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NYS Register/March 25, 2020 Rule Making Activities Department of Health EMERGENCY RULE MAKING Investigation of Communicable Disease; Isolation and Quarantine LD. No, HLT-12-20-00004-8 Filing Date: 2020.03.08 Esfective Date: 2020-03-09 PURSUANT 10 THE PROVISIONS OF THE State Administrative Pro- ‘cedure Act NOTICE is hereby given ofthe following ation ‘Actin taken: Amendment of Pare, section 405.3; and addition of see- thon S41 1 to Tue 10 NYCRR Statutory authority: Public Heallb Law, sections 225, S76 and 2808 Finding of necessity for emergency rule: Presevation of pubic heal Specific reasons underlying the finding of necessity: Where compliance ‘Wit routine adsinistatve procedures would be conzazy to publ inter= {st the Slate Admnistalive Procedure Act (SAPA) & 202(0) empowers Stale agencies to adopt emergency regulauons necessary forthe preserva- tion of public health safety or general welfare. In (hit ease, complianes ‘with SAPA for fing ofthis regulation on a noa-emergeacy basi, includ ing the requirement for a period of ime Lor pubic comment. cannot be met because to do 0 woul be devimenial tothe health and safety of the ‘eneral public The 2019 Coronavirus (COVID-19) i a disease tat has eased mild to severe tespitatory symptoms, including fever, cough. and difheully brestine, People infected with COVID-19 have lind symptoms ranging from those that are mila (ike common cold) to severe pneumonia tha requires medical care in a hospital and canbe fatal, COVID-19 was found to be the eavse of am outbreak of illness in Waban, Hues Province, China in December 2019. shot me later 0 January 30, 2020. the World Health Organization (WHO) designated the COVID-19 outbreak as a Public Health Emergency of Iaterational ‘Concern: On lanuary 31, 2020, the Seetstary of Health and Human Ser- ‘ices determined that ata result of condrmed eases of COVID-19 inthe United States, «public heath emergency exists and has existe since ante sy 27,2020, nationwide. The situation continues to rapidly evolve throughout the werd and the ‘United States. In particular, the United States has quickly progressed fron, sdeatfying uavel-associated cases and person-to-person transmission of COVID-19 among close contacts of travel-associated cates, 10 the ‘enufcation of comunity spread of the disease in certain parts of Call- fornia, Oregon, and Washington sats "Aditionally, at of March |, 2030 New York State has reported cases of ‘COVID-19. Given the spread sofa, the Centers for Disease Contel end Prevention (CDC) expects that ti likely widespread transmission of ‘COVID-19 wall ocew In the United States ‘Given the emergent mare ofthe COVID-19 outbreak, these emergency regilations are necessary to clarify and strengthen the Departrent® futheity and that ofthe local health deparasents to take speci actions to contol the spread of disease, incluing actions elated (investigation tnd eaponse toa disease outneak, aswell as the isuance of lation and ‘quarantine orders. Subject: Investigation of Communicable Disease; Isolation and oarantine Purpose: Conto of communicable disease. Substance of emergency rule (Fulltext is posted atthe following State Website: hips:iregs.health.ny.goviregulations/emergency). Test Tegulations clarity tae sushodty and dy ofthe New York State Depart- tment of Health (Department) and loeal alts departments to poles the bli in the event ofan outbreak of communicable disease rough 4 ‘ropsate public heals orders issued to persons diagnesed with or exposed fo a communicable disease, Taese regulations also require hospitals (0 Teporesyndromic surveillance data tothe Departnent upon ditetion fons the Commissioner and clarity reperting requirements for cinicallbors~ tories with respect o communiable diseases This notice is intended ta serve only a8 noice of emergency adoption ‘This agency intends to adopt this emergency rule asa pertanent rule and ‘rill publish notice of proposed sole making inthe Stave Register a ome Fitufe date, The emergency rule will expe June 62020. Text of rule and any required statements and analyses may be obtained rom: Katerne Cezar DOU re of Moga Coun. Reg Ale (nit. Room 258, ESP Tower Balding, Albany, NY 12255, 018) 403- 788, email: egsuna@healh ny gov Regulatory Impact Statement Sttatody Authority ‘The sattory autheity forthe regulatory amendments to Pa 2 of Ti 10 of the Official Compilation of Codes Rules and Regulations ofthe ‘State of New York Section 295 ofthe Pubic Heath Law (PHL), which Suthorzes the Pablie Healts and Health Plauning Council (PREPO, Subject tothe approval of the Commissioner of Health (Commission, ‘stalish and atend the State Sanitary Code (SSC) provisions related to ‘by mers affecting the scanty of life or heal othe preservation and Improvement of pic heal inthe State of New York Aionally. Sec~ tion 2198 of the PHL requtes all lea! health officers to report cases of ‘communicable disease to the New York State Department of Healt Departmen’ ‘he sattery authority forthe proposed new section S&1.M of Tle 10 ofthe Olfcal Compan of Codes, Rules and Regulations ofthe State ‘of New York i section 576 ofthe PHL. which authorizes tbe Departnent {o adopt regulations prescribing the requirements fo the proper eperation ‘of a clinical laboratry cluding the methods aad the manera which {eating or analynes of samples shall be performed and reports submited “The statutory author Torte proposed amendment o section 408.3 ‘of Title 10 ofthe Oficial Compilation of Coes, Res sad Regulations o the Stae of New York is section 2803 of the PH, which authorizes DPIIMIPC to adept and mend rules and regolations, sujet othe approval ofthe Commsioner, to upletnen the purposes and provisions of PHL ‘Avice 2, and establish minimum standards governing the opecation of ipals care Failives Tegisative Objectives: The legslave objecuve of PHL. § 225 is, in pat, to protest he public heath by authoring PPHPC, withthe approval of the Comnsstoner, to tmoend the SSC to address pubic healt issues telat to camnsunicable disease ‘The ieislative objective of PHL § 576 is, in pss, to promote public ‘eal by establishing munimum standards fr nial laboratory testing ‘and reporting of tet results including tothe Deparment for purposes of {aking prompt action to address outreaks of disease. The legislative objecuve of PHL § 2803 includes among other ojcc- tives authorizing PHHIPC, with the approval othe Cartssone, to adopt regulations concering the operation of facilites licensed purstant €0 ‘Ailcle 28 ofthe PIL nchding general hospitals, Needs ed Benet The 2019 Coronavirus (COVID-19) i disease that has caused mld to severe respiratory symptoms, including fever, cough, snd iffictlly treating, People ifeeted with COVID-19 have had symptoms ranging fom those tha are mild ikea eommoa sold to severe pheumonia that equtes medies eaten a hospital and canbe fatal. ‘COVID-19 was found to be the cause of an outbreak of lps in ‘Waban, Hubei Provine, China ia Decetsber 2019. A short me Iter on Sasoary $0, 202, the World Health Organization (WHO) designated the ‘COVID-I8 outbreak as « Public Health Emergency of International Concern. On Tanusty 31,2020, the Seeretay of Heath snd Human Ser vices determined that az esultof confirmed eases of COVID-19 in United States. «public health emergency exists and as existed snes Fant sey 27, 2020, atone. Te sation continues to rapidly evolve throughout the world and the ‘ited States, ta particular, the United States has quickly progrested for ‘denatying wave associated cases and person-to-person rssiason oF COVID-19 among lore contacts of tavel-steociated cazer, (0 the entiation of community spread of the disease in certain pats of Ca fornia, Oregon ang Wastungton ats. Ac of March 12020, New ork Sate has reported cases of COVID-19, Given the rate spread dat. the Centers for Disease Conte and Preven- ‘ton (CDC) expect th tis ikely widespread tasmision of COVID-19 ‘will eccur the United States. Tn ght ofthis situation, these regulations update clarify and strengthen the Depaztmeats suthonty as well a hat of oval health departeats to lake speci actions to contol te spread of disease, including seins Te- Ineo investigation and respons to disease outbreak, as well the = ance of solaion abd quarantine oners, ‘The following isa stmmary ofthe amendments to the Department's regilaons "Parc? Amendments *Reocate and update detitions and add new definitions. ‘Repeal and replace current section 2.6, elated fo inertigations, to sncke existing cany foal health department sary. ™ Ses forth specie actions that local heals departnens must te to investigate ate, stopet ease, outeak, or unasal disease, 15 Rule Making Activities NYS Register/March 25, 2020 Requires individuals and entities subject to public health investiga tion to fooprate wa the Department and focal helt deparnens * Clasties sulhorty Lor the Commissioner to lead invertigation =" Codiies in regulation the requirement that local health departments send zepors the Deparment during as outbceak * New secon 213 sade to candy isolation and quarantine procedures 1 Chay thatthe State Deparment of Heath hatte auton tse isolation ad quarantine orders. a do local departments of bealth “Caries locations where isolation or quarantine ay be appropiate {Sets forth requizements forthe content of isolation and quarantine orders ~ Species other procedures that epply when 2 person is isolated or guaantined SNe-Expliily states that violation ofan order constiues grounds for civil andfr ermial penalties Relocates and pdaes existing regulatory requirements that require the attending physiean to report eases and suspected eases tothe Tocal health authonty, and to zequres physicians to provide instructions concerning how fo protec others Pax 58 Amendments « New section $8-1.14 added clanifying reporting requirements for cerain communicable diseases “ Requies the Commissioner to designate those communicable disease that require prompt action, and to make svalble sist of sch diese the Sate Deparitent of Health website “Requires clinical laboratories to immediately report positive test results for communicable dacasesidentied ag sequiing prompt ster: tion. a manner and format identiied by the Commissions * Recuites china ahoraores to report al test esl, nsleing negae tie and indeterminate resulta, fo communisble iscages idented as requiring prompt altetion. va the Eletronic Clinical Laboratory Report Ing Sytem (ECLRS) arc 405 Amendments * Mandates hospitals to report syndromic surveillance data during an ‘outbreak of highly contagious coramunicable disease * Permits the Commassione to direct hospitals to ake patios during an outbreak of highly contagious communicable diteate which i co Sistent with the federal Emetgeacy Medical Treatment and Labor Ac (EMTALA) Costs: ests to Regulated Pats: ‘The requuement that hospital submit syadtoaie surveillance reports ‘when request ding an outteae isnot expected to est in ay substan costs. Hospitals are already zegulaly and voluntarily submating data to the Departnen, and pesly al of eta submit suck report eleconially ‘With regard to the Commissioner directing general hospital to accept palleats during an outbreak of «highly contagious communicable disease Fospitas are aueadyreguited to adhere tothe federal Emergency Mest “Treatment and Labor Act (EMTALA), Accordingly, both of hese proposed ameadnents will ot impose ay soba adiooal cost to hospitals ‘Clinical boratones mast aveady report communicable disease testing resus ing the ECLRS and must also immediately tepor communicahle ‘igeases putsuan’ fo PHL $2102. The regulation simply claties existing equremtats and is bot anced to imposes any substasladaonal ‘outs beyond those cost hat laboratories would incur inthe absence of these regulations. ‘Alihoueh there are costs associated with dscase investigation and re~ sponse fr any outeak.theve regulations clarify and strengthen the exist bg authorities and responses of foc! governments As such, these {efulauons do not impeve ay suhstaal addtional costs beyond wi oe ‘a health departments would incur in the absence ofthese regulations. (Coats to Loval and State Government: Although there are cost asocated with disease investigation and 1e- sponse fr any oatreak these regulations clarify and stengiben the exist {ng authonies and responses of loca governmeats As soc, these Tefulatons donot nose any substandal additonal costs beyond wat oe ‘al heath departments would incur in the absence of these regulations Further, making explicit the Department's aor to lead iavestigation Acris will esl ip ineeased coordination of resources, likely fest ing na cost-savings fr State and local governments ‘any cial laboratories operated by local government must already repont communicable disease testing results using the ECLRS and must fto immeditely report eomntnicabledigetses pursuant to PII § 2702, ‘The regulation stp canes existing equiements and is not anipated tolmposes any substan adional costs beyond those costs that labora: teries weld incur inthe sbyence of there repdatons To the extent thatthe State Deparanest of Health and local ee! eparements ise folaon and quarantine orders in response to COVID- St such actions will spose costs upon the sate. Az the scope of ay 16 ‘utbreak i ifical opreic,the cast othe State of ising sich des ‘Ssanot be predsted tis ne Paperwork Scio heopitals may be required to wake addtional syndrome surei- lance reports that they ze not alfeady making. Orherwe, hese repula™ Atos do net reque any ational paperwork. Toca! Government Mandate: Under existing regulation local health departments akeady bave the sory and eofous ht (tke cons to Contel ie pprad of dase thin ir juradictons The proposed amendments clay these existing Solbortis sod dee. Deplioten Talze sno dopiction in exiting Stat or feral awe Alieratives ‘he stmative would he to leave in place the crn regulations on