CMS SOM App. C, Tag D5209

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.

Interpretive Guidelines §493.1235

Refer to §§493.1413(b)(8) and 493.1451(b)(8) for specific testing personnel competency

requirements and refer to §493.1407(e)(12) and §493.1445(e)(13) for establishing

policies to monitor each individual’s competency and identify remedial training or

continuing education needs.

Cite D5209 when the laboratory has developed but is not following personnel

competency policies and procedures. Competency assessment applies to all persons that

perform patient testing and/or report patient test results, including but not limited to

technical and clinical consultants, technical supervisors, general supervisors, and other

laboratory staff.

NOTE: If the laboratory director (LD) is the only individual performing patient testing

and/or reporting patient test results, they must establish and document a minimal level of

proficiency in order to ensure that they maintain the required competency for accurate

and reliable testing and reporting. Cite D5209 when the laboratory has developed, but is

not following, personnel competency policies and procedures for the LD.

Competency Assessment Guidelines

Technical consultant, clinical consultant, technical supervisor, general supervisor

Documented competency assessment is required for the following named positions on the

Form 209: technical consultant, clinical consultant, technical supervisor, and general

supervisor. The laboratory must have policies and procedures to assess competency

based on the position responsibilities listed in Subpart M and these assessments must be

performed at a frequency determined by the laboratory. Cite D5209 (§493.1235). If these

people perform testing on patient specimens, they are required to have the six required

procedures in their competency assessment in addition to a competency assessment based

on their federal regulatory responsibilities (see §493.1413(b)(8) / §493.1451(b)(8)).

Testing personnel in laboratories with a PPM certificate

A laboratory with a Certificate for Provider-performed Microscopy (PPM)

Procedures must establish and follow written policies for competency assessment, as

required in 42 CFR §493.1235. An educational module with a quiz and photos may be

used to assess testing personnel competency. The laboratory must have a mechanism for

assessing testing personnel competency. Competency assessment is the laboratory

director’s responsibility as outlined at §493.1359. Participation in an external PT

program may or may not suffice to meet the competency assessment requirement,

depending on the unique circumstances in the PPM laboratory.

The laboratory director should consider whether the assessment evaluates:

• Training and specific skills for test performance

• Proficiency in using a microscope

• Ability to detect and identify cellular elements present in a specimen

• Ability to differentiate significant elements in the specimen from debris or

artifacts

KEY POINT: In situations in which more than one citation may be used, choose the one

that is most specific to the situation. This will best allow the laboratory to understand the

problem and correct it.

Probes §493.1235

How does the laboratory evaluate the competency of its employees?

If the laboratory uses non-testing personnel to perform preanalytic functions how does it

ensure their competency?

If a laboratory utilizes a consultant, how does the laboratory determine if the consultant is

competent? Does the laboratory have a policy/procedure to determine consultant

competency? Use D6030 or D6103.

How does the laboratory evaluate personnel for consistency in slide review (e.g., ANA,

manual differential, urine sediment)?