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Based on observation, interview, and review of preventive maintenance records, it was determined that the CAH failed to ensure that all electrical and bio-medical patient care equipment had been maintained to ensure an acceptable level of safety and quality. Electronic thermometer devices available for patient use had not been subject to preventive maintenance in accordance with manufacturer's instructions to ensure the accuracy of patient temperature readings.

Findings include:

During tour of the medical/surgical unit on 01/26/2016 at 1600 two WelchAllyn SureTemp thermometer devices were observed to be mounted on the wall in a patient room above beds 101 and 102. Inventory numbers or serial numbers to identify each unit were not evident as the devices were screwed into the wall mounts and could not be removed.

During the tour at 1620 a WelchAllyn SureTemp thermometer device was observed in a drawer behind the nurse's station. The serial number on that device was "00301833A."

Preventive maintenance records reviewed included an electronically generated document titled "Hand held thermometer calibration" with a "Request Date" of 11/27/2013 and a "Completion Date" of 12/05/2013. It contained a list of 19 thermometer devices identified by "Equipment No." and location. Seven additional thermometers were handwritten on the list. Three of the 26 thermometers were identified as being located in "Med/Surg." It was not clear whether the three units observed on 01/26/2016 were on the list. There were no current preventive maintenance records for the thermometer devices.

Engineering staff provided the manufacturer's instructions on file in the department for review:
* The WelchAllyn SureTemp Technical Manual for Models 678 and 679, 1997, reflected "Units which are in service on a regular basis should have the following preventive maintenance performed every 6 months...Units which are stored for an extended period and not used should have the following performed every 12 months..."
* The WelchAllyn SureTemp Plus Service Manual for Models 690 and 692, Rev. B, with a handwritten date on the cover 02/14/2005, reflected "Units that are in service on a regular basis should have the following preventive maintenance performed every six months...Units which are stored for an extended period should have the following maintenance performed every 12 months..."
* The WelchAllyn SureTemp Plus Service Manual for Models 690 and 692, Rev. H, 2012, reflected "Units that are in service on a regular basis should have the following preventive maintenance performed every six months...For units in service on a regular basis, perform the Power-On Self Test and Model 9600 or 9600 Plus Calibration Testing procedure every 12 months..."

During interview with the Facility Manager and the Engineering Lead on 01/29/2016 at 1310 they reported that the hospital had discontinued routine preventive maintenance on the thermometers, that a current inventory of those devices in use throughout the hospital had not been maintained, and that the calibration document dated as completed on 12/05/2013 was the most current preventive maintenance documentation for the thermometers.

Based on observations, interviews, review of drug monitoring records, and review of policies and procedures it was determined that the CAH failed to fully develop and implement policies and procedures to ensure that drugs and biologicals were managed in accordance with accepted professional principles:
* Drugs and biologicals in emergency carts and kits throughout the CAH were not managed consistently to prevent theft, misuse, and tampering; and
* Drugs and biologicals used topically for iontophoresis treatments were not handled, prepared, compounded, and labeled by the pharmacy.

Findings include:

1. The p/p titled "Emergency Drug Supply and Storage WVH", with effective date of "11/2015" was reviewed. It stipulated the following: "An emergency drug kit must use a tamper-evident system and be stored to prevent unauthorized access..."

* On 01/26/2016 at 1445 in the ED, the emergency code cart where emergency medications and supplies were kept was observed with the ED Manager. The cart had a red plastic "lock" with the number 3169650 on it. The cart also had a red "Crash Cart Check" sticker affixed to it on which the "lock" number was recorded. A "West Valley Daily Code Cart Check-Emergency Department Adult Cart Lock" form for the month of January 2016 was located with the cart. The form had a "Cart Locked/Lock Number Recorded" section for recording the "lock" number each "am" and "pm." However, on 13 occasions in January the "lock" number was not recorded and instead the word "Yellow" was written in each of those spaces.

During an interview with the ED Manger at the time of the observation, he/she stated that the "lock" was checked each "am" and "pm" and the red "lock" number or "yellow" (without a lock number) was recorded on the form. The ED Manager stated that on the occasions when staff needed to access the contents of the cart, the red "lock" would be broken and replaced with an unnumbered plastic yellow "lock." The ED Manager stated that yellow "locks" were stocked by pharmacy in the automated medication dispensing machine in the ED. During the interview the ED Manager acknowledged that the integrity of the cart could not be assured when the yellow unnumbered "locks" were on the cart.

* During tour on 01/26/2016 at 1620 the Med/Surg emergency code cart was observed. The cart was observed to be sealed with a red plastic, numbered breakaway "lock". A "Daily Code Cart Check" form for January 2016 was observed located with the cart. The form contained spaces for twice daily checks of "Cart Locked/Lock number recorded" where staff would record the number of the "lock" intact on the cart at the time of the check. However, on 01/01, 01/02, 01/03, and 01/04; and again on 01/22, 01/23, 01/24, and 01/25/2016; a "lock" number was not recorded on the daily checks. Instead, in the "lock" space was recorded the word "yellow".

* During interview with staff including the Director of Clinical Operations and a Med/Surg RN on 01/26/2016 at 1630 it was revealed that the "yellow" referred to a yellow breakaway "lock" used to secure the emergency cart after a red, numbered breakaway "lock" was broken and the cart contents accessed for use. After use, a replacement tray of emergency drugs would be placed in the emergency cart and a yellow breakaway "lock" put in place until such a time that the pharmacy staff was on the CAH premises and placed a red, numbered "lock" back on the cart. The RN stated that the yellow breakaway "locks" were stored in the Omnicell, the Automated Drug Dispensing Machine and demonstrated how to access those locks. The yellow breakaway "locks" stored in the machine were observed at that time and determined to have no number on them. During those periods when the unnumbered yellow "lock" was in place there was no assurance that any theft, misuse, or tampering of the drugs in the cart would be identified within a time frame consistent with that when the red numbered "locks" were in place.

* On 01/26/2016 at 1640 on the bottom shelf of an unlocked cabinet at the Med/Surg and ED nurse's station, three emergency medication kits labeled for "Surge Medication", "OB", and "TPA"; and two emergency code cart replacement trays were observed. Each had a red numbered breakaway lock in place. However, there was no documentation of ongoing monitoring of the integrity of the "locks" and the "lock" numbers consistent with that of the emergency code carts. During interview with staff at the time of the observation they indicated that pharmacy staff checked the kits monthly.

* On 01/27/2016 at 1030 in the outpatient Infusion/Wound Department the emergency code cart was observed with the Assistant NM. The cart had a red plastic "lock" with the number 3360516 on it. A "West Valley Code Cart Check - Infusion and Wound Care Clinic" form for January 2016 was located with the cart. The form had a section for recording the "Cart Locked/Lock Number Recorded" every "AM." On 01/27/2016, the "lock" number on the form was recorded 3360501 which did not match the lock number observed on the cart. Below the designated section for recording the lock number there was another entry that was written as "1/27/16 3360513" which also did not match the number observed on the cart. During an interview with the Assistant NM at the time of the observation, he/she acknowledged that the lock number observed on the "lock" did not match the recorded "lock" numbers on the form.

* On 01/27/2016 at 1005 a tour of the Imaging Department was conducted. A CT emergency medication kit was observed in the CT room and an MRI emergency medication kit was observed in an MRI work space. Each had a red numbered breakaway "lock" observed in place and intact. A"WVH Imaging Daily Safety Check List" in the CT room had spaces for daily checks of "Drug Tray in CT...Safety Lock Intact". The number of the breakaway "lock" on the CT kit matched the number recorded on the checklist. However, there was no documentation of ongoing monitoring of the integrity of the MRI "lock" and the "lock" number. During interview with the Imaging Supervisor at the time of the observations it was confirmed that there was no system for documentation of monitoring of the MRI kit.

* On 01/28/2016 beginning at 1340 the Monmouth Medical Clinic, where provider-based outpatient services were provided, was toured with the CM. At 1420, an "emergency tote" containing a vial of injectable Diphenhydramine 50mg/ml was observed in a cupboard in an open/unsecured area of the clinic. The tote and the cupboard were not locked or secured.

2. During tour of the Rehabilitation Department on 01/27/2016 at 1200 with the Rehab Services Supervisor, four medication bottles were observed in a locked metal box inside a cupboard. The bottles each contained a liquid solution and had handwritten labels attached that included the contents, the expiration and other information.

For example, one bottle had two labels. One label reflected: "Acetate - polarity (-) 2 T vinegar (1 oz) 1 c distilled H20". Other information on that label had been crossed out and was not dated or authenticated. The second label reflected: "Mixed 11/16/15 Exp 5/16/15 (sic)".

Another bottle had two labels. One label reflected: "Salicylate - polarity (-) 2 - 325mg ASA 8 oz. distilled H2O". Other information on that label had been crossed out and was not dated or authenticated. The second label reflected: "Mixed 11/16/15 Exp 5/16/16".

The labels on the remaining two bottles reflected that they contained "compounded" mixtures of chloride, non-iodized salt, magnesium, Epsom salts, and distilled H2O.

During an interview with the Rehab Services Supervisor at the time of the observation, he/she stated the bottles contained medications that were applied topically to patients during iontophoresis treatments. The Rehab Services Supervisor stated the solutions were "compounded" in the rehab therapy department by a PTA and an OT.


* The p/p provided titled "Iontophoresis" was reviewed. It was dated 01/28/2016, the day after the "compounded" medicinal solutions were observed on 01/27/2016. The "Final Approval" and "Effective" dates of the p/p were "Pending Pending (sic)" The p/p reflected "Compound Preparation...A designee clinician will be identified to be responsible for mixing...Compounds will be made every month or sooner if the compound is used up prior to the time frame...Upon refilling the compound containers, the clinician will fill out and attach a new label which will include the name of the compound, the date made, the expiration date and the polarity of the compound." The p/p contained no information related to pharmacy review, approval or any other reference to pharmacy oversight.

* The p/p titled "Drug Distribution System WVH", with effective date of "04/2015" was reviewed. It stipulated the following: "No expired, contaminated, or unidentified medication shall be administered to patients...Ancillary personnel used in drug distribution shall be under the immediate supervision of a registered pharmacist...Drugs used shall meet national standards of quality and shall be obtained only from known, reputable businesses...The use of floor stock medication, which circumvents the pharmacist prospective drug review, is to be minimized...Medication not procured by the pharmacy shall not be administered to a patient prior to a pharmacist or licensed staff physician's inspection and identification of said medication...The use of bulk (multidose) containers is to be minimized where feasible..."

* During an interview on 01/29/2016 at 1030 the Rehab Services Supervisor stated he/she did not know where the Aspirin came from that was used to make the "compounded" medicinal solutions observed above. He/she stated the other ingredients used were obtained "over the counter."

3. During interview on 01/28/2016 at 1500 the Pharmacist In Charge stated that the pharmacy checked emergency kits monthly and he/she was unaware of the development of checklists used to monitor the integrity and security of the emergency code carts and drug kits throughout the CAH. He/she also stated that the pharmacy was not involved in the handling or compounding of the medicinal solutions used in the Rehabilitation Department.


29708

29708

Based on observation, interview, and review of policies and procedures, and other documents it was determined the CAH failed to fully develop and implement policies and procedures for infection prevention in the following areas:
* Disinfection, cleaning, and sterile processing supplies and processes in surgical services, SPD, ED, and other areas were not in accordance with manufacturer's instructions and current, written CAH IC policies and procedures;
* Outdated disinfectant and other cleaning supplies were available for use;
* The CAH failed to evaluate IC risk in all areas where patient care services were furnished, including aquatic facilities used for the provision of physical therapy services; and
* Food sanitation policies and procedures were not fully developed and implemented as food products were not properly packaged and labeled to protect them from contamination; and not all floor surfaces in the kitchen were clean or cleanable.

Findings included:

1. During tour of the ED with the PIC/IP the following observations were made:
* On 01/26/2016 at 1515 in the the janitor closet an open one gallon container of Neutral Multi-use cleaner solution was observed and had no evidence of when it was opened and no expiration date.
* On 01/27/2016 at 1410 in the soiled utility room, four one-gallon containers of Endozyme were observed available for use. During an interview at the time of the observation the PIC/IP indicated that Endozyme was used for cleaning and soaking contaminated instruments used in the ED. One of the Endozyme containers had an illegible expiration date, and the other three containers had expiration dates in 2009 and 2010.

2. On 01/27/2016 beginning at 1030 a tour of the outpatient Infusion/Wound Department was conducted with the Assistant NM and PIC/IP. In treatment room 3 a plastic bin labeled "Dirty" was observed to contain three pairs of scissors. At the time of the observation, the Assistant NM stated the scissors were contaminated and were placed in the bin until they were taken to the SPD to be disinfected. Also at the time of the observation, the PIC/IP stated the scissors in the bin should be soaked in an enzymatic solution prior to delivery to the SPD. However, he/she acknowledged that they had not been.

* An undated document provided titled "Standard Work: Reprocessing of Scissors for Wound Care" reflected "Multiuse scissors will be used once on a patient...After use scissors will be placed in a designated 'dirty' bin...On Mondays and Wednesdays, the dirty bin will be delivered to dirty area in OR for reprocessing..." The document contained no direction that the scissors be soaked in an enzymatic solution.

3. The p/p titled "Monitoring the Sterilization Process WVH" dated as last reviewed 12/18/2014 was reviewed. The "Purpose/Policy Statement" section reflected "To insure proper functioning of sterilizing equipment and control of sterilized articles in Surgery." The p/p further reflected "...Biological indicators will be performed daily with a control, when surgery is open...Indicators will be placed with the load, removed following cycle, and processed in the incubator...Records of biological indicators will be kept...In the event of a positive culture, another culture will be run immediately. The sterilizer will not be used until the result of the second culture is available. If the second culture is positive, the sterilizer will be taken out of service until proper repairs and evaluations are made, and a negative culture is obtained...In the event of a positive culture, all packs and trays are to be recalled immediately. These items are to be resterilized. These steps are to be documented..."

* During an interview with the OSNM on 01/28/2016 at 1040 he/she stated the CAH had one IUSS and one other steam sterilizer that were used for sterilizing surgical instruments.

* Review of IUSS "Flash Sterilizer Log" records provided reflected IUSS loads were performed on 27 days from 08/11/2015 through 01/25/2016. Review of BI records reflected no BI results were documented for any of those 27 days.

* Review of "3M Comply Sterilizer Record Cards" and other records for the SPD steam sterilizer reflected sterilizer loads were performed on 17 days from 12/09/2015 through 01/28/2016. Review of BI records reflected no BIs were performed for any of those 17 days. These findings were confirmed with the Charge Nurse on 01/28/2016 at 1210.

4. On 01/28/2016 at 1130 an open container of Revital-Ox Resert test strips was observed in SPD. There was no indication on the container to reflect when it had been opened. This was confirmed with the OSNM at the time of the observation.

* Manufacturer recommendations provided for the strips were reviewed and reflected "The Revital-Ox Resert Solution Test Strip is a chemical indicator for use in confirming the minimum recommended concentration of...the active ingredient...The shelf life after the first opening of the container is 180 days, or the labeled expiration date, whichever is sooner. When opening the bottle for the first time, record the date opened in the space provided on the immediate container label. Do not use the product beyond the expiration date."

5. On 01/28/2016 at 1145 during tour of surgical services with the OSNM an Olympus cystocope was observed.

* Undated handwritten instructions for the cystoscope observed in the scope processing area were reviewed and reflected the following: "...Wash scope...syringe thru attachments [and] lower port...rinse in white basin in [left] sink [with] sterile H20...Syringe water in [and] out 5-6x thru scope [and] black attachment...Shake excess...Lay in towels...wrap up [and] lock red container."

* Manufacturer instructions provided for the cystoscope reflected the following: "Rinsing ...Immerse the endoscope in water. Using a sterile, lint-free cloth, thoroughly rinse and gently wipe all external surfaces ...Attach a syringe and flush channel with water three times. Inject air three times...Attach a syringe filled with alcohol and flush three times. Inject air three times...Disconnect the syringe. Using a sterile, lint-free cloth, thoroughly and gently wipe and dry the external surfaces of the endoscope ...Using a sterile, lint-free cloth moistened with alcohol, thoroughly and gently wipe the external surfaces of the endoscope."

* The p/p titled "Use of High Level Disinfectants and Sterilants WVH" dated "12/2015" was reviewed. It reflected the following: "...After high level disinfection, the endoscope must be thoroughly rinsed and the channels flushed with water. Each channel must then be flushed with 70% alcohol and dried with forced air before being used or stored."

* The CAH p/p and the handwritten instructions were inconsistent with the manufacturer recommendations.

6. On 01/28/2016 beginning at 1440, the Dallas Aquatic Center where CAH physical therapy services were provided was toured with the CAO. The center had five public pools, bathrooms, shower rooms, dressing rooms, and various exercise and pool equipment/supplies.

* An interview was conducted with the CAO and the center's Assistant Manager at the time of the observation. The Assistant Manager stated that CAH patients had access to, and used two of the center's public pools, and also used the same bathrooms, shower rooms, dressing areas, and pool equipment/supplies as the public.

* There was no evidence provided to reflect that the CAH had evaluated the infection control and prevention factors at the aquatic center to assess the risk to its patients. The CAO acknowledged that had not occurred.

7. A tour of the kitchen was conducted on 01/28/2016 at 1400. In the dry goods storage room a number of packages of dried foods such as coconut, dry chow mein noodles, and cereal were not in the manufacturer's packaging and were observed in open and/or unlabeled and/or undated clear plastic packages.

* In the walk-in refrigerator several clear bags containing a thick liquid substance were observed. The print on the manufacturer's labels was worn off, smeared and unreadable. Some, but not all, of the bags had a secondary label affixed to the package. For example: On one bag the secondary label reflected the "Item" was "Apple", the "Prep Date" was "11-2", and the "Use By" date was blank; On another package the secondary label indicated the "Item" was "Cram (sic)", the "Prep Date" was "11-2", and the "Use By" date was blank; and on another opened bag there was no secondary label.

* In the refrigerator a package of individual cheese cakes was observed to be open and uncovered.

* In the walk-in freezer large clear plastic bags of unidentifiable products in buckets and tubs were not in manufacturer's packaging and were observed to be in open and/or unlabeled and/or undated clear plastic bags. Some of those packages were fully open to the air. Food service staff present during the tour stated that the foods were "turkey", "meatloaf", "chicken", and "bacon bits". Some of the meat products had the appearance of "freezer burn."

* The floor surfaces of the walk-in combination refrigerator and freezer were observed with debris and were in disrepair. The cement floor surfaces were not smooth and conducive to adequate cleaning, particularly around and near the door between the refrigerator and the freezer compartments. There were numerous cracks, broken, uneven, and worn areas; and a build-up of whitish, beige and rust colored areas and matter was observed.

* The p/p titled "Food Handling", with effective date "January 2016", stipulated: "It is the policy of Salem Health that staff will follow procedures that assure safe and sanitary food practices from acquisition of food through its consumption." Guidance related to food packaging and labeling was: "...Food must be stored in a clean, dry place...Items must be stored FIFO (first in, first out), rotated properly, marked, and dated...Any opened perishable food items must be labeled and dated...Date, label, cover, cool, and store all leftovers within 1/2 hour in a refrigerator..." The p/p had not been fully developed as it did not provide guidance or direction related to such as: The use of secondary containers and packing versus manufacturer's containers and packaging; Observance of manufacturer's expiration dates; Length of time for storage of refrigerated and frozen foods and meats; Length of time for storage of leftovers.

Based on observation, interview, and review of contracts and quality documentation it was determined that the CAH failed to ensure that all services not provided directly by the CAH, were provided under a contract, arrangement or agreement that enabled the CAH to comply with all applicable CFRs. There were no written provisions for all those services not provided directly, nor had all services not provided directly been evaluated to ensure the CAHs compliance with the applicable COPs and standards. Those services were:
* Aquatic facilities for the provision of physical therapy services; and
* Microscope preventive maintenance services.

Findings include:

1. The "Agreement for Use of Dallas Aquatic Center" was dated effective 04/30/2015. The document stipulated a financial agreement for use of the aquatic center by patients of the CAH. There was no language in the document to reflect that the CAH had ensured that the aquatic center physical environment was maintained in a manner that allowed the CAH to comply with all applicable COPs and standards.

* There was no evidence provided to reflect that the CAH had monitored and evaluated the aquatic center physical environment, equipment, and infection risk to ensure the provision of safe and appropriate patient care.

* Refer to Tag C278, CFR 485.635(a)(3)(vi), Patient Care Policies, that reflects the CAH's failure to ensure the Dallas Aquatic Center, where physical therapy services were provided, was evaluated for infection control risk and prevention.

2. During tour of the laboratory on 01/27/2016, a Lab Medical Technologist stated that the lab microscopes observed were maintained and serviced by an outside vendor. Service and invoice records were reviewed and reflected that two microscopes had been serviced on 01/26/2016 by an instrument company. There was no evidence of a contract or written arrangement or agreement for the preventive maintenance services, nor evidence that the CAH had monitored and evaluated the services.

3. During interview with staff including the Director of Clinical Operations on 01/29/2016 at 1130 it was confirmed that the CAH had not monitored and evaluated the aquatic center and microscope preventive maintenance services.

29708

Based on interview, review of documentation in 7 of 24 medical records reviewed (Patients 10, 12, 15, 16, 17, 20, and 21), and review of policies and procedures it was determined that the CAH failed to ensure that medical records were complete and accurately documented. Patient care documentation in medical records was not complete, clear or accurate in the following areas:
* Consent for services;
* Patient rights notification:
* Blood transfusions; and
* Tissue and organ donation requests.

Findings include:

1. In the record of Patient 12 there was no "Conditions of Admission" form and no documentation related to receipt or notification of patient rights information. This was confirmed with the ED Manager on 01/28/2016 at 0950.

* In the record of Patient 15 there was no "Conditions of Admission" form and no documentation related to receipt or notification of patient rights information. This was confirmed with the Assistant NM on 01/27/2016 at 1100.

* In the record of Patient 10 the "Conditions of Admission" form signed by the patient on 01/12/2016 was not timed.

* During an interview with the ASR on 01/26/2016 at 1620, he/she indicated that patients were to sign a "Conditions of Admission" consent form during registration. He/she also indicated patients were provided a patient rights brochure and were to initial the bottom of the "Conditions of Admission" form to reflect their receipt of the brochure.

2. The medical record of Patient 20 reflected the patient received two outpatient blood transfusions on 01/08/2016. The "Informed Consent for Blood Transfusion" lacked the times the consent was signed by the patient and the witness as the spaces for "Time" were blank. The "WVH SHAPES Blood [Administration]" electronic flowsheet reflected the transfusion of the second unit of blood product was completed at 1615 on 01/08/2016. A nurse's note recorded at 1612, three minutes prior to the transfusion completion time, reflected "Transfusion completed. ID removed and patient is discharged [ambulatory]." The last vital signs documented were recorded at 1528, the time the transfusion was started.

* The medical record of Patient 21 reflected the patient received an outpatient blood transfusion on 01/08/2016. The "Informed Consent for Blood Transfusion" lacked the time the consent was signed by the witness as the space for "Time" was blank. The "WVH SHAPES Blood [Administration]" electronic flowsheet reflected the transfusion was completed at 1440 on 01/08/2016. A nurse's note recorded at 1446 reflected "Tolerated Transfusion well...Discharged ambulatory." The last vital signs documented were recorded at 1256, the time the transfusion was started.

* On 01/27/2016 several staff were present during the electronic record review, including the HIM Supervisor, the RN Care Manager, and the Infusion Assistant Nurse Manager. During interviews at the time of review of transfusion records at approximately 1530 the hospital's policy for monitoring of vital signs during transfusions was reviewed. It was confirmed that the patent's vital signs, as a way to evaluate patient response to the transfusion, must be taken at least prior to the transfusion, within 15 minutes after the transfusion is started, and at the end of the transfusion.

3. The medical record of Patient 16 reflected the patient presented to the ED on 10/06/2015 at 1850 in cardiac arrest and was pronounced dead on 10/06/2015 at 1940. The only reference to a request for tissues and organs was recorded at 2216 and read "Post Mortem...Call Center Referral: "([Medical Examiner] suggests no call needs to be made.)" It was not clear why no call needed to be made and there was no further explanation for the lack of tissue and organ request.

* The medical record of Patient 17 reflected the patient presented to the ED on 10/29/2016 at 1827 in cardiac arrest and was pronounced dead on 10/29/2016 at 1848. The "Call Center Referral and Post-Mortem Care" form reflected that "According to call center patient is a designated donor - Yes". However it further reflected "According to call center patient is medically suitable to donate - ?" The documentation did not reflect what the outcome of the donor referral was. It was not clear whether the patient was determined to be suitable or whether a request for tissue and organs was made.

* The p/p titled "Tissue and Organ Donation Request WVH", with effective date of "April 2013", was reviewed. It stipulated that "WVH will refer all deaths and potential donors, as defined below, to the donor agencies via the donor referral line...The donation agencies will determine medical suitability...Staff will call the Donor Referral Line...within one hour of cardiac death..."