Laboratory, along with safety training and vaccination.

4. Definition(s)

(Not Applicable)

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5. Equipment/Form(s) Required

5.1. Safety tour check list 5.2. Laboratory safety follow up schedule 5.3. Laboratory safety manual 5.4. Waste log sheets 5.5. Safety warning letters 5.6. Accident report form 5.7. Incident report form 5.8. Laboratory Safety Inspection Log sheet 5.9. Emergency exit 5.10. Fire alarm 5.11. Safety shower 5.12. Eye wash 5.13. First aid kit 5.14. Spill kit 5.15. MSDS/ SDS availability 5.16. Disinfectants 5.17. Chemical storage 5.18. PPD (i.e. goggles, masks, gowns) 5.19. Needle stick and blood splashes instruction 5.20. Sharp waste disposal containers

6. Procedure

6.1. Implementing safety measures tools -

6.1.1. Safety manual 6.1.2. Safety committee-involves a chair person and the safety officers from

each unit. 6.1.3. Regular inspection of safety measures 6.1.4. Regular training 6.1.5. Evacuation plan 6.1.6. Risk management plan checked on a regular basis in the laboratory

council and accreditation team committee meetings.

6.2. The unit safety officer shall -

6.2.1. Perform daily inspection of all laboratory equipment. 6.2.2. Submit the inspection round check list to the laboratory safety officer. 6.2.3. Check waste disinfection and waste disposal daily. (Refer to the waste log

sheets in the forms folder).

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6.2.4. Promote safety measures to individual staff (refer to the laboratory safety manual).

6.2.5. Warn individual staff not adhering to the basic safety rules (refer to the safety warning letters in the forms folder).

6.2.6. Keep a record of incident reports (refer to the incident report form in the forms folder).

6.2.7. Encourage staff to attend safety demonstrations and lectures. 6.2.8. Attend safety meetings and disseminate information to members of the

unit.

6.3. Access to the work areas shall be controlled and areas for members of the public shall be clearly segregated from the work areas.

6.4. The universal biohazard symbol shall be displayed at specific laboratories handling pathogenic microorganisms. Only authorized personnel shall enter a laboratory displaying the universal biohazard sign. Doors9displaying a biohazard symbol shall not be propped open, but shall remain closed.

6.5. Food and drinks are strictly prohibited within the laboratory. There is a designated cafeteria where food and drink are allowed.

6.6. Mouth pipetting is strictly prohibited. A rubber bulb, automatic pipette or, other safety device shall be used for all pipetting.

6.7. For reasons of both safety and security, personal belongings (coats, bags, pocketbooks, etc.) shall not be kept in the work areas of the laboratory. Personal belongings shall be secured in employees’ lockers or staff designated areas.

6.8. All biohazardous waste shall be maintained and stored separately from the general waste stream and from other hazardous wastes.

6.9. All laboratory personnel shall be aware and adhere to laboratory safety policies and procedures. Newly joined staff members shall be given safety lectures.

7. Reference(s) 7.1. Al Amiri Hospital Laboratory Safety Manual

8. Attachment(s)

8.1. Accident Report Form* 8.2. Incident Report Form* 8.3. Laboratory Safety Inspection Log sheet* 8.4. Daily Time Stamp Check Form* 8.5. Safety Tour Checklist*

*All forms are located in the ‘Forms Folder’

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SELECTION AND EVALUATION OF METHODS AND INSTRUMENTS POLICY Effective Date: 01/05/2001 Rev. Date: 01/12/2017

Title: Selection and Evaluation of Methods and Instruments Policy


Policy Code:C-LAB-008





Approval(s):

Signature/Date:

Note(s): No changes

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1. Purpose

1.1. The purpose of this policy is to guide all Amiri laboratory staff in evaluating new machines, reagents, new modification of any present method.

2. Policy Statement(s) 2.1. Ultimate Selection of analytical methods and instruments and approval is

regularly done by the specialized committee under the administration of laboratory services. Specifications and requirements are submitted to the committee from the local laboratory which requires the instrument or the methodology in cases of special requirements.

2.2. All machines, reagents, methodologies that are introduced inside MOH laboratories are already validated by the manufacturer, approved by either FDA or CE and locally verified by a laboratory assigned by the specialized scientific committee under the administration of laboratory services.

2.3. Local verification of the manufacturer claims for all new instruments or methods received in the laboratory to be done before using them for routine analysis of patient specimens as required by accreditation organizations. The verification data records shall be retained in the instrument folder for the life of the instrument.

3. Responsibility

3.1. The head of the unit determines the evaluation protocol with the experiments to be used and timelines and submits them to the unit senior technologist. The unit senior technologist assigns a staff member who shall perform these experiments and record the data.

3.2. The head of unit assigns one of the unit doctors to follow the evaluation procedure, regularly inspect the data and finally assess the acceptability of the method in consultation with the head of the unit using the performance standards and analytical goals.

4. Definition(s)

Validation- Establishing the performance of a new diagnostic tool.

Verification- Determines performance characteristics before the test system is

utilized for patient testing. Verification assures when the method is used in the laboratory, on the instrument, by the personnel for the patient population is performing as the manufacturer claims.

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Decision Level Xc- Any concentration of the analyte that is critical to medical interpretation (diagnosis, treatment or monitoring).

Allowable Error (Ea) - An error that does not cause misinterpretation of a test

result and misdiagnosis or mistreatment of the patient.

Random error (RE)- Imprecision- An error that can be either positive or negative, whose direction and exact magnitude cannot be predicted, quantified by calculating SD in a set of replicate measurements.

Systemic error (SE): Inaccuracy- An error that is always in one direction;

Constant error: an error which is the same over a range of concentrations; Proportional error: an error which changes as the concentration of the analyte changes (% of the conc.)

Linear range (Reportable range): The range of the concentration in a sample

over which the method is applicable without modification.

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

6. Procedure

6.1. Selection of instruments and analytical methods process entails the following-

6.1.1. Establishing the needs for the method/test 6.1.2. Defining the quality goals 6.1.3. Input from the appropriate clinical staff and medical staff 6.1.4. Reviewing of literature, clinical trials, and feedback from clients 6.1.5. Determining some application characteristics such as-

6.1.5.1. Cost/test 6.1.5.2. Type of specimens 6.1.5.3. Sample volume 6.1.5.4. Turnaround time 6.1.5.5. Workload 6.1.5.6. Equipment & personnel requirements 6.1.5.7. Space 6.1.5.8. Portability 6.1.5.9. Safety considerations

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6.1.6. Determining methodology characteristics such as-

6.1.6.1. Choice of chemical reaction 6.1.6.2. Optimization of reaction conditions 6.1.6.3. Principles of standardization & calibration 6.1.6.4. Rigor of the analytical procedure

6.1.7. Determining performance characteristics such as-

6.1.7.1. Working range 6.1.7.2. Precision 6.1.7.3. Accuracy 6.1.7.4. Recovery 6.1.7.5. Interference 6.1.7.6. Detection limit (sometimes)

6.2. Evaluation of instrument/method includes-

6.2.1. Familiarization period- the senior technologists are oriented, trained, and

read the manual and log book prepared. Preparation of the evaluation protocol, setting the analytical goals and performance standards is also part of this period.

6.2.2. Preliminary method verification experiments include-

6.2.2.1. Within run Imprecision- a pool of patient specimens or QC material with a level that is near to the medical decision limits is to be run 20 times within the same run, and then the mean will be calculated along with the within run standard deviation (Sw-run), and CV%.

6.2.2.2. The Sw-run should be less than ¼ the allowable total error (TEa) 6.2.2.3. The RE (4 x Sw-run) must be

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6.3. Final method evaluation experiments includes-

6.3.1. Day to day (batch to batch) imprecision

6.3.1.1. Use QC levels that are near to the medical decision limits for day to day imprecision experiments

6.3.1.2. Run all the QC levels every day for 20 days then calculate Mean & SD & CV%

6.3.1.3. Calculate RE (4 x SD) must be < Tea

6.3.1.3.1. RE calculation depends on the sigma specification as set in the quality goals.

6.3.1.4. 2 Sigma specification- RE = 2 x SD

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axis against the arithmetic difference between the two methods on Y axis (Y-X).

6.3.2.2.1..2. Negative or positive bias between the two methods (all over the examined range or at certain concentration) can be detected using this plot

6.3.2.2.2. Linear regression analysis

6.3.2.2.2..1. Perform a scatter plot (linear regression graph)

between the comparative method value)on X axis against the test method on Y axis

6.3.2.2.2..2. Calculate the following- 6.3.2.2.2..3. Correlation coefficient (r) its value depends on the

range of data.

6.3.2.2.2..3.1. It should not be used to judge acceptability of the test method

6.3.2.2.2..3.2. If r ≥ 0.99; so the range of data is wide to provide reliable estimates of a & b

6.3.2.2.2..3.3. If r < 0.99; so the range of data is not enough and it is recommended either to collect more data to expand the concentration range or calculate SE at the mean of the data or use more complicated regression equation.

6.3.2.2.2..4. Y intercept (a)- Its value reflects the constant error 6.3.2.2.2..5. Regression line slope (b) :Its value reflects the

proportional error

6.3.2.2.2..5.1. From linear regression calculations use the following equation to calculate the systematic error (bias)

6.3.2.2.2..5.2. Y= a+bX 6.3.2.2.2..5.3. SE = Yc-Xc Where Xc is the medical decision

limit for the analyte.

6.3.2.2.2..6. Calculate the total error (TE) According to the following equation: TE= RE+SE

6.3.2.2.2..6.1. TE should be

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6.3.2.2.2..6.2.1. TE=bias+2SD 6.3.2.2.2..6.2.2. TE=bias+3SD 6.3.2.2.2..6.2.3. TE=bias+4SD (When using% bias use

CV instead of SD)

6.4. Assessing Method Acceptability

6.4.1. The calculated TE is compared to the acceptable performance derived from the following-

6.4.1.1. CLIA specification of acceptable performance. 6.4.1.2. Biological variation-

6.4.1.2.1. Coefficient of Variation (CV)-

6.4.1.2.1..1. Minimum acceptable performance- CV less than 0.75 CVi 6.4.1.2.1..2. Desirable performance- CV less than 0.50 CVi 6.4.1.2.1..3. Optimum performance- CV less than 0.25 CVi

6.4.1.2.2. Bias-

6.4.1.2.2..1. Minimum acceptable performance- B less than 0.375

(CV2 i+CV2G)0.5 6.4.1.2.2..2. Desirable performance- B less than 0.250 (CV2i+CV2G) 0.5 6.4.1.2.2..3. Optimum performance- B less than 0.125 (CV

2i+CV2G)0.5

6.4.1.3. After the previous steps have been completed successfully, objective conclusions about the acceptability of method performance are reached through-

6.4.1.3.1. Comparing the estimated errors with the limits defined for the analytical goals.

6.4.1.3.2. When the value for the total error obtained is TEa, it is unacceptable.

6.4.1.3.3. If unacceptable, the performance should be improved. If it cannot be improved, the method is rejected.

6.5. Verify reference interval(s)

6.5.1. Verification of Reference interval-

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6.5.1.1. Select 20 healthy reference samples 6.5.1.2. Questionnaire is needed 6.5.1.3. If ≤ 2 are outside proposed interval ,the range is validated 6.5.1.4. If > 2 are outside proposed intervals-

6.5.1.4.1. Measure another 20 6.5.1.4.2. If ≤ 2 are outside proposed interval, the range is validated by

120 reference individuals’ samples

6.5.2. Transference of the reference interval

6.5.2.1. Use the reference range of the old method if they are comparable. Use the regression equation obtained from the comparison of methods experiment to calculate the new upper and lower reference limits. Then verification by 20 samples technique.

6.5.2.2. Use the reference range of the manufacturer if the new method performs according to that of the manufacturer.

6.5.3. Selection and implementation of the proper QC procedure. 6.5.4. Write Standard operating procedure of the method 6.5.5. Training of all unit technologists on the new method 6.5.6. Introduction of the method into service and monitoring its routine

performance, assess its long term(extended) imprecision (6 months interval).If the method is urgently required for routine or urgent service, it can be introduced into service with ongoing training of other technologists.

6.5.7. Enroll the new method or instrument in the appropriate EQA program according to central QC laboratory and administration of laboratory services rules and regulations.

6.5.8. Maintain all the instrument documents of installation, evaluation report, preventive maintenance & mending documents and monthly performance data

7. Reference(s)

7.1. http://www.validation-online.net/validation-protocol-standards.html 7.2. http://regulatory.com/forum/article/testval.html 7.3. http://www.labcompliance.com/tutorial/methods/default.aspx 7.4. http://www.ehow.com/how-does_5954921_process-validation-protocol.html

8. Attachment(s)

(Not Applicable)

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

Title: Communication Policy







Approval(s):

Signature/Date:


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1. Purpose 1.1. The purpose of this policy is to provide guidance as to the communication within

the unit, with other laboratory units, hospital departments, other laboratories, clients, patients and families.


2.1. Proper communication inside the laboratory among colleagues and doctors is vital in carrying the task of the team to provide high quality service. All staff members are expected to ensure proper endorsements.

2.2. Coordination with the nursing and medical team when needed must be carried out properly.

2.3. Communication of incidents related to staff, patients and others' safety are of utmost importance.

2.4. Critical values shall be informed in a timely manner because of their potential to have a direct impact on patient safety.

2.5. Communication helps us to

2.5.1. Relay information about specimen collection, handling & transportation. 2.5.2. Provide information about the type of tests that done in the laboratory. 2.5.3. Inform about any contaminated specimens and request for fresh samples. 2.5.4. Obtain additional information about the patient condition/ type of drugs or

antibiotics taken

2.6. Laboratory technologist shall communicate with the ward for the following circumstances

2.6.1. No request or no sample received 2.6.2. Wrong patient information 2.6.3. Wrong or leaking sample 2.6.4. Improper sample collection

3. Responsibility 3.1. During duty hours, an acting senior technologist shall be nominated within the

team to be responsible for communication in case of any emergency, shift-to-shift endorsements, and handover.

3.2. The technologists and doctors shall communicate with the physician through phone call whenever required. The responsible nurse shall be informed in cases where contacting the responsible physician failed.

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3.3. The technologists from shift to shift should do proper endorsements both verbally and in writing according to the laboratory handover policy (C-LAB-011).

3.4. Unit doctors and technologists shall document relevant comments in the Report Notes, Doctor’s notes and Technologist’s notes sections on the electronic report.

3.5. The technologists may consult laboratory doctors for any inquiries (directly during regular working hours and by phone calls during duty hours).

3.6. In case of major problems such as a machine breakdown, a non-show of the colleagues for duty, the technologists should inform the Senior Technologist-in charge.

3.7. The acting senior within the team shall call the emergency numbers in case of any emergency inside the laboratory.

3.7.1. Evacuation Activation Number – 711 3.7.2. CPR-Life Support – Ext. 6701/6710 3.7.3. Overhead Calling System – 5551 3.7.4. Medical On Call – 94905077 3.7.5. Anesthesia On Call – 94906055 3.7.6. Cardiology On Call – 94907099

3.8. The quality manager of the laboratory shall check the laboratory complaint

boxes for any complaints and perform the required actions.

4. Definition(s)

Duty hours- Any shift outside regular working hours on official workdays. This includes all afternoon shifts; night shifts and weekends or holidays.

Critical Values- Results that represent a life-threatening condition and require

immediate action.


5.1. List of hospital extensions 5.2. Laboratory doctors monthly on-call schedule including their contact information 5.3. Rejection log books 5.4. Maintenance log books 5.5. Endorsement log book 5.6. Laboratory critical values list (refer to the Critical Test/ Critical Result Reporting

Policy [C-Lab-017]) 5.7. Rejection policy (C-Lab-015) 5.8. Error reporting form

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6. Procedure

6.1. Laboratory

6.1.1. Levels and tools of communication-

6.1.1.1. Communication within the Al-Amiri Laboratory department-

6.1.1.1.1. Circulars 6.1.1.1.2. Members of work teams contact each other through emails

or mobile work groups 6.1.1.1.3. Written instructions given to the new employees 6.1.1.1.4. Meetings held regularly

6.1.1.1.4..1. Laboratory council meetings- which include the laboratory director, chief technologist, head of laboratory units, senior in-charge in each unit, senior in-charge for the reception, senior in-charge for the out-patient, safety officer, and quality assurance officer.

6.1.1.1.4..2. Weekly meeting are held between the chief technologist and the senior technologist in charge.

6.1.1.2. Communication with other laboratories and offices-

6.1.1.2.1. The communication between Al-Amiri laboratory and the other laboratories is performed through-

6.1.1.2.1..1. Letters or faxes 6.1.1.2.1..2. Contact with the Kuwait Central Blood Bank (KCBB)

through telephone communications, as well as documenting the conversation in writing, faxes and requests sent by transport personnel.

6.1.1.2.1..3. Rejection forms are sent with requests if samples or requests do not fulfill the minimal requirements.

6.1.1.2.1..4. The Al-Amiri laboratory director attends regular laboratory director’s council meetings.

6.1.1.2.2. Communication with other departments in the hospital-

6.1.1.2.2..1. Laboratory utilization committee 6.1.1.2.2..2. Circulars between the laboratory and the clinical

department shall be through the hospital director.

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6.1.1.2.2..3. Extension of LIS to other clinical departments (all wards, ICU, CCU, casualty departments, nuclear medicine department, physical medicine department, pharmacy, and X-Ray department).

6.1.1.2.2..4. Laboratory test manual

6.1.1.2.3. Communication with the laboratory administration and the Ministry of Health-

6.1.1.2.3..1. Official letters sent from the hospital director through the capital health area director to the laboratory administration at the MOH.

6.1.1.2.4. Communication with the patients-

6.1.1.2.4..1. Direct communication by doctors (Hematologists in out-patient clinics)

6.1.1.2.4..2. Written instruction given to the patient before tests (if applicable).

6.1.1.2.4..3. Printed educational material 6.1.1.2.4..4. Complaint boxes are placed beside the main

laboratory and the outpatient phlebotomy laboratory for any complaints regarding the laboratory.

6.1.1.2.5. Councils and committees-

6.1.1.2.5..1. Department Council-

6.1.1.2.5..1.1. Members-

6.1.1.2.5..1.1.1. Laboratory director 6.1.1.2.5..1.1.2. Chief technologist 6.1.1.2.5..1.1.3. Heads of the units 6.1.1.2.5..1.1.4. Senior technologists of each unit 6.1.1.2.5..1.1.5. Safety & quality control officer 6.1.1.2.5..1.1.6. The supervisor of reception and

outpatient office 6.1.1.2.5..1.1.7. The supervisor of the training office 6.1.1.2.5..1.1.8. The supervisor of the primary health

care laboratories

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6.1.1.2.5..1.2. The Committees

6.1.1.2.5..1.2.1. Safety Committee 6.1.1.2.5..1.2.2. Blood Transfusion Committee 6.1.1.2.5..1.2.3. Accreditation Team Committee 6.1.1.2.5..1.2.4. Laboratory utilization committee

6.2. Biochemistry

6.2.1. All technologists on duty shall contact the wards, casualties and clinics in

case of -

6.2.1.1. Critical Values (refer to the critical test/ critical result reporting policy [C-LAB-017]).

6.2.1.2. Delay or inability to perform the test requested with the reason in case of rejection or technical errors such as equipment problems.

6.2.1.3. Any errors or rejections performed (refer to the rejection policy [C-LAB-015]).

6.2.2. The technologist on duty shall call the doctors of the unit (according to the 1st and 2nd on call monthly duty schedule) in the following cases-

6.2.2.1. Receiving requests not on the stat list (refer to the urgent/stat policy [C-LAB-018]), but urgently required by the doctor. The on call laboratory doctor shall discuss the request with the physician and decide in such situations.

6.2.2.2. Clinical issues, including interpretation of results. All clinical queries shall be referred to the on call doctors.

6.2.2.3. Any clinical queries the technologists come across while authorizing reports during duty hours.

6.2.3. In case of technical problems or any major problems -

6.2.3.1. All technologists shall contact the senior technologist in case of technical problems, which he or she cannot solve, and major breakdown of equipment.

6.2.3.2. The technologist may call the engineer for the instrument in case of a major breakdown of any instrument. All such reports and calls shall be recorded in the duty logbook, stating the problem, the time the call was made and any actions taken before and after the call.

6.2.3.3. Shift to shift endorsements (handover) shall be done verbally and in writing. Endorsement log books are available. The technologists on

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duty register all the events, equipment status and endorsements for the next shift (refer to the form folder for the endorsement form.).

6.2.3.4. The Laboratory Tests Manual is also distributed to the hospital wards for guidance regarding all laboratory tests.

6.2.3.5. In case of any shared samples or requests received within the laboratory, the unit technologists shall coordinate with the concerned unit staff accordingly.

6.2.3.6. The unit has a section for referral (send-out) specimens with its own policy (refer to the external test policy [C-LAB-020]).

6.2.3.7. The LIS is extended to all wards where all authorized results can be viewed from their computers.

6.2.3.8. There are verbal and written instructions for the patients about pre-test preparation which are available in laboratory tests manual and in specimen collection sections.

6.3. Hematology

6.3.1. The laboratory technologist shall contact the hematologist in cases where-

6.3.1.1. Critical values are encountered (refer to the critical test/ critical

result reporting policy [C-LAB-017]). 6.3.1.2. Cases with the followings-

6.3.1.2.1. Parameter Lower Limit Higher Limit 6.3.1.2.2. Hb 18.0 g/dl 6.3.1.2.3. WBC < 3.0 x 109/L or > 20 x 109/L 6.3.1.2.4. Plt < 100 x 109/L or > 700 x 109/L 6.3.1.2.5. Abnormal cells on the blood film 6.3.1.2.6. Screening of Hb analysis (HPLC) requests 6.3.1.2.7. Screening of Thrombophilia screen requests 6.3.1.2.8. Coagulation test requests other than the routine coagulation

tests 6.3.1.2.9. Problems in coagulation tests 6.3.1.2.10. Problems in pre-transfusion tests 6.3.1.2.11. Adverse transfusion reactions 6.3.1.2.12. Upon receiving a consultation for the hematologist when the

hematologist is not in the office 6.3.1.2.13. Incidents/accidents in the laboratory 6.3.1.2.14. NEQAS tests and results

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6.4. Microbiology

6.4.1. The technologist in charge or doctor shall inform about any urgent report or any growth such as

6.4.1.1. Positive smear blood culture bottle, CSF, or malaria 6.4.1.2. Gram stain or culture results for the important or critical cases 6.4.1.3. Highly antibiotic resistant strains e.g. MRSA, VRE, VISA and other

MDR organisms. (The technologists shall inform the microbiologist doctor responsible for the section, about these organisms for further action and to inform the clinicians & infection control officer)

6.4.1.4. Communication with other laboratory units with respect to specimen transportation within the laboratory and potential safety hazards.

6.5. Histopathology

6.5.1. The Unit does not deal directly with patients. Printed Reports are sent directly to the requesting doctor's ward by porter where they shall be signed for in the report delivery book by senior nurse/ward records clerk. In case of out-patient’s reports are sent to the agreed upon records clerks. We discourage indiscriminate issuance of duplicate reports as a measure of Patient's Health Information Protection.

6.5.2. Timely release and communication of critical results may have a significant impact on medical decisions and subsequent patient outcomes and patient safety. Head of the histopathology unit and consultant in handling the case shall relay critical cases to the corresponding wards.

7. Reference(s)

7.1. Laboratory Administration Policy, MOH Kuwait 7.2. Laboratory & Hospital Handover Policy, Al Amiri Hospital Kuwait

8. Attachment(s)

8.1. Logbook form* 8.2. Maintenance form* 8.3. Error reporting form* 8.4. Handover/endorsement form* 8.5. Complaint form*


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

Title: Handover Policy







Approval(s):

Signature/Date:


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1. Purpose

1.1. The purpose of this policy is to direct and assist laboratory staff in the handover practice for proper and safe transfer of clinical, technical and environmental data throughout the delivery of laboratory services.


2.1. According to the Canadian accreditation standards and WHO recommendations for laboratory services “transfer of patient information at transition sites” is included as a patient safety required area.

2.2. Proper communication throughout the delivery of patient care has a direct impact on patient safety.

2.3. Implementation of a proper handover policy to ensure the continuity of care and reduce risks and incidents related to poor communication.

3. Responsibility

3.1. The laboratory director, heads of unit, and the senior in charge shall-

3.1.1. Participate in the development of handover policies and forms 3.1.2. Ensure that necessary handover policies and forms are developed by their

units to facilitate smooth transfer of information from one technician to another and ensures safe and effective patient care.

3.1.3. Ensure appropriate and consistent implementation of handover policies by laboratory staff.

3.2. All laboratory technicians, senior technicians, and laboratory doctors-

3.2.1. Read and understand the policy to be able to carry out the work according to the guidelines.

3.2.2. Report any incidents or adverse events related to communication and the handover process.

4. Definition(s)

Clinical Handover- The transfer of professional responsibility and accountability for some or all aspects of services to another person or professional group on a temporary or permanent basis when laboratory services the shifts from one provider/s to another (shift to shift).

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Verbal Order/ Communication- Clinical instructions or directions that are communicated orally face to face, by telephone, or by other auditory devices between a sender and a receiver.


5.1. Laboratory handover/endorsement forms 5.2. Phone 5.3. Fax 5.4. LIS 5.5. Laboratory test manual 5.6. Laboratory rejection form 5.7. List of phone numbers (wards, on-call list, clinics...) 5.8. Hematology clinicians handover form 5.9. Hematology critical case handover form

6. Procedure

6.1. Handover takes place in laboratory shift to shift changes. The transition requires

a structured handover process using appropriate communication tools. 6.2. Information exchange during handover process in the laboratory department is

applied through variable practices such as- 6.2.1. Face to face verbal communication without documentation. 6.2.2. Face to face verbal communication with documentation (manual). 6.2.3. Documentation without verbal communication.

6.3. The handover policy includes the following-

6.3.1. Shift to shift handover

6.3.1.1. Shift to shift clinical handover process includes the following steps-

6.3.1.1.1. Preparation of handover documents- This step includes

preparing and updating the handover endorsement book and making sure that continuity of laboratory services are not interrupted during the process.

6.3.1.1.2. Handover shall be held at each shift change in the morning, afternoon, and night to allow the teams to discuss issues from the previous shift.

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6.3.1.2. Environmental awareness- all handovers shall provide the incoming team with a clear idea of the working environment i.e. the situation that they will face and work in.

6.3.1.3. Patient identification- correct patient identification is essential to provide safe and correct data and to prevent provision of care to the wrong patient; thus all handover practices should include clear patient identification processes (refer the rejection policy [C-LAB-015]).

6.3.1.4. Transfer of Information- the transfer of information shall be done by writing and verbally (laboratory log books and endorsement books).

6.3.1.5. Transfer of responsibilities-

6.3.1.5.1. The senior of the outgoing team shall transfer the responsibilities such as required tasks, actions, ongoing care and monitoring requirements to the incoming team members and makes sure these responsibilities are made clear and understood by the incoming team. These instructions and responsibilities shall be documented in the handover logbook and signed by the technician/technologist informing the endorsement and the staff member receiving the endorsement.

6.3.1.5.2. During the morning shift the responsibility belongs solely to the senior technologist of each laboratory unit.

6.3.1.5.3. During the afternoon, and night shifts the responsibility is transferred to the technologist in charge.

6.3.1.6. Verbal / telephone order-

6.3.1.6.1. The use of verbal orders is an error prone process that carries an increased risk of miscommunication which could result in adverse effects.

6.3.1.6.2. Verbal orders shall only be communicated and accepted if both the sender and the receiver are licensed healthcare professionals, and the order is appropriate and lies within their professional scope of practice.

6.3.1.6.3. List of abbreviations shall not be used when documenting verbal orders.

6.3.1.6.4. When using verbal orders it is essential to use read back process.

6.3.1.7. Verbal communication shall be limited to urgent situations in which immediate written reports are not feasible.

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6.3.1.8. The use of verbal orders is unsafe unless applying the following-

6.3.1.8.1. Write it down 6.3.1.8.2. Read it back 6.3.1.8.3. Get confirmation

6.3.1.9. The handover process and documentation shall be monitored and

supervised by the senior in charge and the assigned laboratory staff. 6.3.1.10. Unexpected incidents and adverse events related to the handover

process shall be reported and investigated by the laboratory department and/or risk management committee and corrective action plans shall be monitored for effectiveness.

6.3.2. Doctors-

6.3.2.1. Hematologists communicate through-

6.3.2.1.1. Daily sitting rounds 6.3.2.1.2. Phone group messaging 6.3.2.1.3. Hematology Clinicians Handover Form 6.3.2.1.4. Hematology Critical Case Handover Form

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

8. Attachment(s)

8.1. Laboratory Handover/Endorsement Form* 8.2. Laboratory Rejection Form* 8.3. Hematology Clinicians Handover Form* 8.4. Hematology Critical Case Handover Form*


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QUALITY ASSURANCE AND QUALITY IMPROVEMENT POLICY Effective Date: 01/05/2001 Rev. Date: 01/12/2017

Title: Quality Assurance and Quality Improvement Policy







Approval(s):

Signature/Date:

Note(s): No Changes

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1. Purpose

1.1. The purpose of this policy is to assure the quality and effectiveness of laboratory procedures, identify and correct problems, assure accurate, reliable and prompt reporting test results, assure the adequacy and competing of the staff.


2.1. An ongoing comprehensive process which analyzes every aspect of active operations. It involves determining quality goals, deciding whether or not the goal has been achieved, and implementing a corrective action if the goal has not been reached.

3. Responsibility 3.1. The laboratory director, chief technologist, heads of units and the unit seniors

shall have the ultimate responsibility in supervising, acknowledging, facilitating and ensuring the quality of all laboratory process.

3.2. The units’ quality officers shall supervise and assure the quality of the analytical processes through various types of quality control programs (internal, national, and external) implementation and troubleshooting.

3.3. The laboratory quality managers along with the quality improvement team shall supervise all the quality activities performed with a broad scope to include pre- analytical and post analytical processes. They shall develop quality improvement plans with indicators and corrective actions when required.

4. Definition(s)

Quality assurance- the maintenance of a desired level of quality in a service, especially by means of attention to every stage of the process of delivery or production.

5. Equipment/Form(s) Required 5.1. Quality improvement plan 5.2. Quality indicators 5.3. Action plan

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6. Procedure

6.1. Quality assurance involves the entire testing process

6.1.1. Pre-analytical process. 6.1.2. Analytical (testing) process. 6.1.3. Post analytical process.

6.2. Laboratory quality assurance programs include a number of standards-

6.2.1. Patient test management which includes-

6.2.1.1. Patient preparation 6.2.1.2. Specimen collection 6.2.1.3. Labeling 6.2.1.4. Preservation and transportation of samples 6.2.1.5. Test requisition completeness 6.2.1.6. Relevance and necessity for testing 6.2.1.7. Rejection criteria for specimen 6.2.1.8. Test report completeness 6.2.1.9. Relevance and accuracy 6.2.1.10. Timely reporting of results 6.2.1.11. Storage and retrieve results

6.2.2. Quality control program 6.2.3. Proficiency testing 6.2.4. Assure staff competency 6.2.5. Complaints management

6.2.5.1. The laboratory shall have a system to deal with complaints in a timely manner.

6.2.5.2. The laboratory has a team for incident and risk management.

7. Reference(s)

7.1. Laboratory Administration Policy, MOH Kuwait 7.2. CLIA – Clinical Laboratory Improvement Amendments (US) 7.3. CAP - College of American Pathologists

8. Attachment(s) (Not Applicable)

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QUALITY CONTROL POLICY Effective Date: 01/05/2001 Rev. Date: 01/12/2017

Title: Quality Control Policy






Revision Date: 01/12/2017

Approval(s):

Signature/Date:


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1. Purpose

1.1. The purpose of the policy is to

1.1.1. Provide guidance about all QC programs applied in the laboratory units. 1.1.2. Explain the rules used to assess the analytical performance of instruments

& assays performed.

1.1.3. Explain the protocol used for out of control values and suitable corrective actions.

1.1.4. Improve the quality of health care.

1.1.5. Generate reliable and reproducible results. 1.1.6. Establish the credibility of the laboratory among doctors/clinicians. 1.1.7. Ensure the consistency of results with defined criteria.


2.1. The use of quality control materials is an essential analytical requirement by all laboratory and accreditation organizations.

2.2. Quality control (QC) materials are used with certain statistical procedures to

assess the accuracy and precision of the analytical systems in regular intervals according to stated protocols.

2.3. Each laboratory unit is participating in different quality control programs (internal

and external).

3. Responsibility

3.1. The unit QC Officer and deputy shall use this policy to guide and train all unit

technologists. They are responsible for control materials preparation, distribution

and troubleshooting. 3.2. All unit technologists are responsible in processing Q.C materials and inspect

their results before running patient samples.

3.3. The QC officer is responsible for troubleshooting the out of control results according to the Westgard defined rule violations in case the other technologists are not able to define and correct the problem.

3.4. All doctors and senior technologists must check the QC results for the analyses before authentication of patient reports and discuss with the QC officer in any of out of control value case.

3.5. The head of the unit shall have the final decision for all QC results, troubleshooting processes, preventive & corrective actions as well as implementation of the policy.

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4. Definition(s)

Levey-Jennings chart- a graph where quality control data are plotted on to give

a visual indication whether a laboratory test is in control or out of control range. The distance from the mean is measured in standard deviations (SD).

Westgard multi-rules- QC rules to help analyze whether an analytical run is in-control or out-of-control. It uses a combination of decision criteria, usually five different control rules to judge the acceptability of an analytical run.

IQC- Internal Quality Control- a set of procedures undertaken by the staff of a laboratory to ensure quality from the collection of specimens, the performance of

the test up to the analytical results, and the procedure being planned, ordered and followed up by the staff itself. An internal quality control program should not attempt to evaluate every procedure, reagent, and culture medium on every

working day. It should evaluate each procedure, reagent, culture medium instruments according to a practical schedule, based on the importance of each item to the quality of the test as a whole.

EQA- External Quality Control- provides validation of test results between laboratories. It allows a comprehensive analysis of results and discrepancies.

Root cause analysis of discordant results ensures that errors are corrected. Pretransfusion Testing- includes ABO & Rh (D) grouping, ABSC, and

crossmatching.


5.1. Levey-Jennings chart 5.2. Westgard multi-rules guidelines

5.3. QC materials 5.4. Computer with internet access 5.5. Distilled water

5.6. Pipette 5.7. Refrigerator and freezers 5.8. Barcode labels

5.9. QC log book / LIS QC module 5.10. Hematologists Responsible for NEQAS/OPD New Cases Distribution List 5.11. Inter–Batch Control Checklist for Automated Blood Cell Counters Form

5.12. Coagulation Instruments Daily Maintenance & Quality Control Form 5.13. ESR Logbook 5.14. Hematology Special Test Logbook (G6PD, Sickling Test & Monospot)

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5.15. Hb Analysis QC File

5.16. Sebia Capillarys 5.17. Quality indicator reporting form

6. Procedure 6.1. Biochemistry

6.1.1. Quality Control Programs

6.1.1.1. Internal QC Program

6.1.1.1.1. The controls used for all the tests in the biochemistry lab are

either liquid or lyophilized controls.

6.1.1.1.1.1. These controls shall be run before running the patient

samples and according to a predefined schedule (QC SOP) and compared to the installed QC ranges.

6.1.1.1.1.2. QC ranges used in the start of a new lot number are

that of the manufacturer, after 20 QC results the QC officer shall calculate the cumulative mean, SD (every 6 months or when required) and cumulative range which is used to assess

the QC results. 6.1.1.1.1.3. Calculated ranges and SD are entered in the

machines and the LIS system.

6.1.1.1.1.4. The machine automatically plots the Levey-Jennings chart which will be inspected whenever the QC material is run. Acceptance and rejection of the QC results is assessed

according to the Westgard rules installed on the analyzer and the LIS QC module.

6.1.1.1.1.5. The details of preparing, storing, schedule of

processing, evaluating, troubleshooting and suitable corrective and preventive actions when necessary are available in the biochemistry QC SOP.

6.1.1.1.1.6. The LIS QC module contains all the active QC lot numbers along with their ranges, charts and Westgard multi-rules. Subheadings regarding Control Code Master are used

to install all QC data, Update Control Value submodule is used to review QC chart, assess, write remarks and authorize the QC results. The review chart is used by the QC officer,

unit doctors and all authorized staff before report

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authentication to review the QC values compared to Westgard

rules.

6.1.1.2. External QC Program

6.1.1.2.1. National QC Program- Supplied by Central QC Laboratory

6.1.1.2.1.1. The National QC Program is an external QC program supplied by the Central QC Laboratory on bi-weekly intervals to assess the accuracy of analytical laboratory performance of

all laboratories inside Kuwait compared to the peer groups. The central QC laboratory is under the department of laboratory administration services.

6.1.1.2.1.2. The biochemistry unit is participating in the national QC Program for routine chemistry analyses, therapeutic drugs, hormones, special chemistry, urine, cardiac, HBA1C

and blood gas programs. 6.1.1.2.1.3. The controls are liquid controls except for HBA1C

which is a lyophilized control, and they are analyzed biweekly.

6.1.1.2.1.4. The evaluation of the machine is done by comparison with peer groups within Kuwait.

6.1.1.2.2. International QC Program

6.1.1.2.2.1. The international QC program is an external QC

program selected by the central QC laboratory management in consultation with the specialized committee for Clinical Biochemistry. It is the head of unit’s responsibility to choose

the programs and the instruments to be enrolled under this QC program. Before starting the International QC program, the unit QC officer shall fill the forms required by the program

for methods’ codes units for analyses reporting and instruments’ enrolment forms under the supervision of the head of the unit. Also, she/he shall send any corrections for

incorrectly sent QC results and any updates for methods, analyses or instruments.

6.1.1.2.2.2. Cycles are received with calendar showing specific

start and due date for each sample to run. Each sample has a seven-day period to be processed and the due date should not be exceeded.

6.1.1.2.2.3. Biochemistry unit is participating in RIQAS from RANDOX Company by the following programs- Routine

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Chemistry, Drugs, HBA1C, Immunoassay (Hormones) and

Immunoassay Specialty for PTH and 25-OH Vitamin D, Specific proteins.

6.1.1.2.2.4. Samples for Chemistry, Drugs, Immunoassay and

Immunoassay Specialty are vials of lyophilized control materials to be reconstituted on the assay date by the QC officer.

6.1.1.2.2.5. Each cycle contains 12 samples for a period of 6 months or one year. Those which contain a cycle period of six months shall be analyzed bi-weekly and include Chemistry

program, Immunoassay (Hormones), Specific proteins, and TDM. Others which are for one year are analyzed monthly and include Immunoassay Specialty Vitamin D, PTH and

HbA1C programs. 6.1.1.2.2.6. The QC officer shall run the QC samples and send

the QC results via the internet to the program website

according to their calendar and dead time for result submission.

6.1.1.2.2.7. The QC officer shall store the remaining of the

external QC specimens in the freezer till receiving and troubleshooting process is done as it can be used to rerun the out of control tests and compare with the sent results.

6.1.1.2.2.8. Reports for external QC are received on timely manner via the internet to the assigned e-mail address (Head of unit, Senior in charge and Biochemistry laboratory mail).

When ready they can be checked on the program website by the assigned staff (QC officers) via a username and password defined at the start up time.

6.1.1.2.2.9. The QC officer shall do the troubleshooting for out of control results in consultation with the head of the unit and a corrective action shall be applied accordingly "Corrections are

applied for mistyping the results and in that case the original documents from the machine should be sent. Corrections to be considered at the End of Cycle report

6.1.1.2.2.10. The QC officer shall save the received reports in a QC folder on the desktop computer as well as on a CD/ USB which need to contain two years’ worth of reports.

6.1.1.3. Troubleshooting of Quality Control results

6.1.1.3.1. Westgard single and multi- rules are followed to define out of control and rule violation. (1:2S “Warning Rule”), (2:2S, 1:3S,

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R:4S “Rejection rules”). A multi rule QC procedure uses two or

more statistical tests, (control rules) to evaluate the QC data, and then rejects a run if anyone of these statistical tests is positive.

6.2. Hematology

6.2.1. The quality control officer is responsible for receiving new controls, unit

statistics, and checking the staff compliance in documenting in the files. 6.2.2. The Hematology section is provided with copies of the Hematology

Reagent appendix file which contains complete information for each

reagent, Quality Control Policy file and Standard Operating Procedure file. 6.2.3. The Hematology staff are trained to do maintenance for all analyzers and

perform reagent checks before processing the controls to produce reliable

results. They shall document their actions in the logbook allocated at each section.

6.2.4. Two programs for quality control shall be used

6.2.4.1. Internal QC program 6.2.4.2. External QC program

6.2.5. Prior to performing the QC, the technologist shall check if the analyzer is

properly shutdown followed by start up or daily checks and resolve all the

alarms present. 6.2.6. The Internal QC Program- consists of stabilized human blood

commercially prepared and shall be kept in the fridge at 2-8 degrees Celsius

until expiry date, any lyophilized powder control shall be reconstituted with distilled water and stand at room temperature before using and is useable for up to 8 hours inside the analyzer. Latex controls are available and kept at

room temperature and shall be properly mixed. After using the latex controls, they shall be returned inside the fridge.

6.2.6.1. Multi-level quality controls are used on Hematology analyzers to monitor a range of clinical values .If the control is out or expired it will give a red flag on the value and a black flag if it is within the range. The

Levey-Jennings QC chart is used side by side with the control values and can be seen on the monitor with 2 SD range.

6.2.6.2. Quality controls which are commercially prepared and inside the kit

shall be kept at room temperature before using and the shelf life is until expiry.

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6.3. External QC Program

6.3.1. National QC Program (SABAH QC) - the national program control is

received twice a month and shall be processed in the CBC analyzer randomly check the performance result. Copies for filling and sending to QC laboratory are printed. Evaluation shall be done in comparison with other

governmental hospitals in Kuwait. 6.3.2. UK NEQAS QC Program – the NEQAS program shall be used for the

external QC program to ensure the clinical laboratory test results are

accurate, reliable and comparable wherever they are produced. 6.3.3. UK NEQAS control ranges from 6 to 18 distributions per year, when it is

received, the staff members in each section process the samples and show

the result to the Hematology Doctor assigned to evaluate the result. The QC officer will enter the value on a specific website used for UK NEQAS reviewed by the senior staff and should be submitted before the due date.

6.4. Microbiology

6.4.1. Internal Quality Control

6.4.1.1. Internal QC for the technologists is done in the laboratory to

evaluate the technologist’s performance. Selected known organisms are given to 2 technologists each week to perform identification sensitivity tests.

6.4.1.2. The laboratory conducts an internal QC weekly for each section with known ATCC organisms from the QC Laboratory (Sabah area). Results are recorded in the internal QC logbook where the date,

organism identification and sensitivity testing result, the re-process result, the name of the technologist who processes, re-runs the test and relevant notes are entered.

6.4.1.3. Reagents and stains should be stored in plastic bottles that can be tightly closed, and labeled to indicate the identity, concentration, storage requirements, preparation, expiration date, and the type of

safety hazard associated with their use. 6.4.1.4. QC for the reagents and antibiotic sensitivity are done according to

the recommendations written in the laboratory or company manuals.

QC Registers are kept in the laboratory. 6.4.1.5. It is essential to undertake quality control procedures at regular

intervals. These should be performed-

6.4.1.5.1. With each new batch of reagents

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6.4.1.5.2. With each new vial of reagent

6.4.1.5.3. Daily /weekly/or monthly according to the type of test.

6.4.1.6. Quality control of the locally prepared media: Samples of plates

from each batch are selected for performance testing and are inoculated with the appropriate stock cultures. For each type of medium, at least two or three microorganisms having growth

characteristics with ‘positive’ and ‘negative’ results for the medium should be used. The results are entered in the media QC book.

6.4.1.7. All stains are tested at appropriate intervals for their ability to

distinguish positive and negative organisms and the results are documented in special register.

6.4.1.8. Organisms known to give positive or negative reactions with

various biochemical tests used frequently in the laboratory to assess the authenticity of results of biochemical reactions.

6.4.1.9. Quality control strains are used for identification; antibiotic

susceptibility testing. They are standard reference strains of bacteria that are tested in parallel with the clinical culture by using exactly the same procedure as for the test organisms. They shall preferably be run

every week 6.4.1.10. Positive and negative controls are used for qualitative tests, e.g.

Catalase, oxidase and citrate, DNase, coagulase, B-lactamase.

6.4.1.11. For serological tests, control sera are available commercially. Small volumes are generally available as components in kits but are intended to be used only with a single kit. A few may be available in larger

quantities. Controls shall be run with each batch. 6.4.1.12. Equipment play critical role in assuring quality of results of

laboratory. They are used for measurement and for the preparation and

storage of materials and reagents. Therefore they should be properly installed and maintained to ensure satisfactory working (please check instrumentation in microbiology laboratory).

6.4.1.13. Technologists are monitored by senior technologist on their performance of quality control.

6.4.2. External Quality Control

6.4.2.1. Kuwait External Quality Control program , organized by the

6.4.2.1.1. Quality Control Lab / Ministry of Health (Sabah Area). 6.4.2.1.2. UK National External Quality Assessment Service (UK-

NEQAS) program

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6.4.2.1.3. Specimens are sent out every month to the laboratory. (QC

reports are kept in a designated QC files.)

6.5. Histopathology

6.5.1. All equipment in the unit shall be assessed daily and the performance shall be logged.

6.5.2. Any defects or problems found shall have the appropriate remedial

measures taken. 6.5.3. On a daily basis, surgical biopsy slides shall be processed as quality

controls.

6.5.4. Stain quality controls are used for HNE 6.5.5. Immunohistochemistry – positive controls shall be processed with each

test.

7. Reference(s)

7.1. Westgard JO, Barry PL, Quam EF, Shrmeyer SS, Plaut D, Statland BE. Chapter 6 in Basic QC Practices, Training in Statistical Quality Control for Healthcare Laboratories, 2 nd Edition, Westgard QC, Inc, Madison, WI, 2002, pp77-88.

8. Attachment(s)

8.1. Inter–Batch Control Checklist for Automated Blood Cell Counters Form* 8.2. Coagulation Instruments Daily Maintenance & Quality Control Form* 8.3. QC log sheets*

8.4. Problem analysis form* 8.5. Temperature chart form* 8.6. Logbook forms*

8.7. Quality indicator reporting form*


CPolicy 6- Safety and Risk Management PolicyPolicy 8- Selection and Evaluation of Methods and Instrument PolicyPolicy 10- Communication PolicyPolicy 11- Handover PolicyPolicy 12- Quality Assurance and Quality Improvement PolicyPolicy 13- Quality Control Policy

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