HospitalInspections.org

The facility failed to ensure the Condition of Participation: CFR 482.12 Governing Body was met by failing to ensure:

1. The Operating Room (OR) team followed the Universal Protocol (a protocol developed to prevent wrong person, wrong procedure, wrong site surgery in hospitals and outpatient settings). (Refer to A0951 and A0049)

2. Physician 1 followed the Universal Protocol. (Refer to A0951)

3. Patient 1's informed consent was properly executed prior to surgery. (Refer to A0955)

4. Patient 25's informed consent was signed by the patient before being given general anesthesia. (Refer to A0131 and A0955).

5. The Operating Room (OR) staff were able to verbalize OR temperature and humidity parameters. (Refer to A0951)

6. Temperatures and humidity were within range in the Sterile Processing Department (SPD- is where medical/surgical supplies and equipment, are cleaned, prepared, processed, stored, and issued for patient care) pre/packaging/sterilization area. (Refer to A0951)

7. Manufacturer recommendations were followed for the cleaning maintenance of the Caviwave Ultrasonic Cleaning System # 1 (a machine used to clean, flush, lubricate, and dry reusable patient equipment). (Refer to A0951)

8. Temperatures and Humidity were within range in the Operating Rooms. (Refer to A0951)

9. Registered Nurse (RN 4) immediately provided medical care to Patient 2, when Patient 2 was found on the floor. (Refer to A0392)

10. Telemetry strips (electrocardiograph readings-readings of the electrical activity of the heart) were printed during a code blue (an emergency situation announced in a hospital in which a patient is in cardiopulmonary arrest, requiring a team of providers (code team) to rush to the specific location and begin immediate resuscitative efforts) for Patient 2. (Refer to A0392)

11. Registered Nurses were within ratio when providing patient care. (Refer to A0392)

12. Registered Nurse (RN 7) correctly used personal protective equipment (PPE-items used to protect staff and patients from the spread of infectious diseases). (Refer to A0395)

13. Licensed staff monitored and provided care to all patients in the Emergency Department. (Refer to A0063, A0286, A0392 and A1101)

14. Reassessments and vital signs were obtained timely based on the patient's ESI level. (Refer to A0063, A0286, A0392, A0395 and A1101)

15. Emergency Department licensed staff, failed to accurately assess a patient's "Emergency Severity Index" based on the acuity of the patient's health care problems and the number of resources their care is anticipated to require. (Refer to A0063, A0286, A0392 and A1101)

16. Life-saving equipment was applied to a patient in a timely manner. (Refer to A0063, A0286, A0392 and A1101)

17. Emergency Department staff failed to report and seek out assistance from other departments in the facility to assist with patient care resources to assess and render appropriate care for an ED patient. (Refer to A0063, A0286, A1103)

18. ED staff failed to ensure expired items were removed from the treatment floor. (Refer to A0063, A0286, and A1103)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition of Participation: Governing Body.

Based on interview, and record review, the Governing Body of the facility failed to ensure all members of the Medical Staff followed the facility's policy and procedures when:

1. Physician 1 did not follow the Universal Protocol (a protocol developed to prevent wrong person, wrong procedure, wrong site surgery in hospitals and outpatient settings). This failure resulted in a right varicocelectomy (a surgical procedure that removes varicose veins in the scrotum) being performed on Patient 1 without consent.

2. Physician 1 failed to ensure Patient 1's informed consent was properly executed prior to surgery.This failure resulted in Patient 1 not being able to participate in the planning of his own medical care.

3. Physician 3 failed to ensure Patient 25's informed consent was signed by the patient before being given general anesthesia. This failure had the potential to violate the patient's right to consent or refuse treatment and the potential to result in an adverse medication reaction to the anesthesia.

Findings:

1. A review of Patient 1's facesheet (demographics) indicated Patient 1 was admitted to the facility on August 18, 2017, with a diagnosis of testicular pain.

A review of Patient 1's "History and Physical," dated August 17, 2017, indicated, " ... Patient is a 44-year-old man with history of left testicular discomfort and varicocele .... Plan: Consented for left varicocelectomy (a surgical procedure that removes varicose veins in the scrotum). He [Patient 1] understands the benefits, risks, and alternative treatment options."

A review of the "Consent to Surgery or Special Procedure," dated August 18, 2017 indicated Patient 1 consented and signed for a left varicocelectomy.

During an interview with the OR scrub technician (assist surgeons in the operating room) (ORST 1) on January 4, 2018 at 11:57 AM, she stated once Patient 1 was present in OR room four (4), the circulating nurse [RN 1] initiated the surgical/procedural pause timeout. The ORST 1 stated the surgical/procedural pause time out included stating Patient 1's name, date of birth, procedure name and procedure/surgery site outloud to the OR team. During the timeout, it is the responsibility of the OR team to engage and acknowledge the timeout by stating "yes' or "correct." The ORST 1 stated during the timeout she heard the procedure name but did not hear the surgery site. The ORST 1 stated she should have asked about the surgery site and it was her responsibility to know what side the surgery was going to be performed on. The ORST 1 further stated as the scrub technician she will only view the operative site but did not observe a marking and she did not ask any questions.

The facility's policy and procedure titled, "Universal Protocol (Marking of Operative/Procedural Site & "Time Out"/Surgical/Procedural Pause), dated November 2015, indicated, "...4.5 "Time out must be conducted in the location where the procedure will be done, just before starting the procedure; must actively involve the entire operative/procedural team and use active communication by validating the consent and verbalizing a minimum of the following: ...verify correct procedure, side, and site are marked ...verbal team agreement."

During an interview with the circulating Registered Nurse (RN 1) on January 2, 2018 at 3:37 PM, he stated during pre-op (pre operation-before surgery) he confirmed with Patient 1, Patient 1's name, date of birth, and procedure name and procedure site. RN 1 stated he confirmed Patient 1 was consented for a left varicocelectomy. RN 1 stated he observed Physician 1 marked Patient 1's left hand because the surgery was going to be performed on the left genital area. RN 1 stated Patient 1 was then transported to the OR where he initiated the surgical/procedural pause time out. RN 1 stated once Patient 1 was present in the OR, he was not able to visualize the marking made by Physician 1 because he was at the computer.

RN 1 stated once the procedure was completed Patient 1 was transported to Post Anesthesia Care Unit (PACU- the unit where patients are temporarily admitted after surgical procedures for post anesthesia recovery). RN 1 stated he gave report (accurate up to date pertinent patient information) to RN 2 in the PACU. Once report was given, RN 2 identified Patient 1 had a right side varicocelectomy performed instead of a left varicocelectomy. RN 1 stated he immediately notified Physician 1 of RN 2's findings. RN 1 stated Physician 1's response was that he was going to obtain consent for a right varicocelectomy from Patient 1's fiancée.

During an interview with the PACU Registered Nurse (RN 2) on January 4, 2018 at 11:15 AM, she stated Patient 2 was transported to the PACU. RN 2 stated she received report from RN 1. RN 2 stated she was informed by RN 1 a right varicocelectomy was performed on Patient 1. RN 2 stated she identified Patient 1 had a right varicocelectomy performed without consent. RN 2 stated she assessed the surgical site with RN 1 and confirmed a surgical post operative incision underneath the right scotum of Patient 1.

Review of Patient 1's clinical record titled, "General Information," dated August 18, 2017 at 9:40 AM, documented by RN 2, indicated, "While being given report, I questioned the side of the operation, OR RN [RN 1] repeated right side, I said all paperwork and case scheduled for left side."

Review of Patient 1's clinical record titled, "General Information," dated August 18, 2017 at 10:05 AM, documented by RN 2, indicated, "RN 2 at bedside to take patient back to OR to operate on left side."

During an interview with the Urologist (a physician who specializes in the urinary tract and reproductive organs) (Physician 1) on January 8, 2018 at 1:20 PM, he stated in the pre-procedural area (the time before surgery where all forms of care are provided to the patient) he marked Patient 1's left hand. Physician 1 stated he marked Patient 1's left hand because the surgery was going to be performed in the genital area. Physican 1 stated the left hand was not near the incision site. Physician 1 stated the policy states the marking needs to be near the incision site, the policy was not followed.

Physician 1 stated once Patient 1 was present in the OR room, the Universal Protocol Surgical/Procedural Pause Timeout was initiated by the circulating nurse [RN 1]. Physician 1 stated he should have engaged and acknowledged the time out but did not remember if he did. Physician 1 further stated his eyes tricked him and Patient 1's right side varicocele was more prominent and he performed a right varicocelectomy instead of a left varicocelectomy. Physician 1 stated he performed a right varicocelectomy without Patient 1's consent. Physician 1 stated, "it was a mistake."

The facility's policy and procedure titled, "Universal Protocol (Marking of Operative/Procedural Site & "Time Out"/Surgical/Procedural Pause), dated November 2015, indicated, "...Marking the surgical procedural site ...the correct side & site will be marked with his/her initials ...the mark should be at or near the incision site."

A review of the "Progress Notes," dated August 18, 2017, indicated, "44 year male with hx (history) of left varicocelectomy which showed on scrotal u/s (ultrasound) many months ago. Varicocele was prominent on exam. He [Patient 1] was consented to have left varicocelectomy. Under anesthesia, he was found to have prominent varicocelectomy on right testicle. He had right varicocelectomy and found that he was consented for left side in recovery room.

The facility's policy and procedure titled, "Scopes of Service Main Operating Room," dated October, 2016, indicated, "To outline the scope of care, service and plan for patient care, ...A. Description of Services Provided...Because the patient is unable to respond to enviromental stimuli, a vital aspect of the nursing care is to proceed as patient advocate, safeguarding his well being."

2. Refer to finding # 1.

3. During a review of Patient 25's medical record, it showed the patient was admitted for outpatient surgery on August 30, 2017 at 9:48 AM, for a revision of a dialysis fistula (a surgically created access to use for dialysis which is a machine that removes waste from a patient's blood when their own kidneys no longer function) and had diagnoses that included chronic kidney disease requiring chronic dialysis, hypertension (high blood presure) and Gout (red, swollen and painful joints).

In an interview with Registered Nurse 6 (RN 6) on January 4, 2018 at 3:18 PM, she stated she was a circulator in training (a nurse who is responsible for charting what is happening in the operating room and tracks the supplies and equipment used. The nurse may be called on to obtain supplies and equipment and performs the count of supplies to make sure nothing was left inside the patient's surgical site). She stated the Pre-op (before surgery) nurse gave me report (a brief overview of the patient's condition and what has been done and what needs to be done for the patient). She stated she reviewed the medical record and matched the procedure in the doctor's order with the procedure on the informed consent. She stated she did not verify the consent was signed by the patient. She stated, "I thought the pre-op nurse had verified that the consent was signed." RN 6 then stated she brought the patient into the outpatient operting room one (1) and had the patient state his name, date of birth, the procedure name and surgical site before the anesthesia was started, then the anethesiologist started the anesthesia. Then the surgeon entered and the surgical pause (a review to ensure the right patient, the right procedure and the correct body part is to have surgery) was done. The informed consent was opened and it was identified that the patient had not signed the informed consent. The surgeon told us to stop. The patient was awakened and went to the recovery room (PACU).

In an interview with Patient 25's surgeon (Physician 2) on January 5, 2018 at 8:59 AM, he stated, "I remember the case very well. I did get his informed consent." It varies whether the patient signs the consent before I do. Sometimes the nurses get it signed before I do and sometimes not, so I don't always see the patient's signature. The nurse missed it. Anesthesia should have checked the consent for the patient's signature before giving the anesthesia. "He kind of dropped the ball." He stated the anesthesia usually wears off in about an hour or two. We usually send the patient home alert & oriented after an hour.

In an interview with the Chief Medical Officer (CMO) on January 5, 2018 at 1:15 PM, he stated consents need to be reviewed prior to anesthesia.

Review of the Pre-op "Surgical Documents" dated August 8, 2017, showed the following:

PRE-OP (first entry in outpatient surgery)
"Patient arrival time 08/30/17 10:25:00
Patient ready for transport 08/30/17 11:00:00...case cancelled in room

Surgical Procedure
Procedure Start 08/30/17 11:00:00
Anesthesia Type General
Procedure Stop 08/30/17 11:12:00

OR (operating room) (second time to surgery)
In Room Time 08/30/17 16:25:00 (4:00 PM)
Stop Time 08/30/17 19:12:00 (7:12 PM)"

Review of the Surgical Informed Consent dated August 8, 2017, showed Patient 25 signed the consent at 1:10 PM

In a review of the Anesthesia Physician Note dated August 30, 2017 at 12:08 PM (after the first anesthesia), showed the following:

"Consent was signed by the patient."

In a review of the Anesthesia Physician Note dated August 30, 2017 at 2:45 PM (before the second anesthesia), showed the following:

"Because of the incomplete consent, he did not have surgery."

In an interview with the anesthesiologist (Physician 3) on January 5, 2017 at 9:42 AM, he stated, He did not remember the case. But reviewing the notes he saw that the patient got anesthesia at 11 AM and ended at 12:22 PM. He stated he wrote a brief note "Because of the incomplete consent, he did not have surgery. "I don't remember if it was the surgeon who didn't sign or the patient." When informed it was the patient who didn't sign. He stated, "Oh, I kind of remember now." He stated he explains the type of anesthesia and its risks and benefits to the patient before the surgery, then when the patient signs the surgical consent they are also signing consent for anesthesia. He stated that he usually checks for patient consent signature before anesthesia. He was unable to explain why he gave anesthesia before the consent was signed.

Based on observation, interview and record review, the Governing Body of the facility failed to ensure the following:

1.The Operating Room (OR) team followed the Universal Protocol (a protocol developed to prevent wrong person, wrong procedure, wrong site surgery in hospitals and outpatient settings). This failure resulted in a right varicocelectomy (a surgical procedure that removes varicose veins in the scrotum) being performed on Patient 1 without consent.

2. Physician 1 followed the Universal Protocol. This failure resulted in a right varicocelectomy being performed on Patient 1 without consent.

3. Patient 1's informed consent was properly executed prior to surgery. This failure resulted in Patient 1 not being able to participate in the planning of his own medical care.

4. Patient 25's informed consent for surgery was properly executed by failing to ensure the patient signed the surgical consent. This failure had the potential to violate the patient's right to consent or refuse treatment.

5. The Operating Room (OR) staff were able to verbalize OR temperature and humidity parameters. This failure had potential to affect the health and safety of the patients and OR personnel.

6.Temperatures and humidity (the amount of moisture in the air) were within range in the Sterile Processing Department (SPD- is where medical/surgical supplies and reusable patient equipment, are cleaned, prepared, processed, stored, and issued for patient care) pre/packaging/sterilization area. This failure had the potential for the spread of infection in a universe of 220 patients.

7. Manufacturer recommendations were followed for the cleaning maintenance of the Caviwave Ultrasonic Cleaning System # 1 (a machine used to clean, flush, lubricate, and dry reusable patient equipment).This failure had the potential for the spread of infection in a universe of 220 patients.

8. Temperature and Humidity were within range in the Operating Rooms. This failure had the potential for the spread of infection in a universe of 220 patients.

9. A Registered Nurse (RN 4) immediately responded to provide medical treatment to Patient 2, when Patient 2 was found on the floor. This failure resulted in Patient 2 not receiving immediate medical treatment in a medical emergency situation.

10. Documented evidence of Telemetry strips (cardiac rhythm monitoring which are readings of the electrical activity of the heart) were printed for Patient 2 during a code blue (an emergency situation announced in a hospital in which a patient is in cardiopulmonary arrest, requiring a team of providers to rush to the specific location and begin immediate resuscitative efforts). This failure resulted in no documentation in the clinical record of telemetry strips for Patient 2 during a code blue.

11. Nursing staff were within ratio when providing patient care. This failure had the potential to negatively affect patient care.

12. Registered Nurse (RN 7) correctly used personal protective equipment (PPE-items used to protect staff and patients from the spread of infectious diseases). This failure had the potential to result in the spread of infection to patients and staff.

13. Licensed staff monitored and provided care to all patients in the Emergency Department.

14. Reassessments and vital signs were obtained timely based on the patient's ESI level.

15. Emergency Department licensed staff, failed to accurately assess a patient's "Emergency Severity Index" based on the acuity of the patient's health care problems and the number of resources their care is anticipated to require.

16. Life-saving equipment was applied to a patient in a timely manner.

17. Emergency Department staff failed to report and seek out assistance from other departments in the facility to assist with patient care resources to assess and render appropriate care for an ED patient.

18. ED staff failed to ensure expired items were removed from the treatment floor.

Findings:

1. A review of Patient 1's facesheet (demographics) indicated Patient 1 was admitted to the facility on August 18, 2017, with a diagnosis of testicular pain.

A review of Patient 1's "History and Physical," dated August 17, 2017, indicated, " ... Patient is a 44-year-old man with history of left testicular discomfort and varicocele .... Plan: Consented for left varicocelectomy (a surgical procedure that removes varicose veins in the scrotum). He [Patient 1] understands the benefits, risks, and alternative treatment options."

A review of the "Consent to Surgery or Special Procedure," dated August 18, 2017 indicated Patient 1 consented and signed for a left varicocelectomy.

During an interview with the OR scrub technician (assist surgeons in the operating room) (ORST 1) on January 4, 2018 at 11:57 AM, she stated once Patient 1 was present in OR room four (4), the circulating nurse [RN 1] initiated the surgical/procedural pause timeout. The ORST 1 stated the surgical/procedural pause time out included stating Patient 1's name, date of birth, procedure name and procedure/surgery site outloud to the OR team. During the timeout, it is the responsibility of the OR team to engage and acknowledge the timeout by stating "yes' or "correct." The ORST 1 stated during the timeout she heard the procedure name but did not hear the surgery site. The ORST 1 stated she should have asked about the surgery site and it was her responsibility to know what side the surgery was going to be performed on. The ORST 1 further stated as the scrub technician she will only view the operative site but did not observe a marking and she did not ask any questions.

The facility's policy and procedure titled, "Universal Protocol (Marking of Operative/Procedural Site & "Time Out"/Surgical/Procedural Pause), dated November 2015, indicated, "...4.5 "Time out must be conducted in the location where the procedure will be done, just before starting the procedure; must actively involve the entire operative/procedural team and use active communication by validating the consent and verbalizing a minimum of the following: ...verify correct procedure, side, and site are marked ...verbal team agreement."

During an interview with the circulating Registered Nurse (RN 1) on January 2, 2018 at 3:37 PM, he stated during pre-op (pre operation-before surgery) he confirmed with Patient 1, Patient 1's name, date of birth, and procedure name and procedure site. RN 1 stated he confirmed Patient 1 was consented for a left varicocelectomy. RN 1 stated he observed Physician 1 marked Patient 1's left hand because the surgery was going to be performed on the left genital area. RN 1 stated Patient 1 was then transported to the OR where he initiated the surgical/procedural pause time out. RN 1 stated once Patient 1 was present in the OR, he was not able to visualize the marking made by Physician 1 because he was at the computer.

RN 1 stated once the procedure was completed Patient 1 was transported to Post Anesthesia Care Unit (PACU- the unit where patients are temporarily admitted after surgical procedures for post anesthesia recovery). RN 1 stated he gave report (accurate up to date pertinent patient information) to RN 2 in the PACU. Once report was given, RN 2 identified Patient 1 had a right side varicocelectomy performed instead of a left varicocelectomy. RN 1 stated he immediately notified Physician 1 of RN 2's findings. RN 1 stated Physician 1's response was that he was going to obtain consent for a right varicocelectomy from Patient 1's fiancée.

During an interview with the PACU Registered Nurse (RN 2) on January 4, 2018 at 11:15 AM, she stated Patient 2 was transported to the PACU. RN 2 stated she received report from RN 1. RN 2 stated she was informed by RN 1 a right varicocelectomy was performed on Patient 1. RN 2 stated she identified Patient 1 had a right varicocelectomy performed without consent. RN 2 stated she assessed the surgical site with RN 1 and confirmed a surgical post operative incision underneath the right scotum of Patient 1.

Review of Patient 1's clinical record titled, "General Information," dated August 18, 2017 at 9:40 AM, documented by RN 2, indicated, "While being given report, I questioned the side of the operation, OR RN [RN 1] repeated right side, I said all paperwork and case scheduled for left side."

Review of Patient 1's clinical record titled, "General Information," dated August 18, 2017 at 10:05 AM, documented by RN 2, indicated, "RN 2 at bedside to take patient back to OR to operate on left side."

During an interview with the Urologist (a physician who specializes in the urinary tract and reproductive organs) (Physician 1) on January 8, 2018 at 1:20 PM, he stated in the pre-procedural area (the time before surgery where all forms of care are provided to the patient) he marked Patient 1's left hand. Physician 1 stated he marked Patient 1's left hand because the surgery was going to be performed in the genital area. Physican 1 stated the left hand was not near the incision site. Physician 1 stated the policy states the marking needs to be near the incision site, the policy was not followed.

Physician 1 stated once Patient 1 was present in the OR room, the Universal Protocol Surgical/Procedural Pause Timeout was initiated by the circulating nurse [RN 1]. Physician 1 stated he should have engaged and acknowledged the time out but did not remember if he did. Physician 1 further stated his eyes tricked him and Patient 1's right side varicocele was more prominent and he performed a right varicocelectomy instead of a left varicocelectomy. Physician 1 stated he performed a right varicocelectomy without Patient 1's consent. Physician 1 stated, "it was a mistake."

The facility's policy and procedure titled, "Universal Protocol (Marking of Operative/Procedural Site & "Time Out"/Surgical/Procedural Pause), dated November 2015, indicated, "...Marking the surgical procedural site ...the correct side & site will be marked with his/her initials ...the mark should be at or near the incision site."

A review of the "Progress Notes," dated August 18, 2017, indicated, "44 year male with hx (history) of left varicocelectomy which showed on scrotal u/s (ultrasound) many months ago. Varicocele was prominent on exam. He [Patient 1] was consented to have left varicocelectomy. Under anesthesia, he was found to have prominent varicocelectomy on right testicle. He had right varicocelectomy and found that he was consented for left side in recovery room.

The facility's policy and procedure titled, "Scopes of Service Main Operating Room," dated October, 2016, indicated, "To outline the scope of care, service and plan for patient care, ...A. Description of Services Provided...Because the patient is unable to respond to enviromental stimuli, a vital aspect of the nursing care is to proceed as patient advocate, safeguarding his well being."

2. Refer to finding # 1.

3. Refer to finding # 1.

4. During a review of Patient 25's medical record, it showed the patient was admitted for outpatient surgery on August 30, 2017 at 9:48 AM, for a revision of a dialysis fistula (a surgically created access to use for dialysis which is a machine that removes waste from a patient's blood when their own kidneys no longer function) and had diagnoses that included chronic kidney disease requiring chronic dialysis, hypertension (high blood presure) and Gout (red, swollen and painful joints).

In an interview with Registered Nurse 6 (RN 6) on January 4, 2018 at 3:18 PM, she stated she was a circulator in training (a nurse who is responsible for charting what is happening in the operating room and tracks the supplies and equipment used. The nurse may be called on to obtain supplies and equipment and performs the count of supplies to make sure nothing was left inside the patient's surgical site). She stated the Pre-op (before surgery) nurse gave me report (a brief overview of the patient's condition and what has been done and what needs to be done for the patient). She stated she reviewed the medical record and matched the procedure in the doctor's order with the procedure on the informed consent. She stated she did not verify the consent was signed by the patient. She stated, "I thought the pre-op nurse had verified that the consent was signed." RN 6 then stated she brought the patient into the outpatient operting room one (1) and had the patient state his name, date of birth, the procedure name and surgical site before the anesthesia was started, then the anethesiologist started the anesthesia. Then the surgeon entered and the surgical pause (a review to ensure the right patient, the right procedure and the correct body part is to have surgery) was done. The informed consent was opened and it was identified that the patient had not signed the informed consent. The surgeon told us to stop. The patient was awakened and went to the recovery room (PACU).

In an interview with Patient 25's surgeon (MD 2) on January 5, 2018 at 8:59 AM, he stated, "I remember the case very well. I did get his informed consent." It varies whether the patient signs the consent before I do. Sometimes the nurses get it signed before I do and sometimes not, so I don't always see the patient's signature. The nurse missed it. Anesthesia should have checked the consent for the patient's signature before giving the anesthesia. "He kind of dropped the ball." He stated the anesthesia usually wears off in about an hour or two. We usually send the patient home alert & oriented after an hour.

In an interview with the Chief Medical Officer (CMO) on January 5, 2018 at 1:15 PM, he stated consents need to be reviewed prior to anesthesia.

Review of the Pre-op "Surgical Documents" dated August 8, 2017, showed the following:

PRE-OP (first entry in outpatient surgery)
"Patient arrival time 08/30/17 10:25:00
Patient ready for transport 08/30/17 11:00:00...case cancelled in room

Surgical Procedure
Procedure Start 08/30/17 11:00:00
Anesthesia Type General
Procedure Stop 08/30/17 11:12:00

OR (operating room) (second time to surgery)
In Room Time 08/30/17 16:25:00 (4:00 PM)
Stop Time 08/30/17 19:12:00 (7:12 PM)"

Review of the Surgical Informed Consent dated August 8, 2017, showed Patient 25 signed the consent at 1:10 PM

In a review of the Anesthesia Physician Note dated August 30, 2017 at 12:08 PM (after the first anesthesia), showed the following:

"Consent was signed by the patient."

In a review of the Anesthesia Physician Note dated August 30, 2017 at 2:45 PM (before the second anesthesia), showed the following:

"Because of the incomplete consent, he did not have surgery."

In an interview with the anesthesiologist (MD 3) on January 5, 2017 at 9:42 AM, he stated, He did not remember the case. But reviewing the notes he saw that the patient got anesthesia at 11 AM and ended at 12:22PM. He stated he wrote a brief note "Because of the incomplete consent, he did not have surgery. "I don't remember if it was the surgeon who didn't sign or the patient." When informed it was the patient who didn't sign. He stated, "Oh, I kind of remember now." He stated he explains the type of anesthesia and its risks and benefits to the patient before the surgery, then when the patient signs the surgical consent they are also signing consent for anesthesia. He stated that he usually checks for patient consent signature before anesthesia. He was unable to explain why he gave anresthesia before the consent was signed.

5. During an interview with a Registered Nurse (RN 3) on January 5, 2018 at 8:07 AM, he stated he did not know what the temperature and humidity (measure of moisture in the air) parameters were for the Operating Room (OR). RN 3 stated he was aware that there are standard parameters but did not know what they were.

During an interview with a OR scrub technician (assits surgeons in the operating room) (ORST 2) on January 5, 2018 at 8:21 AM, he stated he was not sure what the temperature and humdity parameters were for the OR.

During an interview with a Infection Control Preventionist (ICP) on January 8, 2018 at 9:20 AM, she stated OR staff should be aware of the standard required temperature and humidity parameters that are set.

A review of "Clinical Nurse Surgery," Job Description dated May 14, 2015, indicated, "Performance Expectations...4.10 Monitor and control environment."

6. A review of the "Sterile Processing Department Prep Area," Temperature and Humidity log dated for the month of January 2018 indicated the following:

January 3, 2018, Temperature 66.0, Humidity 25.4 %

During an interview with a Sterile Processing Technician (SPDT1) on January 4, 2018 at 9:06 AM, she stated she checked the temperature and humidity in the morning and logged it. SPDT 1 stated the temperature and humidity were out of range but she did not call engineering. SPDT1 stated she forgot to call engineer when she identified the temperature and humidity were out of range.

During an interview with the Sterile Processing Manager (SPDM) on January 4, 2018 at 9:08 AM, she stated the expectation was for staff to call engineering when temperature and humidity are out of range.

A review of the "Sterile Processing Department Prep Area," Temperature and Humidity log dated for the month of December 2017 indicated the following:

December 4, 2017, Temperature 66.8, Humidity 18.1%
December 12, 2017, Temperature 66.0, Humidity 13.4%
December 13, 2017, Temperature 64.6, Humidity 20.5%
December 16, 2017, Temperature 66.5, Humidity 19.3%
December 28, 2017, Temperature 63.9, Humidity 21.6%
December 29, 2017, Temperature 63.9, Humidity 27.9%
December 30, 2017, Temperature 64.1, Humidity 20.5%
December 31, 2017, Temperature 65.3, Humidity 24.4%

During a concurrent interview with the SPDM, she stated she was not aware the temperature and humidity were out of range. The SPDM stated the process was not followed.

During an interview with the Infection Control Preventionist (ICP) on January 3, 2018, at 4:17 PM, she stated she should have closely overseen the Sterile Processing Department. The ICP stated the engineering department should have been called when the temperature and humidity where identified as out of range. The ICP stated the SPD staff are aware of the process, however the process was not followed.

The facility's policy and procedure titled, "Temperature, Humidity, and Air Flow Requirements for the Processing Areas, dated December 2014, indicated, "To identify the recommended environmental conditions in the processing area to prevent cross contamination of packs and to maintain packaging material integrity ...2. The Prep/Packaging/Sterilization Area, Temperature of 68-73 degree Celsius, Humidity 35-60%."."

7. A review of the "Caviwave Ultrasonic Cleaning System Operator Manual," indicated, "...4.3 General Cleaning Procedures... "3. Apply cleaning solution with damp cloth to cabinet surfaces and chamber interiors, rubbing in back and forth motion, Rinse cloth and wipe off any detergent residue, then dry surfaces with clean, dry lint-free cloth."

During an interview with a Lead Sterile Processor (LSP1) on January 4, 2018 at 4:22 PM, she stated the Sterile Processing Department (SPD) was responsible for the cleaning maintenance of the Caviwave Ultrasonic Cleaning System (a machine used to clean, flush, lubricate, and dry reusable patient equipment). LSP1 stated the cleaning maintenance was completed on a daily basis. The LSP1 stated she did not have documented evidence for the cleaning maintenance that was completed.

A review of the "Caviwave Ultrasonic Cleaning System Operator Manual," indicated, " ...4.3 Monthly Cleaning Procedure, after each monthly use of the Caviwave Ultrasonic Cleaning System, clean and disinfect system as follows ... check cleaning chamber strainer for debris, clean as required, inspect and clean air filter, clean generators to remove any dust or dirt ..."

During an interview with LSPD1 on January 4, 2018 at 4:22 PM, she stated the Sterile Processing Department does not complete the monthly cleaning procedure per manufacturer recommendations.

During an interview with the Infection Control Preventionist (ICP) on January 8, 2018, she stated the manufacture recommendations were not followed.

The facility's policy and procedure titled, "Decontamination of Soiled Instruments and Devices," dated January 2015, indicated, "All instruments and devices shall be cleaned ...per the device manufacturer's written instructions."

8. A review of the "Hospital Critical Areas Room Temperatures and Humidity," log dated January 3, 2018, indicated the following:

Operating Room 3, Temperature 62.0, Humidity 15%
Operating Room 4, Temperature 61.2, Humidity 16%
Operating Room 7, Temperature 64.5, Humidity 19%

A review of the "Hospital Critical Areas Room Temperature and Humidity," log dated January 2, 2018, indicated the following:

Operating Room 1, Temperature 63.7, Humidity 18%
Operating Room 3, Temperature 62.1, Humidity 13%
Operating Room 7, Temperature 64.3, Humidity 17%

During an interview with the Director of Safety Security and Emergency Management (DSSEM) on January 3, 218 at 3:30 PM, she stated she was temporarily overseeing the Plant Engineering Department. The DSSEM stated multiple temperatures and humidity readings were documented as out of range in multiple operating rooms. The DSSEM stated Operating room temperatures should be maintained between 68-75 degree Celsius, and humidity between 20%-60%. The DSSEM stated once a temperature and humidity is identified as out of range the plant engineering staff is responsible to document corrected actions that were taken. The DSSEM stated there was no documented evidence of corrected actions taken. The DSSEM stated the process was not followed.

The facility's policy and procedure titled, "Scopes of Services Main Operating Room," dated October 2016, indicated, "To outline the scope of care, service and plan for patient care... 10. Department Goals... E. To design and equip the operating room to facilitate effective care and safety of patients..."

The facility's policy and procedure titled, "Temperature, Humidity, and Air Flow Requirements for the Pocessing Areas," dated December, 2014, indicated, "...Tempearture and humidity levels shall be monitored daily by Engineering Department whenever the facility is open to ensure compliance with recommended environmental conditions."

9. A review of Patient 2's clinical record, the "Triage Report," (a procedure used to prioritize emergency care and identify patients who need immediate medical attention) indicated, Patient 2 arrived to the Emergency Department (ED) on October 20, 2017 at 10:31 AM with a chief complaint (the patient's reported reason for seeking medical care) of syncopal episode (fainting).

A review of Patient 2's clinical record, the "Physician History and Physical," dated October 20, 2017, indicated the following:

a. Patient 2 presented to the ED with chief complaint of cough, shortness of breath, wheezing and syncope.

b. Laboratory Data: indicated Troponin 0.113 (a test that measures injury to the heart and indication of a heart attack-normal values are less than 0.01).

c. Plan: The patient [Patient 2] will be admitted to the Telemetry unit (a unit in the hospital that continuously monitors the patient's electrical activity of the heart) unit for monitoring.

During an interview with the Manager of Patient Safety and Accreditation (MPSA) on January 8, 2018, at 9:30 AM, she stated Patient 2 was transported to the Telemetry unit on October 20, 2017 at 4:05 PM.

A review of Patient 2's clinical record, the "EKG Monitor Flow Sheet," dated October 20, 2017 at 4:29 PM, indicated, "Sinus Rhythm (normal regular rhythm of the heart) at a rate of 100 beats per minute (normal heart rate ranges are between 60 to 100 beats per minute)."

During an interview with the MPSA on January 8, 2018 at 9:30 AM, she stated that on the day of the incident [October 20, 2017 at 6:55 PM], during the change of the nursing shift, a Registered Nurse (RN 4) walked by Patient 2's room (room 610) and identified Patient 2 was on the floor faced down. The MPSA stated RN 4 did not provide immediate care to Patient 2, instead RN 4 walked to the North side nurse's station (which is 44 feet away from room 610) to report her findings of Patient 2 being found on the floor faced down. The MPSA stated RN 4 was interviewed and did not have an explanation of why she did not immediately provide medical attention to Patient 2, when she found Patient 2 on the floor faced down. The MPSA stated RN 4 was terminated and is no longer employed at the facility.

A review of a Registered Nurse (RN 5), "Nursing Progress Note, dated October 20, 2017 at 8:06 PM, indicated, "At 6:50 PM-6:55 PM during change of shift, a nurse [RN 4] walked by the pt.'s [Patient 2] room and said something like "There's a patient on the floor in that room, as she walked away."

The MPSA stated, RN 5 and another nurse (RN 5 was not able to recall who the other nurse who responded was) immediately responded to Patient 2. Patient 2 was assessed and was found not breathing with a questionable pulse, immediate resuscitative efforts were initiated and a code blue was called. The MPSA stated she was not sure how long Patient 2 was on the floor. The MPSA stated, the code blue team immediately responded.

During an interview with a Monitor Technician (MT 1) on January 5, 2018, at 9:33 AM, she sated she was the monitor technician on the day of the incident [October 20, 2017]. MT 1 stated she heard "code blue in room 610," and she observed on Patient 2's telemetry monitor sinus bradycardia (means that the heart rate is slower than normal) at 53 beats per minute. MT 1 stated she did not recall if a telemetry strip was printed.

MT 1 further stated telemetry parameters are set from 50 to 150 beats per minute. MT 1 stated if Patient 2's heart rate was lower or higher than the set parameters, the alarms would have alerted her. MT 1 stated she relies on the telemetry monitor to alarm and alert her to possible patient rhythm changes. MT 1 stated Patient 2's heart beat was 53 beats per minute, still within the set parameters.

During a further interview with the MPSA, she reviewed the clinical record for Patient 2 and was not able to find documentation of Patient 2's telemetry strips indicating a heart rhythm of sinus bradycardia at 53 beats per minute. The MPSA stated no telemetry strips were printed out or placed in the clinical record. The MPSA stated the process was not followed.

The facility's policy and procedure titled, "Telemetry Monitoring, Process and Appropriate Use," dated, February 1, 2017, indicated, " ... D. Documentation 1. Rhythm strips will be documented and interpreted upon: ...e. Rapid responses, Code Blue events."

The facility's policy and procedure titled, "Scope of Service Telemetry/DOU," dated October, 2016, indicated, "To outline the scope of care, service and plan for patient care, ...V. Qualifications and Responsibilities of Staff ...Monitor Tech ...recording, reading and posting of tele strips per unit policy."

A further review of RN 5's, "Nursing Progress Note, indicated, "The primary nurse and some of the day shift nurses went running into the room. The pt [Patient 2] was found on the floor unresponsive face to the floor. The code button was pressed. The patient [Patient 2] was turned over and assessed, Patient 2 was found with a faint pulse. A bag valve mask (a hand-held device commonly used to provide positive pressure ventilation to patients who are not breathing or not breathing adequately) was used to provide rescue breaths and compressions were initiated. Patient 2 was placed on the crash cart (a wheeled container carrying medicine and equipment for use in emergency resuscitations) cardiac monitor via the defibrillator pads. Patient 2 was found to have a pulseless sinus rhythm (also known as PEA-pulseless electrical activity, when an organized heart rhythm is observed on the electrocardiogram (ECG) but does not produce a pulse).

RN 5 was not able to be interviewed, she was no longer employed at the facility.

The MPSA further stated, Patient 2 was successfully resuscitated (re-establishing electrical activity of the heart) and transferred to the Intensive Care unit (a unit in the hospital that is dedicated to the care of patients who are seriously ill). The MPSA stated once Patient 2 arrived to the ICU, Patient 2 was found to be in PEA and a code blue was called, Patient 2 subsequently expired.

A review of Patient 2's clinical record, the "Code Blue Record," dated October 20, 2017, at 7:30 PM, indicated, "Time Code Completed 7:54 PM, Expired."

A review of Patient 2's clinical record, the Physician's, "Discharge Summary," dated, October 20, 2017, indicated, "The patient [Patient 2] was found pulseless in her room and CPR (Cardiopulmonary Resuscitation) was initiated and [Patient 2] was transferred to the ICU where she again had another cardiac arrest and was pronounced dead."

During an interview with the Telemetry Manager (TM 1) on January 8, 2018, at 10:43 AM, the TM 1 stated RN 4 was interviewed regarding the events that took place on the day of the incident (October 20, 2017). TM 1 stated through her investigation, RN 4 stated she walked by Patient 2's room [room 610], identified Patient 2 was on the floor faced down, walked by the room, walked back to Patient 2's room to confirm her observation of Patient 2 being on the floor faced down, walked into Patient 2's room and walked back out. RN 4 then proceeded to walk to room 606 where nurses were giving and receiving report. RN 4 asked the nurses if they were assign to Patient 2, the nurses responded "No." At the same time, RN 5 (primary nurse) was walking in the direction of room 606 and overheard RN 4 asking who was the primary nurse for Patient 2, RN 5 stated she was the primary nurse for Patient 2. RN 4 reported to RN 5 that Patient 2 was on the floor. Then RN 4 proceeded to walk to the North side nurses station. TM 1 stated she asked RN 4 why she did not immediately provide medical attention to Patient 2 and RN 4 stated she had her hands full, she did not want to place her water bottle and clip board on the floor.

The facility's policy and procedure titled, "Scope of Service Telemetry/DOU," dated October, 2016, indicated, "To outline the scope of care, service and plan for patient care. A. Description of Services Provided, the Telemetry/DOU unit at (name of facility) delivers quality, competent, compassionate, age appropriate care to the seriously ill medical and surgical patients in an efficient and cost effective manner."

During an interview with the Chief Nursing Executive Officer (CNEO) on January 8, 2018 at 1:32 PM, she stated she interviewed RN 4 regarding the incident on October 20, 2017, and RN 4 stated she did not respond to Patient 2 when she found Patient 2 on the floor faced down because she did not want to place her water bottle and clipboard on the floor. The CNEO stated RN 4 was terminated and reported to the Board of Register Nurses (a state governmental agency established by law to protect the public by regulating the practice of registered nurses). The CNEO stated there was no documentation of Patient 2's telemetry strips in the clinical record. The CNEO stated, "apparently those strips disappeared." The CNEO further stated telemetry parameters should be individualized for each patient.

10. Refer to finding # 9.

11. During an interview with a Registered Nurse (RN 8) on January 3, 2018 at 11:42 AM, he stated the Medical Surgical unit 4th tower East/West was a 5:1 patient to nurse ratio. RN 8 stated the charge nurse had to take an assignment because the unit was short staffed. RN 8 stated the charge nurse normally covers lunches and breaks but since there was no charge nurse, the nurses were covering each other for lunch. RN 8 stated when the nurses cover each other for lunch the nurses are out of ratio.

During an interview with a Registered Nurse (RN 9) on January 3, 2018, at 2:07 PM, she stated there was not a charge nurse assigned to the unit because the Medical Surgical unit 4th tower East/West was short staffed. RN 9 stated the unit was a 5:1 patient to nurse ratio. RN 9 stated the nurses on the unit were covering each other for lunches. RN 9 stated she was assigned to three (3) patients and she covered RN 8's five (5) patients for lunch. RN 9 stated when she was covering RN 8's five (5) patients she had a total of 8 patients, which puts her out of ratio.

During an interview with the Medical Surgical unit 4th tower East/West Manager (MSM 1) on January 3, 2018 at

The facility failed to ensure the Condition of Participation: CFR 482.13 Patient Rights was met by failing to ensure:

1. A patient's informed consent was signed by the patient before being given general anesthesia. (Refer to A-0131)

The cummulative effect of this deficient practice resulted in the condition of participation for patient rights not being met.

Based on interview and record review the facility failed to ensure, for 1 of 30 sampled patients (Patient 25) the patient's informed consent was signed by the patient before being given general anesthesia. This failure had the potential to violate the patient's right to consent or refuse treatment and the potential to result in an adverse medication reaction to the anesthesia.

Findings:

During a review of Patient 25's medical record, it showed the patient was admitted for outpatient surgery on August 30, 2017 at 9:48 AM, for a revision of a dialysis fistula (a surgically created access to use for dialysis which is a machine that removes waste from a patient's blood when their own kidneys no longer function) and had diagnoses that included chronic kidney disease requiring chronic dialysis, hypertension (high blood presure) and Gout (red, swollen and painful joints).

In an interview with Registered Nurse 6 (RN 6) on January 4, 2018 at 3:18 PM, she stated she was a circulator in training (a nurse who is responsible for charting what is happening in the operating room and tracks the supplies and equipment used. The nurse may be called on to obtain supplies and equipment and performs the count of supplies to make sure nothing was left inside the patient's surgical site). She stated the Pre-op (before surgery) nurse gave me report (a brief overview of the patient's condition and what has been done and what needs to be done for the patient). She stated she reviewed the medical record and matched the procedure in the doctor's order with the procedure on the informed consent. She stated she did not verify the consent was signed by the patient. She stated, "I thought the pre-op nurse had verified that the consent was signed." RN 6 then stated she brought the patient into the outpatient operting room one (1) and had the patient state his name, date of birth, the procedure name and surgical site before the anesthesia was started, then the anethesiologist started the anesthesia. Then the surgeon entered and the surgical pause (a review to ensure the right patient, the right procedure and the correct body part is to have surgery) was done. The informed consent was opened and it was identified that the patient had not signed the informed consent. The surgeon told us to stop. The patient was awakened and went to the recovery room (PACU).

In an interview with Patient 25's surgeon (Physician 2) on January 5, 2018 at 8:59 AM, he stated, "I remember the case very well. I did get his informed consent." It varies whether the patient signs the consent before I do. Sometimes the nurses get it signed before I do and sometimes not, so I don't always see the patient's signature. The nurse missed it. Anesthesia should have checked the consent for the patient's signature before giving the anesthesia. "He kind of dropped the ball." He stated the anesthesia usually wears off in about an hour or two. We usually send the patient home alert & oriented after an hour.

In an interview with the Chief Medical Officer (CMO) on January 5, 2018 at 1:15 PM, he stated consents need to be reviewed prior to anesthesia.

Review of the Pre-op "Surgical Documents" dated August 8, 2017, showed the following:

PRE-OP (first entry in outpatient surgery)
"Patient arrival time 08/30/17 10:25:00
Patient ready for transport 08/30/17 11:00:00...case cancelled in room

Surgical Procedure
Procedure Start 08/30/17 11:00:00
Anesthesia Type General
Procedure Stop 08/30/17 11:12:00

OR (operating room) (second time to surgery)
In Room Time 08/30/17 16:25:00 (4:00 PM)
Stop Time 08/30/17 19:12:00 (7:12 PM)"

Review of the Surgical Informed Consent dated August 8, 2017, showed Patient 25 signed the consent at 1:10 PM

In a review of the Anesthesia Physician Note dated August 30, 2017 at 12:08 PM (after the first anesthesia), showed the following:

"Consent was signed by the patient."

In a review of the Anesthesia Physician Note dated August 30, 2017 at 2:45 PM (before the second anesthesia), showed the following:

"Because of the incomplete consent, he did not have surgery."

In an interview with the anesthesiologist (Physician 3) on January 5, 2017 at 9:42 AM, he stated, He did not remember the case. But reviewing the notes he saw that the patient got anesthesia at 11 AM and ended at 12:22PM. He stated he wrote a brief note "Because of the incomplete consent, he did not have surgery. "I don't remember if it was the surgeon who didn't sign or the patient." When informed it was the patient who didn't sign. He stated, "Oh, I kind of remember now." He stated he explains the type of anesthesia and its risks and benefits to the patient before the surgery, then when the patient signs the surgical consent they are also signing consent for anesthesia. He stated that he usually checks for patient consent signature before anesthesia. He was unable to explain why he gave anresthesia before the consent was signed.

The facility failed to ensure the Condition of Participation: CFR 482.21 Quality Assessment and Performance Improvement was met by failing to ensure:

1. The Operating Room (OR) team followed the Universal Protocol (a protocol developed to prevent wrong person, wrong procedure, wrong site surgery in hospitals and outpatient settings). (Refer to A-0951)

2. Physician 1 followed the Universal Protocol. (Refer to A-0951)

3. The infomed consent for Patient 1 was properly executed prior to surgery. (Refer to A-0955)

4. Patient 25's informed consent was signed by the patient before being given general anesthesia (Refer to A-131 and A-0955)

5. The Operating Room (OR) staff were able to verbalize OR temperature and humidity parameters. (Refer to A-0951)

6. Temperatures and humidity were within range in the Sterile Processing Department (SPD- is where medical/surgical supplies and equipment, are cleaned, prepared, processed, stored, and issued for patient care) pre/packaging/sterilization area. (Refer to A-0951)

7. Manufacturer recommendations were followed for the cleaning maintenance of the Caviwave Ultrasonic Cleaning System # 1 (a machine used to clean, flush, lubricate, and dry reusable patient equipment. (Refer to A-0951)

8. Temperatures and Humidity were within range in the Operating Rooms. (Refer to A-0951)

9. Registered Nurse (RN 4) immediately provided medical care to Patient 2, when Patient 2 was found on the floor. (Refer to A-0392)

10. Telemetry strips (electrocardiograph readings-readings of the electrical activity of the heart) were printed during a code blue (an emergency situation announced in a hospital in which a patient is in cardiopulmonary arrest, requiring a team of providers (code team) to rush to the specific location and begin immediate resuscitative efforts) for Patient 2. (Refer to A-0392)

11. Registered Nurses were within ratio when providing patient care. (Refer to A-0392)

12. Registered Nurse (RN 7) correctly used personal protective equipment (PPE-items used to protect staff and patients from the spread of infectious diseases). (Refer to A-0395)

13. Licensed staff monitored and provided care to all patients in the Emergency Department. (Refer to A0063, A392 and A1101)

14. Reassessments and vital signs were obtained timely based on the patient's ESI level. (Refer to A0063, A392, A395 and A1101)

15. Emergency Department licensed staff, failed to accurately assess a patient's "Emergency Severity Index" based on the acuity of the patient's health care problems and the number of resources their care is anticipated to require. (Refer to A0063, A392 and A1101)

16. Life-saving equipment was applied to a patient in a timely manner. (Refer to A0063, A392 and A1101)

17. Emergency Department staff failed to report and seek out assistance from other departments in the facility to assist with patient care resources to assess and render appropriate care for an ED patient. (Refer to A0063, A1103)

18. ED staff failed to ensure expired items were removed from the treatment floor. (Refer to A0063 and A1103)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition of Participation: Quality Assessment and Performance Improvement.

Based on observation, interview, and record review, the Quality Assurance Improvement Program (QAPI), failed to ensure:

1.The Operating Room (OR) team followed the Universal Protocol (a protocol developed to prevent wrong person, wrong procedure, wrong site surgery in hospitals and outpatient settings). This failure resulted in a right varicocelectomy (a surgical procedure that removes varicose veins in the scrotum) being performed on Patient 1 without consent.

2. Physician 1 followed the Universal Protocol. This failure resulted in a right varicocelectomy being performed on Patient 1 without consent.

3. Patient 1's informed consent was properly executed prior to surgery. This failure resulted in Patient 1 not being able to participate in the planning of his own medical care.

4. Patient 25's informed consent for surgery was properly executed by failing to ensure the patient signed the surgical consent. This failure had the potential to violate the patient's right to consent or refuse treatment.

5. The Operating Room (OR) staff were able to verbalize OR temperature and humidity parameters. This failure had potential to affect the health and safety of the patients and OR personnel.

6.Temperatures and humidity (the amount of moisture in the air) were within range in the Sterile Processing Department (SPD- is where medical/surgical supplies and reusable patient equipment, are cleaned, prepared, processed, stored, and issued for patient care) pre/packaging/sterilization area. This failure had the potential for the spread of infection in a universe of 220 patients.

7. Manufacturer recommendations were followed for the cleaning maintenance of the Caviwave Ultrasonic Cleaning System # 1 (a machine used to clean, flush, lubricate, and dry reusable patient equipment.This failure had the potential for the spread of infection in a universe of 220 patients.

8. Temperature and Humidity were within range in the Operating Rooms. This failure had the potential for the spread of infection in a universe of 220 patients.

9. A Registered Nurse (RN 4) immediately responded to provide medical treatment to Patient 2, when Patient 2 was found on the floor. This failure resulted in Patient 2 not receiving immediate medical treatment in a medical emergency situation.

10. Documented evidence of Telemetry strips (cardiac rhythm monitoring which are readings of the electrical activity of the heart) were printed for Patient 2 during a code blue (an emergency situation announced in a hospital in which a patient is in cardiopulmonary arrest, requiring a team of providers to rush to the specific location and begin immediate resuscitative efforts). This failure resulted in no documentation in the clinical record of telemetry strips for Patient 2 during a code blue.

11. Nursing staff were within ratio when providing patient care. This failure had the potential to negatively affect patient care.

12. Registered Nurse (RN 7) correctly used personal protective equipment (PPE-items used to protect staff and patients from the spread of infectious diseases). This failure had the potential to result in the spread of infection to patients and staff.

13. Licensed staff monitored and provided care to all patients in the Emergency Department.

14. Reassessments and vital signs were obtained timely based on the patient's ESI level.

15. Emergency Department licensed staff, failed to accurately assess a patient's "Emergency Severity Index" based on the acuity of the patient's health care problems and the number of resources their care is anticipated to require.

16. Life-saving equipment was applied to a patient in a timely manner.

17. Emergency Department staff failed to report and seek out assistance from other departments in the facility to assist with patient care resources to assess and render appropriate care for an ED patient.

18. ED staff failed to ensure expired items were removed from the treatment floor.

Findings:

1. A review of Patient 1's facesheet (demographics) indicated Patient 1 was admitted to the facility on August 18, 2017, with a diagnosis of testicular pain.

A review of Patient 1's "History and Physical," dated August 17, 2017, indicated, " ... Patient is a 44-year-old man with history of left testicular discomfort and varicocele .... Plan: Consented for left varicocelectomy (a surgical procedure that removes varicose veins in the scrotum). He [Patient 1] understands the benefits, risks, and alternative treatment options."

A review of the "Consent to Surgery or Special Procedure," dated August 18, 2017 indicated Patient 1 consented and signed for a left varicocelectomy.

During an interview with the OR scrub technician (assist surgeons in the operating room) (ORST 1) on January 4, 2018 at 11:57 AM, she stated once Patient 1 was present in OR room four (4), the circulating nurse [RN 1] initiated the surgical/procedural pause timeout. The ORST 1 stated the surgical/procedural pause time out included stating Patient 1's name, date of birth, procedure name and procedure/surgery site outloud to the OR team. During the timeout, it is the responsibility of the OR team to engage and acknowledge the timeout by stating "yes' or "correct." The ORST 1 stated during the timeout she heard the procedure name but did not hear the surgery site. The ORST 1 stated she should have asked about the surgery site and it was her responsibility to know what side the surgery was going to be performed on. The ORST 1 further stated as the scrub technician she will only view the operative site but did not observe a marking and she did not ask any questions.

The facility's policy and procedure titled, "Universal Protocol (Marking of Operative/Procedural Site & "Time Out"/Surgical/Procedural Pause), dated November 2015, indicated, "...4.5 "Time out must be conducted in the location where the procedure will be done, just before starting the procedure; must actively involve the entire operative/procedural team and use active communication by validating the consent and verbalizing a minimum of the following: ...verify correct procedure, side, and site are marked ...verbal team agreement."

During an interview with the circulating Registered Nurse (RN 1) on January 2, 2018 at 3:37 PM, he stated during pre-op (pre operation-before surgery) he confirmed with Patient 1, Patient 1's name, date of birth, and procedure name and procedure site. RN 1 stated he confirmed Patient 1 was consented for a left varicocelectomy. RN 1 stated he observed Physician 1 marked Patient 1's left hand because the surgery was going to be performed on the left genital area. RN 1 stated Patient 1 was then transported to the OR where he initiated the surgical/procedural pause time out. RN 1 stated once Patient 1 was present in the OR, he was not able to visualize the marking made by Physician 1 because he was at the computer.

RN 1 stated once the procedure was completed Patient 1 was transported to Post Anesthesia Care Unit (PACU- the unit where patients are temporarily admitted after surgical procedures for post anesthesia recovery). RN 1 stated he gave report (accurate up to date pertinent patient information) to RN 2 in the PACU. Once report was given, RN 2 identified Patient 1 had a right side varicocelectomy performed instead of a left varicocelectomy. RN 1 stated he immediately notified Physician 1 of RN 2's findings. RN 1 stated Physician 1's response was that he was going to obtain consent for a right varicocelectomy from Patient 1's fiancée.

During an interview with the PACU Registered Nurse (RN 2) on January 4, 2018 at 11:15 AM, she stated Patient 2 was transported to the PACU. RN 2 stated she received report from RN 1. RN 2 stated she was informed by RN 1 a right varicocelectomy was performed on Patient 1. RN 2 stated she identified Patient 1 had a right varicocelectomy performed without consent. RN 2 stated she assessed the surgical site with RN 1 and confirmed a surgical post operative incision underneath the right scotum of Patient 1.

Review of Patient 1's clinical record titled, "General Information," dated August 18, 2017 at 9:40 AM, documented by RN 2, indicated, "While being given report, I questioned the side of the operation, OR RN [RN 1] repeated right side, I said all paperwork and case scheduled for left side."

Review of Patient 1's clinical record titled, "General Information," dated August 18, 2017 at 10:05 AM, documented by RN 2, indicated, "RN 2 at bedside to take patient back to OR to operate on left side."

During an interview with the Urologist (a physician who specializes in the urinary tract and reproductive organs) (Physician 1) on January 8, 2018 at 1:20 PM, he stated in the pre-procedural area (the time before surgery where all forms of care are provided to the patient) he marked Patient 1's left hand. Physician 1 stated he marked Patient 1's left hand because the surgery was going to be performed in the genital area. Physican 1 stated the left hand was not near the incision site. Physician 1 stated the policy states the marking needs to be near the incision site, the policy was not followed.

Physician 1 stated once Patient 1 was present in the OR room, the Universal Protocol Surgical/Procedural Pause Timeout was initiated by the circulating nurse [RN 1]. Physician 1 stated he should have engaged and acknowledged the time out but did not remember if he did. Physician 1 further stated his eyes tricked him and Patient 1's right side varicocele was more prominent and he performed a right varicocelectomy instead of a left varicocelectomy. Physician 1 stated he performed a right varicocelectomy without Patient 1's consent. Physician 1 stated, "it was a mistake."

The facility's policy and procedure titled, "Universal Protocol (Marking of Operative/Procedural Site & "Time Out"/Surgical/Procedural Pause), dated November 2015, indicated, "...Marking the surgical procedural site ...the correct side & site will be marked with his/her initials ...the mark should be at or near the incision site."

A review of the "Progress Notes," dated August 18, 2017, indicated, "44 year male with hx (history) of left varicocelectomy which showed on scrotal u/s (ultrasound) many months ago. Varicocele was prominent on exam. He [Patient 1] was consented to have left varicocelectomy. Under anesthesia, he was found to have prominent varicocelectomy on right testicle. He had right varicocelectomy and found that he was consented for left side in recovery room.

The facility's policy and procedure titled, "Scopes of Service Main Operating Room," dated October, 2016, indicated, "To outline the scope of care, service and plan for patient care, ...A. Description of Services Provided...Because the patient is unable to respond to enviromental stimuli, a vital aspect of the nursing care is to proceed as patient advocate, safeguarding his well being."

2. Refer to finding # 1.

3. Refer to finding # 1.

4. During a review of Patient 25's medical record, it showed the patient was admitted for outpatient surgery on August 30, 2017 at 9:48 AM, for a revision of a dialysis fistula (a surgically created access to use for dialysis which is a machine that removes waste from a patient's blood when their own kidneys no longer function) and had diagnoses that included chronic kidney disease requiring chronic dialysis, hypertension (high blood presure) and Gout (red, swollen and painful joints).

In an interview with Registered Nurse 6 (RN 6) on January 4, 2018 at 3:18 PM, she stated she was a circulator in training (a nurse who is responsible for charting what is happening in the operating room and tracks the supplies and equipment used. The nurse may be called on to obtain supplies and equipment and performs the count of supplies to make sure nothing was left inside the patient's surgical site). She stated the Pre-op (before surgery) nurse gave me report (a brief overview of the patient's condition and what has been done and what needs to be done for the patient). She stated she reviewed the medical record and matched the procedure in the doctor's order with the procedure on the informed consent. She stated she did not verify the consent was signed by the patient. She stated, "I thought the pre-op nurse had verified that the consent was signed." RN 6 then stated she brought the patient into the outpatient operting room one (1) and had the patient state his name, date of birth, the procedure name and surgical site before the anesthesia was started, then the anethesiologist started the anesthesia. Then the surgeon entered and the surgical pause (a review to ensure the right patient, the right procedure and the correct body part is to have surgery) was done. The informed consent was opened and it was identified that the patient had not signed the informed consent. The surgeon told us to stop. The patient was awakened and went to the recovery room (PACU).

In an interview with Patient 25's surgeon (MD 2) on January 5, 2018 at 8:59 AM, he stated, "I remember the case very well. I did get his informed consent." It varies whether the patient signs the consent before I do. Sometimes the nurses get it signed before I do and sometimes not, so I don't always see the patient's signature. The nurse missed it. Anesthesia should have checked the consent for the patient's signature before giving the anesthesia. "He kind of dropped the ball." He stated the anesthesia usually wears off in about an hour or two. We usually send the patient home alert & oriented after an hour.

In an interview with the Chief Medical Officer (CMO) on January 5, 2018 at 1:15 PM, he stated consents need to be reviewed prior to anesthesia.

Review of the Pre-op "Surgical Documents" dated August 8, 2017, showed the following:

PRE-OP (first entry in outpatient surgery)
"Patient arrival time 08/30/17 10:25:00
Patient ready for transport 08/30/17 11:00:00...case cancelled in room

Surgical Procedure
Procedure Start 08/30/17 11:00:00
Anesthesia Type General
Procedure Stop 08/30/17 11:12:00

OR (operating room) (second time to surgery)
In Room Time 08/30/17 16:25:00 (4:00 PM)
Stop Time 08/30/17 19:12:00 (7:12 PM)"

Review of the Surgical Informed Consent dated August 8, 2017, showed Patient 25 signed the consent at 1:10 PM

In a review of the Anesthesia Physician Note dated August 30, 2017 at 12:08 PM (after the first anesthesia), showed the following:

"Consent was signed by the patient."

In a review of the Anesthesia Physician Note dated August 30, 2017 at 2:45 PM (before the second anesthesia), showed the following:

"Because of the incomplete consent, he did not have surgery."

In an interview with the anesthesiologist (MD 3) on January 5, 2017 at 9:42 AM, he stated, He did not remember the case. But reviewing the notes he saw that the patient got anesthesia at 11 AM and ended at 12:22PM. He stated he wrote a brief note "Because of the incomplete consent, he did not have surgery. "I don't remember if it was the surgeon who didn't sign or the patient." When informed it was the patient who didn't sign. He stated, "Oh, I kind of remember now." He stated he explains the type of anesthesia and its risks and benefits to the patient before the surgery, then when the patient signs the surgical consent they are also signing consent for anesthesia. He stated that he usually checks for patient consent signature before anesthesia. He was unable to explain why he gave anresthesia before the consent was signed.

5. During an interview with a Registered Nurse (RN 3) on January 5, 2018 at 8:07 AM, he stated he did not know what the temperature and humidity (measure of moisture in the air) parameters were for the Operating Room (OR). RN 3 stated he was aware that there are standard parameters but did not know what they were.

During an interview with a OR scrub technician (assits surgeons in the operating room) (ORST 2) on January 5, 2018 at 8:21 AM, he stated he was not sure what the temperature and humdity parameters were for the OR.

During an interview with a Infection Control Preventionist (ICP) on January 8, 2018 at 9:20 AM, she stated OR staff should be aware of the standard required temperature and humidity parameters that are set.

A review of "Clinical Nurse Surgery," Job Description dated May 14, 2015, indicated, "Performance Expectations...4.10 Monitor and control environment."

6. A review of the "Sterile Processing Department Prep Area," Temperature and Humidity log dated for the month of January 2018 indicated the following:

January 3, 2018, Temperature 66.0, Humidity 25.4 %

During an interview with a Sterile Processing Technician (SPDT1) on January 4, 2018 at 9:06 AM, she stated she checked the temperature and humidity in the morning and logged it. SPDT 1 stated the temperature and humidity were out of range but she did not call engineering. SPDT1 stated she forgot to call engineer when she identified the temperature and humidity were out of range.

During an interview with the Sterile Processing Manager (SPDM) on January 4, 2018 at 9:08 AM, she stated the expectation was for staff to call engineering when temperature and humidity are out of range.

A review of the "Sterile Processing Department Prep Area," Temperature and Humidity log dated for the month of December 2017 indicated the following:

December 4, 2017, Temperature 66.8, Humidity 18.1%
December 12, 2017, Temperature 66.0, Humidity 13.4%
December 13, 2017, Temperature 64.6, Humidity 20.5%
December 16, 2017, Temperature 66.5, Humidity 19.3%
December 28, 2017, Temperature 63.9, Humidity 21.6%
December 29, 2017, Temperature 63.9, Humidity 27.9%
December 30, 2017, Temperature 64.1, Humidity 20.5%
December 31, 2017, Temperature 65.3, Humidity 24.4%

During a concurrent interview with the SPDM, she stated she was not aware the temperature and humidity were out of range. The SPDM stated the process was not followed.
During an interview with the Infection Control Preventionist (ICP) on January 3, 2018, at 4:17 PM, she stated she should have closely overseen the Sterile Processing Department. The ICP stated the engineering department should have been called when the temperature and humidity where identified as out of range. The ICP stated the SPD staff are aware of the process, however the process was not followed.

The facility's policy and procedure titled, "Temperature, Humidity, and Air Flow Requirements for the Processing Areas, dated December 2014, indicated, "To identify the recommended environmental conditions in the processing area to prevent cross contamination of packs and to maintain packaging material integrity ...2. The Prep/Packaging/Sterilization Area, Temperature of 68-73 degree Celsius, Humidity 35-60%."."

7. A review of the "Caviwave Ultrasonic Cleaning System Operator Manual," indicated, "...4.3 General Cleaning Procedures... "3. Apply cleaning solution with damp cloth to cabinet surfaces and chamber interiors, rubbing in back and forth motion, Rinse cloth and wipe off any detergent residue, then dry surfaces with clean, dry lint-free cloth."

During an interview with a Lead Sterile Processor (LSP1) on January 4, 2018 at 4:22 PM, she stated the Sterile Processing Department (SPD) was responsible for the cleaning maintenance of the Caviwave Ultrasonic Cleaning System. LSP1 stated the cleaning maintenance was completed on a daily basis. The LSP1 stated she did not have documented evidence for the cleaning maintenance that was completed.

A review of the "Caviwave Ultrasonic Cleaning System Operator Manual," indicated, " ...4.3 Monthly Cleaning Procedure, after each monthly use of the Caviwave Ultrasonic Cleaning System, clean and disinfect system as follows ... check cleaning chamber strainer for debris, clean as required, inspect and clean air filter, clean generators to remove any dust or dirt ..."

During an interview with LSPD1 on January 4, 2018 at 4:22 PM, she stated the Sterile Processing Department does not complete the monthly cleaning procedure per manufacturer recommendations.

During an interview with the Infection Control Preventionist (ICP) on January 8, 2018, she stated the manufacture recommendations were not followed.

The facility's policy and procedure titled, "Decontamination of Soiled Instruments and Devices," dated January 2015, indicated, "All instruments and devices shall be cleaned ...per the device manufacturer's written instructions."

8. A review of the "Hospital Critical Areas Room Temperatures and Humidity," log dated January 3, 2018, indicated the following:

Operating Room 3, Temperature 62.0, Humidity 15%
Operating Room 4, Temperature 61.2, Humidity 16%
Operating Room 7, Temperature 64.5, Humidity 19%

A review of the "Hospital Critical Areas Room Temperature and Humidity," log dated January 2, 2018, indicated the following:

Operating Room 1, Temperature 63.7, Humidity 18%
Operating Room 3, Temperature 62.1, Humidity 13%
Operating Room 7, Temperature 64.3, Humidity 17%

During an interview with the Director of Safety Security and Emergency Management (DSSEM) on January 3, 218 at 3:30 PM, she stated she was temporarily overseeing the Plant Engineering Department. The DSSEM stated multiple temperatures and humidity readings were documented as out of range in multiple operating rooms. The DSSEM stated Operating room temperatures should be maintained between 68-75 degree Celsius, and humidity between 20%-60%. The DSSEM stated once a temperature and humidity is identified as out of range the plant engineering staff is responsible to document corrected actions that were taken. The DSSEM stated there was no documented evidence of corrected actions taken. The DSSEM stated the process was not followed.

The facility's policy and procedure titled, "Scopes of Services Main Operating Room," dated October 2016, indicated, "To outline the scope of care, service and plan for patient care... 10. Department Goals... E. To design and equip the operating room to facilitate effective care and safety of patients..."

The facility's policy and procedure titled, "Temperature, Humidity, and Air Flow Requirements for the Pocessing Areas," dated December, 2014, indicated, "...Tempearture and humidity levels shall be monitored daily by Engineering Department whenever the facility is open to ensure compliance with recommended environmental conditions."

9. A review of Patient 2's clinical record, the "Triage Report," (a procedure used to prioritize emergency care and identify patients who need immediate medical attention) indicated, Patient 2 arrived to the Emergency Department (ED) on October 20, 2017 at 10:31 AM with a chief complaint (the patient's reported reason for seeking medical care) of syncopal episode (fainting).

A review of Patient 2's clinical record, the "Physician History and Physical," dated October 20, 2017, indicated the following:

a. Patient 2 presented to the ED with chief complaint of cough, shortness of breath, wheezing and syncope.

b. Laboratory Data: indicated Troponin 0.113 (a test that measures injury to the heart and indication of a heart attack-normal values are less than 0.01).

c. Plan: The patient [Patient 2] will be admitted to the Telemetry unit (a unit in the hospital that continuously monitors the patient's electrical activity of the heart) unit for monitoring.

During an interview with the Manager of Patient Safety and Accreditation (MPSA) on January 8, 2018, at 9:30 AM, she stated Patient 2 was transported to the Telemetry unit on October 20, 2017 at 4:05 PM.

A review of Patient 2's clinical record, the "EKG Monitor Flow Sheet," dated October 20, 2017 at 4:29 PM, indicated, "Sinus Rhythm (normal regular rhythm of the heart) at a rate of 100 beats per minute (normal heart rate ranges are between 60 to 100 beats per minute)."

During an interview with the MPSA on January 8, 2018 at 9:30 AM, she stated that on the day of the incident [October 20, 2017 at 6:55 PM], during the change of the nursing shift, a Registered Nurse (RN 4) walked by Patient 2's room (room 610) and identified Patient 2 was on the floor faced down. The MPSA stated RN 4 did not provide immediate care to Patient 2, instead RN 4 walked to the North side nurse's station (which is 44 feet away from room 610) to report her findings of Patient 2 being found on the floor faced down. The MPSA stated RN 4 was interviewed and did not have an explanation of why she did not immediately provide medical attention to Patient 2, when she found Patient 2 on the floor faced down. The MPSA stated RN 4 was terminated and is no longer employed at the facility.

A review of a Registered Nurse (RN 5), "Nursing Progress Note, dated October 20, 2017 at 8:06 PM, indicated, "At 6:50 PM-6:55 PM during change of shift, a nurse [RN 4] walked by the pt.'s [Patient 2] room and said something like "There's a patient on the floor in that room, as she walked away."

The MPSA stated, RN 5 and another nurse (RN 5 was not able to recall who the other nurse who responded was) immediately responded to Patient 2. Patient 2 was assessed and was found not breathing with a questionable pulse, immediate resuscitative efforts were initiated and a code blue was called. The MPSA stated she was not sure how long Patient 2 was on the floor. The MPSA stated, the code blue team immediately responded.

During an interview with a Monitor Technician (MT 1) on January 5, 2018, at 9:33 AM, she sated she was the monitor technician on the day of the incident [October 20, 2017]. MT 1 stated she heard "code blue in room 610," and she observed on Patient 2's telemetry monitor sinus bradycardia (means that the heart rate is slower than normal) at 53 beats per minute. MT 1 stated she did not recall if a telemetry strip was printed.

MT 1 further stated telemetry parameters are set from 50 to 150 beats per minute. MT 1 stated if Patient 2's heart rate was lower or higher than the set parameters, the alarms would have alerted her. MT 1 stated she relies on the telemetry monitor to alarm and alert her to possible patient rhythm changes. MT 1 stated Patient 2's heart beat was 53 beats per minute, still within the set parameters.

During a further interview with the MPSA, she reviewed the clinical record for Patient 2 and was not able to find documentation of Patient 2's telemetry strips indicating a heart rhythm of sinus bradycardia at 53 beats per minute. The MPSA stated no telemetry strips were printed out or placed in the clinical record. The PMSA stated the process was not followed.

The facility's policy and procedure titled, "Telemetry Monitoring, Process and Appropriate Use," dated, February 1, 2017, indicated, " ... D. Documentation 1. Rhythm strips will be documented and interpreted upon: ...e. Rapid responses, Code Blue events."

The facility's policy and procedure titled, "Scope of Service Telemetry/DOU," dated October, 2016, indicated, "To outline the scope of care, service and plan for patient care, ...V. Qualifications and Responsibilities of Staff ...Monitor Tech ...recording, reading and posting of tele strips per unit policy."

A further review of RN 5's, "Nursing Progress Note, indicated, "The primary nurse and some of the day shift nurses went running into the room. The pt [Patient 2] was found on the floor unresponsive face to the floor. The code button was pressed. The patient [Patient 2] was turned over and assessed, Patient 2 was found with a faint pulse. A bag valve mask (a hand-held device commonly used to provide positive pressure ventilation to patients who are not breathing or not breathing adequately) was used to provide rescue breaths and compressions were initiated. Patient 2 was placed on the crash cart (a wheeled container carrying medicine and equipment for use in emergency resuscitations) cardiac monitor via the defibrillator pads. Patient 2 was found to have a pulseless sinus rhythm (also known as PEA-pulseless electrical activity, when an organized heart rhythm is observed on the electrocardiogram (ECG) but does not produce a pulse).

RN 5 was not able to be interviewed, she was no longer employed at the facility.

The MPSA further stated, Patient 2 was successfully resuscitated (re-establishing electrical activity of the heart) and transferred to the Intensive Care unit (a unit in the hospital that is dedicated to the care of patients who are seriously ill). The MPSA stated once Patient 2 arrived to the ICU, Patient 2 was found to be in PEA and a code blue was called, Patient 2 subsequently expired.

A review of Patient 2's clinical record, the "Code Blue Record," dated October 20, 2017, at 7:30 PM, indicated, "Time Code Completed 7:54 PM, Expired."

A review of Patient 2's clinical record, the Physician's, "Discharge Summary," dated, October 20, 2017, indicated, "The patient [Patient 2] was found pulseless in her room and CPR (Cardiopulmonary Resuscitation) was initiated and [Patient 2] was transferred to the ICU where she again had another cardiac arrest and was pronounced dead."

During an interview with the Telemetry Manager (TM 1) on January 8, 2018, at 10:43 AM, the TM 1 stated RN 4 was interviewed regarding the events that took place on the day of the incident (October 20, 2017). TM 1 stated through her investigation, RN 4 stated she walked by Patient 2's room [room 610], identified Patient 2 was on the floor faced down, walked by the room, walked back to Patient 2's room to confirm her observation of Patient 2 being on the floor faced down, walked into Patient 2's room and walked back out. RN 4 then proceeded to walk to room 606 where nurses were giving and receiving report. RN 4 asked the nurses if they were assign to Patient 2, the nurses responded "No." At the same time, RN 5 (primary nurse) was walking in the direction of room 606 and overheard RN 4 asking who was the primary nurse for Patient 2, RN 5 stated she was the primary nurse for Patient 2. RN 4 reported to RN 5 that Patient 2 was on the floor. Then RN 4 proceeded to walk to the North side nurses station. TM 1 stated she asked RN 4 why she did not immediately provide medical attention to Patient 2 and RN 4 stated she had her hands full, she did not want to place her water bottle and clip board on the floor.

The facility's policy and procedure titled, "Scope of Service Telemetry/DOU," dated October, 2016, indicated, "To outline the scope of care, service and plan for patient care. A. Description of Services Provided, the Telemetry/DOU unit at (name of facility) delivers quality, competent, compassionate, age appropriate care to the seriously ill medical and surgical patients in an efficient and cost effective manner."

During an interview with the Chief Nursing Executive Officer (CNEO) on January 8, 2018 at 1:32 PM, she stated she interviewed RN 4 regarding the incident on October 20, 2017, and RN 4 stated she did not respond to Patient 2 when she found Patient 2 on the floor faced down because she did not want to place her water bottle and clipboard on the floor. The CNEO stated RN 4 was terminated and reported to the Board of Register Nurses (a state governmental agency established by law to protect the public by regulating the practice of registered nurses). The CNEO stated there was no documentation of Patient 2's telemetry strips in the clinical record. The CNEO stated, "apparently those strips disappeared." The CNEO further stated telemetry parameters should be individualized for each patient.

10. Refer to finding # 9.

11. During an interview with a Registered Nurse (RN 8) on January 3, 2018 at 11:42 AM, he stated the Medical Surgical unit 4th tower East/West was a 5:1 patient to nurse ratio. RN 8 stated the charge nurse had to take an assignment because the unit was short staffed. RN 8 stated the charge nurse normally covers lunches and breaks but since there was no charge nurse, the nurses were covering each other for lunch. RN 8 stated when the nurses cover each other for lunch the nurses are out of ratio.

During an interview with a Registered Nurse (RN 9) on January 3, 2018, at 2:07 PM, she stated there was not a charge nurse assigned to the unit because the Medical Surgical unit 4th tower East/West was short staffed. RN 9 stated the unit was a 5:1 patient to nurse ratio. RN 9 stated the nurses on the unit were covering each other for lunches. RN 9 stated she was assigned to three (3) patients and she covered RN 8's five (5) patients for lunch. RN 9 stated when she was covering RN 8's five (5) patients she had a total of 8 patients, which puts her out of ratio.

During an interview with the Medical Surgical unit 4th tower East/West Manager (MSM 1) on January 3, 2018 at 2:18 PM, she confirmed the unit was short staffed and there was not a charge n

The facility failed to ensure the Condition of Participation: CFR 482.22 Medical Staff was met by failing to ensure:

1. Physician 1 followed the Universal Protocol (a protocol developed to prevent wrong person, wrong procedure, wrong site surgery in hospitals and outpatient settings). (Refer to A0951)

2. Patient 1's informed consent was properly executed prior to surgery. (Refer to A0955)

3. Patient 25's informed consent was signed by the patient before being given general anesthesia. (Refer to A0131 and A0955).

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition of Participation: Medical Staff.

Based on interview, and record review the medical staff failed to ensure appointed staff members followed all policies and procedures regarding patient care and safety when:

1. Physician 1 did not follow the Universal Protocol (a protocol developed to prevent wrong person, wrong procedure, wrong site surgery in hospitals and outpatient settings). This failure resulted in a right varicocelectomy (a surgical procedure that removes varicose veins in the scrotum) being performed on Patient 1 without consent.

2. Physician 1 failed to ensure Patient 1's informed consent was properly executed prior to surgery.This failure resulted in Patient 1 not being able to participate in the planning of his own medical care.

3. Physician 3 failed to ensure Patient 25's informed consent was signed by the patient before being given general anesthesia. This failure had the potential to violate the patient's right to consent or refuse treatment and the potential to result in an adverse medication reaction to the anesthesia.

Findings:

1. A review of Patient 1's facesheet (demographics) indicated Patient 1 was admitted to the facility on August 18, 2017, with a diagnosis of testicular pain.

A review of Patient 1's "History and Physical," dated August 17, 2017, indicated, " ... Patient is a 44-year-old man with history of left testicular discomfort and varicocele .... Plan: Consented for left varicocelectomy (a surgical procedure that removes varicose veins in the scrotum). He [Patient 1] understands the benefits, risks, and alternative treatment options."

A review of the "Consent to Surgery or Special Procedure," dated August 18, 2017 indicated Patient 1 consented and signed for a left varicocelectomy.

During an interview with the OR scrub technician (assist surgeons in the operating room) (ORST 1) on January 4, 2018 at 11:57 AM, she stated once Patient 1 was present in OR room four (4), the circulating nurse [RN 1] initiated the surgical/procedural pause timeout. The ORST 1 stated the surgical/procedural pause time out included stating Patient 1's name, date of birth, procedure name and procedure/surgery site outloud to the OR team. During the timeout, it is the responsibility of the OR team to engage and acknowledge the timeout by stating "yes' or "correct." The ORST 1 stated during the timeout she heard the procedure name but did not hear the surgery site. The ORST 1 stated she should have asked about the surgery site and it was her responsibility to know what side the surgery was going to be performed on. The ORST 1 further stated as the scrub technician she will only view the operative site but did not observe a marking and she did not ask any questions.

The facility's policy and procedure titled, "Universal Protocol (Marking of Operative/Procedural Site & "Time Out"/Surgical/Procedural Pause), dated November 2015, indicated, "...4.5 "Time out must be conducted in the location where the procedure will be done, just before starting the procedure; must actively involve the entire operative/procedural team and use active communication by validating the consent and verbalizing a minimum of the following: ...verify correct procedure, side, and site are marked ...verbal team agreement."

During an interview with the circulating Registered Nurse (RN 1) on January 2, 2018 at 3:37 PM, he stated during pre-op (pre operation-before surgery) he confirmed with Patient 1, Patient 1's name, date of birth, and procedure name and procedure site. RN 1 stated he confirmed Patient 1 was consented for a left varicocelectomy. RN 1 stated he observed Physician 1 marked Patient 1's left hand because the surgery was going to be performed on the left genital area. RN 1 stated Patient 1 was then transported to the OR where he initiated the surgical/procedural pause time out. RN 1 stated once Patient 1 was present in the OR, he was not able to visualize the marking made by Physician 1 because he was at the computer.

RN 1 stated once the procedure was completed Patient 1 was transported to Post Anesthesia Care Unit (PACU- the unit where patients are temporarily admitted after surgical procedures for post anesthesia recovery). RN 1 stated he gave report (accurate up to date pertinent patient information) to RN 2 in the PACU. Once report was given, RN 2 identified Patient 1 had a right side varicocelectomy performed instead of a left varicocelectomy. RN 1 stated he immediately notified Physician 1 of RN 2's findings. RN 1 stated Physician 1's response was that he was going to obtain consent for a right varicocelectomy from Patient 1's fiancée.

During an interview with the PACU Registered Nurse (RN 2) on January 4, 2018 at 11:15 AM, she stated Patient 2 was transported to the PACU. RN 2 stated she received report from RN 1. RN 2 stated she was informed by RN 1 a right varicocelectomy was performed on Patient 1. RN 2 stated she identified Patient 1 had a right varicocelectomy performed without consent. RN 2 stated she assessed the surgical site with RN 1 and confirmed a surgical post operative incision underneath the right scotum of Patient 1.

Review of Patient 1's clinical record titled, "General Information," dated August 18, 2017 at 9:40 AM, documented by RN 2, indicated, "While being given report, I questioned the side of the operation, OR RN [RN 1] repeated right side, I said all paperwork and case scheduled for left side."

Review of Patient 1's clinical record titled, "General Information," dated August 18, 2017 at 10:05 AM, documented by RN 2, indicated, "RN 2 at bedside to take patient back to OR to operate on left side."

During an interview with the Urologist (a physician who specializes in the urinary tract and reproductive organs) (Physician 1) on January 8, 2018 at 1:20 PM, he stated in the pre-procedural area (the time before surgery where all forms of care are provided to the patient) he marked Patient 1's left hand. Physician 1 stated he marked Patient 1's left hand because the surgery was going to be performed in the genital area. Physican 1 stated the left hand was not near the incision site. Physician 1 stated the policy states the marking needs to be near the incision site, the policy was not followed.

Physician 1 stated once Patient 1 was present in the OR room, the Universal Protocol Surgical/Procedural Pause Timeout was initiated by the circulating nurse [RN 1]. Physician 1 stated he should have engaged and acknowledged the time out but did not remember if he did. Physician 1 further stated his eyes tricked him and Patient 1's right side varicocele was more prominent and he performed a right varicocelectomy instead of a left varicocelectomy. Physician 1 stated he performed a right varicocelectomy without Patient 1's consent. Physician 1 stated, "it was a mistake."

The facility's policy and procedure titled, "Universal Protocol (Marking of Operative/Procedural Site & "Time Out"/Surgical/Procedural Pause), dated November 2015, indicated, "...Marking the surgical procedural site ...the correct side & site will be marked with his/her initials ...the mark should be at or near the incision site."

A review of the "Progress Notes," dated August 18, 2017, indicated, "44 year male with hx (history) of left varicocelectomy which showed on scrotal u/s (ultrasound) many months ago. Varicocele was prominent on exam. He [Patient 1] was consented to have left varicocelectomy. Under anesthesia, he was found to have prominent varicocelectomy on right testicle. He had right varicocelectomy and found that he was consented for left side in recovery room.

The facility's policy and procedure titled, "Scopes of Service Main Operating Room," dated October, 2016, indicated, "To outline the scope of care, service and plan for patient care, ...A. Description of Services Provided...Because the patient is unable to respond to enviromental stimuli, a vital aspect of the nursing care is to proceed as patient advocate, safeguarding his well being."

2. Refer to finding # 1.

3. During a review of Patient 25's medical record, it showed the patient was admitted for outpatient surgery on August 30, 2017 at 9:48 AM, for a revision of a dialysis fistula (a surgically created access to use for dialysis which is a machine that removes waste from a patient's blood when their own kidneys no longer function) and had diagnoses that included chronic kidney disease requiring chronic dialysis, hypertension (high blood presure) and Gout (red, swollen and painful joints).

In an interview with Registered Nurse 6 (RN 6) on January 4, 2018 at 3:18 PM, she stated she was a circulator in training (a nurse who is responsible for charting what is happening in the operating room and tracks the supplies and equipment used. The nurse may be called on to obtain supplies and equipment and performs the count of supplies to make sure nothing was left inside the patient's surgical site). She stated the Pre-op (before surgery) nurse gave me report (a brief overview of the patient's condition and what has been done and what needs to be done for the patient). She stated she reviewed the medical record and matched the procedure in the doctor's order with the procedure on the informed consent. She stated she did not verify the consent was signed by the patient. She stated, "I thought the pre-op nurse had verified that the consent was signed." RN 6 then stated she brought the patient into the outpatient operting room one (1) and had the patient state his name, date of birth, the procedure name and surgical site before the anesthesia was started, then the anethesiologist started the anesthesia. Then the surgeon entered and the surgical pause (a review to ensure the right patient, the right procedure and the correct body part is to have surgery) was done. The informed consent was opened and it was identified that the patient had not signed the informed consent. The surgeon told us to stop. The patient was awakened and went to the recovery room (PACU).

In an interview with Patient 25's surgeon (Physician 2) on January 5, 2018 at 8:59 AM, he stated, "I remember the case very well. I did get his informed consent." It varies whether the patient signs the consent before I do. Sometimes the nurses get it signed before I do and sometimes not, so I don't always see the patient's signature. The nurse missed it. Anesthesia should have checked the consent for the patient's signature before giving the anesthesia. "He kind of dropped the ball." He stated the anesthesia usually wears off in about an hour or two. We usually send the patient home alert & oriented after an hour.

In an interview with the Chief Medical Officer (CMO) on January 5, 2018 at 1:15 PM, he stated consents need to be reviewed prior to anesthesia.

Review of the Pre-op "Surgical Documents" dated August 8, 2017, showed the following:

PRE-OP (first entry in outpatient surgery)
"Patient arrival time 08/30/17 10:25:00
Patient ready for transport 08/30/17 11:00:00...case cancelled in room

Surgical Procedure
Procedure Start 08/30/17 11:00:00
Anesthesia Type General
Procedure Stop 08/30/17 11:12:00

OR (operating room) (second time to surgery)
In Room Time 08/30/17 16:25:00 (4:00 PM)
Stop Time 08/30/17 19:12:00 (7:12 PM)"

Review of the Surgical Informed Consent dated August 8, 2017, showed Patient 25 signed the consent at 1:10 PM

In a review of the Anesthesia Physician Note dated August 30, 2017 at 12:08 PM (after the first anesthesia), showed the following:

"Consent was signed by the patient."

In a review of the Anesthesia Physician Note dated August 30, 2017 at 2:45 PM (before the second anesthesia), showed the following:

"Because of the incomplete consent, he did not have surgery."

In an interview with the anesthesiologist (Physician 3) on January 5, 2017 at 9:42 AM, he stated, He did not remember the case. But reviewing the notes he saw that the patient got anesthesia at 11 AM and ended at 12:22PM. He stated he wrote a brief note "Because of the incomplete consent, he did not have surgery. "I don't remember if it was the surgeon who didn't sign or the patient." When informed it was the patient who didn't sign. He stated, "Oh, I kind of remember now." He stated he explains the type of anesthesia and its risks and benefits to the patient before the surgery, then when the patient signs the surgical consent they are also signing consent for anesthesia. He stated that he usually checks for patient consent signature before anesthesia. He was unable to explain why he gave anresthesia before the consent was signed.

The facility failed to ensure the Condition of Participation: CFR 482.23 Nursing Services was met by failing to ensure:

1. A Registered Nurse (RN 4) immediately privided medical care to Patient 2, when Patient 2 was found on the floor. (Refer to A0392)

2. Telemetry strips (electrocardiograph readings-readings of the electrical activity of the heart) were printed during a code blue (an emergency situation announced in a hospital in which a patient is in cardiopulmonary arrest, requiring a team of providers (code team) to rush to the specific location and begin immediate resuscitative efforts) for Patient 2. (Refer to A0392)

3. Registered Nurses were within ratio when providing patient care. (Refer to A0392)

4. A Registered Nurse (RN 7) correctly used personal protective equipment (PPE-items used to protect staff and patients from the spread of infectious diseases). (Refer to A0395)

5. Licensed staff monitored and provided care to all patients in the Emergency Department. (Refer to A0392)

6. Reassessments and vital signs were obtained timely based on the patient's ESI level. (Refer to A0392 and A0395)

7. Emergency Department licensed staff, failed to accurately assess a patient's "Emergency Severity Index" based on the acuity of the patient's health care problems and the number of resources their care is anticipated to require. (Refer to A0392)

8. Life-saving equipment was applied to a patient in a timely manner. (Refer to A0392)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition of Participation: Nursing Services.

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

1. A Registered Nurse (RN 4) immediately responded to provide medical treatment to Patient 2, when Patient 2 was found on the floor. This failure resulted in Patient 2 not receiving immediate medical treatment in a medical emergency situation.

2. Documented evidence of Telemetry strips (cardiac rhythm monitoring which are readings of the electrical activity of the heart) were printed for Patient 2 during a code blue (an emergency situation announced in a hospital in which a patient is in cardiopulmonary arrest, requiring a team of providers to rush to the specific location and begin immediate resuscitative efforts). This failure resulted in no documentation in the clinical record of telemetry strips for Patient 2 during a code blue.

3. Nursing staff were within ratio when providing patient care. This failure had the potential to negatively affect patient care.

4. For Patient 11, License staff failed to monitor the patient's location and to provide care to the patient while in the emergency department.

5. For Patient 11, 15, and 16, the facility failed to follow their policy on reassessment determined by the patient's clinical condition or at a minimum of every two (2) hours or sooner if needed. This failure created the potential for harm if the patient's clinical conditions deteriorated.

6. Emergency Department licensed staff, failed to accurately assess a patient's "Emergency Severity Index" based on the acuity of the patient's health care problems and the number of resources their care is anticipated to require.

7. For Patient 13, the facility failed to ensure physician ordered life-saving equipment was applied to a patient in a timely manner. This failure created the potential for undetected abnormal life threatening cardiac arrhythmia's to be detected placing the patient at risk for possible death.

Findings:

1. A review of Patient 2's clinical record, the "Triage Report," (a procedure used to prioritize emergency care and identify patients who need immediate medical attention) indicated, Patient 2 arrived to the Emergency Department (ED) on October 20, 2017 at 10:31 AM with a chief complaint (the patient's reported reason for seeking medical care) of syncopal episode (fainting).

A review of Patient 2's clinical record, the "Physician History and Physical," dated October 20, 2017, indicated the following:

a. Patient 2 presented to the ED with chief complaint of cough, shortness of breath, wheezing and syncope.

b. Laboratory Data: indicated Troponin 0.113 (a test that measures injury to the heart and indication of a heart attack-normal values are less than 0.01).

c. Plan: The patient [Patient 2] will be admitted to the Telemetry unit (a unit in the hospital that continuously monitors the patient's electrical activity of the heart) unit for monitoring.

During an interview with the Manager of Patient Safety and Accreditation (MPSA) on January 8, 2018, at 9:30 AM, she stated Patient 2 was transported to the Telemetry unit on October 20, 2017 at 4:05 PM.

A review of Patient 2's clinical record, the "EKG Monitor Flow Sheet," dated October 20, 2017 at 4:29 PM, indicated, "Sinus Rhythm (normal regular rhythm of the heart) at a rate of 100 beats per minute (normal heart rate ranges are between 60 to 100 beats per minute)."

During an interview with the MPSA on January 8, 2018 at 9:30 AM, she stated that on the day of the incident [October 20, 2017 at 6:55 PM], during the change of the nursing shift, a Registered Nurse (RN 4) walked by Patient 2's room (room 610) and identified Patient 2 was on the floor faced down. The MPSA stated RN 4 did not provide immediate care to Patient 2, instead RN 4 walked to the North side nurse's station (which is 44 feet away from room 610) to report her findings of Patient 2 being found on the floor faced down. The MPSA stated RN 4 was interviewed and did not have an explanation of why she did not immediately provide medical attention to Patient 2, when she found Patient 2 on the floor faced down. The MPSA stated RN 4 was terminated and is no longer employed at the facility.

A review of a Registered Nurse (RN 5), "Nursing Progress Note, dated October 20, 2017 at 8:06 PM, indicated, "At 6:50 PM-6:55 PM during change of shift, a nurse [RN 4] walked by the pt.'s [Patient 2] room and said something like "There's a patient on the floor in that room, as she walked away."

The MPSA stated, RN 5 and another nurse (RN 5 was not able to recall who the other nurse who responded was) immediately responded to Patient 2. Patient 2 was assessed and was found not breathing with a questionable pulse, immediate resuscitative efforts were initiated and a code blue was called. The MPSA stated she was not sure how long Patient 2 was on the floor. The MPSA stated, the code blue team immediately responded.

During an interview with a Monitor Technician (MT 1) on January 5, 2018, at 9:33 AM, she sated she was the monitor technician on the day of the incident [October 20, 2017]. MT 1 stated she heard "code blue in room 610," and she observed on Patient 2's telemetry monitor sinus bradycardia (means that the heart rate is slower than normal) at 53 beats per minute. MT 1 stated she did not recall if a telemetry strip was printed.

MT 1 further stated telemetry parameters are set from 50 to 150 beats per minute. MT 1 stated if Patient 2's heart rate was lower or higher than the set parameters, the alarms would have alerted her. MT 1 stated she relies on the telemetry monitor to alarm and alert her to possible patient rhythm changes. MT 1 stated Patient 2's heart beat was 53 beats per minute, still within the set parameters.

During a further interview with the MPSA, she reviewed the clinical record for Patient 2 and was not able to find documentation of Patient 2's telemetry strips indicating a heart rhythm of sinus bradycardia at 53 beats per minute. The MPSA stated no telemetry strips were printed out or placed in the clinical record. The PMSA stated the process was not followed.

The facility's policy and procedure titled, "Telemetry Monitoring, Process and Appropriate Use," dated, February 1, 2017, indicated, " ... D. Documentation 1. Rhythm strips will be documented and interpreted upon: ...e. Rapid responses, Code Blue events."

The facility's policy and procedure titled, "Scope of Service Telemetry/DOU," dated October, 2016, indicated, "To outline the scope of care, service and plan for patient care, ...V. Qualifications and Responsibilities of Staff ...Monitor Tech ...recording, reading and posting of tele strips per unit policy."

A further review of RN 5's, "Nursing Progress Note, indicated, "The primary nurse and some of the day shift nurses went running into the room. The pt [Patient 2] was found on the floor unresponsive face to the floor. The code button was pressed. The patient [Patient 2] was turned over and assessed, Patient 2 was found with a faint pulse. A bag valve mask (a hand-held device commonly used to provide positive pressure ventilation to patients who are not breathing or not breathing adequately) was used to provide rescue breaths and compressions were initiated. Patient 2 was placed on the crash cart (a wheeled container carrying medicine and equipment for use in emergency resuscitations) cardiac monitor via the defibrillator pads. Patient 2 was found to have a pulseless sinus rhythm (also known as PEA-pulseless electrical activity, when an organized heart rhythm is observed on the electrocardiogram (ECG) but does not produce a pulse).

RN 5 was not able to be interviewed, she was no longer employed at the facility.

The MPSA further stated, Patient 2 was successfully resuscitated (re-establishing electrical activity of the heart) and transferred to the Intensive Care unit (a unit in the hospital that is dedicated to the care of patients who are seriously ill). The MPSA stated once Patient 2 arrived to the ICU, Patient 2 was found to be in PEA and a code blue was called, Patient 2 subsequently expired.

A review of Patient 2's clinical record, the "Code Blue Record," dated October 20, 2017, at 7:30 PM, indicated, "Time Code Completed 7:54 PM, Expired."

A review of Patient 2's clinical record, the Physician's, "Discharge Summary," dated, October 20, 2017, indicated, "The patient [Patient 2] was found pulseless in her room and CPR (Cardiopulmonary Resuscitation) was initiated and [Patient 2] was transferred to the ICU where she again had another cardiac arrest and was pronounced dead."

During an interview with the Telemetry Manager (TM 1) on January 8, 2018, at 10:43 AM, the TM 1 stated RN 4 was interviewed regarding the events that took place on the day of the incident (October 20, 2017). TM 1 stated through her investigation, RN 4 stated she walked by Patient 2's room [room 610], identified Patient 2 was on the floor faced down, walked by the room, walked back to Patient 2's room to confirm her observation of Patient 2 being on the floor faced down, walked into Patient 2's room and walked back out. RN 4 then proceeded to walk to room 606 where nurses were giving and receiving report. RN 4 asked the nurses if they were assign to Patient 2, the nurses responded "No." At the same time, RN 5 (primary nurse) was walking in the direction of room 606 and overheard RN 4 asking who was the primary nurse for Patient 2, RN 5 stated she was the primary nurse for Patient 2. RN 4 reported to RN 5 that Patient 2 was on the floor. Then RN 4 proceeded to walk to the North side nurses station. TM 1 stated she asked RN 4 why she did not immediately provide medical attention to Patient 2 and RN 4 stated she had her hands full, she did not want to place her water bottle and clip board on the floor.

The facility's policy and procedure titled, "Scope of Service Telemetry/DOU," dated October, 2016, indicated, "To outline the scope of care, service and plan for patient care. A. Description of Services Provided, the Telemetry/DOU unit at (name of facility) delivers quality, competent, compassionate, age appropriate care to the seriously ill medical and surgical patients in an efficient and cost effective manner."

During an interview with the Chief Nursing Executive Officer (CNEO) on January 8, 2018 at 1:32 PM, she stated she interviewed RN 4 regarding the incident on October 20, 2017, and RN 4 stated she did not respond to Patient 2 when she found Patient 2 on the floor faced down because she did not want to place her water bottle and clipboard on the floor. The CNEO stated RN 4 was terminated and reported to the Board of Register Nurses (a state governmental agency established by law to protect the public by regulating the practice of registered nurses). The CNEO stated there was no documentation of Patient 2's telemetry strips in the clinical record. The CNEO stated, "apparently those strips disappeared." The CNEO further stated telemetry parameters should be individualized for each patient.

2. Refer to finding # 1.

3. During an interview with a Registered Nurse (RN 8) on January 3, 2018 at 11:42 AM, he stated the Medical Surgical unit 4th tower East/West was a 5:1 patient to nurse ratio. RN 8 stated the charge nurse had to take an assignment because the unit was short staffed. RN 8 stated the charge nurse normally covers lunches and breaks but since there was no charge nurse, the nurses were covering each other for lunch. RN 8 stated when the nurses cover each other for lunch the nurses are out of ratio.

During an interview with a Registered Nurse (RN 9) on January 3, 2018, at 2:07 PM, she stated there was not a charge nurse assigned to the unit because the Medical Surgical unit 4th tower East/West was short staffed. RN 9 stated the unit was a 5:1 patient to nurse ratio. RN 9 stated the nurses on the unit were covering each other for lunches. RN 9 stated she was assigned to three (3) patients and she covered RN 8's five (5) patients for lunch. RN 9 stated when she was covering RN 8's five (5) patients she had a total of 8 patients, which puts her out of ratio.

During an interview with the Medical Surgical unit 4th tower East/West Manager (MSM 1) on January 3, 2018 at 2:18 PM, she confirmed the unit was short staffed and there was not a charge nurse assigned. MSM 1 stated she was aware the nurses were out of ratio when they were covering each other for lunch.

A review of the Medical Surgical 4th East/West Assignment Sheet, dated January 3, 2018, indicated, "No Charge Nurse."

The facility's policy and procedure titled, "Scope of Service 4 Towe Orthopedic/Neurological/Surgical," dated October, 2016, indicated, "..VI. Staffing... C. ...Staffing is based upon the mandated 5:1 RN nurse/patient ratio."


18928

4. Record review conducted on January 3, 2018, revealed Patient 11, presented to the Emergency Department (ED) on December 30, 2017 at 11:35 AM, with complaints of bilateral (left and right side) leg swelling and throat pain.

A review of the patients ED record revealed the patient was seen by Physician Assistant 1 (PA) at 11:39 AM. PA 1 documented the patient had a history of a left nephrectomy (kidney removal), left kidney cancer and recently (two days prior) had a biopsy of his right kidney.

At approximately 11:43 AM, the ED Triage Nurse 1 (EDTN) obtained a blood pressure of 76/47 mmHg, the EDTN further documented the patient was experiencing a pain intensity level of eight (8). No documented evidence could be located in the patients ED record to indicate that a second blood pressure was obtained to validate if the patient the low blood pressure was actual.

According to the ED Physician Notes under the "Impression and Plan" in the "Disposition" section, documentation revealed "Patient care transitioned to: Time 12/30/17 11:49 AM, patient transferred to main (treatment area)."

On January 4, 2018 at 1:35 PM, an interview was conducted with the ED Manager (EDM) and the Director of the ED (DED). During the interview the EDM was asked after the patient left the triage area, who was assigned to care for the patient, the EDM stated, "It is unknown where the patient was taken to." The EDM further stated we are currently investigating the situation, we think the patient was then taken to the fast track area, the "assumption was that was the only open area."

The DED stated the fast track area consisted of 3 rooms and patients could also be placed in the RAP (results are pending-a room consisting of approximately 10 chairs used for patients receiving intravenous {in vein} fluids, awaiting lab results) room. The DED further stated patients from "Main" are also placed in the RAP room.

The DED and the EDM were asked who the patients in the RAP room were assigned to, the EDM stated, if they were a fast track patient then a fast track nurse would take care of them, if they were a main patient then a main nurse would take care of them. The EDM was asked when a patient is placed in the RAP room either as a fast track patient or as a main patient if a specific licensed staff member is assigned to provide the care to the patient, the EDM stated, "No."

Further review of the patient's ED record revealed at approximately 12:40 PM, a "SEPSIS Alert" was computer generated regarding Patient 11. The alert stated, "This patient has met criteria that predict high likelihood of SEVERE SEPSIS. Call the provider immediately to report these results and suggest orders according to the sepsis bundle."

On January 4, 2018 at 1:35 PM, during the interview with the EDM, the EDM was asked who is made aware of a "SEPSIS Alert," the EDM stated, "Whoever opens up the chart will see the notation of "SEPSIS Alert" in any section of the chart (nursing or physician). The EDM was asked if it anyone responded to the "SEPSIS Alert" the EDM stated, "It doesn't look like anyone was logging into the patient's chart." The EDM was asked if it was safe to say that the sepsis protocol was not put into effect, the EDM replied, "You are right."

On January 4, 2018 at 3 PM, another interview was conducted with the EDM, the EDM stated we are looking at the December 30, 2017 video as well as security to try to locate the patient, we've only been able to locate him when he first arrived.

The EDM was asked if the RAP room was an appropriate area for Patient 11 to be placed in after the PA identified that the patient was not a fast track patient and needed more resources, the EDM stated, "This day we were not going to find a bed."

No documented evidence could be located in the ED record to indicate where Patient 11 was placed within the ED after the PA documented "Patient care transitioned to: Time 12/30/17 11:49 AM, patient transferred to main (treatment area). In addition, no documented evidence could be located in the ED record to indicate who was providing care to the patient until EDRN 2 assumed care at 8 PM.

5a. Record review conducted on January 3, 2018, revealed Patient 11, presented to the Emergency Department (ED) on December 30, 2017 at 11:35 AM, with complaints of bilateral (left and right side) leg swelling and throat pain.

A review of the ED Physician Notes dated December 30, 2017, revealed documentation that the patient was seen by Physician Assistant 1 (PA) at 11:39 AM. PA 1 documented the patient had a history of a left nephrectomy (kidney removal), left kidney cancer and recently (two days prior) had a biopsy of his right kidney.

At 11:43 AM, ED Triage Nurse 1 (EDTN) obtained the patient's vital signs which revealed a blood pressure of 76/47 mmHg (millimeters of mercury) with a pain intensity level of eight (8). Patient 11 was assigned as an ESI level 4.

According to the ED Physician Notes under the "Impression and Plan" in the "Disposition" section, documentation revealed "Patient care transitioned to: Time 12/30/17 11:49 AM, patient transferred to main (treatment area)."

Further review of the patient's medical record revealed no reassessment or vital signs were obtained from the patient until December 30, 2017 at 8 PM, approximately 8 hours and 17 minutes after the initial assessment and vital signs were obtained from the patient.

A review of the Emergency Department's Patient Care Services Policy and Procedure titled "Patient Assessment and Reassessment" last approved date August 3, 2016, under the "PURPOSE" section documentation revealed the following:

"1.2 Reassessments are based on individual patient acuity, which is specific to clinical condition, changes in clinical status or diagnosis, or physician's order. However, guidelines are as follows:

ESI level 1 = every 15 minutes or sooner if needed
ESI level 2 = every 30-60 minutes or sooner if needed
ESI level 3 = every 2 hours or sooner if needed
ESI level 4 = every 2-4 hours or sooner if needed
ESI level 5 = upon discharge or sooner if needed"

On January 4, 2018 at 1:35 PM, an interview was conducted with the ED Manager (EDM) and the Director of the ED (DED). During the interview the EDM and the DED were shown the patient's ED record, the EDM was asked if he could provide documentation that a reassessment and additional vital signs were completed, the EDM stated, "No, they were not done again until 2000 (8 PM)." The EDM further stated, "That's not our policy." The EDM further stated, "The expectation is for nurses to triage patients, follow policy's and protocols and provide patient care."

b. Record review conducted on January 5, 2018, revealed Patient 15 presented to the ED on December 30, 2017 at 1:35 PM, with a right arm injury. A review of the December 30, 2017 ED flowsheet revealed the patient was categorized as an ESI level 4. At 1:37 PM, vital signs were obtained and an initial assessment was performed on the patient.

Further review of the December 30, 2017 ED flowsheet, revealed vital signs were not obtained or a reassessment completed until 8 PM, approximately 6 hours and 23 minutes after the initial reassessment and vital signs were obtained.

On January 8, 2018 at 12:15 PM, an interview was conducted with the ED Medical Director (EDMD). The EDMD stated vital signs and reassessments should be completed according to facility policy and procedure further stating this is not standard practice.

c. Record review conducted on January 5, 2018, revealed Patient 16 presented to the ED on December 30, 2017 at 11:13 AM for fever lasting 3 days. A review of the December 30, 2017 ED flowsheet revealed the patient was categorized as an ESI level 4. At 11:33 AM, initial vital signs were obtained.

Further review of the December 30, 2017 ED flowsheet, revealed vital signs were not obtained until 7 PM, approximately 7 hours and 27 minutes after the initial set of vital signs were obtained.

On January 8, 2018 at 12:15 PM, an interview was conducted with the ED Medical Director (EDMD). The EDMD stated vital signs and reassessments should be completed according to facility policy and procedure and this is not standard practice.

6. On December 30, 2017, at 11:35 AM, Patient 11 presented to the ED with complaints of bilateral leg swelling. A review of the ED Physician Notes dated December 30, 2017, revealed documentation that the patient was seen by Physician Assistant 1 (PA) at 11:39 AM.

At 11:43 AM, ED Triage Nurse 1 (EDTN) obtained the patient's vital signs which revealed a blood pressure of 76/47 mmHg (millimeters of mercury) with a pain intensity level of eight (8). EDTN 1 assigned the patient as an "Emergency Severity Index" level four (4): Patients who are likely to require one resource.

On January 4, 2018, at 1:35 PM, an interview was conducted with the ED Manager (EDM). The EDM was asked based on the patient's initial symptom's (BP 76/47 and pain intensity level of 8) if the ESI level four (4) was appropriate, the EDM replied, the patient "should not have been a 4, perhaps a 3 or even a 2."

On January 8, 2018 at 12:15 PM, an interview was conducted with the ED Medical Director (EDMD). During the interview, the EDMD confirmed the patient's ESI level was not accurate and should have been at a minimum an ESI level three and possibly an ESI level two.

7. On January 5, 2018 at 12:50 PM, observation of the ED tracker revealed Patient 13, presented to the Emergency Department at 9:33 AM, following a motor vehicle accident status post seizure. Further observation of the ED tracker revealed "Needs Cardiac Monitor."

At 12:55 PM, an interview was conducted with the EDFTCN, the EDFTCN stated the ED physician wanted the patient in the back (main ED treatment area) and not in the waiting room because he had a seizure. The EDFTCN was asked to point out the patient, the patient was observed sitting in a chair outside the fast track area without a cardiac monitor. The EDFTCN was observed to walk to the nurse's station in the main ED and speak with the physician. Upon the EDFTCN return she stated the physician still wanted the patient on a cardiac monitor.

The EDFTCN was asked why a cardiac monitor had not been placed on the patient, the EDFTCN stated, "There are none available."

On January 5, 2018 at 1 PM, an interview was conducted with the Director of the ED. The DED was asked what they needed to do when they are short on equipment, the DED stated, "We need to locate some."

On January 5, 2018 at 1:55 PM, the DED was asked if he was aware that Patient 13 had an ordered for a cardiac monitor however none were available, the DED stated he did not know.

On January 5, 2018 at 1:57 PM, observation of Patient 13 revealed a cardiac monitor had yet to be applied on to the patient. At 2 PM, an interview was conducted with EDMCN 2, the EDMCN confirmed they were out of cardiac monitors and further stated he was aware that the patient needed a cardiac monitor further stating that the patient hadn't had a seizure in two (2) years and that he assessed the situation and felt the patient was not in need of a cardiac monitor. The EDMCN confirmed he had not elevated the need for a cardiac monitor to ED management.

On January 5, 2018 at 3:41 PM, a review of Patient 13's ED orders revealed the ED physician wrote the order for the cardiac monitor at 10:39 AM and had yet to be applied to the patient until after this surveyor intervened.

On January 8, 2018 at 9 AM, an interview was conducted with the EDM. The EDM stated he was not made aware of the need for a cardiac monitor for Patient 13 until after the fact, the EDM further stated they were able to locate an additional 7 telemetry monitors from the hospital floors. In addition, the EDM stated the EDMCN should have informed ED management of the need and can not make the determination on their own to not have a patient on a cardiac monitor when there is a specific order from the physician.

Based on observation and interview, the facility failed to follow their policy on reassessment determined by the patient's clinical condition or at a minimum of every two (2) hours or sooner if needed. This failure created the potential for harm if the patient's clinical conditions deteriorated. In addition, Registered Nurse (RN 7) failed to correctly use personal protective equipment (PPE-items used to protect staff and patients from the spread of infectious diseases). This failure had the potential to result in the spread of infection to patients and staff.

Findings:

1a. Record review conducted on January 3, 2018, revealed Patient 11, presented to the Emergency Department (ED) on December 30, 2017 at 11:35 AM, with complaints of bilateral (left and right side) leg swelling and throat pain.

A review of the ED Physician Notes dated December 30, 2017, revealed documentation that the patient was seen by Physician Assistant 1 (PA) at 11:39 AM. PA 1 documented the patient had a history of a left nephrectomy (kidney removal), left kidney cancer and recently (two days prior) had a biopsy of his right kidney.

At 11:43 AM, ED Triage Nurse 1 (EDTN) obtained the patient's vital signs which revealed a blood pressure of 76/47 mmHg (millimeters of mercury) with a pain intensity level of eight (8). Patient 11 was assigned as an ESI level 4.

According to the ED Physician Notes under the "Impression and Plan" in the "Disposition" section, documentation revealed "Patient care transitioned to: Time 12/30/17 11:49 AM, patient transferred to main (treatment area)."

Further review of the patient's medical record revealed no reassessment or vital signs were obtained from the patient until December 30, 2017 at 8 PM, approximately 8 hours and 17 minutes after the initial assessment and vital signs were obtained from the patient.

A review of the Emergency Department's Patient Care Services Policy and Procedure titled "Patient Assessment and Reassessment" last approved date August 3, 2016, under the "PURPOSE" section documentation revealed the following:

"1.2 Reassessments are based on individual patient acuity, which is specific to clinical condition, changes in clinical status or diagnosis, or physician's order. However, guidelines are as follows:

ESI level 1 = every 15 minutes or sooner if needed
ESI level 2 = every 30-60 minutes or sooner if needed
ESI level 3 = every 2 hours or sooner if needed
ESI level 4 = every 2-4 hours or sooner if needed
ESI level 5 = upon discharge or sooner if needed"

On January 4, 2018 at 1:35 PM, an interview was conducted with the ED Manager (EDM) and the Director of the ED (DED). During the interview the EDM and the DED were shown the patient's ED record, the EDM was asked if he could provide documentation that a reassessment and additional vital signs were completed, the EDM stated, "No, they were not done again until 2000 (8 PM)." The EDM further stated, "That's not our policy." The EDM further stated, "The expectation is for nurses to triage patients, follow policy's and protocols and provide patient care."

b. Record review conducted on January 5, 2018, revealed Patient 15 presented to the ED on December 30, 2017 at 1:35 PM, with a right arm injury. A review of the December 30, 2017 ED flowsheet revealed the patient was categorized as an ESI level 4. At 1:37 PM, vital signs were obtained and an initial assessment was performed on the patient.

Further review of the December 30, 2017 ED flowsheet, revealed vital signs were not obtained or a reassessment completed until 8 PM, approximately 6 hours and 23 minutes after the initial reassessment and vital signs were obtained.

On January 8, 2018 at 12:15 PM, an interview was conducted with the ED Medical Director (EDMD). The EDMD stated vital signs and reassessments should be completed according to facility policy and procedure further stating this is not standard practice.

c. Record review conducted on January 5, 2018, revealed Patient 16 presented to the ED on December 30, 2017 at 11:13 AM for fever lasting 3 days. A review of the December 30, 2017 ED flowsheet revealed the patient was categorized as an ESI level 4. At 11:33 AM, initial vital signs were obtained.

Further review of the December 30, 2017 ED flowsheet, revealed vital signs were not obtained until 7 PM, approximately 7 hours and 27 minutes after the initial set of vital signs were obtained.

On January 8, 2018 at 12:15 PM, an interview was conducted with the ED Medical Director (EDMD). The EDMD stated vital signs and reassessments should be completed according to facility policy and procedure and this is not standard practice.



25179

2. During observation of the administration of packed red blood cells (blood) on January 4, 2018 at 9:15 AM, in a Contact Isolation (a room used to contain infectious bacteria to prevent the spread of infection) room for a patient who had MRSA (Methicillin Resistant Staphalococcus-a bacteria that is resistant to being killed by antibiotics), Registered Nurse (RN 7) was observed to put on an isolation gown and left the back open and exposed, presenting an opportunity for RN 7 to spread infection. (The gown is disposed of in the isolation room before the nurse exits but the clothing on the back that was exposed could carry the bacteria out of the room and expose people in contact with the nurse).

In an interview with the Intensive Care Unit Manager (ICM) on January 4, 2018 at 9:35 AM, she stated the gown should be closed in the back.

In an interview with the Infection Control Nurse on January 4, 2018 at 4:50 PM, she stated the isolation gown should be tied in the back, the back should be closed. It was their protocol to make rounds and look for improperly used PPE and other infection control issues.

The facility failed to ensure the Condition of Participation: CFR 482.51 Surgical Services was met by failing to ensure:

1. The Operating Room (OR) team followed the Universal Protocol (a protocol developed to prevent wrong person, wrong procedure, wrong site surgery in hospitals and outpatient settings). (Refer to A-0951)

2. Physician 1 followed the Universal Protocol. (Refer to A-0951)

3. The Operating Room (OR) staff were able to verbalize OR temperature and humidity parameters. (Refer to A-0951)

3. Temperatures and humidity were within range in the Sterile Processing Department (SPD- is where medical/surgical supplies and equipment, are cleaned, prepared, processed, stored, and issued for patient care) pre/packaging/sterilization area. (Refer to A-0951)

4. Manufacturer recommendations were followed for the cleaning maintenance of the Caviwave Ultrasonic Cleaning System # 1 (a machine used to clean, flush, lubricate, and dry reusable patient equipment. (Refer to A0951)

5. Temperatures and Humidity were within range in the Operating Rooms. (Refer to A0951)

6. Patient 1's informed consent was properly executed prior to surgery. (Refer to A0955)

7. Patient 25's informed consent for surgery was properly executed by failing to ensure the patient signed the surgical consent. (Refer to A0955)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition of Participation: Surgical Services.

Based on interview, and record review, the facility failed to ensure the delivery of surgical services were provided in accordance with standard of practice when:

1.The Operating Room (OR) team did not follow the Universal Protocol (a protocol developed to prevent wrong person, wrong procedure, wrong site surgery in hospitals and outpatient settings). This failure resulted in a right varicocelectomy (a surgical procedure that removes varicose veins in the scrotum) being performed on Patient 1 without consent.

2. Physician 1 did not follow the Universal Protocol. This failure resulted in a right varicocelectomy being performed on Patient 1 without consent.

3.Temperatures and humidity (the amount of moisture in the air) were not within range in the Sterile Processing Department (SPD- is where medical/surgical supplies and reusable patient equipment, are cleaned, prepared, processed, stored, and issued for patient care) pre/packaging/sterilization area. This failure had the potential for the spread of infection in a universe of 220 patients.

4. Manufacturer recommendations were not followed for the cleaning maintenance of the Caviwave Ultrasonic Cleaning System # 1 (a machine used to clean, flush, lubricate, and dry reusable patient equipment.This failure had the potential for the spread of infection in a universe of 220 patients.

5. Temperature and Humidity were not within range in the Operating Rooms. This failure had the potential for the spread of infection in a universe of 220 patients.

6. The Operating Room (OR) staff were not able to verbalize OR temperature and humidity parameters. This failure had potential to affect the health and safety of the patients and OR personnel.

Findings:

1. A review of Patient 1's facesheet (demographics) indicated Patient 1 was admitted to the facility on August 18, 2017, with a diagnosis of testicular pain.

A review of Patient 1's "History and Physical," dated August 17, 2017, indicated, " ... Patient is a 44-year-old man with history of left testicular discomfort and varicocele .... Plan: Consented for left varicocelectomy (a surgical procedure that removes varicose veins in the scrotum). He [Patient 1] understands the benefits, risks, and alternative treatment options."

A review of the "Consent to Surgery or Special Procedure," dated August 18, 2017 indicated Patient 1 consented and signed for a left varicocelectomy.

During an interview with the OR scrub technician (assist surgeons in the operating room) (ORST 1) on January 4, 2018 at 11:57 AM, she stated once Patient 1 was present in OR room four (4), the circulating nurse [RN 1] initiated the surgical/procedural pause timeout. The ORST 1 stated the surgical/procedural pause time out included stating Patient 1's name, date of birth, procedure name and procedure/surgery site outloud to the OR team. During the timeout, it is the responsibility of the OR team to engage and acknowledge the timeout by stating "yes' or "correct." The ORST 1 stated during the timeout she heard the procedure name but did not hear the surgery site. The ORST 1 stated she should have asked about the surgery site and it was her responsibility to know what side the surgery was going to be performed on. The ORST 1 further stated as the scrub technician she will only view the operative site but did not observe a marking and she did not ask any questions.

The facility's policy and procedure titled, "Universal Protocol (Marking of Operative/Procedural Site & "Time Out"/Surgical/Procedural Pause), dated November 2015, indicated, "...4.5 "Time out must be conducted in the location where the procedure will be done, just before starting the procedure; must actively involve the entire operative/procedural team and use active communication by validating the consent and verbalizing a minimum of the following: ...verify correct procedure, side, and site are marked ...verbal team agreement."

During an interview with the circulating Registered Nurse (RN 1) on January 2, 2018 at 3:37 PM, he stated during pre-op (pre operation-before surgery) he confirmed with Patient 1, Patient 1's name, date of birth, and procedure name and procedure site. RN 1 stated he confirmed Patient 1 was consented for a left varicocelectomy. RN 1 stated he observed Physician 1 marked Patient 1's left hand because the surgery was going to be performed on the left genital area. RN 1 stated Patient 1 was then transported to the OR where he initiated the surgical/procedural pause time out. RN 1 stated once Patient 1 was present in the OR, he was not able to visualize the marking made by Physician 1 because he was at the computer.

RN 1 stated once the procedure was completed Patient 1 was transported to Post Anesthesia Care Unit (PACU- the unit where patients are temporarily admitted after surgical procedures for post anesthesia recovery). RN 1 stated he gave report (accurate up to date pertinent patient information) to RN 2 in the PACU. Once report was given, RN 2 identified Patient 1 had a right side varicocelectomy performed instead of a left varicocelectomy. RN 1 stated he immediately notified Physician 1 of RN 2's findings. RN 1 stated Physician 1's response was that he was going to obtain consent for a right varicocelectomy from Patient 1's fiancée.

During an interview with the PACU Registered Nurse (RN 2) on January 4, 2018 at 11:15 AM, she stated Patient 2 was transported to the PACU. RN 2 stated she received report from RN 1. RN 2 stated she was informed by RN 1 a right varicocelectomy was performed on Patient 1. RN 2 stated she identified Patient 1 had a right varicocelectomy performed without consent. RN 2 stated she assessed the surgical site with RN 1 and confirmed a surgical post operative incision underneath the right scotum of Patient 1.

Review of Patient 1's clinical record titled, "General Information," dated August 18, 2017 at 9:40 AM, documented by RN 2, indicated, "While being given report, I questioned the side of the operation, OR RN [RN 1] repeated right side, I said all paperwork and case scheduled for left side."

Review of Patient 1's clinical record titled, "General Information," dated August 18, 2017 at 10:05 AM, documented by RN 2, indicated, "RN 2 at bedside to take patient back to OR to operate on left side."

During an interview with the Urologist (a physician who specializes in the urinary tract and reproductive organs) (Physician 1) on January 8, 2018 at 1:20 PM, he stated in the pre-procedural area (the time before surgery where all forms of care are provided to the patient) he marked Patient 1's left hand. Physician 1 stated he marked Patient 1's left hand because the surgery was going to be performed in the genital area. Physican 1 stated the left hand was not near the incision site. Physician 1 stated the policy states the marking needs to be near the incision site, the policy was not followed.

Physician 1 stated once Patient 1 was present in the OR room, the Universal Protocol Surgical/Procedural Pause Timeout was initiated by the circulating nurse [RN 1]. Physician 1 stated he should have engaged and acknowledged the time out but did not remember if he did. Physician 1 further stated his eyes tricked him and Patient 1's right side varicocele was more prominent and he performed a right varicocelectomy instead of a left varicocelectomy. Physician 1 stated he performed a right varicocelectomy without Patient 1's consent. Physician 1 stated, "it was a mistake."

The facility's policy and procedure titled, "Universal Protocol (Marking of Operative/Procedural Site & "Time Out"/Surgical/Procedural Pause), dated November 2015, indicated, "...Marking the surgical procedural site ...the correct side & site will be marked with his/her initials ...the mark should be at or near the incision site."

A review of the "Progress Notes," dated August 18, 2017, indicated, "44 year male with hx (history) of left varicocelectomy which showed on scrotal u/s (ultrasound) many months ago. Varicocele was prominent on exam. He [Patient 1] was consented to have left varicocelectomy. Under anesthesia, he was found to have prominent varicocelectomy on right testicle. He had right varicocelectomy and found that he was consented for left side in recovery room.

The facility's policy and procedure titled, "Scopes of Service Main Operating Room," dated October, 2016, indicated, "To outline the scope of care, service and plan for patient care, ...A. Description of Services Provided...Because the patient is unable to respond to enviromental stimuli, a vital aspect of the nursing care is to proceed as patient advocate, safeguarding his well being."

2. Refer to finding # 1.

3. A review of the "Sterile Processing Department Prep Area," Temperature and Humidity log dated for the month of January 2018 indicated the following:

January 3, 2018, Temperature 66.0, Humidity 25.4 %

During an interview with a Sterile Processing Technician (SPDT1) on January 4, 2018 at 9:06 AM, she stated she checked the temperature and humidity in the morning and logged it. SPDT 1 stated the temperature and humidity were out of range but she did not call engineering. SPDT1 stated she forgot to call engineer when she identified the temperature and humidity were out of range.

During an interview with the Sterile Processing Manager (SPDM) on January 4, 2018 at 9:08 AM, she stated the expectation was for staff to call engineering when temperature and humidity are out of range.

A review of the "Sterile Processing Department Prep Area," Temperature and Humidity log dated for the month of December 2017 indicated the following:

December 4, 2017, Temperature 66.8, Humidity 18.1%
December 12, 2017, Temperature 66.0, Humidity 13.4%
December 13, 2017, Temperature 64.6, Humidity 20.5%
December 16, 2017, Temperature 66.5, Humidity 19.3%
December 28, 2017, Temperature 63.9, Humidity 21.6%
December 29, 2017, Temperature 63.9, Humidity 27.9%
December 30, 2017, Temperature 64.1, Humidity 20.5%
December 31, 2017, Temperature 65.3, Humidity 24.4%

During a concurrent interview with the SPDM, she stated she was not aware the temperature and humidity were out of range. The SPDM stated the process was not followed.
During an interview with the Infection Control Preventionist (ICP) on January 3, 2018, at 4:17 PM, she stated she should have closely overseen the Sterile Processing Department. The ICP stated the engineering department should have been called when the temperature and humidity where identified as out of range. The ICP stated the SPD staff are aware of the process, however the process was not followed.

The facility's policy and procedure titled, "Temperature, Humidity, and Air Flow Requirements for the Processing Areas, dated December 2014, indicated, "To identify the recommended environmental conditions in the processing area to prevent cross contamination of packs and to maintain packaging material integrity ...2. The Prep/Packaging/Sterilization Area, Temperature of 68-73 degree Celsius, Humidity 35-60%."."

4. A review of the "Caviwave Ultrasonic Cleaning System Operator Manual," indicated, "...4.3 General Cleaning Procedures... "3. Apply cleaning solution with damp cloth to cabinet surfaces and chamber interiors, rubbing in back and forth motion, Rinse cloth and wipe off any detergent residue, then dry surfaces with clean, dry lint-free cloth."

During an interview with a Lead Sterile Processor (LSP1) on January 4, 2018 at 4:22 PM, she stated the Sterile Processing Department (SPD) was responsible for the cleaning maintenance of the Caviwave Ultrasonic Cleaning System. LSP1 stated the cleaning maintenance was completed on a daily basis. The LSP1 stated she did not have documented evidence for the cleaning maintenance that was completed.

A review of the "Caviwave Ultrasonic Cleaning System Operator Manual," indicated, " ...4.3 Monthly Cleaning Procedure, after each monthly use of the Caviwave Ultrasonic Cleaning System, clean and disinfect system as follows ... check cleaning chamber strainer for debris, clean as required, inspect and clean air filter, clean generators to remove any dust or dirt ..."

During an interview with LSPD1 on January 4, 2018 at 4:22 PM, she stated the Sterile Processing Department does not complete the monthly cleaning procedure per manufacturer recommendations.

During an interview with the Infection Control Preventionist (ICP) on January 8, 2018, she stated the manufacture recommendations were not followed.

The facility's policy and procedure titled, "Decontamination of Soiled Instruments and Devices," dated January 2015, indicated, "All instruments and devices shall be cleaned ...per the device manufacturer's written instructions."

5. A review of the "Hospital Critical Areas Room Temperatures and Humidity," log dated January 3, 2018, indicated the following:

Operating Room 3, Temperature 62.0, Humidity 15%
Operating Room 4, Temperature 61.2, Humidity 16%
Operating Room 7, Temperature 64.5, Humidity 19%

A review of the "Hospital Critical Areas Room Temperature and Humidity," log dated January 2, 2018, indicated the following:

Operating Room 1, Temperature 63.7, Humidity 18%
Operating Room 3, Temperature 62.1, Humidity 13%
Operating Room 7, Temperature 64.3, Humidity 17%

During an interview with the Director of Safety Security and Emergency Management (DSSEM) on January 3, 218 at 3:30 PM, she stated she was temporarily overseeing the Plant Engineering Department. The DSSEM stated multiple temperatures and humidity readings were documented as out of range in multiple operating rooms. The DSSEM stated Operating room temperatures should be maintained between 68-75 degree Celsius, and humidity between 20%-60%. The DSSEM stated once a temperature and humidity is identified as out of range the plant engineering staff is responsible to document corrected actions that were taken. The DSSEM stated there was no documented evidence of corrected actions taken. The DSSEM stated the process was not followed.

The facility's policy and procedure titled, "Scopes of Services Main Operating Room," dated October 2016, indicated, "To outline the scope of care, service and plan for patient care... 10. Department Goals... E. To design and equip the operating room to facilitate effective care and safety of patients..."

The facility's policy and procedure titled, "Temperature, Humidity, and Air Flow Requirements for the Pocessing Areas," dated December, 2014, indicated, "...Tempearture and humidity levels shall be monitored daily by Engineering Department whenever the facility is open to ensure compliance with recommended environmental conditions."

6. During an interview with a Registered Nurse (RN 3) on January 5, 2018 at 8:07 AM, he stated he did not know what the temperature and humidity (measure of moisture in the air) parameters were for the Operating Room (OR). RN 3 stated he was aware that there are standard parameters but did not know what they were.

During an interview with a OR scrub technician (assits surgeons in the operating room) (ORST 2) on January 5, 2018 at 8:21 AM, he stated he was not sure what the temperature and humdity parameters were for the OR.

During an interview with a Infection Control Preventionist (ICP) on January 8, 2018 at 9:20 AM, she stated OR staff should be aware of the standard required temperature and humidity parameters that are set.

A review of "Clinical Nurse Surgery," Job Description dated May 14, 2015, indicated, "Performance Expectations...4.10 Monitor and control environment."

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

1. Patient 1's informed consent for surgery was properly executed. This failure resulted in Patient 1 not being able to participate in the planning of his own medical care.

2. Patient 25's informed consent for surgery was properly executed by failing to ensure the patient signed the surgical consent. This failure had the potential to violate the patient's right to consent or refuse treatment.

Findings:

1. A review of Patient 1's facesheet (demographics) indicated Patient 1 was admitted to the facility on August 18, 2017, with a diagnosis of testicular pain.

A review of Patient 1's "History and Physical," dated August 17, 2017, indicated, " ... Patient is a 44-year-old man with history of left testicular discomfort and varicocele .... Plan: Consented for left varicocelectomy (a surgical procedure that removes varicose veins in the scrotum). He [Patient 1] understands the benefits, risks, and alternative treatment options."

A review of the "Consent to Surgery or Special Procedure," dated August 18, 2017 indicated Patient 1 consented and signed for a left varicocelectomy.

During an interview with the OR scrub technician (assist surgeons in the operating room) (ORST 1) on January 4, 2018 at 11:57 AM, she stated once Patient 1 was present in OR room four (4), the circulating nurse [RN 1] initiated the surgical/procedural pause timeout. The ORST 1 stated the surgical/procedural pause time out included stating Patient 1's name, date of birth, procedure name and procedure/surgery site outloud to the OR team. During the timeout, it is the responsibility of the OR team to engage and acknowledge the timeout by stating "yes' or "correct." The ORST 1 stated during the timeout she heard the procedure name but did not hear the surgery site. The ORST 1 stated she should have asked about the surgery site and it was her responsibility to know what side the surgery was going to be performed on. The ORST 1 further stated as the scrub technician she will only view the operative site but did not observe a marking and she did not ask any questions.

The facility's policy and procedure titled, "Universal Protocol (Marking of Operative/Procedural Site & "Time Out"/Surgical/Procedural Pause), dated November 2015, indicated, "...4.5 "Time out must be conducted in the location where the procedure will be done, just before starting the procedure; must actively involve the entire operative/procedural team and use active communication by validating the consent and verbalizing a minimum of the following: ...verify correct procedure, side, and site are marked ...verbal team agreement."

During an interview with the circulating Registered Nurse (RN 1) on January 2, 2018 at 3:37 PM, he stated during pre-op (pre operation-before surgery) he confirmed with Patient 1, Patient 1's name, date of birth, and procedure name and procedure site. RN 1 stated he confirmed Patient 1 was consented for a left varicocelectomy. RN 1 stated he observed Physician 1 marked Patient 1's left hand because the surgery was going to be performed on the left genital area. RN 1 stated Patient 1 was then transported to the OR where he initiated the surgical/procedural pause time out. RN 1 stated once Patient 1 was present in the OR, he was not able to visualize the marking made by Physician 1 because he was at the computer.

RN 1 stated once the procedure was completed Patient 1 was transported to Post Anesthesia Care Unit (PACU- the unit where patients are temporarily admitted after surgical procedures for post anesthesia recovery). RN 1 stated he gave report (accurate up to date pertinent patient information) to RN 2 in the PACU. Once report was given, RN 2 identified Patient 1 had a right side varicocelectomy performed instead of a left varicocelectomy. RN 1 stated he immediately notified Physician 1 of RN 2's findings. RN 1 stated Physician 1's response was that he was going to obtain consent for a right varicocelectomy from Patient 1's fiancée.

During an interview with the PACU Registered Nurse (RN 2) on January 4, 2018 at 11:15 AM, she stated Patient 2 was transported to the PACU. RN 2 stated she received report from RN 1. RN 2 stated she was informed by RN 1 a right varicocelectomy was performed on Patient 1. RN 2 stated she identified Patient 1 had a right varicocelectomy performed without consent. RN 2 stated she assessed the surgical site with RN 1 and confirmed a surgical post operative incision underneath the right scotum of Patient 1.

Review of Patient 1's clinical record titled, "General Information," dated August 18, 2017 at 9:40 AM, documented by RN 2, indicated, "While being given report, I questioned the side of the operation, OR RN [RN 1] repeated right side, I said all paperwork and case scheduled for left side."

Review of Patient 1's clinical record titled, "General Information," dated August 18, 2017 at 10:05 AM, documented by RN 2, indicated, "RN 2 at bedside to take patient back to OR to operate on left side."

During an interview with the Urologist (a physician who specializes in the urinary tract and reproductive organs) (Physician 1) on January 8, 2018 at 1:20 PM, he stated in the pre-procedural area (the time before surgery where all forms of care are provided to the patient) he marked Patient 1's left hand. Physician 1 stated he marked Patient 1's left hand because the surgery was going to be performed in the genital area. Physican 1 stated the left hand was not near the incision site. Physician 1 stated the policy states the marking needs to be near the incision site, the policy was not followed.

Physician 1 stated once Patient 1 was present in the OR room, the Universal Protocol Surgical/Procedural Pause Timeout was initiated by the circulating nurse [RN 1]. Physician 1 stated he should have engaged and acknowledged the time out but did not remember if he did. Physician 1 further stated his eyes tricked him and Patient 1's right side varicocele was more prominent and he performed a right varicocelectomy instead of a left varicocelectomy. Physician 1 stated he performed a right varicocelectomy without Patient 1's consent. Physician 1 stated, "it was a mistake."

The facility's policy and procedure titled, "Universal Protocol (Marking of Operative/Procedural Site & "Time Out"/Surgical/Procedural Pause), dated November 2015, indicated, "...Marking the surgical procedural site ...the correct side & site will be marked with his/her initials ...the mark should be at or near the incision site."

A review of the "Progress Notes," dated August 18, 2017, indicated, "44 year male with hx (history) of left varicocelectomy which showed on scrotal u/s (ultrasound) many months ago. Varicocele was prominent on exam. He [Patient 1] was consented to have left varicocelectomy. Under anesthesia, he was found to have prominent varicocelectomy on right testicle. He had right varicocelectomy and found that he was consented for left side in recovery room.

The facility's policy and procedure titled, "Scopes of Service Main Operating Room," dated October, 2016, indicated, "To outline the scope of care, service and plan for patient care, ...A. Description of Services Provided...Because the patient is unable to respond to enviromental stimuli, a vital aspect of the nursing care is to proceed as patient advocate, safeguarding his well being."



25179

2. During a review of Patient 25's medical record, it showed the patient was admitted for outpatient surgery on August 30, 2017 at 9:48 AM, for a revision of a dialysis fistula (a surgically created access to use for dialysis which is a machine that removes waste from a patient's blood when their own kidneys no longer function) and had diagnoses that included chronic kidney disease requiring chronic dialysis, hypertension (high blood presure) and Gout (red, swollen and painful joints).

In an interview with Registered Nurse 6 (RN 6) on January 4, 2018 at 3:18 PM, she stated she was a circulator in training (a nurse who is responsible for charting what is happening in the operating room and tracks the supplies and equipment used. The nurse may be called on to obtain supplies and equipment and performs the count of supplies to make sure nothing was left inside the patient's surgical site). She stated the Pre-op (before surgery) nurse gave me report (a brief overview of the patient's condition and what has been done and what needs to be done for the patient). She stated she reviewed the medical record and matched the procedure in the doctor's order with the procedure on the informed consent. She stated she did not verify the consent was signed by the patient. She stated, "I thought the pre-op nurse had verified that the consent was signed." RN 6 then stated she brought the patient into the outpatient operting room one (1) and had the patient state his name, date of birth, the procedure name and surgical site before the anesthesia was started, then the anethesiologist started the anesthesia. Then the surgeon entered and the surgical pause (a review to ensure the right patient, the right procedure and the correct body part is to have surgery) was done. The informed consent was opened and it was identified that the patient had not signed the informed consent. The surgeon told us to stop. The patient was awakened and went to the recovery room (PACU).

In an interview with Patient 25's surgeon (Physician 2) on January 5, 2018 at 8:59 AM, he stated, "I remember the case very well. I did get his informed consent." It varies whether the patient signs the consent before I do. Sometimes the nurses get it signed before I do and sometimes not, so I don't always see the patient's signature. The nurse missed it. Anesthesia should have checked the consent for the patient's signature before giving the anesthesia. "He kind of dropped the ball." He stated the anesthesia usually wears off in about an hour or two. We usually send the patient home alert & oriented after an hour.

In an interview with the Chief Medical Officer (CMO) on January 5, 2018 at 1:15 PM, he stated consents need to be reviewed prior to anesthesia.

Review of the Pre-op "Surgical Documents" dated August 8, 2017, showed the following:

PRE-OP (first entry in outpatient surgery)
"Patient arrival time 08/30/17 10:25:00
Patient ready for transport 08/30/17 11:00:00...case cancelled in room

Surgical Procedure
Procedure Start 08/30/17 11:00:00
Anesthesia Type General
Procedure Stop 08/30/17 11:12:00

OR (operating room) (second time to surgery)
In Room Time 08/30/17 16:25:00 (4:00 PM)
Stop Time 08/30/17 19:12:00 (7:12 PM)"

Review of the Surgical Informed Consent dated August 8, 2017, showed Patient 25 signed the consent at 1:10 PM

In a review of the Anesthesia Physician Note dated August 30, 2017 at 12:08 PM (after the first anesthesia), showed the following:

"Consent was signed by the patient."

In a review of the Anesthesia Physician Note dated August 30, 2017 at 2:45 PM (before the second anesthesia), showed the following:

"Because of the incomplete consent, he did not have surgery."

In an interview with the anesthesiologist (Physician 3) on January 5, 2017 at 9:42 AM, he stated, He did not remember the case. But reviewing the notes he saw that the patient got anesthesia at 11 AM and ended at 12:22PM. He stated he wrote a brief note "Because of the incomplete consent, he did not have surgery. "I don't remember if it was the surgeon who didn't sign or the patient." When informed it was the patient who didn't sign. He stated, "Oh, I kind of remember now." He stated he explains the type of anesthesia and its risks and benefits to the patient before the surgery, then when the patient signs the surgical consent they are also signing consent for anesthesia. He stated that he usually checks for patient consent signature before anesthesia. He was unable to explain why he gave anresthesia before the consent was signed.

The facility failed to ensure the Condition of Participation: CFR 482.55 Emergency Services was met by failing to ensure:

1. Licensed staff monitored and provided care to all patients in the Emergency Department. (Refer to A1101)

2. Reassessments and vital signs were obtained timely based on the patient's ESI level. (Refer to A1101)

3. Emergency Department licensed staff, failed to accurately assess a patient's "Emergency Severity Index" based on the acuity of the patient's health care problems and the number of resources their care is anticipated to require. (Refer to A1101)

4. Life-saving equipment was applied to a patient in a timely manner. (Refer to A1101)

5. Emergency Department staff failed to report and seek out assistance from other departments in the facility to assist with patient care resources to assess and render appropriate care for an ED patient. (Refer to A1103)

6. ED staff failed to ensure expired items were removed from the treatment floor. (Refer to A1103)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver care in compliance with the Condition of Participation: Emergency Services.

Based on observation, interview, and record review, the facility failed to ensure the delivery of emergency services were provided to four (4) of 30 sampled patients (Patients 11, 13, 15 and 16) in accordance with the facility's policy and procedures as follows:

1. For Patient 11, License staff failed to monitor the patient's location and to provide care to the patient while in the emergency department.

2. For Patient 11, 15, and 16, the facility failed to follow their policy on reassessment determined by the patient's clinical condition or at a minimum of every two (2) hours or sooner if needed. This failure created the potential for harm if the patient's clinical conditions deteriorated.

3. Emergency Department licensed staff, failed to accurately assess a patient's "Emergency Severity Index" based on the acuity of the patient's health care problems and the number of resources their care is anticipated to require.

4. For Patient 13, the facility failed to ensure physician ordered life-saving equipment was applied to a patient in a timely manner. This failure created the potential for undetected abnormal life threatening cardiac arrhythmia's to be detected placing the patient at risk for possible death.

Findings:

1. Record review conducted on January 3, 2018, revealed Patient 11, a 77 year old male who presented to the Emergency Department (ED) on December 30, 2017 at 11:35 AM, with complaints of bilateral (left and right side) leg swelling and throat pain.

Further review of the patients ED record revealed the patient was seen by Physician Assistant 1 (PA) at 11:39 AM. PA 1 documented the patient had a history of a left nephrectomy (kidney removal), left kidney cancer and recently (two days prior) had a biopsy of his right kidney.

At approximately 11:43 AM, the ED Triage Nurse 1 (EDTN) obtained a blood pressure of 76/47 mmHg, the EDTN further documented the patient was experiencing a pain intensity level of eight (8). The EDTN 1 assigned the patient as an "Emergency Severity Index" level four (4) based on a level one (1-requiring life-saving interventions) to a level five (5-patients likely to require no resources) scale.

On January 4, 2018, at 9:35 AM, an interview was conducted with EDTN 1. During the interview EDTN 1 stated she had difficulty obtaining the patient's blood pressure, "I checked both arms and changed the cuff, when I got it, it (blood pressure) was low."

According to the ED Physician Notes under the "Impression and Plan" in the "Disposition" section, documentation revealed "Patient care transitioned to: Time 12/30/17 11:49 AM, patient transferred to main (treatment area)."

On January 4, 2018 at 1:35 PM, an interview was conducted with the ED Manager (EDM) and the Director of the ED (DED). During the interview the EDM was asked after the patient left the triage area, who was assigned to care for the patient, the EDM stated, "It is unknown where the patient was taken to."

The EDM further stated we are currently investigating the situation, we know that the patient was taken to triage room 2 upon arrival and they were having a hard time taking his blood pressure, we think the patient was then taken to the fast track area, the "assumption was that was the only open area."

The DED stated the fast track area consisted of 3 rooms and patients could also be placed in the RAP (results are pending-a room consisting of approximately eight to 10 chairs used for patients receiving intravenous {in vein} fluids, awaiting lab results) room. The DED further stated patients from "Main" are also placed in the RAP room.

The DED and the EDM were asked who the patients in the RAP room were assigned to, the EDM stated, if they were a fast track patient then a fast track nurse would take care of them, if they were a main patient then a main nurse would take care of them.

As the interview continued the EDM was asked when a patient is placed in the RAP room either as a fast track patient or as a main patient if a specific licensed staff member is assigned to provide the care to the patient, the EDM stated, "No."

A review of Patient 11's ED record revealed blood work (labs) were obtained from the patient at 12:09 PM. At 12:30 PM documentation revealed ED Registered Nurse 1 (EDRN), assigned to the fast track area on December 30, 2017 inserted an IV into the patient's mid-right forearm.

On January 4, 2018 at 3:15 PM, an interview was conducted with EDRN 1. During the interview EDRN 1 stated he did not recall the patient or recall placing an IV into the patient.

Further review of the patient's ED record revealed at approximately 12:40 PM, a "SEPSIS Alert" was computer generated regarding Patient 11. The alert stated, "This patient has met criteria that predict high likelihood of SEVERE SEPSIS. Call the provider immediately to report these results and suggest orders according to the sepsis bundle."

On January 4, 2018 at 1:35 PM, during the interview with the EDM, the EDM was asked who is made aware of a "SEPSIS Alert," the EDM stated, "Whoever opens up the chart will see the notation of "SEPSIS Alert" in any section of the chart (nursing or physician). The EDM was asked if it anyone responded to the "SEPSIS Alert" the EDM stated, "It doesn't look like anyone was logging into the patient's chart." The EDM was asked if it was safe to say that the sepsis protocol was not put into effect, the EDM replied, "You are right."

On January 4, 2018 at 2:45 PM, an interview was conducted with the ED Fast Track Charge Nurse (EDFTCN). The EDFTCN was asked if she recalled Patient 11, the EDFTCN stated the patient was brought to fast track by the PA, I heard someone say I'll get the work up but I don't recall who it was, further stating she didn't recall anything more about the patient.

The EDFTCN stated around the time of the patient's arrival, they had 40 patients on the tracker, patients in the 3 fast track rooms, about 11-12 patients in the RAP room and patients in IWA (internal waiting room).

On January 4, 2018 at 3 PM, another interview was conducted with the EDM, the EDM stated we are looking at the December 30, 2017 video as well as security to try to locate the patient, we've only been able to locate him when he first arrived.

The EDM was asked if the RAP room was an appropriate area for Patient 11 to be placed in after the PA identified that the patient was not a fast track patient and needed more resources, the EDM stated, "This day we were not going to find a bed."

No documented evidence could be located in the ED record to indicate where Patient 11 was placed within the ED after the PA documented "Patient care transitioned to: Time 12/30/17 11:49 AM, patient transferred to main (treatment area). In addition, no documented evidence could be located in the ED record to indicate who was providing care to the patient until EDRN 2 assumed care at 8 PM.

2a. Record review conducted on January 3, 2018, revealed Patient 11, a 77 year old male, presented to the Emergency Department (ED) on December 30, 2017 at 11:35 AM, with complaints of bilateral (left and right side) leg swelling and throat pain.

A review of the ED Physician Notes dated December 30, 2017, revealed documentation that the patient was seen by Physician Assistant 1 (PA) at 11:39 AM. PA 1 documented the patient had a history of a left nephrectomy (kidney removal), left kidney cancer and recently (two days prior) had a biopsy of his right kidney.

At 11:43 AM, ED Triage Nurse 1 (EDTN) obtained the patient's vital signs which revealed a blood pressure of 76/47 mmHg (millimeters of mercury) with a pain intensity level of eight (8). EDTN 1 assigned the patient as an "Emergency Severity Index" (ESI-a one to five level triage instrument {1: requiring life-saving interventions to 5: Patients that are likely to require no resources} that categorizes emergency department patients based on the acuity of their health care problems and the number of resources their care is anticipated to require) level four (4): Patients who are likely to require one resource.

According to the ED Physician Notes under the "Impression and Plan" in the "Disposition" section, documentation revealed "Patient care transitioned to: Time 12/30/17 11:49 AM, patient transferred to main (treatment area)."

Further review of the patient's medical record revealed no reassessment or vital signs were obtained from the patient until December 30, 2017 at 8 PM, approximately 8 hours and 17 minutes after the initial assessment and vital signs were obtained from the patient.

A review of the Emergency Department's Patient Care Services Policy and Procedure titled "Patient Assessment and Reassessment" last approved date August 3, 2016, under the "PURPOSE" section documentation revealed the following:

"1.2 Reassessments are based on individual patient acuity, which is specific to clinical condition, changes in clinical status or diagnosis, or physician's order. However, guidelines are as follows:

ESI level 1 = every 15 minutes or sooner if needed
ESI level 2 = every 30-60 minutes or sooner if needed
ESI level 3 = every 2 hours or sooner if needed
ESI level 4 = every 2-4 hours or sooner if needed
ESI level 5 = upon discharge or sooner if needed"

On January 4, 2018 at 1:35 PM, an interview was conducted with the ED Manager (EDM) and the Director of the ED (DED). During the interview the EDM and the DED were shown the patient's ED record, the EDM was asked if he could provide documentation that a reassessment and additional vital signs were completed, the EDM stated, "No, they were not done again until 2000 (8 PM)." The EDM further stated, "That's not our policy." The EDM further stated, "The expectation is for nurses to triage patients, follow policy's and protocols and provide patient care."

b. Record review conducted on January 5, 2018, revealed Patient 15 presented to the ED on December 30, 2017 at 1:35 PM, with a right arm injury. A review of the December 30, 2017 ED flowsheet revealed the patient was categorized as an ESI level 4. At 1:37 PM, vital signs were obtained and an initial assessment was performed on the patient.

Further review of the December 30, 2017 ED flowsheet, revealed vital signs were not obtained or a reassessment completed until 8 PM, approximately 6 hours and 23 minutes after the initial reassessment and vital signs were obtained.

On January 8, 2018 at 12:15 PM, an interview was conducted with the ED Medical Director (EDMD). The EDMD stated vital signs and reassessments should be completed according to facility policy and procedure further stating this is not standard practice.

c. Record review conducted on January 5, 2018, revealed Patient 16 presented to the ED on December 30, 2017 at 11:13 AM for fever lasting 3 days. A review of the December 30, 2017 ED flowsheet revealed the patient was categorized as an ESI level 4. At 11:33 AM, initial vital signs were obtained.

Further review of the December 30, 2017 ED flowsheet, revealed vital signs were not obtained until 7 PM, approximately 7 hours and 27 minutes after the initial set of vital signs were obtained.

On January 8, 2018 at 12:15 PM, an interview was conducted with the ED Medical Director (EDMD). The EDMD stated vital signs and reassessments should be completed according to facility policy and procedure and this is not standard practice.

3. On December 30, 2017, at 11:35 AM, a 77 year old (Patient 11) presented to the ED with complaints of bilateral leg swelling. A review of the ED Physician Notes dated December 30, 2017, revealed documentation that the patient was seen by Physician Assistant 1 (PA) at 11:39 AM.

At 11:43 AM, ED Triage Nurse 1 (EDTN) obtained the patient's vital signs which revealed a blood pressure of 76/47 mmHg (millimeters of mercury) with a pain intensity level of eight (8). EDTN 1 assigned the patient as an "Emergency Severity Index" level four (4): Patients who are likely to require one resource.

On January 4, 2018, at 1:35 PM, an interview was conducted with the ED Manager (EDM). The EDM was asked based on the patient's initial symptom's (BP 76/47 and pain intensity level of 8) if the ESI level four (4) was appropriate, the EDM replied, the patient "should not have been a 4, perhaps a 3 or even a 2."

On January 4, 2018, at 9:35 AM, an interview was conducted with EDTN 1. During the interview EDTN 1 stated she had difficulty obtaining a blood pressure on the patient, "I checked both arms and changed the cuff, then I got it, it was low."
As the interview continued, EDTN 1 was asked what the patient's ESI level was, EDTN stated, "A three (3)." EDTN 1 was shown her documentation dated December 30, 2017 at 11:43 AM, which indicated she determined the patient's "Tracking Acuity" level was a four (4-Non-Urgent). EDTN stated, "I was probably rushing."

On January 8, 2018 at 12:15 PM, an interview was conducted with the ED Medical Director (EDMD). During the interview, the EDMD confirmed the patient's ESI level was not accurate and should have been at a minimum an ESI level three and possibly an ESI level two.

4. On January 5, 2018 at 12:50 PM, observation of the ED tracker revealed Patient 13, presented to the Emergency Department at 9:33 AM, following a motor vehicle accident status post seizure. Further observation of the ED tracker revealed "Needs Cardiac Monitor."

At 12:55 PM, an interview was conducted with the EDFTCN, the EDFTCN stated the ED physician wanted the patient in the back (main ED treatment area) and not in the waiting room because he had a seizure. The EDFTCN was asked to point out the patient, the patient was observed sitting in a chair outside the fast track area without a cardiac monitor. The EDFTCN was observed to walk to the nurse's station in the main ED and speak with the physician. Upon the EDFTCN return she stated the physician still wanted the patient on a cardiac monitor.

The EDFTCN was asked why a cardiac monitor had not been placed on the patient, the EDFTCN stated, "There are none available."

On January 5, 2018 at 1 PM, an interview was conducted with the Director of the ED. The DED was asked what they needed to do when they are short on equipment, the DED stated, "We need to locate some."

On January 5, 2018 at 1:55 PM, the DED was asked if he was aware that Patient 13 had an ordered for a cardiac monitor however none were available, the DED stated he did not know.

On January 5, 2018 at 1:57 PM, observation of Patient 13 revealed a cardiac monitor had yet to be applied on to the patient. At 2 PM, an interview was conducted with EDMCN 2, the EDMCN confirmed they were out of cardiac monitors and further stated he was aware that the patient needed a cardiac monitor further stating that the patient hadn't had a seizure in two (2) years and that he assessed the situation and felt the patient was not in need of a cardiac monitor. The EDMCN confirmed he had not elevated the need for a cardiac monitor to ED management.

On January 5, 2018 at 3:41 PM, a review of Patient 13's ED orders revealed the ED physician wrote the order for the cardiac monitor at 10:39 AM and had yet to be applied to the patient until after this surveyor intervened.

On January 8, 2018 at 9 AM, an interview was conducted with the EDM. The EDM stated he was not made aware of the need for a cardiac monitor for Patient 13 until after the fact, the EDM further stated they were able to locate an additional 7 telemetry monitors from the hospital floors. In addition, the EDM stated the EDMCN should have informed ED management of the need and can not make the determination on their own to not have a patient on a cardiac monitor when there is a specific order from the physician.

Based on observation and interview, the Emergency Department (ED) failed to seek out assistance from other departments in the facility to assist with patient care resources to assess and render appropriate care for an ED patient. This failure was created when life-saving equipment was not applied to one (1) of 30 sampled patients (Patient 13) placing the patient at harm for undetected abnormal life threatening cardiac arrhythmias to be detected. In addition ED staff failed to ensure expired items were removed from the treatment floor, this failure created the potential for supplies to be used on patients coming into the ED.

Findings:

1. On January 5, 2018 at 12:50 PM, observation of the ED tracker revealed Patient 13, presented to the Emergency Department at 9:33 AM, following a motor vehicle accident status post seizure. Further observation of the ED tracker revealed "Needs Cardiac Monitor."

At 12:55 PM, an interview was conducted with the ED Fast Track Charge Nurse (EDFTCN), the EDFTCN was asked why a cardiac monitor had not been placed on the patient, the EDFTCN stated, "There are none available."

On January 5, 2018 at 1 PM, an interview was conducted with the Director of the ED. The DED was asked what they needed to do when they are short on equipment, the DED stated, "We need to locate some."

On January 5, 2018 at 1:55 PM, the DED was asked if he was aware that Patient 13 had an ordered for a cardiac monitor however none were available, the DED stated he did not know.

On January 5, 2018 at 2 PM, an interview was conducted with ED Main Charge Nurse (EDMCN), the EDMCN confirmed they were out of cardiac monitors confirmed he had not elevated the need for a cardiac monitor to ED management.
On January 8, 2018 at 9 AM, an interview was conducted with the EDM. The EDM stated he was not made aware of the need for a cardiac monitor for Patient 13 until after the fact, the EDM further stated they were able to locate an additional 7 telemetry monitors from the hospital floors. In addition, the EDM stated the EDMCN should have informed ED management of the need for cardiac monitors.

2. On January 3, 2018 at 8:50 AM, a tour of the Emergency Department (ED) was conducted. During the tour the following expired items were located:

In the blue IV line cart located in the Fast Track EKG room:
a. Tincture of Benzoin U.S.P., 10% swab sticks (1 swab stick per pack)
Two (2) packs with expiration date of July 2017
Six (6) packs with expiration date of December 2017
15 packs with expiration date of October 2017

b. Petrolatum dressing package expiration date August 2017

c. Monocryl Plus Antibacterial Sutures (needle and thread pack)
11-6.0 with expiration date of July 2017
12-6.0 with expiration date of September 30, 2017
11-5.0 with expiration date of May 2017
10-5.0 with expiration date of December 31, 2017
22-4.0 with expiration date of April 2017
Seven (7)-4.0 with expiration date of October 31, 2017
10-4.0 with expiration date of December 31, 2017

In the Fast Track EKG room, on the shelves the following expired items were located:

a. 32 light blue top 1.8 milliliter (ml) vacutainers with expiration date of December 31, 2017

b. One (1) sealed box 1.8 ml light blue vacutainers 100 count with expiration date of November 30, 2017

In the Fast Track EKG room in the cabinet, a lab draw tray the following expired items were located:

a. One (1) light blue top vacutainers with an expiration date of December 31, 2017

b. One (1) light blue top vacutainer with an expiration date of May 31, 2017.

During the discovery of the expired items a concurrent interview was conducted with the ED Manager (EDM). The EDM was asked who was responsible for checking for expired items, the EDM replied the ED Techs.