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Based on observations, interviews and document review, the facility failed to ensure patient care equipment was maintained according to manufacturer's instructions.

This failure created the potential for patient harm due to the facility's inability to ensure patient care equipment was maintained and safe for patient use.

FINDINGS

POLICY

According to the policy, Cleaning of the Hydrocollator, the Hydrocollator will be cleaned once a month or more often if needed, to maintain cleanliness of hot packs. Chart on date of cleaning and temperature.

REFERENCE

According to the Service Manual Sigma International Model Spectrum Infusion Pump, pumps should be tested for proper performance annually and whenever damage from drop, fluid intrusion and other causes is suspected.

According to Hydrocollator Heating Units User Manual, the tank should be drained cleaned and inspected at minimum intervals of every two weeks.

According to ReVel Ventilator Operator's Manual, The oxygen inlet filter has a small cone which is an integral part of the oxygen inlet connector, should be replaced by a service technician trained and certified by CareFusion as part of regularly scheduled maintenance.

Daily maintenance schedule includes the following: verify alarms are working properly, check the Air Inlet Filter and replace if soiled, check the Cooling Fan Filter, clean if necessary, replace if damaged or worn.

Routine testing should be performed a minimum of once a month: Button test, Vent Inop Alarm test, External power disconnect test, disconnect power and removable battery pack test, verify the Vte or VE monitor, verify the Airway Pressure or PIP monitor, verify the delivered o2 concentration.

1. The facility failed to perform preventative maintenance (PM) on patient care equipment according to manufacturer's recommendations.

a) On 11/27/17 at 4:15 p.m., a tour was conducted of the Emergency Room (ER). During the tour it was observed the Sigma Spectrum intravenous (IV) pump did not have a PM sticker to provide proof of PM. A Revel transport ventilator was also observed to be missing a PM proof sticker.

On 11/27/17 at 4:25 p.m., during tour of the Obstetric Unit or birthing room, it was observed a second Sigma Spectrum IV pump was missing a PM proof sticker.

b) On 11/28/17 at 10:45 a.m., a tour of the Outpatient Therapy unit was performed. On the tour with Director #13, the Hydrocollator (a machine that maintains a constant set temperature for heating pads) was discussed. Director #13 stated that Hydrocollator was cleaned monthly as well as temperature monitoring. Review of the Hydrocollator policy also indicated routine cleaning was performed monthly. This was in contrast to the manufacturer's instructions.

c) On 11/30/17 at 12:27 p.m., the preventive maintenance (PM) log was provided. Review of this log verified the PMs were not completed for the identified IV pumps and transport ventilator.

d) Review of the Hydrocollator log, dated 2017, showed staff performed monthly cleaning as well as monthly temperature monitoring. There was no evidence which showed staff followed the manufacturer's instructions for biweekly cleaning.

e) On 11/29/17 at 2:05 p.m., an interview with Director #20 was conducted. Director #20 stated that daily ventilator checks were performed in the ER by transport staff. Director #20 also stated there were no logs kept for proof of daily or monthly checks. Director #20 further stated s/he did not know for sure checks were being completed, since there were no logs maintained.

f) On 11/29/17 at 2:10 p.m., an interview with the Director of Nursing (DON) #1 was conducted. DON #1 stated the reasoning to perform PM was to ensure equipment was working properly. DON #1 stated the IV pumps were used regularly for patient care.

Based on the manner and degree of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation, §485.635 Provision of Services was out of compliance.

C-0276- Patient Care Policies: Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. The facility failed to ensure outdated medications were removed from stock according to manufacturer's expiration. This failure created the potential for patients to receive compromised or expired medications

C-0278 - Patient Care Policies: A system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. The facility failed to maintain a sanitary environment in 1 of 1 patient case tracers (Patient #26) conducted, with the lack of infection control processes in the area of hand hygiene, disinfecting the rubber septum of intravenous (IV) medications and wearing Personal Protective Equipment (PPE).
These failures created the risk for staff and patient exposure to bacteria that had the potential for negative outcomes such as healthcare associated infections.

C-0282- Patient Services: The CAH provides basic laboratory services essential to the immediate diagnosis and treatment of the patient that meet the standards imposed under section 353 of the Public Health Service Act (42 U.S.C. 236a). (See the laboratory requirements specified in part 493 of this chapter.) The services provided include the following: (iii) Blood glucose. Tthe facility failed to provide blood glucose monitoring in a manner which met the manufacturer's specifications. This failure created a potential for inaccurate lab values.

C-0283- Patient Services: Radiology services furnished by the CAH are provided by personnel qualified under State law, and do not expose CAH patients or personnel to radiation hazards. The facility failed to ensure radiology equipment was inspected and maintained in accordance with State laws. This failure resulted in potential exposure of staff and patients to harmful radiation.

C-0294 - Nursing Services: Nursing services must meet the needs of patients. (1) A registered nurse must provide (or assign to other personnel) the nursing care of each patient, including patients at a SNF level of care in a swing-bed CAH. The care must be provided in accordance with the patient's needs and the specialized qualifications and competence of the staff available. The facility failed to ensure nursing staff met the needs of the patient and followed established protocols to prevent skin breakdown in 1 of 30 patient records reviewed (Patient #3). This failure potentially resulted in pressure injuries.

C-0297- Nursing Services: All drugs, biologicals, and intravenous medications must be administered by of under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal law. The facility failed to ensure verbal orders were signed and verified by the ordering physician in 3 of 30 medical records reviewed (Patients #6 and #15). This failure resulted in the potential for patient orders to be administered without the supervision of an authorized ordering provider.

Based on observation and interviews, the facility failed to ensure outdated medications were removed from stock according to manufacturer's expiration.

This failure created the potential for patients to receive compromised or expired medications.

FINDINGS

POLICY

According to the policy, Checking Outdated Medications, it is the responsibility of nursing to personnel to do monthly checks of the Emergency room, the birthing room, and the medication room at Nurse's Station. Nursing personnel will check out dates and take outdated medication from the above departments and replace the medication with in-date medication.

According to the policy, Multiple Dose Medication Vial Expiration, multiple dose medication vials (except for multi-dose vial vaccinations) will be dated and initialed with permanent marker when opened and discarded after 28 days of use.

REFERENCE

According to CDC (Centers for Disease Control), Frequently Asked Questions (FAQ) 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 ensure outdated medications were removed and not available for patient use.

a) On 11/27/17 at 3:45 p.m., a tour of the Emergency Room, with the Director of Nursing (DON #1), revealed several multidose intravenous (IV) medications which were opened and outdated according to the CDC guidelines. As example:

Lidocaine HCL 1% and Epinephrine with a written date of 09/03/17
Marcaine 0.5% 250 milligram (mg)/50 milliliter (ml) with a written date of 10/20/17
Marcaine 0.25% 125 mg/50 ml with epinephrine with a written date of 10/20/17

Director of Nursing (DON) #1 stated the date written on the bottle indicated the date opened. DON #1 also stated multidose bottles were usable for 30-60 days after opened, dependent on medication. This was in contrast to facility policy.

A tour of the Obstetrical (OB) room, also referred to as the birthing room, revealed several medications that were past the manufacturer's printed expiration date. As example:

1 bag of 0.9% Sodium Chloride 100 ml expired 12/2016
6 vials Magnesium Sulfate 50% 1 gm/2 ml expired 10/2016

A tour of the nurse's station on 11/30/17 at 10:30 a.m. revealed an open multidose vial of Humulin R insulin with a written date of 10/22/17.

b) A patient tracer in the operating room (OR) was conducted on 11/30/17 at 9:11 a.m. An inspection of the anesthesia cart showed an opened multidose vial of Labetalol 20 mg/100 mL with a written date of 05/02/17. Certified Registered Nurse Anesthetist (CRNA) #4 stated the Labetalol would have to be discarded.

c) On 11/30/17 at 11:36 a.m., an interview with Registered Nurse (RN) #2 was conducted. RN #2 stated all multidose vials were usable for 28 days once opened. RN #2 also stated the night shift RN was supposed to inspect medication expiration dates every month, but did it weekly instead. RN #2 further stated the reason not to use a medication after it had been opened for 28 days was that there was no assurance the medication was still effective. RN #2 also stated the facility had a policy related to multidose vials.

d) On 11/30/17 at 12:27 p.m., an interview with DON #1 was conducted. DON #1 stated that disposing of multidose vials after 28 days of being accessed was the normal practice in facility. DON #1 stated that the pharmacy consultant instructed them to dispose of multidose vials after 28 days of opening. DON #1 further stated that values could be skewed if multidose vials were not discarded after 28 days of opening.

e) On 11/30/17 at 1:40 p.m., an interview with CRNA #4 and the Chief Nursing Officer (CNO #3) was conducted. CRNA #4 stated s/he thought multidose vials should be discarded 30 days after opening. CRNA #4 further stated the reason to discard vials 30 days after opening would be a possible decrease in potency or effectiveness. Both CRNA #4 and CNO #3 stated there was also a possibility of an increased infection risk if multidose vial medications were administered after the discard date.

Based on observation, interviews and document review, the facility failed to maintain a sanitary environment in 1 of 1 patient case tracers (Patient #26) conducted, with the lack of infection control processes in the area of hand hygiene, disinfecting the rubber septum of intravenous (IV) medications and wearing Personal Protective Equipment (PPE).

These failures created the risk for staff and patient exposure to bacteria that had the potential for negative outcomes such as healthcare associated infections.

FINDINGS

POLICY

According to the policy, IV Therapy-IV Admixtures, wash hands and gather supplies, the attachment site must be cleaned with alcohol for 15 seconds prior to the tubing being secured.

According to the policy, Infection Control-Infection Prevention Program Overview, prevention of the spread of infections is accomplished by use of Standard Precautions and other barriers. Staff and patient education focuses on risk infection and practices to decrease risk.

REFERENCE

According to CDC (Centers for Disease Control) recommended guidelines, When and How to Perform Hand Hygiene, hand hygiene should be done:

Before eating
Before and after having direct contact with patients intact skin.
After contact with body fluids or excretions, mucous membranes, non-intact skin and wound dressings.
After contact with inanimate objects in the immediate vicinity of the patient.
If hands will be moving from a contaminated-body site during patient care.
After glove removal.
After using a restroom.

According to the CDC recommended guidelines, Frequently Asked Questions - Sterilization - Cleaning, instruments should be handled as though contaminated until processed through the sterilization cycle. To avoid injury gloves should be worn. Because splashing is likely to occur, they should also wear a facemask, eye protection or face shield, and gown or jacket.

1. The facility failed to ensure all clinical care team members adhered to hand hygiene practices.

a) On 11/30/17 at 07:45 a.m., a cataract removal surgical tracer was observed for Patient #26. Certified Registered Nurse Anesthetist (CRNA) #4 was observed entering patient #26's room without performing hand hygiene. CRNA #4 placed a stethoscope to Patient #26's chest, then left the room without performing hand hygiene. CRNA #4 then re-entered Patient #26's room without performing hand hygiene, donned gloves and inserted an IV after 2 attempts. CRNA #4 then removed gloves and left Patient #26's room. No hand hygiene was done according to infection control guidelines after direct contact with the patient's skin during IV insertion.

At 8:50 a.m., Patient #26 was taken to the Operating Room (OR) by Chief Nursing Officer (CNO) #3. CNO #3 donned gloves and repositioned the patient. CNO #3 then removed his/her gloves and then donned sterile gloves without performing hand hygiene and proceeded to clean Patient #26's operative eye (right eye). CNO #3 then removed the sterile gloves and discarded the used supplies with his/her bare hands. CNO #3 did not perform hand hygiene after providing direct patient care and glove removal.

At 9:11 a.m., CNO #3 donned gloves (no hand hygiene) and administered eye drops to Patient #26's right eye and then removed the gloves without performing hand hygiene.

b) On 11/30/17 at 12:27 p.m., an interview with the Director of Nursing (DON#1) was conducted. DON #1 stated the facility utilized Centers for Disease Control (CDC) for guidelines for standards of practice.

c) On 11/30/17 at 1:40 p.m., an interview with CRNA #4 and CNO #3 was conducted. After review of the observations conducted in Patient #26's room, earlier on 11/30/17, CRNA #4 stated s/he knew it was expected to perform hand hygiene every time going in or out of a patient room.

CNO #3 stated s/he was unsure if facility had an infection control policy. CNO #3 further stated s/he was not sure if the facility followed a certain organization's guideline for standards of practice, and that s/he would just follow the facilities policy for infection control.

After review of the observations conducted in the OR, CNO #3 stated s/he was unaware s/he had not performed hand hygiene.

2. The facility failed to follow standardized practices to prevent infection when removing medication from a vial and administering IV medications.

a) On 11/30/17 at 07:45 a.m., a cataract removal surgical tracer was observed for Patient #26. At 8:54 a.m., CRNA #4 administered Patient #26 IV Versed (a sedative to relax or make sleepy). CRNA #4 did not disinfect the patient's IV connection prior to administering medication. This was in contrast to policy.

At 9:00 a.m., CNO #3 was asked by the surgical technician for Lidocaine. CNO #3 removed the IV Lidocaine vial from his/her scrub pocket. S/he then removed the plastic cap from the medication vial and immediately pierced the medication with a needle. CNO #3 did not disinfect the rubber septum on the bottle. The medication was then administered to the patient by the surgical technician.

b) On 11/30/17 at 1:40 p.m., an interview with CRNA #4 was conducted. CRNA #4 stated that ideally s/he should have disinfected the connection to administer the Versed for 15 seconds with an alcohol wipe prior to administering medication. CRNA #4 went on to state the rubber septum of a medication vial should be disinfected after plastic cap was removed because it was not an airtight cover and not sterile. CRNA #4 further stated the reasoning to disinfect both the IV connection and rubber septum would be due to potential for bacteria and germs to accumulate in those areas.

3. The facility failed to ensure sterile processing staff wore PPE and maintained a sanitary environment during processing of instruments.

a) On 11/30/17 at 10:30 a.m., Sterile Processing Technician (SPT) #8 was observed cleaning and sterilizing instruments used on Patient #26 during the cataract tracer conducted earlier the same day. SPT #8 did not wear eye protection, face shield or gown according to the CDC infection control guidelines while removing the contaminated debris from the surgical instruments.

b) On 11/30/17 at 11:11 a.m., an interview with SPT #8 was conducted after SPT was observed cleaning and sterilizing instruments. SPT #8 stated PPE was provided for him/her. SPT #8 went on to state that s/he usually wore a gown, and mask when cleaning contaminated equipment.

c) On 11/30/17 at 1:40 p.m., an interview with CNO #3 was conducted. CNO #3 stated s/he monitored SPT #8's sterilization logs and process. CNO #3 stated SPT #8 should have been wearing gloves, eye protection and a gown during cleaning of contaminated instruments to prevent personal contamination or soap suds splashing into eyes. CNO #3 stated there was never a time that PPE should not have been worn while cleaning instruments.

Based on observations and interviews, the facility failed to provide blood glucose monitoring in a manner which met the manufacturer's specifications.

This failure created a potential for inaccurate lab values.

FINDINGS

REFERENCE

According to Evencare G2 Blood Glucose Test Strips manufacturer's instructions, use within 6 months after first opening.

According to Evencare G2 Blood Glucose Control Solutions manufacturer's instructions, discard any unused control solution 90 days after first opening or after expiration date.

1. The facility failed to ensure that glucose control strips and test solution were not outdated.

a) On 11/27/17 at 3:45 p.m., a tour of the Emergency Room (ER) was conducted. During this tour the following items were observed without a date which indicated when the items were open:

One Evencare G2 blood glucose low control solution bottle was open and not dated.
One Evencare G2 blood glucose high control solution bottle was open and not dated.
One Evencare G2 blood glucose test strips bottle was open and not dated.

On 11/30/17 at 10:30 a.m., a tour of the nurse's station was conducted. During this tour it was observed that the following items were not dated:

One Evencare G2 blood glucose low control solution bottle was open and not dated.
One Evencare G2 blood glucose high control solution bottle was open and not dated.
One Evencare G2 blood glucose test strips bottle was open and not dated.

There was no evidence which showed when the control solution and test strip bottles were opened or needed to be discarded.

b) On 11/30/17 at 11:36 a.m., an interview with Registered Nurse (RN) #2 was conducted. RN #2 stated that Certified Nurses Assistants (CNA) performed blood glucose controls every night. RN #2 further stated s/he was unsure of how long blood glucose controls and test strips were viable for after they had been opened and would have to refer to the facility policy.

Based on observations, interviews and document review, the facility failed to ensure radiology equipment was inspected and maintained in accordance with State laws.

This failure resulted in potential exposure of staff and patients to harmful radiation.

FINDINGS

POLICY

According to the policy, Safety-Patient, Visitor, Employee, all equipment to be used by nursing personnel for patient care shall be in full working order at all times.

REFERENCE

According to the Code of Colorado Regulations 6 CCR 1007-1 Part 02 (2.5.1.3): Summary of Frequency of Radiation Machine Inspection, each bone densitometry radiation machine frequency of inspection is every three years.

1. The facility did not ensure a bone density scanner was inspected according to State regulations.

a) On 11/27/17 at 4:25 p.m., the facility's radiology department was toured with the facility's Director of Nursing (DON #1). A bone density scanner (used to measure bone loss) was viewed and contained a blue inspection sticker that was expired 03/17.

b) On 11/30/17 at 1:23 p.m., an interview with Radiology Manager (RM) #5 was conducted. RM #5 stated the radiation certificate was proof the facility registered their equipment for compliance with state regulations. RM #5 stated the reasoning to certify the bone density scanner was to check the amount of radiation the machine emitted and make sure it was safe. RM #5 went on to state the last certification was performed in 2014 and was required every 3 years.

Based on interviews and document review, the facility failed to ensure nursing staff met the needs of the patient and followed established protocols to prevent skin breakdown in 1 of 30 patient records reviewed (Patient #3).

This failure potentially resulted in pressure injuries.

FINDINGS

POLICY

According to the policy, Patient Care - Wound/Decubitus (pressure area) Care Protocol, all pressure areas are to be photographed each week, measured and recorded on pressure area sheet weekly until healed. Notation will be made in the nursing notes daily as appropriate. When a patient is identified as a high risk patient for skin breakdown, the physician will order decub precautions. Decubitus precautions include: turning a patient every 2 hours, floating the heels or heel protectors as appropriate, nutrition monitoring by the provider, hourly incontinent checks as appropriate and nursing care plan initiated for Risk for Skin Breakdown.

REFERENCE

According to the National Pressure Ulcer Advisory Panel, "NPUAP Pressure Injury Stages" 2016, a pressure injury is localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical or other device. The injury can present as intact skin or an open ulcer and may be painful. The injury occurs as a result of intense and/or prolonged pressure or pressure in combination with shear. The tolerance of soft tissue for pressure and shear may also be affected by microclimate, nutrition, perfusion, co-morbidities and condition of the soft tissue.

A Stage 2 Pressure injury is partial-thickness skin loss with exposed dermis.

A Stage 3 Pressure Injury is a full-thickness skin loss.

1. Nursing staff did not maintain Patient #3's skin integrity and follow physician ordered Decubitus Precautions according to policy.

a) Review of Patient #3's History and Physical, dated 11/14/17, revealed Patient #3 was transferred to the facility from another hospital after suffering a left intraparenchmal hemorrhage (bleeding in the brain) with residual right hemiplegia (paralysis) on 11/07/17. Patient #3's physician documented the patient stated s/he was unable to move his/her right lower extremity except for wiggling of the toes. The physician documented the patient was a maximum assist with mobility. There was no documented evidence the patient had a wound to his/her right ankle/heel or buttocks.

Review of Patient #3's nurse admission assessment, documented 11/14/17 at 4:20 p.m., showed no evidence of skin breakdown. According to the Registered Nurse's documentation (RN #2), the prior facility reported a duoderm dressing was placed on the patient's coccyx to prevent breakdown. On 11/14/17 at 8:50 p.m., another RN removed the dressing to assess the skin. The nurse documented there was no redness under the dressing.

Review of nurse progress notes and shift assessments notes, from 11/14/17 through 11/28/17, showed Patient #3 had multiple areas of skin breakdown documented by nursing staff, which were not present upon admission to the facility on 11/14/17. Nursing staff documented wounds to the patient's buttocks on 11/15/17, 11/16/17, 11/19/17, 11/21/17, 11/22/17, 11/23/17, 11/25/17, 11/26/17 and 11/27/17. On 11/27/17 at 9:00 a.m., RN #2 documented the patient had a Stage 2 decubitus x 2 on his/her buttocks.

Review of physician orders, dated 11/17/17, showed Decubitus Precautions were ordered. There was no evidence of a decubitus wound documented in the physician's progress notes dated the same day the Decubitus Precautions were ordered.

There was no evidence in Patient #3's medical record which showed the physician, Director of Nursing (DON) and dietary were aware or notified about the wounds located on the buttocks. Additionally, there were no photographs taken of the wounds. This was in contrast to the Wound/Decubitus Care Protocol.

According to the physician's progress noted, dated 11/28/17, the patient was seen by his/her physician due to right foot pressure sores. Patient #3's right foot/ankle had a stage 2 (partial-thickness skin loss with exposed dermis) decubitus on his/her heel and a stage 2 or 3 (full-thickness skin loss) on the outer side of the ankle. There was no evidence the physician who documented the note was aware of all of Patient #3's skin breakdown, including wounds to his/her buttocks.

c) On 11/30/17 at 11:35 a.m., an interview was conducted with Registered Nurse (RN) #2 who stated for decub precautions, s/he would make sure the patient had an air mattress, received pericare with barrier cream, was showered and repositioned if the patient was at risk for a decubitus. RN #2 reviewed the picture of Patient #3's right ankle/heel which was taken on 11/28/17. S/he stated it looked like the patient's ankle got rubbed or bumped on something. RN #3 stated although the wound could happen over night, it was preventable. RN #3 further stated Patient #3 was at high risk for skin breakdown due to right sided hemiparesis and needed to be repositioned.

d) On 11/30/17 at 12:27 p.m., an interview was conducted with the Director of Nursing (DON#1) who stated s/he was notified about Patient #3's right ankle/heel wound on 11/28/17. DON #1 stated s/he had reviewed the nursing documentation and talked with staff who provided care for the patient. DON #1 stated the staff were not aware of the wound prior to 11/28/17 and all charted the patient was repositioned every two hours. When asked if turning every two hours would prevent a wound to the patient's ankle, DON #1 reported staff documented the heels were floated after the wound was discovered. However, s/he stated s/he was unable to find any documentation in Patient #3's chart which would show the patient's heels were floated consistently or the patient's right leg was repositioned prior to 11/28/17.

DON #1 stated the facility did have heel protectors available for patient use. S/he stated the patient was at risk for skin breakdown due to his/her right sided weakness.

DON #1 then provided the protocol for Decubitus precautions.

e) On 11/30/2017 at 2:01 p.m. an interview was conducted with Physician #9 who stated Patient #3's ankle/heel wound may or may have not been preventable. Physician #9 stated the patient's right leg did not move. S/he further sated s/he was unsure if the wound was caused by pressure or trauma.

Based on interviews and document reviews, the facility failed to ensure verbal orders were signed and verified by the ordering physician in 3 of 30 medical records reviewed (Patients #6 and #15).

This failure resulted in the potential for patient orders to be administered without the supervision of an authorized ordering provider.

FINDINGS

REFERENCE

According to the Medical Staff Rules & Regulations-2017, all orders must be signed and dated, either manually or electronically, within 24 hours of being written.

The attending physician shall be responsible for the medical care and treatment of their patient, with prompt completeness and accuracy of the medical record.

A telephone order shall be considered in writing if dictated to a duly authorized person functioning within his/her sphere of competence, and must be signed by the responsible practitioner within 24 hours.

1. The facility failed to ensure that qualified ordering providers were countersigning, or validating, orders after issuing a verbal order to nursing staff. The facility also failed to ensure that ordering providers were countersigning all verbal orders within a timeframe defined by Medical Staff Rules and Regulations.

a) Medical record review for Patient #6 showed the patient was admitted through the Emergency Room (ER) on 11/09/17 with complaints of epigastric pain (upper abdominal region). Review of the daily physician orders revealed multiple days of verbal orders which were not signed by multiple physicians as followed: On 11/09/17 verbal orders were obtained from Physician #10 for Protonix (a medication to treat gastroesophageal reflux disease) and Dilaudid (a narcotic medication to treat pain). On 11/10/17 a verbal order was obtained by Physician #10 to change the dose of Dilaudid and to add a lab for the following morning. On 11/14/17 a verbal order was obtained by Physician #11 for Bisacodyl (a medication to treat constipation). The medications had not been signed by multiple physicians for 13-17 days.

b) Medical record review for Patient #15 showed the patient was admitted with pneumonia on 09/11/17. Review of the daily physician orders revealed on 09/12/17 a verbal order was written but never signed by Physician #11. The order was for daily site care for an abdominal feeding tube and for a Levemir (Insulin) dose. The orders had not been validated by a physician for 77 days.

c) On 11/30/17 at 11:36 a.m., an interview with Registered Nurse (RN) #2 was conducted. RN #2 stated the process for obtaining a verbal order was to write the order in the paper chart and place the order into the electronic health record. RN #2 also stated the physician was required to cosign orders. RN #2 further stated if the ordering physician did not cosign the verbal order obtained, then the following provider would be required to cosign the verbal order.

d) On 11/30/17 at 2:01 p.m., an interview with Physician #9 was conducted. Physician #9 stated s/he was responsible for every order s/he gave verbally or wrote. Physician #9 went on to state verbal orders needed to be cosigned within a 24 hour time period. Physician #9 further stated the reasoning for a co-signature would be to confirm the order was what the physician said and intended.

Based on interviews and document reviews, the facility failed to ensure a written informed consent was obtained for an invasive procedure performed 1 of 30 patient records reviewed (Patient #7).

This failure created the potential for a patient not to be aware of the risk and benefits of the procedure, as well as other options of care available.

FINDINGS

POLICY

According to the policy, Consents-Elective Procedures, it is the policy of this hospital that a properly informed consent for any surgery or procedure performed in the emergency room be signed before the surgery or procedure is performed. This includes in-patients taken to the emergency room for any type of centesis. If the patient is unable to sign, appropriate documentation should be dictated in the Procedure Note or History and Physical. The Physician must obtain and complete the procedure consent form.

1. The physician did not obtain written informed consent for Patient #7's thoracentesis (a procedure done with a needle to remove the fluid from the space between the lungs and the chest wall).

a) Review of Patient #7's History and Physical, dated 10/06/17, revealed Patient #7 came into the emergency room after being sent by a clinic for hypoxia (low oxygen in the tissues) and worsening dyspnea (difficult or labored breathing). The patient's physician documented Patient #7 was very alert and responsive. Patient #7 was admitted to an acute bed.

According to the physician progress notes documented 10/08/17 at 1:50 p.m., a left side thoracentesis procedure note was dictated. Review of the dictated note showed the left pleural effusion had increased significantly. After the physician had a discussion with Patient #7 and received verbal consent, the decision was made to proceed with the procedure.

There was no evidence a procedure consent form was completed by the physician and signed by the patient prior to Patient #7's invasive procedure was performed. Additionally, the facility was unable to provide documentation the patient was unable to sign a consent. This was in contrast to policy.

b) On 11/29/17 at 11:43 a.m., the Director of Nursing (DON #1) stated s/he was unable to find a signed consent for Patient #7's thoracentesis. S/he stated, after review of the record, s/he only found the verbal consent which was in the dictation report for the procedure.

c) On 11/30/17 at 2:01 PM, an interview was conducted with one of the facility's hospital physicians (Physician #9). Physician #9 stated s/he would have expected to see a written consent for a thoracentesis. S/he reported the procedure was risky. Physician #9 stated the consent was a legal document which allowed the patient to know why the procedure was being done, the risk of the procedure, and evidence the patient wanted to continue with the procedure.