---
kind: "range"
citation: "42 C.F.R. §§ 493.1231–493.1236"
title: "42"
from: "493.1231"
to: "493.1236"
count: 6
url: "https://uscodex.org/cfr/42/493.1231..493.1236"
---

# §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.


# §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.


# §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.


# §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 person who orders or receives test results.


# §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.


# §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](/cfr/42/subpartI.md) 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.