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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.618 Emergency Services was out of compliance.

C-0202 - Equipment, supplies and medication used in treating emergency cases are kept at the CAH and are readily available for treating emergency cases. Based on observations, interviews, and document review, the facility failed to ensure emergency patient care supplies, to include supplies in the crash carts were not expired.

Based on interviews and medical record review, the facility failed to ensure an Emergency Department patient received a complete physical examination prior to discharge from the facility (Patient #12).

Findings include:

Policies:

According to the policy, Discharge of the Emergency Room Patient, all patients must be medically stable prior to discharge. The purpose of the discharge policy reads, to provide patients with appropriate written instructions and follow-up instructions for care at home with proper follow-up instructions with private physician.

According to the policy, Jail Custody Patients, patient care of a jail custody patients will receive the same level of care as provided to other patients at the hospital.

1. The facility failed to ensure an Emergency Department (ED) patient (Patient #12) received a complete physical exam prior to discharge. Specifically, the patient was discharged from the facility prior to the return of a blood alcohol level.

a. Review of Patient #12's Medical Record revealed the patient presented to the ED on 1/1/19 at 3:37 a.m. Registered Nurse (RN #2) documented at 3:37 a.m., on the emergency documentation in the nursing document, the patient was brought in accompanied by deputy sheriff for medical clearance. Laceration to right parietal lobe noted. Additionally RN #2 documented Patient #12 was unable to verbalize appropriately due to alcohol intoxication.

At 3:44 a.m. an order for an ethanol level was noted in the laboratory orders document.

At 4:02 a.m. Patient #12 was triaged by Registered Nurse (RN #2), which was documented on the ED triage and assessment adult Assessment forms. RN #2 documented Patient #12's chief complaint as in police custody for medical clearance.

At 4:59 a.m., the physician (Physician #14) documented, under history of present illness on the ED note, Patient #12 was brought in by law enforcement after arrest for alcohol intoxication. The patient had been involved in an altercation with his brother and fell through a glass window. The document further stated Patient #12 was unable to answer questions appropriately secondary to intoxication, and had an abrasion to the right parietal scalp. Additionally, the physician documented a physical examination which stated the patient was alert. Physician #14 documented the impression and plan was: labs unremarkable with a blood alcohol level pending. Patient was medically cleared for jail and left the ED with law enforcement.

At 5:18 a.m. RN #2 documented Patient #12 was discharged to jail in police custody.

At 5:35 a.m., following the patient's discharge from the facility, in the toxicology flowsheet, an ethanol level of 422 was called to staff. Within the same toxicology flowsheet interpretive data revealed an ethanol level greater than 400 was a "fatal" level.

b. On 2/11/19 at 12:30 p.m., an interview was conducted with Physician #14 who had seen Patient #12 on 1/1/19. Physician #14 stated when a patient had alcohol in their system it was important to evaluate for injuries because they would be unable to tell the provider if they had pain in their head or back. Additionally, Physician #14 stated when a patient presents with head trauma after falling through a glass window it is important to assess for loss of consciousness (LOC). Physician #14 explained LOC can occur when a patient hits their head and should be documented in the medical record. Physician #14 further explained it was important because it helps to determine whether a patient was at risk for head trauma such as a closed head injury, or subdural hematoma (bleeding between the brain and the skull which can be life threatening). Physician #14 also explained LOC adds to the clinical decision as to the severity of the injury.

Patient #12's medical record was reviewed with Physician #14. Physician #14 confirmed there was no neurological assessment done by her and no documentation in the medical record if the Patient #12 had LOC after falling through a glass window.

After review of Patient #12's medical record, Physician #14 stated she felt he was safe to discharge to jail "because there was staff at the jail", however, Physician #14 was unable to provide evidence the patient was monitored after discharge or a hand off of medical information was provided to staff in the jail. Additionally, Patient #12's discharge instructions provided no information, instructions, or teaching regarding possible neurological emergencies following trauma to the head to monitor for after discharge. The only instructions noted in the discharge instructions provided to the patient was information regarding alcohol intoxication.

Based on observations, interviews, and document review, the facility failed to ensure emergency patient care supplies, to include supplies in the crash carts were not expired.

Findings include:

References:

According to the Ethilon Suture instructions for use, instructions state: do not use after the expiry date.

Cleaning-Maintenance of Clean Utility Room (including floor crash cart) supply checklist states: monthly: check all supplies for outdates.

Nursery supply checklist states: Bimonthly: check all outdates, remove if indicated and restock.

Neonatal Emergency "Red Box" checklist states: bimonthly and after each use: Check supplies for outdates, and organize.

Crash Carts - ER and Clean Utility: Every Shift: Check for outdates on electrodes and pads.

1. The facility failed to ensure expired emergency supplies were removed from the crash cart (supply cart for medical emergencies and from other locations in which emergency supplies were kept) and throughout the facility.

a. On 2/4/19 at 11:46 a.m., a tour of the nursery was conducted with the Chief Clinical Officer (CCO #1). Inspection of the infant incubator revealed the following expired supplies: one umbilical cord clamp (a clamps used on a newborn infant to clamp the umbilical cord after delivery) with an expiration date of 8/2017, seven ThermoPads (a temperature probe cover, used to monitor an infant's temperature) which had expired between 9/2017 and 2/2015, one IV extension tube with an expiration date of 9/2012, and one Yankauer (a device used to suction secretions) with expiration date 11/2016 .

At the time of the tour CCO #1 confirmed the items were expired and should have been discarded by staff. CCO #1 stated the incubator was utilized for infants in need of critical care who were awaiting transfer to a facility for a higher level of care.

b. On 2/4/19 at 12:15 p.m., a tour of the nursery supply room was conducted with Registered Nurse (RN #2). RN #2 explained the Neonatal Emergency "Red Box" contained emergency supplies needed in an emergency situation for an infant needing resuscitation.

Inspection of the Neonatal Emergency "Red Box," revealed two vacationer push button blood collection sets with an expiration date of 12/31/2018, and three Huggables ECG Electrodes (used to monitor the heart rhythm in an infant) with an expiration date of 1/9/2019.

Additional expired patient care supplies stored in the nursery supply room included:
-one Ethilon 6-0 suture package (sutures used to repair a laceration) with an expiration date of 7/2016.
-two Sodium Chloride 0.9% 3 ml with an expiration date of 9/18.
-one ChloraPrep one step (used to prep the skin prior to insertion of an IV catheter) with an expiration date of 10/2018.
-one uri-cath set (used to catheterize an infant for urine) with an expiration date 8/2008.
-one uri-cath set (used to catheterize an infant for urine) with an expiration date 8/2008.
-two boxes of Enfamil 5% Glucose in Water 2 oz (12 bottles) with an expiration date 12/1/2018.

At the time of the tour an interview was conducted with RN #2. RN #2 stated the expired supplies should have been discarded by staff during the bimonthly nursery supply check. RN #2 stated expired items should not be used because the products may not work the way the manufacture intended.

c. On 2/4/19 at 12:50 p.m., an inspection of the inpatient crash cart was conducted with Registered Nurse (RN # 3). During inspection the following expired supplies were observed: one CO 2 detector (a device used to ensure proper placement of an endotracheal tube), with an expiration date of 8/21/18, three Chlora Prep one step (used to prep the skin prior to insertion of an IV catheter) with an expiration date of 10/2018.

At the time of the tour RN #3 stated staff would not be able to use the expired CO 2 detector because they could not ensure it worked properly.

d. On 2/4/19 at 1:15 p.m., a tour of an inpatient room was conducted with CCO #1. During inspection of the inpatient room an ammonia capsule was noted hanging from a cabinet in a plastic bag with the words "OD" written on the bag, with an expiration date of 11/2018.

At the time of the tour CCO #1 confirmed the item was expired and stated the ammonia capsules were available for use in patient rooms for the possible emergency event of a drug overdose.

e. On 2/4/19 at 11:46 a.m., a tour of the emergency department (ED) was conducted with the Director of Nursing (DON #4). Inspection of the ED crash cart revealed: one set of pediatric defibrillator electrodes (delivers a dose of electric current to the heart in an emergency resuscitation) with an expiration date of 1/14/19.

Upon inspection of the ED Emergency Preparedness Cart the following supplies were observed:

-Two Sodium Chloride 1,000 IV fluid which had expired 9/2018
-Two Sodium Chloride flushes which had expired 11/1/2018
-Four 24 gauge IV angiocatheters which had expired 6/2018
-Four 16 gauge IV angiocatheters which had expired 10/2017
-One bottle of Hibiclens which had expired 10/2017

Inspection of the ED Splint Cart, revealed petroleum jelly with an expiration date of 7/1993.

At the time of the tour Registered Nurse (RN # 5) stated she was in charge of emergency preparedness for the facility and was also in charge of checking the Emergency Preparedness Cart. RN #5 stated she had not checked the cart in over a month. Additionally, RN #5 stated she did not have any documentation of checks done on the cart.

f. On 2/4/18 at 12:30 p.m., a tour of the PACU was conducted with DON #4. Inspection of the PACU crash cart revealed: two blue top blood collection tubes (tubes used for collecting patient blood for lab tests) with an expiration date of 1/31/19, and one green top blood collection tube with an expiration date of 12/31/18.

g. On 2/7/19 at 2:40 p.m., an interview was conducted with DON #4. DON #4 stated staff should have followed the facility's process of removing all expired patient care supplies and replace them when doing the bimonthly cleaning and supply check. DON #4 further stated the integrity of an item was not guaranteed if it was used after the date of expiration. DON #4 stated, she expected the bimonthly cleaning checklist be completed and directions for removing outdated supplies be followed.

h. Document review of the Nursery, Neonatal Emergency "Red Box," and Cleaning-Maintenance of Clean Utility Room, and Crash Carts - ER and Clean Utility checklists revealed:

-Nursery was checked by staff two times in January, 2019
-Neonatal Emergency "Red Box" was checked by staff two times in January, 2019.
-Cleaning-Maintenance of Clean Utility Room had been completed six times in January, 2019.
-Crash Carts - ER and Clean Utility had been completed once in January, 2019.

However, outdated supplies remained in these areas despite instructions on each checklist which stated supplies should be checked for outdates.

Base on the onsite investigation, completed February 19, 2019, the facility failed to comply with the regulations set forth for Life Safety and, therefore, deficiencies were cited under Life Safety Code Tags K291, K321, K322, K325, K345, K346, K353, K354, K372, K712, K741and K918.

Based on observation, interviews, and document review, the facility failed to ensure the perioperative area and decontamination room temperature was maintained in accordance to national standards, to reduce the risk of infection.

Findings include:

References :

According to the International Association of Healthcare Central Services Material Management (IAHCSMM), Central Services Technician Manual, eighth edition:

Infection Prevention (page 113): Decontamination work area temperature range is listed at 60 degrees Fahrenheit - 65 degrees Fahrenheit.

1. The facility failed to ensure the perioperative area and decontamination room temperature was not above acceptable national standards.

a. On 2/5/19 at 11:00 a.m., a tour of the perioperative decontamination room was conducted with Surgical Tech #15. The temperature in the room was observed at 67.6 degrees Fahrenheit.

An interview was conducted with Surgical Tech #15. Surgical Tech #15 stated the temperature was outside of International Association of Healthcare Central Services Material Management (IAHCSMM) standards. Surgical Tech #15 also stated it was important for temperatures to stay within the recommended range to prevent bacterial growth which may occur with elevated temperatures.

b. On 2/6/19 at 8:59 a.m., a tour was conducted of the perioperative decontamination room. The temperature in the room was observed at 68 degrees Fahrenheit.

c. Document review of the facility's Monthly Temperature / Humidity / Fluid Warmer Checklist logs, which included the perioperative decontamination room, for January and February 2019 revealed the following temperatures:

-January 23, 2019: 68 degrees Fahrenheit
-January 25, 2019: 68 degrees Fahrenheit
-January 28, 2019: 68 degrees Fahrenheit
-January 29, 2019: 68 degrees Fahrenheit
-January 30, 2019: 67 degrees Fahrenheit
-February 1, 2019: 68 degrees Fahrenheit
-February 4, 2019: 68 degrees Fahrenheit
-February 5, 2019: 68 degrees Fahrenheit

d. On 2/7/19 at 2:45 p.m. an interview was conducted with the Director of Nursing (DON) #4 who also functioned as the Infection Control RN for the facility. As the infection control RN she stated it was her responsibility to monitor for gaps in all department. DON #4 stated, however, she did not monitor for infection control gaps in the perioperative area, to include the decontamination area. DON #4 further stated she has not done any infection control auditing of the perioperative department. DON #4 stated she did not oversee the perioperative area for infection control issues because she was not knowledgeable about the department and trusted staff would follow infection control standards on their own.

Based on observations and interviews, the facility failed to discard opened multi-dose vials, which had expired.

Findings include:

Policy:

According to the policy, Drug Administration, multiple dose vial (MDV) once opened are able to be used for 28 days, unless the manufacturer recommends less. The nurse is to fill out date vial opened, and date MDV expires. If the vial is found to be opened but not labeled, the entire vial is discarded.

According to the policy, Single Dose Vial/ Multi-dose Vial Charting and Charging, MDV are further denoted to nursing staff by having an outdate sticker placed on the vial/box. The outdate sticker is placed by pharmacy staff. When the nurse removes first dose of multi-dose vial, it is her responsibility to complete the required fields on the outdate sticker.

If a multi-dose vial is found without a label, and is opened, it must be discarded.

If a vial is labeled from the manufacturer as multi-dose vial, but does not have our outdate sticker affixed, it is to be treated as a single dose vial.

Reference:

According to CDC (Centers for Disease Control), Frequently Asked Questions (FAQs) Regarding Safe Practices for Medical Injections, if a multidose vial has been opened or accessed the vial should be dated and discarded within 28 days unless the manufacturer's expiration date specifies a different date for that opened vial.

1. The facility failed to discard an opened medication which had expired.

a. A tour of the facility's nursery supply room was conducted on 2/4/19 at 12:15 p.m. During the tour, a vial of 1% Lidocaine (a medication used as a local anesthetic) was observed on the counter in a basket. The vial was opened, and had been previously used. However, no opened or expiration date was written on the vial.

b. During the tour an interview was conducted with Registered Nurse (RN #2). RN #2 stated the 1% Lidocaine was used on infants for circumcisions (a procedure to remove the foreskin of the penis) by the physician. RN #2 further stated the Lidocaine should have been labeled with a date once it was opened and used by staff. RN #2 also stated the medication was not safe for patient use after the expiration date. RN #2 confirmed there was no expiration date indicated on the vial of 1% Lidocaine, therefore she was unsure of when it had been used.

c. An interview was conducted with the Chief Clinical Officer (CCO #1) on 2/4/19 at 12:35 p.m. CCO #1 stated the Lidocaine was a multi-dose vial and once the vial was opened an expiration date should have been placed on the vial according to facility policy. CCO #1 was unsure why the date had not be placed on the vial by staff as expected.

d. On 2/7/19 at 2:45 p.m. and interview was conducted with the Infection Control Nurse who was also the Director of Nursing (DON #4). DON #4 stated multi-dose vials were to be discarded after 28 days which would be indicated by the date on the vial. DON #4 also stated using the medication after 28 days created a risk for infection due to the preservative no longer be as effective and the potency of the medication could not be guaranteed.

Based on observations, interviews and document review, the facility failed to maintain appropriate infection control processes in the areas of perioperative services, equipment reprocessing and food storage. Specifically, the facility failed to have a process in place which ensured staff wore appropriate surgical attire in the perioperative area, bronchoscopes and endoscopes were hung according to manufacturer's instructions and food in the kitchen was properly labeled and stored with an use-by-date.

Findings include:

Policies:

According to the policy, Immediate Use Steam Sterilization (IUSS), IUSS will only be used in cases of defined emergency when no other option is available and there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Document cycle information and monitoring results including: the items processed, patient identification, type of cycle, cycle parameters, monitoring results, date and time of cycle and operator information.

According to the policy, Infection Prevention Policies Central Supply, the purpose of the policy is to prevent cross contamination. OR personnel are responsible for maintaining correct cleaning and sterilization procedures.

According to the policy, Philosophy and Organization of the Operating Room, infection control will be the responsibility of the entire hospital staff. One of the major concerns regarding the care of the patient in the operating room is the infection prevention.

According to the policy, Food Receiving, Storage, and Issuing, all goods will contain a label with the date opened or received, contents, and expiration date. Working containers holding food or food ingredients that are removed from their original packages for use the food establishment shall be identified with the common name of the food. Food stock will be rotated following the first in-first out method (FIFO). Shelf storage will be 6 inches above the floor and 18 inches below the ceiling.

According to the policy, Receiving Deliveries, check frozen foods to ensure that they are all frozen solid and show no signs of thawing and refreezing, such as the presence of large ice crystals or liquids. Check dates of milk, eggs, and other perishable goods to ensure safety and quality. Check the integrity of food packaging.

According to the policy, Quality Assurance (QA), a QA study will be conducted, at a minimum, yearly in the dining services department.

According to the policy, General Food Preparation and Handling, the kitchen and serving areas will be kept neat, clean, and orderly.

According to the policy, Surgical Attire, clean surgical attire, including scrub suits, shoes, head coverings, masks, jackets, and identification badges, will be work in semi restricted and restricted areas. Non-perioperative personnel entering semi restricted or restricted areas of the facility for a brief time for a specific purpose (e.g., law enforcement officers, parents, biomedical engineers) will cover all head and facial hair with a single-use head cover and don freshly laundered surgical attire or a single-sue gown. Masks in restricted areas stated all individuals entering restricted areas will wear a mask when open sterile supplies and equipment are present. Masks will cover the mouth and nose and be tied securely. All individuals who enter semi restricted and restricted areas will wear freshly laundered or single-use scrub attire provided by the facility and intended for use within perioperative areas. All personal clothing must be completely covered by surgical attire. Shoes worn within the perioperative environment must be worn exclusively at this facility and not worn outside without shoe coverings.

References:

According to the Olympus CYF-5 OES Cystonephrofiberscope manufacturer's guidelines for storage: Hang the endoscope in the storage cabinet with the distal end hanging freely. Make sure that the insertion tube hangs vertically and as straight as possible. The section: guidelines, warnings and cautions read, using improperly reprocessed or stored instruments may cause patient cross-contamination and an infection.

According to the Olympus BF Type Q180 Evis Exera II Bronchovideoscope manufacturer's guidelines, storage of the endoscope: Hang the endoscope in the storage cabinet with the distal end hanging freely. Make sure that the insertion tube hangs vertically and as straight as possible.

According to the Association of periOperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2017:

Recommendation VII.e.3. (page 873): Items processed using immediate use steam sterilization should be differentiated from items processed using terminal sterilization.

Recommendation VII.f.2. (page 873): Docuemantion of cycle information and monitoring results should be maintained in a log. Documentation of cycle information provides a means for tracking items that are processed using IUSS to individual patient and for quality monitoring.

Recommendation VII.g.1 (page 873): IUSS records should include information on each load, including: the items processed, the patient on whom the items were used, the type of cycle, the cycle parameters uses, monitoring results, the date and time the cycle was run, the operator information and the reason IUSS was used.

Recommendation IX (page 765): Flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination.

Recommendation IX.b. (page 765): Flexible endoscopes should be stored in accordance with the endoscope and storage cabinet manufacturer's IFU (instructions for use). Following the manufacturer's IFU helps ensure safe and effective storage of endoscopes.

Recommendation IX.c. (page 766): Flexible endoscopes that have been mechanically processed should be stored in a cabinet that is either designed and intended by the cabinet manufacturer for horizontal storage of flexible endoscopes or of sufficient height, width, and depth to allow flexible endoscopes to hang vertically, without coiling and without touching the bottom of the cabinet.

Recommendation III (Page 121), personnel entering the semi-restricted or restricted areas should cover the head, hair, ears and facial hair. The benefit of covering the head, ears, and hair is the reduction of patient 's exposure to potentially pathogenic microorganisms from the perioperative team member's head, hair, ears and facial hair. Proper surgical attire for the head to be: A clean surgical head cover or hood that confines all hair and completely covers the ears, scalp, skin, sideburns, and nape of the neck should be worn.

Recommendation II (Page 120), home laundering is not monitored for quality, safety or consistency. Home washing machines may not have the adjustable parameters or controls required to achieve the necessary thermal measures (e.g.. water temperature); mechanical measures (e.g.. agitation); or chemical measures (e.g.. capacity for additives to neutralize the alkalinity of the water, soap, or detergent) to reduce microbial levels in soiled scrub attire. Scrub attire that is home laundered may not be protected from contaminants in the environment during transport.

Recommendation I (Page 114), a fresh surgical mask should be donned before the health care worker performs or assists with each new procedure. The mask should be replaced and discarded whenever it becomes wet or soiled or has been taken down. Masks should not be worn hanging around the neck.

1. The facility failed to follow self-identified national standards for the sterile processing department. Specially, the facility failed to maintain a log of items, which had undergone immediate use steam sterilization (IUSS) and a way to track the items which had undergone IUSS back to the patient whom they had been used on.

a. According to the IUSS policy, IUSS will only be used in cases of defined emergency when no other option is available and there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Document cycle information and monitoring results including: the items processed, patient identification, type of cycle, cycle parameters, monitoring results, date and time of cycle and operator information.

According to AORN guidelines which were also national guidelines followed in the perioperative area according to the perioperative director, items processed using IUSS should be differentiated from items processed using terminal sterilization. Documentation of cycle information and monitoring results should be maintained in a log. Documentation of cycle information provides a means for tracking items that are processed using IUSS to individual patients and for quality monitoring. IUSS sterilization records should include information on each load, including the items processed, the patient on whom the items were uses, the date and time the cycle was run and the reason for IUSS.

b. On 2/5/19 at 10:34 a.m., a tour of the perioperative area was conducted with Surgical Technician (ST) #15. ST #15 stated the facility had two autoclaves for sterilization of instrumentation with separate sterilization record logs for each. ST #15 stated if immediate use steam sterilization occurred on instrumentation, it was done only in sterilizer #2. ST #15 stated the facility utilized IUSS, however, he stated there would be no indication on sterilizer #2's log to indicate which items had undergone IUSS and furthermore there would be no documentation of the patient on whom the items were used. ST #15 stated he had been at the facility for two years and did the sterilization process for the operating rooms, to include maintaining the sterilization logs.

c. On 2/7/19 at 10:00 a.m., a follow up interview was conducted with ST #15. ST #15 reviewed the surgical schedule from 8/1/18/2/5/19 and on review, ST #15 stated on days with cataract procedures there were typically 11-13 cases scheduled for those days.

Review of the surgical schedule from 8/1/18-2/5/19 revealed the following:

-On 8/22/18 there were nine cataract extraction with intraocular lens implantation (cataract) procedures scheduled between 9:00 a.m. and 1:00 p.m.
-On 9/13/18 there were 12 cataract procedures scheduled between 8:00 a.m. and 2:45 p.m.
-On 11/28/18 there were 14 cataract procedures scheduled between 8:00 a.m. and 4:00 p.m.
-On 1/23/19 there were 11 cataract procedures scheduled between 9:30 a.m. and 3:30 p.m.

Similar findings were found on 9/26/18, 10/11/18, 10/24/18.

After review of the surgical schedule, ST #15 stated IUSS had been used for the cataract instruments for those days.

On review of the sterilization record log with ST #15, he stated the facility had three cataract instrument trays for the facility but only used two of the three trays in case the physician needed an instrument and the other tray was processing, the staff would not have to wait.

ST #15 then reviewed sterilization log #2 from 12/1/17 to 2/7/19 and confirmed there was no documentation of IUSS for the cataract instrumentation despite IUSS being utilized. DT #15 then stated there would also be no way for staff to be able to trace the items which had undergone IUSS back the patient on whom they were used.

ST #15 then reviewed the manufacture instructions for the cataract tray. On review ST #15 stated he had confirmed with the manufacture the facility was using IUSS on the cataract trays.

ST #15 stated using IUSS increased the risk of infection for patients. ST #15 then stated having a log would allow staff if needed to trace items which had undergone IUSS to be tracked back to the person on whom they had been used. ST #15 stated he had been trained by the previous sterile processing technician and he had not be trained to identify instruments which had undergone IUSS or the need to identify the patient on whom the instruments had been used on.

d. On 02/07/2019 at 1:27 p.m., an interview was conducted with the perioperative Co-Director (Director #10). Director #10 reviewed the sterilization log from 12/1/17-2/7/19, the surgery schedule from 8/1/18-2/5/19. Further Director #10 reviewed AORN guidelines and the IUSS policy and stated IUSS was utilized at the facility but was not documented as such. Further Director #10 stated there was not process in place for staff to be able to track items which had undergone IUSS back to the patient on whom it had been used. Director #10 stated staff were expected to follow the guidelines and policy and was unsure why staff had not followed the guidelines and policy.

e. On 2/7/19 at 2:45 p.m. an interview was conducted with the Director of Nursing (DON) #4 who also functioned as the Infection Control RN. As the infection control RN she stated it was her responsibility to monitor for gaps in all department. DON #4 stated, however, she did not monitor for infection control gaps in the perioperative area. DON #4 further stated she has not done any infection control auditing of the perioperative department. DON #4 stated she did not oversee the perioperative area for infection control issues because she was not knowledgeable about the department and trusted staff would follow infection control standards on their own.





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2. The facility failed to follow manufacturer's instructions for the storage of endoscopes in a manner that would decrease the risk for contamination and infection.

a. On 2/5/19 at 10:34 a.m., a tour was conducted of Operating Room (OR) 2, with Surgical Tech #15. Observed hanging in a cabinet were four endoscopes. Two of the four endoscopes were cystoscopes, Olympus CYF-5 OES. The cystoscopes were observed hanging in the cabinet, draped across other hooks causing the scopes to have a loop, preventing the scopes from hanging freely. This was in contrast to the manufacturers instructions which stated the endoscope should be hung with the distal end hanging freely making sure the insertion tube hangs vertically and as straight as possible to prevention infection.

Also observed in the same cabinet was a bronchoscope, Olympus BF Type Q180, also noted to be draped across another hook causing the scope to have a loop, preventing the scopes from hanging vertically. This was against manufacturers instructions which stated the bronchoscope must be stored vertically and as straight as possible.

b. On 2/5/19 at 2:27 p.m., an interview was conducted with Surgical Tech #15. Surgical Tech #15 confirmed the Olympus CYF-5 scopes and the Olympus BF Type Q180 were looped in the cabinet and not hanging vertically as directed by the manufacturer's guidelines. Surgical tech #15 explained the reason scopes should hang without loops was to prevent fluid from being trapped in the bend of the scope. Surgical Tech #15 stated it was important to prevent fluid from pooling in the loops because this could cause a risk of infection to patients.

c. On 2/7/19 at 2:45 p.m. an interview was conducted with the Director of Nursing (DON) #4 who also functioned as the Infection Control RN for the facility. As the infection control RN she stated it was her responsibility to monitor for gaps in all department. DON #4 stated, however, she did not monitor for infection control gaps in the perioperative area, to include the decontamination area. DON #4 further stated she has not done any infection control auditing of the perioperative department. DON #4 stated she did not oversee the perioperative area for infection control issues because she was not knowledgeable about the department and trusted staff would follow infection control standards on their own.

3. The facility failed to ensure food throughout the kitchen was identified, labeled, and dated with expiration or use by dates. Further, the facility failed to develop and use a consistent process for kitchen staff to ensure food was labeled and safe to serve to patients.

a. On 2/5/19 at 9:30 a.m., a tour of the kitchen was conducted with the Kitchen Supervisor (Supervisor #6). Inspection of the refrigerator revealed the following expired food items: five loaves of expired bread with the expiration dates from 12/12/18 - 1/26/19.

Additional inspection of the refrigerator revealed the following food items with mold growing within the containers, and no label to indicate when food had been received or a use by date: one container of blueberries, eight containers of blackberries, one package of discolored grapes.

Also noted within the refrigerator: apples, oranges, broccoli, spinach, and celery with no label to indicate when the items were received or a use by date.

Additionally stored within the refrigerator was an opened bottle of mayonnaise indicating it had been opened on 12/15/18.

b. An interview was conducted with Supervisor #6 on tour. Supervisor #6 stated the mayonnaise should have been discarded after one month on 1/14/19 (21 days prior to the kitchen tour). However, mayonnaise remained available for use. Supervisor #6 additionally stated he was responsible for checking food items every morning, however he could provide no documentation of the process.

Inspection of the freezer revealed the following food items with no expiration or use by date written on them: Carrots, peas, squash, ham steak and pork chops. Additionally, the pork chops were noted to have ice crystals on the meat.

An interview was conducted with Cook #7. When asked how long steak was good for once it was placed in the freezer, Cook #7 stated three to six months.

An interview was conducted with Supervisor #6. When asked how long steak was good for once it was placed in the freezer, Supervisor #6 stated I don't know, a month.

During the tour an interview was conducted with Cook #7. Cook # 7 stated the dietary department did not have any guidelines to follow regarding the storage and handling of food. Cook #7 stated staff just knew when food was safe for consumption. Cook #7 stated she had taken a test and had a certificate which made her competent to handle the food.

c. Inspection of the dry storage area revealed the following food items with no expiration or use by date written on them: Kluski noodles, penne pasta, macaroni pasta, whole wheat flour, vanilla wafers, croutons, powdered sugar, bread crumbs, a container of sugar, and a container of flour. Additionally, the following items were located on the floor in a crate with holes: Gluten free rice flour, bagels, one package of opened spaghetti pasta, and an opened bag of gluten free flour. Also noted in the dry storage area was an opened package of whole wheat flour with no date to indicate when it had been opened.

An interview was conducted with Supervisor #6. Supervisor #6 stated the whole wheat flour belonged to an employee and had been in the dry storage area for several days. Supervisor #6 additionally stated the employee's whole wheat flour should not have been stored with the patient food items.

d. During the tour an interview was conducted with Supervisor #6. Supervisor #6 stated the dietary department did not have any guidelines to follow regarding the storage and handling of food. Supervisor #6 also stated staff just knew when food was safe for consumption. Supervisor #6 stated he also had a certificate which made him competent to handle food. Supervisor #6 additionally stated staff should have labeled food items and use the first in first out method for food storage.

e. On 2/7/19 at 2:40 p.m., an interview was conducted with the Director of Nursing (DON #4). DON #4 stated she was also the Infection Control Nurse for the facility. DON #4 stated as the Infection Control Nurse she did not provide any oversight for dietary services. DON #4 stated she was not familiar with the regulations surrounding food handling and storage, therefore she did not monitor the dietary services department. DON #4 further stated improper handling of food could create a potential for infections such as salmonella and hepatitis A. However, DON #4 stated she did not provide infection control oversight of dietary serves. DON #4 additionally stated probably no one provided infection control oversight to the department. DON #4 also said she would defer all questions to the Kitchen Supervisor.

f. On 2/7/19 at 1:46 p.m., an interview was conducted with the Quality and Risk Director (Director #12). The dining services policy for Quality Assurance (QA) was reviewed with Director #12 which stated a QA study was to be conducted, at a minimum, yearly in the dining services department. Director #12 stated she was unaware of the policy and the QA study had not been done, further she was unsure who was responsible for conducting the study.

4. The facility failed to ensure surgical attire was worn according to nationally recognized standards chosen to be followed by the facility.

a. On 2/6/19 at 7:04 a.m., surgical tracer observation was performed of Patient #23, who had a tonsillectomy and adenoidectomy surgery. The Certified Registered Nurse Anesthetist (CRNA #8) was observed in operating room (OR) #1 with his mask around his neck, with his mouth and nose exposed, when sterile instrumentation necessary for the surgery was opened and exposed for patient use.

On 2/6/19 at 7:33 a.m., the Pharmacy Coordinator Nurse (RN #9) was observed in OR #1 wearing a yellow isolation gown working on the anesthesia computer. Observed were black dress pants exposed from under the yellow isolation gown. Additionally, RN #9's mask was down, around her neck, with her mouth and nose exposed while sterile instrumentation necessary for the surgery was opened and exposed for patient use. RN #9 was then observed leaving OR #1 with her mask around her neck. A red line to denote the sterile area from the non-sterile area was visualized on the floor of the OR hallway in the sterile corridor. RN #9 while still in the sterile corridor directly outside of OR #1, removed her isolation gown, hat (hair cover), and shoe covers exposing her "street clothes" - black dress pants and a gray and yellow cardigan while in the sterile area.

b. On 2/7/19 at 10:13 a.m. an interview was conducted with OR Registered Nurse (RN #11). RN #11 stated the process for putting on proper surgical attire prior to entering the OR was to change clothes from "street clothes" or your clothes from home in the locker room prior to walking into the sterile corridor of the OR. RN #11 stated the sterile corridor was identified by a red line on the ground in the hallway leading to the operating room suites which indicated to personnel they were entering the sterile corridor.

RN #11 stated the following surgical attire was required for all personnel prior to stepping across the red line into the sterile corridor: hospital laundered scrubs, shoe covers, and a hat. RN #11 stated she was unaware of any hospital approved disposable gowns or suits available for use at the facility. RN #11 also stated staff was required to wear laundered attire provided by the facility for the purpose of infection control to ensure staff did not bring any germs from the outside environment into the sterile environment that may cause an increased risk for infection such as pet hair.

Additionally, RN #11 stated OR staff have shoes specific to the OR. RN #11 stated staff were not to wear shoes from home while in the sterile corridor or in the OR. RN #11 stated the purpose of this was because shoes from the outside carry unknown contaminants which could create a risk for infection. RN #11 further stated if OR shoes are unavailable staff should have shoe covers on over their shoes.

RN #11 stated personnel were also required to have a hat on prior to entering the sterile corridor. RN #11 stated this was important because hair may fall out onto the sterile field which would be unsafe for surgical patients.

RN #11 stated all staff were required to wear a mask when sterile instruments were opened in the OR. This applied to all staff, providers, and visitors or vendors. RN #11 stated the purpose of wearing a mask in the OR was to ensure germs were not transferred from staff to an open surgical area through activities such as talking. RN #11 explained that even when talking, droplets may fly out of your mouth and onto a patient or sterile instruments. RN #11 also explained sneezing unexpectedly could contaminate the sterile environment without a mask as a barrier.

c. On 2/7/19 at 1:35 p.m., an interview was conducted with the OR Co-Director (Director #13. Director #13 stated the facility followed AORN guidelines. Director #13 stated AORN provided guidance that masks should be worn in the OR when sterile instruments were opened for patient use. Director #13 further explained there was a red line in the OR corridor to help staff understand when surgical attire was required. Additionally, Director #13 stated anyone past the red line was required to have a hat, beard covers, hospital scrubs, and shoe covers. Director #13 stated it was not appropriate to wear outside clothing in the OR.

d. On 2/7/19 at 2:45 p.m. an interview was conducted with the Director of Nursing (DON) #4 who also functioned as the Infection Control RN for the facility. As the infection control RN she stated it was her responsibility to monitor for gaps in all department. DON #4 stated, however, she did not monitor for infection control gaps in the perioperative area. DON #4 stated she did not oversee the perioperative area for infection control issues because she was not knowledgeable about the department and trusted staff would follow infection control standards on their own.

Based on observation, interviews, and document review, the facility failed to administer medications in accordance with physician written orders (Patient #10).

Findings include:

Policies:

According to the policy, Medication Administration General Guidelines, before the medication is administered the five rights are adhered to: the right patient, the right drug, the right dose, the right time, the right route. Staff must verify the medication selected is the correct one based on the medication order and product label.

According to the policy, Medication Administration Scanning by Barcode, all nursing staff administering medications will follow the policy. All patients and medications will be scanned unless delay will impact patient outcome.

1. Based on observation, interviews, and document review, the facility failed to ensure patient #10's medication were administered in accordance with the physicians written orders.

a. On 2/5/19 at 0732 an observation of a medication administration process was observed on the inpatient unit with student nurse (SN) #16, and registered nurse (RN) #17. SN #16 and RN #17 were observed checking intravenous (IV) compatibility, in a drug reference guide, for a medication that was to be administered, Toradol, with IV fluid lactated ringers (LR), which was ordered by the provider for Patient #10. RN #17 directly observed the medication administration process with SN #16. SN #16 then gave IV Toradol (a medication for pain) to Patient #10 through Patient #10's IV fluid line, SN #16 and RN #17 were not observed verifying the IV fluid infusing continuously through Patient #10's IV prior to giving IV medication.

Following the medication administration, normal saline (NS) was observed infusing continuously through Patient #10's IV line which was in contrast to what RN #17 and SN #16 had stated, that lactated ringers had been infusing.

Upon leaving Patient #10's room an interview was conducted with RN #17. RN #17 stated LR had been infusing for Patient #10 continuously at a rate of 125 ml/hr (milliliters per hour) at the time of IV medication administration. Additionally, an interview was conducted with SN #16. SN #16 also stated LR was infusing at the time she administered IV Toradol and she was sure because she had looked at the IV fluid when she entered the room.

Upon returning to Patient #10's room with RN #17 and SN #16, both confirmed NS was infusing at 125 ml/hr. RN #17 stopped the infusion of NS and left the room with SN #16 to retrieve the correct physician ordered LR IV fluid.

b. On 2/5/19 at 7:32 a.m. an interview was conducted with RN #17. RN #17 reviewed Patient #10's electronic medical record and verified LR had been ordered at a rate of 125 ml/hr. RN #17 stated it had been documented as initiated at 2:55 a.m. that morning. RN #17 also stated IV fluid was supposed to be scanned with the barcode scanner like all other medications given to patients to prevent medication errors from occurring. RN #17 also stated this was done as a triple check to verify the right medication was being administered. RN #17 stated this was part of the 5 rights of medication administration.

c. On 2/6/19 at 3:00 p.m., an interview was conducted with the pharmacy coordinator nurse (RN #9). RN #9 stated if nurses did not scan medications prior to administering them it places put the patient at risk for a medication error. RN #9 additionally stated along with ensuring the five rights of medications administration, scanning medications can prevent errors from occurring and barcode scanning should be done with all medications including IV fluids to prevent errors from occurring. RN #9 explained it was important to ensure the patient was receiving what the physician ordered because each IV fluid had different components and you wouldn't want to administer the wrong fluids. RN #9 explained this was important for patient safety.

Based on interviews and document review, the facility failed to ensure patients received a complete anesthesia evaluation by the Certified Registered Nurse Anesthetists (CRNA) immediately prior to surgery to evaluate the risk of anesthesia in 7 of 8 medical records reviewed in which the patient required anesthesia (Patient #4, #7, #8, #10, #18, #23, and #24).

Findings include:

Policy:

According to the policy, Medical Record Guidelines for Physicians, the provider/practitioner who treats the patient shall have the ultimate responsibility for documenting and authenticating the care rendered. The provider is responsible for the accuracy of all documentation entered, including imported and pasted information. Providers documenting in the electronic health record (EHR) must avoid indiscriminately copying and pasting documentation from other parts of the applicable patient's records. Documentation in the medical record must be specific to each patient encounter. Cloned/Copied/Pasted documentation may be considered a misrepresentation of the patient condition and can lead to potential patient safety concerns and financial sanctions to the facility. Copying or cloning documentation may be acceptable when it is: based on verifiable sources such as demographic data such to include the patient name or DOB. If the provider uses information from a prior note, he/she must reference the date of the previous note or original source.

Providers are responsible for clearly identifying who performed each service
documented within the note. When copying patient data into the medical record that
the provider did not personally take or test, the provider must attribute the information to the person who did it, unless it is readily apparent, based upon the nature of the information copied, that the data was entered by another provider (as it occurs automatically when using the tagging functionality in Cerner Dynamic Documentation).

If the provider references a form within the record, he/she must reference the form
with sufficient detail to uniquely identify the source. Example: "for review of systems,
see form dated 6/1/13."

References:

According to the American Association of Nurse Anesthetists (AANA), Standards for Nurse Anesthesia Practice, the preanesthesia assessment and evaluation record, under required: listed a physical examination to include: Cardiac examination, and pulmonary examination.

The AANA, Preanesthesia Assessment and Evaluation Record, also stated the preanesthesia assessment and evaluation record documented the patient demographics, height and weight, vital signs, allergies and medication history, health history and review of systems, physical examination, relevant diagnostic test results, physical status designation, and anesthesia plan of care.

1. The facility failed to ensure patients received a complete anesthesia evaluation by the CRNA immediately prior to surgery to evaluate the risk of anesthesia in 7 of 8 medical records reviewed in which the patient required anesthesia (Patient #4, 7, 8, 10, 18, 23, 24).

a. Review of Patient #18's Medical Record revealed the patient was a 67 year old male who was admitted to the facility on 11/12/18 for knee irrigation and debridement. On 11/12/18 at 2:41 p.m. the anesthesia pre-operative (pre-op) note revealed anesthesia planned for Patient #18 to undergo general anesthesia (a combination of medications that were intended to make the patient unaware of what was happening around them to prevent pain and to paralyze the body during a procedure). This required Patient #18 to be intubated (the process of inserting a tube, called an endotracheal tube, through the mouth and then into the airway; this was done so the patient could be placed on a ventilator to assist with breathing during anesthesia). Review of the Physical Examination within the anesthesia pre-op note revealed no documentation that a physical exam had been conducted by CRNA #8 prior to the procedure, including listening to the patient's heart and lungs.

Additional review of Patient #18's Medical Record revealed the patient also had a history of obstructive sleep apnea (a condition in which breathing repeatedly stops and starts during sleep), atrial fibrillation (a quivering or irregular heartbeat), hypertension (elevated blood pressure), and long term use of anticoagulants (blood thinning medications). Despite Patient #18's past medical history there was no physical examination of the patient's heart and lungs documented by an anesthesia provider.

b. Review of Patient #24's medical record revealed the patient was a 91-year-old female who was admitted to the facility on 9/16/18 following a fall down stairs. Patient #24 sustained a cervical (neck) fracture, humerus (upper arm) fracture, and a distal radius and ulna (wrist) fracture. Patient #24 subsequently had surgery to repair the wrist fracture during the hospital admission.

On 9/17/18 at 3:31 p.m., the anesthesia pre-op note revealed anesthesia planned for Patient #24 to undergo general anesthesia, which required intubation. Review of the Physical Examination within the anesthesia pre-op note revealed no documentation that a physical examination had been conducted by the certified registered nurse anesthetist (CRNA #8) prior to the procedure, including listening to the patient's heart and lungs.

c. Review of Patient #23's Medical Record revealed the patient was a 2 year old female who was admitted to the facility on 2/6/19 for tonsillectomy and adenoidectomy. On 2/6/19 at 7:41 a.m. the anesthesia pre-op note revealed anesthesia planned for Patient #23 to undergo general anesthesia which required intubation. Review of the Physical Examination within the anesthesia pre-op note revealed no documentation that a physical examination had been conducted by CRNA #8 prior to the procedure, including listening to the patient's heart and lungs.

d. Review of Patient #4's Medical Record revealed the patient was a 53 year old male who was admitted to the facility on 2/4/19 for hip surgery. On 2/4/19 at 7:40 a.m. the anesthesia pre-op note revealed anesthesia planned for Patient #4 to undergo general anesthesia which required intubation. Review of the Physical Examination within the anesthesia pre-op note revealed no documentation that a physical examination had been conducted by CRNA #8 prior to the procedure, including listening to the patient's heart and lungs.

e. Similar findings were noted in Patient #7, #8 and #10's medical record review.

f. On 2/6/19 at 2:11 p.m. an interview was conducted with Certified Registered Nurse Anesthetist (CRNA) #8. CRNA #8 stated all patients who have anesthesia, whether they are receiving an epidural (anesthetic injected close to the spinal cord which causes the entire lower half of the body to feel numb) for labor and deliver, or a total hip replacement, receive an anesthesia assessment prior to surgery. CRNA #8 stated the reason for performing an anesthesia assessment prior to surgery was to plan for the appropriate form of anesthesia, ensure the patient was safe, and he was prepared for any unplanned events. CRNA #8 stated he looked through the patient's medical record to have a basic understanding of the patient, he then spoke to the patient regarding allergies, prior surgeries, past medical history, smoking and alcohol history, and an anesthesia plan. CRNA #8 explained he did not routinely assess the heart, and lung sounds of a patient himself because "the registered nurse (RN) did this" function prior to surgery, and occasionally the surgeons assessed the heart and lung sounds prior to surgery.

This was in contrast to facility policy which stated the provider/practitioner who treats the patient shall have the ultimate responsibility for documenting and authenticating the care rendered. Documentation in the medical record must be specific to each patient encounter. Cloned/Copied/Pasted documentation may be considered a misrepresentation of the patient condition and can lead to potential patient safety concerns and financial sanctions to the facility.

CRNA #8 stated he did not perform a physical examination on Patient #23. CRNA #8 stated he watched her take her medications and watched her breath, but did not listen to heart or lung sounds. CRNA #8 also stated he did not physically examine the patient.

CRNA #8 stated he followed the American Association of Nurse Anesthetist (AANA) and they provided the guidelines on preoperative anesthesia assessments, and physical examinations.

g. On 2/7/19 at 9:10 a.m. a follow up interview was conducted with CRNA #8. CRNA #8 provided AANA guidelines which he stated he followed for the patient pre-operative assessments. CRNA #8 stated for a cardiac and pulmonary exam he looks at the patient's vital signs documented by the RN staff, which included the heart rate, pulse oxygenation saturation, and an electrocardiogram (measures the patient's electrical activity of the heart) if done.

This was in contrast to the AANA Preanesthesia Assessment and Evaluation Record guidelines which stated, the preanesthesia assessment and evaluation record documents patient demographics, height and weight, vital signs, allergies and medication history, health history and review of systems, physical examination, relevant diagnostic test results, physical status designation, and anesthesia plan of care.

Additionally, AANA provides a template titled Preanesthesia Evaluation which lists in addition to the assessment: vital signs, heart rate, pulse ox and EKG under the section titled, Pre-Procedure Vital Signs, and Diagnostic Studies.

h. On 2/7/19 at 8:39 a.m., an interview was conducted with The Chief of Staff (Physician) #14. Physician #14 stated she felt it was important for anesthesia to assess a patient prior to a procedure so they would know if there had been any changes in the patient's medical condition. Physician #14 stated a cardiac and pulmonary exam would include listening to a patient's heart and lungs.

Based on interview, and document review, the facility failed to ensure the required community based risk assessment for the facility's emergency preparedness plan was conducted.

References:

According to the facilities 2019 emergency operations plan (EOP), which was provided by the chief clinical officer, the primary objective of the EOP was to maintain continuity of patient care operations, access to patient care, and meet the medical needs of our patients and the community during an emergency situation.

Findings include:

1. The facility failed to ensure a community based risk assessment was conducted as part of the emergency preparedness program.

a. On 2/11/19 at 4:12 p.m., an joint interview was conducted with Registered Nurse (RN) #5 who was the facilities emergency preparedness coordinator and the Chief Operating Officer (CCO #1). A review of the emergency preparedness (EP) program and EP documentation was conducted with RN #5. Upon review, RN #5 stated she had not done a community based risk assessment. RN #5 stated she had been working to develop the EP program at the facility but had overlooked the required community based risk assessment during her development. RN #5 also stated it was important to understand the population the facility served and a community based risk assessment was important because the hospital needed to understand the emergency risks in the community and be prepared if those risks occurred.