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Design and development in a company that only provides services?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Stephen Sheehan, Jul 3, 2018.

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  1. Stephen Sheehan

    Stephen Sheehan Member

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    Hi everyone,

    I was wondering if someone could help me out with understanding if 8.3 applied to the company I work for?

    Our company contracts out allied health services to the aged care based off of direct referrals from our client organizations. E.g. "Organisation A" has a client that needs physio services to assist with decreased strength/balance, so we send out a physio who assesses and treats this client over a period of time to help rectify this through 1:1 treatments and home exercise programs. We do not create the service, rather provide the service as referred by the referring organisation.

    We also provide occupational therapy services where some home mods may need to be recommended, but we only provide the assessment and directives and a builder completes the modifications. Or we would refer for equipment, but we don't make the equipment, only recommend and reassess once delivered.

    We also provide podiatry where they may need to assess a client for shoes or inserts and sometimes may need to cut an insert to fit into a shoe.

    We also provide allied health into nursing homes, but we have strict roles/duties as set by the nursing home when they sign a service agreement with us. Primarily documentation and some rehabilitation and pain management.

    Finally we also provide manual handling training to different organisations in how to safely handle clients in both a nursing home or in a community setting. These manual handling programs were created a long time ago and are unlikely to change.

    Are any of these areas considered design/development??

    Look forward to hearing any thoughts on this!

    - Stephen
     
    Stephen Sheehan, Jul 3, 2018
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  2. RoxaneB

    RoxaneB Moderator Staff Member

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    I feel like we've had this discussion already here in QFO, but I cannot seem to find the post. Also in community healthcare here. :)

    For the most part, it sounds like you are not designing anything, but rather utilizing programs and applications already out there in the marketplace.

    The exception may be the training material. You said that they were created a long time ago...by whom?...and are unlikely to change...but you never know.
     
    RoxaneB, Jul 3, 2018
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  3. RoxaneB

    RoxaneB Moderator Staff Member

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    Found it...I thought it sounded familiar (and it was asked earlier by you, Stephen ;) ).
     
    RoxaneB, Jul 3, 2018
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  4. Stephen Sheehan

    Stephen Sheehan Member

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    Haha, thanks Roxane! I thought I'd go into more detail than the last time to make sure I have it covered :)

    Another question I have is how does your company ensure traceability under 8.5.2 in community health? Do we need to place GPS's in cars or in phones to ensure we can trace where our service is at any given time? Or are clinical notes or practitioner schedules sufficient?

    Thanks again!
     
    Stephen Sheehan, Jul 5, 2018
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  5. RoxaneB

    RoxaneB Moderator Staff Member

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    The standard doesn't tell us how to effectively ensure traceability, unfortunately. Since clinical notes are the professional evidence that the visit occurred, they might work - presuming that they are part of the client's overall health record. Are you on paper or do you have an EHR in place (or in progress)? For us, not all of our staff are required to complete chart documentation for each visit (i.e., unregulated care providers don't do any documentation).

    We do have GPS monitoring to ensure that a staff member was at a client's point-of-care - the system will flag it as 'unusual activity' if the visit is started/stopped more than a pre-determined distance from the point-of-care address provided in the system. This GPS monitoring is part of a package we use that also provides all the necessary client and visit information to the regulated health professional or unregulated care provider going in (e.g., address, lock box codes, pets, care plan task list that they check off to indicate care was provided, etc.)

    Front line staff weren't too thrilled at the idea of GPS monitoring, but part of the change management (and this actually valid) was to indicate that it was for their safety, as well. If they're driving in poor weather and end up in an accident, the GPS will allow us to locate them. If a device is stolen, again, we can locate it and/or remotely deactivate it, thus ensuring client confidentiality - supporting traceability from the perspective than only authorized personnel can access client information.
     
    RoxaneB, Jul 5, 2018
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  6. Stephen Sheehan

    Stephen Sheehan Member

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    Thanks for the information :)

    We use FrontDesk as our internal EHR, but it is not directly linked to our customer's own health databases. We obviously send all our reports to them and clinical notes on request, so they do receive all their relevant information. We don't currently record in resident's home when we visit since most of our referring customers are turning to electronic solutions.

    We are also looking at GPS tracking for our fleet, but some staff have a company car and some drive their own cars, so getting uniformity across the company will be impossible using only car GPS tracking. Have you used phone-based GPS tracking? I know you're in Canada, but what GPS monitoring system do you use?? We raised GPS tracking 3 years ago and their was widespread backlash across all staff, but if we need to prove a staff member attended each resident, then we will have no choice if we want to achieve 9001. I like the safety angle and if a vehicle is stolen as "pros" to a GPS tracking system.
     
    Stephen Sheehan, Jul 6, 2018
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  7. RoxaneB

    RoxaneB Moderator Staff Member

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    All of our front line staff - regulated and unregulated - have company-issued mobile devices with the required apps that allow them to get their schedules and review the details of the clients' care plan, as well as, send reports electronically.

    The app with the details of the clients' profile (i.e., address) and care plan (i.e., tasks to be done during that visit) is CellTrak.

    Our office can make changes to the schedules and it will update CellTrak so that front line staff can see live, updated schedules (updates cycle through about every 30 minutes). For areas where there is poor/no signal strength (e.g., rural areas, locations close to the US border, etc.), or if the tech fails, we have a Plan B which allows staff to call in and confirm/verify their visits via phone.

    Both processes tie in to our billing and timekeeping (paying staff) activities.
     
    RoxaneB, Jul 6, 2018
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