Volume 2025 | No. 2
SURVEYOR
CLINICAL LABORATORY
Compliance tips for:
Examples of ACHC Surveyor findings: ■ External controls are not being run on new lots/shipments of urine pregnancy kits. ■ Internal quality control tests were not documented. ■ Two levels of urine HCG quality control were not performed monthly as required by the manufacturer’s instruction. ■ External quality control was not being run monthly as required by the manufacturer’s instructions. Compliance tips for:
The standard requires that the laboratory document the date and time it receives each specimen. Policy must define criteria for acceptance, and the procedure for processing based on the type of testing to be performed. Unacceptable specimens are likewise defined, with the procedure for notifying an authorized person that the specimen was unsuitable for testing and the disposition of the rejected specimen. ■ Audit policy and procedure to ensure that all testing specialties are addressed with processing criteria. ■ Audit documentation for date and time of receipt. ■ Educate staff on documentation requirements. ■ Review and update policies and procedures whenever test systems change.
Nerd Newbies (understand the requirement)
Nerd Apprentices (audit for excellence)
Quality control is expected for each new shipment of kits/reagents, each change in lot number, and each new operator. Controls are handled the same way as patient samples and by the same personnel who perform patient testing.
Nerd Newbies (understand the requirement)
Nerd Trailblazers (prepare the path for others)
■ Audit external control runs. ■ Audit internal quality control documentation.
Nerd Apprentices (audit for excellence)
CHAPTER 06: ANALYTIC SYSTEMS 06.02.01 Essential conditions Frequency of the citation: 24%
■ Review contract/agreement templates to ensure that all required elements are captured. ■ Schedule contract review prior to expiration/renewal.
Nerd Trailblazers (prepare the path for others)
Overview of the requirement: Water quality, temperature, humidity, and protection from variations in electrical current are conditions that must be defined for storage of reagents/specimens, operation of test systems, and test results reported. When conditions are out of range, the laboratory must document corrective actions. Comment on deficiencies: Compliance is assessed through interviews and document review. Surveyors noted issues with:
CHAPTER 05: GENERAL SYSTEMS 05.05.04 Specimen Receipt/Acceptability and Rejection/Processing Frequency of the citation: 19% Overview of the requirement: Written policies and procedures define specimen receipt and criteria for acceptance and processing based on the testing specialty. Specimen rejection and disposition are included. Comment on deficiencies: Compliance is evaluated through interviews and document review. Time of specimen receipt is a required element which was noted as the source of most deficiencies. Examples of ACHC Surveyor findings: ■ The laboratory’s approved procedure manual requires a receipt time and a completion time. Mohs Specimen Maps and logs revealed that the laboratory failed to follow its policy and procedure. ■ The time that the laboratory receives specimens is not documented.
■ Uncertified or expired thermometers and humidistats. ■ Documentation that essential conditions are monitored. ■ Evidence of corrective action when conditions fall out of range.
Examples of ACHC Surveyor findings: ■ Log sheets recorded out of range issues without documented corrective actions.
ٝ The room humidity in the laboratory was out of the acceptable range in January, February, and March, for 21 days in April, and 10 days in October. ٝ Freezer 1 temperature was out of acceptable range for 2 days in June, 6 days in August, 4 days in September, and 2 days in October. ٝ Freezer 3 temperature was out of range for 5 days in August and 4 days in September. ٝ Refrigerator 3 temperature was out of range for 4 days in August and 2 days in October.
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