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Subpart K--Quality Systems for Nonwaived Testing

Section
493.1200 Introduction
493.1201  Condition Bacteriology
493.1202 Condition: Mycobacteriology
493.1203 Condition: Mycology
493.1204 Condition: Parasitology
493.1205 Condition: Virology  
493.1207 Condition: Syphilis serology
493.1208 Condition: General immunology
493.1210 Condition: Routine chemistry
493.1211 Condition:  Urinalysis 
493.1212 Condition: Endocrinology
493.1213 Condition:  Toxicology
493.1215 Condition:  Hematology
493.1217 Condition:  Immunohematology
493.1219 Condition:  Histopathology
493.1220 Condition: Oral pathology
493.1221 Condition:  Cytology
493.1225 Condition: Clinical cytogenetics   
493.1226 Condition: Radiobioassay
493.1227 Condition: Histocompatibility
493.1230 Condition: General laboratory systems
493.1231 Standard: Confidentiality of patient information
493.1232 Standard: Specimen identification and integrity
493.1233 Standard:  Complaint investigations  
493.1234 Standard: Communications
493.1235 Standard:  Personnel competency assessment policies
493.1236 Standard:  Evaluation of proficiency testing performance
493.1239 Standard:  General laboratory systems assessment
493.1240 Condition: Preanalytic systems
493.1241 Standard:  Test request
493.1242 Standard:  Specimen submission, handling, and referral
493.1249 Standard:  Preanalytic systems assessment  
 493.1250 Condition: Analytic Systems
 493.1251 Standard:  Procedure manual   
493.1252 Standard:  Test systems, equipment, instruments, reagents, materials, and supplies
493.1253 Standard: Establishment and verification of performance specifications
493.1254  Standard: Maintenance and function checks
493.1255 Standard:  Calibration and calibration verification procedures
493.1256 Standard:  Control procedures
493.1261 Standard:  Bacteriology
493.1262 Standard:  Mycobacteriology
493.1263 Standard:  Mycology  
493.1264 Standard:  Parasitology
493.1265 Standard: Virology
493.1267 Standard:  Routine chemistry
493.1269 Standard:  Hematology
493.1271 Standard:  Immunohematology
493.1273 Standard:  Histopathology
493.1274 Standard: Cytology
493.1276 Standard:  Clinical cytogenetics
493.1278 Standard:  Histocompatibility
493.1281 Standard:  Comparison of test results
493.1282 Standard: Corrective actions
493.1283 Standard:  Test records
493.1289 Standard:  Analytic systems assessment
493.1290 Condition:  Postanalytic systems
493.1291 Standard:  Test report
493.1299 Standard: Postanalytic systems assessment
 
Subpart K--Quality Systems for Nonwaived Testing
      
Sec.  493.1200  Introduction

 (a) Each laboratory that performs nonwaived testing must establish 
and maintain written policies and procedures that implement and monitor 
quality systems for all phases of the total testing process (that is, 
preanalytic, analytic, and postanalytic) as well as general laboratory 
systems.
    (b) Each of the laboratory's quality systems must include an 
assessment component that ensures continuous improvement of the 
laboratory's performance and services through ongoing monitoring that 
identifies, evaluates and resolves problems.
    (c) The various components of the laboratory's quality systems are 
used to meet the requirements in this part and must be appropriate for 
the specialties and subspecialties of testing the laboratory performs, 
services it offers, and clients it serves.
      
Sec. 493.1201 Condition: Bacteriology

    If the laboratory provides services in the subspecialty of 
Bacteriology, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, Sec.  493.1261, and Sec. Sec.  
493.1281 through 493.1299.

      
Sec. 493.1202  Condition: Mycobacteriology

      
    If the laboratory provides services in the subspecialty of 
Mycobacteriology, the laboratory must meet the requirements specified 
in Sec. Sec.  493.1230 through 493.1256, Sec.  493.1262, and Sec. Sec.  
493.1281 through 493.1299.

      
Sec. 493.1203  Condition: Mycology
     
    If the laboratory provides services in the subspecialty of 
Mycology, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, Sec.  493.1263, and Sec. Sec.  
493.1281 through 493.1299.

      
Sec. 493.1204  Condition: Parasitology

    If the laboratory provides services in the subspecialty of 
Parasitology, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, Sec.  493.1264, and Sec. Sec.  
493.1281 through 493.1299.
  
Sec.  493.1205  Condition: Virology

    If the laboratory provides services in the subspecialty of 
Virology, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, Sec.  493.1265, and Sec. Sec.  
493.1281 through 493.1299.
Sec.  493.1207  Condition: Syphilis serology

    If the laboratory provides services in the subspecialty of Syphilis 
serology, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, and Sec. Sec.  493.1281 through 
493.1299.

Sec.  493.1208  Condition: General immunology

    If the laboratory provides services in the subspecialty of General 
immunology, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, and Sec. Sec.  493.1281 through 
493.1299.

Sec.  493.1210  Condition: Routine chemistry

    If the laboratory provides services in the subspecialty of Routine 
chemistry, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, Sec.  493.1267, and Sec. Sec.  
493.1281 through 493.1299.

Sec. 493.1211 Condition: Urinalysis

    If the laboratory provides services in the subspecialty of 
Urinalysis, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, and Sec. Sec.  493.1281 through 
493.1299.

Sec.  493.1212  Condition: Endocrinology

    If the laboratory provides services in the subspecialty of 
Endocrinology, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, and Sec. Sec.  493.1281 through 
493.1299.
      
Sec.  493.1213  Condition: Toxicology

    If the laboratory provides services in the subspecialty of 
Toxicology, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, and Sec. Sec.  493.1281 through 
493.1299.

Sec. 493.1215  Condition: Hematology

    If the laboratory provides services in the specialty of Hematology, 
the laboratory must meet the requirements specified in Sec. Sec.  
493.1230 through 493.1256, Sec.  493.1269, and Sec. Sec.  493.1281 
through 493.1299.

Sec. 493.1217  Condition: Immunohematology

    If the laboratory provides services in the specialty of 
Immunohematology, the laboratory must meet the requirements specified 
in Sec. Sec.  493.1230 through 493.1256, Sec.  493.1271, and Sec. Sec.  
493.1281 through 493.1299.
      
Sec. 493.1219  Condition: Histopathology

    If the laboratory provides services in the subspecialty of 
Histopathology, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, Sec.  493.1273, and Sec. Sec.  
493.1281 through 493.1299.
      
Sec.  493.1220  Condition: Oral pathology

    If the laboratory provides services in the subspecialty of Oral 
pathology, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, and Sec. Sec.  493.1281 through 
493.1299.

Sec. 493.1221  Condition: Cytology

    If the laboratory provides services in the subspecialty of 
Cytology, the


[[Page 3705]]


laboratory must meet the requirements specified in Sec. Sec.  493.1230 
through 493.1256, Sec.  493.1274, and Sec. Sec.  493.1281 through 
493.1299.
      
Sec. 493.1225  Condition: Clinical cytogenetics

    If the laboratory provides services in the specialty of Clinical 
cytogenetics, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, Sec.  493.1276, and Sec. Sec.  
493.1281 through 493.1299.
      
Sec.  493.1226  Condition: Radiobioassay

    If the laboratory provides services in the specialty of 
Radiobioassay, the laboratory must meet the requirements specified in 
Sec. Sec.  493.1230 through 493.1256, and Sec. Sec.  493.1281 through 
493.1299.

Sec. 493.1227  Condition: Histocompatibility

    If the laboratory provides services in the specialty of 
Histocompatibility, the laboratory must meet the requirements specified 
in Sec. Sec.  493.1230 through 493.1256, Sec.  493.1278, and Sec. Sec.  
493.1281 through 493.1299.


General Laboratory Systems
      
Sec.  493.1230  Condition: General laboratory systems

    Each laboratory that performs nonwaived testing must meet the 
applicable general laboratory systems requirements in Sec. Sec.  
493.1231 through 493.1236, unless HHS approves a procedure, specified 
in Appendix C of the State Operations Manual (CMS Pub. 7), that 
provides equivalent quality testing. The laboratory must monitor and 
evaluate the overall quality of the general laboratory systems and 
correct identified problems as specified in Sec.  493.1239 for each 
specialty and subspecialty of testing performed.

Sec. 493.1231  Standard: Confidentiality of patient information

    The laboratory must ensure confidentiality of patient information 
throughout all phases of the total testing process that are under the 
laboratory's control.

Sec.  493.1232  Standard: Specimen identification and integrity

    The laboratory must establish and follow written policies and 
procedures that ensure positive identification and optimum integrity of 
a patient's specimen from the time of collection or receipt of the 
specimen through completion of testing and reporting of results.

Sec. 493.1233 Standard: Complaint investigations

    The laboratory must have a system in place to ensure that it 
documents all complaints and problems reported to the laboratory. The 
laboratory must conduct investigations of complaints, when appropriate.


Sec.  493.1234  Standard: Communications

    The laboratory must have a system in place to identify and document 
problems that occur as a result of a breakdown in communication between 
the laboratory and an authorized individual who orders or receives test 
results.

Sec. 493.1235  Standard: Personnel competency assessment policies

    As specified in the personnel requirements in subpart M, the 
laboratory must establish and follow written policies and procedures to 
assess employee and, if applicable, consultant competency.

Sec. 493.1236  Standard: Evaluation of proficiency testing 
performance

    (a) The laboratory must review and evaluate the results obtained on 
proficiency testing performed as specified in subpart H of this part.
    (b) The laboratory must verify the accuracy of the following:
    (1) Any analyte or subspecialty without analytes listed in subpart 
I of this part that is not evaluated or scored by a CMS-approved 
proficiency testing program.
    (2) Any analyte, specialty or subspecialty assigned a proficiency 
testing score that does not reflect laboratory test performance (that 
is, when the proficiency testing program does not obtain the agreement 
required for scoring as specified in subpart I of this part, or the 
laboratory receives a zero score for nonparticipation, or late return 
of results).
    (c) At least twice annually, the laboratory must verify the 
accuracy of the following:
    (1) Any test or procedure it performs that is not included in 
subpart I of this part.
    (2) Any test or procedure listed in subpart I of this part for 
which compatible proficiency testing samples are not offered by a CMS-
approved proficiency testing program.
    (d) All proficiency testing evaluation and verification activities 
must be documented.
  
Sec.  493.1239  Standard: General laboratory systems assessment

    (a) The laboratory must establish and follow written policies and 
procedures for an ongoing mechanism to monitor, assess, and, when 
indicated, correct problems identified in the general laboratory system 
requirements specified at Sec. Sec.  493.1231 through 493.1236.
    (b) The general laboratory systems assessment must include a review 
of the effectiveness of corrective actions taken to resolve problems, 
revision of policies and procedures necessary to prevent recurrence of 
problems, and discussion of general laboratory systems assessment 
reviews with appropriate staff.
    (c) The laboratory must document all general laboratory systems 
assessment activities.

Preanalytic Systems

Sec.  493.1240  Condition: Preanalytic systems

    Each laboratory that performs nonwaived testing must meet the 
applicable preanalytic system(s) requirements in Sec. Sec.  493.1241 
and 493.1242, unless HHS approves a procedure, specified in Appendix C 
of the State Operations Manual (CMS Pub. 7), that provides equivalent 
quality testing. The laboratory must monitor and evaluate the overall 
quality of the preanalytic systems and correct identified problems as 
specified in Sec.  493.1249 for each specialty and subspecialty of 
testing performed.

Sec. 493.1241  Standard: Test request

    (a) The laboratory must have a written or electronic request for 
patient testing from an authorized person.
    (b) The laboratory may accept oral requests for laboratory tests if 
it solicits a written or electronic authorization within 30 days of the 
oral request and maintains the authorization or documentation of its 
efforts to obtain the authorization.
    (c) 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.


[[Page 3706]]


    (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.
    (d) The patient's chart or medical record may be used as the test 
requisition or authorization but must be available to the laboratory at 
the time of testing and available to CMS or a CMS agent upon request.
    (e) If the laboratory transcribes or enters test requisition or 
authorization information into a record system or a laboratory 
information system, the laboratory must ensure the information is 
transcribed or entered accurately.
      
Sec. 493.1242  Standard: Specimen submission, handling, and referral

    (a) 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.
    (b) The laboratory must document the date and time it receives a 
specimen.
    (c) The laboratory must refer a specimen for testing only to a 
CLIA-certified laboratory or a laboratory meeting equivalent 
requirements as determined by CMS.
    (d) If the laboratory accepts a referral specimen, written 
instructions must be available to the laboratory's clients and must 
include, as appropriate, the information specified in paragraphs (a)(1) 
through (a)(7) of this section.

Sec. 493.1249  Standard: Preanalytic systems assessment

    (a) The laboratory must establish and follow written policies and 
procedures for an ongoing mechanism to monitor, assess, and when 
indicated, correct problems identified in the preanalytic systems 
specified at Sec. Sec.  493.1241 through 493.1242.
    (b) The preanalytic systems assessment must include a review of the 
effectiveness of corrective actions taken to resolve problems, revision 
of policies and procedures necessary to prevent recurrence of problems, 
and discussion of preanalytic systems assessment reviews with 
appropriate staff.
    (c) The laboratory must document all preanalytic systems assessment 
activities.


Analytic Systems

Sec.  493.1250  Condition: Analytic systems

    Each laboratory that performs nonwaived testing must meet the 
applicable analytic systems requirements in Sec. Sec.  493.1251 through 
493.1283, unless HHS approves a procedure, specified in Appendix C of 
the State Operations Manual (CMS Pub. 7), that provides equivalent 
quality testing. The laboratory must monitor and evaluate the overall 
quality of the analytic systems and correct identified problems as 
specified in Sec.  493.1289 for each specialty and subspecialty of 
testing performed.

Sec. 493.1251  Standard: Procedure manual

    (a) A written procedure manual for all tests, assays, and 
examinations performed by the laboratory must be available to, and 
followed by, laboratory personnel. Textbooks may supplement but not 
replace the laboratory's written procedures for testing or examining 
specimens.
    (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 Sec.  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 Sec.  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 imminent life threatening results, or panic, or 
alert values.
    (14) Description of the course of action to take if a test system 
becomes inoperable.
    (c) Manufacturer's test system instructions or operator manuals may 
be used, when applicable, to meet the requirements of paragraphs (b)(1) 
through (b)(12) of this section. Any of the items under paragraphs 
(b)(1) through (b)(12) of this section not provided by the manufacturer 
must be provided by the laboratory.
    (d) Procedures and changes in procedures must be approved, signed, 
and dated by the current laboratory director before use.
    (e) The laboratory must maintain a copy of each procedure with the 
dates of initial use and discontinuance as described in Sec.  
493.1105(a)(2).

Sec.  493.1252  Standard: Test systems, equipment, instruments, 
reagents, materials, and supplies

    (a) Test systems must be selected by the laboratory. The testing 
must be performed following the manufacturer's instructions and in a 
manner that provides test results within the laboratory's stated 
performance specifications for each test system as determined under 
Sec.  493.1253.
    (b) The laboratory must define criteria for those conditions that 
are essential for proper storage of reagents and specimens, accurate 
and reliable test system operation, and test result reporting. The 
criteria must be consistent with the manufacturer's instructions, if 
provided. These conditions must be monitored and documented and, if 
applicable, include the following:
    (1) Water quality.
    (2) Temperature.
    (3) Humidity.
    (4) Protection of equipment and instruments from fluctuations and 
interruptions in electrical current that adversely affect patient test 
results and test reports.
    (c) 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.
    (d) Reagents, solutions, culture media, control materials, 
calibration materials,


[[Page 3707]]


and other supplies must not be used when they have exceeded their 
expiration date, have deteriorated, or are of substandard quality.
    (e) Components of reagent kits of different lot numbers must not be 
interchanged unless otherwise specified by the manufacturer.

Sec. 493.1253  Standard: Establishment and verification of performance 
specifications

    (a) Applicability. Laboratories are not required to verify or 
establish performance specifications for any test system used by the 
laboratory before April 24, 2003.
    (b)(1) 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.
    (2) 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, Gram stain, or potassium hydroxide preparations), 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.
    (3) Determination of calibration and control procedures. The 
laboratory must determine the test system's calibration procedures and 
control procedures based upon the performance specifications verified 
or established under paragraph (b)(1) or (b)(2) of this section.
    (c) Documentation. The laboratory must document all activities 
specified in this section.

Sec.  493.1254  Standard: Maintenance and function checks

    (a) Unmodified manufacturer's equipment, instruments, or test 
systems. The laboratory must perform and document the following:
    (1) Maintenance as defined by the manufacturer and with at least 
the frequency specified by the manufacturer.
    (2) Function checks as defined by the manufacturer and with at 
least the frequency specified by the manufacturer. Function checks must 
be within the manufacturer's established limits before patient testing 
is conducted.
    (b) Equipment, instruments, or test systems developed in-house, 
commercially available and modified by the laboratory, or maintenance 
and function check protocols are not provided by the manufacturer. The 
laboratory must do the following:
    (1)(i) Establish a maintenance protocol that ensures equipment, 
instrument, and test system performance that is necessary for accurate 
and reliable test results and test result reporting.
    (ii) Perform and document the maintenance activities specified in 
paragraph (b)(1)(i) of this section.
    (2)(i) Define a function check protocol that ensures equipment, 
instrument, and test system performance that is necessary for accurate 
and reliable test results and test result reporting.
    (ii) Perform and document the function checks, including background 
or baseline checks, specified in paragraph (b)(2)(i) of this section. 
Function checks must be within the laboratory's established limits 
before patient testing is conducted.

Sec. 493.1255  Standard: Calibration and calibration verification 
procedures

    Calibration and calibration verification procedures are required to 
substantiate the continued accuracy of the test system throughout the 
laboratory's reportable range of test results for the test system. 
Unless otherwise specified in this subpart, for each applicable test 
system the laboratory must do the following:
    (a) Perform and document calibration procedures--
    (1) Following the manufacturer's test system instructions, using 
calibration materials provided or specified, and with at least the 
frequency recommended by the manufacturer;
    (2) Using the criteria verified or established by the laboratory as 
specified in Sec.  493.1253(b)(3)--
    (i) Using calibration materials appropriate for the test system 
and, if possible, traceable to a reference method or reference material 
of known value; and
    (ii) Including the number, type, and concentration of calibration 
materials, as well as acceptable limits for and the frequency of 
calibration; and
    (3) Whenever calibration verification fails to meet the 
laboratory's acceptable limits for calibration verification.
    (b) Perform and document calibration verification procedures--
    (1) Following the manufacturer's calibration verification 
instructions;
    (2) Using the criteria verified or established by the laboratory 
under Sec.  493.1253(b)(3)--
    (i) Including the number, type, and concentration of the materials, 
as well as acceptable limits for calibration verification; and
    (ii) Including at least a minimal (or zero) value, a mid-point 
value, and a maximum value near the upper limit of the range to verify 
the laboratory's reportable range of test results for the test system; 
and
    (3) 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.
      
Sec.  493.1256  Standard: Control procedures

    (a) For each test system, the laboratory is responsible for having 
control procedures that monitor the accuracy and precision of the 
complete analytical process.
    (b) The laboratory must establish the number, type, and frequency 
of testing control materials using, if applicable, the performance 
specifications verified


[[Page 3708]]


or established by the laboratory as specified in Sec.  493.1253(b)(3).
    (c) The control procedures must--
    (1) Detect immediate errors that occur due to test system failure, 
adverse environmental conditions, and operator performance.
    (2) Monitor over time the accuracy and precision of test 
performance that may be influenced by changes in test system 
performance and environmental conditions, and variance in operator 
performance.
    (d) Unless CMS approves a procedure, specified in Appendix C of the 
State Operations Manual (CMS Pub. 7), that provides equivalent quality 
testing, the laboratory must--
    (1) Perform control procedures as defined in this section unless 
otherwise specified in the additional specialty and subspecialty 
requirements at Sec. Sec.  493.1261 through 493.1278.
    (2) For each test system, perform control procedures using the 
number and frequency specified by the manufacturer or established by 
the laboratory when they meet or exceed the requirements in paragraph 
(d)(3) of this section.
    (3) 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.
    (4) For thin layer chromatography--
    (i) Spot each plate or card, as applicable, with a calibrator 
containing all known substances or drug groups, as appropriate, which 
are identified by thin layer chromatography and reported by the 
laboratory; and
    (ii) Include at least one control material on each plate or card, 
as applicable, which must be processed through each step of patient 
testing, including extraction processes.
    (5) For each electrophoretic procedure include, concurrent with 
patient specimens, at least one control material containing the 
substances being identified or measured.
    (6) Perform control material testing as specified in this paragraph 
before resuming patient testing when a complete change of reagents is 
introduced; major preventive maintenance is performed; or any critical 
part that may influence test performance is replaced.
    (7) Over time, rotate control material testing among all operators 
who perform the test.
    (8) Test control materials in the same manner as patient specimens.
    (9) When using calibration material as a control material, use 
calibration material from a different lot number than that used to 
establish a cut-off value or to calibrate the test system.
    (10) Establish or verify the criteria for acceptability of all 
control materials.
    (i) When control materials providing quantitative results are used, 
statistical parameters (for example, mean and standard deviation) for 
each batch and lot number of control materials must be defined and 
available.
    (ii) The laboratory may use the stated value of a commercially 
assayed control material provided the stated value is for the 
methodology and instrumentation employed by the laboratory and is 
verified by the laboratory.
    (iii) Statistical parameters for unassayed control materials must 
be established over time by the laboratory through concurrent testing 
of control materials having previously determined statistical 
parameters.
    (e) For reagent, media, and supply checks, the laboratory must do 
the following:
    (1) Check each batch (prepared in-house), lot number (commercially 
prepared) and shipment of reagents, disks, stains, antisera, and 
identification systems (systems using two or more substrates or two or 
more reagents, or a combination) when prepared or opened for positive 
and negative reactivity, as well as graded reactivity, if applicable.
    (2) Each day of use (unless otherwise specified in this subpart), 
test staining materials for intended reactivity to ensure predictable 
staining characteristics. Control materials for both positive and 
negative reactivity must be included, as appropriate.
    (3) Check fluorescent and immunohistochemical stains for positive 
and negative reactivity each time of use.
    (4) Before, or concurrent with the initial use--
    (i) Check each batch of media for sterility if sterility is 
required for testing;
    (ii) Check each batch of media for its ability to support growth 
and, as appropriate, select or inhibit specific organisms or produce a 
biochemical response; and
    (iii) Document the physical characteristics of the media when 
compromised and report any deterioration in the media to the 
manufacturer.
    (5) Follow the manufacturer's specifications for using reagents, 
media, and supplies and be responsible for results.
    (f) Results of control materials must meet the laboratory's and, as 
applicable, the manufacturer's test system criteria for acceptability 
before reporting patient test results.
    (g) The laboratory must document all control procedures performed.
    (h) If control materials are not available, the laboratory must 
have an alternative mechanism to detect immediate errors and monitor 
test system performance over time. The performance of alternative 
control procedures must be documented.
 
Sec. 493.1261  Standard: Bacteriology

    (a) The laboratory must check the following for positive and 
negative reactivity using control organisms:
    (1) Each day of use for beta-lactamase methods other than 
Cefinase\TM\.
    (2) Each week of use for Gram stains.
    (3) When each batch (prepared in-house), lot number (commercially 
prepared), and shipment of antisera is prepared or opened, and once 
every 6 months thereafter.
    (b) For antimicrobial susceptibility tests, the laboratory must 
check each batch of media and each lot number and shipment of 
antimicrobial agent(s) before, or concurrent with, initial use, using 
approved control organisms.
    (1) Each day tests are performed, the laboratory must use the 
appropriate control organism(s) to check the procedure.
    (2) The laboratory's zone sizes or minimum inhibitory concentration 
for control organisms must be within established limits before 
reporting patient results.
    (c) The laboratory must document all control procedures performed, 
as specified in this section.

Sec. 493.1262  Standard: Mycobacteriology

    (a) Each day of use, the laboratory must check all reagents or test 
procedures used for mycobacteria identification with at least one acid-
fast organism that produces a positive reaction and an acid-fast 
organism that produces a negative reaction.
    (b) For antimycobacterial susceptibility tests, the laboratory must


[[Page 3709]]


check each batch of media and each lot number and shipment of 
antimycobacterial agent(s) before, or concurrent with, initial use, 
using an appropriate control organism(s).
    (1) The laboratory must establish limits for acceptable control 
results.
    (2) Each week tests are performed, the laboratory must use the 
appropriate control organism(s) to check the procedure.
    (3) The results for the control organism(s) must be within 
established limits before reporting patient results.
    (c) The laboratory must document all control procedures performed, 
as specified in this section.

Sec. 493.1263  Standard: Mycology

    (a) The laboratory must check each batch (prepared in-house), lot 
number (commercially prepared), and shipment of lactophenol cotton blue 
when prepared or opened for intended reactivity with a control 
organism(s).
    (b) For antifungal susceptibility tests, the laboratory must check 
each batch of media and each lot number and shipment of antifungal 
agent(s) before, or concurrent with, initial use, using an appropriate 
control organism(s).
    (1) The laboratory must establish limits for acceptable control 
results.
    (2) Each day tests are performed, the laboratory must use the 
appropriate control organism(s) to check the procedure.
    (3) The results for the control organism(s) must be within 
established limits before reporting patient results.
    (c) The laboratory must document all control procedures performed, 
as specified in this section.

Sec.  493.1264  Standard: Parasitology

    (a) The laboratory must have available a reference collection of 
slides or photographs and, if available, gross specimens for 
identification of parasites and use these references in the laboratory 
for appropriate comparison with diagnostic specimens.
    (b) The laboratory must calibrate and use the calibrated ocular 
micrometer for determining the size of ova and parasites, if size is a 
critical parameter.
    (c) Each month of use, the laboratory must check permanent stains 
using a fecal sample control material that will demonstrate staining 
characteristics.
    (d) The laboratory must document all control procedures performed, 
as specified in this section.

Sec.  493.1265  Standard: Virology

    (a) When using cell culture to isolate or identify viruses, the 
laboratory must simultaneously incubate a cell substrate control or 
uninoculated cells as a negative control material.
    (b) The laboratory must document all control procedures performed, 
as specified in this section.      

Sec. 493.1267  Standard: Routine chemistry

    For blood gas analyses, the laboratory must perform the following:
    (a) Calibrate or verify calibration according to the manufacturer's 
specifications and with at least the frequency recommended by the 
manufacturer.
    (b) Test one sample of control material each 8 hours of testing 
using a combination of control materials that include both low and high 
values on each day of testing.
    (c) Test one sample of control material each time specimens are 
tested unless automated instrumentation internally verifies calibration 
at least every 30 minutes.
    (d) Document all control procedures performed, as specified in this 
section.
      
Sec.  493.1269  Standard: Hematology

    (a) For manual cell counts performed using a hemocytometer--
    (1) One control material must be tested each 8 hours of operation; 
and
    (2) Patient specimens and control materials must be tested in 
duplicate.
    (b) For all nonmanual coagulation test systems, the laboratory must 
include two levels of control material each 8 hours of operation and 
each time a reagent is changed.
    (c) For manual coagulation tests--
    (1) Each individual performing tests must test two levels of 
control materials before testing patient samples and each time a 
reagent is changed; and
    (2) Patient specimens and control materials must be tested in 
duplicate.
    (d) The laboratory must document all control procedures performed, 
as specified in this section.
      
Sec. 493.1271  Standard: Immunohematology

    (a) Patient testing. (1) The laboratory must perform ABO grouping, 
D(Rho) typing, unexpected antibody detection, antibody identification, 
and compatibility testing by following the manufacturer's instructions, 
if provided, and as applicable, 21 CFR 606.151(a) through (e).
    (2) The laboratory must determine ABO group by concurrently testing 
unknown red cells with, at a minimum, anti-A and anti-B grouping 
reagents. For confirmation of ABO group, the unknown serum must be 
tested with known A1 and B red cells.
    (3) The laboratory must determine the D(Rho) type by testing 
unknown red cells with anti-D (anti-Rho) blood typing reagent.
    (b) Immunohematological testing and distribution of blood and blood 
products. Blood and blood product testing and distribution must comply 
with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 
640.5(a), (b), (c), and (e); and 640.11(b).
    (c) Blood and blood products storage. Blood and blood products must 
be stored under appropriate conditions that include an adequate 
temperature alarm system that is regularly inspected.
    (1) An audible alarm system must monitor proper blood and blood 
product storage temperature over a 24-hour period.
    (2) Inspections of the alarm system must be documented.
    (d) Retention of samples of transfused blood. According to the 
laboratory's established procedures, samples of each unit of transfused 
blood must be retained for further testing in the event of transfusion 
reactions. The laboratory must promptly dispose of blood not retained 
for further testing that has passed its expiration date.
    (e) Investigation of transfusion reactions. (1) According to its 
established procedures, the laboratory that performs compatibility 
testing, or issues blood or blood products, must promptly investigate 
all transfusion reactions occurring in facilities for which it has 
investigational responsibility and make recommendations to the medical 
staff regarding improvements in transfusion procedures.
    (2) The laboratory must document, as applicable, that all necessary 
remedial actions are taken to prevent recurrences of transfusion 
reactions and that all policies and procedures are reviewed to assure 
they are adequate to ensure the safety of individuals being transfused.
    (f) The laboratory must document all control procedures performed, 
as specified in this section.

Sec. 493.1273  Standard: Histopathology

    (a) Fluorescent and immunohistochemical stains must be checked for 
positive and negative reactivity each time of use. For all other 
differential or special stains, a control slide of known reactivity 
must be stained with each patient slide or group of patient slides. 
Reaction(s) of the control slide with each special stain must be 
documented.
    (b) The laboratory must retain stained slides, specimen blocks, and 
tissue remnants as specified in Sec.  493.1105. The remnants of tissue 
specimens must be maintained in a manner that ensures proper 
preservation of the tissue specimens until the portions submitted for 
microscopic examination have been examined and a diagnosis made by an


[[Page 3710]]


individual qualified under Sec. Sec.  493.1449(b), (l), or (m).
    (c) An individual who has successfully completed a training program 
in neuromuscular pathology approved by HHS may examine and provide 
reports for neuromuscular pathology.
    (d) Tissue pathology reports must be signed by an individual 
qualified as specified in paragraph (b) or, as appropriate, paragraph 
(c) of this section. If a computer report is generated with an 
electronic signature, it must be authorized by the individual who 
performed the examination and made the diagnosis.
    (e) The laboratory must use acceptable terminology of a recognized 
system of disease nomenclature in reporting results.
    (f) The laboratory must document all control procedures performed, 
as specified in this section.

Sec. 493.1274  Standard: Cytology

    (a) Cytology slide examination site. All cytology slide 
preparations must be evaluated on the premises of a laboratory 
certified to conduct testing in the subspecialty of cytology.
    (b) Staining. The laboratory must have available and follow written 
policies and procedures for each of the following, if applicable:
    (1) All gynecologic slide preparations must be stained using a 
Papanicolaou or modified Papanicolaou staining method.
    (2) Effective measures to prevent cross-contamination between 
gynecologic and nongynecologic specimens during the staining process 
must be used.
    (3) Nongynecologic specimens that have a high potential for cross-
contamination must be stained separately from other nongynecologic 
specimens, and the stains must be filtered or changed following 
staining.
    (c) Control procedures. The laboratory must establish and follow 
written policies and procedures for a program designed to detect errors 
in the performance of cytologic examinations and the reporting of 
results. The program must include the following:
    (1) A review of slides from at least 10 percent of the gynecologic 
cases interpreted by individuals qualified under Sec. Sec.  493.1469 or 
493.1483, to be negative for epithelial cell abnormalities and other 
malignant neoplasms (as defined in paragraph (e)(1) of this section).
    (i) The review must be performed by an individual who meets one of 
the following qualifications:
    (A) A technical supervisor qualified under Sec. Sec.  493.1449(b) 
or (k).
    (B) A cytology general supervisor qualified under Sec.  493.1469.
    (C) A cytotechnologist qualified under Sec.  493.1483 who has the 
experience specified in Sec.  493.1469(b)(2).
    (ii) Cases must be randomly selected from the total caseload and 
include negatives and those from patients or groups of patients that 
are identified as having a higher than average probability of 
developing cervical cancer based on available patient information.
    (iii) The review of those cases selected must be completed before 
reporting patient results.
    (2) Laboratory comparison of clinical information, when available, 
with cytology reports and comparison of all gynecologic cytology 
reports with a diagnosis of high-grade squamous intraepithelial lesion 
(HSIL), adenocarcinoma, or other malignant neoplasms with the 
histopathology report, if available in the laboratory (either on-site 
or in storage), and determination of the causes of any discrepancies.
    (3) For each patient with a current HSIL, adenocarcinoma, or other 
malignant neoplasm, laboratory review of all normal or negative 
gynecologic specimens received within the previous 5 years, if 
available in the laboratory (either on-site or in storage). If 
significant discrepancies are found that will affect current patient 
care, the laboratory must notify the patient's physician and issue an 
amended report.
    (4) Records of initial examinations and all rescreening results 
must be documented.
    (5) An annual statistical laboratory evaluation of the number of--
    (i) Cytology cases examined;
    (ii) Specimens processed by specimen type;
    (iii) Patient cases reported by diagnosis (including the number 
reported as unsatisfactory for diagnostic interpretation);
    (iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or 
other malignant neoplasm for which histology results were available for 
comparison;
    (v) Gynecologic cases where cytology and histology are discrepant; 
and
    (vi) Gynecologic cases where any rescreen of a normal or negative 
specimen results in reclassification as low-grade squamous 
intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant 
neoplasms.
    (6) An evaluation of the case reviews of each individual examining 
slides against the laboratory's overall statistical values, 
documentation of any discrepancies, including reasons for the deviation 
and, if appropriate, corrective actions taken.
    (d) Workload limits. The laboratory must establish and follow 
written policies and procedures that ensure the following:
    (1) The technical supervisor establishes a maximum workload limit 
for each individual who performs primary screening.
    (i) The workload limit is based on the individual's performance 
using evaluations of the following:
    (A) Review of 10 percent of the cases interpreted as negative for 
the conditions defined in paragraph (e)(1) of this section.
    (B) Comparison of the individual's interpretation with the 
technical supervisor's confirmation of patient smears specified in 
paragraphs (e)(1) and (e)(3) of this section.
    (ii) Each individual's workload limit is reassessed at least every 
6 months and adjusted when necessary.
    (2) The maximum number of slides examined by an individual in each 
24-hour period does not exceed 100 slides (one patient specimen per 
slide; gynecologic, nongynecologic, or both) irrespective of the site 
or laboratory. This limit represents an absolute maximum number of 
slides and must not be employed as an individual's performance target. 
In addition--
    (i) The maximum number of 100 slides is examined in no less than an 
8-hour workday;
    (ii) For the purposes of establishing workload limits for 
individuals examining slides in less than an 8-hour workday (includes 
full-time employees with duties other than slide examination and part-
time employees), a period of 8 hours is used to prorate the number of 
slides that may be examined. The formula--
Number of hours examining slides x 100
			8
is used to determine maximum slide volume to be examined;
    (iii) Nongynecologic slide preparation made using liquid-based 
slide preparatory techniques that result in cell dispersion over one-
half or less of the total available slide may be counted as one-half 
slide; and
    (iv) Technical supervisors who perform primary screening are not 
required to include tissue pathology slides and previously examined 
cytology slides (gynecologic and nongynecologic) in the 100 slide 
workload limit.
    (3) The laboratory must maintain records of the total number of 
slides examined by each individual during


[[Page 3711]]


each 24-hour period and the number of hours spent examining slides in 
the 24-hour period irrespective of the site or laboratory.
    (4) Records are available to document the workload limit for each 
individual.
    (e) Slide examination and reporting. The laboratory must establish 
and follow written policies and procedures that ensure the following:
    (1) A technical supervisor confirms each gynecologic slide 
preparation interpreted to exhibit reactive or reparative changes or 
any of the following epithelial cell abnormalities:
    (i) Squamous cell.
    (A) Atypical squamous cells of undetermined significance (ASC-US) 
or cannot exclude HSIL (ASC-H).
    (B) LSIL-Human papillomavirus (HPV)/mild dysplasia/cervical 
intraepithelial neoplasia 1 (CIN 1).
    (C) HSIL-moderate and severe dysplasia, carcinoma in situ (CIS)/CIN 
2 and CIN 3 or with features suspicious for invasion.
    (D) Squamous cell carcinoma.
    (ii) Glandular cell.
    (A) Atypical cells not otherwise specified (NOS) or specified in 
comments (endocervical, endometrial, or glandular).
    (B) Atypical cells favor neoplastic (endocervical or glandular).
    (C) Endocervical adenocarcinoma in situ.
    (D) Adenocarcinoma endocervical, adenocarcinoma endometrial, 
adenocarcinoma extrauterine, and adenocarcinoma NOS.
    (iii) Other malignant neoplasms.
    (2) The report of gynecologic slide preparations with conditions 
specified in paragraph (e)(1) of this section must be signed to reflect 
the technical supervisory review or, if a computer report is generated 
with signature, it must reflect an electronic signature authorized by 
the technical supervisor who performed the review.
    (3) All nongynecologic preparations are reviewed by a technical 
supervisor. The report must be signed to reflect technical supervisory 
review or, if a computer report is generated with signature, it must 
reflect an electronic signature authorized by the technical supervisor 
who performed the review.
    (4) Unsatisfactory specimens or slide preparations are identified 
and reported as unsatisfactory.
    (5) The report contains narrative descriptive nomenclature for all 
results.
    (6) Corrected reports issued by the laboratory indicate the basis 
for correction.
    (f) Record and slide retention. (1) The laboratory must retain all 
records and slide preparations as specified in Sec.  493.1105.
    (2) Slides may be loaned to proficiency testing programs in lieu of 
maintaining them for the required time period, provided the laboratory 
receives written acknowledgment of the receipt of slides by the 
proficiency testing program and maintains the acknowledgment to 
document the loan of these slides.
    (3) Documentation of slides loaned or referred for purposes other 
than proficiency testing must be maintained.
    (4) All slides must be retrievable upon request.
    (g) Automated and semi-automated screening devices. When performing 
evaluations using automated and semi-automated screening devices, the 
laboratory must follow manufacturer's instructions for preanalytic, 
analytic, and postanalytic phases of testing, as applicable, and meet 
the applicable requirements of this subpart K.
    (h) The laboratory must document all control procedures performed, 
as specified in this section.
      
Sec. 493.1276  Standard: Clinical cytogenetics

    (a) The laboratory must have policies and procedures for ensuring 
accurate and reliable patient specimen identification during the 
process of accessioning, cell preparation, photographing or other image 
reproduction technique, photographic printing, and reporting and 
storage of results, karyotypes, and photographs.
    (b) The laboratory must have records that document the following:
    (1) The media used, reactions observed, number of cells counted, 
number of cells karyotyped, number of chromosomes counted for each 
metaphase spread, and the quality of the banding.
    (2) The resolution is appropriate for the type of tissue or 
specimen and the type of study required based on the clinical 
information provided to the laboratory.
    (3) An adequate number of karyotypes are prepared for each patient.
    (c) Determination of sex must be performed by full chromosome 
analysis.
    (d) The laboratory report must include a summary and interpretation 
of the observations, number of cells counted and analyzed, and use the 
International System of Cytogenetic Nomenclature.
    (e) The laboratory must document all control procedures performed, 
as specified in this section.

Sec. 493.1278  Standard: Histocompatibility

    (a) General. The laboratory must meet the following requirements:
    (1) An audible alarm system must be used to monitor the storage 
temperature of specimens (donor and recipient) and reagents. The 
laboratory must have an emergency plan for alternate storage.
    (2) All patient specimens must be easily retrievable.
    (3) Reagent typing sera inventory prepared in-house must indicate 
source, bleeding date and identification number, reagent specificity, 
and volume remaining.
    (4) If the laboratory uses immunologic reagents (for example, 
antibodies, antibody-coated particles, or complement) to facilitate or 
enhance the isolation of lymphocytes, or lymphocyte subsets, the 
efficacy of the methods must be monitored with appropriate quality 
control procedures.
    (5) Participate in at least one national or regional cell exchange 
program, if available, or develop an exchange system with another 
laboratory in order to validate interlaboratory reproducibility.
    (b) HLA typing. The laboratory must do the following:
    (1) Use a technique(s) that is established to optimally define, as 
applicable, HLA Class I and II specificities.
    (2) HLA type all potential transplant recipients at a level 
appropriate to support clinical transplant protocol and donor 
selection.
    (3) HLA type cells from organ donors referred to the laboratory.
    (4) Use HLA antigen terminology that conforms to the latest report 
of the World Health Organization (W.H.O.) Committee on Nomenclature. 
Potential new antigens not yet approved by this committee must have a 
designation that cannot be confused with W.H.O. terminology.
    (5) Have available and follow written criteria for the following:
    (i) The preparation of cells or cellular extracts (for example, 
solubilized antigens and nucleic acids), as applicable to the HLA 
typing technique(s) performed.
    (ii) Selecting typing reagents, whether prepared in-house or 
commercially.
    (iii) Ensuring that reagents used for typing are adequate to define 
all HLA-A, B and DR specificities that are officially recognized by the 
most recent W.H.O. Committee on Nomenclature and for which reagents are 
readily available.
    (iv) The assignment of HLA antigens.
    (v) When antigen redefinition and retyping are required.
    (6) Check each HLA typing by testing, at a minimum the following:
    (i) A positive control material.
    (ii) A negative control material in which, if applicable to the 
technique performed, cell viability at the end of


[[Page 3712]]


incubation is sufficient to permit accurate interpretation of results. 
In assays in which cell viability is not required, the negative control 
result must be sufficiently different from the positive control result 
to permit accurate interpretation of results.
    (iii) Positive control materials for specific cell types when 
applicable (that is, T cells, B cells, and monocytes).
    (c) Disease-associated studies. The laboratory must check each 
typing for disease-associated HLA antigens using control materials to 
monitor the test components and each phase of the test system to ensure 
acceptable performance.
    (d) Antibody Screening. The laboratory must do the following:
    (1) Use a technique(s) that detects HLA-specific antibody with a 
specificity equivalent or superior to that of the basic complement-
dependent microlymphocytotoxicity assay.
    (2) Use a method that distinguishes antibodies to HLA Class II 
antigens from antibodies to Class I antigens to detect antibodies to 
HLA Class II antigens.
    (3) Use a panel that contains all the major HLA specificities and 
common splits. If the laboratory does not use commercial panels, it 
must maintain a list of individuals for fresh panel bleeding.
    (4) Make a reasonable attempt to have available monthly serum 
specimens for all potential transplant recipients for periodic antibody 
screening and crossmatch.
    (5) Have available and follow a written policy consistent with 
clinical transplant protocols for the frequency of screening potential 
transplant recipient sera for preformed HLA-specific antibodies.
    (6) Check each antibody screening by testing, at a minimum the 
following:
    (i) A positive control material containing antibodies of the 
appropriate isotype for the assay.
    (ii) A negative control material.
    (7) As applicable, have available and follow written criteria and 
procedures for antibody identification to the level appropriate to 
support clinical transplant protocol.
    (e) Crossmatching. The laboratory must do the following:
    (1) Use a technique(s) documented to have increased sensitivity in 
comparison with the basic complement-dependent microlymphocytotoxicity 
assay.
    (2) Have available and follow written criteria for the following:
    (i) Selecting appropriate patient serum samples for crossmatching.
    (ii) The preparation of donor cells or cellular extracts (for 
example, solubilized antigens and nucleic acids), as applicable to the 
crossmatch technique(s) performed.
    (3) Check each crossmatch and compatibility test for HLA Class II 
antigenic differences using control materials to monitor the test 
components and each phase of the test system to ensure acceptable 
performance.
    (f) Transplantation. Laboratories performing histocompatibility 
testing for transfusion and transplantation purposes must do the 
following:
    (1) Have available and follow written policies and protocols 
specifying the histocompatibility testing (that is, HLA typing, 
antibody screening, compatibility testing and crossmatching) to be 
performed for each type of cell, tissue or organ to be transfused or 
transplanted. The laboratory's policies must include, as applicable--
    (i) Testing protocols for cadaver donor, living, living-related, 
and combined organ and tissue transplants;
    (ii) Testing protocols for patients at high risk for allograft 
rejection; and
    (iIi) The level of testing required to support clinical transplant 
protocols (for example, antigen or allele level).
    (2) For renal allotransplantation and combined organ and tissue 
transplants in which a kidney is to be transplanted, have available 
results of final crossmatches before the kidney is transplanted.
    (3) For nonrenal transplantation, if HLA testing and final 
crossmatches were not performed prospectively because of an emergency 
situation, the laboratory must document the circumstances, if known, 
under which the emergency transplant was performed, and records of the 
transplant must reflect any information provided to the laboratory by 
the patient's physician.
    (g) The laboratory must document all control procedures performed, 
as specified in this section.

Sec.  493.1281  Standard: Comparison of test results

    (a) If a laboratory performs the same test using different 
methodologies or instruments, or performs the same test at multiple 
testing sites, the laboratory must have a system that twice a year 
evaluates and defines the relationship between test results using the 
different methodologies, instruments, or testing sites.
    (b) The laboratory must have a system to identify and assess 
patient test results that appear inconsistent with the following 
relevant criteria, when available:
    (1) Patient age.
    (2) Sex.
    (3) Diagnosis or pertinent clinical data.
    (4) Distribution of patient test results.
    (5) Relationship with other test parameters.
    (c) The laboratory must document all test result comparison 
activities.
     
Sec.  493.1282  Standard: Corrective actions

    (a) Corrective action policies and procedures must be available and 
followed as necessary to maintain the laboratory's operation for 
testing patient specimens in a manner that ensures accurate and 
reliable patient test results and reports.
    (b) The laboratory must document all corrective actions taken, 
including actions taken when any of the following occur:
    (1) Test systems do not meet the laboratory's verified or 
established performance specifications, as determined in Sec.  
493.1253(b), which include but are not limited to--
    (i) Equipment or methodologies that perform outside of established 
operating parameters or performance specifications;
    (ii) Patient test values that are outside of the laboratory's 
reportable range of test results for the test system; and
    (iii) When the laboratory determines that the reference intervals 
(normal values) for a test procedure are inappropriate for the 
laboratory's patient population.
    (2) Results of control or calibration materials, or both, fail to 
meet the laboratory's established criteria for acceptability. All 
patient test results obtained in the unacceptable test run and since 
the last acceptable test run must be evaluated to determine if patient 
test results have been adversely affected. The laboratory must take the 
corrective action necessary to ensure the reporting of accurate and 
reliable patient test results.
    (3) The criteria for proper storage of reagents and specimens, as 
specified under Sec.  493.1252(b), are not met.

Sec. 493.1283  Standard: Test records

    (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


[[Page 3713]]


of the personnel who performed the test(s).
    (b) Records of patient testing including, if applicable, instrument 
printouts, must be retained.
      
Sec. 493.1289  Standard: Analytic systems assessment

    (a) The laboratory must establish and follow written policies and 
procedures for an ongoing mechanism to monitor, assess, and when 
indicated, correct problems identified in the analytic systems 
specified in Sec. Sec.  493.1251 through 493.1283.
    (b) The analytic systems assessment must include a review of the 
effectiveness of corrective actions taken to resolve problems, revision 
of policies and procedures necessary to prevent recurrence of problems, 
and discussion of analytic systems assessment reviews with appropriate 
staff.
    (c) The laboratory must document all analytic systems assessment 
activities.


Postanalytic Systems

Sec.  493.1290  Condition: Postanalytic systems

    Each laboratory that performs nonwaived testing must meet the 
applicable postanalytic systems requirements in Sec.  493.1291 unless 
HHS approves a procedure, specified in Appendix C of the State 
Operations Manual (CMS Pub. 7) that provides equivalent quality 
testing. The laboratory must monitor and evaluate the overall quality 
of the postanalytic systems and correct identified problems as 
specified in Sec.  493.1299 for each specialty and subspecialty of 
testing performed.

Sec.  493.1291  Standard: Test report

    (a) The laboratory must have adequate manual or electronic systems 
in place to ensure test results and other patient-specific data are 
accurately and reliably sent from the point of data entry (whether 
interfaced or entered manually) to final report destination, in a 
timely manner. This includes the following:
    (1) Results reported from calculated data.
    (2) Results and patient-specific data electronically reported to 
network or interfaced systems.
    (3) Manually transcribed or electronically transmitted results and 
patient-specific information reported directly or upon receipt from 
outside referral laboratories, satellite or point-of-care testing 
locations.
    (b) Test report information maintained as part of the patient's 
chart or medical record must be readily available to the laboratory and 
to CMS or a CMS agent upon request.
    (c) The test report must indicate the following:
    (1) For positive patient identification, either the patient's name 
and identification number, or an 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.
    (d) Pertinent ``reference intervals'' or ``normal'' values, as 
determined by the laboratory performing the tests, must be available to 
the authorized person who ordered the tests and, if applicable, the 
individual responsible for using the test results.
    (e) The laboratory must, upon request, make available to clients a 
list of test methods employed by the laboratory and, as applicable, the 
performance specifications established or verified as specified in 
Sec.  493.1253. In addition, information that may affect the 
interpretation of test results, for example test interferences, must be 
provided upon request. Pertinent updates on testing information must be 
provided to clients whenever changes occur that affect the test results 
or interpretation of test results.
    (f) Test results must be released only to authorized persons and, 
if applicable, the individual responsible for using the test results 
and the laboratory that initially requested the test.
    (g) The laboratory must immediately alert the individual or entity 
requesting the test and, if applicable, the individual responsible for 
using the test results when any test result indicates an imminent life-
threatening condition, or panic or alert values.
    (h) When the laboratory cannot report patient test results within 
its established time frames, the laboratory must determine, based on 
the urgency of the patient test(s) requested, the need to notify the 
appropriate individual(s) of the delayed testing.
    (i) If a laboratory refers patient specimens for testing--
    (1) The referring laboratory must not revise results or information 
directly related to the interpretation of results provided by the 
testing laboratory;
    (2) The referring laboratory may permit each testing laboratory to 
send the test result directly to the authorized person who initially 
requested the test. The referring laboratory must retain or be able to 
produce an exact duplicate of each testing laboratory's report; and
    (3) The authorized person who orders a test must be notified by the 
referring laboratory of the name and address of each laboratory 
location where the test was performed.
    (j) All test reports or records of the information on the test 
reports must be maintained by the laboratory in a manner that permits 
ready identification and timely accessibility.
    (k) When errors in the reported patient test results are detected, 
the laboratory must do the following:
    (1) Promptly notify the authorized person ordering the test and, if 
applicable, the individual using the test results of reporting errors.
    (2) Issue corrected reports promptly to the authorized person 
ordering the test and, if applicable, the individual using the test 
results.
    (3) Maintain duplicates of the original report, as well as the 
corrected report.

Sec.  493.1299  Standard: Postanalytic systems assessment

    (a) The laboratory must establish and follow written policies and 
procedures for an ongoing mechanism to monitor, assess and, when 
indicated, correct problems identified in the postanalytic systems 
specified in Sec.  493.1291.
    (b) The postanalytic systems assessment must include a review of 
the effectiveness of corrective actions taken to resolve problems, 
revision of policies and procedures necessary to prevent recurrence of 
problems, and discussion of postanalytic systems assessment reviews 
with appropriate staff.
    (c) The laboratory must document all postanalytic systems 
assessment activities.

This page last reviewed: 7/7/2004
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