1. Regarding the quality management standards of blood stations, the following description is correct.
A According to the Law of People's Republic of China (PRC) on Blood Donation. Oh-ba
B/ Specification is the basic criterion of blood station quality management, which is applicable to general blood stations providing blood collection and related services. ` vfhk \ K;
C/ Specification is the basic criterion of blood station quality management, which is applicable to all blood stations that provide blood collection and related services. & ltU^EMq
D/ specification is the highest criterion of blood station quality management, which is suitable for general blood stations that provide blood collection and related services. & gtKR88CnV-
2. Regarding the quality management responsibilities, the following descriptions are wrong: (d) at > F & gt。 r”;
A/ The legal representative is the first person responsible for the quality of blood stations, and the legal representative shall be responsible for the establishment, implementation, monitoring and improvement of the quality system. 4F * 5 & amp
The legal representative shall review the quality management system at planned intervals; Supervise the improvement of quality management system to ensure its suitability, sufficiency and effectiveness. 4 X8? e +
C/ All employees are responsible for the quality within their responsibilities. ^[yq7/%
All employees shall record and save the information and contents of management audit. {M.sK & ltbr & gt3. Regarding institutions and personnel, the following descriptions are correct: (d) U6+/FM.
C/ The employee must have been trained in the relevant documents and practical skills of the proposed post responsibilities, and the evaluation shows that he is competent. ? ; Q5Q|v
Employee signatures must be registered and kept, updated regularly as required, and previous records should be filed. B8@8Y
5。 Regarding the quality system documents, the following descriptions are correct: (a) AXR U6a.
A/ Quality system documents shall include quality manual, process documents, operating procedures and records. @Qu: MI*w
Establish and implement sop to form documents and document management. \u5azaa*
C/ The originals and copies of the invalid documents shall be marked and filed, and the invalid documents shall not appear on the job site. ; d*d]a}E#
D/ Ensure that employees can easily obtain documents related to their posts in the unit and use them correctly. $|GA
6. Buildings, facilities and environment, the following descriptions are correct: (c); Ty4bw ]m
A/ The consultation area and physical examination area for blood donors can conduct effective physical examination for blood donors, so as to correctly judge the qualifications of blood donors. {U~ZZklL
B/ Safely place and discard blood bags in the designated area of blood collection area to avoid reuse, pollution and mistakes; . E. if! w
C/ Rest area after blood donation should ensure that blood donors get proper rest. hgdB * & lt-
D/ Blood storage area, which should be set with isolated storage area for blood to be tested and isolated storage area for waste blood. 7#"6pCl@
7. Equipment, the following description is wrong: (d) (Fw=zb.
Management systems such as equipment confirmation, maintenance, calibration and continuous monitoring must be established and implemented to ensure that the equipment meets the expected use requirements. B/ Measuring instruments shall meet the verification requirements, and have obvious periodic verification conformity marks. | VO & ampj=7
C/ Large and key equipment shall be marked with unique labels, and the maintenance and calibration period shall be clearly specified. Archives should be managed by special personnel, with records of use, maintenance and calibration. q,,WVq@
D/ All emergency standby key equipment needs special management. 3 & ampVvcGGMu
8. Materials, the following descriptions are correct: (b) PA7G "r (&; x
A/ Materials used for blood collection and supply meet relevant national standards, and shall not have adverse effects on blood quality. MDy*:tA+,
B/ The manufacturers and suppliers who purchase key materials have the corresponding qualifications stipulated by national laws and regulations, and are reviewed once a year. Five feet tall
C/ For materials with special requirements on temperature, humidity or other conditions, temperature and humidity monitoring shall be carried out four times a day. 4 & gtwq 1#g%G\
D/ The storage period and validity period of materials shall be set from the date of warehousing, usually half a year, but not more than one year at most, and labeled. 6YVS9wgY
9. Safety and health, the following description is incorrect: (c) 4 @ W7.
A/ Formulate and implement a safety and health management system, which should at least include the responsibilities of organizations and employees to ensure safety and health in the workplace. E_pf%(
B/ There is a person responsible for safety and health, who is directly responsible to the legal representative. Financial Times & (MVW
C/ Establish employee health records and conduct blood-borne pathogen infection detection for employees once every two years. Employees with negative antibody to hepatitis B virus surface should be vaccinated with hepatitis B vaccine. ]pbyyB & lt; #)t
D/ Take effective measures to protect blood donors and employees; Avoid the pollution of blood, blood samples and the environment in the process of blood collection, inspection, preparation, storage, packaging and transportation. sMz & ampVm5
10. Computer information management system, the following description is correct: (b) \p "
Computers must be used to manage the main process of blood collection and supply. }9 eDy#`9
B/ The development, design, change and confirmation of management information system should follow the basic principles of development, design, change and confirmation of software engineering. |E|X sC8
C/ ensure blood supply. Two-way electricity should be set. ! 1r_! "
D/ Clear user authorization settings to prevent users from changing their permissions on important data. 9D; Daou
10. Identification and traceability of blood, the following descriptions are wrong: (c) {lr; +& lt; The background color of the br & gtA/ label should be white, and it should be firmly stuck on the blood bag, which is waterproof and wear-resistant, and the adhesive on the back should not affect the blood quality. Label information is recommended to use pure black font and be generated by printing or printing. 7k/msbCK & lt; Br & gtB/ The contents in the blood label shall comply with the relevant provisions in the Measures for the Administration of Blood Stations and the Quality Requirements for Whole Blood and Components, including at least four parts: blood donation number, variety identification, blood type identification and expiration date identification. z8V)' 7J & lt; The coding program of E & ltbr & gtC/ blood donation barcode should ensure the uniqueness of the blood donation code, and the same blood donation code should not be repeated for at least 30 years. Qgt t ~ rdho & ltbr & GTD/The steps and requirements of labeling should be clearly defined, and only one bag of blood and homologous blood samples can be labeled at a time, and the labeling should be matched with the query single sheet. hmL]tuh & lt; Br> 1 1. Record, the following description is correct: (d) # s {> JU+z^! & ltbr & gtA/ includes the whole process of blood collection, detection, preparation, storage, distribution and transportation. 9QZod * Ir & ltbr & gtB/ The original records of blood donation, testing and blood supply shall be kept for about ten years. n " XLD-xO & lt; Br & gtC/ Data information should be available for key reference. H6tPry & ltbr & gtD/ Keep the personal data, blood donation information, blood test results and corresponding blood use information of blood donors confidential to prevent unauthorized contact and external disclosure. Ku g FDPFA & LTBR & gt12. Monitoring and continuous improvement, the following description is correct: (a) BCK (GGR
A/ Check the information of blood donors before blood collection to ensure that the blood collected comes from blood donors who meet the requirements of blood donors' health examination. YsYtt x
B/ Before blood collection, check the appearance of blood bag and blood preservation solution to ensure that the blood bag is free from damage and mildew, and it is within the validity period. VwISP-g#
C/ The identification process should be strictly controlled to ensure that the blood bags, specimen tubes and blood donation records of the same blood donor are in one-to-one correspondence, and the identification is correct. 8\ qLl
D/ At the end of blood collection, make relevant records. 【/goh9? \s
17. Regarding the blood donation record, the following descriptions are incorrect: (d) 6a @ y0} e.
A/ The blood donation record shall at least include the personal data of the blood donor. G"~T9t~ `
B/ The results of health consultation shall be signed by blood donors and consultants. 7bFNt:Q
C/ the physical examination result shall be signed by the physical examination person. z}XaQ93
D/ The date, quantity and response of blood donation shall be signed by the visiting doctor. J R3U /@
18. Blood component sampling, the following description is correct: (c) "V5 eejcuv.
A/ The work must be carried out by trained nursing staff, and the trained medical staff should be responsible for monitoring. #e_=4 SIa
B/ Blood cell separators should be maintained and monitored daily to ensure safety and effectiveness. Xf! & gtfB\4b
C/ Disposable blood component separation pipelines approved and registered by the US Food and Drug Administration must be used. 8Mue)YW^
D/ Discard and destroy all used disposable component separation pipelines in the device in time. . =S_! ' b '
19. Blood test, the following description is correct: (c) XH, = Rh>g.
A/ In blood stations that carry out blood testing business, blood testing laboratories must obtain the practice certificate of "Quality Management Standards for Blood Stations". 5C p~hSO7
B/ Blood stations that do not carry out blood testing business only need to complete the handover procedures to ensure that the blood samples are correct. %=HtBJW
C/ Establish and implement procedures for receiving and using inspection reports to ensure the correct receipt and use of inspection reports. Zuda! C}}
D/ The blood station quality control laboratory shall meet the relevant requirements of the blood station quality management standard. TFb[xE
20. blood preparation, the following descriptions are wrong: (a) E, z.
A/ The prepared blood must meet the requirements of quality management standards of blood stations. Z5#MT\sF
B/ Carry out the procedures of blood preparation, labeling, packaging and warehousing. ; Za'9lq\
C/ The blood preparation environment should be clean and hygienic, disinfected regularly and effectively, and the ambient temperature should be controlled to ensure the safety and effectiveness of blood. W me Q
D/ Blood preparation should be carried out in a closed system as far as possible. If it can only be prepared in an open system, it should be strictly controlled to avoid microbial pollution. ? T CI~7)
2 1. blood preparation, the following description is correct: (d) ngnn {] m.
A/ All blood preparation equipment shall be maintained and calibrated according to regulations to ensure reliable and stable operation. EY 53/udC
B/ The procedures and methods of blood preparation need not be verified. f4= 7'Q+h
C/ Disposable plastic blood bags for blood preparation can only be used after being confirmed by the quality control department. ! ,%gFS^
D/ Carry out routine blood sampling procedures, conduct statistical analysis and deviation investigation on the sampling results, and take corrective and preventive measures. 5#r.5_4
22. Regarding blood and its packaging label, the following description is correct: (b) CW'
A/ When the combined bag is used, before separating the original bag from the transfer bag, the consistency of the blood donation barcode on the original bag should be checked. :kxx#8n '
B/ When non-integrated blood bags are used for blood, it is necessary to ensure that each blood bag is affixed with the correct blood donation barcode. -kxWVX
C/ When using the integrated blood bag to collect blood, it is necessary to ensure that each blood bag is affixed with the correct blood donation barcode. g,B 1? eight
D/ Check the information in the query table again when labeling qualified blood. 3Z! X9`bS
23. Regarding the blood preparation records, the following descriptions are incorrect: (b) b #' ut c.
A/ Ensure the traceability of personnel, equipment, blood sources and raw materials, methods and steps, environmental conditions and other related information during blood preparation; ww 1 VD`lA
B/ Traceability at least includes: blood handover, ingredient preparation process, instrument use, maintenance and calibration, ingredient preparation environment control, etc. za~r? *> The best brandy (premium grade)
C/ Traceability at least includes: blood handover, ingredient preparation process, routine sampling inspection and quality result analysis of ingredients, instrument use, maintenance and calibration, environmental control of ingredient preparation, medical waste treatment, etc. v ' & gtqK#z
D/ Records shall be signed by the operator. d"st7x '
24. The release procedure of qualified blood follows the following principles. The following descriptions are incorrect: (d) ~ x9oib $+
A/ Release personnel should be trained, qualified and authorized before engaging in release work, and quality management personnel should monitor the release of blood. oMJ"4d['
B/ Check all unqualified blood in each batch of blood, and release qualified blood only after accurate and safe transfer and disposal. Pb; 7 ohm mercury
C/ Determine all the prepared qualified blood in each batch of blood, and label the qualified blood. Only after the release is approved can it be transferred from the isolation warehouse to a qualified blood bank for clinical distribution. ; x~XmTMs {
D/ All unqualified blood should be burned immediately after counting and verification. mTv! }L^
25. Blood preservation management procedures shall meet the following requirements, except (c)? 1Qo|@rCB
A/ Blood storage places should have fire prevention, anti-theft and rat prevention measures, and unauthorized personnel are not allowed to enter. )”Vs8 ^F
B/ Blood storage equipment shall be reliable in operation, with balanced temperature, temperature recording device and alarm device. j5BVRS2J
C/ Monitor the preservation status to ensure that the blood is preserved under effective conditions. h @ r-it
D/ According to the storage requirements, separate the blood of different varieties and blood types and clearly mark them. u|5Zcr
26. Regarding the distribution and transportation of blood, the following description is correct: (d) (6DO) GWP.
A/ establish and implement blood distribution procedures. We should follow the principle of first in and last out. h { 7 & lty
B/ Establish and implement blood transportation management procedures to ensure that blood is always transported at 4℃. Bob. ^7d_0
C/ The storage temperature of blood during the whole transportation process should be continuously monitored. o||VQZ
D/ The blood transport box shall be marked, indicating the blood type and transport destination. `% { j; F & ltbr & gt27. Regarding the requirements of blood inventory management procedures, the following descriptions are incorrect: (c) LBG/, =%
D/ blood inventory should be counted regularly. MMRb & gt
28. Regarding blood collection, the following descriptions are incorrect: (c) OJNW.
Blood collection procedures should be established and implemented to determine the blood to be collected, the personnel responsible for collection and their responsibilities. FJ 1[ g
B/ Ensure that there is a special person to answer and deal with complaints and defects of blood quality at any time, and can quickly recover the blood that has been distributed or track the whereabouts of blood, and promptly notify relevant units to take corresponding measures. Okqa
C/ After blood with serious quality defects is recovered, it should be treated immediately. e! m * m[j & amp;
D/ The blood recovery record shall include the recovery, tracking, analysis, review and disposal of defective blood, as well as the corrective and preventive measures taken. & gt3a & gtaK(Cz
29. Regarding the procedures for handling blood quality complaints, the following description is correct: (c) :}! ^X2-
A/ designate the person in charge of the blood bank. =l_! Sports games
B/ Designate quality control laboratory personnel to be responsible. #^i<; M^o`}
C/ Designate the personnel of quality control laboratory and quality control department to be responsible. U@ # field effect transistor
D/ When receiving complaints about major blood quality problems, report to the provincial health administrative department in time. =Q`oF d
30. The following description of the qualification requirements for staff in key positions in blood stations is correct: (d) 6DT)Oci5Mi.
A/ Medical examiner, bachelor degree or above, assistant doctor or above, trained in blood safety and first aid. ]Wf nHRs$
B/ Inspection director, college degree or above, junior professional title or above, trained in blood safety, and trained or advanced in a professional way consistent with the work for more than 3 months. bKT^)ml
C/ Information management position, college degree or above in computer related major, junior professional title or above, with relevant qualification or professional (training) certificate, and received 94$cS6 xW blood safety training.
D/ Quality management post, college degree or above in related major, primary title or above, and received blood safety training. c#-bJ
Second, multiple choices KLU; ordinary
1, quality management responsibilities, the following description is correct: (abcd) 8E=XJ{
A/ The quality system shall cover all processes of blood collection and related services. 8K+2|l'@ 9
B/ The legal representative is the first person responsible for the quality of blood stations, and the legal representative is responsible for the establishment, implementation, monitoring and improvement of the quality system. R}'rj/
C/ The legal representative shall review the quality management system at planned intervals; Supervise the improvement of quality management system to ensure its suitability, sufficiency and effectiveness. K * \ MB% p USD
The quality system meets the requirements of laws, regulations, standards and specifications. bJfc Vc
2. Organization and personnel, the following description is correct: (acd) 0. \7nZ+M[
It is necessary to establish an organizational structure suitable for its business. . @ (Queue
B/ Health technicians should account for more than 85% of the total number of employees. Page 3
C/ The legal representative or principal responsible person of the blood center and the central blood station shall have a bachelor's degree or above. SL & amp+ high frequency
D/ The newly-added technical and management personnel should have a bachelor degree or above, and not less than 60%. =A\4 T
3. In the quality system documents, the following descriptions are incorrect: (ab) k: pav/+w.
A/ The quality system document covers the main flow of blood collection and supply business. & amphbD'3"h+
B/ The documents used shall be the approved version. b0)%gJL 1
C/ The document shall be reviewed regularly, and the document revision status list and document release list shall be listed. Come to an end
D/ Before the formal implementation of the document, relevant employees should be trained, their abilities should be evaluated, and relevant records should be kept. ` ZnX
4. Buildings, facilities and environment, the following descriptions are correct: (ABCD)g | n h & amp; Ed (male name)
A/ The overall layout of blood collection and supply business, life, management, logistics and auxiliary areas shall be reasonable and shall not interfere with each other. ? Fiscal year 43
B/ The layout of blood collection and supply workplace should meet the business needs, and the flow should be reasonable and orderly to prevent personnel and blood from being polluted. 7p46JL~f
C/ having safe and effective emergency power supply facilities. ^0)p |]& amp;
D/ Facilities such as fire fighting, sewage treatment and medical waste treatment comply with relevant national regulations. . }HS)-73qN
5. Equipment, the following description is correct: (acd) :5q vd
A/ Equipment configuration should meet the needs of blood bank business. o$+)I0-
B/ measuring instruments should be calibrated every two years. RTRNi & amp4l
C/ Faulty or invalid equipment shall be clearly marked to prevent misuse. s $ sb & ampN6
D/ Emergency measures for key equipment shall not affect the normal work and blood quality of blood stations. ? vh。 [~NGi
6. Material, the following description is correct: (abc) RI8)PY
A/ A management system should be established, the list of key materials should be defined, and the procurement, acceptance, storage, distribution and use of blood collection and supply materials should be standardized. /6fH[D & lt; three
B/ Control the quality of key materials to ensure that only qualified materials can be put into use. iX|-A
C/ Qualified products, products to be inspected and unqualified products shall be strictly managed and stored in different regions. For similar key materials in the inventory area, there are clearly identifiable status categories. = 1- 1DJl/
D/ Materials shall be stored according to the specified service life, and the principle of first-in first-out shall be followed to ensure their use within the validity period. Me & ltU~U:
8. Safety and health, the following description is correct: (abcd)! ZCPqaX
A) Establish and implement procedures for preventing and controlling occupational exposure, including prevention and treatment, registration, monitoring and reporting of occupational exposure. 8`PdXLOjW
B/ Eating, smoking and wearing ornaments that affect safety and hygiene are not allowed in the work area. *sFvA[ vu
C/ Formulate disinfection and cleaning procedures, and specify the areas, equipment and articles that need disinfection and cleaning, as well as the methods and frequency of disinfection and cleaning, so as to keep the operation area clean and tidy. - ! & gtFg4^
D/ Implement relevant regulations on medical waste management, and collect and treat medical waste. T) I $@L
9. Computer information management system, the following description is correct: (abcd) [2! =fH6r,
A/ Maintenance of management information system should include all components in the system, such as hardware, software, documents and personnel training; Q 1rI% 1~o? ^
B/ Measures must be taken to ensure data security, make regular backups of the database, and ensure that the backup inventory points are effectively and safely separated from the main database. /o 4r! Y dollars
C/ Users should ensure the security of electronic passwords and prevent, check and remove computer viruses. {:^0`3
D/ The date, time and content of all operator login and operation activities shall be recorded in detail. L."V `
10. Identification and traceability of blood, the following description is correct: (abd) TgVYi "(
A/ Management procedures for blood identification must be established and implemented to ensure that all blood can be traced back to the corresponding blood donors and their blood donation process, batch numbers of key materials used and complete records of all preparation and inspection. R"T_+pc+
B/ The background color of the label should be white, and it should be firmly adhered to the blood bag, which is waterproof and wear-resistant. Sticking on the back will not affect the blood quality. Label information is bold and must be printed. ~}4aDAP,Z
C/ The identification of blood shall adopt barcode technology to ensure that each bag of blood has unique identification and traceability. ARWq|){kv
D/ barcode technology should be able to identify different kinds of blood and blood types in different process states. It should be ensured that each blood donation has a unique bar code identification and can be traced back to the blood donor. lM-Sknuq。 U