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Facility location on SOPs


Cliff

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Is anyone aware of a rule that requires the location of your facility to be on an SOP?  I am not referring to a patient report where I need to include the location of the lab, the lab director, and the CLIA number.  These are internal SOPs.

Thank you

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Another bureaucratic authoritarian idiocy?  Sorry, couldn't restrain myself, but there is a cadre of "quality gurus" who are constantly thinking up irrelevant, pointless make work stuff for the rest of us.  This is how civilizations come to an end.  Why in the world would an SOP have to have the address, name, GPS co-ordinates, topographic elevation and postal code of the facility?  How does that address any patient care issue in the universe?  

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21 minutes ago, Neil Blumberg said:

Another bureaucratic authoritarian idiocy?  Sorry, couldn't restrain myself, but there is a cadre of "quality gurus" who are constantly thinking up irrelevant, pointless make work stuff for the rest of us.  This is how civilizations come to an end.  Why in the world would an SOP have to have the address, name, GPS co-ordinates, topographic elevation and postal code of the facility?  How does that address any patient care issue in the universe?  

Neil, sorry to have touched a nerve.  :)

I think a lot of us "quality guru's" let one requirement bleed over into another.  It is a CMS rule that a patient report has the CLIA information as well as address of the performing lab on any patient result report.  That seems to have turned into "anything the lab publishes must have our address".

I am making some rather substantial changes to our SOP process and wanted to make sure I wasn't missing something as I do not believe this is required.

Thank you

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Quality knobhead here - details are required on reports, not SOPs. ISO 15189 states that docuements need to have:

a)        All documents are identified to include:

—     a title;

—     a unique identifier on each page;

—     the date of the current edition and/or edition number;

—     page number to total number of pages (e.g. "Page 1 of 5," "Page 2 of 5,");

—     authority for issue.

Information for users (ie lab handbook)

The laboratory shall have information available for patients and users of the laboratory services. The information shall include as appropriate:

                  a)    the location of the laboratory;

b)        types of clinical services offered by the laboratory including examinations referred to other laboratories;

c)         opening hours of the laboratory;

d)        the examinations offered by the laboratory including, as appropriate, information concerning samples required, primary sample volumes, special precautions, turnaround time, (which may also be provided in general categories or for groups of examinations), biological reference intervals, and clinical decision values;

e)        instructions for completion of the request form;

f)          instruction for preparation of the patient;

g)        instructions for patient-collected samples;

h)        instructions for transportation of samples, including any special handling needs;

i)          any requirements for patient consent (e.g. consent to disclose clinical information and family history to relevant healthcare professionals, where referral is needed);

j)     the laboratory’s criteria for accepting and rejecting samples;

k)  a list of factors known to significantly affect the performance of the examination or the interpretation   of the results;

I)     availability of clinical advice on ordering of examinations and on interpretation of examination results;

m)      the laboratory’s policy on protection of personal information;

n)        the laboratory’s complaint procedure.

o) The laboratory shall have information available for patients and users that includes an explanation of the clinical procedure to be performed to enable informed consent. Importance of provision of patient and family information, where relevant (e.g. for interpreting genetic examination results), shall be explained to the patient and user.

Reports however need to include:

a)         a clear, unambiguous identification of the examination including, where appropriate, the examination procedure;

b)        the identification of the laboratory that issued the report;

c)         identification of all examinations that have been performed by a referral laboratory;

d)        patient identification and patient location on each page;

e)        name or other unique identifier of the requester and the requester’s contact details;

f)          date of primary sample collection (and time, when available and relevant to patient care);

g)        type of primary sample;

h)        measurement procedure, where appropriate;

i)          examination results reported in SI units, units traceable to SI units, or other applicable units;

j)           biological reference intervals, clinical decision values, or diagrams/nomograms supporting clinical decision values, where applicable;

k)         interpretation of results, where appropriate;

l)           other comments such as cautionary or explanatory notes (e.g. quality or  adequacy  of  the  primary sample which may have compromised the result, results/interpretations from referral laboratories, use of developmental procedure);

m)      identification of examinations undertaken as part of a research or development programme and for which no specific claims on measurement performance are available;

n)        identification of the person(s) reviewing the results and authorizing the release of the report (if not contained in the report, readily available when needed);

o)         date of the report, and time of release (if not contained in the report, readily available when needed);

p)        page number to total number of pages (e.g. “Page 1 of 5", "Page 2 of 5”, etc.).

These are the basic ISO requirements - Other standards may require further info ie JACIE/CLIA

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This was an issue here as well, the full address of the hospital was in the header of all of my SOPs. I removed them all one by one as updates/reviews were required. There is nothing in JC/FDA or AABB that says you need the location of the lab in an SOP. You are correct that this needs to be on reports. I left the name of the hospital and Department of Pathology and Laboratory Services in my header, that's it. :)

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1 hour ago, Neil Blumberg said:

Another bureaucratic authoritarian idiocy?  Sorry, couldn't restrain myself, but there is a cadre of "quality gurus" who are constantly thinking up irrelevant, pointless make work stuff for the rest of us.  This is how civilizations come to an end.  Why in the world would an SOP have to have the address, name, GPS co-ordinates, topographic elevation and postal code of the facility?  How does that address any patient care issue in the universe?  

I could not agree more.  I believe that, if unchecked, some of the accrediting agencies will eventually regulate themselves into irrelevance. 

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i had an AABB inspection years ago. At the summation the inspector said:  "I know I'd have to dig to find something in Dave's lab."  That should have been a warning.  My only deficiency (which was cited by the Area Chair, who determined the deficiencies based on the Inspection report form) was that I did not have my facility ID on my antibody panel sheets.  I immediately called my area chair and told him I wanted to inspect his lab (UT@Knoxville), which of course is not allowed.  I became an AABB inspector/assessor after that fact.

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37 minutes ago, David Saikin said:

i had an AABB inspection years ago. At the summation the inspector said:  "I know I'd have to dig to find something in Dave's lab."  That should have been a warning.  My only deficiency (which was cited by the Area Chair, who determined the deficiencies based on the Inspection report form) was that I did not have my facility ID on my antibody panel sheets.  I immediately called my area chair and told him I wanted to inspect his lab (UT@Knoxville), which of course is not allowed.  I became an AABB inspector/assessor after that fact.

I had a CAP inspection years ago with someone who was also an AABB inspector. He made a 'recommendation/suggestion' that we include our facility name/address on antibody panel sheets even though they were not (and are not) scanned to patient EMR's. He had experience with  an FDA inspector requiring that and joked that they (FDA inspectors) must have been aware of a HUGE black market of filled out antibody panels available for purchase. I had a stamp made with our facility name/address and we plop that on those forms. It's silly, but we do it. Looks good if we send those worksheets off to a reference lab with a specimen I guess.

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4 hours ago, David Saikin said:

i had an AABB inspection years ago. At the summation the inspector said:  "I know I'd have to dig to find something in Dave's lab."  That should have been a warning.  My only deficiency (which was cited by the Area Chair, who determined the deficiencies based on the Inspection report form) was that I did not have my facility ID on my antibody panel sheets.  I immediately called my area chair and told him I wanted to inspect his lab (UT@Knoxville), which of course is not allowed.  I became an AABB inspector/assessor after that fact.

Dr. Jones?

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4 hours ago, AMcCord said:

I had a CAP inspection years ago with someone who was also an AABB inspector. He made a 'recommendation/suggestion' that we include our facility name/address on antibody panel sheets even though they were not (and are not) scanned to patient EMR's. He had experience with  an FDA inspector requiring that and joked that they (FDA inspectors) must have been aware of a HUGE black market of filled out antibody panels available for purchase. I had a stamp made with our facility name/address and we plop that on those forms. It's silly, but we do it. Looks good if we send those worksheets off to a reference lab with a specimen I guess.

 

9 minutes ago, Baby Banker said:

Dr. Jones?

9 minutes ago, Baby Banker said:

Dr. Jones?

yes

 

 

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8 hours ago, Neil Blumberg said:

Just the person you want operating on your brain or reading your prostate biopsy, no doubt.  Makes one proud to be a part of the same profession.  Not.  Pettifogging fool.  Perhaps he is nice to his dog and children.

"Pettifogging".....an 'olde worde" that is so relevant today. Thank you for reminding me. I shall try to work it into as many conversations as possible.

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We are inspected by FDA, NY State, AABB, CAP and FACT.  Lots of opportunities for self-important, obsessive folks to make useless work for the people trying to take care of patients.  The stories I could tell. 

We've also had many rational, balanced, thoughtful inspectors who clearly are only focused on the important stuff, to be fair.  But a significant portion of our profession(s)' people do not realize that getting staff to focus on minutiae that will not affect patient outcomes distracts staff from doing the important things well. A well known psychologic/cognitive fact.  Keep it simple and avoid worrying about unimportant stuff. 

The notion that documentation is more important than anything else is the most pernicious piece of rubbish in medicine, and driven by the administrative/legal model (and billing of course).  And people proudly spout this nonsense as if it actually helped anyone but those in accounts receivable.  

I'd personally like the technologist doing my pre-transfusion testing to get the ABO and antibody screen correct as a trillion fold more important relative to them documenting what time, date or temperature all of that was done.  Not to mention what that person had for lunch or dinner before the crossmatch (coming soon to an inspection near you). 

For the record I'm a Gemini, which I assiduously and loyally document in every interpretation and progress note I write. :)

Edited by Neil Blumberg
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5 hours ago, Neil Blumberg said:

We are inspected by FDA, NY State, AABB, CAP and FACT.  Lots of opportunities for self-important, obsessive folks to make useless work for the people trying to take care of patients.  The stories I could tell. 

We've also had many rational, balanced, thoughtful inspectors who clearly are only focused on the important stuff, to be fair.  But a significant portion of our profession(s)' people do not realize that getting staff to focus on minutiae that will not affect patient outcomes distracts staff from doing the important things well. A well known psychologic/cognitive fact.  Keep it simple and avoid worrying about unimportant stuff. 

The notion that documentation is more important than anything else is the most pernicious piece of rubbish in medicine, and driven by the administrative/legal model (and billing of course).  And people proudly spout this nonsense as if it actually helped anyone but those in accounts receivable.  

I'd personally like the technologist doing my pre-transfusion testing to get the ABO and antibody screen correct as a trillion fold more important relative to them documenting what time, date or temperature all of that was done.  Not to mention what that person had for lunch or dinner before the crossmatch (coming soon to an inspection near you). 

For the record I'm a Gemini, which I assiduously and loyally document in every interpretation and progress note I write. :)

  I'd also like the phlebotomist to identify me correctly and label my pre-transfusion sample correctly with MY name.

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My previous boss always said they had to come up with new rules to justify their jobs.

When they can't find the "low hanging fruit" because we all try hard to do the right things and follow the rules, they start digging deeper and come up with stupid stuff. As long as they keep coming up with new rules, they keep their jobs. 

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