42 C.F.R. §§ 493.1230–493.1256

§493.1230. Condition: General laboratory systems.

42 C.F.R. § 493.1230

Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in §§ 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 § 493.1239 for each specialty and subspecialty of testing performed.

Notes, amendments, and revision history

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

§493.1231. Standard: Confidentiality of patient information.

42 C.F.R. § 493.1231

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

Notes, amendments, and revision history

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

§493.1232. Standard: Specimen identification and integrity.

42 C.F.R. § 493.1232

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.

Notes, amendments, and revision history

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

§493.1233. Standard: Complaint investigations.

42 C.F.R. § 493.1233

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.

Notes, amendments, and revision history

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

§493.1234. Standard: Communications.

42 C.F.R. § 493.1234

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 person who orders or receives test results.

Notes, amendments, and revision history

Amendments

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

Amendments

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]

§493.1235. Standard: Personnel competency assessment policies.

42 C.F.R. § 493.1235

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.

Notes, amendments, and revision history

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

§493.1236. Standard: Evaluation of proficiency testing performance.

42 C.F.R. § 493.1236

(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.

Notes, amendments, and revision history

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

§493.1239. Standard: General laboratory systems quality assessment.

42 C.F.R. § 493.1239

(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 systems requirements specified at §§ 493.1231 through 493.1236.

(b)

The general laboratory systems quality 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 quality assessment reviews with appropriate staff.

(c)

The laboratory must document all general laboratory systems quality assessment activities.

Notes, amendments, and revision history

Amendments

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

Amendments

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]

§493.1240. Condition: Preanalytic systems.

42 C.F.R. § 493.1240

Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in §§ 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 § 493.1249 for each specialty and subspecialty of testing performed.

Notes, amendments, and revision history

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

§493.1241. Standard: Test request.

42 C.F.R. § 493.1241

(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.

(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.

Notes, amendments, and revision history

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

§493.1242. Standard: Specimen submission, handling, and referral.

42 C.F.R. § 493.1242

(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.

Notes, amendments, and revision history

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

§493.1249. Standard: Preanalytic systems quality assessment.

42 C.F.R. § 493.1249

(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 §§ 493.1241 through 493.1242.

(b)

The preanalytic systems quality 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 quality assessment reviews with appropriate staff.

(c)

The laboratory must document all preanalytic systems quality assessment activities.

Notes, amendments, and revision history

Amendments

[68 FR 3703, Jan. 24, 2003; 68 FR 3703, Aug. 22, 2003]

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

Amendments

[68 FR 3703, Jan. 24, 2003; 68 FR 3703, Aug. 22, 2003]

§493.1250. Condition: Analytic systems.

42 C.F.R. § 493.1250

Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in §§ 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 § 493.1289 for each specialty and subspecialty of testing performed.

Notes, amendments, and revision history

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

§493.1251. Standard: Procedure manual.

42 C.F.R. § 493.1251

(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 § 493.1242.

(2)

Microscopic examination, including the detection of inadequately prepared slides.

(3)

Step-by-step performance of the procedure, including test calculations and interpretation of results.

(4)

Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing.

(5)

Calibration and calibration verification procedures.

(6)

The reportable range for test results for the test system as established or verified in § 493.1253.

(7)

Control procedures.

(8)

Corrective action to take when calibration or control results fail to meet the laboratory's criteria for acceptability.

(9)

Limitations in the test methodology, including interfering substances.

(10)

Reference intervals (normal values).

(11)

Imminently life-threatening test results, or panic or alert values.

(12)

Pertinent literature references.

(13)

The laboratory's system for entering results in the patient record and reporting patient results including, when appropriate, the protocol for reporting imminently life-threatening results, or panic, or alert values.

(14)

Description of the course of action to take if a test system becomes inoperable.

(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 § 493.1105(a)(2).

Notes, amendments, and revision history

Amendments

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

Amendments

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]

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

42 C.F.R. § 493.1252

(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 § 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, 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.

Notes, amendments, and revision history

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

§493.1253. Standard: Establishment and verification of performance specifications.

42 C.F.R. § 493.1253

(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), 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.

Notes, amendments, and revision history

Amendments

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

Amendments

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]

§493.1254. Standard: Maintenance and function checks.

42 C.F.R. § 493.1254

(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.

Notes, amendments, and revision history

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

§493.1255. Standard: Calibration and calibration verification procedures.

42 C.F.R. § 493.1255

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 § 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 § 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.

Notes, amendments, and revision history

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

§493.1256. Standard: Control procedures.

42 C.F.R. § 493.1256

(a)

For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process.

(b)

The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in § 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 §§ 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, (except those specifically referenced in § 493.1261(a)(3)) 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.

Notes, amendments, and revision history

Amendments

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]

Source

Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.

Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

Amendments

[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]