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Poll: HIPPA - Is it really stopping us? (6 member(s) have cast votes)

So after reading and/or looking at the HIPPA website are we really stopped from asking?

  1. No - I guess we are not (4 votes [66.67%])

    Percentage of vote: 66.67%

  2. Yes - You are leading your corporate offices to their destruction (2 votes [33.33%])

    Percentage of vote: 33.33%

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Mr. Incognito

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Posted 10 July 2014 - 03:04 PM

So Setanta brought up HIPPA in relation to communicable disease and I have been doing some research on if we were in compliance with FSSC and the CFR (Code of Federal Regulations for those who don't follow USA laws) I found this on the HIPPA website:

 

  • Quality, safety or effectiveness of a product or activity regulated by the FDA. Covered entities may disclose protected health information to a person subject to FDA jurisdiction, for public health purposes related to the quality, safety or effectiveness of an FDA-regulated product or activity for which that person has responsibility. Examples of purposes or activities for which such disclosures may be made include, but are not limited to: 
    • Collecting or reporting adverse events (including similar reports regarding food and dietary supplements), product defects or problems (including problems regarding use or labeling), or biological product deviations; 
    • Tracking FDA-regulated products; 
    • Enabling product recalls, repairs, replacement or lookback (which includes locating and notifying individuals who received recalled or withdrawn products or products that are the subject of lookback); and 

Conducting post-marketing surveillance.  See 45 CFR 164.512(b)(1)(iii). The “person” subject to the jurisdiction of the FDA does not have to be a specific individual. Rather, it can be an individual or an entity, such as a partnership, corporation, or association. Covered entities may identify the party or parties responsible for an FDA-regulated product from the product label, from written material that accompanies the product (know as labeling), or from sources of labeling, such as the Physician’s Desk Reference. 

http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/publichealth/index.html

 

 

As food is an FDA regulated product HIPPA does not apply to food manufacturers in relation to their status as a disease carrier if it could be transported through the food.

 

At least that's how I read what I found on the HIPPA website.  I found it under the "Public Health" section of their website http://www.hhs.gov/o...alth/index.html

 

so... what do you all think?  Am I leading my corporate offices to destruction?

 


Edited by Mr. Incognito, 10 July 2014 - 03:06 PM.

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Posted 10 July 2014 - 03:07 PM

(I added the poll because everyone likes polls)


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Posted 10 July 2014 - 03:22 PM

TL, DR. (or vote) Reading QA rules and regs is enough for me, I can't do more government jargon!  :death:

 

Basically I do what HR says I can get by with.  They've OK'ed my GMP phrasing and until HR or an Auditor tell me it needs to change, that's how it is going to stay.


-Setanta         

 

 

 


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Posted 10 July 2014 - 03:36 PM

I just think there is too much fear of HIPPA and nobody really knows what is allowed and not allowed... they just think "if it's health related it's covered by HIPPA" which may not actually be true.


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Posted 10 July 2014 - 03:48 PM

I just think there is too much fear of HIPPA and nobody really knows what is allowed and not allowed... they just think "if it's health related it's covered by HIPPA" which may not actually be true.

 

Possibly, but I have learned that swimming against the HR tide can have less than positive outcomes.  :eekout:  


-Setanta         

 

 

 


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Posted 10 July 2014 - 04:32 PM

Well, we're all QA here, so its based on risk, right?

Is the risk (probabilty and severity) an employee is going to sue you for it greater than the risk posed to your business if you do not ask? Anyway, as I read this, it looks more like if you have some outbreak and you need to investigate, then it's okay to ask if someone was sick, not a blanket thumbs up. 

 

I force my employees not to use nicknames that describe physical stature.  It's not because I think calling someone "Le Tigre" is harassment, it's becuase if that employee sued the company, we'd go under.

 

If someone sues the company for asking too many questions, then yeah, that's a real risk.  And do you really want YOUR judgement of what is reportable to be on the line?   For ex, lets say you list diarrhea on your reportable illnesses.  "Yes, your honor, Mr. I demanded to know about the quality of my stool.  I felt uncomfortable disclosing this information but was told I'd be fired if I did not comply. I do not believe Mr. I is qualified to medically diagnose my health condition and my personal care provider did not consider my health a risk to others.  I only had a minor, nontransferrable illness and I need to support my family."

 

Anyway, there's room for abuse - if the HIPPA laws are designed to protect employees from something and that protection is taken away supervisors can easily descriminate based on health issues.   Someone who stole your parking space shows up with a runny nose?  Sent home without pay.  Jane Doe coughed in the hallway and she cheated on my brother, sent home without pay until she can afford a doctor to give her a note.  Etc. My inner Wobbly doesn't like it one bit and the workers of our factories fought pretty hard to get these rights.


Edited by magenta_majors, 10 July 2014 - 04:35 PM.

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Posted 26 February 2015 - 08:35 PM

I happened to see this topic, and I wanted to inject some thought on the legal aspect.

 

The quoted part of the regulation says that " Covered entities may disclose protected health information to a person subject to FDA jurisdiction, for public health purposes related to the quality, safety or effectiveness of an FDA-regulated product or activity for which that person has responsibility. Examples of purposes or activities for which such disclosures may be made include..."

 

 

The key to all this is the term "Covered Entities."  At the very start of the HIPPA regulations is the stipulation:

 

 

§ 160.102 Applicability.

(a) Except as otherwise provided, the standards, requirements, and implementation specifications adopted under this subchapter apply to the following entities: (1) A health plan. (2) A health care clearinghouse. (3) A health care provider who transmits any health information in electronic form in connection with a transaction covered by this subchapter.

 

Employers or potential employers are not covered by this regulation under any circumstances.  It only applies to doctors, health insurance companies, and other health care providers.  What Mr I quoted said that the doctors , etc., can give up information to someone covered by the FDA if the information pertains to food safety.

 

HIPPA caused a panic in the country, because people think that it applies to anyone.  It got so bad that churches stopped including the names of sick parishioners in prayers out of fear of breaking the law.  This protects you from your doctor or your insurance company giving out your medical information.  That's all.

 

Martha


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Posted 26 February 2015 - 08:41 PM

Wow a Mr. I poll that only got one vote. 


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Posted 26 February 2015 - 08:43 PM

Wow a Mr. I poll that only got one vote. 

I guess it was not one of his more popular topics.

 

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Posted 26 February 2015 - 08:44 PM

Probably not but then this one did not get much discussion at all, which is surprising.  Not even I chimed in. 


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Posted 26 February 2015 - 08:48 PM

I am glad someone brought this gem back to life. I somehow managed to miss this on the first round.

 

MM - There are no words, that post is amazeballs.

 

For us, we know we can't ask about diseases, etc. but we let them know that they can and should tell us. Then I bring up, youd want someone working in a food plant that makes something you eat to have the same courtesy, wouldn't you??? hmmm...

 

 

Tricky subject. Nice responses everyone, well done.


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Posted 26 February 2015 - 08:52 PM

We had a worked that admitted to a fellow co-worker that he was HIV positive. His job was working in the highest risk zone we have with open / raw, (albeit pre-processed) ingredients. The concerned co-worker came to me and the HR manager and we were both at a loss for what we were allowed to do, say.. what restrictions, if any we were allowed to implement. 

 

Blessing/ Curse, he quit shortly after he learned that there were others that knew (blessing?) but too soon for me or the HR manager to figure out what we can/ should do in these instances (curse?)


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Posted 26 February 2015 - 10:32 PM

We had a worked that admitted to a fellow co-worker that he was HIV positive. His job was working in the highest risk zone we have with open / raw, (albeit pre-processed) ingredients. The concerned co-worker came to me and the HR manager and we were both at a loss for what we were allowed to do, say.. what restrictions, if any we were allowed to implement. 

 

Blessing/ Curse, he quit shortly after he learned that there were others that knew (blessing?) but too soon for me or the HR manager to figure out what we can/ should do in these instances (curse?)

 

I hate the blessing/curse thing. 


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Posted 27 February 2015 - 08:24 AM

If any of you subscribe to Sedex, there used to be a question there regarding if any of your staff were HIV positive.

 

I refused to answer as I thought it was a breach of confidentiality under their human rights! and frankly, nobodies business but theirs. And what affect would it have on our product? there's just as much risk with someone who has a snotty nose or a runny arse!

 

I do think though, that if you have (some) illnesses that it is prudent to let your manager know. As a diabetic, my manager knows. I wouldn't want him coming into my office and finding me having a hypo on the floor, and not know what to do!

 

So do we ban all people with a disability or illness from working?

 

In the UK, some diseases are notifiable under NOIDS. BUT it is the doctor who does the notifying not the patient (or the employer!)



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Posted 27 February 2015 - 12:28 PM

Caz it didn't have anything to do with a disability we are talking about diseases that have been identified by the FDA as being a risk to human health if food manufacturers that are infected by them were to contaminate food.

 

As much as even I go :offtopic: we aren't talking about diabetes or any "disability".


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Posted 27 February 2015 - 12:37 PM

I happened to see this topic, and I wanted to inject some thought on the legal aspect.

 

The quoted part of the regulation says that " Covered entities may disclose protected health information to a person subject to FDA jurisdiction, for public health purposes related to the quality, safety or effectiveness of an FDA-regulated product or activity for which that person has responsibility. Examples of purposes or activities for which such disclosures may be made include..."

 

 

The key to all this is the term "Covered Entities."  At the very start of the HIPPA regulations is the stipulation:

 

 

§ 160.102 Applicability.

(a) Except as otherwise provided, the standards, requirements, and implementation specifications adopted under this subchapter apply to the following entities: (1) A health plan. (2) A health care clearinghouse. (3) A health care provider who transmits any health information in electronic form in connection with a transaction covered by this subchapter.

 

Employers or potential employers are not covered by this regulation under any circumstances.  It only applies to doctors, health insurance companies, and other health care providers.  What Mr I quoted said that the doctors , etc., can give up information to someone covered by the FDA if the information pertains to food safety.

 

HIPPA caused a panic in the country, because people think that it applies to anyone.  It got so bad that churches stopped including the names of sick parishioners in prayers out of fear of breaking the law.  This protects you from your doctor or your insurance company giving out your medical information.  That's all.

 

Martha

 

 

I'm not sure I agree with your estimation of the text here is a copy/paste of a portion:

 

Other Public Health Activities. The Privacy Rule recognizes the important role that persons or entities other than public health authorities play in certain essential public health activities. Accordingly, the Rule permits covered entities to disclose protected health information, without authorization, to such persons or entities for the public health activities discussed below. 

 

  • <I cut out the child abuse part because... it doesn't apply to this obviously>
     
  • Quality, safety or effectiveness of a product or activity regulated by the FDA. Covered entities may disclose protected health information to a person subject to FDA jurisdiction, for public health purposes related to the quality, safety or effectiveness of an FDA-regulated product or activity for which that person has responsibility. Examples of purposes or activities for which such disclosures may be made include, but are not limited to:
    • Collecting or reporting adverse events (including similar reports regarding food and dietary supplements), product defects or problems (including problems regarding use or labeling), or biological product deviations; 
    • Tracking FDA-regulated products; 
    • Enabling product recalls, repairs, replacement or lookback (which includes locating and notifying individuals who received recalled or withdrawn products or products that are the subject of lookback); and 
    • Conducting post-marketing surveillance.  See 45 CFR 164.512(b)(1)(iii). The “person” subject to the jurisdiction of the FDA does not have to be a specific individual. Rather, it can be an individual or an entity, such as a partnership, corporation, or association. Covered entities may identify the party or parties responsible for an FDA-regulated product from the product label, from written material that accompanies the product (know as labeling), or from sources of labeling, such as the Physician’s Desk Reference. 

 

Because we, the food manufacturer, is a person subjected to FDA jurisdiction a doctor (covered entity) is able to notify the employer that someone is infected with one of the diseases listed by the FDA as a risk to human health and is listed as a disease that should cause the exclusion of that worker from contacting food.

 

This is what the question / poll was about.

 

 

<edit below>

 

ooo I see what you are saying:

 

Your Health Information Is Protected By Federal Law

Most of us believe that our medical and other health information is private and should be protected, and we want to know who has this information. The Privacy Rule, a Federal law, gives you rights over your health information and sets rules and limits on who can look at and receive your health information. The Privacy Rule applies to all forms of individuals' protected health information, whether electronic, written, or oral. The Security Rule is a Federal law that requires security for health information in electronic form.

Who Must Follow These Laws

We call the entities that must follow the HIPAA regulations “Covered Entities”.

Covered entities include:

  • Health Plans, including health insurance companies, HMOs, company health plans, and certain government programs that pay for health care, such as Medicare and Medicaid.
     
  • Most Health Care Providers—those that conduct certain business electronically, such as electronically billing your health insurance—including most doctors, clinics, hospitals, psychologists, chiropractors, nursing homes, pharmacies, and dentists.
     
  • Health Care Clearinghouses—entities that process nonstandard health information they receive from another entity into a standard (i.e., standard electronic format or data content), or vice versa.
  • In addition, Business Associates of Covered Entities must follow parts of the HIPAA regulations.

    Often, contractors, subcontractors, and other outside persons and companies that are not employees of a covered entity will need to have access to your health information when providing services to the covered entity. We call these entities “Business Associates.” Examples of business associates include:

    Covered Entities must have contracts in place with their Business Associates, ensuring that they use and disclose your health information properly and safeguard it appropriately. Business Associates must also have similar contracts with subcontractors. Business Associates (including subcontractors) must follow the use and disclosure provisions of their contracts and the Privacy Rule, and the safeguard requirements of the Security Rule.

    • Companies that help your doctors get paid for providing health care, including billing companies and companies that process your health care claims.
    • Companies that help administer health plans.
    • People like outside lawyers, accountants, and IT specialists.
    • Companies that store or destroy medical records.

 

 

So we are able to ask.  "Hey Mr. I.  Do you have HIV" and that's legal.

 

Ok so maybe the poll is lacking.  I am also saying that a doctor can call my facility and say "Hey just for an FYI yo.  Mr. I. has HIV and is disallowed from working with food directly"


Edited by Mr. Incognito, 27 February 2015 - 12:42 PM.

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Posted 27 February 2015 - 12:46 PM

And as I'm always working hard to beat dead horses:

 

Who Is Not Required to Follow These Laws

Many organizations that have health information about you do not have to follow these laws.

Examples of organizations that do not have to follow the Privacy and Security Rules include:

  • life insurers,
  • employers,
  • workers compensation carriers,
  • most schools and school districts,
  • many state agencies like child protective service agencies,
  • most law enforcement agencies,
  • many municipal offices.

 

http://www.hhs.gov/o...mers/index.html


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Posted 27 February 2015 - 04:31 PM

If any of you subscribe to Sedex, there used to be a question there regarding if any of your staff were HIV positive.

 

I refused to answer as I thought it was a breach of confidentiality under their human rights! and frankly, nobodies business but theirs. And what affect would it have on our product? there's just as much risk with someone who has a snotty nose or a runny arse!

 

I do think though, that if you have (some) illnesses that it is prudent to let your manager know. As a diabetic, my manager knows. I wouldn't want him coming into my office and finding me having a hypo on the floor, and not know what to do!

 

So do we ban all people with a disability or illness from working?

 

In the UK, some diseases are notifiable under NOIDS. BUT it is the doctor who does the notifying not the patient (or the employer!)

 

 

Caz x

 

Ah Sedex....another example of bad questions.  Again the questionnaire does not allow for different possibilities so how you answer may lower your score unfairly. 


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Posted 27 February 2015 - 04:32 PM

never heard of sedex


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Posted 04 March 2015 - 10:41 PM

never heard of sedex

 

You lucky soul.  Sedex is social and environmental responsibility.  They have an audit called SMETA.  It is mostly about employment practices such which usually falls under the domain of HR, but also deals with safety issues, business ethics and environmental responsibility.  Their website is a PITA. 


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Posted 05 March 2015 - 11:02 AM

One time I worked at a call center doing an outbound survey for the CDC and they made us ask race.  Like, four times a call.  It was awful.  Just as asking someone their medical history is awful.   Maybe you could legally, but do you really want to be digging into that shit?  I've seen set ups where supervisors draft a checklist to enter to production.  As though their supervisors are registered doctors who can diagnose illness on sight.  Do you appear to have AIDS?  No, okay then, head on into production. 


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Posted 05 March 2015 - 11:47 AM

There are wrong ignorant ways to handle things Magenta just as there are appropriate ways to handle important issues.

 

Would you rather ignore the FDA's guidelines and potentially cause thousands of people to become infected with something (possibly something they can never be cured of) or ask a question and follow the law?


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Posted 05 March 2015 - 01:42 PM

There are wrong ignorant ways to handle things Magenta just as there are appropriate ways to handle important issues.

 

Would you rather ignore the FDA's guidelines and potentially cause thousands of people to become infected with something (possibly something they can never be cured of) or ask a question and follow the law?

I would absolutely rather break the law than ask someone if they had AIDs before allowing them to work with food.   If there's blood in the food, we don't sell it.

 

  If they have a transmissible food borne illness, they are mandated to report it.  They agree to report illness.  We don't ask or guess if they are sick.  We are mandated to give workers paid days off (at least in California) if they are working in the food industry for illness.   If they're worried about not getting paid, they tell us, and we have them work on things that aren't food.   There's plenty of break room trash can wall stains to scrub and fun safety training and SOPs to read. 

 

This law isn't here for you to go digging through your employee's health history.   It's here so when the next Typhoid Mary serves up some special soup you can test her for the strain and identify the source.


Edited by magenta_majors, 05 March 2015 - 01:48 PM.

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Posted 05 March 2015 - 02:02 PM

Sensitive subjects are the worst. All i know is that most times people are too afraid of the consequences to do the right thing. That can be applied from all angles. Like for example,  if anyone cut themselves on the production floor, AIDS or not, how eager are they to tell a supervisor?? Then production would be stopped so the incident can be taken care of properly, (if they did have a contagious disease like HIV or AIDS - would they then tell the supervisor so those cleaning up could take extra precautions?? Or are they ashamed and keep quiet? Any time production is stopped at a single workers expense, there is naturally going to be some ashamed feelings, wondering about consequences, etc....

 

But in the event they dont say anything because the fear of the consequences is more real than the potential for others becoming infected (or I dont know - lack of responsibility - which is common among infectious disease carriers).... I dont know - the risk is there. Its out there right now. So we do what we can. When I give new employee orientations I tell them straight up - because of HIPPA laws and yada yada regulatory crap I can not ASK if you are a carrier of something infectious - but you can tell me. And Im gonna make you sign a piece of paper that says if you're sick you're gonna tell me (legal reasons, in case of an event) but it is also the courteous thing to do. You would want the people making your food to do the same thing. You would want your co-workers to be truthful. It is a confidential disclosure and we trust that you make the right decision. I try to explain how dire the consequences could be and hope they care enough to bite.

 

My two cents.  


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Posted 05 March 2015 - 02:26 PM

All this has been very interesting, because everyone has found different ways to make their site safe.  From treating all blood contaminated material as a BBP item (which is how the CDC says we should handle it) to requiring people report when they have a communicable disease.  Good stuff.

 

HIV/AIDS was originally looked at as a lifestyle issue as well, since it was first seen and most prevalent in the gay community.  For that reason, in Maryland, you cannot force anyone to be tested for HIV.  Ever.  So if they bleed on you and you have an open wound (a knife fight comes to mind), you can't find out if you have been exposed.  You have to assume that the blood has some kind of BBP and proceed with corrective measures based on the chance of exposure, not on their disease state.   We probably all do this for blood in food safety as well.

 

Martha


Edited by MWidra, 05 March 2015 - 02:27 PM.

"...everything can be taken from a man but one thing:  the last of the human freedoms--to choose one's attitude in any given set of circumstances, to choose one's own way."  Viktor E. Frankl

 

"Life's like a movie, write your own ending."  The Muppets




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