CMS SOM App. C, Tag D5445

(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--

(d)(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.

(d)(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.

(d)(3) At least once each day patient specimens are assayed or examined

perform the following for:

Interpretive Guidelines §493.1256(d)

INDIVIDUALIZED QUALITY CONTROL PLAN (IQCP)

INTRODUCTION

§493.1250 provides for HHS’ approval of a procedure that provides equivalent quality

testing as an alternative to meeting the Analytic Systems requirements in §493.1251 -

§493.1283. CMS has approved use of an equivalent quality control procedure, which

permits laboratories to develop and customize laboratory-specific quality control

procedures for their healthcare setting(s). This procedure is termed Individualized

Quality Control Plan (IQCP).

An IQCP is composed of three parts: a Risk Assessment (RA), a Quality Control Plan

(QCP), and a Quality Assessment (QA) plan. The RA is the identification, evaluation,

and documentation of potential failures and errors in a testing process. The QCP

documents a laboratory’s standard operating procedure that describes the practices,

resources, and procedures to control the quality of a test process. The QA consists of the

laboratory’s written policies and procedure for the ongoing monitoring of the

effectiveness of their IQCP.

IQCP is only available for select quality control requirements, which are identified below

in Table 1 “Eligibility for IQCP.”

When the manufacturers’ instructions do not address quality control or those

instructions are less stringent than the regulatory control procedures for Analytic

Systems (see Table 1), the laboratory needs to follow the regulatory requirements

or develop an IQCP. Laboratories have the flexibility to follow all regulatory

requirements as written or customize their control procedures using the IQCP

procedure. Whichever option is selected laboratories are not permitted to establish

quality control procedures that are less stringent than those specified by the

manufacturer of the test system.

LABORATORY DIRECTOR RESPONSIBILITIES

Under subpart M, the laboratory director is responsible for ensuring that quality

control (use D6020 or D6093 as appropriate) and quality assessment programs are

established and maintained to assure the quality of laboratory services, including the

identification of failures in quality as they occur.

The laboratory director is responsible for deciding whether a laboratory will seek to

meet its CLIA quality control obligations through IQCP, and if the laboratory

director decides to do so, the laboratory director is also responsible for ensuring that

the QCP the laboratory develops meets the IQCP requirements.

The laboratory director must consider the laboratory’s clinical and legal responsibility

for providing accurate, reliable and timely patient test results (§493.1407 or §493.1445)

prior to implementing a QCP that is less stringent than the applicable Analytic Systems

control regulations listed in Table 1, Eligibility for IQCP.

REGULATORY CONSIDERATIONS WHEN USING IQCP

All CLIA regulations, other than those specifically designated as eligible for IQCP in

Table 1, Eligibility for IQCP, continue to be in force and must be followed.

Table 1, Eligibility for IQCP, lists those specialties/subspecialties and general

regulations which are designated as “eligible” for IQCP, that is, those

specialties/subspecialties and general regulations for which the laboratory has the

flexibility to develop control procedures using the IQCP procedure. Table 1 also lists

those specialties/subspecialties and specialty/subspecialty regulations which are not

eligible for IQCP.

• The first column lists the CLIA specialties/subspecialties: Bacteriology,

Mycobacteriology, Mycology, Parasitology, Virology, Syphilis Serology, General

Immunology, Routine Chemistry, Urinalysis, Endocrinology, Toxicology,

Hematology, Immunohematology, Clinical Cytogenetics, Radiobioassay,

Histocompatibility, Pathology, Histopathology, Oral Pathology and Cytology.

• The second column indicates whether or not each specialty/subspecialty is

eligible for IQCP. The specialties/subspecialties eligible for IQCP are;

Bacteriology, Mycobacteriology, Mycology, Parasitology, Virology, Syphilis

Serology, General Immunology, Routine Chemistry, Urinalysis,

Endocrinology, Toxicology, Hematology, Immunohematology, Clinical

Cytogenetics, Radiobioassay and Histocompatibility. The

specialties/subspecialties not eligible for IQCP are Pathology, Histopathology,

Oral Pathology and Cytology.

• The third column lists the general regulations that are eligible for IQCP and may

be applied to the eligible specialty/subspecialties listed in column one:

§493.1256(d)(3)-(5) and §493.1256(e)(1)-(4).

• The fourth column lists the specialty/subspecialty regulations that are

eligible for IQCP: §493.1261, §493.1262, §493.1263, §493.1264,

§493.1265, §493.1267(b), (c), §493.1269, and §493.1278(b)(6), (c), (d)(6),

(e)(3).

• The fifth column lists the specialty/subspecialty regulations that are not

eligible for IQCP: §493.1267(a), (d), §493.1271, §493.1276, §493.1278(a),

(b)(1-5), (d)(1-5), (d)(7), (e)(1-2), (f), (g), §493.1273 and §493.1274.

Table 1: Eligibility for IQCP

CLIA Specialty/

Subspecialty

Eligible

for

IQCP?

General

Regulations

Eligible for IQCP

Specialty/

Subspecialty

Regulations

Eligible for IQCP

Specialty/

Subspecialty Regulations

NOT Eligible for IQCP

Bacteriology Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

§493.1261 N/A

Mycobacteriology Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

§493.1262 N/A

Mycology Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

§493.1263 N/A

Parasitology Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

§493.1264 N/A

Virology Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

§493.1265 N/A

Syphilis Serology Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

N/A N/A

General Immunology Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

N/A N/A

Routine Chemistry Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

§493.1267(b), (c) §493.1267(a),

(d)

Urinalysis Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

N/A N/A

Endocrinology Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

N/A N/A

Toxicology Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

N/A N/A

Hematology Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

§493.1269 N/A

Immunohematology Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

N/A §493.1271

Clinical Cytogenetics Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

N/A §493.1276

Radiobioassay Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

N/A N/A

Histocompatibility Yes §493.1256(d)(3)-(5)

§493.1256(e)(1)-(4)

§493.1278(b)(6), (c),

(d)(6), (e)(3)

§493.1278(a), (b)(1-5),

(d)(1-5), (d)(7),

(e)(1-2), (f), (g)

Pathology No None (Not eligible

for IQCP)

N/A N/A

Histopathology No None (Not eligible

for IQCP)

N/A §493.1273

Oral Pathology No None (Not eligible

for IQCP)

N/A N/A

Cytology No None (Not eligible)

for IQCP)

N/A §493.1274

Probe(s) §493.1256(d)

For each test system, does the laboratory perform quality control testing procedures as

specified in the manufacturer’s instructions? Use D5411.

If the manufacturer’s instructions are less stringent than the CLIA regulatory

requirements for control procedures, did the laboratory perform an IQCP or are they

following the CLIA regulatory requirements for control procedures?

As stated above, an IQCP must include:

• Risk Assessment (RA)

• Quality Control Plan (QCP)

• Quality Assessment (QA)

Risk Assessment

Risk assessment is the identification and evaluation of potential failures and sources of

errors in a testing process.

Risk assessments for IQCP must include, at a minimum, an evaluation of the

following five components:

1. Specimen

2. Test system

3. Reagent

4. Environment

5. Testing personnel

The scope of risk assessments must encompass the entire testing process - preanalytic,

analytic, and postanalytic phases - and include, at a minimum, the evaluation of the five

risk assessment components listed above for each test for which the laboratory wishes

to employ IQCP. Use D5445.

The laboratory director has the responsibility for ensuring that the risk assessment

considers the CLIA Quality System requirements at 42 C.F.R. 493, Subpart K for

accurate, reliable, and timely test results and that test result quality is appropriate for

patient care. Re-evaluation of the RA must be considered by the director or his/her

designee when changes occur in any of the following components: specimen, test

system, reagent, environment and testing personnel.

Conducting the Risk Assessment

To conduct a risk assessment, the laboratory must identify the sources of potential

failures and errors for a testing process, and evaluate the frequency and impact of those

failures and sources of error on test quality.

In-house data, established by the laboratory in its own environment and by its own

personnel, must be utilized to demonstrate that the stability of the test system as it is

used in that laboratory supports the number and frequency of the QC documented in the

QCP. Use D5425. Data from verification or establishment of performance

specifications, historical (existing) QC data, and data/documentation compiled to meet

other existing CLIA Quality System regulations at 42 C.F.R. 493, Subpart K can be

included. Published data or data from manufacturers (e.g. package inserts) may be

taken into consideration, but may not be used as the sole criteria for decision-making.

The laboratory must document all activities completed for the risk assessment,

including data to support their risk assessment decisions. Use D5481. All RA

documentation must be maintained for at least two years after the corresponding QCP

has been discontinued. Use D3029.

NOTE: Manufacturer-provided tools and templates, if available, may be helpful for

laboratories implementing IQCP; however, laboratories will need to supplement

these materials with laboratory-specific information as part of the Risk Assessment.

The manufacturer information is not sufficient in and of itself.

Laboratories must assess information provided by manufacturers as part of the RA, such

as the manufacturer’s instructions (e.g. intended use, limitations, interferences,

recommendations). If additional information is required to conduct the risk assessment,

that is not available in the manufacturer’s instructions, the laboratory should contact the

manufacturer to request the needed information.

The following list contains additional possible sources of information for conducting a

risk assessment:

• Regulatory requirements

• Manufacturer’s package insert (including intended use, limitations,

environmental requirements, QC frequency, specimen requirements, reagent

storage, maintenance, calibration, interfering substances, etc.)

• Manufacturer’s operator manual

• Troubleshooting guide

• Manufacturers’ alerts and bulletins

• Verification or establishment of performance specifications

• Testing personnel qualifications, training and competency records

• QC data

• Proficiency testing data

• QA information, including corrective action

• Scientific publications

• Other information as appropriate

In laboratories with multiple identical devices (same make and model), a single risk

assessment may be performed for the test system. However, differences in testing

personnel and environments where the device will be used must be taken into

consideration when performing the risk assessment; therefore, there may be a need to

customize a QCP for each individual location and/or device.

NOTE: Multiple devices may be included in a single QCP; however, performance

specifications must be established or verified for each individual device and each analyte.

Probes §493.1256(d)

Does the laboratory’s RA support its procedures for testing quality control samples,

including the frequency of testing? Use D5445.

Has the laboratory included all five components and all phases of testing in their risk

assessment, and have they reasonably identified and evaluated the potential failures and

sources of error? Use D5445.

Has the laboratory conducted a risk assessment for each location where testing is

performed on multiple numbers of identical devices (i.e. same make, model)?

For example, has the laboratory conducted a risk assessment with respect to:

• Multiple laboratory/testing locations within a single CLIA number

• Point-of -care devices throughout health care/laboratory systems

• Multiple identical devices or kits in a single location

• Differences in testing personnel

Has the laboratory’s RA identified the sources of potential failures and sources of error

contained in the most current version of the manufacturer’s instructions?

Has the laboratory documented all activities completed for the risk assessment? Does

the laboratory have documentation, including data, to support their risk assessment

decisions? Use D5481.

SPECIMEN

Probe §493.1256(d)

Has the laboratory identified and evaluated the potential failures and sources of error

in the preanalytic phase, as applicable, for:

• Patient preparation

• Specimen collection

• Specimen labeling

• Specimen storage, preservation and stability

• Specimen transportation

• Specimen processing

• Specimen acceptability and rejection

• Specimen referral

TEST SYSTEM

The risk assessment must include consideration of the manufacturer instructions for

function checks and maintenance checks. In addition, the risk assessment should take

into consideration the laboratory’s test volume, and intended use of the test results (i.e.

screening or diagnostic).

Additional factors to consider in the risk assessment for analyte and test systems may

include, but are not limited to potential failures and sources of error due to:

• Inadequate sampling

• Clot detection capabilities

• Capabilities for detection of interfering substances (e.g., hemolysis, lipemia,

icterus, turbidity)

• Calibration associated issues

• Mechanical/electronic failure of test system

• Optics

• Pipettes or pipettors

• Barcode readers

• Failure of system controls and function checks

• Built-in procedural and electronic controls (internal controls)

• External or internal liquid quality control (assayed vs. unassayed)

• Temperature monitors and controllers

• Software/Hardware

• Transmission of data to Laboratory Information System

• Result reporting

REAGENT

Factors to consider in the risk assessment for reagents, quality control materials,

calibrators, and similar materials may include, but are not limited to potential failures

and sources of error related to:

• Shipping/Receiving

• Storage condition requirements

• Expiration Date (may vary based on storage requirements)

• Preparation

Probes §493.1256(d)

Has the laboratory assessed potential test system failures or sources of error, which may

result from reagent, quality control material, and calibrator contamination or

deterioration and reagent lot variation?

Has the laboratory assessed potential test system failures or sources of error due to the

risk of inadvertently mixing reagents from different kits or lot numbers, if applicable?

ENVIRONMENT

Probes §493.1256(d)

Has the laboratory evaluated environmental conditions, which may affect test

system performance including, but not limited to potential failures and sources

of error due to:

• Temperature

• Airflow/ventilation

• Light intensity

• Noise and vibration

• Humidity

• Altitude

• Dust

• Water

• Utilities (e.g. Electrical failure/power supply variance or surge)

• Adequate space

Has the laboratory evaluated potential failures and sources of error due to the

transport of instruments and reagents in a mobile laboratory?

TESTING PERSONNEL

Testing personnel must participate in the process of conducting the risk

assessment. It is not necessary for all personnel to be involved.

Probe §493.1256(d)

Has the laboratory assessed the potential failures and sources of error due to testing

personnel by evaluating the following:

• Training

• Competency

• Appropriate education and experience qualifications

• Adequate staffing

After the laboratory has identified the sources of potential failures and errors for a testing

process and evaluated the frequency and impact of those failures and errors on test

quality, the resulting risk assessment is then used to develop the Quality Control Plan

(QCP).

Quality Control Plan

A QCP is a document that describes the practices, resources, and procedures to

control the quality of a particular test process. The QCP must ensure accurate,

reliable and timely test results, and that test result quality is appropriate for patient

care. The QCP must be available to, and followed by, laboratory personnel. Use

D5401.

The QCP must provide for the immediate detection of errors that occur due to test

system failure, adverse environmental conditions, and operator performance. It must

also monitor, over time, the accuracy and precision of test performance that may be

influenced by changes in the test system, environmental conditions, or variance in

operator performance. Use D5441.

The QCP must at least include the number, type, frequency of testing and

criteria for acceptable result(s) of the quality control(s). Use D5441 or D5469,

as appropriate.

If indicated by the evaluation of the risk assessment, the QCP may also include:

• Electronic controls

• Procedural controls

• Training and competency assessment

• Other specified quality control activities

Laboratories implementing IQCP for new tests are encouraged to perform control

procedures at more frequent intervals during initial implementation, allowing the

laboratory to identify performance issues that could indicate a need to adjust the QCP.

There must be documented evidence that the laboratory director has approved, signed,

and dated the QCP (§493.1251(d)). The task of development and implementation of

QCPs may be delegated (in writing) to a qualified individual (§493.1407(e)(14) or

§493.1445(e)(15)). However, the laboratory director has the ultimate responsibility for

the proper development and implementation of a QCP. (§493.1407(b) or §493.1445(b)).

Use D5407. Re-evaluation of the QCP must be considered by the director or his/her

designee when changes occur in any of the following components: specimen, test

system, reagent, environment and testing personnel.

Probes §493.1256(d)

Does the laboratory have a written QCP for each test system, as applicable? Use D5441

or D5445, as appropriate.

Does the QCP specify the number, type, and frequency of testing of the quality control

material(s)? Does the QCP provide for immediate detection of errors? Use D5441.

Does the QCP contain criteria to determine acceptable quality control results? Use

D5469.

Does the QCP require that the laboratory perform QC as specified by the

manufacturer’s instructions? Regardless, if the laboratory is performing QC less

frequently than required by the manufacturer, use D5411 or D5445, as

appropriate.

Is there documented evidence of laboratory director approval of the QCP before it

was put into use? Use D5407.

Quality Assessment

All IQCP Quality Assessment monitoring must be part of the laboratory’s overall

Quality Assessment plan. The laboratory must establish and follow written policies and

procedures for the ongoing monitoring of the effectiveness of their IQCP. The

monitoring must include, but is not limited to, the following components:

1. Specimen

2. Test System

3. Reagent(s)

4. Environment

5. Testing Personnel

Re-evaluation of the RA and the QCP must be considered by the director or his/her

designee when changes occur in any of the above components.

Laboratories implementing IQCP for new tests are encouraged to perform monitoring

activities at more frequent intervals during initial implementation, allowing the

laboratory to identify performance issues that could indicate a need to adjust the QCP.

Documents to consider for QA review may include, but are not limited to:

• QC review

• Proficiency testing records (e.g. scores, testing failures, trends)

• Patient results review

• Specimen rejection logs

• Turnaround time reports

• Records of preventive measures, corrective actions, & follow-up

• Personnel Competency Records

When the laboratory discovers a testing process failure, the laboratory must conduct an

investigation to identify the cause of the failure, its impact on patient care, appropriate

corrective action for affected patients and appropriate modifications to their QCP to

prevent recurrence, as applicable. The investigation must include documentation of all

corrections, corresponding corrective actions for all patients affected by the testing

process failure, and evaluation of the effectiveness of the corrective action(s). The

laboratory must implement the correction(s) and corresponding corrective action(s)

necessary to resolve the failure and reduce the risk of recurrence of the failure in the

future. If necessary, the laboratory must update the risk assessment with the new

information and modify the QCP, as needed.

Probes §493.1256(d)

Has the laboratory established written policies and procedures for the ongoing

monitoring of the QCP (use D5391, D5791 or D5891 as appropriate) and evaluation of

its effectiveness? (Use D5393, D5793 or D5893 as appropriate)

In the event of a testing process failure, has the laboratory evaluated all patient test results

since the last acceptable quality control? Use D5783.