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2629 N 7TH ST

SHEBOYGAN, WI 53083

FORM AND RETENTION OF RECORDS

Tag No.: A0438

Based on staff interview (staff E and D) and 1 out of 1 out of a total of 8 MR reviews (Pt. #1), this facility failed to ensure that documentation in the MR is complete and accurate and reflects interventions related to patient care. Failure to keep a complete and accurate MR has the potential to affect all patients receiving care in this facility. There were no patients scheduled for surgery on the date of the survey.

Findings include:

An MR review was conducted on Pt. #1's closed surgical record on 7/17/2013 at 10:30 a.m. Pt. #1 had Nasal Septal reconstructive surgery for a deviated septum (repair of the nasal bone) on 7/9/2013 at an off-site department of the hospital at 10:00 a.m.

In Phase I recovery Pt. #1's blood pressure (BP) became markedly elevated (from 109/92 at 11:04 a.m. to 239/102 at 11:27 a.m. RN D contacted CRNA E for a medication order (Hydralazine) which was given for the increased BP at 11:35 a.m. and again at 11:43 a.m.

A phone interview with CRNA E was conducted on 7/17/2013 at 2:00 p.m. CRNA E stated that after the BP came down E went to Pt. #1's bedside and talked to Pt. #1. CRNA E did not document this encounter with Pt. #1 and there is no notation from the nursing staff that CRNA E had this encounter or the time it occurred.

At 12:30 p.m. RN C documents that Pt. #1 was noted to have difficulty speaking due to an enlarged tongue, swelling of lips and left eye. RN D, working with RN C, called MD F who was at another facility in surgery at this time.

An interview with RN D was conducted on 7/17/2013 at 1:10 p.m. RN D stated that MD F told D to contact anesthesia, that this was an anesthesia issue and the patient probably had trauma from intubation. This phone call is not documented.

RN D stated D then called Dr. G who stated, "We don't think its trauma, maybe it could be, watch [#1]." This phone call is not documented.

RN D stated D made another call to MD F at approximately 1:10 p.m. to report no improvement in Pt. #1's condition and an increase in the swelling and received orders to give Benadryl (for a potential allergic reaction) and the standing order for Decadron (steroid to decrease inflammation, standing order to give prior to discharge on MD F's patients who have this procedure). This phone call is not documented.

These findings were reviewed with CNO A at 1:30 p.m. who confirmed this documentation was not in the MR.

ANESTHESIA SERVICES

Tag No.: A1000

Based on 3 of 3 staff interviews (staff A, E, and D), 8 out of 8 MR reviews (Pt. #1-8), and P/P reviews, this facility failed to provide complete anesthesia evaluations by a provider of anesthesia in a time frame that was appropriate for anesthesia recovery. Failure to complete comprehensive post-anesthesia evals by an anesthesia provider has the potential to affect all patients receiving anesthesia services in this facility. There were no patients scheduled for surgery on the date of the survey.


Findings include:

This facility failed to complete comprehensive post-anesthesia evaluations by an anesthesia provider that included respiratory function (including rate, airway patency, and oxygen saturation), cardiovascular function (including pulse rate and blood pressure), mental status, temperature, pain, nausea and vomiting, and post-operative hydration in a time frame that is sufficient for the patient to recover from anesthesia. See tag 1005.


The cumulative affects of this failure have the potential to affect all patients receiving anesthesia services at this out patient facility.

POST-ANESTHESIA EVALUATION

Tag No.: A1005

Based on 8 out of 8 MR reviews (Pt. #1-8), P/P review, and staff interview, this facility failed to complete comprehensive post-anesthesia evaluations by an anesthesia provider that included respiratory function (including rate, airway patency, and oxygen saturation), cardiovascular function (including pulse rate and blood pressure), mental status, temperature, pain, nausea and vomiting, and post-operative hydration in a time frame that is sufficient for the patient to recover from anesthesia. Also, orders for discharge from anesthesia services and the facility were written prior to the patient's being recovered from anesthesia. Failure to complete comprehensive post-anesthesia evals by an anesthesia provider has the potential to affect all patients receiving anesthesia services in this facility. There were no patients scheduled for surgery on the date of the survey.

Findings include:

The facility's policy titled, "Standards of Care," from the Anesthesia Manual, dated 2/2013 was reviewed on 7/17/2013 between 9:15 a.m. and 9:45 a.m. The policy states in part on page 3 of 5, #4.16, "All patients that receive general, regional, or managed anesthesia care will receive appropriate post-anesthesia care."
#4.20 states, "Qualified anesthesia personnel will evaluate the patients's condition post-procedure status upon admission and discharge from the PACU. Discharge documentation will include but is not limited to: a. Status of patient for discharge, b. Compliance with discharge criteria, c. Physicians written order for discharge."
#4.21 states, "A post-anesthesia summary report is completed on the anesthesia record. Each post-anesthesia visit specifies the date and time and should be made within 24 hours of anesthesia procedure."

The facility's policy titled, "Post Anesthesia Care Unit," from the Anesthesia Manual, dated 2/2013, was reviewed on 7/17/2013 between 9:15 a.m. and 9:45 a.m. The policy states in part, on page 2 of 3, 4.8, "Qualified physician medical coverage will be available throughout the patient's post-anesthesia recovery period."
On page 3 of 3, 4.13 states in part, "The administering anesthesiologist and/or physician is responsible for the decision to discharge the patient from the PACU. a. The responsible practitioner will sign the discharge order."

In a phone interview with CRNA E on 7/17/2013 at 2:00 p.m., CRNA E stated that the expectations for post-anesthesia evaluations are to stay until the patient is on their way to Phase II recovery and the patient is stable and responding properly to commands. This facility does not require anesthesia personnel to remain in the facility until the last patient has left the facility.

MR reviews were completed on the closed surgical MRs for Pt.s #1-8 on 7/17/2013 between 10:30 a.m. and 2:15 p.m.

The post-anesthesia evaluation, which is documented by an anesthesia provider on the Anesthesia Record, consists of a 1 inch by 1 inch box in the lower right hand corner of the paper form and is titled, "Post Anesthesia Visit." There are two small check boxes in this area. One says "No anesthesia complications," the other says, "See progress notes." There is a line for date, time, and signature also in this box. There is nowhere on this form, or any other form completed by the anesthesia provider that captures the required criteria for appropriate post-anesthesia evaluations: respiratory function (including rate, airway patency, and oxygen saturation), cardiovascular function (including pulse rate and blood pressure), mental status, temperature, pain, nausea and vomiting, and post-operative hydration in a time frame that is sufficient for the patient to recover from anesthesia.

Pt. #1's anesthesia started at 9:55 a.m. on 7/9/13 and ended with report to the PACU nurse at 11:04 a.m. The post-anesthesia eval was completed at 11:10 a.m. (6 minutes) and states "no anesthesia complications." In Phase I recovery Pt. #1's blood pressure (BP) became markedly elevated (from 109/92 at 11:04 a.m. to 239/102 at 11:27 a.m.). RN D contacted CRNA E for a medication order (Hydralazine) which was given for the increased BP at 11:35 a.m. and again at 11:43 a.m. At 11:50 a.m. Pt. #1's BP was 163/79. Anesthesia signed discharge orders (DC) at 10:20 a.m. (during the surgical procedure) and the MD signed DC orders at 11:00 a.m. (immediately after surgery before Pt. #1 arrived in Phase I).

In an interview with RN D on 7/17/2013 at 1:10 p.m. RN D confirmed that anesthesia does leave the building when cases are finished and does not stay until all patients have left the building. RN D stated that CRNA E probably left around noon on 7/9/2013. When shown the requirements for the post anesthesia evaluation in the federal regulations RN D stated that an anesthesia provider normally does not document the elements of the post-anesthesia evaluation. RN D went on to say, "Usually the last time they see them is when they hand off to the PACU nurse and they don't see them again before they leave unless they happen to have another case. This was the last case of the day. [E] hung around until noon and then left."

At 12:30 p.m. on 7/9/2013 Pt. #1 began to experience symptoms of an allergic reaction (anaphylaxis) with a swollen tongue, lips, left eye, and left side of the neck. These symptoms persisted and worsened over the course of 2 and 1/2 hours, through which time there was no medical staff on site (MD or CRNA). Despite phone calls made to MD F and G and orders to give medications for inflammation and allergic reaction, and after the arrival of Emergency Medical Technicians at 3:00 p.m., Pt. #1 became PNB and was unable to be intubated or resuscitated due to the severe swelling in the neck and tongue. Attempts to resuscitate Pt. #1 started at this facility and continued throughout transport to, and while at, an acute care facility however efforts were unsuccessful and Pt. #1 was pronounced dead at 4:26 p.m. on 7/9/2013.

In an interview with the CNO A on 7/17/2013 at 8:32 a.m., CNO A stated that the organization immediately convened an emergent review of the case, developed a time line of events, conducted a root cause analysis on 7/15/2013, and had one of several planned leadership meetings regarding this case on 7/16/2013. This facility has identified weaknesses in its processes and is actively working towards improving their practice to safeguard patient care.

On 5/14/13 Pt. #2's anesthesia started at 10:32 a.m. and ended with a report off to PACU at 11:19 a.m. The MD order to DC when criteria were met was written at 11:09 a.m. The post anesthesia evaluation was documented at 11:22 a.m. (3 minutes). Pt. #2 left the facility at 3:00 p.m.

On 7/9/13 Pt. #3's anesthesia started at 9:22 a.m. and ended with report off at 10:24 a.m. The MD signed DC orders at 9:50 a.m. and anesthesia signed DC orders at 9:59 a.m. The post anesthesia eval was documented at 10:29 a.m. (5 minutes). Pt. #3 left the facility after 1:35 p.m.

On 6/20/13 Pt. #4's anesthesia started at 8:19 a.m. and ended at 10:41 a.m. with report off to PACU. Anesthesia signed DC orders at 9:00 a.m. The post anesthesia eval was documented at 10:51 a.m. (10 minutes). Pt. #4 left the facility after 1:40 p.m.

On 6/19/2013 Pt. #5's anesthesia started at 7:56 a.m. and ended at 8:58 a.m. with report off to PACU. The DC orders were signed at 8:15 a.m. The post anesthesia eval was documented at 9:00 a.m. (2 minutes). Pt. #5 left the facility after 12:20 p.m.

On 5/21/2013 Pt. #6's anesthesia started at 12:38 p.m. and ended at 2:20 p.m. with a report off to PACU. Anesthesia signed the DC order at 1:00 p.m. and the MD signed DC orders at 2:00 p.m. The post anesthesia eval was done in an appropriate time frame (3:21 p.m. with Pt. #6 leaving the facility sometime shortly after the eval) however the content of the eval is not complete.

On 5/16/2013 Pt. #7's anesthesia started at 11:31 a.m. and ended at 12:42 p.m. with a report off to PACU. Anesthesia signed DC orders at 11:31 a.m. and the MD signed DC orders at 12:33 p.m. The time of the post anesthesia eval is not documented. Pt. #7 left the facility some time after 3:00 p.m.

On 7/9/2013 Pt. #8's anesthesia started at 8:22 a.m. and ended at 9:32 a.m. with a report off to PACU. Anesthesia signed DC orders at 8:00 a.m. and the MD signed DC orders at 9:24 a.m. The post anesthesia eval was documented at 9:37 a.m. (5 minutes). Pt. #8 left Phase I recovery at 10:02 a.m. for Phase II recovery. No information is available at the time of this writing regarding when Pt. #8 left the facility.

The final findings of the DC orders being signed before the patient is recovered, post anesthesia evaluation content and time frame was discussed with CNO A at 3:00 p.m. on 7/17/2013.