"Mdeg Inspection Form" - Nevada

Mdeg Inspection Form is a legal document that was released by the Nevada State Board of Pharmacy - a government authority operating within Nevada.

Form Details:

  • Released on May 23, 2016;
  • The latest edition currently provided by the Nevada State Board of Pharmacy;
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Nevada State Board of Pharmacy
431 W. Plumb Lane Reno, Nevada 89509
(775) 850-1440 (800)-364-2081 Fax (775) 850-1444
From:
Nevada State Board of Pharmacy Inspector
Subject:
Self-Evaluation Inspection Process
Medical Devices, Equipment and Gases (MDEG) industry managers and the Board of
Pharmacy have jointly adopted the concept of a self-evaluation inspection process for several
purposes. First, the inspection process is designed not to incriminate but to educate by
providing ample notice and sufficient time to fill out the report. Secondly, you can correct non-
compliance matters before inspection.
The process recognizes you as the responsible person to implement and review policies and
procedures necessary to provide a quality standard of MDEG services. An inspection
evaluation form must be obtained on the website and is to self-assess compliance with Nevada
MDEG law.
I will review the form with you and inspect your facility during the month listed on the
>
Inspection Notice.
Your inspection will occur during normal business hours, at no specific date or time.
The procedure involves the following:
minimum
1.
At the
, print and fill out the self-evaluation form. I cannot evaluate or
help you if I don’t know what you don’t know. Retain the form and have it readily
available in a packet along with last years
inspection report so if you are not
present when I arrive, your staff can make it available to me.
2.
Use the form to guide you through examination of your policies and procedures.
3.
I will conduct a review of your operation. My observations, along with your
findings will assure understanding and compliance with Nevada law.
4.
This plan has been established as a cooperative approach to annual inspections.
I would appreciate any input you may have on this joint review process.
Nevada State Board of Pharmacy MDEG Inspection Form
5/23/2016
Page 1 of 7
Nevada State Board of Pharmacy
431 W. Plumb Lane Reno, Nevada 89509
(775) 850-1440 (800)-364-2081 Fax (775) 850-1444
From:
Nevada State Board of Pharmacy Inspector
Subject:
Self-Evaluation Inspection Process
Medical Devices, Equipment and Gases (MDEG) industry managers and the Board of
Pharmacy have jointly adopted the concept of a self-evaluation inspection process for several
purposes. First, the inspection process is designed not to incriminate but to educate by
providing ample notice and sufficient time to fill out the report. Secondly, you can correct non-
compliance matters before inspection.
The process recognizes you as the responsible person to implement and review policies and
procedures necessary to provide a quality standard of MDEG services. An inspection
evaluation form must be obtained on the website and is to self-assess compliance with Nevada
MDEG law.
I will review the form with you and inspect your facility during the month listed on the
>
Inspection Notice.
Your inspection will occur during normal business hours, at no specific date or time.
The procedure involves the following:
minimum
1.
At the
, print and fill out the self-evaluation form. I cannot evaluate or
help you if I don’t know what you don’t know. Retain the form and have it readily
available in a packet along with last years
inspection report so if you are not
present when I arrive, your staff can make it available to me.
2.
Use the form to guide you through examination of your policies and procedures.
3.
I will conduct a review of your operation. My observations, along with your
findings will assure understanding and compliance with Nevada law.
4.
This plan has been established as a cooperative approach to annual inspections.
I would appreciate any input you may have on this joint review process.
Nevada State Board of Pharmacy MDEG Inspection Form
5/23/2016
Page 1 of 7
Nevada State Board of Pharmacy
431 W. Plumb Lane Reno, Nevada 89509
(775) 850-1440 (800)-364-2081 Fax (775) 850-1444
Inspector:
Date:
MDEG Company:
Address:
City/State/Zip:
Phone #:
Fax #:
Email:
Pre-opening
Yes:
No:
License #
Weekday Hours of Operation:
Sat Hours of Operation:
Sun Hours of Operation:
If the records are located at an address different than the location of the equipment, give the address of the
location of the records: (circle) Records On site / Records Off site address
Administrator:
NAC 639.694 1. (d) The administrator must be employed by the medical products provider or medical products
wholesaler at the place of business or facility of the employer at least 40 hours per week or during all regular
business hours if the business or facility is regularly open less than 40 hours per week.
PRODUCTS & SERVICES PROVIDED (check all that apply)
 Assistive Equipment
 Enteral Services & Equipment
 Respiratory Equipment
 Orthotics & Prosthetics
 Medical Gases
 Diabetic Equipment & Supplies
 Life-sustaining Equipment
Please list of your current employees and a separate list of employees terminated or transferred since your last
.
inspection (or provide a computer printout)
Terminated or Transferred Employees
Active Employees
Name and Duty
Name and Duty
(include title where appropriate)
(include title where appropriate)
Nevada State Board of Pharmacy MDEG Inspection Form
5/23/2016
Page 2 of 7
Nevada State Board of Pharmacy
431 W. Plumb Lane Reno, Nevada 89509
(775) 850-1440 (800)-364-2081 Fax (775) 850-1444
General Requirements for all MDEG Registrants
NAC 639.6946
Facility clean and maintained in an orderly manner?
Yes
No
Current registration displayed?
Yes
No
NAC 639.6942
Restroom with sink with hot and cold running water?
Yes
No
Restroom clean, has hand soap and paper towels, and has sign (employees to wash
hands after use)?
Yes
No
City or county business license?
Yes
No
City or county fire code approval?
Yes
No
Proof of general liability insurance (minimum of $1,000,000)
Exp. Date:
Does your company have an internet web site?
Yes
No
If so, what is the web address:
Does your company sell any products that require a prescription via the web
site/internet?
Yes
No
Inspector’s comments:
Records Requirement for all MDEG Registrants
Consumer records kept so that they may be readily retrieved by:
NAC 639.695
Consumer's name
Yes
No
Practitioner’s name
Yes
No
Date equipment or service provided
Yes
No
Type of equipment or product
Yes
No
Practitioner orders kept in an orderly and readily accessible manner
Yes
No
Records of communications with health professionals including:
NAC 639.6952
Consumer’s physical, functional and associated needs?
Yes
No
Therapeutic or ameliorative objectives for equipment, product, or service provided?
Yes
No
Records of consumer assessment including:
NAC 639.6952
Safety of the environment where equipment will be used
Yes
No
Ability to comply with instructions
Yes
No
Ability to clean and maintain the equipment or product
Yes
No
Records of consumer communications including:
NAC 639.6951
Delineation of the commercially available choices
Yes
No
The set up and use of the equipment or product
Yes
No
The maintenance, servicing, cleaning, and repair of the equipment or product
Yes
No
Does the facility repair equipment on site?
NAC 639.6946
(If yes-have available a repair log that identifies the following:)
(If no-have available a log that shows where equipment was repaired plus identifies the
following:)
Yes
No
Type of equipment
Yes
No
Manufacturer of equipment
Yes
No
Model or model number of equipment
Yes
No
Serial number of equipment
Yes
No
Date of Repair
Yes
No
Specific repair made
Yes
No
Name of person who made the repair
Yes
No
Certification that repair brought equipment back to manufacturer's specification
Yes
No
Nevada State Board of Pharmacy MDEG Inspection Form
5/23/2016
Page 3 of 7
Nevada State Board of Pharmacy
431 W. Plumb Lane Reno, Nevada 89509
(775) 850-1440 (800)-364-2081 Fax (775) 850-1444
Proof that calibration or testing equipment is accurate and maintained according to
manufacturer's directions and specifications
NAC 639.6946 (attach certifications)
Yes
No
FDA medical device tracking records kept in orderly and readily accessible manner
NAC 639.6949
Yes
No
Inspector’s comments:
Requirements for Providers of Medical Gases, Respiratory Equipment and CPAP –
BIPAP and BIPAP ST
Any company providing respiratory services that require a
.
practitioner order (prescription) needs to have an RT or Nurse on staff or on contract.
NAC 639.6954 If not applicable skip to next section
If a nurse is providing respiratory services, the nurse should provide a signed and dated statement that the
nurse has been trained in the respiratory modality that the nurse is training a patient to use and that the nurse
is qualified to train others in those modalities that the nurse has been trained to provide. If a delivery person is
instructing a patient in any respiratory modality, provide a signed and dated statement that the delivery person
has been trained by the Respiratory Therapist or Nurse, contracted or employed by the facility, in the modality
that the delivery person is instructing the patient to use. NRS 630.047
Stocking only medical grade gases
Yes
No
Service records regarding all equipment
Yes
No
Verification that equipment has been checked and is defect free before the equipment is
dispensed
Yes
No
Checking that equipment has not been modified in any way that would affect the
effectiveness of the equipment
Yes
No
Checking that the equipment does not present a fire or shock hazard
Yes
No
Checking that the equipment has all warning labels and tags
Yes
No
Records tracking all gases dispensed, including the lot numbers
Yes
No
Records regarding recalls of gases
Yes
No
System to track and locate all gases and equipment dispensed <circle>
Written Electronic
Records of serial numbers and model numbers of all equipment dispensed
Yes
No
Protocol for cleaning and disinfecting equipment
Yes
No
Material safety data sheet for solutions and products used in cleaning and disinfecting
Yes
No
Designated areas for clean and unclean equipment with signs posted
Yes
No
Designated area for quarantined equipment with signs posted
Yes
No
Policy and procedure or other documentation for the providing of emergency supply of
gases, supplies, and equipment
Yes
No
Does the facility provide CPAP- BIPAP or BIPAP ST (spontaneous timed) Equipment?
Provide the following information for your Respiratory Therapist(s) or Nurse(s) Providing
Respiratory services that require a practitioner order (prescription).
Yes
No
Name
Exp. Date
License #
Inspector’s comments:
Nevada State Board of Pharmacy MDEG Inspection Form
5/23/2016
Page 4 of 7
Nevada State Board of Pharmacy
431 W. Plumb Lane Reno, Nevada 89509
(775) 850-1440 (800)-364-2081 Fax (775) 850-1444
Special Requirements for Providers of Life Sustaining Equipment (Ventilators)
NAC 639.6955
If not applicable skip to next section.
24-hour toll-free number for consumers
Yes
No
Written emergency information and procedure that is attached to the life-sustaining
equipment
Yes
No
Policy and procedure or other documentation for the providing of emergency supply of
gases, supplies, and equipment.
Yes
No
Inspector’s comments:
Special Requirements for Providers of Enteral Services
NAC 639.6956
If not applicable skip to next section.
Consumer orientation and written checklist
Yes
No
Manufacturer's instructions provided to consumers
Yes
No
Policy for handling of outdated products
Yes
No
Inspector’s comments:
Special Requirements for Providers of Orthotics & Prosthetics
If not applicable skip to next section.
List product categories provided: (i.e.: prosthetic limbs, mastectomy, supports, braces)
Does the facility provide pressurized stockings rated above 20mm/HG?
Yes
No
Orders for stockings filed with consumer’s record?
Yes
No
Documentation is available of consumer training in the proper use & maintenance of
stockings?
Yes
No
List facility certifications by company & certification category:
( attach list for additional certifications)
Certified fitters names:
Inspector’s comments:
Nevada State Board of Pharmacy MDEG Inspection Form
5/23/2016
Page 5 of 7
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