ASC Z80

Parent Committee Meeting

August 25, 2015,8:30 AM-12:00 Noon

Westin Alexandria, Edison EFG

Alexandria, Virginia

Minutes

Attendees: Dr. Tom White (chair), QuidoCappelli (vice chair), Dr. Karl Citek (fill-in secretary), Rick Van Arnam (legal counsel), Jeff Endres (secretariat);Dr. Bill Brown, Carl Buckholt, Charlie Campbell,Greg Chavez, Nick Mileti, Dale Pfriem, Neil Roché, Lyle Rubin, Jonathan Schwartz, Dan Simonetta, Dr. Carl Tubbs, Mike Vitale, Paul Wade, Dick Whitney, Greg Williams

1. Call to order – Dr. White

8:36 AM

Introduction of attendees

2. Acceptance of Agenda – Dr. White

Remove Item 3 Acceptance of minutes, since minutes from last meeting were not available or distributed. Amended agenda accepted.

3. Acceptance of minutes from the March 4, 2015, meeting – not available

4. Chairman’s comments – Dr. White

Welcome and thank you to everyone for their participation in the standards process. A reminderthat we all need to treat everyone with respect and courtesy, for all are legitimate experts. At the same time, the leaders of the various subcommittees, working groups, and project groups have a responsibility to recruit members who may have truly special knowledge in areas not generally available from others. It is the practice that groups utilize this input into their processes and it is generally understood by all that this in no way diminishes the legitimacy of any experts or, in the case of the ISO, delegates.

5. Vice Chairman’s comments – Mr. Cappelli

None.

6. Legal Counsel’s report – Mr. Van Arnam

Review of OMB Circular A-119, which calls for use of consensus standards rather than government-unique standards when possible, with a preference for voluntary rather than non-voluntary standards. Also allows for individual parts of standards to be made mandatory. ASC Z80 submitted comments on this last year, and the current status is “close to conclusion.”

Review of “intersection of physiological compatibility” requirements within certain standards and as possibly required by certain state laws, such as California Proposition 65 (for now, OR, WA, VT, and ME have similar, but less stringent, laws, also known as “green chemistry” laws). Standards are established for human health and safety, such as regarding nickel release, designed to minimize exposure to hazardous substances. Such laws can trigger warning requirements when certain substances are used, and they can even prohibit the use of certain items. Some laws have exempted medical devices, such as spectacles and contact lenses, others address only products used by or for children, but CA law applies to everyone and everything. Consider adding language to future standards and revisions that such laws may need to be observed.

7. Secretariat’s report – Mr. Endres

The Vision Council became Secretariat about 6 years ago, and Mr. Endres assumed the role about 4 years ago. He has now left the staff and is returning to industry. Mr. Vitale will assume this role after today.

Budget remains on track to collect all budgeted funds by the end of the fiscal year. ASC Z80 holds constant with 20 member organizations.

Comments by Dr. White: Thank you to Mr. Endres for his years of service. Committee needs to try to keep costs down: present DC-area hotel is about 4 times more costly than that in Clearwater, Florida, so Fall 2016 meeting may be in Florida, Crystal City, or other less expensive venue.

8. Subcommittee reports

1. SC1 – Mr. Whitney

Pleased to announce that Z80.1 Prescription lenses revision is approved by SC1 and ready to be submitted for publication. The revision does include an editorial change to prism power determination, which was accepted unanimously by SC1 yesterday.

Received an inquiry that California Board of Optometry references Z80.1-1972, which has much more restrictive refractive requirements and other sections that no longer apply to modern products. Will forward the inquiry to Mr. Van Arnam.

At ISO meeting in Shanghai in May 2015, Japan raised the question of using a single reference wavelength (currently US uses yellow d-line, ISO uses green e-line). For various reasons and for now, we all still agree to disagree.

2. SC2 – Dr. Citek

Pleased to announce that Z80.3 Nonprescription sunglass and fashion eyewear revision is approved by SC2 and ready to be submitted for publication. Comments received during balloting, including one vote to disapprove, were addressed by SC2 with editorial changes, all of which were accepted unanimously by SC2 yesterday. The result is that the negative vote changed to positive (see Annex 1).

Review of Z80.31 Single-vision ready-to-wear near-vision spectacles (due in 2017) will begin at next meeting in Spring 2016.

3. SC3 – Mr. Mileti

SC3 accepts wholly adopting three ISO standards (7998, 12870, and 8624) into a single Z80.5 Spectacle frame standard. OEOSC has approved the use of ISO standards in this way. SC3 accepts use of UK English spellings and numerics (e.g., comma in place of decimal point in numbers); a note in the Foreword will identify these differences to the reader. This concludes the PINS and the revision will be submitted for vote.

SC3 will continue to work on a revised definition of “effective diameter” and a revision of the current lens retention test for the subsequent standard revision.

4. SC4 – Dr. Tubbs

Three on-going items: Z80.29Accommodating IOLs, in review; Z80.30 Toric IOLs, voted to reaffirm; and Z80.35 Extended Depth of Focus (EDF) IOLs, in process of defining testing and measurement to align with ISO 11797.

MOTION:Circulate Z80.30 for ballot. By Dr. Tubbs, second by Mr. Cappelli. Motion passes.

Consideration of minimization of endotoxin release from devices, as required by FDA.

5. SC6 – Dr. Brown

Received 28 total comments on Z80.28 Methods of reporting optical aberrations of the human eye. Most were editorial in nature, 5 were deemed to be technical and will be considered for the next revision, and 1 vote to disapprove.

Both Z80.21 Visual acuity charts and Z80.9 Low vision devices were renewed, with next revision in 2020.

Review of relevant proceedings from ISO meeting in Shanghai in May 2015, including discussion of ISO 15004-2 Light hazard protection, which several US and international experts believe allows for unsafe levels of exposure. SC6 will develop a parallel ANSI standard, designated as Z80.36, that includes the lower limits favored by US experts.

MOTION: Request for PINS for Z80.36. By Dr. Brown, second by Mr. Cappelli. Motion passes.

SC6 also will develop a standard for exposure limits for operating microscopes, parallel to ISO 10936-2, ANSI designation as yet not determined.

MOTION: Request for PINS to develop standard parallel to ISO 10936-2. By Dr. Brown, second by Mr. Schwartz. Motion passes.

ISO also is considering merger of 15253 Low vision devices and 15254 Electro-optical devices for low vision into a single standard, similar to what ANSI has done.

Additional details can be found at SC6 report, attached (Annex 2).

6. SC7 – Mr. Cappelli

SC7 met on July 31, 2015, due to conflicting schedule of many attendees for the current meeting. Review of proceedings of that meeting and relevant proceedings from ISO meeting in Shanghai in May 2015. Details of the meeting can be found at SC7 report, attached (Annex 3).

MOTION: Request approval for mail ballot for Z80.20 Contact lenses. By Mr. Cappelli, second by Dr. Brown. Motion passes.

7. SC8 – Mr. Endres

Z80.24 Data communication mirrors ISO 16284. SC8 is in process of converting from ANSI to ISO format. No timeline challenge for this work.

Z80.34 Billing & billing requirements is on hold until sister committee, ANSI X12, completes its work, which is expected to take about another 12 months.

MOTION: Disband Z80.34 for now, but hold designation number in reserve until the committee reforms. By Mr. Endres, second by Mr. Vitale. Motion passes.

Additional details can be found at SC8 report, attached (Annex 4).

9. Information reports

1. ANSI Z87 – Mr. Whitney

Z87.1 published June 2015. OSHA recognized Z87.1-2010 shortly before that, as well as prior two standards.

2. FDA – included as part of Dr. Tubbs report above.

3. ISO/TC94/SC6 – Mr. Pfriem

Met in Paris in June 2015. Reviewed proceedings from that meeting, details can be found at TC94 report attached (Annex 5).

4. ISO/TC172/SC7 – Mr. Endres

Met in Shanghai in May 2015. Reviewed proceedings from that meeting, details can be found at TC172 report attached (Annex 6).

Term as TAG leader expires February 2016 at Photonics West meeting. Chair of TC172 names new TAG leader, Mr. Endres is on nominating committee and will nominate Mr. Vitale for the position.

Comments by Dr. White: only current national regulatory body to participate at ISO is FDA. It will be helpful to suggest to other ISO members to encourage their national regulatory agencies to participate, so that FDA can receive alternate viewpoints that do not arise from industry or other non-governmental concerns.

10. Next meetings – Dr. White

ASC Z80

Spring 2016 – March 6-8 in Clearwater, Florida

Fall 2016 – August 21-23 or 28-30, TBD

ISO/TC172/SC7

Fall 2016 – October 24-28 in Sydney, Australia

Dr. White and TVC will draft a proposal to Z80 member organizations to encourage sponsors to support upgraded travel for attendees when distance exceeds 3,000 miles or travel time exceeds 10 hours.

Spring 2018 meeting will be in either US or Europe. If it is in the US, Z80 member organizations will be requested to contribute to costs of hosting the meeting, estimated at $50,000.

11. New business

None.

12. Good of the order

Congratulations from ASC Z80 to Amber Robinson on her nuptials and best wishes for a happy and harmonious marriage.

13.Adjourn – Dr. White

10:00 AM

Respectfully submitted,

Karl Citek, OD, PhD

Fill-in Secretary

1

Annex 1

ANSI Z80 SC2

Non-Prescription Eyewear Subcommittee Meeting

August 24, 2015, 11:00 AM-3:00 PM

Westin Alexandria, Bell Room

Alexandria, Virginia

Minutes

Attendees: Karl Citek (chair), Nick Brown, Carl Buckholt, Brian Engesser,Tom Garrido, Tom Hicks, Nick Mileti, Dale Pfriem, Neil Roché, Lyle Rubin, Jonathan Schwartz, Dan Simonetta, Mike Vitale, Dick Whitney, Greg Williams

1) Call to order: 11:12 AM

2) Introductions & introductory comments

3) Acceptance of Agenda – no changes

4) Acceptance of minutes from the March 3, 2015, meeting – no changes

5) Review and discussion of Z80.3 voting results and comments

Received 14 votes to approve, one with comments (8 typographical errors identified), and one vote to disapprove.

Corrected typographical errors.

Made editorial changes to address comments of negative vote:

1) add definition of “reference point” and “intended visual axis,” and references to these terms, as well as to “geometric center,” later in the document; and

2) switch order of clauses in 5.4.

MOTION: Accept all typographical error and editorial changes as reviewed and discussed. By Mr. Vitale, second by Mr. Roché. Passes unanimously. The result of this action is that the original vote to disapprove the standard is changed to approve, now that the comments have been addressed.

6) Other business – none

7) New business – none

8) Adjourn: 12:05 PM

1

Annex 2

Report to ASC Z80

ANSI Z80 SC6

Instruments & Low Vision Devices Subcommittee Meeting

August 25, 2015

Alexandria, VA

1. Meeting was called to order 8/24/15 at 2:15 p.m. by Chair Bill Brown.

2. Attendees: Charles Campbell, Bruce Drum (FDA), Robert Rosenberg (Am OptomAssoc), Thomas White (Am AcadOphthalmol), Thomas Garrido (USAF), Bill Brown (Am OptomAssoc)

3.Standards approved since March, 2015 meeting

  • Z80.21- 2010 (R2015) Visual Acuity Charts
    – Approved 2015. Next revision deadline 2020.
  • Z80.9 – 2010 (R2015)Ophthalmics - Devices for Low Vision
    – Approved 2015. Next revision deadline 2020.

4.Z80.28 - 2010 Methods for reporting optical aberrations of the eye

  • Balloting completed August 10, 2015 with sufficient votes to pass.
  • One negative ballot with comments
  • One affirmative ballot with comments
  • Several minor editing comments
  • Comments were discussed.
  • 20 of 25 comments were accepted
  • All are considered editorial.
  • 5 comments not accepted
  • All considered technical in nature and requiring more consideration
  • None had been raised in this revision cycle before the balloting.
  • SC6 concluded the comments are not critical to the success of the document and require more consideration than is feasible at this late date in the approval process.

5.ISO/TC172/SC7/WG6 Discussion of the following standards as a result of work done in Shanghai, with emphasis on the highlighted bullet action items below.

  • ISO DIS 15004-2 Light hazard protection
  • In Shanghai, the project group decided to ignore recommendations that had been put together with consensus of the group and revert to a previous draft that has limits for photochemical radiation from instruments that the US and UK experts consider dangerous to the ocular health of certain populations of patients, e.g., patients with aphakia or diseased retinas.
  • In consideration of this occurrence, and since the ISO 10936-2(Light hazard from operation microscopesused in ocular surgery),is a highly important standard that refers to 15004-2 for radiation levels,
    SC6 decided to:
  • Prepare a new ANSI standard parallel to ISO 15004-2, using language taken from 15004-2 but inserting radiation limits that the US experts feel provide more safety. A new PINS is being prepared together with the document.
  • Prepare a new ANSI standard parallel to ISO 10936-2, using language taken from 10936-2 but inserting radiation limits that the US experts feel provide more safety. A new PINS is being prepared together with the document.
  • ISO/DIS 10938: Ophthalmic optics — Chart displays for visual acuity measurements — Printed, projected and electronic
  • In Shanghai PG10938 decided to return 10938 to its original content, restricting it to the physical characteristics of the optotypes and the instruments producing them and moving the contents on clinical optotypes to ISO 8596 in an informative annex (Use of informative instead of normative annex was chosen to expedite the approval process.)
  • ISO 8596(Standard optotype and itspresentation) is also being revised with a 2 year deadline, under PG Leader LudgerWollring.
  • UK and US have proposed combining 10938 and 8596 as a long term solution.
  • Merging of 2 standards for low vision:
  • ISO 15253 Ophthalmic optics and instruments -- Optical devices for enhancing low vision
  • ISO 15254 Ophthalmic optics and instruments -- Electro-optical devices for enhancing low vision
  • New work item, Project Leader Bill Brown, 3 year time frame with CD ready for next ISO meeting in 18 months

6.Adjourn – 4:25 p.m.

1

Annex 4

Report SC8 Information Interchange

ASC Z80 Fall 2015

  1. ASC Z80.24/ISO Mirror “ISO 16284”
  • Currently in draft conversion from ANSI format to ISO format.
  • No time challenge
  1. ASC Z80.34 Billing Billing Reimbursement

Executive Summary

This project is on-hold within the ASC Z80 committee. Motion to disband the committee until X12 work is complete.

To create a uniform communication standard for data interchange between participating entities as applies to the financial and benefits transaction, as well as manufacturing data, for the vision portion of medical services and under the auspices of ANSI X12 using an augmented ASC X12 837P EDI format.

Beneficiaries and effected parties to such a standard development include:

  • Patients and Practitioners
  • Insurance providers
  • Service Providers – optical and testing laboratories
  • Manufacturers and Material suppliers – frames, lenses, inter-oculars, consumables
  • Medicare/Medicaid, Federal and State governments, institutional employers

Long Term Goal - Mirror Pharmacy

Over the last 15 years the pharmacy community has developed a highly organized and universally beneficial data communication scheme to the benefit of all users and patients. The goals for the program are to mimic this success and bring the following features to the community:

  • Vision specific transaction
  • Fields for additional data, including manufacturing information
  • Formatting in a manner that allows for data (possibly in an XML format) to be inserted into X12 format. The technical feasibility of this remains under review.
  • HIPAA compliance
  • Improvement Of the Experience For all participants
  • Creation of a new set of transactions that encompass member benefits and eligibility and today's data requirements
  • Achieve framework for eventual “real-time” Dynamic Transaction experience without breaking our current methodology
  • This could include a small level of core benefit information such as co-pays, allowances and frequency
  • Provide an electronic non-binding claim calculation that is the key to achieving our goal of dramatically improving the member experience while reducing the transactional cost associated with insured benefit adjudication
  • With the pre-authorization received, the provider creates the order in detail, and a summary version of the 837V is sent to the insurer with all of the manufacturing information included in one of the currently accepted formats.
  • The insurers system can then interpret the product that is being supplied to their member and calculate insured payment, member payment & contractual discount along with the insurer specific coding that their systems are expecting in order to adjudicate the claim.

Status

  • Motion to Disband
  • The current phase of work resides in the X12 Committee
  • Until such time as NWIP’s are proposed and accepted by X12, the needed “touch points” do not exist such that the current ANSI Z80.24 standard can be made to “pair” with the X12 as it now exists
  • This effort is now lead by the NAVCP who has joined the X12 group
  • We are looking at 12 months until additional work can be done

End

1

Annex 5

Liaison Report of ISO/TC 94/SC 6 "Eye and Face Protection" to ANSI Z80

Alexandria, VA, August 25, 2015

The full committee of ISO/TC94/SC6 and its working groups last met in Paris, France June 22 – 26, 2014. Thirty seven delegates representing eleven countries (plenary) were present. Four delegates from the U.S. were present. The time and location for the next meeting has not been set as of this date.

Dr Colin Fowler was reappointed as Chair of ISO/TC 94/SC 6 for a further three years until the end of 2017.The number of P-members of SC 6 has risen to 18 as Mexico and Chile have joined the committee in March and June respectively.

WG Activity Summary

WG1 – Definitions:

-ISO 4007 is being revised. A call for experts to participate in the work has been issued.

WG 2 – Test Methods:

A number of new test method documents are being revised and/or going forward as NWI’s: