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TABLE  Sources for Quality Improvement Tools and Methods
Quality Improvement Method Description
Health Resources and Services Administration quality improvement tools
The Joint Commission quality improvement tools
Root Cause Analysis (Six Sigma) A commercial quality improvement program that provides methodologies for
Failure Mode Effects Analysis (FMEA)
A toolbox of clinical quality and performance measures provided by the U.S. Department of Health and Human Services, including tools for data collection and performance measurement webinars.
A suite of tools and resources for healthcare organizations to help them meet TJC standards and National Patient Safety Goals. These tools are available only to TJC­accredited organizations.
improving quality and reducing variation in any new or existing process. The steps of analysis for new processes include define, measure, analyze, design, and verify. The steps of analysis for existing processes include define, measure, analyze, improve, and control.
Step-by-step method to identify all of the possible causes of failure in a process or service. These causes are then prioritized according to their seriousness and frequency. Each problem is then analyzed and corrective actions are taken. As each corrective action is completed, the date and results are recorded.
Chapter Summary
Related NAACLS
Learning Outcome Key Concepts/Examples
Competency
 . Identify policies
and procedures used in phlebotomy and in the clinical laboratory to ensure quality in obtaining blood specimens.
. Carry out documentation of quality control.
. Identify corrective actions for failures of quality control.
• Systems exist for monitoring the quality of laboratory procedures, including blood collection.
• Quality assurance processes include assessment and evaluation of all steps in a procedure.
• Quality control is the activity that ensures that specific steps in a procedure meet performance standards.
Accurate documentation of all quality assurance and quality control activities is essential for monitoring quality.
Quality assessment and process improvement (QAPI) provides a system for error detection and correction to ensure patient safety and satisfaction, valid test results, and accurate reporting of results.
8.00, 8.1, 8.2
8.00, 8.1, 8.2
8.00, 8.1, 8.2
 Chapter  Quality Essentials
Copyright © 2019 by McGraw-Hill Education
Chapter Review
A: Labeling
For the following form, indicate what is recorded in each numbered section.
QUALITY ASSESSMENT: OCCURRENCE OF VARIANCE
(1)
(2)
(3)
(4)
(5)
(6)
Patient name
Patient location
Specimen accession #
Complaint:
Pre-Examination-Specimen Related
[ ]
Clotted
Hemolyzed
[ ] [ ]
Insucient specimen
Examination Results Questionable
[ ]
Delta check
Post-Examination Results Invalid
[ ] [ ]
Reported on wrong patient
[ ]
Patient Issue Safety Issue Armband Issue Employee Issue
[ ] [ ]
Specimen integrity issue Other concern
Medical record # Date
Form completed by
Specimen type
[ ] [ ] [ ]
[ ]
Laboratory collect Nurse collect
[ ]
Mislabeled Wrong patient
Missing specimen
[ ] [ ]
Missed test / wrong order
[ ]
Laboratory collect Nurse collect
Laboratory collect
[ ] [ ]
Erroneous results reported Other
[ ]
[ ]
Wrong specimen type
[ ] [ ]
Wrong collection time
[ ]
Nurse collect
[ ]
Tests aected
(7)
(8)
(9)
(10)
Copyright © 2019 by McGraw-Hill Education
Licensed caregiver notified Investigation Summary
Severity
Training issue
[ ]
Follow-up
[ ]
Discussed variance with employee
[ ]
Reviewed SOP with employee
[ ]
Modified procedure
[ ]
Re-training scheduled
[ ]
Other
Caused healthcare provider to take wrong action Caused delay in patient care
[ ] [ ]
Non-compliance issue Other
Supervisor Date
Date and time
[ ][ ]
DateEmployee
Chapter  Quality Essentials 
1. [LO 12.3]                                               
2. [LO 12.3]                                               
3. [LO 12.3]                                               
4. [LO 12.3]                                               
5. [LO 12.3]                                               
6. [LO 12.3]                                               
7. [LO 12.3]                                               
8. [LO 12.3]                                               
9. [LO 12.3]                                               
10. [LO 12.3]                                               
B: Matching
Match each term with its definition.
11. [LO 12.3] audit
12. [LO 12.3] competency assessment
13. [LO 12.3] corrective action
14. [LO 12.3] preventive action
15. [LO 12.3] process improvement
16. [LO 12.3] proficiency testing
17. [LO 12.1] quality assurance
18. [LO 12.2] quality control
19. [LO 12.2] random errors
20. [LO 12.2] systematic errors
21. [LO 12.3] training
C: Fill in the Blank
Write in the word(s) to complete the statement.
a. examining process functionality b. ensuring acceptability of a specific procedural
step
c. fixing problems that have occurred d. ensuring that errors do not reoccur e. educating employees f. testing and documenting an employee’s ability to
perform tasks correctly
g. external agency evaluation of a testing procedure
or process
h. examination of records i. making processes and procedures better k. can cause a shift or trend in test results k. have no predictable pattern
22. [LO 12.1] The terms quality          and quality         
are often used interchangeably.
23. [LO 12.1] The CLSI has established a hierarchy of         , or step-by-step events, that
help laboratories achieve high-quality results.
24. [LO 12.1] How close a test result is to being correct is its         .
25 [LO 12.1] Rules of practice are commonly called         .
26. [LO 12.3]          is the examination of a process or procedure for acceptability of
outcomes.
 Chapter  Quality Essentials
Copyright © 2019 by McGraw-Hill Education
27. [LO 12.1] A laboratory procedure manual contains the          for every test
performed in the laboratory.
28. [LO 12.1] Test results are considered          if they are both believable and dependable.
29. [LO 12.1]          is the procedure used to check and adjust settings on instruments.
30. [LO 12.2] Serum that is specially prepared for use in testing the reliability of instruments is a(n)
        .
31. [LO 12.2] A graph that shows if control results are within acceptable limits is a(n)
        .
32. [LO 12.2] A jump in the values of control results is a(n)         , whereas a gradual
change in one direction is a(n)         .
33. [LO 12.1] Factors that may decrease a patient’s or customer’s          with the
services he or she has received include inaccurate results, long wait times, and phlebotomists with an unprofessional appearance.
D: Sequencing
Place the links of quality performance in the correct order of occurrence for the laboratory testing process (from 1 to 9).
34. [LO 12.1] Analyze the results.
35. [LO 12.1] Collect the specimen.
36. [LO 12.1] Identify the patient.
37. [LO 12.1] Interpret the physician’s orders.
38. [LO 12.1] Label the specimen.
39. [LO 12.1] Prepare the lab requisition.
40. [LO 12.1] Process the specimen.
41. [LO 12.1] Report the results.
42. [LO 12.1] Transport the specimen.
E: Case Studies/Critical Thinking
43. [LO 12.1] You are about to perform a venipuncture procedure. Upon examining the expiration dates on
the evacuated tubes, you notice that the EDTA tube has been expired for 2 months. What is your course of action? How is this action part of quality assurance? What would be the consequences if you had not checked the expiration dates?
44. [LO 12.2] You are performing a routine quality control check on the glucometer machine prior to using
it. The machine function check is fine with the low control check, and the high control check reading is
90. The machine you are using has a high control value of 110 mg/dL with an acceptable range of 105– 115 mg/dL and a low control value of 75 mg/dL with an acceptable range of 70–80 mg/dL. Determine what actions, if any, are required.
45. [LO 12.3] You have been serving on the laboratory’s QAPI committee for more than a year now. A new
committee member approaches you and asks what her responsibilities will be. What should you tell her?
46. [LO 12.3] A phlebotomy supervisor has received a complaint that the turnaround times for STAT tests
ordered by the emergency department are too long. The complaint was communicated through the laboratory manager, who was informed by laboratory personnel that the specimens were not delivered to them for more than 30 minutes after the collection time on the tubes. What should be put in place
Copyright © 2019 by McGraw-Hill Education
and what are some possible scenarios for this variance in quality care?
Chapter  Quality Essentials 
F: Exam Prep
Choose the best answer for each question.
47. [LO 12.1] Surveying patient satisfaction with
the healthcare delivery system at a facility is an example of
a. quality assurance. b. quality control. c. quality documentation. d. quality management.
48. [LO 12.1] Which event will most likely negatively
affect patient satisfaction with the laboratory? a. One attempt was needed to obtain a blood
specimen.
b. No hematoma formed after the venipuncture
procedure.
c. The patient’s breakfast was delayed because
the phlebotomist was late in arriving to collect the fasting specimen.
d. The phlebotomist wore a lab coat during the
procedure.
49. [LO 12.1] A system for evaluating the delivery of a
healthcare service, such as specimen collection, is
a. quality assurance. b. quality control. c. quality documentation. d. quality management.
50. [LO 12.1] An ongoing set of activities used to
monitor turnaround times is an example of
a. quality assurance. b. quality control. c. quality documentation. d. quality management.
51. [LO 12.1] The focus of quality assurance is on
processes that involve all of these except
a. requisitioning of tests. b. integrity of the specimen. c. performance on lab inspections. d. laboratory staff salaries.
53. [LO 12.1] Liquid or freeze-dried serum with a
known value from the manufacturer is a(n)
a. analyte. b. control material. c. reagent. d. testing agent.
54. [LO 12.1] When should quality assurance
activities be in place?
a. In the pre-evaluation phase of testing b. In the evaluation phase of testing c. In the post-evaluation phase of testing d. In all of these
55. [LO 12.1] Rules of practice for performing a
procedure are referred to as
a. standards. b. codes of ethics. c. parameters. d. validations.
56. [LO 12.1] Determining the turnaround time for
STAT tests ordered for patients in the emergency department is a function of
a. quality assurance. b. quality control. c. competency assessment. d. proficiency testing.
57. [LO 12.1] Acceptable limits for quality control
results are referred to as
a. standards. b. variances. c. parameters. d. validations.
58. [LO 12.1] Deviations from the standard
operating procedure are referred to as
52. [LO 12.1] Achieving complete correctness or
acceptable measures as close as possible to the true value is known as
a. accuracy. b. calibration. c. process. d. procedure.
 Chapter  Quality Essentials
a. standards. b. variances. c. parameters. d. limitations.
Copyright © 2019 by McGraw-Hill Education
59. [LO 12.1] An individual’s ability to perform
a procedure, such as blood collection, is documented in the
a. quality assessment form. b. standard operating procedures. d. competency assessment form. d. proficiency testing materials.
60. [LO 12.2] Recording the temperatures of the
refrigerators used to store blood for testing is an activity of
a. quality assurance. b. quality control. c. competency assessment. d. proficiency testing.
61. [LO 12.3] Reviewing the temperature logs for
variances in blood storage temperatures is an activity of
a. quality assessment and process improvement. b. quality control. c. competency assessment. d. proficiency testing.
62. [LO 12.3] Questioning the accuracy of test
results may occur if a. the results are significantly different than the last
time the test was performed on the same patient.
b. the results are consistent with the medical
provider’s diagnosis or expectations.
c. the results are consistent with the patient’s
clinical symptoms.
d. all of these apply.
64. [LO 12.3] Problems with any step in a process may
be discovered when reviewing (Choose all that apply.)
a. incident report forms. b. competency assessments. c. proficiency testing results. d. continuing education records.
65. [LO 12.3] Educating employees about the use
of a new piece of phlebotomy equipment is an example of
a. audit and evaluation. b. corrective action. c. competency assessment. d. training.
66. [LO 12.3] Developing and implementing ways
to make processes and procedures better is the purpose of
a. audit and evaluation. b. corrective action. c. preventive action. d. process improvement.
67. [LO 12.1] Which of the following is a purpose of
total quality management?
a. To measure and manage the cost of quality b. To ensure that specific steps in a process meet
acceptable standards
c. To design operations that produce a high level
of customer satisfaction
d. To discover and eliminate weaknesses in labo-
ratory processes
63. [LO 12.2] Quality control activities include
recording temperatures for (Choose all that apply.) a. freezers.
Enhance your learning by completing these exercises and more at connect.mheducation.com.
b. incubators. c. refrigerators. d. patients.
References
Clinical and Laboratory Standards Institute. (2011). Quality management system: A model for laboratory services; approved
guidelines (4th ed.). Wayne, PA: Author. GP26-A4.
Cox, P., & Wilken, D. (2011). Palko’s medical laboratory procedures (3rd ed.). New York, NY: McGraw-Hill. Harmening, D. (2007). Laboratory management principles and processes (2nd ed.). St. Petersburg, FL: D. H. Publishing & Consulting. Kurec, A. S., Schofield, S., & Walters, M. C. (Eds.). (2000). The CLMA guide to managing a clinical laboratory (3rd ed.). Wayne, PA:
Clinical Laboratory Management Association.
National Accrediting Agency for Clinical Laboratory Sciences. (2010). NAACLS entry-level phlebotomist competencies. Rosemont, IL: Author.
Copyright © 2019 by McGraw-Hill Education
U.S. Department of Health & Human Services. (2011). Hospital compare. Retrieved August 8, 2011, from www.hospitalcompare.hhs.gov/
Chapter  Quality Essentials 
NAME: _____________________________________ DATE: _____________________________________
COMPETENCY CHECKLIST: QUALITY ASSURANCE IN THE LABORATORY
Practice Performed
Procedure Steps Yes No Master
Preprocedure
. Interprets the physician’s order correctly.
. Prepares the laboratory requisition and labels.
. Greets the patient and introduces self.
. Identifies the patient using at least two unique identifiers.
Procedure
. Collects the required specimens according to the facility’s
standard operating procedures to help ensure the integrity of the specimens.
. Labels the specimens accurately and completely while still
with the patient.
. Thanks and dismisses the patient.
. Transports the specimens to the processing area of the
laboratory, takingcare to follow any special temperature or other requirements for specific specimens.
. Documents specimen collection in EHR using LIS.
. Checks specimens for acceptability. If a specimen is not
acceptable, documents this in the EHR using LIS and reor­ders the tests.
. If the specimens are acceptable, runs quality control tests
as indicated for each specimen and laboratory test.
. Verifies that control results are within normal limits.
. Performs the ordered laboratory tests.
. Performs delta checks. If delta check fails, documents the
results and cancellation, and reorders the tests.
Postprocedure
. If the results are acceptable, reports the results within the
accepted turnaround time.
. Documents the test results.
COMMENTS: ______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________
SIGNED
EVALUATOR: ___________________________________________________________________________ STUDENT: ______________________________________________________________________________
 Chapter  Quality Essentials
Copyright © 2019 by McGraw-Hill Education
NAME: _____________________________________ DATE: _____________________________________

COMPETENCY CHECKLIST: TEMPERATURE QUALITY CONTROL

Practice Performed
Procedure Steps Yes No Master
Preprocedure
. Locates the appropriate temperature log for the instrument
to be checked.
Procedure
. Correctly reads the minimum temperature.
. Correctly reads the maximum temperature.
. Correctly records temperatures on the temperature log.
. Compares temperatures with acceptable range.
. Applies corrective action (according to facility policy).
. Correctly documents corrective action.
. Properly signs and dates the temperature log.
Postprocedure
. Returns thermometer and temperature log to the correct
location.
COMMENTS: ______________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________ ________________________________________________________________________________________
SIGNED
EVALUATOR: ___________________________________________________________________________ STUDENT: _____________________________________________________________________________
Design Elements: Communicate & Connect icon (patient and doctor) ©Rocketclips, Inc./Shutterstock.com RF; Think It Through icon (staircase) ©Lightspring/Shutterstock.com RF.
Copyright © 2019 by McGraw-Hill Education
Chapter  Quality Essentials 
Special Phlebotomy
13
A1c aerobic anaerobic antibiotic removal
device (ARD) arterial puncture autologous bacteremia biotinidase cannula congenital
essential terms
culture media cystic fibrosis diabetes mellitus differential false-negative false-positive
Procedures
fistula galactosemia gestational diabetes glycolysis hemochromatosis heparin lock hypothyroidism normal flora phenylketonuria
(PKU) polycythemia vera saline lock septicemia sickle cell disease therapeutic
phlebotomy
Learning Outcomes
 . Describe special considerations and
procedures needed to collect specimens for blood cultures.
. Identify the various types of glucose
tests and the indications and procedures for each.
. List common neonatal screening tests and
the conditions they are used to diagnose.
. Explain the procedure for creating
acceptable thin and thick blood smears.
. Recognize the special requirements for
carrying out blood collection for blood bank use.
. Identify steps to competent and effective
arterial puncture.
. Classify venous access sites and their uses.
©Total Care Programming, Inc.
Related NAACLS Competencies
. Demonstrate knowledge of infection control
and safety.
. Demonstrate understanding of the
importance of specimen collection and specimen integrity in the delivery of patient care.
. Describe the types of patient specimens that
are analyzed in the clinical laboratory.
. Define the phlebotomist’s role in collecting
and/or transporting these specimens to the laboratory.
. List the general criteria for suitability of a
specimen for analysis, and reasons for specimen rejection or re-collection.
. Explain the importance of timed, fasting, and
stat specimens, as related to specimen integrity and patient care.
. Demonstrate knowledge of collection
equipment, various types of additives used, special precautions necessary, and instances

that can interfere in clinical analysis of blood constituents.
. Describe the proper order of draw for
specimen collections.
. Describe substances that can interfere in
clinical analysis of blood constituents and ways in which the phlebotomist can help avoid these occurrences.
. Follow standard operating procedures to
collect specimens.
. Differentiate between sterile and antiseptic
techniques.
. Describe and demonstrate the steps in the
preparation of a puncture site.
. Describe the limitations and precautions of
alternate collection sites for venipuncture and capillary (dermal) puncture.
. Demonstrate understanding of requisitioning,
specimen transport, and specimen processing.
. Explain methods for transporting and
processing blood specimens for routine and special testing.
. Follow written and verbal instructions.

Introduction

Some laboratory tests require specimens collected in a manner that is differ­ent from routine venipuncture or dermal (capillary) puncture. This chapter describes tests that require specialized techniques, equipment, processes, or patient preparation for the collection of the required blood specimen. The pro­cedure for making peripheral blood smears, which is sometimes part of the phlebotomist’s duties, is also included.
Although routine blood collection is the procedure most commonly per­formed by phlebotomists, on occasion, special protocols must be followed depending on the reason for the collection or analyte (substance) to be tested. Special procedures that phlebotomists may perform include the following:
Collection of specimens for blood cultures
Collection of glucose tolerance specimens
Collection of specimens for neonatal blood screening
Preparation of blood smears
Special identification procedures for type and cross-match specimens
Collection of donor blood
Be sure to check your state scope of practice and facility policy before performing any special procedure. In some places, these procedures are per­formed by other healthcare personnel.
.

Blood Cultures

A blood culture is the testing of blood for the presence of septicemia (the pres­ence of pathogenic microorganisms in the blood). Septicemia usually causes a fever, so blood culture samples are frequently requested for patients who have a fever of unknown origin (FUO). The purpose of a blood culture test is to iso­late any microorganisms present in the patient’s blood specimen to determine which organism is causing the fever. Strict sterile technique and attention to detail are required for preparation of the blood culture collection site. In addi­tion, blood cultures must be obtained in tubes or bottles that contain culture media, which enhance microorganism growth. The evacuated tubes designed for blood cultures are the yellow-stoppered SPS (sodium polyanethol sulfo­nate) tubes. Blood culture bottles are usually larger and more cumbersome
Copyright © 2019 by McGraw-Hill Education
to handle than normal venipuncture tubes. However, blood culture bottles
Chapter  Special Phlebotomy Procedures 