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Based on observation, interview, and record review, the hospital failed to ensure that:

1. Critical medications potentially needed during a Malignant Hyperthermia (MH - a type of severe reaction that occurs to particular medications used in surgery; symptoms include muscle rigidity, high fever, and a fast heart rate) emergency were immediately available. Without adequate supplies of emergency medications to treat MH, patients are at risk for severe harm or death.

2. Medications were given an appropriate Beyond Use Date (BUD - an expiration date at which a medication should no longer be used). Numerous IV (intravenous - in the vein) medications were given an 8 week (56 days) BUD despite the manufacturer's specification that it should only be 30 days. Several insulin (a medication used to treat high blood sugar levels) vials were given a BUD that was longer than what the manufacturer allowed. Placing extended BUD's on medications without adequate evidence for the longer BUD increases the risk for contaminated or impotent medication which can lead to patient harm.

3. Hazardous medications (e.g. chemotherapy; medications that treat cancer) were prepared separate from non-hazardous medications. Preparing hazardous medications in the same area or room as non-hazardous medications increases the risk that the non-hazardous medications may be contaminated with hazardous particles. Potentially non-hazardous medications that have been contaminated with hazardous particles and administered to patients may lead to patient harm.

4. Appropriate room pressures were kept in the hospital pharmacy IV preparation areas. Without proper room pressures, small particles and microorganisms may contaminate IV medications prepared in the IV area. Administering contaminated medications may lead to serious patient harm or death.

Findings:

1. During a tour of the Post-Anesthesia Care Unit (PACU) on May 30, 2018, at 3:05 PM, the MH emergency cart was inspected. Observed to be stored in the MH cart were 2 separate IV injection bags of 1 Liter of Sterile Water for Injection (SWFI). Also observed to be stored in the MH cart were 36 vials of Revonto (brand name for dantrolene - a medication used to treat MH).

A review of the dantrolene vial labels indicated the following for reconstitution of each vial, "Each vial of Revonto (brand name for the dantrolene) (dantrolene sodium for injection) should be reconstituted by adding 60 mL of sterile water for injection". 36 vials of dantrolene reconstituted with 60ml SWFI would require 2,160mL of SWFI.

During a concurrent interview with the Director of Pharmacy (DOP), the DOP confirmed that the 2 separate 1 liter bags (total of 2,000mL) were for reconstituting the Revonto/dantrolene vials. In addition, the DOP confirmed that the 2 separate 1 Liter bags of SWFI would not be sufficient to reconstitute all 36 vials of dantrolene. Further discussion with the DOP included the use of SWFI vials instead of injection bags in order to avoid accidental administration of the SWFI bag which can lead to significant harm if given IV.

A review of the MH cart content list indicated that only 2 bags of 1 Liter each Sterile Water were included in the MH cart as part of hospital policy and procedure.

A review of the website for MHAUS (Malignant Hyperthermia Association of the United States - a nonprofit national organization dedicated to understanding of MH and considered the authority on treatment of MH), under the section "What Should be on an MH Cart", found at https://www.mhaus.org/healthcare-professionals/be-prepared/what-should-be-on-an-mh-cart/, MHAUS states, "REVONTO® - Each 20 mg vial should be reconstituted by adding 60 ml of sterile water for injection ...and the vial shaken until the solution is clear. If the MH episode is proceeding rapidly, simply mix and inject. We advise that the sterile water be stored in 100 ml vials, not bags, to avoid accidental IV administration of this hypotonic solution."

2a. During a tour of the Direct Observation Unit (DOU) on May 29, 2018, at 2:45 PM, the Pyxis (an Automated Drug Dispensing System used to store medications) was inspected. One open and used vial of Lantus (a long acting insulin used to reduce high blood sugar in the blood) and one unopened vial of Humulin N (a long acting insulin used to reduce high blood sugar in the blood) were observed to be stored in the Pyxis at room temperature. Both the Lantus vial and the Humulin N vials were labeled with an expiration date of "7-26-18", which was 58 days from the current day.

During a concurrent interview with the Director of Pharmacy (DOP), the DOP confirmed that the Lantus vial was open and used, both vials were stored at room temperature, and that both vials were labeled with an expiration date of July 26, 2018. The DOP confirmed that the expiration date was longer than it should be and stated that hospital pharmacy policy was to label each vial with only 28 days expiration date.

A review of the manufacturer prescribing information for Lantus, under the section "Storage", the manufacturer indicates that Lantus vials, when opened or stored at room temperature, should be used within "28 days".

A review of the manufacturer prescribing information for Humulin N, under the section "Storage and Handling", the manufacturer states, "If stored at room temperature, below 86°F (30°C) the vial must be discarded after 31days."

2b. During a tour of the hospital pharmacy on May 29, 2018, at 9:55 AM, the IV medication storage area was inspected. Observed to be stored in drawers were numerous medication vials attached to 250mL bags of 5% Dextrose in Water (a medication used to mix with other medications and administer IV) or 0.9% sodium chloride (also known as "normal saline"; a medication used to mix with other medications and administer IV). Over 10 vials of azithromycin (an antibiotic used to treat infections) 500mg vials were attached to 250mL EXCEL (type of IV container) bags of 5% Dextrose in Water bags via an "addEASE binary connector" (a device used to connect medication vials to IV bags for later reconstitution and administration). The manufacturer of the addEASE connector identifies the connector as a "N7995" connector. Other medications were also observed to be connected to 250mL EXCEL bags of 5% Dextrose in Water or normal saline via the N7995 addEASE connector including cefazolin (an antibiotic used to treat infections) 1 gram vials.

During a concurrent interview with the Director of Pharmacy (DOP), the DOP confirmed that the pharmacy used the N7995 connector on multiple medications utilizing the 250mL EXCEL bags of 5% Dextrose in Water or normal saline.

A review of hospital policy and procedure titled "Sterile IV Compounding - BUD", dated "6/17", under the section "Point of Care Activation Systems", the policy states, "POC (point of care) systems will be assembled by pharmacy ...and BUD will be based on manufacturer's recommendation for labeling and dating. Example: addEASE (B. Braun) ...56 days when connected to EXCEL 250mL bags".

A review of a letter provided to the hospital from B. Braun, the manufacturer of N7995 addEASE connector, dated "May 30, 2018", the letter states, "B. Braun recommends that the N7995, connected to a 250mL EXCEL container and 20mm drug additive vial (the type of vials used for the medications) can be stored per the Drug Manufacturer's recommendations for up to 30 days."

During an interview with the DOP on May 30, 2018, at 11:05 AM, the DOP confirmed that the pharmacy policy of dating for 56 days was incorrect and that the N7995 connected to 250mL EXCEL bags should only be a maximum of 30 days according to the manufacturer B. Braun. The DOP then directed staff to immediately correct all N7995/250mL EXCEL bag medication connections to 30 days BUD.

3. During a tour of the hospital pharmacy on May 29, 2018, at 11:00 AM, the IV preparation area was inspected. While in the "buffer room" (a sterile room where IV medications are prepared), a Biological Safety Cabinet (BSC - a type of IV preparation workbench device typically used to prepare hazardous medications) and a Laminar Flow Hood (LFH - a type of IV preparation workbench typically used to prepare non-hazardous medications) were observed to be approximately 6 feet apart.

During a concurrent interview with the Director of Pharmacy (DOP), the DOP confirmed that the BSC and LFH were in the same room and only a few feet apart. The DOP was asked if the BSC was used to prepare hazardous medications and the LFH was used to prepare non-hazardous medications. The DOP confirmed that the BSC was used to prepare hazardous medications and the LFH was used to prepare non-hazardous medications.

During an interview with the Lead Pharmacy Technician (LPT) on May 29, 2018, at 11:15 AM, the LPT was asked if the pharmacy prepared hazardous medications in the buffer room. The LPT confirmed that hazardous medications were prepared in the BSC of the buffer room next to the LFH.

A review of USP 797 (sterile compounding standards issued by the United States Pharmacopeia (USP), USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded), under the section "Hazardous Drugs as CSPs (compounded sterile products)", USP <797> states, "The ...BSC ...shall be placed in an ...area that is physically separated (i.e., a different area from other preparation areas)...".

4. During a tour of the hospital pharmacy on May 29, 2018, at 11:00 AM, the IV preparation area was inspected. While in the ante-room (the room used to cleanse and garb in preparation for entering the buffer area room (a sterile room where IV medications are prepared)), the room pressure gauge was inspected. The gauge indicated that the pressure of the buffer room relative to the ante-room was 0.075 inches water column (IWC - a unit of pressure between 2 different areas) positive pressure.

During a concurrent interview with the Director of Pharmacy (DOP), the DOP confirmed that the pressure gauge of the buffer room indicated 0.075 IWC.

A follow-up inspection of the pressure gauge for the buffer room on May 29, 2018, at 11:45 AM, indicated that the pressure was again 0.075 IWC.

A review of the pressure logs for the buffer room for January through May 2018, revealed that the buffer room pressure was too high several times throughout each month. For January 2018, the log indicated that the buffer room pressure was high 12 days of the month. For February 2018, it was high 2 days of the month. For March 2018, it was high 5 days of the month. For April 2018, it was high 6 days of the month. For May 2018, it was high 8 days of the month.

During an interview with Pharmacy Technician 1 (PT 1) on May 29, 2018, at 11:35 AM, PT 1 was asked if one of her duties was to record the buffer room pressure on the pressure logs. PT 1 confirmed that she often recorded the room pressures. PT 1 was asked whether she evaluated the room pressures for appropriateness or if she was just recording the results on the log. PT 1 stated that she was just recording the results on the log. PT 1 was given the log for May 2018 and asked to explain what the ">0.2" next to "IV Room to Ante Room" column meant. PT 1 stated that she did not know what the ">0.2" meant.

During an interview with the DOP on May 29, 2018, at 11:40 AM, the DOP confirmed that the buffer room pressure should be positive 0.02 to 0.05 IWC. She confirmed that the ">0.2" listed on the pressure log was incorrect and stated that she was going to update the log to indicate 0.02 - 0.05 IWC should be the correct range.

A review of the most recent IV room certification documents indicate that the IV room was tested on May 10, 2018. The report indicated that the buffer room pressure tested was negative 0.07 IWC, which was significantly lower than the acceptable range.

During an interview with the DOP on May 31, 2018, at 11:00 AM, the DOP confirmed the buffer room pressure certification result was not acceptable and stated that she was having maintenance personnel fix the pressure and that she would obtain a new certification once the repairs were complete.

A review of USP 797 (sterile compounding standards issued by the United States Pharmacopeia (USP), USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded), under the section "Facility Design and Environmental Controls" discussing positive pressure IV room areas, USP 797 states, "For rooms providing a physical separation through the use of walls, doors, and pass-throughs, a minimum differential positive pressure of 0.02- to 0.05-inch water column is required."

Based on observation, interview, and record review, the hospital failed to ensure that outdated and unusable medications were not available for use. Expired medications may not be as potent as intended by the manufacturer or prescriber. Administering impotent or contaminated medications may lead to serious patient harm or death.

Findings:

During a tour of the Surgery Department on May 30, 2018, at 2:40 PM, the Operating Room #6 anesthesia Pyxis (an Automated Drug Dispensing System used to store medications) machine was inspected. Observed to be stored in the bottom drawer were numerous vials of medication and an inhaler that were either expired, unusable, or potentially contaminated:

-2 vials of epinephrine (a medication used during cardiac rhythm emergencies, commonly known as "heart attacks") 1mg/mL with a manufacturer expiration date of "1APR 2018", indicating that the medications expired on April 1, 2018.
-1 vial of etomidate (a medication used to prevent any feeling/pain, called anesthesia) 40mg/20mL single dose vial which was open and used. The vial had a manufacturer expiration date of "1DEC 2017", indicating that medication expired on December 1, 2017.
-1 vial of succinylcholine (a medication used to paralyze patients during surgery) 200mg/10mL. The manufacturer expiration date was "1DEC 2017", indicating that the medication had expired December 1, 2017.
-1 vial of Protonix (a medication used to treat stomach ulcers) 40mg powder for injection. The manufacturer expiration date was "07/2016", indicating that the medication expired July 31, 2016.
-1 meter dose inhaler of Ventolin (a medication used to improve breathing) with a manufacturer expiration date of "APR 2017", indicating that the medication expired April 30, 2017.

During a concurrent interview, the Director of Pharmacy (DOP) confirmed that the medications had expired and that the open and used single dose vial of etomidate was potentially contaminated.

A review of hospital policy and procedure, titled "Outdated Medications", dated "12/16", under the section "Procedure", the policy states, "2. Any expired, contaminated, deteriorated medication ...shall be removed from stock." The policy further states, "2.2 All Pyxis medications stations and medication rooms shall be checked monthly." Lastly, the policy states, "2.4 Unacceptable medications shall be immediately pulled from stock."

Based on observation, interview, and record review, the facility failed to ensure one of two crash carts (a wheeled container carrying medicine and equipment for use in emergency resuscitations) in the Intensive Care Unit (ICU) was equipped with necessary supplies, when it had no oxygen tank available for use. This failure had the potential for patients not to receive life threatening medical emergency services, which could lead to serious harm and/or death in a universe of 12 patients in ICU.

Findings:

During a facility tour on May 29, 2018, at 9:07 AM, one of two crash carts in the Intensive Care Unit (ICU) was observed not having an oxygen tank in place.

During a concurrent interview with the Director of ICU (RND 2,) after reviewing the crash cart contents, the RND 2 confirmed an oxygen tank should be available for use on the crash cart at all times.

A review of the facility policy and procedure titled, "Code Cart Exchange and Restocking", revised May 2017, under section policy indicated that "[Name of the facility] pharmacy department shall ensure all Emergency Carts are available and stocked with appropriate medications and supplies for all patient care departments". It further indicated that the crash cart is required to have an "oxygen tank at least ¼ [one fourth] full."

The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases.

This Condition is not met as evidenced by:

Based on observation, staff interview, and document review, the hospital failed to ensure its infection control program was designed and implemented to prevent sources of infectious organisms when the infection control program failed to:

1. Ensure safe storage of Potentially Hazardous Foods (Foods such as meat and milk that have a high potential for bacteria growth especially if not stored above 135 degrees (*) Fahrenheit [F] and below 41* F for 4 hours or less) to prevent the potential for food borne illness (Illness caused by ingesting food contaminated with bacteria which can be severe enough to cause death) when staff did not follow time temperature control for food stored in nursing station pantry refrigerators and food was held in the danger zone (135 degrees Fahrenheit (F) to 41 degrees F) for an unknown amount of time for 1 of 9 nourishment refrigerators that held food for 10 patient beds in a total of 148 licensed beds. A survey of the facility refrigerators containing patient nutritional items found eight of 10 refrigerators to have out of range temperatures from May 1, 2018, through May 31, 2018. (Cross Reference A749); and

2. Date the dressing on the intravenous (IV in the vein, used to deliver medications or exchange blood) access site on four (4) of 30 sampled patients (Patient 2, 3, 4 and 5). This failure had the potential for patients to be exposed to bloodstream infections which can lead to severe morbidity and mortality. (Cross Reference A749)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure a safe and sanitary environment and put ill and medically compromised patients at risk of food and blood borne illness.

Based on observation, interview, and record review, the facility failed to:

1. Develop a system to identify food safety issues when potentially hazardous foods (PHF; Foods such as meat and milk that have a high potential for bacteria growth especially if not stored above 135 degrees [*] Fahrenheit [F] and below 41* F for less than 4 hours) in a patient food refrigerator were measure between 41* F and 135* F and were held at this temperature for an unknown amount of time for food held in one of nine nourishment refrigerators. A survey of the facility refrigerators containing patient nutritional items found eight of nine refrigerators to have out of range temperatures from May 1, 2018, through May 31, 2018.

This failure had the potential to contaminate food with the growth of bacteria and cause food borne illness (Illness caused by food contaminated with bacteria that can be severe enough to cause death) for 10 beds in a total of 148 licensed beds; and

2. Date the dressing on the intravenous (IV in the vein, used to deliver medications or exchange blood) access site on four (4) of 30 sampled patients (Patient 2, 3, 4 and 5). This failure had the potential for patients to be exposed to bloodstream infections which can lead to severe morbidity and mortality.

On 5/31/18 at 4:30 p.m., Immediate Jeopardy (IJ) was called. The administration staff, including the Chief Nursing Officer and the Chief Executive Officer, were verbally notified of the IJ regarding temperatures of food stored above 41* F for an unknown amount of time.

Findings:

1. According to the Federal Food Code (2017) refrigerated time/temperature control food also known as PHF is to be 41* F or less and when the food temperature increases above 41*F it is to be discarded within 4 hours. Perishable foods such as meat and milk are capable of supporting bacterial growth associated with foodborne illness.

A review of the policy and procedure titled "Refrigerators on Patient Care Units" dated 9/17, read "... Refrigerator temperatures must be maintained at 41* F or below ... When temperatures exceed 41*F for the refrigerators, temperatures shall be adjusted and rechecked. If still not at correct level, Engineering shall be notified. The time that Engineering has been notified is noted on the record log ... If the refrigerator temperature cannot be maintained at 41*F and it cannot be repaired within 1 hour, all perishable foodstuffs must be transferred to another unit for proper storage. Food and Nutrition Services can be called to assist with moving the contents to another refrigerator ..." It was noted that the policy titled "Refrigerators on Patient Care Units" did not include when thermometer temperatures were above 41*F, it was not required that food be discarded if it was held above 41* F and it could not be shown that it was above 41* F for less than 4 hours.

A review of the "Refrigerator Food and Freezer Temperature Log" located in seven pantries (a food storage area) areas including the Catheterization (Cath; a procedure used to look at the heart) Lab, Medical Surgery (Med Surg; an unit where patients are ill and/or recovering from surgery) West Wing, Emergency Room (ER; where patients are treated immediately for illnesses and injuries), Med Surg Central, Med Surg East Wing, the Intensive Care Unit (ICU; for critically ill patients), and the Definitive Observation Unit (DOU; for patients who are do not need ICU care but need more intense care than Med-Surg units) showed that the refrigerator temperature range was to be between 36 * F and 41 * F. There was a column by each date to document an a.m. and p.m. temperature, an intervention if the temperature was not "in range" and another temperature an hour after the original not in range temperature.

On 5/31/18 at 10:50 a.m. an observation and concurrent interview with Registered Nurse Director 1 (RND 1) and the Director of Nutrition (DN), showed the temperature of a nourishment refrigerator in the Cath Lab was 43* F on a thermometer located inside the refrigerator. The DN confirmed the temperature. The temperature of PHF food stored in the refrigerator was measured with the surveyor's calibrated thermometer. One milk was 47.3 * F, another milk was 45.5 * F, and the sliced turkey inside a sandwich with a use by date of 5/31/18 was 44.6 * F. Based on the temperature of the food compared to the refrigerator thermometer temperature, the food was 1.6 to 4.3*F higher than the thermometer temperature. It was noted the documentation of the a.m. temperature for the same refrigerator the was 41* F but it was shown that the turkey sandwiches and milk were 1.6 to 4.3* F higher than the thermometer temperature when the food temperatures were measured by the surveyor later in the morning on 5/31/18 at 10:50 a.m. The DN confirmed the temperatures of the food and explained that the kitchen staff stocked the food and there was not a way to know exactly how long a particular food was in the refrigerator. She said the turkey sandwiches were placed in the refrigerator on 5/30 or 5/29 based on the use by date.

On 5/31/18 at 11:05 a.m. an observation and concurrent interview with Charge Nurse 1 (CN 1), showed a nourishment refrigerator on the West Wing Pantry contained milk and sliced turkey sandwiches. A review of the refrigerator log showed documented temperatures between 42* F and 48* F, 33 times for the month of May 2018. The log showed documented temperatures did not go below 42* F and as high as 48*F between 5/5/18 to 5/9/18 and 5/19/18 to 5/28/18. CN 1 stated if a temperature of the pantry refrigerator was above 41* F then whoever took the temperature should readjust the refrigerator dial to make the refrigerator colder then check the temperature again in 15 to 30 minutes. He confirmed there was no documentation on the log to show that there was an intervention or the refrigerator was reassessed when temperatures were documented above 41* F during the month of May. He also stated on the West Wing, orderlies or Certified Nursing Assistants (CNAs) were responsible for taking the temperatures.

In an interview on 5/31/18 at 11:20 a.m., Certified Nursing Assistant 1 (CNA 1), confirmed her signature on the May 2018 West Wing refrigerator temperature log for temperatures that were above 41* F. She stated that when temperatures were above 41* F she was supposed to go back within an hour to recheck the temperature. She confirmed that there were no interventions or recheck temperatures documented and that she forgot to recheck the temperatures probably because she was busy.

On 5/31/18 at 11:30 a.m., an observation of the refrigerator in the East Wing pantry and concurrent interview with the DN, showed the storage of milk and sliced turkey sandwiches. The temperature log showed documentation of the refrigerator temperature was above 41* F from 5/18/18 to 5/20/18 with temperatures of 42* F to 48* F. The DN confirmed there was no intervention or recheck temperatures documented for these dates.

On 5/31/18 at 2:05 p.m., an observation and concurrent interview with Registered Nurse Director 2 (RND 2) and DN, showed four temperatures were documented at 42* F on the Refrigerator Log in the ICU Pantry. There was no documentation to show there was an intervention or temperature rechecked. RND 2 stated that when the refrigerator temperature was above 41* F the person checking should turn the dial to adjust the refrigerator temperature, within an hour recheck the temperature and document the intervention and the temperature. She confirmed there was no documentation of intervention or temperature rechecks when the documented temperature was 42*F. This refrigerator held milk and sliced turkey sandwiches. The DNS stated that if she knew there was a problem with the refrigerator she would remove the food items but she was not notified that there were high temperatures in any of the pantry refrigerators for the month of May.

On 5/31/18 at 2:25 p.m., an observation of the patient food refrigerator located in the DOU pantry showed storage of sliced turkey sandwiches and milk. The refrigerator temperature log showed a temperature of 42*F on 5/5/18. RND 2 confirmed there was no documentation to show an intervention or recheck temperature was done.

On 5/31/18 at 2:30 p.m., an observation of the patient food refrigerator temperature log located in the Central Med Surg pantry, showed 30 temperatures documented above 41* F for May 2018. From 5/17/18 to 5/24/18 documented temperatures did not drop below 42* F and were documented from 42* F to 49* F. Registered Nurse Director 4 (RND 4) confirmed there was no documentation to show that an intervention was taken or the temperature was rechecked. This refrigerator stored milk and sliced turkey sandwiches.

On 5/31/18 at 2:40 p.m., an observation and concurrent interview with Registered Nurse Director 3 (RND 3) and the DN, showed the temperature of the digital thermometer of the patient food refrigerator located in the Recovery Unit (where patients are cared for after surgery) read 43* F. Packaged gelatin with a label that read "perishable keep refrigerated" and sliced turkey sandwiches were stored in the refrigerator. The temperature of the packaged gelatin taken with the surveyors calibrated thermometer read 46.4* F for one gelatin and 45.9* F for another gelatin. These temperatures demonstrated the temperatures of the other food stored in the refrigerator. The DN confirmed the temperature of the refrigerator and the gelatin. The document titled "Refrigerator Temperature Control Log" showed that the refrigerator temperature was above 41* F twelve times, between 42 and 44* F, in the month of May 2018. The Refrigerator Temperature Control Log document was different from the refrigerator logs on the other units. This log was also used to document the temperature of the medication refrigerator as well as the nourishment refrigerator. The temperatures for the nourishment refrigerator were documented once a day and the log read "Nourishment Refrigerator TEMPERATURE (Range 45* or lower)." The DN and RND 3 stated they did not know why there was a different refrigerator temperature log for this unit. RND 3 said there would be no reason to recheck the temperatures or contact engineering to fix the temperature of the refrigerator if the temperature was 45*F or below. The DN confirmed food should be stored at 41* F or below and the storing food up to 45* F as the Temperature Control Log stated was incorrect.

On 5/31/18 at 2:50 p.m., an observation of the ER patient food refrigerator showed the refrigerator temperature documentation log hanging on the refrigerator dated May 2017, had 39 documented temperatures above 41* F with no documented interventions or temperature rechecks. From 5/1/18 to 5/6/18 the temperatures ranged from 42*F to 48*F, from 5/9/18 to 5/13/18 the range was 42*F to 48*F, from 5/16/18 to 5/18/18 the range was 42*F to 44*F, from 5/23/18 to 5/26/18 the range was 44*F to 48*F, and from 5/30/18 to 5/31/18 the range was 44*F to 50*F. This refrigerator stored milk and sliced turkey sandwiches.

In an interview with the CNO on 5/31/18 at 3 p.m., she confirmed that there was no intervention or recheck temperature documentation on the ER refrigerator temperature log. She stated the staff responsible for checking the temperatures were to adjust the dial to make the refrigerator colder if it was above 41* F, then they were to recheck and document the temperature within an hour. If the temperature was still above 41*F engineering should have been contacted.

The IJ was removed on 6/1/18 at 5:02 p.m., when the facility submitted an acceptable plan of action that included replacing the food refrigerator in the Cath Lab, revising the policy and procedures for "Refrigerators on Patient Care Units" to include staff taking temperatures of food and discarding if above 41* F, immediately in-serving staff regarding the revised policy, it was shown that refrigerator temperatures and thermometers were functioning properly, and the refrigerator in the Cath Lab was replaced with a new refrigerator.


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2a. During an observation on May 29, 2018, at 9:07 AM, Patient 2 was observed lying on the bed with a peripherally inserted central catheter (PICC- a form of intravenous access that can be used for a prolonged period of time) on the right upper arm. The dressing was observed without a date indicating when the dressing was placed over the PICC line site.

During a concurrent interview with Registered Nurse (RN 10), she confirmed the dressing was not dated, and stating the dressing needed to be dated to know when the dressing has to be changed.

During an interview with the Director of Intensive Care Unit (RND 2), on May 31, 2018, at 11:31 AM, she stated the IV site dressings have to be dated with each dressing change time, to alert the staff to when the next dressing change is due. RND 2 reviewed the facility policy and procedure titled "Standards of Practice to Nursing Services" and stated the facility uses the Elton B. Stephens Company (EBSCO) that provides guidelines on various health care supplies for IV site dressing changes. She further stated the facility uses Transparent Semi-Permeable Membrane (TSM- a type of dressing used on wound or skin) dressing for peripheral and central IV sites.

A review of the facility policy and procedure titled "Standards of Practice to Nursing Services, Patient Care Manual" revised February 2017, indicated the following:

"Policy: Desert Valley Hospital nursing department has adopted the following references to define the Standards of Practice for Nursing which shall be provided at Desert Valley Hospital. CLINICAL AREA...Intensive Care Unit/Definitive Observation - REFERENCE...EBSCO." A review of the EBSCO guidelines for TSM dressings indicated that the dressing had to be changed every 5-7 days. It further indicated that the sterile gauze dressing had to be changed every 2 days.

2b. During an observation on May 29, 2018, at 9:11 AM, Patient 3 was observed lying on the bed with a dialysis catheter (a form of catheter used for exchanging blood during a dialysis treatment for patients with kidney insufficiency) on the right femoral (a large artery in the thigh) vein/artery. The dressing on the catheter site was observed as saturated with a mild yellowish color fluid, and was without a date indicating when the dressing was placed on the catheter site.

During an interview with Director of Intensive Care Unit (RND 2), on May 31, 2018, at 11:31 AM, she stated the IV site dressings have to be dated with each dressing change time, to alert the staff to when the next dressing change is due. RND 2 reviewed the facility policy and procedure titled "Standards of Practice to Nursing Services" and stated the facility uses EBSCO guidelines for IV site dressing changes. She further stated the facility uses Transparent Semi-Permeable Membrane (TSM- a type of dressing used on wound or skin) dressing for peripheral and central IV sites.

A review of the facility policy and procedure titled "Standards of Practice to Nursing Services" revised February 2017, indicated the facility uses EBSCO guidelines for IV site dressing. A review of the EBSCO guidelines for TSM dressings indicated that the dressing had to be changed every 5-7 days. It further indicated that the sterile gauze dressing had to be changed every 2 days.

2c. During an observation on May 29, 2018, at 9:15 AM, Patient 4 was observed lying on the bed with a peripheral (away from the center, on the edge) IV on his right hand, without a date on the dressing indicating when it was placed.

During a concurrent interview with RN 12, she stated the dressing had to be dated to identify when to change the dressing.

During an interview with Director of Intensive Care Unit (RND 2), on May 31, 2018, at 11:31 AM, she stated the IV site dressings have to be dated with each dressing change time, to alert the staff to when the next dressing change is due. RND 2 reviewed the facility policy and procedure titled "Standards of Practice to Nursing Services" and stated the facility uses EBSCO to provide guidelines on various health care supplies, and guidelines for IV site dressing changes. She further stated the facility uses Transparent Semi-Permeable Membrane (TSM- a type of dressing used on wound or skin) dressing for peripheral and central IV sites.

A review of the facility policy and procedure titled "Standards of Practice to Nursing Services" , revised February 2017, indicated the facility uses EBSCO guidelines for IV site dressing. A review of the EBSCO guidelines for TSM dressings indicated that the dressing had to be changed every 5-7 days. It further indicated that the sterile gauze dressing had to be changed every 2 days.

2d. During an observation on May 29, 2018, at 9:18 AM, Patient 5 was observed laying on the bed with an undated IV dressing on the peripheral (on the edge, away from the center) right external jugular (a vein located in the neck or throat) and a Central Venous Catheter (CVC- a form of intravenous catheter inserted into a main vein for the purpose of medication and fluid administration) on the right groin area.

During a concurrent interview with RN 12, she confirmed the IV dressings were not dated, stating the staff are required to date IV site dressings.

During an interview with Director of Intensive Care Unit (RND 2), on May 31, 2018, at 11:31 AM, she stated the IV site dressings have to be dated with each dressing change time, to alert the staff to when the next dressing change is due. RND 2 reviewed the facility policy and procedure titled "Standards of Practice to Nursing Services" and stated the facility uses EBSCO that provides guidelines on various health care supplies and guidelines for IV site dressing changes. She further stated the facility uses Transparent Semi-Permeable Membrane (TSM- a type of dressing used on wound or skin) dressing for peripheral and central IV sites.

A review of the facility policy and procedure titled "Standards of Practice to Nursing Services" , revised February 2017, indicated the facility uses EBSCO guidelines for IV site dressing. A review of the EBSCO guidelines for TSM dressings indicated that the dressing had to be changed every 5-7 days. It further indicated that the sterile gauze dressing had to be changed every 2 days.