Circular 53/2017/TT-BYT on medical record and material retention periods

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Circular No. 53/2017/TT-BYT dated December 29, 2017 of the Ministry of Health on medical record and material retention periods
Issuing body: Ministry of HealthEffective date:
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Official number:53/2017/TT-BYTSigner:Nguyen Viet Tien
Type:CircularExpiry date:Updating
Issuing date:29/12/2017Effect status:
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Fields:Medical - Health

SUMMARY

Medical records and materials must be retained for at least 5 years

This content is prescribed in the Ministry of Health’s Circular No. 53/2017/TT-BYT dated December 29, 2017, on medical record and material retention periods.

Medical records and materials comprise 10 groups of records and materials as follows: Materials related to medical examination, treatment and rehabilitation; Pharmaceutical and cosmetic materials; Medical equipment materials; Traditional medicinal and pharmaceutical materials; Preventive medicine materials; Medical environment materials; Materials related to food safety; Population materials; Materials related to maternal and child health; Health insurance materials.

The retention period of each type of record and material ranges from 5-70 years or permanent. For materials and records of which the retention periods expire, the agencies’ or units’ Councils for evaluating the material value shall consider and evaluate them for destruction in accordance with the law on archives, or extend the retention periods, if necessary.

This Circular takes effect from February 15, 2018.

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THE MINISTRY OF HEALTH
___________

No. 53/2017/TT-BYT

THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
_____________

Hanoi, December 29, 2017

CIRCULAR

On medical record and material retention periods

 

Pursuant to the Law on Archives No. 01/2011/QH13 dated November 11, 2011;

Pursuant to the Government’s Decree No. 01/2013/ND-CP dated January 03, 2013, detailing the implementation of a number of articles of the Law on Archives;

Pursuant to the Government's Decree No. 75/2017/ND-CP dated June 20, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Chief of Office of the Ministry of Health;

The Minister of Health hereby promulgates the Circular on medical record and material retention periods.

 

Article 1. Scope of regulation and subjects of application

1. This Circular regulates the medical record and material retention periods.

2. This Circular applies to health facilities of Departments, Ministry Office, Ministry Inspectorate, units affiliated to the Ministry, Departments of Health of provinces and centrally-run cities, health departments of relevant ministries, sectors, organizations, agencies and individuals.

Article 2. Interpretation of terms

In this Circular, the terms below are construed as follows:

1. Medical materials mean those carrying information formed in the process of handling works serving agencies’ and units’ medical operations.

2. Medical records mean materials formed in medical operations with common or related characteristics about a specific issue, event, or object.

Article 3. Medical record and material retention periods

The Table of medical record and material retention periods is promulgated to promulgate together with this Circular, including the following groups of dossiers and materials:

1. Group 01. Materials related to medical examination, treatment and rehabilitation.

2. Group 02. Pharmaceutical and cosmetic materials.

3. Group 03. Medical equipment materials.

4. Group 04. Traditional medicinal and pharmaceutical materials.

5. Group 05. Preventive medicine materials

6. Group 06. Medical environment materials.

7. Group 07. Materials related to food safety.

8. Group 08. Population materials.

9. Group 09. Materials related to maternal and child health.

10. Group 10. Health insurance materials.

Article 4. Instructions for applying the Table of medical record and material retention periods

1. The Table of retention periods shall be used as a basis for units to formulate the lists of records and materials and determine the retention periods of records and materials.

2. For materials and records of which the retention periods expire, the agencies’ or units’ Councils for evaluating the material value shall consider and evaluate them for destruction in accordance with the law on archives, or extend the retention periods, if necessary.

Article 5. Effect

This Circular takes effect from February 15, 2018.

Article 6. Implementation organization

Chief of the Ministry Office; Chief of Ministry Inspectorate; Directors and General Directors of the Health Environment Management Agency, Departments and Directorates of the Ministry of Health; heads of agencies and units of the Ministry of Health; Directors of Health Departments of provinces and centrally-run cities; heads of health agencies of ministries and branches, relevant organizations and individuals shall be responsible for the implementation of this Circular.

Any difficulties arising in the course of implementation should be promptly reported to the Ministry of Health for consideration and settlement./. 

 

FOR THE MINISTER
THE DEPUTY MINISTER



Nguyen Viet Tien

 

TABLE OF MEDICAL RECORD AND MATERIAL
RETENTION PERIODS

(Attached to the Minister of Health’s Circular No. 53/2017/TT-BYT dated December 29, 2017)

 

No.

Name of dossier or material group

Retention period

I

Group 01. Materials related to medical examination, treatment and rehabilitation

 

1

Records related to professional inspection and instructions for hospitals

Permanent

2

Records of monitoring health centers

Permanent

3

Records of appraising and permitting medical examination and treatment establishments to apply new technologies and methods that are performed in Vietnam for the first time as prescribed by law

Permanent

4

Records of formulating the lists of surgery and operation classification

Permanent

5

Records of formulating technical procedures applicable to hospitals

Permanent

6

Records of directing and administering the safe, reasonable and effective use of drugs during the treatment

Permanent

7

Records of formulating plans and organizing the national reserve in terms of drugs, chemicals, medical equipment, and equipment for the prevention of epidemic and, natural disasters according to the national reserve list decided by the Government and law regulations

50 years

8

Records of formulating the treatment regimens for non-communicable diseases, guiding the implementation, inspection and surveillance of medical examination and treatment establishments in terms of treating non-communicable diseases and participating in the dissemination and consultancy of non-communicable disease prevention

50 years

9

Records of monitoring foreign investment in medical examination and treatment

50 years

10

Records of directing and guiding the implementation and inspection of the reasonable, safe and effective use of drugs in medical examination and treatment, the prescription and use of drugs, and the control of drug resistance prevention

30 years

11

Records of directing and guiding the implementation, inspection and surveillance of clinical pharmacy practice; providing consultancy and information about use of drugs and pharmacovigilance in medical examination and treatment establishments

30 years

12

Records of directing medical examination and treatment establishments to protect and care for the health of mid- and senior-level cadres, or perform medical work in service of the State’s important conferences and events

30 years

13

Records of granting, re-granting or revoking medical practice certificates, and granting, re-granting, modifying and revoking operation licenses of medical examination and treatment establishments as prescribed by law

20 years

14

Records of appraising professional contents of the dossiers of registration for advertising medical examination and treatment activities

20 years

15

Records of coordinating with relevant ministries and sectors in carrying out the State management over prices for medical examination and treatment as prescribed by law

20 years

16

Records of coordinating with relevant agencies in providing emergency and treatment for victims of natural disasters

20 years

17

Records of receiving specimens

20 years

18

Records of hospital quality management

20 years

19

Books, supply distribution, drug import and export vouchers

20 years

20

Medical records of:

- Deceased patients;

- Patients suffering mental illness;

- Occupational accidents or life accidents;

- Normal inpatient or outpatient.

 

30 years

20 years

15 years

10 years

21

Records of implementing the prevention and control of tobacco harms

20 years

22

Patient and health staff satisfaction survey sheets

5 years

23

Records of conclusion of the medical assessment, forensic mental health assessment

Permanent

24

Medical examination records

70 years

25

Records of directing, coordinating and implementing international coordination projects in medical examination and treatment, forensic medicine, forensic psychiatry

20 years

26

Records of formulating criteria on the quality of drugs in the list of national drug reserve

Permanent

27

Reports on assessment of strategic schemes and pharmaceutical development schemes

Permanent

28

Records of developing and managing pharmaceutical and cosmetic database

Permanent

29

Records of guiding the implementation of regulations on clinical trials of drugs

Permanent

30

Records of guiding the implementation of regulations on pharmaceutical business and practice

Permanent

31

Records of formulating lists of essential drugs, over-the-counter drugs and drugs covered by health insurance

Permanent

32

Records of formulating and directing the implementation of quality criteria and types, drug materials and drug quality

Permanent

33

Records of monitoring and detecting abnormal signs related to drugs

70 years

34

Records of organizing drug and pharmacovigilance information activities

70 years

35

Drug distribution, preservation and supply records

70 years

36

Records of grant and re-grant of pharmacy practice certificates

50 years

37

Records of manufacturing and preparing of drugs in medical examination and treatment establishments

50 years

38

Records of clinical trials of drugs and bioequivalence trials of drugs

50 years

39

Records of processing warning information on drug and cosmetic safety

50 years

40

Records of appraising and granting drug and cosmetic registration number

30 years

41

Records of testing drugs and cosmetics; drug materials, and packages directly exposed to drugs

20 years

42

Records of granting or revoking certificates of good manufacturing practice (GMP); good laboratory practice (GLP), good storage practice (GSP), good manufacturing practices of pharmaceutical packaging

20 years

43

Records of directing and implementing the management of business of medicinal herbs and drugs from medicinal materials (including manufacturing, quality inspection, storage, circulation, distribution, and import-export)

20 years

44

Records of directing and implementing the tasks of:

- Supplying drugs for hospitals;

- Managing prices and quality of drugs provided to hospitals, including drugstores of a hospital, preparation of drugs according to prescription;

- Guiding the implementation of the principles and standards for good storage practice (GSP);

- Making statistics of data related to drug supply.

 

20 years

20 years


20 years


20 years

45

Records of bidding for drugs of hospitals and projects of the Ministry of Health

20 years

46

Records odd directing, guiding, implementing the management of information and advertising of drugs and cosmetics nationwide

20 years

47

Records of appraising professional contents of the dossiers of registration for advertising of drugs and cosmetics

20 years

48

Records of first-time registration, re-registration and registration for extending drug components, etc.

20 years

49

Records of registration for transferring the right to manufacture drugs inside and outside the country

20 years

50

Records for granting and re-granting certificates of free sale for pharmaceutical products and cosmetics, etc.

20 years

51

Records of circulation cancellation, revocation and destruction of poor-quality drugs and cosmetics as prescribed by law

20 years

52

Records of grant of import or export licenses, approval of materials, psychotropic drugs, precursors and finished combination drugs containing a habit-forming, psychotropic ingredient or a pre-substance

20 years

53

Records of granting import licenses for drugs, vaccines and medical biologicals

10 years

III

Group 03. Medical equipment materials

 

54

Records of formulating national technical standards on medical equipment; promulgating specialized regulations and national technical regulations on medical equipment

Permanent

55

Records of issuing the lists of essential equipment for health units or facilities

Permanent

56

Records of coordinating with relevant agencies in formulating and promulgating technical regulations and design standards -designs of medical works

Permanent

57

Records of monitoring medical waste-related projects

Permanent

58

Records of grant, cancellation or revocation of certificates of registration for circulation of domestically-manufactured medical equipment, equipment import permits

20 years

59

Records of appraising professional contents of registration for advertising medical equipment as prescribed by law

10 years

IV

Group 04. Traditional medicinal and pharmaceutical materials

 

60

Records of monitoring the application of traditional medicine in taking care of the community health

Permanent

61

Records of managing, inspecting and monitoring traditional medicine and pharmacy establishments’ operations

50 years

62

Records of supplying, processing and preparing traditional drugs in medical examination and treatment establishments

20 years

63

Records of planting, harvesting and processing medicinal materials

70 years

64

Records of preserving medicinal materials, quality of medicinal materials

70 years

65

Records of registration, circulation and revocation of traditional drugs

20 years

66

Records of clinical trials of traditional drugs before circulation

20 years

67

Records of grant or re-grant of medical practice certificates by traditional medicine; grant, re-grant, modification or revocation of certificates of folk remedies

20 years

68

Records of granting operation licenses for medical examination and treatment establishments applying traditional medicine as prescribed by law

20 years

69

Records of appraising professional contents of registration for advertising medical examination and treatment activities by traditional medicine

10 years

V

Group 05. Preventive medicine materials

 

70

Records of formulating professional regulations, national technical regulations and standards on Supervision, prevention of non-communicable diseases and communicable diseases

Permanent

71

Records of formulating professional regulations, national technical regulations and standards on occupational diseases, accidents and injuries; border health quarantine

Permanent

72

Records of formulating and supplementing the list of communicable diseases in the groups and lists of communicable diseases requiring the use of vaccines and medical biologicals

Permanent

73

Records of monitoring communicable diseases, non-communicable diseases or idiopathic diseases, early detecting communicable diseases that can cause epidemics

Permanent

74

Records of making the list of occupational diseases eligible for occupational disease regimes in Vietnam

Permanent

75

Records of coordinating with relevant ministries and sectors in promulgating the list of diseases subject to long-term treatment and eligible for illness regimes

50 years

76

Records of implementing the border health quarantine at border gates; timely reporting the severe communicable diseases

30 years

77

Records of appraising the health impact assessment reports of industrial park, urban area, concentrated residential area construction projects, and projects of medical examination and treatment establishments for communicable diseases

30 years

78

Records of carrying out activities for prevention and control of harms of liquor and alcohol abuse

20 years

79

Records of granting qualifications and certificates of occupational health, first aid and emergency training at the workplace as prescribed by law

20 years

80

Records of granting, canceling, revoking and re-granting receipts of conformity announcement for tobacco

20 years

81

Records of directing, guiding, inspecting, examining and supervising the implementation of specialized regulations and national technical regulations on preventive medicine nationwide

20 years

82

Records of decentralizing, canceling or revoking health facilities’ certificates of eligibility for using vaccines and medical biologicals, certificates of satisfaction of biosafety standards of laboratories

20 years

83

Records of granting, canceling or revoking certificates of circulation registration, appraisal of professional contents of dossiers of registration for advertising chemicals, insecticidal and germicidal preparations for household and medical use

20 years

84

Records of presiding and coordinating with relevant agencies in accurately and timely providing information about communicable diseases

20 years

85

Records of inspecting, supervising and supporting units and localities in implementing anti-epidemic measures

20 years

86

Records of guiding the implementation of initial healthcare provided to citizens in the community

20 years

87

Records of announcing epidemics, declaring the end of epidemics in accordance with law provisions

10 years

88

Records of organizing the immunization with vaccines and medical biologicals for compulsory subjects as prescribed by law

50 years

89

Records of formulating, supplementing and amending regulations on classification of technical operations, professional rules and national technical regulations on HIV/AIDS prevention

Permanent

90

Records of managing and directing professional operations of the network of HIV/AIDS prevention nationwide

Permanent

91

Records of treating and caring for people infected with HIV/AIDS

70 years

92

Records of harm reduction intervention to prevent HIV transmission

50 years

93

Records of consulting and managing HIV testing

50 years

94

Records of supervising HIV/AIDS/STI, monitoring and evaluating the HIV/AIDS prevention programs

50 years

95

Prophylaxis records of:

- HIV exposure due to occupational accidents;

- Mother-to-child HIV transmission;

- HIV transmission in healthcare settings.

 

50 years

50 years

50 years

96

Records of scientific research, specialized and professional qualification training in the field of HIV/AIDS prevention

50 years

97

Records of prevention of HIV/TB co-infection

50 years

98

Records of blood transfusion safety in prevention of HIV/AIDS

50 years

99

Records of directing, coordinating and implementing international coordination projects related to HIV/AIDS prevention

30 years

100

Records of prevention of sexually transmitted diseases

50 years

101

Records of treatment of addiction to opium-related substances with substitute substances

50 years

102

Records of inter-regional coordination in HIV/AIDS prevention

20 years

103

Records of inspecting, examining and proposing measures to handle violations of regulations on HIV/AIDS prevention

20 years

104

Records of drug addiction treatment, post-treatment rehabilitation and management at concentrated facilities and in the community

20 years

VI

Group 06. Medical environment materials

 

105

Records of coordination in promulgating national technical regulations, standards and provisions on environmental protection in healthcare operations

Permanent

106

Records of coordination in promulgating regulations and standards on environmental protection in cremation, burial rites, and medical environment quality

Permanent

107

Records of strategic environmental assessment and environmental impact assessment reports applicable to projects decided by the Ministry of Health

Permanent

108

Records of organizing and carrying out the observation of impacts of healthcare activities on the environment

Permanent

109

Records of organizing and implementing measures to prevent the people’s health from impacts of climate change, environmental pollution and other negative environmental factors

Permanent

110

Records of implementing, inspecting and monitoring the implementation of legal normative documents and national technical regulations on management and destruction of medical wastes, and environmental protection in healthcare activities

Permanent

111

Records of organizing the remediation of environmental pollution and medical environment healing

Permanent

112

Records of collecting, archiving and providing environment information related to fields within the management

20 years

VII.

Group 07. Materials related to food safety

 

113

Records of developing food safety database; summarizing, making statistics and reports on food safety management on the basis of monitoring and summarizing reports of ministries

Permanent

114

Records of monitoring, preventing, inspecting and coordinating in prevention of food poisoning and remediation of food safety incidents:

- Serious cases

- Others

 



Permanent

20 years

115

Permanent records of food hygiene and safety of Vietnam National Codex Committee

30 years

116

Records of promulgating regulations on general conditions for food safety assurance applicable to facilities manufacturing and trading food, tool, packing materials directly exposed to food

30 years

117

Records of promulgating regulations on general conditions for food safety assurance applicable to collective kitchens, hotels, restaurants and street food vendors, etc.

30 years

118

Records of managing the process of manufacture, processing, transportation, import, export and trade of:

- Functional food

- Micronutrient-fortified foods

- Food additives and beverage

 


30 years

30 years

30 years

119

Records of inspecting, guiding and monitoring the implementation of the law on food safety

Permanent

120

Records of granting certificates of registration for circulation of rapid test kits for food safety criteria

20 years

121

Records of granting the conformity announcement receipts, certificates of conformity to food safety regulations for prepackaged processed foods, food additives, processing aids, packing materials

20 years

122

Records of canceling or revoking the conformity announcement receipts, certificates of conformity to food safety regulations for prepackaged processed foods, food additives, processing aids, packing materials

20 years

123

Records of granting and revoking certificates of food safety eligibility for facilities producing and trading products within the management

20 years

124

Records of granting certificates of approval of advertising contents of food additives, food processing aids and packing materials

20 years

125

Records of the propaganda and dissemination of food safety

10 years

VIII

Group 08. Population materials

 

126

Records of managing population fluctuation, proposing solutions to change the birth rate and population growth rate nationwide

Permanent

127

Records of formulating, guiding the inspection and implementation of criteria, indicators and solutions for population quality, population structure by gender and age

Permanent

128

Records of inspecting, surveying, collecting and analyzing population data

Permanent

129

Records of directing, guiding, implementing and inspecting, monitoring the implementation of legal normative documents, national technical regulations, policies, programs and projects related to population

Permanent

130

Records of appraising socio-economic development programs, plans and projects related to population and development policies

Permanent

131

Records submitted to competent authorities for promulgation of population policies, including population scale, structure and quality

Permanent

132

Records of specialized and professional procedures, criteria, indicators and norms for distribution and use of contraceptive devices

50 years

133

Records of formulating and proposing quality standards, regulations on archive and distribution, channels for free-of-charge distribution, social promotion, management of contraceptive devices

50 years

134

Records of design, production of materials for population dissemination and education

20 years

135

Records of organizing the provision of population-related services

20 years

IX

Group 09. Materials related to maternal and child health

 

136

Records of formulating and promulgating the system of reproductive health criteria and indicators

Permanent

137

Records of professional regulations and national technical regulations on reproductive healthcare service

Permanent

138

Records of developing orientations, policies, strategies and plans for reproductive healthcare

Permanent

139

Records of developing plans and implementing professional and technical tasks of reproductive health

Permanent

140

Records of directing, guiding, carrying out professional and technical inspection of health facilities’ reproductive health activities

Permanent

141

Records of permitting health facilities to carry out sex determination, recognizing health facilities eligible for conducting assisted reproductive techniques (in vitro fertilization, intrauterine insemination) as prescribed by law

Permanent

142

Records of making plans and organizing continuous training courses for officers conducting professional and technical operations in the field of reproductive healthcare

20 years

143

Records of disseminating, communicating and educating in the field of reproductive healthcare

20 years

144

Adolescent reproductive healthcare records

20 years

145

Records of managing and implementing domestic and overseas schemes, projects and programs on reproductive healthcare

20 years

146

Records of managing organizations providing reproductive healthcare services

20 years

147

Records of providing maternal, newborn, and child healthcare services

20 years

148

Records related to maternal and child nutrition

20 years

149

Records related to male and geriatric reproductive healthcare

20 years

150

Records of managing services of safe abortion, prevention and control of reproductive tract infections and cancers, infertility treatment

20 years

X

Group 10. Health insurance materials

 

151

Records of promulgating the lists of drugs, medical supplies, and technical services covered by health insurance

Permanent

152

Records of developing healthcare system, medical technical professional operations, funding for protection, taking care and improvement of people’s health based on health insurance

Permanent

153

Records submitted to the competent authorities for promulgation of solutions to ensure the Health Insurance Fund balance

Permanent

154

Records of directing and guiding the implementation, inspecting medical facilities, organizations and individuals in complying with the law on health insurance

Permanent

155

Records of reports and statistics on health insurance

Permanent

156

Records of directing and guiding the implementation of the health insurance regimes

Permanent

 

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