We currently check the BB Alarms by using iced water to bring the containers holding the probes to a temp down below 1.5 and warmer water to bring above 5.5. Our Helmer refrigerators have automatic alarm checks- press a button and POOF - done.  Is the automatic check sufficient for all or part of the required checks?  This is a question I ask myself every 3 months.

I do the ice water/warm water in January and July; the electronic check in April and October. 

I guess it would depend on who inspects/assesses you how they feel about the electronic check.  The companies do say that they increase/decrease the probe temp . . . as an inspector/assessor I like to see the hot and cold manual method.  It probably is prudent to check with your regulatory agency to see what they deem to be valid for their certification.

I've been doing the ice water/warm water checks once a year and electronic check the other quarters for a long time. I've not had any concerns from CAP inspectors.

Since I'm relatively lazy I remember doing just the electronic checks once we had units that had that as an option.  I don't recall ever having an issue with an inspection.  I think it goes back to the old matra of "follow the manufacture's directions grasshopper" and I don't recall  Helmer recommending the old ice water trick.  

2 hours ago, AMcCord said:

I've been doing the ice water/warm water checks once a year and electronic check the other quarters for a long time. I've not had any concerns from CAP inspectors.

This is what we are doing.  An AABB assessor suggested we do the ice bath once a year.  We are TJC inspected.

I view the chart drive and digital display as electronic thermometers.  When we used them in the distant past, we validated / calibrated them monthly.  When we moved to Rees, they told us there monitoring devices were thermistors and are only required to be validated annually.

[Title 21, Volume 7] [Revised as of April 1, 2017] [CITE: 21CFR606.60] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER F--BIOLOGICS PART 606 -- CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Subpart D--Equipment Sec. 606.60 Equipment. (a) Equipment used in the collection, processing, compatibility testing, storage and distribution of blood and blood components shall be maintained in a clean and orderly manner and located so as to facilitate cleaning and maintenance. The equipment shall be observed, standardized and calibrated on a regularly scheduled basis as prescribed in the Standard Operating Procedures Manual and shall perform in the manner for which it was designed so as to assure compliance with the official requirements prescribed in this chapter for blood and blood products. (b) Equipment that shall be observed, standardized and calibrated with at least the following frequency, include but are not limited to: Equipment Performance check Frequency Frequency of calibration Temperature recorder Compare against thermometer Daily As necessary. Refrigerated centrifuge Observe speed and temperature Each day of use Do. Hematocrit centrifuge     Standardize before initial use, after repairs or adjustments, and annually. Timer every 3 mo. General lab centrifuge     Tachometer every 6 mo. Automated blood-typing machine Observe controls for correct results Each day of use   Hemoglobinometer Standardize against cyanmethemoglobin standard ......do   Refractometer Standardize against distilled water ......do   Blood container scale Standardize against container of known weight ......do As necessary. Water bath Observe temperature ......do Do. Rh view box ......do ......do Do. Autoclave ......do Each time of use Do. Serologic rotators Observe controls for correct results Each day of use Speed as necessary. Laboratory thermometers     Before initial use. Electronic thermometers     Monthly. Vacuum blood agitator Observe weight of the first container of blood filled for correct results Each day of use Standardize with container of known mass or volume before initial use, and after repairs or adjustments. (c) Equipment employed in the sterilization of materials used in blood collection or for disposition of contaminated products shall be designed, maintained and utilized to ensure the destruction of contaminating microorganisms. The effectiveness of the sterilization procedure shall be no less than that achieved by an attained temperature of 121.5 deg. C (251 deg. F) maintained for 20 minutes by saturated steam or by an attained temperature of 170 deg. C (338 deg. F) maintained for 2 hours with dry heat. [40 FR 53532, Nov. 18, 1975; 40 FR 55849, Dec. 2, 1975, as amended at 45 FR 9261, Feb. 12, 1980; 57 FR 11263, Apr. 2, 1992; 57 FR 12862, Apr. 13, 1992]

On 2/2/2018 at 7:12 AM, Cliff said:

I view the chart drive and digital display as electronic thermometers.  When we used them in the distant past, we validated / calibrated them monthly.  When we moved to Rees, they told us there monitoring devices were thermistors and are only required to be validated annually.

[Title 21, Volume 7] [Revised as of April 1, 2017] [CITE: 21CFR606.60] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER F--BIOLOGICS PART 606 -- CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Subpart D--Equipment Sec. 606.60 Equipment. (a) Equipment used in the collection, processing, compatibility testing, storage and distribution of blood and blood components shall be maintained in a clean and orderly manner and located so as to facilitate cleaning and maintenance. The equipment shall be observed, standardized and calibrated on a regularly scheduled basis as prescribed in the Standard Operating Procedures Manual and shall perform in the manner for which it was designed so as to assure compliance with the official requirements prescribed in this chapter for blood and blood products. (b) Equipment that shall be observed, standardized and calibrated with at least the following frequency, include but are not limited to: Equipment Performance check Frequency Frequency of calibration Temperature recorder Compare against thermometer Daily As necessary. Refrigerated centrifuge Observe speed and temperature Each day of use Do. Hematocrit centrifuge     Standardize before initial use, after repairs or adjustments, and annually. Timer every 3 mo. General lab centrifuge     Tachometer every 6 mo. Automated blood-typing machine Observe controls for correct results Each day of use   Hemoglobinometer Standardize against cyanmethemoglobin standard ......do   Refractometer Standardize against distilled water ......do   Blood container scale Standardize against container of known weight ......do As necessary. Water bath Observe temperature ......do Do. Rh view box ......do ......do Do. Autoclave ......do Each time of use Do. Serologic rotators Observe controls for correct results Each day of use Speed as necessary. Laboratory thermometers     Before initial use. Electronic thermometers     Monthly. Vacuum blood agitator Observe weight of the first container of blood filled for correct results Each day of use Standardize with container of known mass or volume before initial use, and after repairs or adjustments. (c) Equipment employed in the sterilization of materials used in blood collection or for disposition of contaminated products shall be designed, maintained and utilized to ensure the destruction of contaminating microorganisms. The effectiveness of the sterilization procedure shall be no less than that achieved by an attained temperature of 121.5 deg. C (251 deg. F) maintained for 20 minutes by saturated steam or by an attained temperature of 170 deg. C (338 deg. F) maintained for 2 hours with dry heat. [40 FR 53532, Nov. 18, 1975; 40 FR 55849, Dec. 2, 1975, as amended at 45 FR 9261, Feb. 12, 1980; 57 FR 11263, Apr. 2, 1992; 57 FR 12862, Apr. 13, 1992]

Do you calibrate your digital thermometer monthly?

38 minutes ago, Eagle Eye said:

Do you calibrate your digital thermometer monthly?

We don't have any.  We have some we use to validate modifications to our tube system and we validate those before each validation.

Actually we have donor thermometers and those we validate monthly.

You know what i had brain block!!

I was thinking about digital/electronic timer....and panicked as we validate them every six month.....Oh thank GOD!