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Dear Madam,…

Dear Madam, Dear Sir,

On behalf of the IVD Industry Connectivity Consortium we are pleased to provide written comments to the Office of the National Coordinator for Health Information Technology (ONC) in response to the 2017 Interoperability Standards Advisory (ISA).

The IVD Industry Connectivity Consortium (IICC) is a global, nonprofit organization dedicated to creating and encouraging adoption of a unified connectivity standard to reduce the cost and variability of data exchange between IVD devices and healthcare informatics in clinical laboratories. This will improve healthcare efficiency and patient care.

The IICC has collaborated with several government bodies, including the US Food and Drug Administration (DMD/OIR/CDRH), US Centers for Disease Control and Prevention, and US Department of Health and Human Services (HHS) (ONC), National Institutes of Health (NIH), and industry organizations such as IHE International, HL7, Clinical Laboratory Standards Institute, the College of American Pathologists, the Association of Public Health Laboratories (APHL), the Medical Device Innovation Consortium (MDIC), and the Regenstrief Institute to develop two standards that together allow for true Plug Play connectivity of IVD instruments to Middleware and Laboratory Information Systems (LIS) .

The IVD Industry Connectivity Consortium appreciates the opportunity to leverage our volunteers’ expertise in commenting on the Standards Advisory, and we look forward to continuing our dialogue with ONC on identifying, assessing, and determining the best available interoperability standards and implementation specifications. We feel that this effort will provide the necessary foundation for more rapidly advancing interoperability.

The IVD Industry Connectivity Consortium finds that it would be beneficial if ONC would add the LAW – Laboratory Analytical Workflow Profile Web Site Disclaimers and LIVD – Digital Format for Publication of LOINC to Vendor IVD Test Results Web Site Disclaimers standards to the following proposed new sections:

For more information on LAW [ click here ] Web Site Disclaimers

For more information on LIVD Amara Asymmetrical Hem Dress Eva Franco Free Shipping Largest Supplier HZE3EIII
Web Site Disclaimers

Why are LAW and LIVD important for clinical laboratories?

The LAW Profile and LIVD specifications should have a significant positive impact on laboratory operations. Clinical laboratories are encouraged to ask their instrument, middleware, and LIS vendors about their current or planned support for the IICC/IHE Laboratory Analytical Workflow (LAW) and LIVD. The LAW Profile is currently being implemented by all major IVD companies.

The IVD Industry Connectivity Consortium (IICC) would also ask ONC’s support to make both standards “Federally Required” for federal agencies as well as commercial entities.

We appreciate the opportunity to submit comments on the 2017 ISA. Our comments are intended to recognize the importance of each stakeholder’s role in advancing standards-based interoperability and health information exchange, and ensuring that each domain is invested in overcoming the inherent challenges, while further enhancing health IT’s pivotal role in enabling healthcare transformation.

Please feel free to contact me if you have any questions or to obtain more information.

Sincerely,

Serge Jonnaert, BiD President, IVD Industry Connectivity Consortium - ivdconnectivity.org [email protected] +1.949.259.3807 / Board Member, At-Large - IHE International - ihe.net / President, AERTWORKS® LLC – www.aertworks.com Web Site Disclaimers

LAW – Laboratory Analytical Workflow Profile

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Most people know little about the Seventh-day Adventists beyond that they worship on Saturdays, not Sundays. But there’s more to this unique sect.

Adventist History

The Seventh-day Adventist church traces its roots to American preacher William Miller (1782–1849), a Baptist who predicted the Second Coming would occur between March 21, 1843, and March 21, 1844. Because he and his followers proclaimed Christ’s imminent advent, they were known as "Adventists."When Christ failed to appear, Miller reluctantly endorsed the position of a group of his followers known as the "seventh-month movement," who claimed Christ would return on October 22, 1844 (in the seventh month of the Jewish calendar).When this didn’t happen either, Miller forswore predicting the date of the Second Coming, and his followers broke up into a number of competing factions. Miller would have nothing to do with the new theories his followers produced, including ones which attempted to save part of his 1844 doctrine. He rejected this and other teachings being generated by his former followers, including those of Ellen Gould White.Miller had claimed, based on his interpretation of Daniel and Revelation, that Christ would return in 1843–44 to cleanse "the sanctuary" (Dan. 8:11–14, 9:26), which he interpreted as the earth. After the disappointments of 1844, several of his followers proposed an alternative theory. While walking in a cornfield on the morning of October 23, 1844, the day after Christ failed to return, Hiram Edson felt he received a spiritual revelation that indicated that Miller had misidentified the sanctuary. It was not the earth, but the Holy of Holies in God’s heavenly temple. Instead of coming out of the heavenly temple to cleanse the sanctuary of the earth, in 1844 Christ, for the first time, went into the heavenly Holy of Holies to cleanse it instead.Another group of Millerites was influenced by Joseph Bates, a retired sea captain, who in 1846 and 1849 issued pamphlets insisting that Christians observe the Jewish Sabbath—Saturday—instead of worshipping on Sunday. This helped feed the intense anti-Catholicism of Seventh-day Adventism, since they blamed the Catholic Church for changing the day of worship from Saturday to Sunday.These two streams of thought—Christ entering the heavenly sanctuary and the need to keep the Jewish Sabbath—were combined by White, who claimed to have received many visions confirming these doctrines. Together with Edson and Bates, she formed the Seventh-day Adventist denomination, which officially received its name in 1860.Today the denomination reports that it has 780,000 members in the United States and 7.8 million members elsewhere, many in Catholic countries.

Adventist Propaganda

White claimed to receive the first of several hundred visions in December of 1844. She gained recognition in Adventist circles as a prophetess and became the church’s leader. Over the next few decades, she provided guidance on almost every.aspect of belief and worship, writing over fifty books commenting on health, education, finance, and other topics. Her works are held by her followers to be inerrant on matters of doctrine, as is the Bible, though they are on a slightly lower plane of honor than the Bible.Her most important books, especiallyand, are frequently reprinted by Seventh-day Adventist publishing houses in a variety of formats. They often appear with different covers and titles. For example,is often marketed as. They are printed whole or in excerpted form. Sometimes Ellen Gould White’s name appears on the cover, sometimes a less well-known form of her name appears (e.g., E. G. White), and sometimes her name does not appear on the outside of the book at all.This allows Adventists to put White’s works in the hands of non-Adventists without alerting them that they are reading an Adventist publication until they are well into the work.Adventist publishing houses also keep the terms "Seventh-day" and "Adventist" out of their names. Typical Adventist and Adventist-related publishing houses have names including Inspiration Books, Amazing Truth Publications, Review Herald Publishing Association, and Pilgrims’ Press.This is because Adventists have always been regarded suspiciously by Evangelicals and have often been viewed as a fanatical cult (as have some of their offshoots, such as the Branch Davidians). Many Evangelical leaders even have asserted—that Adventists are not Christians, even though they believe in Christ’s divinity and use a valid Trinitarian form of baptism.Often Adventist-related publishing houses conduct mass mailings of their literature to every home and post office box in a community. This has been done regularly with Amazing Truth Publications’ anti-Catholic volume,.

Adventist Beliefs

Seventh-day Adventists agree with many Catholic doctrines, including the Trinity, Christ’s divinity, the virgin birth, the atonement, a physical resurrection of the dead, and Christ’s Second Coming. They use a valid form of baptism. They believe in original sin and reject the Evangelical teaching that one can never lose one’s salvation no matter what one does (i.e., theyreject "once saved, always saved").Unfortunately, they also hold many false and strange doctrines. Among these are the following: (a) the Catholic Church is the Whore of Babylon; (b) the pope is the Antichrist; (c) in the last days, Sunday worship will be "the mark of the beast"; (d) there is a future millennium in which the devil will roam the earth while Christians are with Christ in heaven; (e) the soul sleeps between death and resurrection; and (f) on the last day, after a limited period of punishment in hell, the wicked will be annihilated and cease to exist rather than be eternally damned. (For rebuttals of many of these ideas, see the Catholic Answers tracts,, and)Many Adventists insist that, as a matter of discipline (not doctrine), one must not eat meats considered unclean under the Mosaic Law (many endorse total vegetarianism), and one must avoid "worldly entertainments" (card-playing, dancing, smoking, drinking, reading non-religious books, listening to non-religious music, watching non-religious television, going to the movies, etc.).Adventists also subscribe to the two Protestant shibboleths,(the Bible is therule of faith) and(justification is by faith alone). Other Protestants, especially conservative Evangelicals and Fundamentalists, often attack Adventists on these points, claiming they do not really hold them, which is often used as "proof" that they are "a cult." However, along the spectrum of Protestantism (from high-church Lutherans and Anglicans to low-church Pentecostals and Baptists), there is little agreement about the meaning of these two phrases or about the doctrines they are supposed to represent.

Adventist Anti-Catholicism

As is clear from some of the beliefs listed above, Adventist theology is intensely anti-Catholic. Many Catholics who do not frequently come in contact with Adventists or their literature do not realize just how hostile they can be toward the Church.Trying to give others the benefit of the doubt, Catholics may suppose that anti-Catholicism is part of Adventism’s radical fringe. Unfortunately, this is untrue. Adventists who are moderate on Catholicism are a minority. Anti-Catholicism characterizes the denomination because it is embraced in White’s "divinely inspired" writings. A few illustrations help indicate the scope of the problem:"Babylon the Great, the mother of harlots . . . is further declared to be ‘that great city, which reigneth over the kings of the earth.’ Revelation 17:4–6, 18. The power that for so many centuries maintained despotic sway over the monarchs of Christendom is Rome. The purple and scarlet color, the gold and precious stones and pearls, vividly picture the magnificence and more than kingly pomp affected by the haughty see of Rome" (, 338)."It is one of the leading doctrines of Romanism that the pope is the visible head of the universal Church of Christ . . . and has been declared infallible. He demands the homage of all men. The same claim urged by Satan in the wilderness of temptation is still urged by him [Satan] through the Church of Rome, and vast numbers are ready to yield him homage" (ibid., 48)."Marvelous in her shrewdness and cunning is the Roman Church. She can read what is to be. She bides her time, seeing that the Protestant churches are paying her homage in their acceptance of the false Sabbath. . . . And let it be remembered, it is the boast of Rome that she never changes. The principles of Gregory VII and Innocent III are still the principles of the Roman Catholic Church. And has she but the power, she would put them in practice with as much vigor now as in past centuries. . . . Rome is aiming to reestablish her power, to recover her lost supremacy" (ibid., 507–8)."God’s word has given warning of the impending danger; let this be unheeded, and the Protestant world will learn what the purposes of Rome really are, only when it is too late to escape the snare. She is silently growing into power. Her doctrines are exerting their influence in legislative halls, in the churches, and in the hearts of men. She is piling up her lofty and massive structures, in the secret recesses of which her former persecutions will be1 repeated. Stealthily and unsuspectedly she is strengthening her forces to further her own ends when the time shall come for her to strike. All that she desires is vantage ground, and this is already being given her. We shall soon see and shall feel what the purpose of the Roman element is. Whoever believe and obey the word of God will thereby incur reproach and persecution" ( ibid., 508–9).Strong stuff! Unfortunately, most Adventists believe this. Bear in mind that these quotes are not taken from an obscure work of White’s that nobody ever reads. They are from what is probably her single most popular volume,.

Adventist Eschatology

Seventh-day Adventism is basically consumed with the concept of the last days. It was formed from the remnants of the Millerite movement, which was created to await the world’s end. In White’s end times view, the Jewish Sabbath and the Catholic Church play prominent roles.According to her, the papacy is the seven-headed beast from the sea in Revelation 13:1–10. Accompanying this beast is a lamb-like beast from the earth (Rev. 13:11–18). The latter causes the world to worship the former and has an image made of it. White proclaimed that the second beast is the United States (, 387–8), and that it will force people to worship the papacy by "enforcing some observance which shall be an act of homage to the papacy" (ibid., 389). This observance, she says, is Sunday worship rather than Saturday worship.White claims that the papacy changed the day of worship from Saturday to Sunday, making this change a mark of its authority. In her view, there will come a time when the United States will establish a "national Sunday law" and compel its citizens to worship on Sunday and thus take the mark of the beast. It will not compel them to become Catholics, but to join a Protestant state-church that is an "image" of the papacy, and thus, "the image of the beast" (ibid., 382–96).Seventh-day Adventism cannot change its views on the Catholic Church being the Whore of Babylon without admitting that it was wrong on Sunday worship. It cannot admit that Sunday worship is not the mark of the beast without changing its views on the Jewish Sabbath. Seventh-day Adventism cannot cease to be anti-Catholic without ceasing to beAdventism.There is a "moderate" wing of Adventism that is more open to Catholics as individuals (though still retaining White’s views concerning the papacy). In fact, White was willing to concede that—in the here and now (before the end times)—some Catholics are saved. She wrote that "there are now true Christians in every church, not excepting the Roman Catholic communion, who honestly believe that Sunday is the Sabbath of divine appointment. God accepts their sincerity of purpose and their integrity before him. But when Sunday observance shall be enforced by law, and the world shall be enlightened concerning the obligation of the true Sabbath, then whoever shall transgress the command of God, to obey a precept which has no higher authority than Rome, will thereby honor popery above God" (ibid., 395).Unfortunately, this one tolerant statement is embedded in hundreds of hostile statements. While this.aspect of her teaching can be played up by her more moderate followers, it is difficult for them to do so, because the whole Adventist milieu in which they exist is anti-Catholic. The group is an eschatology sect, and its central eschatological teaching, other than Christ’s Second Coming, is that the Second Coming will be preceded by a period in which the papacy will enforce Sunday worship on the world. Everyone who does not accept the papacy’s Sunday worship will be killed; and everyone who does accept the papacy’s Sunday worship will be destroyed by God.By virtue of their valid baptism, and their belief in Christ’s divinity and in the doctrine of the Trinity, Seventh-day Adventists are both ontologically and theologically Christians. But Christians, once separated from the Church our Lord founded, are susceptible to being "tossed to and fro and carried about with every wind of doctrine" (Eph. 4:14).

: I have concluded that the materialspresented in this work are free of doctrinal or moral errors.: In accord with 1983 CIC 827permission to publish this work is hereby granted.

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