University Hoeptiale 4/10/2018 2:18:27 PM PAGE 1/011 Fax Server Approved 04/19/18 Last Date 04/10/18 University Hospitals? To Ohio Department of Health, Attn: Wanda Iacovetta Fax Phone University Hospitals Fertility Center Fax 614?564?2416 University Hospitals Ahuja Medical Center Kathy Risman Pavilion woo-Auburn Drive, Suite 310 r: m? Beachwood, OH 44122 Phone UH Cleveland Medical Center phone; 216-285-5028 Fax Fax: 216-201 ?5390 216-201-5390 Date. April 10, 2018 re CC Pages _11 Message RE: UH Cleveland Medical Center, CCN: 360137, Survey: March 14, 2018, Plan of Correction The information accompanying this transmission is strictly confidential and is intended for the use of the addressee only. University Hospitals disclaims any responsibility for the unauthorized disclosure of this information to individuals or parties-other than the addressee This information has been disclosed to you from records whose con?dentiality is protected by Federal and Ohio law, including HIPAA, Federal Regulation (42 CFR Part 2). and Ohio Revised Code sections 5122.31 and 3701.243 which prohibit you from making any further disclosure of it without the speci?c written consent of the person to whom it pertains, or as otherwise permitted by such laws. Ageneral authorization for the-release of medical or other information. including HIV/AlDS-related information, is net sufficient for-this purpose. if you received this information in error. please notify the sender immediately by e-mail, fax or telephone, or call lnformationSeryices at 216-844-3327 to arrange for return of the original documents as'soon as possible. In addition, if you are not the intended recipient, any dissemination. distribution or duplication of this transmission is strictly prohibited. University Hosptials 4/10/2018 2:18:27 PM PAGE 2/011 Fax Server Approved 04/19/18 Last Date 04/10/18 University Hospitals Fertility Center Univers'ty Ho?pltals Kathleen J. Sanniti Cleveland Medical Center Director .1000 Auburn Drive Kathy Risman Pavilion, Suite 310 Beechwood, OH 44122 (216) 844-1335 April 10, 2018 (Via email: Centers for Medicare and Medicaid Services Non-Long-Term Care Certi?cation and Enforcement Branch 233 North Michigan Ave, Suite 600 Chicago, Illinois 6060] Attention: Pam Para, Nurse Consultant (Via Fax: (614) 564-2416) Ohio Department of Health Office of Health Assurance and Licensing Bureau of Survey and Certification 245 North. High Street, Floor Columbus,.0hio 43215 Attention: Wanda lacovetta Re: UH Cleveland Medical Center CCN: 360137 Survey: March 14, 20l 8' Plan of Correction Dear Ms. Para and Ms. lacovetta: Enclosed please find the UH Cleveland Medical Center?s plan of correction (POC) related to the. above referenced survey. If you have any questions regarding the attached plan of correction, please contact me at (216) 844-1335 Or Sincerely, Kathleen J. Sanniti Director University Hospitals Fertility Center Encl. cc: James Liu, MD, Medical Director . James 3.35 ?1315331 We! 85:95 pane-"m etio'sa?ed. u111vax?51ty nosptiats 4/10/2018 2:18:27 PM PAGE 3/011 Approved 04/19/18 Last Date 04/10/18 Fax._. server 4/2/2018 4:07:01 PM PAGE 5/013 uterine: 84/532518 DEPARTMENT OF HEALTH eno HUMAN SERVECES FoRir neea?oven' CENTERS FOR OMB [40.509380391- smemerir 0? use osenesee we; on; you me err no; em: sewer on: ism coeaecr-c?: (241110? mustn?t-3' MM commas 33913: a wire? 0314/2018 [was oF Hammer: smear. #:2123555. 3 7's, zit-Are. 23-9;ch . I . AVENUE UH GLEVE LAHD memo-At. cams-a 0H gins (m3 .3 .eurmm' oeegoeut?sfsg in women?s Ru." 9? confession Lg p?gpjx MUST- St? FISLL m; emu: mm on I meme-N :5 :wonmnom ms TO my: gamer-Rm F, 54175 caricature: ?5 DUB COW MENTS COO April .10. Substantial Allegation 2018 An entrance conference was conducted with administrative staff on 0312/1 a at 9:43 AM, and an exitoonferenoe was completed with the administrative staff on oai?tei'f?l'?ot Are. The feilowiog de?eieneies are leased upon inc? substantial-a Negation survey .ocmpleteci u: I Cleveland Medina: Ce liter-ts not the requirements 423?}? Part 432' icrAeute Care Heepttat?ancl the iotowlng de?ciencies a're cited. A 700 . A 709 PHveicAL ENWROHMENT A 709' 724 April 10; Gems): 45241 2013 Facility Position: ThisPlan of Correction is The hospital arranged. and being Submitted in accordance-with a. maintainedto ens'uretne.safety' or the patient. applicable law. The reviewer of this citation and to provide facilities for diagnosis'and- should note the following: UH- Cleveland treatment and?for special hcgpitaisewices Medical Center is committed to prot'riiling the needs 5* lhe 'ccmmum?f quality services and has policies and . procedures in place designed to ensure that its Tm CONS is [animal by: equipment is maintained to ensure acceptable . 5854511 on Interweave obeewattoirsand 1 W218 fsaf a . d. 1 record rexiewe, it was .detetmined the-facility - qua} mime 1,3 a {?ed to: ensur?-mg ?quid commenced to take actione upon learning of ccmamer ma Tan-H ?Eyed for 399 the problem With our fertility center. .A very- and was inspected and signi?cant amount of activity took place from maintained This effected see patients. March 4. 2013 mm Present. However. please and Involved a sum totaE-of?zf?t eggsand accept April 10, 2018 as the date nponwhich emu-arcs. all of these steps had' been ?nalized and A F24 racemes. SUPPLIES. mu on cm A completed. . All?i 10: risen-(qua; 2018 Facizaties. supplies: end-equipment must be maintained to ensure an aoeepiobie-ievel of tiers anemone anemone DR or; ozg Kathleen I. Sanniti, Director 7 My (tenderer Etstomer-torarq with an assertekv} depetoss?de?omncy whim me institution mat: bo'p'xcuwd from correcting pic-.1an it 'is'netahrirpc?ga( other eateguzrcs. ore-vice stiilcient protection tome patientst (Son matruetions EXGeri?tnr-mrsurg harms. the [indemni?ed above are memento Q?Goaye render-g tho out: at eungw weather or not quietly-oi oorrzcuor- ?5 pr?otiidoo. For oust/'5) limits-Pittman their-.9: gird planeoft?znc?hon 1.1 days following; that date these doc-emote: are mademeilebt: to the iasility. 1r ce?oienciEs are oiled. aneypteved pier of correctionis-renuisile loo: Piliin program perti?imtim Fax Server Fax Server- eoeyw mien-i au-ncir'sn- 1::an Ib? pit-mun it :iciitibuitron slicer Paq'e 1 c1 Jam-as mail [emu tlt?tl?eu muses! Wd' 38:90:? pastas; on. in satin-d University Hosptials 4/10/2018 2:18:27 PM PAGE Fax Server- 4/2/2018. 4:07:01 PM PAGE 4/011 Fa}: Server Approved 04/19/18 Last Date 04/10/18 8/ 013 Fax Server ammo; con?rm DEPARTMENT OF HEALTH AND HUMAN Rmpqoogg CENTERS FOE at SERV CES onto NO. 0938-0391 STATEMENT o? DEF Grannies {x41 :32; our maconsrnucr on no; our, some? and contrast? Cr! ammonium a Wilma gunman E. 350137 5' ?"13 . 03/14/2018 mm: or" mama 55: or? SUPPLIER STREET not: Roda: :2 tr, stairs. 21!? soon moo auctlo man a . UH CLEVELAND MEDICAL ENTER. I GLEVEMND. 0H ?ma (xg; eujinim?v simmer? or: stem: moss- io- Finn op connection gag-gm: [mu MUST Br?. merino-EL: mu. EREF 1 ire-ion sonneorwc-mmn amount: as th'hgtm ms or: i so inFmiFr-?uolemommrroni TAG Trims THF memo:24 Continued From 724 (com) safety and This STAN as not met as evidenced by (toned on ain?tf mt?rvtc?ws ,observatiomiand record reviews, the facility failed to ensure one Ilouio' nitrogen storage container LNZ Tank? [container Used'ior'eg?g storage "was irispanted and maintained The off?cled 9210 patients and involved a sum total of 2.751 eggs 3' nd embryos. Findings} inciude' 1. Observation or the fertility stints warn Staff Ann - PM and revealeo .a liquid nihogen storage container [Container #23) In the-'invitro laboratory area ={Grgro'roorn} which was being used'to-s'toreoggs and-embrv'oa. aloft A stated this was a toarier ta was;an into den aller'the other liq uid nitrogon storage commas-arm was disaover?doo 03:04.15. 'Goriralher#i Waaooserve'o beside Containe'r#2 and was no: ourrentlir Inus?e to store eggs" and embryos an additionoi smailer liquid ontogen s?ior'aga container (Container ihai'was imam to hold eggs and embryos-whim had not Egan transit?aired into the 1 larger storage tank. Start A stared otter the storage container [container #11) maltunctioned all the eggs and Embryos-were movedfrom and into the loanerooniatner [Container Containers . the. audiology container for: sperm garage} and im-Mldiog or: ntainnr were. all observedwitn an elooironii; alarm device on the outside of the containers: Staff A ?stated storage-Containersm and #zwere i There were a numberol statements in this _5 Statement ofDe?ciencics that could bene?t from additional clarity; in the interestof i brevity, we are limiting suchciari?cotions to i the following: 1. Container #1 had both a local alarm and a remote alarm (the remote alarm had been turned offal the lime oltlie March 4 incident}. These two separate alarms were set with different parameters. and thus at times an alarm condition for one alarm would not be an'alarm condition for the other alarm. The-lanuary 201810cal alarm may not hat/e triggered the remote alarm. I 2. Through-January 2018. Staff'C was receiving communications indicating the remote notification system was working. 3. While the temperature of Container #1 is documented once. per day, the temperature of Container #1 was monitored constantly by two'temperaturc sensors in the container. 4, The ?rst high temperatu rc local alarm did not activate until 5:06 9.11}. on March 3, 2018 or minus 156 degrees Celsius. scan woman-22.99] mom; nicnons'omqnm mm: a; Horro- i-jL-nitg {o 0H5W05. Poor: 27H 3 University Hosptials 4/10/2018 2:18:27 PM PAGE Fax Server 4/2/2018 4:07:01 pm 5/011 Fan Server Approved 04/19/18 Last Date 04/10/18 PAGE, 7x013 Fax Server zoo-nan; consortia Jams ma;me mama! no snow national. ct.- :0 .ta?aa DEPARTMENT OF HEALTH AND HUMAN DES Appq'ovm CENTERS FOR WEDECARE 3c IAEDECAID SERV CES OMB NO. 093843391 citations on: mien-2m {3'22} 171.5 c-tt cot Ann FUN or on can-1F CFHCIM NUMEER . a I mm?a - ?t Emu; Num?wnw 39013? 5 bald-?2018 twice or P?'awn?? on TY. star 5. in: cool: . . . . . our;qu UH CLEVELAND MEDICAL CENTER cm ?ms u} stating-1t Damn EMIZES to m?o?g?nEno Root-m bonit?m?n c5} {mu moor as mom FREFX ranch connect Iva-lactic?: swan-m as -- uncomm- 1m; rennin Maw on I so mama-win m; To In: mom?an 9-7.9 scrim-prior, A 1'14 Continued m?pag?equipped with two comers {one planar} A 724 (cor-1L) higher and one-placed tower] inside the container maria-organ temperatures maids: mo unit Staff AslatedJn-the event-me alarm tripp?d. an audml? alarm would sound on the container and tire alarm would also be electronically submitted to a tit-mote mnttortng company in an n?sit'? location. anoint! monitoth coman would'then notify the designated person via a. robs-call or onion ot'tne alarm. i Stat! Acomirmed-the toilet Should be Dormer: 10:23'lnches inatcie'tne storage Container to maintain proper internal. temn?ratut'e and tho-local and remote alarms would sound it tho tomperaium rose groatorthan 4180 dogmas Celsius 1. 2. bahvoa'rt 4 3? PM and 5 sop-M, anintertrtew was conducted with Statt malfunctioning'liqmd nth-coon storage container Staff 0 stated-the container had been used to store?eg'gs and embryos untilafter a temperature malfunction occurred inside the conta mac and this technique continued to be practiced urrlil this . canta- contairor one to Increascd Intemal t'?mperaturesott Gamma and antenna. Staff 3 stated in Janus $3018 tie/she. was ln-thc- the taco! alarm sounded on Container #1 . The-alarm'wao one tq-a sensor tor-the lavat'mstde me contotnot. Starr stated - the. ma hufactur?rWas noti?ed and sifan were instructed to man-uniti- m: the container with-mun nitrogen dua'to the malfunctioning-sensor. Stall -: stated her/she wasmt noti?ed oi the 5. Whilethc manufacturer of Container #1 . proridcd recommended maintenance, there were no recommendations regarding the frequency of such maintenance. Following March 4, 2013, when asked to provide recommended frequencies, the manufacturer declined to do 50. Plan of Correction: 1. Container #1 was permanently removed from service on March 4, 2028. 2. All eggs and embryos were removed from Container #1 on March 4, .2018 and placed in Container 3. All liquid nitrogenstorage tanks now have a remote alarm notification system with an . identi?ed 3-ticrcd chain o{ persons receiving noti?cation, totaling 5 people. 4. We have implemented a new policy and procedure to perform the checks and preventative maintenance in accordance with manufacturer?s recommendations. While the manufacturer does not specify frequency. the - policy and procadurc we have. implemented contains required frequencies for each maintenance step and test. Such maintenance and testing is documented as it occurs. Lab staffhave been on this policy and procedure by the lab director. i 1-1255 Frat-inurt Vomiting Shut-tit: til it} . amat- {?01705 t' o?nlruation st?cc't Pug: act ii uu mutant-n 9; 10-33525- Jamasxe?. mm: lawn. m?u?no mama! did some University Hosptials 4/10/2018 2:18:27 PM PAGE Fax Server DEPARTMENT OF HEALTH AND HUMAN SERVICES PAGE B/Oll Fa}: Server Approved 04/19/18 Last Date 04/10/18 '8 {01.3 Fax Server coca-5cm FORM APPROVED CENTERS FOR 5: MEDICAID SERVE ES 6513 NO. 0938-0331 STATE-KENT OF warmes? t: mC?alomsumaEn-tzm 51:: ii certain-act on not 0an ounce mo Fm: detonation,- on :EEfa?t?iF carton durum. a, conmErEn soars?- 5 - 03/11/2018- rcsii'n or soppucn. ACCRESS, ctr. smarwcoda I ME CENTS +1100 Euctjo AVENUE CLEVELAND. OH 44106 mi in ,Eviinn?fv STATEMENT dED'En'c NCIES to Pant-tom's Emit BF contraction on, te?mH oer minor 55 monomer; E?l' mu. men; taunts-561th mourns:- zany-rm T35 nF?nm-m' Dn- or; on; m; con-SSWFEnI-?Nnmm THF ?3 A724 continued Front-page's A ?'24 A 700 alarm by'tiie remote A 724 (cont) outside service company rumba-malfunction of ecntalnerm?? anion" sensor to Januarv 20.16. or when thettempc-Iamre's increased-to an unacceptab':o lave] lnsidc?Contalner #1 on Sialf 'oeniedfbeing present in die fa ctliiy. when the malfunction-occurred inside containem'! tr. Moron 2018. Staff stated tie/she should have been nottrted for these two .evenls due to being the contact person fol-those alarms. scan 6 denied any or me facility-stain nact ccntacieotne suicide reroq't? monitoring con-[pang to. question win,- the denignaieti coolant person did not receive the alarm in January 2-313. There was no documented evidence provided by hospital otatt or investigation as to Why the designated contact persoofailed to receive notification of thea?utomatic-aiatm In January - 2015 when the: aut'oi'iit sensor alarm failed. and prior to the maidmction for the container rotated to increas?dlamp'eraturas Iodide-tho tanker: G3i03118i Staff slated on Mimi/18 hefsh? Was. not present :nltho'iacz-Itty When .Sta'it: arrived and discovered a high unaccept'a bio temperature or 437 degrees Ceislus on the outside display- panel inf Container-#1 which revealedihe internal ta rilt- ta mparature Ste? stated acceptable to mperat'ure insideine liquid nitrogen nontainer should have remained benveen3t60 degree Cot-stun {Cd'?ltd ?1 fie-degrees Gaining, Stair stated-14;: discriminated?a safe temperature and below iathe'desired temperature. Stat: stated "if alarmsounds and somebody say they: would have a couple hours to respond and the upper alarm tells the I 5. We have purchased 4 new liquid nitrogen tanks for egg and embryo storage. All-4 tanks are operationai and are being monitored and maintained in accordance with the new policy noted above. Lab staff have been on [he use of these new - tanks by the lab director. 6. We have implemented a new policyr and procedure speci?c to our new remote monitoring technology. Lab staff were in- serviced on this new remote monitoring technology on March 22, 2018. 7. Embryology laboratory staff were inserviced on the chain of command on March 16, 2.018. 8. The'Lab Director or conduct. weekly audits ofcompliance with both politics described above for four weeks, and. then 9. The Martino ald Quality Council wiil be receiving the results ofthese audits and taking any necessary action. I:th Prat-[a as torsion; Unable ?ve i1! HOT 91' awn-1D. OH 3115- sr'cnr Pogo-:4 or it sutv awmtr 1m [Jamaal ct-Jq?a?ed Jauaa XE-J tutu; [am tq?u?ea University Hosptials 4/10/2018 2:18:27 PM PAGE 7/011 Fax Server Approved 04/19/18 Last Date 04/10/18 Fax Server 4/2/2018 4:07:01 PM PAGE 9/013 Fax server. 13436252411 3? DEPARTMENT OF HEALTH AND Hutu/mu SERWSES Amway EB, MEDICARE DES DMB NO. 0935-0391 . CfEhthg I 5:2: WELT FLE EQHSTEQGT Gt! 351.31? ma pm: CORRECT Cw; F?ru??F?C?Tlon NUMBER gum "5m gamma 35m;- 8 ?tie nmamms mus OF mavtnsa or: supFuti?t- ADDRESS, t: n: 3mm}? 111W AVENUE a: n- . UH CLEVELAND EHTE CLEVELAND, 0H ?we as swarm-w mm mm caner amass" 1p mmcews ELAN cmaa?mi?un :33: {mu Dar-mew? as: av mg: 5.: ?13an BE ovum? hymn-v ram an 13:. mmaw I337.- 714- Ccminued Fro m?-page a! ??24 ievets have exceeded temperatures." Statt stated rte/shearan contacted on 036411.13; by Star! and Staff otthe unacceptabte tempe?tawre .?Staff'Q hat/she again-cud not seesaw not?iaali?cn'rmm the remcte-oulside- mu nitoring con-pang cat-the alarm and stated he/sne should have beenmmte?a {at the atatm due to being the sole deSlgnat?d-cnntact-person; 319:: 0 stated there'mme alamts for me tiqtiid ware tested 335: Mare or April/2017; however, as at 135/1 4:18 the taming! i talaed'to provide-duwmented evidence of this test Statf?slated he/she was-snails; af?ne days a manth andln other states grates; cf the manth. 3. F'E?rit', Staff Lganfitmed afterthe- matfunctiaft c-n cam/ta. the tan.th stat! contacted the cmsadear?mote manitcring company in Invasttgate why the designated was not anti/fed about the unacceptabje high-tempErattJl-e level inside Cantainer?t can-93:02:18. Staff alarmWas renewed Urmate'mme company, hawev?r. the-atarmwas hat transmitted It: the fac?ity's sch'?esignatefdcontact paracm 4. on Hart 3313 between 11-th 9PM mm 2111: PM an intemew was comunted with Stat! ho. the teca?r'audlble warm and mete-3199c! unaca?ep'tabhe tampelaiui'e- Simon: the neta'ogsn storage cremains? #1 the at 93104118 stat! stated the 'tollawlng: efsne wag. the ?rst person is arrive on 03/03/10 and 03/04/18.- He'isne arrived ?tc-tha'tezrtility' 03/051128 ans-557411249) i-a'mlny 03.11735 1f Pat}: afrai- laws we turn; lawn. NBMEG mamaai Wd sszsuw a warm uo m. 40' ola?ed University Hosptials 4/10/2018 2:18:27 PM PAGE Fax 56rver DEPARTMENT OF HEALTH AND HUMRN SERVICES Approved 04/19/18 Last Date 04/10/18 4/2/2018 4:07:01 PM PAGE 101013 8/011 Fax Fax server cam/fen: ED. 0MB NO. 0938-9391 CENTERS FOR ?.5010th SERV 0E8 mums?;- pgr?cz-Emms pee: [3:1 wane-t c-n. ma Fun I corzrcecr ram. cam? NUMBER. .: . 1? 'cauPLErsn A. 35013? 5; mar; 03/14/201 3 mm DR SUFFLIER Him/mas; 1:11 3mm gav-cacy? c' LAND men mm. CENTER 11m Eucm AVENUE LEVE CLEVELAND. OH #4106 my ID smarmm? sThrEMEm m: 50' momma-shun CJ-F 9,5; raging mach mus? m-Fbu. FREF x. 5531.12: HE ggsu??un TM, ml ace-r: ?rmware ms masts-REF In mF "?75 gamma-2:91 A we: Ocnzinued Fro m" page 5 A 324 around ?.12 AM: want inicjhe' Bryc- rocm. {Used to house Cnntai?n'er at 17:20 AM and lanai-aIarm sounding cm i Gamainer #1 and 1emperaturo3 reading at .32 degrees c. Siaff shut as: the audible alarm and noti?ed Sga?'F of ihe alarm and incrc'as'?ci temperature Staff (phy?si?aian) was. sm?omed as heighe Was nnsite wnu men. notified Sta? '6 (designatad'comaut person) by phone. Sia?E me plevicus day an c3/03'i18. heir-she ward 11110 the Ergo mam arid observediheiemparature'priar to leaving aruu?d - 1:23 PM. and stated the meniperanire readingwas appropriate and denied hearing an audible alarm. nglew of the Emperature ngarevealed ma internal tamperature sensms18ensor A and Senscr'ay. The1e.mperature began rlsl'ng inside Certainty-#1 cum/03:18 beginning 31.2.00 PM The Intemal 1empsrature roan-:30. -32 degrees mn'Senspr hand eduagtees?: nn sensor 3. The infernal undesired elevated ter?aerature me untli assume at 3:00 PM at which time Sensors Aancl were?.185 degrees Celsius. The ?Quid nrtrogen Iev?ljns'id? the g?htaimr?was 1'3 inches at 2 00 PM. on 03/0331 Bwhen Se?n'sar was at 450 degree-Ls C. The have! drapp?ed'to 1 inch an 03/04/18 at2:GD PM when the temperatljre inside-1119' tank was L1, DC'Uagre?es an bpih? Sensor-5 Apnd Bl Staff confirmed pri'ur {he malfunction or Co?iainar on and 03mm 8. the tempetature readings wage: only upon arm's! to me {away In the mowing and did 1131 list a time 3111?: mourdln?gs. 5. On 03:13:18. behv?en 12:11 PM and 12:54 PM Blah? stated Stan sent a text pic1urel1o 5.13%: an 03/04/13 a?er'T'LSDv AM..;Slaff' slated the text piciug?e was a tempe- raiure reading afl?'fadegreas 1' Pam-l EMS rim-mus Yam/9 pug-mamm- man's .31: Fa?lfm' Fag-1m.- IU. us If canlir'mrian ?l?ccx Pay: Hot 9 Jar-193 ?a sum: [emu NEE/inn watsaamd 89:90: swarms: no pal-nasal 321. so Ina?ad University Hosptials 4/10/2018 2:18:27 PM PAGE Fax Server 9/011 Fax Server Approved 04/19/18 Last Date 04/10/18 4:07:01 PM PAGE DEPARTMENT OF HEALTH AND HUMAN 11/013 Fax Server- :r-erB: FORM np?nmg-iheiop of the'mnialner?. SiaffF siated 'a?er reaming the te'xt pictui?irom51??'?'cn 63/04/18. upon arm! aniha?t same date; there CENTERS FOR MEDECARE usmcmosmvcea OMBNO. mania 5.1.515 man OF DEF CiErirLl?ES m1: {3:55 m; m; misumm mj'FLmq cpg??z'r'cn 2:15th caTemNumsm= - - - ELI-LB HG 351313? a was 52:14:2013 NMEDF #ananaa cream-?HER err. srmz. manna UH OLE MEDICAL CENTER ?190%th ?Ems . - VE CLEVELAND. OH #4105 {mg ?3 swarm 0F DEF-1C Er-rczEs m, meuzoeg'gmgm mam?25:11:35 m; ragga; {EhtHnE?nzm?cr r5051 BE: macaw HM. I mfg-magma 43.1": p: I'm RF-rsu: 9mm DR Lsr: Mama-{mm TM Tramp. APPREFRWF Ecr'iz.c11a'r; i . A Unnamed From page 5 A- 13-4 3 c. on tha-digifal central screenpn 1130 Giomainer Staff staged has/She arrived a: AM;and ngnlirmedme temperagung?eacmg {he was; "100 nlgn. gaze-if staiec', 5431!! weret'ralned 'tn-check an automa?c digi'tal 3 screen on-ihe outside-cf the ?15:an 3' cantainer which contained far the liqan mungen??ll level inside the 1' storage-cantata. Staff F-alsa.s1ated me?! were to, i . 1 - . inspect the 251591.:- oi-me co?taauer for vapors by a E. i i andchanges." were no Vapors present when the C'untaln'erim was opened for inspactidn; 5135 St'aled ma pre?ense Eat vaporswnuld Indicate 1hE? prasence of liquid nitrqgen inside the shrage container. 6. 031131 ref/gewrwas Jannduuted 01 the. ma nuac?mrier?s?for use-manual (Container 11.- This manual contained the fallmvingt "Prepare a Contact list. Have at'lea51 'a-pecpm an yaw contact lie? HOme', Gel:- and Pager Number. Review the list ragulawior'accusacy "Recommen?e'd Practices. Seoundan; or backup-alarm. it is sirengly'r'ecommended to have. a1 a minimum, an indepehdeni {e r?pemture ala'rm'for'e'ech ?Keep a dam! mg. Track tameratwes claw; Recch 1m [men/315 and?amuunt or LNZ Ti'lieuml'o vessaz (manual or paw-?ll freezer "c Th1; Iniotmauor. shank! be .documei-rle-?d daily-and revi'm'ved mommy 16- faresee and pres/em {mum pr'bblerns such-as 1e mperatura ?ucly'a?itb n5 arid va wing quui: levels." [2:311 255 (02-31 B) Pmlpus ?Mrtlans CE F- igmmj' [13' 334131 P35 I cerimmt'fon?ric?t P?g?d 7 d- El Jams was: my {awn In?ll?eawazsnal 21d ua par-5933.1 cl. 10 manna University Hosptials 4/10/2018 2:18:27 PM PAGE 4/2/2018 DEPARTMENTOF HEALTH SERVICES 10/011 Fa}: Server Approved 04/19/18 Last Date 04/10/18 4 :01 PM PAGE 12/013 Fax, Server (3413312518 FORM APPROVED CENTERS FDR a CES 0115119. 093843391 STATEMENT DEF on: :32: min comafaumnu :33; users suave: nun-Fm: ?rmness? IcermF care-nu NUMEER mm m; :3 330137 0321412613 13F QR EUFPUER UH CLEVELAND 51511119111. STREEF 11?. STAR-1 moo EUCLID AVENUE CLEVELAN I). OH 441 as to your Dalia Rb?'m or'Rer?note Aufo Dialer CL WW anbuld {like my remate alarm reatareco'r .cunriactioh? A. if an-alarm cactus after hours? on a? week?nd cr hcliclay the feminine alarm comedian waitstaff yams: a?problem and let you address 11 gummy." 1 "Chem: unil daily to ensure proper opetatibn and safatr of ihe stored sampie-a For the-.11 series unita?ype used in. iaa?m?, Ill Evessentiat to lift the Itueach day and tin-31:ka vapar and sl'gns ?or proper fr'eegmg.? "meaning a nd Maintena nae. Sysie In Check. 1. Test all aiatm function's Ior?proper oper?'atian. Chap}: any connected Remote Alarms. at Auto malic Dialiag agsiema {censure pmper cperati?n. See page-26 goivmanual} detailed on clause a? (3H aia?nn cemacts. 3. Check for leaks at alt connection paints of {he liquid gnitwge n" line-s. 4. Eva sure thatail-?lecttisnl wires are'free cf damage 'anq'plugs are ?rmly until the maifunctipn chContainer #1 was 4/18 533'51aff'physiically pwsent in 1hr: {001113112 mpm?mring indicate meamount of liquid In1ne storage Bank-crme presence/absencsof?va pars. Sjaff began logging- .absngatgcn 3193901?; and liqukiniirbgen teat-Is an 213306513; There'st m-dacume?ntad evidenced cleanan ?cr inspeclion af? Contains: #1 which Included- ca?baiing and testing of HEGH and LOW alarms, (x4, .0 :21: WW STATELEEHF 93': DEFEC was In PRC-ram;ng nu.? a; smash hater-BE FRECEIEI: m: Pm; PREP am 5111mm Ba 331/112}le mt; .91va 3R 1 ac: Ir?j?mmaml THE: WE CEFJSLI: Mar; A 724 Ct: nzinued?Frc page 5 mm: ?rmsurgx?rglmotmwo l-y?rll at: 2:119?- l-arllity- It.? NS shunt Page: 5! 61-5! Jams 2:23 ma}; lawn-mama 111615931 wascmoajmuzw no EL 16 name University Hosptials 4/10/2018 2:18:27 PM PAGE Fax 83rver 11/011 Fax Server Approved 04/19/18 Last Date 04/10/18 4/2/2018 4:07:91 PM PAGE 18/013 Fax Server MAN APPROVED CENTERS FOR 8: SERV CES 0313 NO. 0938-0391 sure 1.1 Ern? 93:: MP Ger-:9: 129:: $3.23 as cL-?r ms :c-Hsmuc?r C-H moms. EUR: m: FUN 3F CCRRECT 01: :5th :a?norl NUMBER gum N5 anyway I 35013? 51" In? ?2011!! NAME QF msv'mma?' #1353555. 2172?. stare, amass: . . 1.1100 EUCLID AVENUE UH I CLEVELAND, OH ?105 ?ng in mamn??ss mm: w-noRHEarmu in, . BE-P?eg?c?l; FELL . amid: 30w?7m v.5- TA: n15: mnp?m?m my; DEF A. 124 From page 8 were'rirmh; inplace. checking-fer leaks at cgnnedt-zn points-of 11.11.16. n?rogerl lines, c?r of lhfi??leclrical wiresm mama-th [emained free at damage 'a'nq plugs It was- con?rmed-through skiff irdewiews. {Staff A, G, a M. prior in 03/03/13., there was?cnh; nne. ante dealgnated 'c'onta ctpers?bn 1: receive hotmcail?n of the si'am?: in ineew'sm or-liquld nitrogen slmage ?tank malfunction instead uf-three tontaCls redommende?d by [he mariufashire r15 Instrucisnhs. Wing an Intewi?ew min Stair on sen?m 8 10.51 Hueizi?ed-ahwe was he policy {or mtihcgtinn of a dessgna'jed .persdn In reiatae?n to {enmealarma forequipment (-inciudzng' nii'rogen Ian}: contalner?}. Stat! 51ath the aut?qfill issue-en Containerm was on or around 02/01/18 and :qn?rmed the. sole-diess'gnated anntact person (Staff clad notificatan ofthe remote atarm. 'on 03/11/18 between 5:45 AM and 9? 15 AM, Sta? D. .3. and Lwere made aWane cfthe aforementioned cancarnsand-no-turt?er Nari-nation was prowded at that time. A T24 9M$2$?fmr9$f PFIWIOIIG wm?mm {mmhm bit-?t au-?qrw Hungry-1n ORV: :05- I pamtruamn 9 a; 9'