guideline for monitoring and assessment of medical laboratory quality...

Guideline for Monitoring and Assessment ofMedical Laboratory Quality Standards

Ministry of Public Health, Thailand

Medical Laboratory Quality Standards, Ministry of Public Health of 31

Contents

Page

Preface………………………………………………………………………………………………………………… 3

Guideline for Monitoring and Assessment of ………………………………………………………. 4

Medical Laboratory Quality Standards

Instruction for Use of the Guideline and Checklist………………………………………………... 4

Laboratory Quality Performance…………………………………………………………………………… 5

Recommendation/suggestion/comments from assessor/auditor…………………………. 30

Summary of the Assessment Finding…………………………………………………………………….. 31


Preface

The operation of the medical laboratory plays a major role in the public health service system. The operation involves testing of specimens from the patients or service users by the methodologies based on modern science and technology. The test results or data are used for supporting the diagnosis and treatment of the patients, follow-up, disease surveillance and control. Additionally, they can be used for the health policy planning and administration of the public health of the country. The laboratory operation with the quality standards will facilitate high efficiencies and effectiveness of the people’s public health services.

The Medical Laboratory Quality Standards are used for the national level in which all laboratories can use as the basic and required quality measures. In Thailand, the Ministry of Public Health has issued the quality standards for development and accreditation of the laboratory quality standards. The laboratories then can develop further for the accreditation for International Standard ISO 15189.

The Medical Laboratory Quality Standards include the requirements in accordance to the International Standard “ISO 15189” and are categorized into the assessment checklist comprising 75 items, with 67 items as the general requirement and 8 items as the “must” requirements. Each item can be scored, i.e. 2 scores, 1 score and 0 score for the fulfilled, partially fulfilled operational requirements and none, respectively. The overall scores from the laboratory assessment equal to or more than 80% will be granted the certificate and the items which receive 0 score will be recommended for the laboratory development plan.

There are several countries which have not developed the laboratory quality standards system. It is recommended that the development of the national quality standards system should be initiated and implemented before further developed for the international accreditation leading to the recognition of the laboratories internationally.

The Bureau of Laboratory Quality Standards aims that this Guideline for Monitoring and Assessment of Medical Laboratory Quality Standards shall facilitate the establishment of the laboratory quality standards at the national level for the countries where the laboratory quality standards have not been established and further developed to the international quality standards which shall be beneficial to their people and service users in the future.

Sukhum Karnchanapimai, M.D., Ph.D. Director General of the Department of Medical Sciences

Ministry of Public Health, Thailand December 2016


Instruction for Use of the Guideline and Checklist

1. The table below is also used as the checklist for the self-assessment, internal

auditing and external-assessment.

2. Guidance for scoring of each requirement is given in column 3.

3. Scoring criteria are explained in the rows below each number of the

requirement.

4. The assessment finding remarks should be recorded in column 4.

5. Total score is the sum of requirement scores 1-75.

Laboratory Quality Performance

The assessment result for the laboratory quality performance according to the standard services of the medical laboratory quality standards, Ministry of Public Health is considered as follows:

1. Total scores is equal or more than 80%. 2. No “0” score for “the must” requirements.

This Guideline for Monitoring and Assessment of Medical Laboratory Quality Standards, Ministry of Public Health, Thailand, is directly translated from the original Thai version “แนวทางการตรวจประเมินระบบบริหารคุณภาพห้องปฏิบัติการทางการแพทย์ตามมาตรฐานห้องปฏิบัติการทางการแพทย์” prepared by the Working Group comprising the Advisory Team, the Editors from the Bureau of Laboratory Quality Standards, the Department of Medical Science, Ministry of Public Health, and members from the Regional Medical Centers and provincial hospitals under the Ministry of Public Health of Thailand.


Requirement Quality System and Service Standards

Documentation/records for Assessors

Given Score & Assessment Finding

1. Organization and Management

1 The medical laboratory is legally operated under the administration system and management structure with the required resources in accordance with the laboratory quality standards. There shall be organization and internal administration structure.

1. Medial laboratory license (private hospital).

2. Quality manual with details of the organization, policy, vision, mission, operation procedure within its responsibility, etc.

3. Organization chart showing the relationship of each structure and its responsibility.

2 points Having all 3 items.

1 point Having 1 and 2 or 1 and 3.

0 point None.

2 There shall be an appointment of a quality manager for quality policy documented in the medical laboratory quality standards manual and delegated responsibility with the sufficient support of resources

1. Quality policy in the medical laboratory quality standards manual of the Ministry of Public Health.

2. Supporting documents for sufficient resources for the services, e.g. personnel, budget, equipment, materials, etc. provided by the administrators


1 point Having 1 or 2.

0 point None.

3 There shall be delegation of responsibilities and duties of personnel with the policy for continuous training and development

1. Documentation of responsibilities and duties of laboratory personnel in all levels.

2. Documentation of policy for continuous quality training and development.



0 point None.





4 There shall be the policy and procedures for protecting the confidential data and patients’ right.

1. Policy and guideline or standard operating procedures for protecting the confidential data and patients’ right.

2 points Having completed documents.

1 point Having partially completed documents.

0 point None.

5 There shall be policy for safety in the laboratory.

1. Documents containing the policy and guideline and standard operating procedures in the management of safety in the laboratory.

2 points Having complete documents.

1 point Having partially complete documents.

0 point None.

2. Accommodation and Environmental Conditions

2.1 Accommodation

6

(The must)

There shall be sufficient spaces for the operation with appropriate designs for convenience and safety of both personnel and patients. The spaces shall be divided into 3 parts, i.e. specimen storage, handling and testing, general administration and staff common rooms with the concerns for contamination, use, quality and safety for operation.

1. Having complete and appropriate allocations of spaces accordingly with separation of each space with doors or having system for protection of contamination.

2 points Having 3 allocated spaces with complete operation for the purposes.

1 point Having less than 3 allocated spaces or with incomplete operation for the purposes.

0 point None.





7 The specimen collection space shall be separated from the laboratory with procedures for safety and privacy of the patients including the disables.

1. Having the specimen collection area which is convenient and separated from the laboratory.

2. Having procedures for the convenience and safety for the patients, i.e. cleanliness and privacy.



0 point None.

8 For a blood bank, blood collection from the blood donors shall be separated from the laboratory with adequate equipment for the convenience and safety of the blood donors. First Aid Kit with the Thai Red Cross Society standard shall be provided.

1. Having a clean, spacious and well-ventilation waiting area for the blood donors.

2. Use of disposable gloves which shall be discarded after used.

3. Having the biohazard waste bin for potentially infectious materials from blood donors.

4. Having the ready to use First Aid Kit.

5. Having the spill kits for prevention and control of the spill or leakage of biohazard materials.


1 point Having 3 or 4 items.

0 point None.

9 The sputum collection area shall be separated from the laboratory with sink, soap or antiseptic and biohazard waste bin and safety system to prevent spreading of the infectious pathogens.

1. Having sputum collection area separated from the laboratory with a safety system to prevent spreading of the infectious pathogens.

2. Having a sink, liquid soap or antiseptic.

3. Having the biohazard waste bin.


1 point Having 1 and 2 or 1 and 3.

0 point None.





10 The urine collection areas in WC shall be convenient and clean, separated for men and women and disables.

Observation:

1. Having the separated, convenient and clean WC for men and women for urine collection.

2. Having the separated, convenient and clean WC for disables for urine collection.



0 point None.

11 The traffic in and out of the laboratory shall be controlled to prevent entry of unauthorized personnel. A separate area to prevent cross contamination during operation shall be designated.

Observation:

1. Having control for personnel entry and exit.

2. Having separated areas for personnel and testing.



0 point None.

12 There shall be separated refrigerators for storages of specimens and testing reagents. If not possible, they must be clearly separated in different shelves. Testing reagents and chemicals shall be kept in the upper shelves.

Observation for the storages of specimens and reagents in refrigerators:

1. Storage of blood for transfusion.

2. Storage of reagents.

3. Storage of specimens.

4. Storage of specimens to be disposed.

2 points Having all items.

1 point Having not all items.

0 point None.

13 Testing not included in the main laboratory testing lists such as Point of Care Testing (POCT) shall be performed under the testing guideline for the Thai patients issued by the Ministry of Public Health.

Observation of records for internal and external quality controls of the POCT machines provided at different sites.

2 points Having testing quality warranty of 100% of the machines.

1 point Having testing quality warranty of more than or equal to 50% of the machines.

0 point Having testing quality warranty of more less than 50% of the machines.





14 Each equipment which may interfere testing results to the others shall be arranged in separate areas.

Observation for the arrangement and operation of the machines which may interfere the testing results to the others, e.g.

1. Microscope and centrifuge or shaker.

2. Sink and machine in which testing result is interfere by humidity.

3. Centrifuge or shaker with plate reader.

2 points Having correct and appropriate arrangement of the machines.

1 point Having partially correct and appropriate arrangement of the machines.

0 point Incorrect and inappropriate arrangement of the machines.

2.2 Operation in the Appropriate Environment

15 There shall be adequate lighting system.

1. Having adequate lighting system in all areas of the laboratory, especially microbiology laboratory for bacterial growth observation, antibiotic sensitivity and immunology laboratory for reading of immunological reactions.

2 points Having adequate lighting system in all important areas.

1 point Having partially adequate lighting system in all important areas.

0 point Inadequate lighting system in all important areas.

16 There shall be control systems for prevention of spreading of pathogens and chemical hazards, especially in high risk areas.

Observation for adequate air ventilation:

1. Having air ventilation fan.

2. Having the fume hood.

3. Having the biological safety cabinet class II.

2 points Having complete ventilation system.

1 point Having partially complete ventilation system.

0 point None.





17 The work areas shall be clean and convenient according to the standard procedures.

Observation of work areas:

2 points Work areas shall be clean and well-maintained under the standard procedures.

1 point Work areas are clean but not maintained under standard procedures or partially clean with the standard procedures.

0 point Unclean and not well-maintained under the standard procedures

18 There shall be records for environmental conditions which may affect the test results such as temperature and humidity of the laboratory.

1. Having records for room temperature.

2. Having records for humidity.

2 points Having 2 items.

1 point Having 1 item.

0 point No record.

19 There shall be control and records of the temperatures of incubator and refrigerator used for storages of specimens, blood for transfusion, reagents, quality control materials.

Inspection of the system and temperature records for:

1. Refrigerator for storage of specimen.

2. Refrigerator for storage of donors’ blood.

3. Refrigerator for storage of reagents/quality control materials.

2 points Having all system and records.

1 point Having incomplete system and records.

0 point None

20 There shall be adequate uninterruptible power supply for major equipment and refrigerator for storage of donors’ blood.

Observation for the uninterruptible power supply system and records.

2 points Having the complete power supply system and records.

1 point Having incomplete power supply system and records.

0 point None





3. Quality Manual and Document Control

21 The operation is conducted according to the standard operating procedures for quality documents with updated document lists and control.

1. Having document lists.

2. Having updated and validated documents.

2 points Having all document lists, updated, validated with control.

1 point Having partially complete document lists.

0 point None

22 There shall be the standard operating procedures for document storage, accessibility, correction with names of authorized personnel, recording dates for both hard and electronic copies

Checking both hard and electronic copies of the documents for:

1. Guideline for document storage.

2. Guideline for document accessibility.

3. Guideline for document correction.

4. Delegation of authorized personnel for document records and control.

5. Dates for quality document storage.

2 points Having 4-5 items.

1 point Having 3-4 items.

0 point Having 1 item or none

4. Personnel

23 The must be the staff with medical technology license and expertise and experiences in both theory and laboratory practice.

Having the licensed medical technologist working in the laboratory.

2 points Having the licensed medical technologist.

1 point -

0 point None

24 The number of personnel for services shall meet the requirement stated in the health service regulations, Ministry of Public Health.

1. Having required number of personnel according to the health service regulations.

2. Having appropriate administrative system if the number of the personnel does not meet the regulations.





2 points Having the required number of personnel.

1 point Having less required number of personnel but having appropriate administrative system for the health services.

0 point Having less required number of personnel and no administrative system for the health services.

25

(The must)

There shall be appropriate and continuous programs of training/seminars for the operation and evaluation for work competency.

Assessed by:

1. Having appropriate internal and external training/seminars in both academic and administrative work with evaluation within 2 years.

2. Having assessment and evaluation for work competency of personnel.

2 points Having both academic and administrative assessment and evaluation in more than 80% of personnel.

1 point Having either academic or administrative assessment and evaluation in less than 80% of personnel.

0 point None.

26 There shall be personnel records comprising education background, professional license, responsibilities, experience and expertise, work competency, vaccination, accident history, health checkups, etc.

Personal records for:

1. Education background.

2. Professional license.

3. Work responsibility.

4. Expertise.

5. Competency evaluation.

6. Work performance.

7. Vaccination history.

8. Accident history.

9. Health checkup results.



0 point Having less than 4 items





27 There shall be delegation of medical technologists with high experience and expertise in both theory and practical work to give advices on the laboratory results to internal and external service users.

1. Appointment order of the laboratory academic advisors.

2. Consultation records containing details of advisor, title, dates and consultants.

2 points Having complete documentation.

1 point Having 1 item

0 point None

5. Equipment and Scientific Materials

5.1 Equipment

28 There shall be appropriate and sufficient number of laboratory equipment

Observation for:

1. Having administration system for acquisition of sufficient number of required and ready-to-use equipment.

2. Having administration system for acquisition of appropriate equipment.

3. Having records for problems with equipment within the previous year.

2 points Having complete documentation.

1 point Having partial documentation.

0 point None

29 There shall be history records of major equipment, e.g. equipment code, manufacturer, model and serial number, distributor and contact address, dates of received and operation, log book, maintenance, repair and modification records, guardian, etc.

Inspect for:

1. Equipment code number.

2. Model and serial number.

3. Manufacturer and distributor with contact address and phone number.

4. Maintenance, repair and modification records.

5. Name of guardian.

2 points Having items 1-5 in all 3 randomly checked equipment.

1 point Having items 1-5 but not in all 3 randomly checked equipment

0 point No items 1-5 in 3 randomly checked equipment





30 Major equipment users shall have appropriate training and pass the evaluation.

1. Having the equipment training history of personnel.

2. Evaluation records, e.g. training certificate or equipment use evaluation results.

2 points Having items 1-2 in all randomly selected equipment users.

1 point Having items 1-2 but not in all randomly selected equipment users.

0 point No items 1-2 in all randomly selected equipment users.

31 There shall be equipment manuals for all major equipment

1. Having equipment manuals for all major equipment

2 points Having equipment manuals in all 3 randomly selected equipment.

1 point Having equipment manuals at least 1 in 3 randomly selected equipment.

0 point No equipment manual found in 3 randomly selected equipment.

32 There shall be maintenance plans and records for all major equipment.

1. Having maintenance manuals.

2. Having maintenance plan.

3. Having maintenance records.

2 points Having all items 1-3.

1 point Having incomplete items 1-3.

0 point None.

33

(The must)

There shall be calibration plan for major equipment which the results have health impact.

1. Having calibration plans.

2. Having calibration results.

3. Having calibration results validated.



0 point None.

34 There shall be alternative plan for breakdown of major equipment or in emergency event.

1. Having alternative plan in case the major equipment breakdown.

2. Having alternative plan or administration in case there is an emergency event occurs.







0 point None.

5.2 Scientific Materials

35 All reagents and scientific materials are stored in the appropriate environment.

Observation or randomly inspection for the appropriateness of the storage of reagents and scientific materials according to the stated temperature and places

2 points Having appropriate storage conditions of all reagents and scientific materials in the correct temperature and places

1 point Having appropriate storage conditions of parts of reagents and scientific materials in the correct temperature and places

0 point Having inappropriate storage conditions of reagents and scientific materials.

36 There shall be appropriate recording system for control of the stocks of reagents, scientific materials and chemicals

1. Having inventory cards.

2. Having priority lists of the reagents, scientific materials and chemical according to the expiry dates



0 point None.

37 All scientific and quality control materials shall have required specifications, unexpired and labeled for dates of receipt, first usages and expiry dates.

Observation or randomly inspection for:

1. Having the correct specification.

2. Unexpired.

3. Having labels for dates of receipt.

4. Having labels for the dates of first usages.

5. Having labels for the expiry dates after first usages.



0 point None.





6. Procurement and outsourcing

38 There shall be guidelines for selection of distributors/sellers, evaluation records and lists of approved distributors/sellers.

1. Having guideline for selection of distributors/sellers.

2. Having evaluation records.

3. Having lists of approved distributors/sellers.



0 point None.

39 There shall be guidelines for procurements of medical equipment, materials and reagents, quality control materials, calibration materials which have impacts on the services with appropriate receiving system.

Observation for the guidelines for procurement of medical equipment materials and reagents, quality control materials, calibration materials with records of the receiving system. Priority is given to the quality of the items.

2 points Having guidelines for procurement and receiving system.

1 point Having incomplete guidelines for procurement and receiving system.

0 point None.

40 Outsourcing of external laboratory services shall have guidelines for selection and evaluation for competency of the laboratories.

1. Having guidelines for selection of outsourcing laboratories.

2. Having evaluation results for competency of the laboratories such as PT/EQA.

2 points Having both items.

1 point Having either item.

0 point None.





7. Communication Means between Operators and Recipient Laboratories

7.1 Internal Communication

41 There shall be appropriate internal communication means.

1. Having records, announcements, laboratory meeting reports or equivalent during the last 3 months.

2 points Having record of the item within 3 months.

1 point Having record of the item more than 3 months.

0 point Having record of the item more than 6 months.

7.2 External Communication and Customer Satisfaction

42 There shall be appropriate facilities for the customers.

Observation for the facilities: 1. Having chairs while

customers wait for the test results.

2. Having clean WC. 3. Having blood collection

facilities which are convenient for elderly and disables.

2 points Having all items. 1 point Having either item. 0 point None. 43 There shall be the updated

laboratory service manual for each work unit or specimen collection site containing:

1. Tests in service (performed at site or outsourced).

2. Test methods. 3. Working hours. 4. Specimen collection

recommendations. 5. Method of requests

(electronic, verbal, phone and additional test request)

6. Type and volume of specimens.

7. Specimen container or culture media.

8. Collection methods. 9. Appropriate time and

temperature for transportation. 10. Turnaround time (urgent or

normal). 11. Method for result reports

(hard copies, electronic, verbal, phone; urgent result report, critical result report, outlier result report, specimen storage).

Laboratory service manual can be in hard copies or stored in the computer:

1. Having laboratory service manual.

2. Having the manual at service sites.

3. Having complete information required according to the laboratory standards.







0 point None.

44 There shall be communication manual for laboratory services which are validated every 12 months with the customers to learn their needs, including academic recommendations, interpretation of the test results and test method modification.

1. Communication manual such as memos, circulated mails, document control at various work units, etc.

2. Manual is updated and/or memos requesting the customer’s needs.



0 point None.

45 There shall be notification in writing to the customers regarding test modifications which have clinical impact such as change of test methods, equipment, reagents, reference materials, etc. before the modifications.

1. Memos on agreement review.

2. Notifications for the customers, e.g. memos or other forms of documents.

2 points Having items 1 and 2 or 2 .

1 point Having item 1.

0 point None.

8. Test methods and Test Result Reporting

8.1 Procedures before testing

46 Test requests or electronic test requests include name and surname, HN, sex, age, important medical information, types of tests requested, type and/or site of specimen collection and date of specimen collection.

Test request containing

1. Name and surname.

2. HN.

3. Sex.

4. Age.

5. Types of tests requested.

6. Type and/or site of specimen collection.

7. Date of specimen collection.


1 point Having parts of items.

0 point None.

47 All specimens can be traced back to the names, HN, etc. on the test requests.

By random selection, secondary specimen containers transferred from the primary specimen container have names and HN or specific codes which can be traced back to the customers.





2 points Having labels of all specimens which can be traced back to the customers

1 point Having labels of specimens which can be traced back to not all of customers

0 point Not able to trace back the specimens to customers.

48 There shall be records for specimen receiving, specified dates and specimen receiving person and any detail for the inappropriate specimen.

1. Specimen receiving guideline.

2. Specimen receiving records with details on time, date and specimen receiving person.


1 point Having parts of items.

0 point None.

8.2 Test methods.

49 There shall be standard test methods and validation of the required results. For blood banking, guidelines of the Thai Red Cross blood banking standards are used.

Randomly inspect the SOP/Work instruction or direct observation of the operation.

2 points Having complete validation of operation and results or documentation on the previous standard work operation.

1 point Having incomplete validation of operation and results.

0 point No validation of operation and results.

50 There shall be verification of reagents, test methods, equipment, products and services to comply with the regulations.

Randomly inspect verification records of reagents, test methods, equipment, products and services to comply with the regulations.

2 points Having the verification records in 2 randomly selected items.

1 point Having incomplete verification records.

0 point No verification records.

51 There shall be test method manuals for operators to perform similarly in real test operations.

Randomly inspect for the test methods to comply with SOP/WI.

2 points Having SOP/WI with real work operation.

1 point Having incomplete SOP/WI and real work operation.

0 point No SOP/WI.





52 There shall be result validation system by assigned personnel

Inspect for result reports including document system and computer system for:

1. Validation system.

2. SOP for validation method.

2 points Having 2 items.


0 point None.

53 There shall be appropriate management of the specimens after testing, able to perform additional testing if needed and safe disposal of the specimens.

Observation for specimen storage after testing.

1. Appropriate specimen storage method in writing.

2. Guideline for specimen disposal with safety in writing.

2 points Having complete items.

1 point Having either item, but not in writing.

0 point None.

8.4 Test Result Reporting

54 There shall be methods for test result reporting to customers in both hard copies and computer system with concerns on confidentiality, patients’ data and methods for access, search and modification of the data.

Randomly inspect for test result reporting system including hard copies and computer system, especially HIV testing, Rape testing, narcotics in urine.

1. Use of patient’s code instead of name, or in sealed document.

2. Document storage in locked cabinet, unable doe access by unauthorized person.

3. User name and password for computer system.



0 point None.

55 There shall be method for critical result report to the clinician.

1. Guideline for critical tests which require urgent report.

2. Records for updating of the critical test list with the clinician within 1 year.

3. SOP for the reporting in writing.

4. Records of critical result reports, names, HN, critical test results, result receiving person.







0 point None.

56 Result reports contain names and surnames, HN, sex, age, type and volume of specimens, types of tests, test results in international standards, date of reporting, reference range, appropriate result interpretation, comment on specimen quality which may have impact on test results, reporter and person who validated the results.

Randomly inspect the test result reports for:

1. Name and surname, HN, sex, age, type and volume of specimen.

2. Types of tests, test results in international standards, time and date of report, reference range.

3. Appropriate interpretation.

4. Reporter and person who validated the results.

2 points Having complete items 1-4.

1 point Having part of items.

0 point None.

57 There shall be notification of clinician in case for delayed specimen testing from the testing schedule.

Records of notification to clinician and correction procedures in delayed testing from the schedule.

2 points Having notification records and correction procedures.


0 point None.

58 There shall be records of test result reports in writing or computer system which can be retrieved if needed within the specified period.

Observe on recording system for the test result reports, both in writing and computer system.

1. Having records or log book.

2. Having data backup for computer system.

3. Having specified period of record storage.


1 point Having item 1 or 2.

0 point None.

9 Quality Control of Testing.

9.1 Internal Quality Assessment.

59 There shall be inspection of internal quality control materials for correctness before use.

Inspection records of internal quality control materials for correctness before use.





2 points Having internal control materials in laboratory and 80-100% are inspected for correctness before use.

1 point Having internal control materials in laboratory and 51-79% are inspected for correctness before use.

0 point Having internal control materials in laboratory and less than 50% are inspected for correctness before use.

60

(The must)

There shall be internal quality control system and records to monitor test results according to SOP in all testing services and assign the tolerance limit. Number and frequency of control material shall be appropriately specified according to the tests. There shall be result review, inclusion of quality control data and related information in problem-solving operation and validation of the test results. In case that the internal quality control is not conformed to the guideline, problem analysis and correction shall be made before the patient’s specimen testing.

Records of internal quality control results and problem-solving.

2 points Having records of internal quality control result evaluation in 80-100% of tests in services and problem solving operation.

1 point Having records of internal quality control result evaluation in 51-79% of tests in services and problem solving operation.

0 point Having records of internal quality control result evaluation in less than 50% of tests in services and problem solving operation.

9.2 External Quality Assessment

61

(The must) There shall be participation of

EQA programs participation in all tests in serviced. In case where EQA program is not available, inter-laboratory comparison is used.

Records for EQA program participation or inter-laboratory comparison result reports.





2 points Having records of external quality assessment result reports or inter-laboratory comparison result reports in 80-100% of tests in service.

1 point Having records of external quality assessment result reports or inter-laboratory comparison result reports in 51-79% of tests in service.

0 point Having records of external quality assessment result reports or inter-laboratory comparison result reports in less than 50% of tests in service.

62 There shall be review for participation of external quality assessment program and analysis of problems, development of corrective plan with results in case EQA failed.

Records on external quality assessment results, problem analysis and corrective plan.

2 points Having records of external quality assessment results, problem analysis and corrective plan in 80-100% of tests in service.

1 point Having records of external quality assessment results, problem analysis and corrective plan in 51-79% of tests in service.

0 point Having records of external quality assessment results, problem analysis and corrective plan in less than 50% of tests in service.

10. Control of Non-conformance to the Guidelines

63 There shall be corrective procedures for control of the non-conformance tests.

Note: Non-conformance can be found from complains, quality index, equipment calibration, inspection of disposable materials, internal audit, external quality assessment, recommendation, inspection of reports, equipment calibration certificate, service review, etc.

1. Records or memos on nominations of experts to give consultation on non-conformant test results.

2. Incident report between workers.

3. Presentation to the top administrators in order to act for improvement of the procedures and prevention of repeated non-conformance.





2 points Having corrective procedures and records.

1 point Having incomplete corrective procedures and records.

0 point None.

64 There shall be analysis and search for risk/incidence recorded in workplace to prevent repeated incidence such as misinterpretation, delayed test result report, etc.

Search and review the records of non-conformances to minimize the incidence such as problems in specimen collection, transportation, delayed result report, misreport of test and critical results, etc.

2 points Having problem analysis and incidence report.

1 point Having incomplete problem analysis and incidence report.

0 point None.

65 There shall be procedures to manage complaints from customers, investigation and corrective action as well as analysis to prevent repeated risk/incidence.

Guideline for management of complaints:

1. Records of management operation of complaints and corrective action.

2. Risk/incidence analysis for corrective action and prevention.

3. Guideline for corrective action and prevention.

4. Presence of efficient channel for complaints.



0 point None.

66 There shall be guideline for consultation on non-conformant test results from qualified personnel.

1. Nominations of experts to give consultation on non-conformant laboratory test results.

2. Records of consultations from qualified experts.

2 points Having nomination of experts and consultation records.

1 point Having no nomination of expert or incomplete records.

0 point None.





11. Continuous Quality Improvement

67

(The must)

There shall be continuous laboratory quality development program such as internal quality monitoring, administration review, EQA, inter laboratory comparison, recommendation or complaint for corrective action, etc.

Observation from memos/records and inquiry of person in charge regarding quality activities within 1 year.

1. Internal quality monitoring.

2. Administration review.

3. EQA or inter laboratory comparison.

4. Records of incidence, complaints, corrective action.

5. Activities which improve quality work operation.

6. Examples for use of data to solve problems or improve quality of work.

7. Work system improvement from risk/incidence surveillance.

2 points Having continuous quality improvement activities in 6 of 7 items.

1 point Having continuous quality improvement activities in 3 of 7 items.

0 point None.

68 There shall be the survey for the customer’s satisfaction for the quality improvements.

Records of the survey for the customer’s satisfaction and consideration for correction leading to continuous quality improvement.

2 points Having records of customer’s satisfaction survey, correction and improvement.

1 point Having incomplete records of customer’s satisfaction survey, correction and improvement

0 point None.

12. Internal Quality Auditing

69 There shall be Internal Quality Auditing for at least once a year. Specify the name of auditor, date of auditing including the period for corrective action after the auditing. Auditing results shall be summarized and present to the administrator.

1. Having Internal Administration System Quality Auditing plan by auditing team with professional license or trained personnel at least once a year.

2. Having the last Internal Administration System Auditing results.





3. Having work improvement from Internal Administration System Auditing results.

4. Reporting the Internal Administration System Auditing results to administrator.

5. Having revision of quality system.



0 point None.

70 Internal auditor shall be trained for knowledge and auditing technics, being registered auditor with records of training.

1. Training certificate/records with registration number of auditors.

2 points Having Training certificate/records with registration number of auditors.

1 point -

0 point None.

71 Internal auditors shall not be responsible or have monitoring activities for their own work place.

Details of the internal auditor such as name, title, work place, etc. auditing of own work place is prohibited.

2 points No auditing of own work place.

1 point -

0 point No documents.

13. Laboratory Safety

13.1 Laboratory

72

(The must)

There shall be system to prevent electric short circuit or installing earth wire.

1. Observe for electric short circuit prevention system and installation of earth wire.

There shall be plan and fire prevention system such as fire extinguisher, emergency exit signs, fire exit stairs, etc.

2. Safety operation include:

- Having safety and fire prevention system

- Having risk evaluation for fire in laboratories such as minimizing the number of 24-hour operated equipment, such as water bath, centrifuge, etc. Regularly turning them off and unplugged after use.

- Organizing chemicals, highly combustible reagents such as ethanol, acetone shall be kept away from machines having

electric sparks, secured gas tanks





with chains, etc.

- Having signs for emergency exits, fire exit stairs and fire alarms.

- Having guideline for fire prevention.

- Having evaluation of appropriate and adequate number and installation sites of fire extinguishers for the work areas.

- Having testing and maintenance of fire prevention equipment and system.

- Having records for the last fire prevention operation practice in the work place.

- Having training program for all personnel.

- Having plan to solve problems found during fire prevention practice.

There shall be eye washing station in case of emergency

3. Eye washing station at appropriate sites.

There shall be management and disposal system for hazardous chemicals

4. Inquire person in charge regarding the guidelines for management and disposal system for hazardous chemicals

There shall be SOP for laboratory safety to prevent infection to work operators.

5. Inquire person in charge for infection risk of laboratory work operators in the previous year for major accident, danger, problem, etc. and corrective action plans.

There shall be signals and signs for different floor levels.

6. Observe for signal and signs depicting the different floor levels.

There shall be sink in areas where contacting of blood or secretion can occur.

7. Observe for appropriate and adequate number of sinks in the laboratory.

There shall be spill kit for management and disposal of spilled chemicals, blood, secretion or infectious agents.

8. Observe or inquire person in charge for spill kit for management and disposal of chemicals, blood, secretion or infectious agents with easily assessible and ready to use.

There shall be First Aid kit. 9. Observe or inquire person in charge for the storage site of First Aid kit with easily assessible and ready to use.







0 point Having less than 4 items.

13.2 Personal safety

73

(The must)

The shall be appropriate and adequate number of personnel protective equipment such as protective gown, gloves, masks, goggles, etc.

- Gown shall be properly cleaned before repeated use.

- All personnel shall be properly trained for laboratory safety.

1. Observe the performance of the working personnel to comply with proper personal precautions such as gown dressing, wearing gloves, mask, goggles, etc.

2. Inquire person in charge regarding proper cleaning of gowns.

3. Records of safety training history of personnel.



0 point None.

13.3 Management of dangerous agents and chemical waste

74 There shall be registration of storages of pathogens and animal toxins according to the Pathogen and Animal Toxin Act.

1. Registration records of number of stored pathogens and animal toxins according to the Pathogen and Animal Toxin Act.

2 points Having complete registration records.

1 point Having incomplete registration records.

0 point None.

75 There shall be proper transportation of specimens, dangerous agents according to the international standards.

1. Observe for procedures for transportation of specimens, dangerous agents.

There shall be guideline for storage and disposal of dangerous materials derived from laboratory analyses.

2. Observe for management and procedure for disposal of used sharp objects from person in charge.

Inquire person in charge for procedure for disposal of infectious materials or dangerous laboratory chemicals.

There shall be sorting of waste, laboratory waste and disposing according to the hospital system.

3. Observe and inquire person in charge for:

3.1 Proper sorting of wastes according to the guideline for infectious waste control in the hospital.





3.2 Proper sorting of different types of wastes (red bag for infectious materials, black bag for non-infectious waste)

3.3 Having guideline for management and disposal of dangerous waste from the laboratory such as clinical specimens, specimen containers, contaminated waste, chemicals, etc.

Used needles and syringes shall be disposed in labeled, sealed strong containers with infectious and sharp object signs.

There shall be warning signs on specified equipment, containers or areas regarding biohazard, dangerous chemical, radioactive, sharp objects and infectious materials, etc.

4. Observe for laboratory warning signs such as biohazard, dangerous chemical, radioactive, sharp objects, infectious materials, etc.



0 point None.


Recommendation/suggestion/comments from assessor/auditor

Good Quality performance

Opportunity for improvement


Summary of the Assessment Finding (Please record clearly & completely)

Requirements Full scores (2 marks for each of the requirements)

Total score obtained (marks)

General (67) 134

The Must (8) 16 Accepted

Number of requirements (.................)

Corrective action requested

Number of requirements (.................)

Total (75) 150

Percent (%)

Quality performance Qualified (total given score > 80% with 16 marks for “The must”

Improvement needed

Assessor/auditor name(s).

1 ……………………………………………………..……………………………………………………..…

2 ……………………………………………………..……………………………………………………….

3 ……………………………………………………..……………………………………………………….

Laboratory team name(s).

1 ……………………………………………………..……………………………………………………..…

2 ……………………………………………………..……………………………………………………….

3 ……………………………………………………..……………………………………………………….

Assessment date ……………………………………

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