Subpart I--Proficiency Testing Programs for Tests of Moderate Complexity
(Including the Subcategory), High Complexity, or Any Combination of
These Tests
Source: 57 FR 7151, Feb. 28, 1992, unless otherwise noted.
Sec. 493.901 Approval of proficiency testing programs.
In order for a proficiency testing program to receive HHS approval,
the program must be offered by a private nonprofit organization or a
Federal or State agency, or entity acting as a designated agent for the
State. An organization, Federal, or State program seeking approval or
reapproval for its program for the next calendar year must submit an
application providing the required information by July 1 of the current
year. The organization, Federal, or State program must provide technical
assistance to laboratories seeking to qualify under the program, and
must, for each specialty, subspecialty, and analyte or test for which it
provides testing--
(a) Assure the quality of test samples, appropriately evaluate and
score the testing results, and identify performance problems in a timely
manner;
(b) Demonstrate to HHS that it has--
(1) The technical ability required to--
(i) Prepare or purchase samples from manufacturers who prepare the
samples in conformance with the appropriate good manufacturing practices
required in 21 CFR parts 606, 640, and 820; and
(ii) Distribute the samples, using rigorous quality control to
assure that samples mimic actual patient specimens when possible and
that samples are homogeneous, except for specific subspecialties such as
cytology, and will be stable within the time frame for analysis by
proficiency testing participants;
(2) A scientifically defensible process for determining the correct
result for each challenge offered by the program;
[[Page 923]]
(3) A program of sufficient annual challenge and with the frequency
specified in Secs. 493.909 through 493.959 to establish that a
laboratory has met minimum performance requirements;
(4) The resources needed to provide Statewide or nationwide reports
to regulatory agencies on individual's performance for gynecologic
cytology and on individual laboratory performance on testing events,
cumulative reports and scores for each laboratory or individual, and
reports of specific laboratory failures using grading criteria
acceptable to HHS. These reports must be provided to HHS on a timely
basis when requested;
(5) Provisions to include on each proficiency testing program report
form used by the laboratory to record testing event results, an
attestation statement that proficiency testing samples were tested in
the same manner as patient specimens with a signature block to be
completed by the individual performing the test as well as by the
laboratory director;
(6) A mechanism for notifying participants of the PT shipping
schedule and for participants to notify the proficiency testing program
within three days of the expected date of receipt of the shipment that
samples have not arrived or are unacceptable for testing. The program
must have provisions for replacement of samples that are lost in transit
or are received in a condition that is unacceptable for testing; and
(7) A process to resolve technical, administrative, and scientific
problems about program operations;
(c) Meet the specific criteria for proficiency testing programs
listed by specialty, subspecialty, and analyte or test contained in
Secs. 493.901 through 493.959 for initial approval and thereafter
provide HHS, on an annual basis, with the information necessary to
assure that the proficiency testing program meets the criteria required
for approval; and
(d) Comply with all applicable packaging, shipment, and notification
requirements of 42 CFR part 72.
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]
Sec. 493.903 Administrative responsibilities.
The proficiency testing program must--
(a)(1) Provide HHS or its designees and participating laboratories
with an electronic or a hard copy, or both, of reports of proficiency
testing results and all scores for each laboratory's performance in a
format as required by and approved by CMS for each CLIA-certified
specialty, subspecialty, and analyte or test within 60 days after the
date by which the laboratory must report proficiency testing results to
the proficiency testing program.
(2) Provide HHS with reports of PT results and scores of individual
performance in cytology and provide copies of reports to participating
individuals, and to all laboratories that employ the individuals, within
15 working days of the testing event;
(b) Furnish to HHS cumulative reports on an individual laboratory's
performance and aggregate data on CLIA-certified laboratories for the
purpose of establishing a system to make the proficiency testing
program's results available, on a reasonable basis, upon request of any
person, and include such explanatory information as may be appropriate
to assist in the interpretation of the proficiency testing program's
results;
(c) Provide HHS with additional information and data upon request
and submit such information necessary for HHS to conduct an annual
evaluation to determine whether the proficiency testing program
continues to meet the requirements of Secs. 493.901 through 493.959;
(d) Maintain records of laboratories' performance for a period of
five years or such time as may be necessary for any legal proceedings;
and
(e) Provide HHS with an annual report and, if needed, an interim
report which identifies any previously unrecognized sources of
variability in kits, instruments, methods, or PT samples, which
adversely affect the programs' ability to evaluate laboratory
performance.
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]
[[Page 924]]
Sec. 493.905 Nonapproved proficiency testing programs.
If a proficiency testing program is determined by HHS to fail to
meet any criteria contained in Secs. 493.901 through 493.959 for
approval of the proficiency testing program, CMS will notify the
program and the program must notify all laboratories enrolled of the
nonapproval and the reasons for nonapproval within 30 days of the
notification.
Proficiency Testing Programs by Specialty and Subspecialty
Sec. 493.909 Microbiology.
The subspecialties under the specialty of microbiology for which a
program may offer proficiency testing are bacteriology,
mycobacteriology, mycology, parasitology and virology. Specific criteria
for these subspecialties are found at Secs. 493.911 through 493.919.
Sec. 493.911 Bacteriology.
(a) Types of services offered by laboratories. In bacteriology, for
proficiency testing purposes, there are five types of laboratories:
(1) Those that interpret Gram stains or perform primary inoculation,
or both; and refer cultures to another laboratory appropriately
certified for the subspecialty of bacteriology for identification;
(2) Those that use direct antigen techniques to detect an organism
and may also interpret Gram stains or perform primary inoculation, or
perform any combination of these;
(3) Those that, in addition to interpreting Gram stains, performing
primary inoculations, and using direct antigen tests, also isolate and
identify aerobic bacteria from throat, urine, cervical, or urethral
discharge specimens to the genus level and may also perform
antimicrobial susceptibility tests on selected isolated microorganisms;
(4) Those that perform the services in paragraph (a)(3) of this
section and also isolate and identify aerobic bacteria from any source
to the species level and may also perform antimicrobial susceptibility
tests; and
(5) Those that perform the services in paragraph (a)(4) of this
section and also isolate and identify anaerobic bacteria from any
source.
(b) Program content and frequency of challenge. To be approved for
proficiency testing for bacteriology, the annual program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The samples
may be provided to the laboratory through mailed shipments or, at HHS'
option, may be provided to HHS or its designee for on-site testing. For
the types of laboratories specified in paragraph (a) of this section, an
annual program must include samples that contain organisms that are
representative of the six major groups of bacteria: anaerobes,
Enterobacteriaceae, gram-positive bacilli, gram-positive cocci, gram-
negative cocci, and miscellaneous gram-negative bacteria, as
appropriate. The specific organisms included in the samples may vary
from year to year. The annual program must include samples for bacterial
antigen detection, bacterial isolation and identification, Gram stain,
and antimicrobial susceptibility testing.
(1) An approved program must furnish HHS with a description of
samples that it plans to include in its annual program no later than six
months before each calendar year. At least 50 percent of the samples
must be mixtures of the principal organism and appropriate normal flora.
The program must include other important emerging pathogens (as
determined by HHS) and either organisms commonly occurring in patient
specimens or opportunistic pathogens. The program must include the
following two types of samples; each type of sample must meet the 50
percent mixed culture criterion:
(i) Samples that require laboratories to report only organisms that
the testing laboratory considers to be a principal pathogen that is
clearly responsible for a described illness (excluding immuno-
compromised patients). The program determines the reportable isolates,
including antimicrobial susceptibility for any designated isolate; and
(ii) Samples that require laboratories to report all organisms
present. Samples must contain multiple organisms frequently found in
specimens such as
[[Page 925]]
urine, blood, abscesses, and aspirates where multiple isolates are
clearly significant or where specimens are derived from immuno-
compromised patients. The program determines the reportable isolates.
(2) An approved program may vary over time. For example, the types
of organisms that might be included in an approved program over time
are--
Anaerobes:
Bacteroides fragilis group
Clostridium perfringens
Peptostreptococcus anaerobius
Enterobacteriaceae
Citrobacter freundii
Enterobacter aerogenes
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Salmonella typhimurium
Serratia marcescens
Shigella sonnei
Yersinia enterocolitica
Gram-positive bacilli:
Listeria monocytogenes
Corynebacterium species CDC Group JK
Gram-positive cocci:
Staphylococcus aureus
Streptococcus Group A
Streptococcus Group B
Streptococcus Group D (S. bovis and enterococcus)
Streptococcus pneumoniae
Gram-negative cocci:
Branhamella catarrhalis
Neisseria gonorrhoeae
Neisseria meningitidis
Miscellaneous Gram-negative bacteria:
Campylobacter jejuni
Haemophilis influenza, Type B
Pseudomonas aeruginosa
(3) For antimicrobial susceptibility testing, the program must
provide at least one sample per testing event that includes gram-
positive or gram-negative strains that have a predetermined pattern of
sensitivity or resistance to the common antimicrobial agents.
(c) Evaluation of a laboratory's performance. HHS approves only
those programs that assess the accuracy of a laboratory's responses in
accordance with paragraphs (c) (1) through (7) of this section.
(1) The program determines staining characteristics to be
interpreted by Gram stain. The program determines the reportable
bacteria to be detected by direct antigen techniques or isolation. To
determine the accuracy of a laboratory's response for Gram stain
interpretation, direct antigen detection, identification, or
antimicrobial susceptibility testing, the program must compare the
laboratory's response for each sample with the response which reflects
agreement of either 80 percent of ten or more referee laboratories or 80
percent or more of all participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must isolate and identify
the organisms to the same extent it performs these procedures on patient
specimens. A laboratory's performance will be evaluated on the basis of
its final answer, for example, a laboratory specified in paragraph
(a)(3) of this section will be evaluated on the basis of the average of
its scores for paragraphs (c)(3) through (c)(6) as determined in
paragraph (c)(7) of this section.
(3) Since laboratories may incorrectly report the presence of
organisms in addition to the correctly identified principal organism(s),
the grading system must provide a means of deducting credit for
additional erroneous organisms that are reported. Therefore, the total
number of correct responses for organism isolation and identification
submitted by the laboratory divided by the number of organisms present
plus the number of incorrect organisms reported by the laboratory must
be multiplied by 100 to establish a score for each sample in each
testing event. For example, if a sample contained one principal organism
and the laboratory reported it correctly but reported the presence of an
additional organism, which was not considered reportable, the sample
grade would be 1/(1+1) x 100=50 percent.
(4) For antimicrobial susceptibility testing, a laboratory must
indicate which drugs are routinely included in its test panel when
testing patient samples. A laboratory's performance will be evaluated
for only those antibiotics for which service is offered. A correct
response for each antibiotic will be determined as described in
Secs. 493.911(c) (1) using criteria such as
[[Page 926]]
the guidelines established by the National Committee for Clinical
Laboratory Standards. Grading is based on the number of correct
susceptibility responses reported by the laboratory divided by the
actual number of correct susceptibility responses determined by the
program, multiplied by 100. For example, if a laboratory offers
susceptibility testing for Enterobacteriaceae using amikacin,
cephalothin, and tobramycin, and the organism in the proficiency testing
sample is an Enterobacteriaceae, and the laboratory reports correct
responses for two of three antimicrobial agents, the laboratory's grade
would be 2/3 x 100=67 percent.
(5) The performance criterion for qualitative antigen tests is the
presence or absence of the bacterial antigen. The score for antigen
tests is the number of correct responses divided by the number of
samples to be tested for the antigen, multiplied by 100.
(6) The performance criteria for Gram stain is staining reaction,
i.e., gram positive or gram negative. The score for Gram stain is the
number of correct responses divided by the number of challenges to be
tested, multiplied by 100.
(7) The score for a testing event in bacteriology is the average of
the scores determined under paragraphs (c)(3) through (c)(6) of this
section kbased on the type of service offered by the laboratory.
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]
Sec. 493.913 Mycobacteriology.
(a) Types of services offered by laboratories. In mycobacteriology,
there are five types of laboratories for proficiency testing purposes:
(1) Those that interpret acid-fast stains and refer specimen to
another laboratory appropriately certified in the subspecialty of
mycobacteriology;
(2) Those that interpret acid-fast stains, perform primary
inoculation, and refer cultures to another laboratory appropriately
certified in the subspecialty of mycobacteriology for identification;
(3) Those that interpret acid-fast stains, isolate and perform
identification and/or antimycobacterial susceptibility of Mycobacterium
tuberculosis, but refer other mycobacteria species to another laboratory
appropriately certified in the subspecialty of mycobacteriology for
identification and/or susceptibility tests;
(4) Those that interpret acid-fast stains, isolate and identify all
mycobacteria to the extent required for correct clinical diagnosis, but
refer antimycobacterial susceptibility tests to another laboratory
appropriately certified in the subspecialty of mycobacteriology; and
(5) Those that interpret acid-fast stains, isolate and identify all
mycobacteria to the extent required for correct clinical diagnosis, and
perform antimycobacterial susceptibility tests on the organisms
isolated.
(b) Program content and frequency of challenge. To be approved for
proficiency testing for mycobacteriology, the annual program must
provide a minimum of five samples per testing event. There must be at
least two testing events per year. The samples may be provided through
mailed shipments or, at HHS' option, provided to HHS or its designee for
on-site testing events. For types of laboratories specified in
paragraphs (a)(1) and (a) (3) through (5) of this section, an annual
program must include samples that contain species that are
representative of the 5 major groups (complexes) of mycobacteria
encountered in human specimens. The specific mycobacteria included in
the samples may vary from year to year.
(1) An approved program must furnish HHS and its agents with a
description of samples that it plans to include in its annual program no
later than six months before each calendar year. At least 50 percent of
the samples must be mixtures of the principal mycobacteria and
appropriate normal flora. The program must include mycobacteria commonly
occurring in patient specimens and other important emerging mycobacteria
(as determined by HHS). The program determines the reportable isolates
and correct responses for antimycobacterial susceptibility for any
designated isolate.
(2) An approved program may vary over time. For example, the types
of
[[Page 927]]
mycobacteria that might be included in an approved program over time
are--
TB
Mycobacterium tuberculosis
Mycobacterium bovis
Group I
Mycobacterium kansasii
Group II
Mycobacterium szulgai
Group III
Mycobacterium avium-intracellulare
Mycobacterium terrae
Group IV
Mycobacterium fortuitum
(3) For antimycobacterial susceptibility testing, the program must
provide at least one sample per testing event that includes
mycobacterium tuberculosis that has a predetermined pattern of
sensitivity or resistance to the common antimycobacterial agents.
(4) For laboratories specified in paragraphs (a)(1) and (a)(2), the
program must provide at least five samples per testing event that
includes challenges that are acid-fast and challenges which do not
contain acid-fast organisms.
(c) Evaluation of a laboratory's performance. HHS approves only
those programs that assess the accuracy of a laboratory's response in
accordance with paragraphs (c)(1) through (6) of this section.
(1) The program determines the reportable mycobacteria to be
detected by acid-fast stain, for isolation and identification, and for
antimycobacterial susceptibility. To determine the accuracy of a
laboratory's response, the program must compare the laboratory's
response for each sample with the response that reflects agreement of
either 80 percent of ten or more referee laboratories or 80 percent or
more of all participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must interpret acid-fast
stains and isolate and identify the organisms to the same extent it
performs these procedures on patient specimens. A laboratory's
performance will be evaluated on the basis of the average of its scores
as determined in paragraph (c)(6) of this section.
(3) Since laboratories may incorrectly report the presence of
organisms in addition to the correctly identified principal organism(s),
the grading system must provide a means of deducting credit for
additional erroneous organisms reported. Therefore, the total number of
correct responses submitted by the laboratory divided by the number of
organisms present plus the number of incorrect organisms reported by the
laboratory must be multiplied by 100 to establish a score for each
sample in each testing event. For example, if a sample contained one
principal organism and the laboratory reported it correctly but reported
the presence of an additional organism, which was not present, the
sample grade would be
1/(1+1) x 100=50 percent
(4) For antimycobacterial susceptibility testing, a laboratory must
indicate which drugs are routinely included in its test panel when
testing patient samples. A laboratory's performance will be evaluated
for only those antibiotics for which susceptibility testing is routinely
performed on patient specimens. A correct response for each antibiotic
will be determined as described in Sec. 493.913(c)(1). Grading is based
on the number of correct susceptibility responses reported by the
laboratory divided by the actual number of correct susceptibility
responses as determined by the program, multiplied by 100. For example,
if a laboratory offers susceptibility testing using three
antimycobacterial agents and the laboratory reports correct response for
two of the three antimycobacterial agents, the laboratory's grade would
be \2/3\ x 100=67 percent.
(5) The performance criterion for qualitative tests is the presence
or absence of acid-fast organisms. The score for acid-fast organism
detection is the number of correct responses divided by the number of
samples to be tested, multiplied by 100.
(6) The score for a testing event in mycobacteriology is the average
of the scores determined under paragraphs (c)(3) through (c)(5) of this
section
[[Page 928]]
based on the type of service offered by the laboratory.
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]
Sec. 493.915 Mycology.
(a) Types of services offered by laboratories. In mycology, there
are four types of laboratories for proficiency testing purposes that may
perform different levels of service for yeasts, dimorphic fungi,
dermatophytes, and aerobic actinomycetes:
(1) Those that isolate and identify only yeasts and/or dermatophytes
to the genus level;
(2) Those that isolate and identify yeasts and/or dermatophytes to
the species level;
(3) Those that isolate and perform identification of all organisms
to the genus level; and
(4) Those that isolate and perform identification of all organisms
to the species level.
(b) Program content and frequency of challenge. To be approved for
proficiency testing for mycology, the annual program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The samples
may be provided through mailed shipments or, at HHS' option, may be
provided to HHS or its designee for on-site testing. An annual program
must include samples that contain organisms that are representative of
five major groups of fungi: Yeast or yeast-like fungi; dimorphic fungi;
dematiaceous fungi; dermatophytes; and saprophytes, including
opportunistic fungi. The specific fungi included in the samples may vary
from year to year.
(1) An approved program must, before each calendar year, furnish HHS
with a description of samples that it plans to include in its annual
program no later than six months before each calendar year. At least 50
percent of the samples must be mixtures of the principal organism and
appropriate normal background flora. Other important emerging pathogens
(as determined by HHS) and organisms commonly occurring in patient
specimens must be included periodically in the program.
(2) An approved program may vary over time. As an example, the types
of organisms that might be included in an approved program over time
are--
Candida albicans
Candida (other species)
Cryptococcus neoformans
Sporothrix schenckii
Exophiala jeanselmei
Fonsecaea pedrosoi
Microsporum sp.
Acremonium sp.
Trichophvton sp.
Aspergillus fumigatus
Nocardia sp.
Blastomyces dermatitidis \1\
Zygomycetes sp.
Note: \1\ Provided as a nonviable sample.
(c) Evaluation of a laboratory's performance. HHS approves only
those programs that assess the accuracy of a laboratory's response, in
accordance with paragraphs (c)(1) through (5) of this section.
(1) The program determines the reportable organisms. To determine
the accuracy of a laboratory's response, the program must compare the
laboratory's response for each sample with the response that reflects
agreement of either 80 percent of ten or more referee laboratories or 80
percent or more of all participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must isolate and identify
the organisms to the same extent it performs these procedures on patient
specimens.
(3) Since laboratories may incorrectly report the presence of
organisms in addition to the correctly identified principal organism(s),
the grading system must deduct credit for additional erroneous organisms
reported. Therefore, the total number of correct responses submitted by
the laboratory divided by the number of organisms present plus the
number of incorrect organisms reported by the laboratory must be
multiplied by 100 to establish a score for each sample in each shipment
or testing event. For example, if a sample contained one principal
organism and the laboratory reported it correctly but reported the
presence of an additional organism, which was not
[[Page 929]]
present, the sample grade would be 1/(1+1)x100=50 percent.
(4) The score for the antigen tests is the number of correct
responses divided by the number of samples to be tested for the antigen,
multiplied by 100.
(5) The score for a testing event is the average of the sample
scores as determined under paragraph (c)(3) or (c)(4), or both, of this
section.
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]
Sec. 493.917 Parasitology.
(a) Types of services offered by laboratories. In parasitology there
are two types of laboratories for proficiency testing purposes--
(1) Those that determine the presence or absence of parasites by
direct observation (wet mount) and/or pinworm preparations and, if
necessary, refer specimens to another laboratory appropriately certified
in the subspecialty of parasitology for identification;
(2) Those that identify parasites using concentration preparations
and/or permanent stains.
(b) Program content and frequency of challenge. To be approved for
proficiency testing in parasitology, a program must provide a minimum of
five samples per testing event. There must be at least three testing
events at approximately equal intervals per year. The samples may be
provided through mailed shipments or, at HHS's option, may be provided
to HHS or its designee for on-site testing. An annual program must
include samples that contain parasites that are commonly encountered in
the United States as well as those recently introduced into the United
States. Other important emerging pathogens (as determined by HHS) and
parasites commonly occurring in patient specimens must be included
periodically in the program.
(1) An approved program must, before each calendar year furnish HHS
with a description of samples that it plans to include in its annual
program no later than six months before each calendar year. Samples must
include both formalinized specimens and PVA (polyvinyl alcohol) fixed
specimens as well as blood smears, as appropriate for a particular
parasite and stage of the parasite. The majority of samples must contain
protozoa or helminths or a combination of parasites. Some samples must
be devoid of parasites.
(2) An approved program may vary over time. As an example, the types
of parasites that might be included in an approved program over time
are--
Enterobius vermicularis
Entamoeba histolytica
Entamoeba coli
Giardia lamblia
Endolimax nana
Dientamoeba fragilis
Iodamoeba butschli
Chilomastix mesnili
Hookworm
Ascaris lumbricoides
Strongyloides stercoralis
Trichuris trichiura
Diphyllobothrium latum
Cryptosporidium sp.
Plasmodium falciparum
(3) For laboratories specified in paragraph (a)(1) of this section,
the program must provide at least five samples per testing event that
include challenges which contain parasites and challenges that are
devoid of parasites.
(c) Evaluation of a laboratory's performance. HHS approves only
those programs that assess the accuracy of a laboratory's responses in
accordance with paragraphs (c)(1) through (6) of this section.
(1) The program must determine the reportable parasites. It may
elect to establish a minimum number of parasites to be identified in
samples before they are reported. Parasites found in rare numbers by
referee laboratories are not considered in scoring a laboratory's
performance; such findings are neutral. To determine the accuracy of a
laboratory's response, the program must compare the laboratory's
response with the response that reflects agreement of either 80 percent
of ten or more referee laboratories or 80 percent or more of all
participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must determine the presence
or absence of a parasite(s) or concentrate and identify the parasites to
the same extent it performs these procedures on patient specimens.
[[Page 930]]
(3) Since laboratories may incorrectly report the presence of
parasites in addition to the correctly identified principal parasite(s),
the grading system must deduct credit for these additional erroneous
parasites reported and not found in rare numbers by the program's
referencing process. Therefore, the total number of correct responses
submitted by the laboratory divided by the number of parasites present
plus the number of incorrect parasites reported by the laboratory must
be multiplied by 100 to establish a score for each sample in each
testing event. For example, if a sample contained one principal parasite
and the laboratory reported it correctly but reported the presence of an
additional parasite, which was not present, the sample grade would be
1/(1+1) x 100=50 percent.
(4) The criterion for acceptable performance for qualitative
parasitology examinations is presence or absence of a parasite(s).
(5) The score for parasitology is the number of correct responses
divided by the number of samples to be tested, multiplied by 100.
(6) The score for a testing event is the average of the sample
scores as determined under paragraphs (c)(3) through (c)(5) of this
section.
Sec. 493.919 Virology.
(a) Types of services offered by laboratories. In virology, there
are two types of laboratories for proficiency testing purposes--
(1) Those that only perform tests that directly detect viral
antigens or structures, either in cells derived from infected tissues or
free in fluid specimens; and
(2) Those that are able to isolate and identify viruses and use
direct antigen techniques.
(b) Program content and frequency of challenge. To be approved for
proficiency testing in virology, a program must provide a minimum of
five samples per testing event. There must be at least three testing
events at approximately equal intervals per year. The samples may be
provided to the laboratory through mailed shipments or, at HHS's option,
may be provided to HHS or its designee for on-site testing. An annual
program must include viral species that are the more commonly identified
viruses. The specific organisms found in the samples may vary from year
to year. The annual program must include samples for viral antigen
detection and viral isolation and identification.
(1) An approved program must furnish HHS with a description of
samples that it plans to include in its annual program no later than six
months before each calendar year. The program must include other
important emerging viruses (as determined by HHS) and viruses commonly
occurring in patient specimens.
(2) An approved program may vary over time. For example, the types
of viruses that might be included in an approved program over time are
the more commonly identified viruses such as Herpes simplex, respiratory
syncytial virus, adenoviruses, enteroviruses, and cytomegaloviruses.
(c) Evaluation of laboratory's performance. HHS approves only those
programs that assess the accuracy of a laboratory's response in
accordance with paragraphs (c)(1) through (5) of this section.
(1) The program determines the reportable viruses to be detected by
direct antigen techniques or isolated by laboratories that perform viral
isolation procedures. To determine the accuracy of a laboratory's
response, the program must compare the laboratory's response for each
sample with the response that reflects agreement of either 80 percent of
ten or more referee laboratories or 80 percent or more of all
participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must isolate and identify
the viruses to the same extent it performs these procedures on patient
specimens.
(3) Since laboratories may incorrectly report the presence of
viruses in addition to the correctly identified principal virus, the
grading system must provide a means of deducting credit for additional
erroneous viruses reported. Therefore, the total number of correct
responses determined by
[[Page 931]]
virus culture techniques submitted by the laboratory divided by the
number of viruses present plus the number of incorrect viruses reported
by the laboratory must be multiplied by 100 to establish a score for
each sample in each testing event. For example, if a sample contained
one principal virus and the laboratory reported it correctly but
reported the presence of an additional virus, which was not present, the
sample grade would be 1/(1+1) x 100=50 percent.
(4) The performance criterion for qualitative antigen tests is
presence or absence of the viral antigen. The score for the antigen
tests is the number of correct responses divided by the number of
samples to be tested for the antigen, multiplied by 100.
(5) The score for a testing event is the average of the sample
scores as determined under paragraph (c)(3) and (c)(4) of this section.
Sec. 493.921 Diagnostic immunology.
The subspecialties under the specialty of immunology for which a
program may offer proficiency testing are syphilis serology and general
immunology. Specific criteria for these subspecialties are found at
Secs. 493.923 and 493.927.
Sec. 493.923 Syphilis serology.
(a) Program content and frequency of challenge. To be approved for
proficiency testing in syphilis serology, a program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The samples
may be provided through mailed shipments or, at HHS' option, may be
provided to HHS or its designee for on-site testing. An annual program
must include samples that cover the full range of reactivity from highly
reactive to non-reactive.
(b) Evaluation of test performance. HHS approves only those programs
that assess the accuracy of a laboratory's responses in accordance with
paragraphs (b)(1) through (4) of this section.
(1) To determine the accuracy of a laboratory's response for
qualitative and quantitative syphilis tests, the program must compare
the laboratory's response with the response that reflects agreement of
either 80 percent of ten or more referee laboratories or 80 percent or
more of all participating laboratories. The proficiency testing program
must indicate the minimum concentration, by method, that will be
considered as indicating a positive response. The score for a sample in
syphilis serology is the average of scores determined under paragraphs
(b)(2) and (b)(3) of this section.
(2) For quantitative syphilis tests, the program must determine the
correct response for each method by the distance of the response from
the target value. After the target value has been established for each
response, the appropriateness of the response must be determined by
using fixed criteria. The criterion for acceptable performance for
quantitative syphilis serology tests is the target value ± 1 dilution.
(3) The criterion for acceptable performance for qualitative
syphilis serology tests is reactive or nonreactive.
(4) To determine the overall testing event score, the number of
correct responses must be averaged using the following formula:
Number of acceptable
responses for the analyte
------------------------------- x 100=Analyte score for the testing event
Total number of all challenges
for the analyte
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
Sec. 493.927 General immunology.
(a) Program content and frequency of challenge. To be approved for
proficiency testing for immunology, the annual program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The annual
program must provide samples that cover the full range of reactivity
from highly reactive to nonreactive. The samples may be provided through
mailed shipments or, at HHS' option, may be provided to HHS or its
designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per
[[Page 932]]
testing event the program must provide for each analyte or test
procedure is five. Analytes or tests for which laboratory performance is
to be evaluated include:
Analyte or Test Procedure
Alpha-l antitrypsin
Alpha-fetoprotein (tumor marker)
Antinuclear antibody
Antistreptolysin O
Anti-human immunodeficiency virus (HIV)
Complement C3
Complement C4
Hepatitis markers (HBsAg, anti-HBc, HBeAg)
IgA
IgG
IgE
IgM
Infectious mononucleosis
Rheumatoid factor
Rubella
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c)(1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's response for
quantitative and qualitative immunology tests or analytes, the program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 80 percent of ten or more
referee laboratories or 80 percent or more of all participating
laboratories. The proficiency testing program must indicate the minimum
concentration that will be considered as indicating a positive response.
The score for a sample in general immunology is either the score
determined under paragraph (c)(2) or (3) of this section.
(2) For quantitative immunology analytes or tests, the program must
determine the correct response for each analyte by the distance of the
response from the target value. After the target value has been
established for each response, the appropriateness of the response must
be determined by using either fixed criteria or the number of standard
deviations (SDs) the response differs from the target value.
Criteria for Acceptable Performance
----------------------------------------------------------------------------
Criteria for acceptable Analyte or test performance are-
----------------------------------------------------------------------------
| Alpha-1 antitrypsin |
Target value ±3
SD |
| Alpha-fetoprotein (tumor
marker) |
Target value ±3
SD |
| Antinuclear antibody |
Target value ±2 dilutions
or positive or negative |
| Antistreptolysin O |
Target value ±2 dilution
or positive or negative |
| Anti-Human Immunodeficiency
virus |
Reactive or nonreactive |
| Complement C3 |
Target value ±3
SD |
| Complement C4 |
Target value ±3
SD |
| Hepatitis (HBsAg, anti-HBc,
HBeAg) |
Reactive (positive) or
nonreactive (negative) |
| IgA |
Target value ±3
SD |
| IgE |
Target value ±3
SD |
| IgG |
Target value ±25% |
| IgM |
Target value ±3
SD |
| Infectious mononucleosis |
Target value ±2 dilutions
or positive or negative |
| Rheumatoid factor |
Target value ±2 dilutions
or positive or negative |
| Rubella |
Target value ±2 dilutions
or immune or
nonimmune
or positive or negative |
------------------------------------------------------------------------
(3) The criterion for acceptable performance for qualitative general
immunology tests is positive or negative.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
Number of acceptable
responses for the analyte
------------------------------- x 100=Analyte score for the testing event
Total number of all challenges
for the analyte
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
Number of acceptable
responses for the analyte
------------------------------- x 100=Analyte score for the testing event
Total number of all challenges
for the analyte
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
[[Page 933]]
Sec. 493.929 Chemistry.
The subspecialties under the specialty of chemistry for which a
proficiency testing program may offer proficiency testing are routine
chemistry, endocrinology, and toxicology. Specific criteria for these
subspecialties are listed in Secs. 493.931 through 493.939.
Sec. 493.931 Routine chemistry.
(a) Program content and frequency of challenge. To be approved for
proficiency testing for routine chemistry, a program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The annual
program must provide samples that cover the clinically relevant range of
values that would be expected in patient specimens. The specimens may be
provided through mailed shipments or, at HHS' option, may be provided to
HHS or its designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure listed below is five serum, plasma or blood samples.
Analyte or Test Procedure
Alanine aminotransferase (ALT/SGPT)
Albumin
Alkaline phosphatase
Amylase
Aspartate aminotransferase (AST/SGOT)
Bilirubin, total
Blood gas (pH, pO2, and pCO2)
Calcium, total
Chloride
Cholesterol, total
Cholesterol, high density lipoprotein
Creatine kinase
Creatine kinase, isoenzymes
Creatinine
Glucose (Excluding measurements on devices cleared by FDA for home use)
Iron, total
Lactate dehydrogenase (LDH)
LDH isoenzymes
Magnesium
Potassium
Sodium
Total Protein
Triglycerides
Urea Nitrogen
Uric Acid
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c)(1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's response for
qualitative and quantitative chemistry tests or analytes, the program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 80 percent of ten or more
referee laboratories or 80 percent or more of all participating
laboratories. The score for a sample in routine chemistry is either the
score determined under paragraph (c)(2) or (3) of this section.
(2) For quantitative chemistry tests or analytes, the program must
determine the correct response for each analyte by the distance of the
response from the target value. After the target value has been
established for each response, the appropriateness of the response must
be determined by using either fixed criteria based on the percentage
difference from the target value or the number of standard deviations
(SDs) the response differs from the target value.
Criteria for Acceptable Performance
------------------------------------------------------------------------------
Criteria for acceptable Analyte or test performance are-
------------------------------------------------------------------------------
| Alanine aminotransferase (ALT/SGPT) |
Target value ±
20% |
| Albumin |
Target value ±
10% |
| Alkaline phosphatase |
Target value ±
30% |
| Amylase |
Target value ±
30% |
| Aspartate aminotransferase (AST/SGOT) |
Target value ±
20% |
| Bilirubin, total |
Target value ±
0.4 mg/dL or ±20%
(greater) |
| Blood gas pO2 |
Target value ±3
SD |
| pCO2 |
Target value ±5
mm Hg or ±8% (greater) |
| pH |
Target value ± .04 |
| Calcium, total |
Target value ±
1.0 mg/dL |
| Chloride |
Target value ±
5% |
| Cholesterol, total |
Target value ±
10% |
| Cholesterol, high density
lipoprotein |
Target value ±
30% |
| Creatine kinase |
Target value ±
30% |
| Creatine kinase isoenzymes |
Creatine kinase isoenzymes |
| Creatinine |
Target value ± 0.3
mg/dL or ± 15%
(greater)
|
[[Page 934]]
Glucose (excluding glucose performed on Target value ±6 monitoring
evices cleared by FDA for mg/dl or ±10% home use. (greater).
| Iron, total |
Target value ±
20% |
| Lactate dehydrogenase (LDH) |
Target value ±
20% |
| LDH isoenzymes |
LDH1/LDH2 (+ or -) or Target
value ± 30% |
| Magnesium |
Target value ±
25% |
| Potassium |
Target value ± 0.5 mmol/L |
| Sodium |
Target value ±4 mmol/L |
| Total Protein |
Target value ±
10% |
| Triglycerides |
Target value ±
25% |
| Urea nitrogen |
Target value ±2 mg/dL or ±9%
(greater) |
| Uric acid |
Target value ±
17% |
(3) The criterion for acceptable performance for qualitative routine
chemistry tests is positive or negative.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
Number of acceptable
responses for the analyte
------------------------------- x 100=Analyte score for the testing event
Total number of all challenges
for the analyte
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
Number of acceptable
responses for the analyte
------------------------------- x 100=Analyte score for the testing event
Total number of all challenges
for the analyte
Sec. 493.933 Endocrinology.
(a) Program content and frequency of challenge. To be approved for
proficiency testing for endocrinology, a program must provide a minimum
of five samples per testing event. There must be at least three testing
events at approximately equal intervals per year. The annual program
must provide samples that cover the clinically relevant range of values
that would be expected in patient specimens. The samples may be provided
through mailed shipments or, at HHS' option, may be provided to HHS or
its designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure is five serum, plasma, blood, or urine samples.
Analyte or Test
Cortisol
Free Thyroxine
Human Chorionic gonadotropin (excluding urine pregnancy tests done by
visual color comparison categorized as waived tests)
T3 Uptake
Triiodothyronine
Thyroid-stimulating hormone
Thyroxine
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c)(1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's response for
qualitative and quantitative endocrinology tests or analytes, a program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 80 percent of ten or more
referee laboratories or 80 percent or more of all participating
laboratories. The score for a sample in endocrinology is either the
score determined under paragraph (c)(2) or (c)(3) of this section.
(2) For quantitative endocrinology tests or analytes, the program
must determine the correct response for each analyte by the distance of
the response from the target value. After the target value has been
established for each response, the appropriateness of the response must
be determined by using either fixed criteria based on the percentage
difference from the target value or the number of standard deviations
(SDs) the response differs from the target value.
Criteria for Acceptable Performance
------------------------------------------------------------------------
Criteria for acceptable Analyte or test performance are-
------------------------------------------------------------------------
| Cortisol |
Target value ±25% |
| Free Thyroxine |
Target value ±3 SD |
[[Page 935]]
Human Chorionic Gonadotropin (excluding Target value ±3 SD urine pregnancy
tests done by visual positive or negative. color comparison categorized as waived
tests).
| T3 Uptake |
Target value ±3 SD |
| Triiodothyronine |
Target value ±3 SD |
| Thyroid-stimulating hormone |
Target value ±3 SD |
| Thyroxine |
Target value ±20% or 1.0
mcg/dL (greater) |
------------------------------------------------------------------------
(3) The criterion for acceptable performance for qualitative
endocrinology tests is positive or negative.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
Number of acceptable
responses for the analyte
------------------------------- x 100=Analyte score for the testing event
Total number of all challenges
for the analyte
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
Number of acceptable
responses for the analyte
------------------------------- x 100=Analyte score for the testing event
Total number of all challenges
for the analyte
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
Sec. 493.937 Toxicology.
(a) Program content and frequency of challenge. To be approved for
proficiency testing for toxicology, the annual program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The annual
program must provide samples that cover the clinically relevant range of
values that would be expected in specimens of patients on drug therapy
and that cover the level of clinical significance for the particular
drug. The samples may be provided through mailed shipments or, at HHS'
option, may be provided to HHS or its designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure is five serum, plasma, or blood samples.
Analyte or Test Procedure
Alcohol (blood)
Blood lead
Carbamazepine
Digoxin
Ethosuximide
Gentamicin
Lithium
Phenobarbital
Phenytoin
Primidone
Procainamide
(and metabolite)
Quinidine
Theophylline
Tobramycin
Valproic Acid
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c)(1) through (4) of this
section.
(1) To determine the accuracy of a laboratory's responses for
quantitative toxicology tests or analytes, the program must compare the
laboratory's response for each analyte with the response that reflects
agreement of either 80 percent of ten or more referee laboratories or 80
percent or more of all participating laboratories. The score for a
sample in toxicology is the score determined under paragraph (c)(2) of
this section.
(2) For quantitative toxicology tests or analytes, the program must
determine the correct response for each analyte by the distance of the
response from the target value. After the target value has been
established for each response, the appropriateness of the response must
be determined by using fixed criteria based on the percentage difference
from the target value
Criteria for Acceptable Performance
------------------------------------------------------------------------
Criteria for acceptable Analyte or test performance are-
------------------------------------------------------------------------
| Alcohol, blood |
Target Value ±
25% |
| Blood lead |
Target Value ± 10% or 4 mcg/dL
(greater) |
| Carbamazepine |
Target Value ±
25% |
| Digoxin |
Target Value ± 20% or ± 0.2 ng/mL
(greater) |
| Ethosuximide |
Target Value ±
20% |
| Gentamicin |
Target Value ±
25% |
| Lithium |
Target Value ± 0.3 mmol/L or ± 20%
(greater) |
| [[Page 936]] |
|
| Phenobarbital |
Target Value ± 20% |
| Phenytoin |
Target Value ±
25% |
| Primidone |
Target Value ±
25% |
| Procainamide (and metabolite) |
Target Value ±
25% |
| Quinidine |
Target Value ±
25% |
| Tobramycin |
Target Value ±
25% |
| Theophylline |
Target Value ±
25% |
| Valproic Acid |
Target Value ±
25% |
------------------------------------------------------------------------
(3) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
Number of acceptable
responses for the analyte
------------------------------- x 100=Analyte score for the testing event
Total number of all challenges
for the analyte
(4) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
Number of acceptable
responses for the analyte
------------------------------- x 100=Analyte score for the testing event
Total number of all challenges
for the analyte
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
Sec. 493.941 Hematology (including routine hematology and coagulation).
(a) Program content and frequency of challenge. To be approved for
proficiency testing for hematology, a program must provide a minimum of
five samples per testing event. There must be at least three testing
events at approximately equal intervals per year. The annual program
must provide samples that cover the full range of values that would be
expected in patient specimens. The samples may be provided through
mailed shipments or, at HHS' option, may be provided to HHS and or its
designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure is five.
Analyte or Test Procedure
Cell identification or white blood cell differential
Erythrocyte count
Hematocrit (excluding spun microhematocrit)
Hemoglobin
Leukocyte count
Platelet count
Fibrinogen
Partial thromboplastin time
Prothrombin time
(1) An approved program for cell identification may vary over time.
The types of cells that might be included in an approved program over
time are--
Neutrophilic granulocytes
Eosinophilic granulocytes
Basophilic granulocytes
Lymphocytes
Monocytes
Major red and white blood cell abnormalities
Immature red and white blood cells
(2) White blood cell differentials should be limited to the
percentage distribution of cellular elements listed above.
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c) (1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's responses for
qualitative and quantitative hematology tests or analytes, the program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 80 percent of ten or more
referee laboratories or 80 percent or more of all participating
laboratories. The score for a sample in hematology is either the score
determined under paragraph (c) (2) or (3) of this section.
(2) For quantitative hematology tests or analytes, the program must
determine the correct response for each analyte by the distance of the
response from the target value. After the target value has been
established for each response, the appropriateness of the response is
determined using either fixed criteria based on the percentage
difference from the target value or the number of standard deviations
(SDs) the response differs from the target value.
[[Page 937]]
Criteria for Acceptable Performance
------------------------------------------------------------------------
Criteria for acceptable Analyte or test performance are-
------------------------------------------------------------------------
| Cell identification |
80% or greater consensus on
identification |
| White blood cell differential |
Target ± 3SD based on the
percentage of different types of
white blood cells in the
samples |
| Erythrocyte count |
Target ± 6% |
| Hematocrit (Excluding spun hematocrits). |
Target ± 6% |
| Hemoglobin |
Target ± 7% |
| Leukocyte count |
Target ± 15% |
| Platelet count |
Target ± 25% |
| Fibrinogen. |
Target ± 20% |
| Partial thromboplastin time |
Target ± 15% |
| Prothrombin time |
Target ± 15% |
------------------------------------------------------------------------
(3) The criterion for acceptable performance for the qualitative
hematology test is correct cell identification.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
Number of acceptable
responses for the analyte
------------------------------- x 100=Analyte score for the testing event
Total number of all challenges
for the analyte
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
Number of acceptable
responses for the analyte
------------------------------- x 100=Analyte score for the testing event
Total number of all challenges
for the analyte
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
Sec. 493.945 Cytology; gynecologic examinations.
(a) Program content and frequency of challenge. (1) To be approved
for proficiency testing for gynecologic examinations (Pap smears) in
cytology, a program must provide test sets composed of 10- and 20-glass
slides. Proficiency testing programs may obtain slides for test sets
from cytology laboratories, provided the slides have been retained by
the laboratory for the required period specified in place Sec. Sec.
493.1105(a)(7)(i)(A) and 493.1274(f)(2). If slide preparations are still subject
to retention by the laboratory they may be loaned to a proficiency testing
program if the program provides the laboratory with documentation of the
loan of the slides and ensures that slides loaned to it are retrievable
upon request. Each test set must include at least one slide representing
each of the response categories described in paragraph (b)(3)(ii)(A)
of this section, and test sets should be comparable so that equitable
testing is achieved within and between proficiency testing providers.
(2) To be approved for proficiency testing in gynecologic cytology,
a program must provide announced and unannounced on-site testing for
each individual at least once per year and must provide an initial
retesting event for each individual within 45 days after notification of
test failure and subsequent retesting events within 45 days after
completion of remedial action described in Sec. 493.855.
(b) Evaluation of an individual's performance. HHS approves only
those programs that assess the accuracy of each individual's responses
on both 10- and 20-slide test sets in which the slides have been
referenced as specified in paragraph (b)(1) of this section.
(1) To determine the accuracy of an individual's response on a
particular challenge (slide), the program must compare the individual's
response for each slide preparation with the response that reflects the
predetermined consensus agreement or confirmation on the diagnostic
category, as described in the table in paragraph (b)(3)(ii)(A) of this
section. For all slide preparations, a 100% consensus agreement among a
minimum of three physicians certified in anatomic pathology is required.
In addition, for premalignant and malignant slide preparations,
confirmation by tissue biopsy is required either by comparison of the
reported biopsy results or reevaluation of biopsy slide material by a
physician certified in anatomic pathology.
(2) An individual qualified as a technical supervisor under
Sec. 493.1449 (b) or
[[Page 938]]
(k) who routinely interprets gynecologic slide preparations only after
they have been examined by a cytotechnologist can either be tested using
a test set that has been screened by a cytotechnologist in the same
laboratory or using a test set that has not been screened. A technical
supervisor who screens and interprets slide preparations that have not
been previously examined must be tested using a test set that has not
been previously screened.
(3) The criteria for acceptable performance are determined by using
the scoring system in paragraphs (b)(3) (i) and (ii) of this section.
(i) Each slide set must contain 10 or 20 slides with point values
established for each slide preparation based on the significance of the
relationship of the interpretation of the slide to a clinical condition
and whether the participant in the testing event is a cytotechnologist
qualified under Secs. 493.1469 or 493.1483 or functioning as a technical
supervisor in cytology qualified under Sec. 493.1449 (b) or (k) of this
part.
(ii) The scoring system rewards or penalizes the participants in
proportion to the distance of their answers from the correct response or
target diagnosis and the penalty or reward is weighted in proportion to
the severity of the lesion.
(A) The four response categories for reporting proficiency testing
results and their descriptions are as follows:
------------------------------------------------------------------------
Category Description
------------------------------------------------------------------------
A................................. Unsatisfactory for diagnosis due to:
(1) Scant cellularity.
(2) Air drying.
(3) Obscuring material (blood,
inflammatory cells, or lubricant).
B................................. Normal or Benign Changes--includes:
(1) Normal, negative or within
normal limits.
(2) Infection other than Human
Papillomavirus (HPV) (e.g.,
Trichomonas vaginalis, changes or
morphology consistent with Candida
spp., Actinomyces spp. or Herpes
simplex virus).
(3) Reactive and reparative changes
(e.g., inflammation, effects of
chemotherapy or radiation).
C................................. Low Grade Squamous Intraepithelial
Lesion--includes:
(1) Cellular changes associated with
HPV.
(2) Mild dysplasia/CIN-1.
D................................. High Grade Lesion and Carcinoma--
includes:
(1) High grade squamous
intraepithelial lesions which
include moderate dysplasia/CIN-2
and severe dysplasia/carcinoma in-
situ/CIN-3.
(2) Squamous cell carcinoma.
(3) Adenocarcinoma and other
malignant neoplasms.
------------------------------------------------------------------------
(B) In accordance with the criteria for the scoring system, the
charts in paragraphs (b)(3)(ii)(C) and (D) of this section, for
technical supervisors and cytotechnologists, respectively, provide a
maximum of 10 points for a correct response and a maximum of minus five
(-5) points for an incorrect response on a 10-slide test set. For
example, if the correct response on a slide is "high grade squamous
intraepithelial lesion" (category "D" on the scoring system chart)
and an examinee calls it "normal or negative" (category "B" on the
scoring system chart), then the examinee's point value on that slide is
calculated as minus five (-5). Each slide is scored individually in the
same manner. The individual's score for the testing event is determined
by adding the point value achieved for each slide preparation, dividing
by the total points for the testing event and multiplying by 100.
(C) Criteria for scoring system for a 10-slide test set. (See table
at (b)(3)(ii)(A) of this section for a description of the response
categories.) For technical supervisors qualified under Sec. 493.1449(b)
or (k):
------------------------------------------------------------------------
Examinee's response: A B C D
------------------------------------------------------------------------
Correct response category:
| A |
10 0 0 0 |
| B |
5 10 0 0 |
| C |
5 0 10 5 |
| D |
0 5 5 10 |
------------------------------------------------------------------------
(D) Criteria for scoring system for a 10-slide test set. (See table
at paragraph (b)(3)(ii)(A) of this section for a description of the
response categories.) For cytotechnologists qualified under
Secs. 493.1469 or 493.1483:
[[Page 939]]
------------------------------------------------------------------------
Examinee's response: A B C D
------------------------------------------------------------------------
Correct response category:
| A |
10 0 5 5 |
| B |
5 10 5 5 |
| C |
5 0 10 10 |
| D |
0 -5 10 10 |
------------------------------------------------------------------------
(E) In accordance with the criteria for the scoring system, the
charts in paragraphs (b)(3)(ii)(F) and (G) of this section, for
technical supervisors and cytotechnologists, respectively, provide
maximums of 5 points for a correct response and minus ten (-10) points
for an incorrect response on a 20-slide test set.
(F) Criteria for scoring system for a 20-slide test set. (See table
at paragraph (b)(3)(ii)(A) of this section for a description of the
response categories.) For technical supervisors qualified under
Sec. 493.1449(b) or (k):
------------------------------------------------------------------------
Examinee's response: A B C D
------------------------------------------------------------------------
Correct response category:
| A |
5 0 0 0 |
| B |
2.5 5 0 0 |
| C |
2.5 0 5 2.5 |
| D |
0 -10 2.5 5 |
------------------------------------------------------------------------
(G) Criteria for scoring system for a 20-slide test set. (See table
at (b)(3)(ii)(A) of this section for a description of the response
categories.) For cytotechnologists qualified under Secs. 493.1469 or
493.1483:
------------------------------------------------------------------------
Examinee's response: A B C D
------------------------------------------------------------------------
Correct response category:
| A |
5 0 2.5 2.5 |
| B |
2.5 5 2.5 2.5 |
| C |
2.5 0 5 5 |
| D |
0 -10 5 5 |
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
Sec. 493.959 Immunohematology.
(a) Types of services offered by laboratories. In immunohematology,
there are four types of laboratories for proficiency testing purposes--
(1) Those that perform ABO group and/or D (Rho) typing;
(2) Those that perform ABO group and/or D (Rho) typing, and
unexpected antibody detection;
(3) Those that in addition to paragraph (a)(2) of this section
perform compatibility testing; and
(4) Those that perform in addition to paragraph (a)(3) of this
section antibody identification.
(b) Program content and frequency of challenge. To be approved for
proficiency testing for immunohematology, a program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The annual
program must provide samples that cover the full range of interpretation
that would be expected in patient specimens. The samples may be provided
through mailed shipments or, at HHS' option, may be provided to HHS or
its designee for on-site testing.
(c) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure is five.
Analyte or Test Procedure
ABO group (excluding subgroups)
D (Rho) typing
Unexpected antibody detection
Compatibility testing
Antibody identification
(d) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
response in accordance with paragraphs (d)(1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's response, a program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 100 percent of ten or more
referee laboratories or 95 percent or more of all participating
laboratories except for unexpected antibody detection and antibody
identification. To determine the accuracy of a laboratory's response for
unexpected antibody detection and antibody identification, a program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 95 percent of ten or more
referee laboratories or 95 percent or more of all participating
laboratories. The score for a sample in immunohematology is either the
score determined under paragraph (d)(2) or (3) of this section.
[[Page 940]]
(2) Criteria for acceptable performance
------------------------------------------------------------------------
Criteria for acceptable Analyte or test performance are-
------------------------------------------------------------------------
| ABO group |
100% accuracy |
| D (Rho) typing |
100% accuracy |
| Unexpected antibody detection |
80% accuracy |
| Compatibility testing |
100% accuracy |
| Antibody identification |
80% accuracy |
------------------------------------------------------------------------
(3) The criterion for acceptable performance for qualitative
immunohematology tests is positive or negative.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
Number of acceptable
responses for the analyte
------------------------------- x 100=Analyte score for the testing event
Total number of all challenges
for the analyte
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
Number of acceptable
responses for the analyte
------------------------------- x 100=Analyte score for the testing event
Total number of all challenges
for the analyte
|