Mix Flashcards
Procedure Manual
(b) The procedure manual must include the following when applicable to the test procedure:
(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in § 493.1242.
(2) Microscopic examination, including the detection of inadequately prepared slides.
(3) Step-by-step performance of the procedure, including test calculations and interpretation of results.
(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing.
(5) Calibration and calibration verification procedures.
(6) The reportable range for test results for the test system as established or verified in § 493.1253.
(7) Control procedures.
(8) Corrective action to take when calibration or control results fail to meet the laboratory’s criteria for acceptability.
(9) Limitations in the test methodology, including interfering substances.
(10) Reference intervals (normal values).
(11) Imminently life-threatening test results, or panic or alert values.
(12) Pertinent literature references.
(13) The laboratory’s system for entering results in the patient record and reporting patient results including, when appropriate, the protocol for reporting imminently life-threatening results, or panic, or alert values.
(14) Description of the course of action to take if a test system becomes inoperable.
Test Requisition
The laboratory must ensure the test requisition solicits the following information:
(1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values.
(2) The patient’s name or unique patient identifier.
(3) The sex and age or date of birth of the patient.
(4) The test(s) to be performed.
(5) The source of the specimen, when appropriate.
(6) The date and, if appropriate, time of specimen collection.
(7) For Pap smears, the patient’s last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy.
(8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable.
Specimen Collection and Handling
The laboratory must establish and follow written policies and procedures for each of the following, if applicable:
(1) Patient preparation.
(2) Specimen collection.
(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source.
(4) Specimen storage and preservation.
(5) Conditions for specimen transportation.
(6) Specimen processing.
(7) Specimen acceptability and rejection.
(8) Specimen referral.
Reagent Labels
Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following:
(1) Identity and when significant, titer, strength or concentration.
(2) Storage requirements.
(3) Preparation and expiration dates.
(4) Other pertinent information required for proper use.
Establishment of Performance Specifications
Establishment of performance specifications. Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable:
(i) Accuracy.
(ii) Precision.
(iii) Analytical sensitivity.
(iv) Analytical specificity to include interfering substances.
(v) Reportable range of test results for the test system.
(vi) Reference intervals (normal values).
(vii) Any other performance characteristic required for test performance.
Verification of performance specifications
Verification of performance specifications. Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results:
(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics:
(A) Accuracy.
(B) Precision.
(C) Reportable range of test results for the test system.
(ii) Verify that the manufacturer’s reference intervals (normal values) are appropriate for the laboratory’s patient population.
Calibration verification frequency
At least once every 6 months and whenever any of the following occur:
(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes.
(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance.
(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory’s acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem.
(iv) The laboratory’s established schedule for verifying the reportable range for patient test results requires more frequent calibration verification.
Required number and type of controls
At least once each day patient specimens are assayed or examined perform the following for—
(i) Each quantitative procedure, include two control materials of different concentrations;
(ii) Each qualitative procedure, include a negative and positive control material;
(iii) Test procedures producing graded or titered results, include a negative control material and a control material with graded or titered reactivity, respectively;
(iv) Each test system that has an extraction phase, include two control materials, including one that is capable of detecting errors in the extraction process; and
(v) Each molecular amplification procedure, include two control materials and, if reaction inhibition is a significant source of false negative results, a control material capable of detecting the inhibition.
Test Records Requirements
(a) The laboratory must maintain an information or record system that includes the following:
(1) The positive identification of the specimen.
(2) The date and time of specimen receipt into the laboratory.
(3) The condition and disposition of specimens that do not meet the laboratory’s criteria for specimen acceptability.
(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s).
(b) Records of patient testing including, if applicable, instrument printouts, must be retained.
Test Report Requirements
The test report must indicate the following:
(1) For positive patient identification, either the patient’s name and identification number, or a unique patient identifier and identification number.
(2) The name and address of the laboratory location where the test was performed.
(3) The test report date.
(4) The test performed.
(5) Specimen source, when appropriate.
(6) The test result and, if applicable, the units of measurement or interpretation, or both.
(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory’s criteria for acceptability.
When should controls be tested
once a day AND
before resuming patient testing when:
1) a complete change of reagents is introduced;
2) major preventive maintenance is performed
3) or any critical part that may influence test performance is replaced
7 Record Types that must be retained
test requisition/authorization
test procedures
analytical system records (QC, patient test records, analytical systems activities, test system performance specifications established or verified,
PT records
quality system assessment
test reports
slides, blocks, tissues
List elements of the pre-analytical phase
1)patient preparation,
2)specimen collection/labelling and accessioning
3) Specimen preservation/storage/transport
4) test requisitions
5) Relevance of test requests
6) specimen rejection criteria and actions initiated
7) confirmation of oral requests
8) Evaluation and verification of employee competence
9) Safety
10) Procedure updates and reviews
What is the DMAIC method?
Identifies and eliminates errors. Followed by six-sigma process. Five phases.
Define: identify high level processes for improvements
Measure: baseline data on current processes, pinpoint problems and areas of improvement
Analyze: root causes, validate root causes against captured data
Improve: implement improvements that address root causes
Control: perform before and after analysis, monitor systems, document results and determine next step recommendations
What are the differences between the 4 types of error?
-Systematic: influences values consistently in ONE DIRECTION (Examples 22S
-Random: exists in all measurements and is due to CHANCE (Example 13S)
-Active: occurs at the interface between a laboratories and patient samples
-Latent: related to the organization or design of a laboratory
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What are sources of variation?
Sample error
Random analytical error
Method/instrument bias (analytical systematic error)
operator error
sample variation within patient day to day
patient variation
What are analytical phase elements?
1) INstrument monitoring, validation, operation functions, inspections, preventative maintanece, operational parameters
2) Calibration and calibration verification
3) Quality control evaluations
4) Proficiency test results
5) Comparative analysis for multiple analyze methodologies/locations
6) Quality management of lab supplies, reagents and materials
What are elements of post-analytical phase?
1)Appropriateness and acceptability of test results
2) completeness of test reports
3) timely reporting of all test results including STAT
4) Accuracy and reliability of test reporting systems
5) Appropriate storage and retrieval of records of test results
6) Problems in communicating with physicians or other workers
7) complaint investigation and evaluation and corrective actions
8) Compliance with regulatory requirements
9) User satisfaction monitors (physician and patient)
10) Incidence reports
11) Review of QA reports with staff
List the fully loaded cost components and how each are calculated
Prime Costs = Direct Labor + Direct Materials
Conversion Costs = Direct Labor + Section Overhead
Full Production Costs = Direct Labor + Direct Materials + Section Overhead
Ready to Serve Costs = Section Overhead + Collection & Reporting + General Laboratory Overhead
Fully Loaded Costs = Prime Costs + Ready to Serve Costs
What are the 7 criteria used by FDA to determine test complexity and categorize tests?
1) scientific/technical knowledge
2) training and experience required
3) reagents/materials preparation, stability, reliability
4) operational steps
5) calibration, QC, proficiency testing materials availability
6) test system troubleshooting and equipment maintenance
7) interpretation and judgment required to perform all 3 phases of testing
what are examples of PPM procedures?
wet mount preparations for presence or absence of bacteria, fungi, parasites, human cellular elements
KOH preparations
pinworm examinations
fern tests
post coital, direct exams of vaignal or cervical mucous
urine sediment exams
nasal smears for granulocyts
fecal leukocyte
qualitative semen analysis
What are the facility administration requirements for non waived testing from CLIA?
Facility: construction/arrangement/maintenance must ensure space, ventilation, utilities, minimizes contamination, unidirectional workflow
appropriate and sufficient equipment, instruments reagents, materials and supplies for volume of testing
comply with applicable federal, state and local requirements
safety precautions must be established, posted and observed
List major components of the quality systems required for non-waived testing
Confidentiality of patient information and specimen identification and integrity
complaint investigations
communications
personnel competency
Proficiency testing
General Lab systems assessment - monitor and correct problems and effectiveness
test requisition
specimen submission / handling
procedure manual
test systems, equipment, instrumentation, reagents, materials and supplies
Method performance specifications
Equipment maintenance and function checks
calibration and calibration verifications
Control procedures
Comparison of test reults
corrective actions
test records
test results
systems assessment
What are the moderate complexity technical consultant responsibilties?
Accessible to lab for onsite, electronic consultation as needed
S election of test methodology appropriate for clinical use of the test results
Verification of test procedures, establishment of test performance characteristics including preciesion and accuracy
enrollment participation in PT pgrogram
Establish QC program appropriate for testing performed, parameters for acceptable levels of analytic performance, levels are maintained
Resolving technical problems and esnuring remedial actions are taken
test results not reported until corrective actiosn have been taken and system is functioing
Identifying training needs and assuring each indivudal perforing tests recieved regular in service training, education
Evaluating competency of all testing personnel and assuring its maintained
Evaluating performance/competency at least semiannually during 1st year and then annually afterwards
