---
kind: "range"
citation: "42 C.F.R. §§ 493.1355–493.1365"
title: "42"
from: "493.1355"
to: "493.1365"
count: 6
url: "https://uscodex.org/cfr/42/493.1355..493.1365"
---

# §493.1355. Condition: Laboratories performing PPM procedures; laboratory director.


The laboratory must have a director who meets the qualification requirements of [§ 493.1357](/cfr/42/493.1357.md) and provides overall management and direction in accordance with [§ 493.1359](/cfr/42/493.1359.md).


# §493.1357. Standard; laboratory director qualifications.


The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of PPM procedures as specified in [§ 493.19(c)](/cfr/42/493.19.md?p=c) and must be eligible to be an operator of a laboratory within the requirements of [subpart R](/cfr/42/subpartR.md) of this part.

- (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if the licensing is required.
- (b) The laboratory director must meet one of the following requirements:
  - (1) Be a physician, as defined in [§ 493.2](/cfr/42/493.2.md).
  - (2) Be a midlevel practitioner, as defined in [§ 493.2](/cfr/42/493.2.md), authorized by a State to practice independently in the State in which the laboratory is located.
  - (3) Be a dentist, as defined in [§ 493.2](/cfr/42/493.2.md).

# §493.1359. Standard; PPM laboratory director responsibilities.


The laboratory director is responsible for the overall operation and administration of the laboratory, including the prompt, accurate, and proficient reporting of test results. The laboratory director must—

- (a) Direct no more than five laboratories; and
- (b) Ensure that any procedure listed under [§ 493.19(c)](/cfr/42/493.19.md?p=c)—
  - (1) Is personally performed by an individual who meets the qualification requirements in [§ 493.1363](/cfr/42/493.1363.md); and
  - (2) Is performed in accordance with applicable requirements in this subpart and subparts H, J, and K of this part;
- (c) Evaluate the competency of all testing personnel and ensure that the staff maintains their competency to perform test procedures and report test results promptly, accurately, and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to—
  - (1) Direct observations of routine patient test performance, including, if applicable, specimen handling, processing, and testing;
  - (2) Monitoring the recording and reporting of test results;
  - (3) Review of test results or worksheets;
  - (4) Assessment of test performance through testing internal blind testing samples or external proficiency testing samples; and
  - (5) Assessment of problem solving skills; and
- (d) Evaluate and document the performance of individuals responsible for PPM testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations and documentation must be performed at least annually.

# §493.1361. Condition: Laboratories performing PPM procedures; testing personnel.


The laboratory must have a sufficient number of individuals who meet the qualification requirements of [§ 493.1363](/cfr/42/493.1363.md) to perform the functions specified in [§ 493.1365](/cfr/42/493.1365.md) for the volume and complexity of testing performed.


# §493.1363. Standard: PPM testing personnel qualifications.


Each individual performing PPM procedures must—

- (a) Possess a current license issued by the State in which the laboratory is located if the licensing is required; and
- (b) **Meet one of the following requirements—**
  - (1) Be a physician, as defined in [§ 493.2](/cfr/42/493.2.md).
  - (2) Be a midlevel practitioner, as defined in [§ 493.2](/cfr/42/493.2.md), under the supervision of a physician or in independent practice if authorized by the State in which the laboratory is located.
  - (3) Be a dentist as defined in [§ 493.2](/cfr/42/493.2.md) of this part.

# §493.1365. Standard; PPM testing personnel responsibilities.


The testing personnel are responsible for specimen processing, test performance, and for reporting test results. Any PPM procedure must be—

- (a) **Personally performed by one of the following practitioners—**
  - (1) A physician during the patient's visit on a specimen obtained from his or her own patient or from a patient of a group medical practice of which the physician is a member or employee.
  - (2) A midlevel practitioner, under the supervision of a physician or in independent practice if authorized by the State in which the laboratory is located, during the patient's visit on a specimen obtained from his or her own patient or from the patient of a clinic, group medical practice, or other health care provider, in which the midlevel practitioner is a member or an employee.
  - (3) A dentist during the patient's visit on a specimen obtained from his or her own patient or from a patient of a group dental practice of which the dentist is a member or an employee; and
- (b) **Performed using a microscope limited to a brightfield or a phase/contrast microscope.**