Volume 2024 | No. 2
SURVEYOR
CLINICAL LABORATORY
CHAPTER 6: ANALYTIC SYSTEMS 06.02.01 Essential conditions
Overview of the requirement:
Conditions under which reagents/specimens are stored, test system operated, and results reported are specifically defined with regard to water quality, temperature, humidity, and protection from variations in electrical current that are required for. Compliance is assessed through interviews and document review. Most deficiencies related to room humidity-levels or freezer temperatures that were documented as out of range without corrective action. Other deficiencies stemmed from monitoring instruments that were not certified.
Comment on deficiencies:
Frequency of citation:
27%
Examples of surveyor findings:
n Temperature and humidity were frequently logged well outside of acceptable range with no remedial action documented. n Chemistry products were not stored according to manufacturer’s temperature requirements. During the survey, all items were moved to a freezer that met the temperature requirements. n Humidity reading were below the lowest measurable level by the hygrometer in use (20%) making it impossible to know if humidity was within the acceptable range of 10-80%. n Humidity in the blood gas laboratory was below the acceptable range of 5-85% for 25 days in January, 19 days in February and 13 days in March. Logs noted “manager aware” with no indication of corrective action. n The laboratory did not have a National Institute of Standards and Technology (NIST) certified thermometer or humidistat. n Educate staff on the importance of maintaining essential conditions. n Ensure that all temperature and humidity monitoring equipment have a current certification of calibration. n Log temperature/humidity on a regular basis so that lapses are identified and appropriate corrective action measures taken. Be sure to document all review activities.
06.06.06 Qualitative procedure controls Overview of the requirement:
Positive and negative controls must be used daily for all qualitative procedures when patient samples are examined. Compliance is evaluated through interview and review of documentation. Most deficiencies noted that controls were not used on each day of patient testing. This could be acceptable, but requires a documented individualized quality Control plan (IQCP).
Comment on deficiencies:
Frequency of citation:
18%
Examples of surveyor findings:
n Review of photomicrographs of all possible microscopic components is not performed and documented when wet mounts and KOH preparations are examined. n The procedure for eosinophil estimations lacks instructions that a positive and negative control should be performed each day of patient testing. The hematology lab technician confirmed that no quality control is performed for eosinophil estimations. n Positive and negative external controls are not performed for fetal fibronectin on each day of patient testing. The laboratory’s procedure FFN-1 Fetal Fibronectin states that liquid external quality control will be performed with each new lot number or shipment. This QC frequency variance requires an individualized quality control plan (IQCP). n Use photo micrographs or charts to meet control requirements for manual microscopic examinations.
Tips for compliance:
Note that materials that permit a wide range of acceptable temperature and/or humidity must still be maintained within that range.
Tips for compliance:
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