University Hospitals 4/18/2018 2:00:01 PM PAGE 1/014 Fa}: Server University Hospitals? To Ohio Department of Health, Attn: Wanda Iacovetta Fax Phone University Hospitals Fertility Center Fax 614'564'241 6 University Hospitals Ahuja Medical Center Kathy Risman Pavilion - . - 1000 Auburn Drive, Suite 310 From UH Cleveland Medical Center Beachwood? OH 44122 Phone Phone: 216-285-5028 Fax. 216-201-5390 Fax: 215-201?5390 Date 4/18/18 Plan of Correction~ Follow Up a (D CC Pages 4 Message CCN: 360137 The information accompanying this transmission is strictly con?dential and is intended forthe use of the addressee only, University Hospitals disclaims any responsibility for the unauthorized disciosure of this information to individuals or parties other than the addressee. This information has been disclosed to you from records whose confidentiality is protected by Federal and Ohio law, including HIPAA. Federal Regulation (42 CFR Part2). and Ohio Revised Code sections 5122.31 and 3701.243 which prohibit you from making any further disclosure of itwithout the speci?c written consent of the person to whom it pertains, or as otherwise permitted by such laWs. A general authorization for the release of medical or- other information, including HinAlDS-related 'infonnation, is not suf?cient-for this purpose. if you received this information in error, please notify the sender immediately by e-mail. fax or telephone. or call information Services 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 Hospitals 4/18/2018 2:00:01 PM PAGE 2/014 Fa}: Server so .. . - - University Hospitals Fertility Center Hospitals Kathleen J. 33mm Cleveland Medical Center Director til 1000 Auburn Drive Kathy Risman Pavilion, Suite 310 Beechwood, OH 44122 (216) 844-1335 April 18, 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) 564-24} 6) Ohio Department of Health Of?ce of Health Assurance and Licensing Bureau of Survey and Certi?cation 245 North High Street, Floor Columbus, Ohio 43215 Attention: Wanda lacovetta Re: UH Cleveland Medical Center CCN: 360l37 Survey: March 14, 2018 Plan of Correction - Follow-up Dear Ms. Para and Ms. lacovetta: in response to your follow?up request regarding the Plan of Correction (POC) that was submitted to you last week, enclosed please find all of the policies referenced in the POC. You also asked for clari?cation as to who would be ?monitoring? the plan of correction, as you indicated it was unclear as to whether it was the Lab Director or the MacDonald Quality Council. The (Io-Medical Director, who is also Chair of the Department of Obstetrics Gynecology, will be in charge of monitoring the implementation of the FCC as the designee of the Laboratory Director. The Co?Medical Director will be responsible for ensuring all inservicing is completed and audits are completed in accordance with the FCC. MacDonald Quality Council is the hospital?s quality assurance committee. Although the Co?Medical Director will be directly responsible formonitoring the POC, the results of the monitoring will be reported to the quality assurance committee for review. 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, Clo-Medical Director Chair, Department of Obstetrics 8: Gynecology University Hospitals 4/18/2018 2:00:01 PM PAGE 3/014 Fax Server @University Hospitals Policy and Procedure Cteveland Medical Center Routine Maintenance and Monitoring of Cryopreservation? Storage Units Department of Reproductive Endocrinology and Infertility 1. Purpose tut Embryos created through in vitrc fertilization techniques, gametes (oocytes and spermatozoa) and.reproductivetissues (ovarian and testicular biopsies) from patients undergoing treatment or fertility cryopreservation are stored in a biologically viable state under uitra-low temperature conditions in specialized cryopreservation storage container devices, by either immersion in liquid nitrogen or in the liquid nitrogen vapor phase, with temperatures ranging between to #16000. Routine maintenance and surveillance of the cryopreservation tanks? physicai integrity and the stability of the liquid nitrogen contents of each tank are criticai to assure the optimal storage environment and preservation of the gametes and "reproductive tissue. 2. Generai 2.1 The. UH Fertility Clinic has two types of cryopreservation storage container devices (cryopreservation storage tanks) in use. 2.1.1 Liquid nitrogen ?immersion? cryopreservation tanks (also called Liquid Nitrogen Dewars), comprising of large metallic vacuum ?asks, compietely filled with LN2(at in which reproductive cells or reproductive tissues are suspended in direct contact with liquid nitrogen after being identified, labeled. and secured in metallic supports calied 1 sleehvets. The temperatures of the biological materials cryopreserved in suc orage units corres? onds tot liquid nitrogen he temperature of the surrounding 2.1.2 Liquid nitrogen ?vapor phase? cryopreservalion'tanks, comprising of large metallic storage containers, which maintain uttra~low temperature conditions in the vapor phase of LN2 with an automatic LN2 filling system connected to a Liquid Nitrogen source. The reproductive cells (gametes/embryos) or tissues are stored in such tanks in open metallic racks in the vapor phase of with temperatures ranging between to without direct contact with liquid nitrogen. 2.13 General maintenance and monitoring: Immersion Tanks 2.2. 'l a week visual inspection of the tanks to rule out any physical amage to the exterior surface ofthe tank. 2.2.2; Daiiy inspection for frost or sweat present on the external'tank. 2.2.2 Daily measurement of LN2 levels inside the Cryotank using a yardstick measurement device to assure a liquid nitrogen level of 14-16 inches. University Hospitals 4/18/2018 2:00:01 PM PAGE Policy and Procedure 4/014 Fa}: Server University Hospitals Cleveland Medical Center Routine-Maintenance and Monitoring ofCryopreservation Storage Units Department of Reproductive E-ndocrinotogy and Infertility 2.2.3 2.2.4 Every Monday, Wednesday, and Friday liquid nitrogen is added to the tank to a level of 16 inches. 24 hour continuous monitoring of interior tank temperature with commercial remote alarm monitoring services Once a month testing of the remote alarm notification system. Genera! maintenance and monitoring: Vapor Phase CBS Tank 2.3.1. 2.3.2. 2.3.3. 2.3.9. Daily confirmation of vapor and signs of proper freezing. Daily monitoring of the LN2 level display panel. Continuous monitoring of interior tank temperature with commercial remote alarm monitoring services (isensix Guardian). 2.3.3.1. in addition, the Andrology CBS tank temperature is monitored with commercial remote alarm monitoring service through Accsense. Daily monitoring of internal tank temperature display panet. Once a week visual inspection of the tank to rule out any physical damage to the exterior surface of the tank, detect any leaks at connection pointso?f the LN2 hose lines. Once a week inspection to assure electrical wires are free of damage and plugs are firmly in place. Once a month testing of the remote alarm notification system (isensix Guardian). Once a month verification of the high and low level and temperature alarms. Doctumentation of fill interval and amount of LN2 filled into vessel when the CBS vapor phase tank is in the ?manual till" mode. . 2.3.10. Fluid Level and Temperature Alarm Verification 2.3.10.1. Low level alarm veri?cation 2,310.2. Using the. manual valve on the liquid nitrogen supply tanky turn off the liquid supply. 2.3.10.3, Create a low level alarm condition. This is done by adjusting the level set-points above the actual liquid level. University Hospitals 4/18/2018 2:00:01 PM PAGE Policy and Procedure Routine Maintenance and Monitoring of Cryopreservatlon Storage Units Department of Reproductive Endocrinology and infertility 2.3.11. 2.3.10.4. 2.3.10.5. 2.3.10.6. 5/014 Fax Server a University Hospitals Cleveland Medical Center in 7310 minutes a low alarm should occur. This will be indicated by the text flashing and the audible alarm sounding. The remoted alarm output will activate also. Return set points to the desired settings. Open manual valve on supply tank to resume normal operation. High Level Alarm verification 2.3.111. 2.3.11.2. 2.3.11.3. 2.3.11.4. Create a high level alarm condition. This is done by adjusting "the level set~points at least one inch below the actual liquid level. in 3?5 minutes. a high alarm should occur. This will be indicated by the text flashing and the audible alarm sounding. The remote-alarm output will activate. Return set? points to the desired settings. Unit is now ready for normal operation. Temperature Display Verification 2.3.12.1. 2.3.12.2. 2.3.12.3. 2.3.12.4. 2.3.12.5. 2.3.12.6. 2.3.12.7. Open storage unit lid and locate temperature sensing probes. Carefully remove probe from protective sleeve. Submerge the sensor probe into liquid nitrogen. The digital temperature display should read -196?Celsius PC). Remove probe from liquid nitrogen and place tip of probe in an ice bath and wait 30 seconds. While the probe is submerged. the digital display should read 0? degrees Celsius. Check probe-end for cracks or damage, return probe into its protective sleeve at the desired depth. Close the storage unit lid and resume normal operation. if the temperature display doesn?t operate as described. there may be a problem with the probe or the probe connections. See the troubleshooting gdide of the CBS University Hospitals 4/18/2018 2:00:01 PM PAGE 6/014 Fax Server University Hospitals Policy and Procedure Cleveland Medical Center Routine Maintenance. and Monitoring ofCryopreservation Storage Units Department of Reproductive Endocrinology and Infertility Manual (page 29) for further information if a problem is detected. 24. Temperature Maintenance 2.4.1. teens-ix technology provides independent temperature monitoring of all IVF and Andrology tanks. 2.4.2. Accsense Remote Auto Dialer technology allows for dual temperature monitoring of the Andrology tanks. 2.4.3. The lower temperature threshold is (-) 160? Celsius. 2.4.4. Temperatures falling below the (-) 160? Celsius threshold trigger an audible alarm on the CBS vapor tank and remote alarm for both the CBS Vapor tank and immersion tank. See lsensix Guardian for Fertility Human Tissue. Monitoring policy. 2.4.5. Lab technicians document their reSponse to the isensix alarm system in the isensix software. 3. Precautions 3.1. The storage tank lid remains closed except during depositing or removing a specimen and should beopened for only minimal amount of-time. 1352. Lab personnel follow the necessary safety precautions when handling liquid nitrogen See safe handling of liquid nitrogen policy. I Owner: UH Division of REI Date Approved: All/"av 3/ Date Revie?e/?q Approval Clinical Lit?3i? Dire?or I it? \v'g r? Medics/LD'rector University Hospitals 4/18/2018 2:00:01 PM PAGE 7/014 Fa}: Server University Hospitals Policy and Procedure .55" Cleveland Medical Center Safe Handling of Liquid Nitrogen UH Dept of Reproductive Endocrinology and infertility Purpose Safety precautions are followed to avoid potential injury or damage which could result from harmful exposure to Liquid Nitrogen. Liquid Nitrogen is extremely cold and small amounts of liquid can vaporize into large amounts of gas. Liquid Nitrogen in contact with skin or eyes may cause serious freezing (frostbite) injury. Nitrogen gas can cause suffocation without warning; as the liquid evaporates, the resulting gas tends to displace the normal air from the area. In closed areas, excessive amounts of nitrogen gas reduce the concentration of oxygen and can. result in Because nitrogen gas is colorless, odorless and tasteless, it cannot be detected by the human senses and will be breathed as if it were air. 1. To prevent injury by frostbite, use extreme care whenever handling liquid nitrogen. 13? Leave no area of skin exposed. 1.2 Always wear proper safety attire over clothing, a face shield, cryogenic gloves. and cryogenic apron. i .3 Use extreme care to prevent spilling and splashing liquid nitrogen during transfer. 2, To prevent the risk of from nitrogen vapors, store or use liquid nitrogen containers in a well?ventilated space. 2.1 Oxygen sensors are in place to assure appropriate levels of Oxygen in the environment. Anyone feeling dizzy or losing consciousness should be moved immediately to a well ventilated area and an emergency response team activated. I) .- I 3. in'the event of a spill or Splash take immediate action to prevent injury. immediately remove any clothing or safety attire on which liquid nitrogen has spilled. 3.2 Get immediate medical attention for any frostbite injuries due to. liquid nitrogen, 5. Training in the safe use and. handling of liquid nitrogen occurs on initial employment and then reviewed at least annually. Owner: UH Division of REI Date Approved: Date Reviewed 1' 5 - x" I. A. (It. ?l .. Approval . HCLD (Asa) Clinical Lab Director Mr . MD Medical Director University Hospitals 4/18/2018 2:00:01 PM PAGE 8/014 Fax Server University Hospitals Policy ?ind Procedure Cleveland Medicai Canter Response Plan for Unresolved Aiarm or Equipment Malfunction Department of Reproductive Endocrinoiogy and infertility Purpose In the event of equipment malfunction or unresolved equrpment alarms, routine measures are taken to quickly mitigate the identified problem. notify the appropriate lab leadership and assure optimal preservation of tissue. 1. In the event of an equipment aiarm. routine measures are taken to resolve he alarm based on the manufacturer recommendations. ti. Cryotank temperature alarms are to be resolved within 30 minutes. 1.1.1. If alarms aren't resolved after 30 minutes, leadership is notified and steps are initiated to transfer tissue from the malfunctioning equipment to functional equipment. 1.2 incubator temperature alarms are to be resolved within .45 minutes. 1.2.1. If alarms aren't resolved after 45 minutes. leadership is notified and steps are initiated to transfer tissue from the matfunctioning equipment to functional equipment. Leadership is notified immediately in the event of CBS tank iiquid nitrogen level alarms and steps are initiated to transfer tissue from the malfunctioning equipment to functional equipment, 1.4, Once tissue are secured. the manufacturer is notified for inepection and repair of the equipment. 1.5 If repair is not possibie. measures are initiated to replace the equipment as indicated, 2 In the event of equipment malfunction, routine measures are. taken to notify lab leadership and initiate steps to transfer tissue from the malfunctioning equipment to functional equipment. 3. An empty immersion tank is maintained to receive tissue that requires transfer in the event of an emergency in the embryology lab. .4, An empty vapor phase tank is maintained to receive tissue that requires transfer in the event of an emergency in the andrology lab. Procedure for troubleshooting equipment failure 5.1 Laminar Flow Hoods 5.1.1. Proceed with procedure using replacement Laminar Flow Hood that is equipped with a microscope. 5.1.2. Notify leadership ofthe equipment malfunction.- 5.1.3. Contact the manufacturer for equipment repair. 5.2. incubators if an incubator is giving inconsistent CO2 or temperature readings 5.2.1. Remove any patient embryos or oocytes from malfunctioning incubator toa functioning incubator. I 5.22. Notify lab leadership of'the equipment malfunction. 5 2.3. Contact manufacturer for repair. 5 3 Stage Warmers 5.3.1. Proceed with procedure using replacement microscope with functional stage warmer. 5.3.2. Transfer any embryosioocytes to appropriate patient incubator. 5.3.3. Notify lab leadership of the equipment malfunction. 5.3.4. if problem persists, contact the manufacturer for equipment inspection and repair. University Hospitals 4/18/2018 2:00:01 PM PAGE 9/014 Policy and Procedure Fax University Hospitals Cleveland Medical Center Response Plan for Unresolved Alarm or Equipment Malfunction Department of Reproductive Endocrinology and Infertility 5.4. 5.8.. .4 5.8. RefrigeratorfFreezer 5.4.1. Remove all media/solutions from refrigerator. Place them in alternative re frigeratori freezer. 5.4.2. Unplug if concern for threat of electrical fire. 5.4.3. Contact the manufacturer for Facilities Engineering for equipmentrepair. Centrifuges 5.5.1. In case of centrifuge failure. use the backup centrifuges. 5.5.2. Unplug the centrifuge if concern for threat of electrical fire. 5.5. . Contact the manufacturer or Clinical Engineering for repair. Micromanipulatorsf Injectors! Holding injectors 6.1. Transfer any embryos foocytes to appropriate incubator- .6.2. Replace injector with the backup. If needle injector needs replaced, use the backup micromanipulator for the injection. using an airtight syringe for the holding pipette or Assisted Hatching mouthpiece set for manual injecting. 6.4. Notify lab leadership of alarm or equipment failure. 6.5. Contact the manufacturer for equipment repair. 0? (.71 {5'1 Coarse/Fine Manipulators 5.7.1.. Transfer any embryosfoocytes to appropriate incubator. 5.7.2. Both sets of manipulators are interchangeable for either the injector or holding side. 5.7.3. Use the backup manipulator setups. 5.7.4. When the injector manipulator malfunctions, replace it with the holding manipulator. Manually adjust the holding pipette as a stationary pipette. 5.27-5. If all manipulators fail. perform conventional insemination in place of iCSl. 57.5.1. Be sure to increase the concentration of sperm accordingly. 5.16. Notify lab leadership of alarm or-equlpmen?t failure. 573.7. Contact the manufacturer for equipment inspection and repair. Cryo-storage Tanks 5.8.1. Troubleshoot'the alarm or equipment malfunction by referencing the manufacturer?s operations manual. 5.8.2. if unable to resolve the alarm within 30 minutes. initiate transfer of all frozen embryos. oocytesf sperm to the backup tank. 5.8.3. Notify lab leadership of alarm or equipment failure. 5.8.4, Contact the manufacturer for equipment repair. 6. Leadership Notification Chain of Command {it 6.4. 6.5. 6.6. The Lab Supervtsor is the first to be notified in the event of unresolved alarms or equipment malfunction. 6.1.1. if the lab Supervisor is unavailable, the Lab Director is notified via phone or email. The Lab Supervisor escalates unresolved concerns via the chain of command. if the incident occurs after normal hours of operation, the technician on call or the staff member in nearest-proximity to the IVF clinic responds to the alarm and is on site within 60 minutes of the alarm. For issues involving the physical plant, notify Facilities Engineering at 593-1760 between the hours of 7a and 3:30p or 593-5777 between the hours of 3:3th and 7a. For issues involving chemical safety. notify the Safety team at 593-5777. For issues involving security. notify the Hospital Police Departmental 593-5760. University Hospitals 4/18/2018 2:00:01 PM PAGE 10/014 Fax Server @University Hospitals Policy and Procedure Cleveland Medical CGHTEF Response Plan for Unresolved Alarm or Equipment Malfunction Department ?of Reproductive Endocrinology and Infertility Owner: fivision of RB Date Approved: . Date Reviewzed I Approval HCLD (ABB) Clinical Lab ire . MD Medical Diabr University Hospitals 4/18/2018 2:00:01 PM PAGE 1.) Lu 11/014 Fast. Server University Hospitals Cleveland Medical Center UH Fertility Center Chain of Notification for isensix Guardian Alarm Monitoring lsensix Guardian Monitoring Devices are on: '4 incubators in the Embryology Lab --Risman 2 CBS vapor cryo?tanks in Embryology Lab - Risman 5 Dewar immersion tanks in Embryology Lab Risman 1035 vapor cryo~tank in Androl'ogy Lab Risman 3 Dewar immersion tanks in Andrology Lab Risman 1 Dewar immersion tanks in Androiogy Lab - Crocker 1 freezer in the Embryology Lab Risman freezer in Andrology Lab Risman 1 freezer in Andrology lab Crocker 1 refrigerator in Andrology Lab - Risman 1 refrigerator in Andrology Lab ?'Crocker .1. refrigerator in Embryology Lab - Risman lsensix Guardian remote monitoring will alert by text, pager and email, on a rotating- basis, the following: Dr. James Liu, Medical Director (cell 216?407-8105; pager 30559} Andrew Bhatnager, Lab Director (cell 239-410-3033) (2.) Lauren Palayos, Embryologist (cell 440822-5907; pager 31150) James Hamrick, Embryologist (cell 440?991-6105; pager 31653) Brooke Belyin, Embryologist i (cell 440413-2663; pager 31470} Shady Hamdailah, Embryologist i (call 216-970?9714; pager 31344) Kathleen Price, Andrologistl (cell 216469-3479; pager-31907) Rebecca Cull, Embryologist i (cell 330698-2193; pager 31904) Staff'will respond by either investigating the equipment alarm when on site and taking approoriate action or responding according to a predetermined call schedule to arrive on site. The Lab Director will be the lsensix Administrator and will be responsible for any changes in notification schedulesand/or alarm parameters on the lsensix website. Level I - Text page sent to designated team member consisting of Embryologists i, ll, or ill incubator alarm intervals are set at 15 minutes from initiation of alarm state University Hospitals 4/18/2018 2:00:01 PM PAGE 12/014 Fax Server LNZ Crvo?tanks, refrigerators and freezers alarm intervals are set at5 minutes from initiation of alarm state Level II - Designated team member from Level 1 plus an additional Embryologist incubator alarm intervals are set at- 25 minutes from initiation of alarm state LN2 Crvo-taoks, refrigerators andfreezers alarm intervals are set at 15 minutes from initiation of alarm state Level Designated team from Level 1 8! ll plus Medical Directorls) and Lab Director incubator alarm intervals are set at 45 minutes from initiation of alarm state LN2 refrigerators and freezers alarm intervals are set at 30 minutes from initiation of alarm state 4.) intervention to correct the alarm will be noted on the daily report found on the lsensix website by the staff member who addressed the issue. Any attempt to trouble shoot an unresolvable alarm must be done in consultation with the Fertility Lab Director and Medical Director. Owner: UH Division of Date Approved: March 26, 2018 Date Revised: April 7, 2018 Approval Aux/2* - .mo If. . M?dic?lioireoto - (i Lab Director University Hospitals 4/18/2018 2:00:01 PM PAGE 13/014 Fast Server iUniversity Hospitals Cleveland Medical Center Policy and Procedure. lsensth-Guardian for Fertility Human Tissue Monitoring Department of Reproductive Endocrinology and Infertility Policy 1. lsensix is a proprietary tool assisting in monitoring and notification of staff that temperatures or other measures in a given refrigeratorffreezer, cryo-tank, room. incubator or area are within or outside of its intended range or set parameters. 1.1. lsensix is used for monitoring 1.1.1. Room temperature and C02 for fertility incubators for human tissue 1.1.2. LN2 cryo-tank-temperature for fertility human tissue 1.1.3. Refrigerators and freezers for fertility media, reagents, human tissue and previous tested blood samples 1.2. Each piece of equipment has a wireless sensor connected to a collection point. 1.2.1. The system monitors on a continuous basis 1.3. lsensix equipment function verification checks are performed and documented. 1.3.1. Yearly calibration is done by the proprietary Organization, lsensix 1.3.1.1. For areas requiring more frequent calibration per manufacturer standards or protocol, that calibration is done by lsensix. 1.3.1.2. Documentation of calibration is maintained by lsensix online. 1.3.2. Daily checks are done through the lsensix software on critical temperature and monitoring dependent devices as determined by the respective department. These areas per otheraccreditations or standards. complete checks per that protocol. 1.3.3. Areas with critical temperature dependent devices that are not open daily are checked by a team member when unit opens, ie. when called in for patient service or the day the area reopens after being closed. 1.3.3.1. Documentation is provided in the software as to alarm status during the hours/days closed. 1.4. Alarm set points are established and set in the software. Profiles and settings are dynamic and subject to change. See'Attachment A 1.4.1 Alarm intervals are set by the department. 1.4.2 Alarm responders are area personnel assigned by alarm level to respond to alarms. 1.4.3 This responder list will be reviewed and updated quarterly. 1.5. Out of range temperature initiates an alarm at the collection point and notifies the assigned responders at a set interval and level. 1.5.1 Level I Text page sent to designated team member consisting of Embryologists i, ll. or ill incubator alarm intervals are set at 15 minutes from initiation of alarm state LNZ Cryo?tanks, refrigerators and freezers alarm intervals are set-at 5 minutes from initiation of alarm state University Hospitals 4/18/2018 2:00:01 PM PAGE 14/014 Fast Server University Hospitals Policy and Procedure Cleveland Medical Center lsensix Guardian for Fertility Human'Tissue Monitoring Department of Reproductive Endocrinology and Infertility 1.5.2 Level it Designated team member from Levet'i plus an additional Embryologist Incubator alarm intervals are set at 25 minutes from initiation of alarm state LN2 Cryo-tanks. refrigerators and freezers alarm intervals are set at 15 minutes from initiation of alarm state 1.5.3 Level ll 1 Designated team from Level I a it plus Medical Director and Lab Director incubator alarm intervals are set at 45 minutes from initiation of alarm state LN2 Owe-tanks, refrigerators and freezers alarm intervais are set at 30 minutes-from initiation of alarm state 1.6 Reportses to alarms that cannot be resolved: 1.6.1 Human Tissue - follows internal procedures for management of contents in room, refrigerator/freezer. incubator, or cryo-ireezer when in alarm state. 1 6.2 Any attempt to trouble shoot an unresolvable alarm must be done in consultation with the Fertility Laboratory Director and Medical Director. 1 .7 Follow software directions for printing temperature logs andtor actions taken. 1.7.1 All alarm notifications will be tested and documented Owner: UH Division of Date Approved: March 16; 2018 Date Revised: Aprit 2. 2018 Xxx/?ix Approval . ile?[11.1. Its-1?1?" 1, I ?fig-DD Lab Director