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Based on interviews and review of the medical record for 1 of 1 patient who underwent an invasive emergency procedure in the ED (Patient 11), and review of policies and procedures it was determined that the hospital failed to fully develop and implement policies and procedures to ensure the provision of safe emergency services as processes to prevent wrong site/side procedures and related errors were not clear or consistently implemented in areas that included:
* Procedure site/side marking was not done for Patient 11.
* A procedure "time-out" with the participation of all members of the team was not conducted for Patient 11.

Patient 11 experienced harm as a result of the hospital's failure to ensure its p/ps to prevent wrong site/side procedures were clear and followed. A chest tube was inserted into the wrong side causing the patient's condition to worsen and requiring a second procedure to insert a chest tube into the correct side. The patient experienced an extended hospitalization for management of two chest tubes and the resulting complications.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. a. The undated p/p provided titled "Lippincott Procedures - Chest tube insertion, assisting" was reviewed. It reflected:
* "Conduct a preprocedure verification to make sure that all relevant documentation, related information, or equipment is available and correctly identified...Verify that the doctor has marked the insertion site with his initials or with another unambiguous mark designated by your facility before the procedure is performed...Obtain the patient's baseline data...Conduct a time-out immediately before starting the procedure to perform a final assessment that the correct patient, site, positioning, and procedure are identified..."

b. The undated p/p provided titled "Lippincott Procedures - Prevention of Wrong Site Surgery" was reviewed. It reflected that the principles and processes described applied to invasive procedures performed outside of the OR as well as surgical procedures in the OR. It included the following:
* "Wrong site, wrong procedure, wrong person surgery can be prevented. This universal protocol is intended to achieve that goal...In developing this protocol, consensus was reached on the following principles: Wrong site, wrong procedure, wrong person surgery can and must be prevented. An active approach - using multiple, complementary strategies - is necessary to achieve the goal of eliminating wrong site, wrong procedure, wrong person surgery. Active involvement and effective communication among all members of the surgical team is important for success. To the extent possible, the patient (or legally designated representative) should be involved in the process. Consistent implementation of a standardized approach using a universal, consensus-based protocol will be most effective. The protocol should be flexible enough to allow for implementation with appropriate adaptation when required to meet specific patient needs. A requirement for site marking should focus on cases involving right/left distinction, multiple structures (fingers/toes), or levels (spine). The universal protocol should be applicable or adaptable to all operative and other invasive procedures that expose patients to harm, including procedures done in settings other than the operating room."
* "In concert with these principles, the following steps, taken together, comprise the Universal Protocol for eliminating wrong site, wrong procedure, wrong person surgery...Marking the operative site...To identify unambiguously the intended site of incision or insertion...For procedures involving right/left distinction, multiple structures (such as fingers and toes), or multiple levels (as in spinal procedures), the intended site must be marked such that the mark will be visible after the patient has been prepped and draped. 'Time out' immediately before starting the procedure...To conduct a final verification of the correct patient, procedure, site and, as applicable, implants...Active communication among all members of the surgical/procedure team, consistently initiated by a designated member of the team, conducted in a 'fail-safe' mode, i.e., the procedure is not started until any questions or concerns are resolved."
* "Pre-operative verification process...At the time of admission or entry into the facility. Anytime the responsibility for the care of the patient is transferred to another caregiver. With the patient involved, awake and aware, if possible. Before the patient leaves the preoperative area or enters the procedure/surgical room."
* "Marking the operative site - Make the mark at or near the incision site. Do NOT mark any non-operative site(s) unless necessary for some other aspect of care. The mark must be made by the licensed practitioner who has primary responsibility for the surgery. The mark must be unambiguous (e.g., use initials or 'YES' or a line representing the proposed incision; consider that 'X' may be ambiguous). The mark must be positioned to be visible after the patient is prepped and draped. The mark must be made using a marker that is sufficiently permanent to remain visible after completion of the skin prep. Adhesive site markers should not be used as the sole means of marking the site. The method of marking and type of mark should be consistent throughout the organization...The person performing the procedure should do the site marking. Marking must take place with the patient involved, awake and aware, if possible. Final verification of the site mark must take place during the 'time-out.'"
* "'Time out' immediately before starting the procedure - Must be conducted in the location where the procedure will be done, just before starting the procedure. It must involve the entire operative team, use active communication, be briefly documented, such as in a checklist and must, at the least, include: Correct patient identity. Correct side and site. Agreement on the procedure to be done. Correct patient position. Availability of correct implants and any special equipment or special requirements. The organization should have processes and systems in place for reconciling differences in staff responses during the 'time out.'"
* "Procedures for non-OR settings including bedside procedures - Site marking must be done for any procedure that involves laterality, multiple structures or levels (even if the procedure takes place outside of an OR). Verification, site marking, and 'time out' procedures should be as consistent as possible throughout the organization, including the OR and other locations where invasive procedures are done."

2. Review of the medical record for Patient 11 reflected that he/she presented to the ED on 09/07/2018 at 1424 with a chief complaint of chest pain for the past two weeks.

* The "ED Provider Note" dated as signed by the MD on 09/07/2018 at 2106 contained a section titled "ED Course." Documentation in that section reflected "Patient with Atypical chest pain, [CXR] with a large right pneumothorax, no chest tube placement permit signed by the patient due to lack of upper extremities (phocomelia), But (sic) [he/she] expressed verbal consent. Unfortunately CXR was flipped and I placed a chest tube in the left side, [he/she] required another chest tube in the right side, it was placed without complication. Followup CXR shows good expansion on the right side but a moderated pneumothorax in the left side. No surgeon available in this facility. case (sic) discussed with [surgeon] from Bay Area Hospital, [he/she] recommended to change the tube on the left side. left (sic) chest tube changed, patient tolerated well procedure (sic), follow-up [CXR] shows good lung expansion, but also it shows right lower lobe infiltrate that it wasn't (sic) present in previous CXR. in (sic) the emergency room also patient also (sic) received Rocephin 2 g IV and Zithromax 500 mg IV before blood cultures. Case discussed with hospitalist [Physician] accepted the patient for admission."

* A CT Pulmonary Angiogram report with procedure completed date as 09/07/2018 at 1608 reflected "Large right pneumothorax is again seen with collapse of the right lung. The left lung is well-expanded."

* A CXR report with procedure completed date as 09/07/2018 at 1745 reflected "Small caliber chest tube is seen placed on the left. Left pneumothorax is seen at the costophrenic angle. Large right pneumothorax remains with collapse of most of the right lung."

* A CXR report with procedure completed date as 09/07/2018 at 1810 reflected "Since the previous radiograph, a right-sided chest tube has been placed. Left chest tube is unchanged in position. Partial reexpansion is seen of the right lung with residual pneumothorax present. Residual pneumothorax is also seen on the left."

* An undated and untimed Respiratory Therapist note in the ED record reflected "At bedside for support with chest tube insertion." A Respiratory Therapist note dated 09/07/2018 at 1805 reflected "1st chest tube insertion on the left." On 09/07/2018 at 1819 the Respiratory Therapist documented "Placed patient on 6L oxymask due to desaturations." Additional Respiratory Therapist notes that were undated and untimed reflected "Placed patient on Vapotherm 37 degrees 35 Liters and 50%. Patient oxygen saturations and WOB improved. 2nd chest tube inserted on the left."

* There was no chest tube insertion procedure related documentation in the ED record by the ED RN or other ED staff.

* The ED Physician's "Impression" was documented as "Right spontaneous pneumothorax, left iatrogenic pneumothorax, right lower lobe pneumonia" and "Disposition" was "Admitted to hospital."

* The inpatient medical record reflected the patient had an extended hospital stay during which care and services were required to manage two chest tubes and the patient's worsened condition that resulted from the initial wrong side chest tube insertion. A physician discharge note reflected that the patient's condition did improve after four days and he/she was discharged to home on 09/11/2018.

3. During interview with the CPHQ on 09/12/2018 beginning at 1330 he/she indicated that the Respiratory Therapist in an interview had reported that the RN in the ED had told him/her that a R side chest tube insertion was planned for Patient 11 and that the Respiratory Therapist as a result set up for a R side chest tube. He/she reported that the Physician positioned him/herself on the patient's L side and confirmed that the insertion was to be on the L side. The Physician proceeded to insert the chest tube on the L side and the patient began to experience a worsening in respiratory condition. The error was noted and a chest tube was then placed on the R side.

During the interview with the CPHQ on 09/12/2018 he/she indicated that the Physician in an interview had reported that when he/she viewed the imaging results he/she assumed the pneumothorax was on the L side and did not realize that the image was flipped and the pneumothorax was on the R side. The Physician reported that as he/she started the procedure he/she remembered a voice asking if the chest tube was supposed to go on the R side and he/she answered that no, it was to go on the L side, and he/she proceeded to insert the tube.

Further, the CPHQ indicated that the ED RN in an interview had reported that he/she advised the Respiratory Therapist to set up for a chest tube on the patient's R side. The RN was called away to another patient and when he/she returned he/she observed that the chest tube had been inserted on the L side.

4. The reports from staff involved in the procedure and the review of ED record confirmed that the policies and procedures had not been followed as there was no documentation that included:
* Preprocedure verification for all relevant documentation, related information, and that equipment was available and correctly identified;
* Verification that the doctor had marked the insertion site with his/her initials or with another unambiguous mark designated by the facility before the procedure was performed;
* A "time-out" immediately before starting the procedure to perform a final assessment that the correct patient, site, positioning, and procedure were identified.





40575

Based on observations, interviews, review of medical records for 8 of 8 patients who underwent surgery and invasive procedures (Patients 1, 2, 3, 4, 10, 11, 13 and 16), and review of policies and procedures it was determined that the hospital's organizational structure and governing body failed to ensure the provision of safe surgical and emergency services as processes to prevent wrong site/side surgeries and procedures and related errors were not followed.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

* Refer to Tag C200 for the deficiency cited at CFR 485.618, CoP: Emergency Services, that reflects the hospital failed to ensure the provision of safe emergency services as processes to prevent wrong site/side procedures and related errors were not followed.

* Refer to Tag C320 for the deficiency cited at CFR 485.639, CoP: Surgical Services, that reflects the hospital failed to ensure the provision of safe surgical services as processes to prevent wrong site/side surgeries and related errors were not followed.

Based on observations, interviews, review of medical records for 8 of 8 patients who underwent surgery and invasive procedures (Patients 1, 2, 3, 4, 10, 11, 13 and 16) and review of policies and procedures it was determined that the hospital failed to fully develop and implement policies and procedures to ensure the provision of safe surgical and emergency services as processes to prevent wrong site/side surgeries and procedures and related errors were not followed.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

* Refer to Tags C271, C274, and C284 for Standard-level deficiencies cited under this CoP that reflect the hospital failed to ensure the provision of safe surgical and emergency services as processes to prevent wrong site/side surgeries and procedures and related errors were not followed.

* Refer to Tag C200 for the deficiency cited at CFR 485.618, CoP: Emergency Services, that reflects the hospital failed to ensure the provision of safe emergency services as processes to prevent wrong site/side procedures and related errors were not followed.

* Refer to Tag C320 for the deficiency cited at CFR 485.639, CoP: Surgical Services, that reflects the hospital failed to ensure the provision of safe surgical services as processes to prevent wrong site/side surgeries and related errors were not followed.

Based on observations, interviews, review of medical records for 8 of 8 patients who underwent surgery and invasive procedures (Patients 1, 2, 3, 4, 10, 11, 13 and 16) and review of policies and procedures it was determined that the hospital failed to fully develop and implement policies and procedures to ensure the provision of safe surgical and emergency services as processes to prevent wrong site/side surgeries and procedures and related errors were not followed.

Findings include:

* Refer to Tag C200 for the deficiency cited at CFR 485.618, CoP: Emergency Services, that reflects the hospital failed to ensure the provision of safe emergency services as processes to prevent wrong site/side procedures and related errors were not followed.

* Refer to Tag C320 for the deficiency cited at CFR 485.639, CoP: Surgical Services, that reflects the hospital failed to ensure the provision of safe surgical services as processes to prevent wrong site/side surgeries and related errors were not followed.

Based on interviews and review of the medical record for 1 of 1 patient who underwent an invasive emergency procedure in the ED (Patient 11), and review of policies and procedures it was determined that the hospital failed to fully develop and implement policies and procedures to ensure the provision of safe emergency services as processes to prevent wrong site/side procedures and related errors were not followed.

Findings include:

* Refer to Tag C200 for the deficiency cited at CFR 485.618, CoP: Emergency Services, that reflects the hospital failed to ensure the provision of safe emergency services as processes to prevent wrong site/side procedures and related errors were not followed.

Based on observations and interviews it was determined that the hospital failed to ensure that drugs and biologicals available for patient use were not mislabeled or otherwise unusable.

Findings include:

1. The following observations were made during cataract eye surgery in the operating room on 09/13/2018 beginning at 0800:
* Two unlabeled 1 ml syringes of clear liquid were observed in a blue plastic bin. During interview with an RN at the time of the observation he/she stated that he/she had drawn epinephrine 0.25 cc into the syringes from vials at 0630 that morning to be injected into IV bags for cases scheduled throughout that day.
* Two unlabeled 3 cc syringes filled with brown liquid were observed on a counter. The RN stated the liquid in the syringes was one-part betadine and two-parts saline drawn up at 0630 that morning to be used by the surgeon for eye prep for cases scheduled later that day.



40353

Based on observations and interviews it was determined that the hospital failed to ensure that infection prevention policies and procedures had been fully developed and implemented. Procedures and processes to prevent cross-contamination and to ensure infection prevention had not been enforced in the following areas:
* Outdated and expired supplies were available for patient use and their sterility and integrity could not be assured.
* The sterile field during surgery was compromised.
* Oxygen tubing connected to a patient was touching the floor during surgery.
* Staff failed to observe appropriate hand hygiene and glove changes in pre-op.
* Outdated food items were available for patient use.
* Not all surfaces were in good repair and readily cleanable.
* Tasks associated with equipment disinfection were conducted in a handwashing sink.
* A water-borne pathogens program had not been developed and implemented.

Findings include:

1. The following observations were made during tour of the emergency department with the CPHQ on 09/11/2018 starting at 1525:
* An 8-ounce bottle of providone iodine topical solution previously opened was observed on the counter in Room 4 and had no open date.
* The wall above the sink in Room 4 was observed to have peeled paint on both sides of the soap dispenser.
* The front right corner of the sink cabinet in Room 4 was observed with peeled laminate.

2. The following observations were made in the M/S staff break room with the CPHQ and Nurse Supervisor on 09/12/2018 at 1150:
* Two 18-gauge needles observed in a container attached to an AccuVein machine had expiration dates of 07/2018 and four 16-gauge needles had expiration dates of 04/2018.

3. The following observations were made in the patient nourishment room with the Nurse Supervisor on 09/12/2018 at 1200:
* Two chocolate puddings observed in the refrigerator had expiration dates of 09/05/2018 and another had an expiration date of 08/22/2018.
* Two cans of V8 juice observed in the refrigerator had expiration dates of 08/09/2018.
* The Manitowoc ice machine was observed to have a buildup of debris and a piece of duct tape applied next to the opening where ice is collected and had areas that were corroded and not readily cleanable.

4. The following observations were made in the pre-op area on 09/13/2018 at approximately 0715:
With gloved hands, an RN took a patient's oral temperature, touched the privacy curtain, documented in the paper medical record, made a telephone call, touched the computer keyboard, and at three separate times administered eye drops into the patient's right eye. No hand hygiene or glove changes were observed during these activities.

5. The following observations were made during cataract eye surgeries in the operating room on 09/13/2018 beginning at 0800:
* Three 25-gauge spinal needles observed on a metal shelf had expiration dates of 08/2018.
* An RN reached across and over the sterile field with his/her bare hands to give an open implant package to a scrub tech.
* Oxygen tubing connected to a patient was observed touching the floor during surgery.

6. During observations in the ultrasound room with the ultrasound technician on 09/13/2018 at 1650 he/she stated that the disinfection process for ultrasound probes included washing them in the handwashing sink in the ultrasound room. Handwashing sinks in patient treatment and exam areas and rooms are dedicated for handwashing purposes.

7. During interview with the CPHQ on 09/14/2018 at 1100 he/she stated that the hospital had not conducted a water-borne pathogens risk assessment, had not developed related policies and procedures or a plan. He/she confirmed that the hospital had purchased a kit for testing for water-borne pathogens but had not yet conducted any testing.





40353








40575

Based on interviews and review of the medical record for 1 of 1 patient who underwent an invasive emergency procedure in the ED (Patient 11), and review of policies and procedures it was determined that the hospital failed to fully develop and implement policies and procedures to ensure the provision of safe emergency services as processes to prevent wrong site/side procedures and related errors were not followed.

Findings include:

* Refer to Tag C200 for the deficiency cited at CFR 485.618, CoP: Emergency Services, that reflects the hospital failed to ensure the provision of safe emergency services as processes to prevent wrong site/side procedures and related errors were not followed.

Based on observations, interviews, review of medical records for 6 of 6 patients who underwent surgery (Patients 1, 2, 3, 4, 10 and 13), review of the medical record for 1 of 1 patient who underwent an invasive procedure at the bedside (Patient 16) and review of policies and procedures it was determined that the hospital failed to fully develop and implement policies and procedures to ensure the provision of safe surgical/procedure services as processes to prevent wrong site/side surgeries and related errors were not clear or consistently implemented in areas that included:
* P/ps contained conflicting information about who was to mark the surgical/procedure site/side, and site/side marking was not done by either the patient or the surgeon as required by the conflicting policies.
* Surgical/procedure site/side marking practice was inconsistent and not done using hospital-specific, defined protocols for when, where on the body, with what, how, and by whom site/sides were to be marked.
* Surgical/procedure "time-outs" conducted prior to transport to the OR and after arrival in the OR prior to incision were not conducted with the participation of all members of the OR team and failed to identify practices that were inconsistent with the p/ps.
* Surgeries were conducted when the surgical site/side mark was not visible.
* Medical record documentation of site/side marking and "time-out" processes were not consistent with observations made during surgery.
* Medical record documentation of site/side marking and confirmation was generic and did not include identification of the site/side marked, prepped, or operated on.
* Medical record documentation of "time-outs" was generic and did not include identification of the required "time-out" elements.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. a. The undated p/p provided titled "Lippincott Procedures - Identification of the Operative Site" was reviewed. It reflected:
* "To enhance the safety of surgical patients having procedures in the perioperative (Surgical) department by verifying the patient's identity, the scheduled procedure, and procedure side within the perioperative period. This verification, which includes verbal consensus, must occur prior to the surgical incision. Staff members will incorporate this safety standard with all patients undergoing surgical procedures. There are potentially seven (7) areas of risk related to accuracy in the pre-operative patient process...identification and verification of scheduled procedure and site."
* "Procedure - "Verification of patient identity, correct site and correct procedure begins with the scheduling of the procedure by the Surgeons' office and is carried through discharge from the hospital. All patient information is confirmed and the consent is verified by all surgical team members...Diagnostic reports coincide with site/side procedure. Site/side will be marked by patient prior to transport to perioperative department. Pre-operative checklist will be done...At the time of the pre-op assessment and education, the patient identity, correct procedure and correct site are confirmed...The patient is asked to mark or sticker the area referred to on the consent if laterally (right or left), multiple structures (fingers, toes, etc) or multiple levels (spine) are involved. Marks or stickers stating 'No' or 'X' are not to be used...The consent and the marked site(s) are verified by the surgeon and the operating room nurse prior to transport to the operating room...Prior to prep of the surgical site a 'time out' is taken by all operating room team members to verify the patient identity, consent, correct site and stickers/marks placed by the patient. The 'time out' is documented on the 'Operating Room Record.' The 'Operating Room Record' will document the area prepped for the procedure. The surgical intervention may proceed only when all patient information is verified and all operating room team members agree to the correct patient, correct site and correct procedure."

b. The undated p/p provided titled "Lippincott Procedures - Prevention of Wrong Site Surgery" was reviewed. It reflected:
* "Wrong site, wrong procedure, wrong person surgery can be prevented. This universal protocol is intended to achieve that goal...In developing this protocol, consensus was reached on the following principles: Wrong site, wrong procedure, wrong person surgery can and must be prevented. An active approach - using multiple, complementary strategies - is necessary to achieve the goal of eliminating wrong site, wrong procedure, wrong person surgery. Active involvement and effective communication among all members of the surgical team is important for success. To the extent possible, the patient (or legally designated representative) should be involved in the process. Consistent implementation of a standardized approach using a universal, consensus-based protocol will be most effective. The protocol should be flexible enough to allow for implementation with appropriate adaptation when required to meet specific patient needs. A requirement for site marking should focus on cases involving right/left distinction, multiple structures (fingers/toes), or levels (spine). The universal protocol should be applicable or adaptable to all operative and other invasive procedures that expose patients to harm, including procedures done in settings other than the operating room."
* "In concert with these principles, the following steps, taken together, comprise the Universal Protocol for eliminating wrong site, wrong procedure, wrong person surgery...Marking the operative site...To identify unambiguously the intended site of incision or insertion...For procedures involving right/left distinction, multiple structures (such as fingers and toes), or multiple levels (as in spinal procedures), the intended site must be marked such that the mark will be visible after the patient has been prepped and draped. 'Time out' immediately before starting the procedure...To conduct a final verification of the correct patient, procedure, site and, as applicable, implants...Active communication among all members of the surgical/procedure team, consistently initiated by a designated member of the team, conducted in a 'fail-safe' mode, i.e., the procedure is not started until any questions or concerns are resolved."
* "Pre-operative verification process...At the time of admission or entry into the facility. Anytime the responsibility for the care of the patient is transferred to another caregiver. With the patient involved, awake and aware, if possible. Before the patient leaves the preoperative area or enters the procedure/surgical room."
* "Marking the operative site - Make the mark at or near the incision site. Do NOT mark any non-operative site(s) unless necessary for some other aspect of care. The mark must be made by the licensed practitioner who has primary responsibility for the surgery. The mark must be unambiguous (e.g., use initials or 'YES' or a line representing the proposed incision; consider that 'X' may be ambiguous). The mark must be positioned to be visible after the patient is prepped and draped. The mark must be made using a marker that is sufficiently permanent to remain visible after completion of the skin prep. Adhesive site markers should not be used as the sole means of marking the site. The method of marking and type of mark should be consistent throughout the organization...The person performing the procedure should do the site marking. Marking must take place with the patient involved, awake and aware, if possible. Final verification of the site mark must take place during the 'time-out.'"
* "'Time out' immediately before starting the procedure - Must be conducted in the location where the procedure will be done, just before starting the procedure. It must involve the entire operative team, use active communication, be briefly documented, such as in a checklist and must, at the least, include: Correct patient identity. Correct side and site. Agreement on the procedure to be done. Correct patient position. Availability of correct implants and any special equipment or special requirements. The organization should have processes and systems in place for reconciling differences in staff responses during the 'time out.'"
* "Procedures for non-OR settings including bedside procedures - Site marking must be done for any procedure that involves laterality, multiple structures or levels (even if the procedure takes place outside of an OR). Verification, site marking, and 'time out' procedures should be as consistent as possible throughout the organization, including the OR and other locations where invasive procedures are done."

2. a. The following observations were made during a R eye cataract surgery on Patient 1 on 09/13/2018 that was scheduled for 0630 and was completed at 0826:
* A gold sticker was observed above the patient's R eye.
* The sticker was not visible above the patient's R eye after the patient's head had been draped for the surgery.
* An RN stated that "a nurse" who checked in the patient in the lobby before surgery put the sticker on the patient to mark the surgical side. He/she stated that whoever brings the patient in marks the side with a sticker.
* There were five people in the OR. During the "time-out" immediately prior to the surgery only two persons participated and verbalized agreement that it was the correct patient, the correct procedure, and the correct site, and there was no communication about the correct position or whether team members had questions or concerns about those verifications or any other patient safety issues.

b. Review of Patient 1's medical record for the 09/13/2018 procedure revealed the following:
* The patient was admitted for OP Surgery on 09/13/2018 for "Cataract Extraction with Insertion of Intraocular Lens of the Right Eye."
* The Surgeon's Operative Note dated 09/13/2018 at 1107 contained a section titled "Description of Procedure." Documentation in that section reflected "This procedure was started with a 'Time Out' process confirmed by the operating members."
* There was no documentation in the Surgeon's Operative Note to reflect that the Surgeon had marked the right eye surgical site/side prior to the procedure. The only reference to the right eye in the "Description of the Procedure" section was "The right eye was prepped and draped in the usual sterile fashion for intraocular surgery."
* Operative nurse's notes dated 09/13/2018 included the following entries relevant to site/side marking, "time-outs," and the sequence of events in the OR:
- At 0715 reflected "Pt escorted to pre-op area."
- At 0718 reflected "Op-site confirmed with patient & chart. Op site marked w/pt & confirmed w/Surgeon. Consent confirmed/signed by pt/on chart...ID band and consent confirmed by Surgeon...'Time Out' for Final Verification Done."
- At 0805 reflected "OR In Time: 0804...OR Personnel Present: Surgeon...Circulator RN...1st Scrub...Nurse Monitor...Sitepath [implant company staff person]...Op Site Confirmed."
- At 0806 reflected "'Time Out' for Final verification done."
- At 0808 reflected "Procedure Start Time: 0808."
- At 0825 reflected "OR-Transported To: PACU...Procedure End Time: 0825."
- At 0830 reflected "OR Out Time: 0830."

3. a. The following observations were made during a R eye cataract surgery on Patient 2 on 09/13/2018 that was scheduled for 0645 and was completed at 0912:
* A sticker in the shape of a star was observed above the patient's R eye in the pre-op area prior to surgery.
* The star sticker was not observed and a tattoo-like sticker with the word "YES" on it was observed approximately 1 inch above the patient's R eyebrow in the OR immediately prior to draping for the surgery.
* The surgeon stated the star sticker fell off and an RN placed the "YES" sticker on the patient to mark the surgical site/side.
* The "YES" sticker was not visible above the patient's R eye after the patient's head was draped for the surgery.
* There were five people in the OR. During the "time-out" immediately prior to the surgery, as in the first case above, only two persons participated and verbalized agreement that it was the correct patient, the correct procedure, the correct site/side, and the correct implant, and there was no communication about the correct position, or whether team members had questions or concerns about those verifications or any other patient safety issues.

b. Review of Patient 2's medical record for the 09/13/2018 procedure revealed the following:
* The patient was admitted for OP Surgery on 09/13/2018 for "Cataract Extraction with Insertion of Intraocular Lens of the Right Eye."
* The Surgeon's Operative Note dated 09/13/2018 at 1110 contained a section titled "Description of Procedure." Documentation in that section reflected "This procedure was started with a 'Time Out' process confirmed by the operating members."
* There was no documentation in the Surgeon's Operative Note to reflect that the Surgeon had marked the right eye surgical site/side prior to the procedure. The only reference to the right eye in the "Description of the Procedure" section was "The right eye was prepped and draped in the usual sterile fashion for intraocular surgery."
* Operative nurse's notes dated 09/13/2018 included the following entries relevant to site/side marking, "time-outs," and the sequence of events in the OR:
- At 0701 reflected "Mode of Arrival to Pre Op...Op Site Confirmed."
- At 0705 reflected "Op-site confirmed with patient & chart. Consent confirmed/signed by pt/on chart."
- At 0846 reflected "OR In Time: 0845...OR Personnel Present: Surgeon...Circulator RN...1st Scrub...Nurse Monitor...Sitepath [implant company staff person]...Op Site Confirmed."
- At 0848 reflected "'Time Out' for Final verification done."
- At 0850 reflected "Procedure Start Time: 0850."
- At 0915 reflected "Procedure End Time: 0912."
- At 0916 reflected "OR-Transported To: PACU...OR Out Time: 0916."

4. a. The following observations were made during a L eye cataract surgery on Patient 3 on 09/13/2018 that was scheduled for 0700 and was completed at 0953:
* A sticker in the shape of a star was observed immediately above the patient's L eyebrow just touching the top of the eyebrow.
* An RN placed the sticker on the patient to mark the surgical side.
* There were five people in the OR. During the "time-out" immediately prior to the surgery only three persons participated and verbalized agreement that it was the correct patient, the correct procedure, the correct site/side, and the correct implant, and there was no communication about the correct position or whether team members had questions or concerns about those verifications or any other patient safety issues.

b. Review of Patient 3's medical record for the 09/13/2018 procedure revealed the following:
* The patient was admitted for OP Surgery on 09/13/2018 for "Cataract Extraction with Insertion of Intraocular Lens of the Left Eye."
* The Surgeon's Operative Note dated 09/13/2018 at 1118 contained a section titled "Description of Procedure." Documentation in that section reflected "This procedure was started with a 'Time Out' process confirmed by the operating members."
* There was no documentation in the Surgeon's Operative Note to reflect that the Surgeon had marked the left eye surgical site/side prior to the procedure. The only reference to the left eye in the "Description of the Procedure" section was "The left eye was prepped and draped in the usual sterile fashion for intraocular surgery."
* Operative nurse's notes dated 09/13/2018 included the following entries relevant to site/side marking, "time-outs," and the sequence of events in the OR:
- At 0716 reflected "Op Site Confirmed with patient & chart. Consent confirmed/signed by pt/on chart."
- At 0730 reflected "Mode of Arrival to Pre Op...Op Site Confirmed."
- At 0920 reflected "OR In Time: 0920...OR Personnel Present: Surgeon...Circulator RN...1st Scrub...Nurse Monitor...Sitepath [implant company staff person]...Op Site Confirmed."
- At 0923 reflected "'Time Out' for Final verification done."
- At 0940 reflected "Procedure Start Time: 0940."
- At 0953 reflected "Procedure End Time: 0953."
- At 0957 reflected "OR-Transported To: PACU...OR Out Time: 0957."

5. a. The following observations were made during a L eye cataract surgery on Patient 4 on 09/13/2018 that was scheduled for 0745 and completed at 1025:
* A tattoo-like sticker with the word "YES" on it was observed approximately 1 inch above the patient's L eyebrow with a piece of opaque tape over the sticker.
* The sticker was not visible above the patient's L eye after the patient's head had been draped for the surgery.
* There were five people in the OR. During the "time-out" immediately prior to the surgery, as in the first case above, only four persons participated and verbalized agreement that it was the correct patient, the correct procedure, the correct site/side, and the correct implant, and there was no communication about the correct position or whether team members had questions or concerns about those verifications or any other patient safety issues.

b. Review of Patient 4's medical record for the 09/13/2018 procedure revealed the following:
* The patient was admitted for OP Surgery on 09/13/2018 for "Cataract Extraction with Insertion of Intraocular Lens of the Left Eye."
* The Surgeon's Operative Note dated 09/13/2018 at 1124 contained a section titled "Description of Procedure." Documentation in that section reflected "A 'Time Out' process was confirmed by the operating members."
* There was no documentation in the Surgeon's Operative Note to reflect that the Surgeon had marked the left eye surgical site/side prior to the procedure. The only reference to the left eye in the "Description of the Procedure" section was "The left eye was prepped and draped in the usual sterile fashion for intraocular surgery."
* Operative nurse's notes dated 09/13/2018 included the following entries relevant to site/side marking, "time-outs," and the sequence of events in the OR:
- At 0800 reflected "Op Site Confirmed with patient & chart. Consent confirmed/signed by pt/on chart...Mode of Arrival to Pre Op...Op Site Confirmed."
- At 1015 reflected "OR In Time: 1015...OR Personnel Present: Surgeon...Circulator RN...1st Scrub...Nurse Monitor...Sitepath [implant company staff person]...Op Site Confirmed."
- At 1020 reflected "'Time Out' for Final verification done."
- At 1024 reflected "Procedure Start Time: 1024."
- At 1045 reflected "Procedure End Time: 1045."
- At 1050 reflected "OR-Transported To: PACU...OR Out Time: 1050."

6. Review of Patient 10's medical record reflected the following:
* The patient was admitted for OP Surgery on 09/10/2018 for "Amputation of 3rd Didgit (sic) of Lt Ft."
* The Surgeon's Operative Note dated 09/10/2018 at 1701 lacked documentation to reflect that the Surgeon had marked the toe on the left foot surgical site/side prior to the procedure and that any "time-outs" had been conducted.
* Operative nurse's notes dated 09/10/2018 included the following entries relevant to site/side marking, "time-outs," and the sequence of events in the OR:
- At 1124 reflected "Surgical consent signed; site/side verified Yes."
- At 1141 reflected "Surgeon verifies, initials site/side: Yes."
- At 1204 reflected "OR In Time: 1204...Op Site Confirmed with patient & chart. Consent confirmed/signed by pt/on chart."
- At 1210 reflected "'Time out' for final verification done."
- At 1221 reflected "Surgical Start Time: 1221."
- At 1238 reflected "Surgical End Time: 1238...OR Personnel Present: Surgeon...CRNA...Circulator RN...1st Scrub."
- At 1243 reflected "OR Out Time: 1243...OR-Transported To: PACU."

7. Review of Patient 13's medical record reflected the following:
* The patient was admitted for OP Surgery on 08/10/2018 for "Lt Subcutaneous Mastectomy."
* The Surgeon's Operative Note dated 08/10/2018 at 0848 contained a section titled "Operative Summary." Documentation in that section reflected "The procedure was started with a 'Time Out' process confirmed by the operating members...A marking pen was used to demarcate the curvilinear smile at the skin areolar at junction inferiorly." However, there was no documentation to reflect what side was marked.
* Operative nurse's notes dated 08/10/2018 included the following entries relevant to site/side marking, "time-outs," and the sequence of events in the OR:
- At 0710 reflected "Surgical consent signed; site/side verified Yes."
- At 0740 reflected "Surgeon verifies, initials site/side: Yes."
- At 0810 reflected "OR In Time: 0810...Op Site Confirmed with patient & chart. Consent confirmed/signed by pt/on chart."
- At 0814 reflected "Op Site Confirmed with patient & chart. Op site marked w/pt & confirmed w/Surgeon. Consent confirmed/signed by pt/on chart. 'Time out' for final verification done."
- At 0816 reflected "Surgical Start Time: 0816."
- At 0834 reflected "Surgical End Time: 0834...OR Personnel Present: Surgeon...Anesthesia...Circulator RN...1st Scrub...2nd Scrub."
- At 0839 reflected "OR Out Time: 0839...OR-Transported To: PACU."

8. Review of Patient 16's medical record reflected the following:
* The patient was admitted as an IP on 04/06/2018 for respiratory failure.
* The patient underwent a "R Sided Thoracentesis" procedure while hospitalized on 04/09/2018. The Physician's Operative Note dated 04/09/2018 at 1141 contained a section titled "Procedure Summary." Documentation in that section reflected "A "time-out" was performed and the chest x-ray was reviewed, the appropriate location was confirmed by ultrasound and marked." However, there was no documentation to reflect what side was marked.

9. During interview with a Scrub Tech on 09/13/2018 at 0850 regarding the placement of the stickers to mark the surgical sides he/she stated that he/she couldn't see the stickers and "I can't see anything there. I don't look for that. It's usually covered by the cap when they come in [to the OR.]"

10. During interview with an RN on 09/13/2018 at 1050 he/she stated that two types of stickers were used for surgical site markings. The RN stated he/she got stickers from the Dollar Store and those were used for eye procedures. The RN stated that MediChoice tattoo-like "YES" stickers provided by the hospital were "used for everything else." At the time of the interview, the RN provided five packages of stickers. Observation of the packages revealed they contained multiple craft type stickers of various colors, shapes and sizes.

11. On 09/13/2018 at approximately 1100 MediChoice tattoo-like "YES" stickers were observed and reflected a one-half inch diameter sticker and one-inch diameter sticker. The stickers were round and white with a blue "YES" printed on them.

12. During interview with an RN in the OR on 09/13/2018 at 0944 he/she stated that the clock in the OR was "off" by seven minutes and the computer system's time was not accurate "so we have to wait to chart so we don't chart ahead of ourselves."




29708

Based on observations, interviews, review of medical records for 8 of 8 patients who underwent surgery and invasive procedures (Patients 1, 2, 3, 4, 10, 11, 13 and 16) and review of policies and procedures it was determined that the hospital's periodic evaluation and quality assurance processes failed to ensure the provision of safe surgical and emergency services as processes to prevent wrong site/side surgeries and procedures and related errors were not followed.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

* Refer to Tag C336 for the Standard-level deficiency cited under this CoP that reflect the quality assurance program failed to ensure the provision of safe surgical and emergency services as processes to prevent wrong site/side surgeries and procedures and related errors were not followed.

* Refer to Tag C200 for the deficiency cited at CFR 485.618, CoP: Emergency Services, that reflects the hospital failed to ensure the provision of safe emergency services as processes to prevent wrong site/side procedures and related errors were not followed.

* Refer to Tag C320 for the deficiency cited at CFR 485.639, CoP: Surgical Services, that reflects the hospital failed to ensure the provision of safe surgical services as processes to prevent wrong site/side surgeries and related errors were not followed.

Based on interview and review of documentation of the CAH's periodic evaluation of its total program it was determined that the CAH failed to fully carry out or arrange for a periodic evaluation of its total program at least once a year during the previous three years to include review of:
* The utilization of CAH services as required by CFR 485.641(a)(1)(i);
* A representative sample of both active and closed clinical records as required by CFR 485.641(a)(1)(ii);
* The CAH's health care policies as required by CFR 485.641(a)(1)(iii); and
* A determination whether the utilization of services was appropriate, the established policies were followed, and any changes were needed as required by CFR 485.641(a)(2).

Findings include:

1. During interview with the CEO on 09/14/2018 at 1015, documentation of a draft CAH annual program evaluation dated FY ending 06/30/2018 was reviewed. The CEO stated the draft was planned to be presented to the CAH's Board on 09/27/2018. Although that documentation reflected an evaluation was in process, the CEO stated that there was no documentation from the previous CEO to reflect that an annual evaluation of the CAH's total program had been conducted for the hospital's FYs ending 2016 or 2017.

2. Review of the draft "Annual Critical Access Hospital (CAH) Program Review" dated "July 1, 2017 to June 30, 2018" revealed that it had not been fully developed. For example:
* There was no documentation to reflect details about review of representative samples of active and closed clinical records including what review samples consisted of, what criteria was reviewed, and what the results of the reviews were. The only related language broadly reflected "Quality and Patient Safety data continues to be collected via chart abstraction, retrospective closed chart audits, and real time observation audits. Standard audit tools are used to facilitate comparisons."
* The "Conclusion" of the evaluation did not identify whether policies were followed and whether changes in policies or practices were needed. It reflected broadly "Overall, the utilization of services is appropriate Southern Coos Hospital and Health Center. (sic) The patients who visit SCHHS (sic) are extremely satisfied with the care they receive. The trend continues on providing more outpatient services."

Based on observations, interviews, review of medical records for 8 of 8 patients who underwent surgery and invasive procedures (Patients 1, 2, 3, 4, 10, 11, 13 and 16) and review of policies and procedures it was determined that the hospital failed to ensure that the quality assurance program evaluated the quality and appropriateness of patient care services. The program failed to ensure the provision of safe surgical and emergency services as processes to prevent wrong site/side surgeries and procedures and related errors were not followed.

Findings include:

* Refer to Tag C200 for the deficiency cited at CFR 485.618, CoP: Emergency Services, that reflects the hospital failed to ensure the provision of safe emergency services as processes to prevent wrong site/side procedures and related errors were not followed.

* Refer to Tag C320 for the deficiency cited at CFR 485.639, CoP: Surgical Services, that reflects the hospital failed to ensure the provision of safe surgical services as processes to prevent wrong site/side surgeries and related errors were not followed.