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Based on staff interview and review of medical records, the facility's governing body and administrator failed to ensure the facility and medical staff policies and procedures were reviewed after Sample Patient #1 experienced a negative outcome while being followed-up by the facility as an outpatient during the week following his/her outpatient surgery at the facility. The failure to initiate timely policy/procedure review related to the patient's care, and to institute changes to correct any processes that contributed to the patient's negative outcome, created the potential for other negative patient outcomes.

The Findings were:

1. Medical Record Review:

On 8/30/2010, the medical record of Sample Patient #1 was reviewed and revealed the following, in pertinent parts:

The facility failed to ensure a patient (Sample Patient #1) who had an outpatient surgery (sub-muscular transposition, right ulnar nerve) was adequately assessed and all post-operative follow-up visits and all clinical findings accurately/completely documented. In addition, the facility failed to ensure the providers who saw and assessed the patient for symptoms (including pain, fever, swelling, numbness, blisters related to the condition of the surgical area and right arm/hand) on five occasions (on post-operative days one, four, five, and six) notified or consulted with the orthopedic surgeon about clinical findings and treatment strategies for the patient.

When the patient was seen by the orthopedic surgeon on post-operative day seven for the scheduled follow-up appointment, the patient had symptoms of pain, swelling, blistering and sloughing of skin and tissue on lower right arm, evidence of a massive infection (later determined to be gas gangrene due to Clostridium botulinum, per Staff #9) of the right hand and forearm and no right radial pulse. The orthopedic surgeon arranged for a transfer of care to a limb preservation unit at a hospital in Denver. The patient was urgently transported by family car to the other facility, where s/he underwent an initial below-the-elbow amputation and a subsequent above-the-elbow amputation of the right arm. In addition, the patient remained in that facility for several weeks for treatment of septic shock and renal failure. The patient's condition also required ventilator support and weaning.

2. Staff/Physician Interviews:
Staff interviews (Staff #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11 and #12) conducted on 8/30 and 8/31/10 and 9/1/10 with all of the nursing staff, physicians and physicians assistants (PA's) confirmed that the visiting specialty orthopedic surgeon (located in another community several hours away), who performed the sub-muscular transposition of the right ulnar nerve, was never contacted or consulted about any of the patient's symptoms and care related to visits to the clinic and the Emergency Department during the week following the surgery. In addition, the staff/providers all confirmed that no one who saw the patient for these multiple visits took all of the patient's wraps, splints and dressing off, so that the arm/hand and surgical repair site at the right elbow could be completely visualized/assessed. Three (Staff #1, #6 and #9) of the four providers who saw the patient verbalized reluctance to remove the splints/dressings completely for fear of damaging the surgical repair. They all verbalized that they believed the patient's symptoms indicated a circulation problems rather than an infection, and simply loosening the wrap had brought relief to the patient's complaints. The fourth provider (Staff #7) stated that s/he had been the first assistant in the surgery and felt no concern about damaging the surgical repair by removing the splints/dressings. S/he state that s/he had warned one of the other practitioners, who consulted with him/her about the type of splint used, not to remove the splint because "it was hard to get it on during the surgery and you'll never get it back on if you take it off." The practitioner also stated that none of the symptoms indicated a need for concern and were to be expected after surgery. That practitioner also failed to document his/her contact with patient on post-operative day five.

Staff/provider interviews (Staff #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13 and #14) conducted on 8/30 and 8/31/10 and 9/1/10 revealed that the providers failed to provide safe and effective care in the following ways:
- failure to fully assess the patient (Sample Patient #1), including removing dressing to assess the patient's arm/hand and surgical site,
- failure to notify and consult with the surgeon about the patient's repeated visits back to the facility and
- failure to record one of the Emergency Department visits.
Despite the fact that these failures had been identified and discussed by staff and providers prior to the survey, no corrective actions had been taken at the time of the survey.

3. Administrator Interview:
On 8/30/10 at approximately 1:40 p.m., the administrator of the facility was interviewed and stated that the facility had had staff, provider and board discussions about the case (Sample Patient #1), but that no conclusions had been reached and no corrective action had been taken. S/he stated that the state had been notified and s/he anticipated that surveyors would be sent to investigate the case. S/he stated that his/her "plan was to wait to see what the surveyors found and that they would tell us (the facility) what we need to correct." In addition, the administrator stated that the facility/provider staff was waiting for the results from the pathology report and the other hospital's records before evaluating the case and/or making any changes. Interviews with other facility staff indicated that they had been directed by the administrator not to make any corrections until after the pathology report, surgeon report and records from the other hospital were received and reviewed and recommendations made.

In summary, the facility failed to initiate timely analysis and take corrective action related to practice/process problems that potentially contributed to the negative outcome for Sample Patient #1, once they were identified.

Based on the nature of deficiencies cited, it was determined that the facility was not in compliance with the Condition of Participation of Provision of Services. The facility failed to ensure that facility policies/procedures for emergency medical services adequately addressed guidelines for the medical management of health problems including the conditions requiring medical consultation and/or referral for orthopedic surgery follow-up, and maintenance of health care records for each Emergency Department visit.

The facility failed to meet the following standard under the condition of Provision of Services:

Tag C274 - Patient Care Policies - Emergency Medical Services
The facility failed to ensure that emergency medical services policies/procedures address guidelines for care of a patient for unanticipated post-operative follow-up care in the Emergency Department. The facility also failed to ensure that staff/providers had adequate guidelines to ensure that all care provided in the Emergency Department was complete and fully documented, as required by CMS (Centers for Medicare and Medicaid Services) regulations, including special EMTALA (Emergency Medical Treatment and Active Labor Act) requirements.

Tag C275 - Patient Care Policies - Medical Consultation/Referral
The facility failed to ensure that policies/procedures addressed guidelines for provider consultation with the out-of-town orthopedic surgeon for managing post-operative follow-up for orthopedic surgery patients.

Based on staff/provider interviews and medical record, personnel/credential files and polices/procedures reviews, the facility failed to ensure that emergency medical services policies/procedures adequately addressed guidelines for care of a patient for unanticipated post-operative follow-up care in the Emergency Department. The facility also failed to ensure that staff/providers had adequate guidelines/training to ensure that all care provided in the Emergency Department was complete and fully documented, as required by CMS (Centers for Medicare and Medicaid Services) regulations, including special EMTALA (Emergency Medical Treatment and Active Labor Act) requirements. The failures may have contributed to the negative outcome for sample patient #1, whose unanticipated post-operative symptoms were not adequately assessed, his/her surgeon was not notified or consulted. In addition, one of Sample Patient #1's Emergency Department visits was not documented and the patient was released by the provider before the full assessment, including the nursing assessment could be completed.

The findings were:

1. Review of Emergency Department Policy/Procedure:

Review on 8/31/10 of the policy/procedure "Emergency Room Admission and Discharge Policies" revealed the following, in pertinent parts:
"...Admission Medical Screening:
1. All individuals presenting to the (facility) ED will be evaluated by a physician or certified physician's assistant (PAC), FNP (family nurse practitioner) or on call provider (OCP) and treated or stabilized as appropriate to their condition as consistent with resources generally available for such treatment or stabilization at (the facility).
2. An RN (registered nurse) will perform the initial triage assessment on all patients presenting to the (facility) ED, and these findings will be given to the on call provider (OCP). The detail and nature of the information will be dictated by the particular circumstances of the situation.
...Medical Record:
1. An emergency department record is filled out for every person seeking treatment through the ED.
...Record Maintenance;
...2. Each ED admission is recorded in the ED log..."

2. Personnel/Credential File Review Regarding EMTALA Training:

On 8/21/10, the personnel and credential files of all staff/physicians involved in the post-operative care of Sample Patient #1 were reviewed and were found to contain no documentation of facility training of staff related to EMTALA regulations and compliance. on 9/1/10 at approximately 9:00 a.m., the director of nursing stated that the facility did not do in-house EMTALA of nursing staff and physicians/providers and relied on all staff to have TNCC (Trauma Nurse Course Certification) and all physicians/providers to have ATLS (Advanced Trauma Life Support). The personnel/credential files reviewed revealed that all ED staff/providers did have current TNCC or ATLS certification. Despite the TNCC/ATLS training for all ED staff and providers, the nurse and PA failed to recognize that the failure to fully triage/assess and provide a medical screening exam, and document the same, for Sample Patient #1 (on 7/27/10) was a violation of EMTALA requirements for a medical screening exam (MSE).

3. Staff/Physician Interviews:
Staff interviews (Staff #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11 and #12) conducted on 8/30 and 8/31/10 and 9/1/10 with all of the nursing staff, physicians and physicians assistants (PA's) confirmed that the visiting specialty orthopedic surgeon (located in another community several hours away), who performed the sub-muscular transposition of the right ulnar nerve, was never contacted or consulted about any of the patient's symptoms and care related to visits to the clinic and the Emergency Department during the week following the surgery. In addition, the staff/providers all confirmed that no one who saw the patient for these multiple visits took all of the patient's wraps, splints and dressing off, so that the arm/hand and surgical repair site at the right elbow could be completely visualized/assessed. Three (Staff #1, #6 and #9) of the four providers who saw the patient verbalized reluctance to remove the splints/dressings completely for fear of damaging the surgical repair. They all verbalized that they believed the patient's symptoms indicated a circulation problem rather than an infection, and simply loosening the wrap had brought relief to the patient's complaints. The fourth provider (Staff #7) stated that s/he had been the first assistant in the surgery and felt no concern about damaging the surgical repair by removing the splints/dressings. S/he state that s/he had warned one of the other practitioners, who consulted with him/her about the type of splint used, not to remove the splint because "it was hard to get it on during the surgery and you'll never get it back on if you take it off." The practitioner also stated that none of the symptoms indicated a need for concern and were to be expected after surgery. That practitioner also failed to document his/her contact with patient on post-operative day five.

Staff/provider interviews (Staff #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13 and #14) conducted on 8/30 and 8/31/10 and 9/1/10 revealed that the providers failed to provide safe and effective care in the following ways:
-failure to fully assess the patient (Sample Patient #1), including removing
dressing to assess the patient's arm/hand and surgical site,
- failure to notify and consult with the surgeon about the patient's repeated visits back to the facility and
- failure to record one of the Emergency Department visits.
Despite the fact that these failures had been identified and discussed by staff and providers prior to the survey, no corrective actions had been taken at the time of the survey.

Based on medical record review and staff interviews, the facility failed to ensure that policies/procedures addressed guidelines for provider consultation with the out-of-town orthopedic surgeon for managing post-operative follow-up for orthopedic surgery patients. The failures may have contributed to the negative outcome for sample patient #1, whose unanticipated post-operative symptoms were not adequately assessed and his/her surgeon was not notified or consulted regarding the patient's assessment and treatment.

The findings were:

1. Medical Record Review:

On 8/30/2010, the medical record of Sample Patient #1 was reviewed and revealed the following, in pertinent parts:

Review of the patient's medical record revealed that the patient was an adult patient that underwent a submuscular transposition, right ulnar nerve on 7/22/10 as an outpatient surgery at the facility. Patient tolerated surgery well, procedure uneventful and patient discharged home to family that day with follow-up outpatient appointment with the orthopedic surgeon on 7/29/10.

On 7/23/10 at 10:30 a.m. the patient was seen by a physician at the facility's outpatient clinic with complaint of "(R)ight arm pain and numbness. Is 2 day status post elbow surgery. No other complaints."
Physical Examination: "Dressing and splint intact on right arm. Fingers sensation intact. FROM (full range of motion). Capillary refill less than 2 seconds."
Assessment/Plan: "Continue Percocet for pain, circulation intact, recheck with (orthopedic surgeon) next week."

On 7/23/10 at 6:02 p.m., the patient presented to the ED with chief complaint of "Surgery on elbow yesterday. Running fever tonight. Saw (clinic doctor) at clinic this a.m. for pain. Changed pain medications." Nurse also noted "...Complaining of pain in right elbow. Face flushed...Dressings dry and intact...Patient given instruction on IS (Incentive spirometer)"

The physician assistant (PAC) that saw the patient gave the patient the diagnosis of post-operative atelectasis.

Patient History and Physical: "...presents with temperature elevation (100.8). S/he is 24 hours post-operative Right ulnar nerve transposition under general anesthesia. Denies cough..." Treatment: "Patient instructed on incentive spirometry every hour while awake. Advil 400 mg every 4 hours as needed for temperature elevation. Return if symptoms worsen."

On 7/26/10 at 9:13 a.m., the patient returned to the ED with chief complaint of "Surgery 7/22 ulnar nerve repair...Hit elbow on bed during the night. Burning pain, unable to move fingers. Sling and ace wraps on."

Nursing assessment: fingers pale, cool, patient unable to move fingers, capillary refill greater than 2 seconds."

The nurse noted "Physician assistant (PAC) in to see patient...Right arm re-wrapped by PAC. 60 mg Toradol given in left deltoid..." PAC exam findings included the following: "...presents to the ED for Right elbow pain. 4 day status post ulnar nerve entrapment repair. Hit elbow on doorway during middle of last night, complain of increased pain...Right arm immobilized in plaster splint. Fingers puffy, cool, decreased AROM (active rage of motion)...Splint solid/intact."
Orders: "Toradol 60 mg IM (intramuscular)."
Diagnosis: "Right elbow pain status post ulnar nerve relocation."
Treatment: "Toradol 60 mg IM x1. Reapplied ACE bandage (loose). Continue ibuprofen. Reassured patient that multiple layers of splint material, intact, elbow well-protected."
Instructions to Patient: "Discharge home. Schedule follow-up with (orthopedic surgeon) for this week. Return for any further problems."

The patient was seen in the ED on the evening of 7/27/10 for complaint of numbness, difficulty moving fingers and a large blister on the right hand between the thumb and index finger, but the provider did not document the visit and released the patient before the paperwork, including the nursing assessment, could be completed.

On 7/28/10 at 9:00 a.m. was seen in the outpatient clinic for worsening swelling of right arm and blood blisters distally on right arm status post elbow surgery. Provider stated that patient was seen on 7/27/10 in ER and blood blister was popped. Provider notes stated the following, in pertinent parts: "Good distal pulses, swelling of right hand in splint, with fluid and blood filled blister. Assessment: Tight splint with distal swelling. 2. Type II diabetes mellitus in good control.
Plan: Splint unwrapped and cast padding split with immediate symptomatic relief and ace re-wrapped. Polysporin dressing to popped blisters. Follow-up with (surgeon) tomorrow. Follow-up in 1 month for diabetes mellitus and obesity evaluation and monitoring."

On 7/29/10 at 3:47 p.m. for routine outpatient follow-up with surgeon. No description of symptoms by surgeon. Outpatient super-bill lists diagnosis of "Arterial Compromise of Right Hand."

On 7/30/10 a note by the surgeon stated: "Today I spoke with the physician at the limb preservation center in Denver, on two different occasions. This patient ultimately had a guillotine type mid forearm amputation. S/he apparently had pus throughout the entire forearm, and with the Gram stain results, the physician felt that s/he probably developed a clostridium infection. S/he said s/he will keep me apprised of his/her situation. Apparently, pre-operatively was starting to become toxic with early renal failure. Post-operatively, s/he said s/he is in the ICU, going into renal failure and also was intubated."

Refer to Tag C274 for additional findings related to the facility's failure to adequately assess the patient.

Based on staff/physician interviews, medical record and policy/procedure reviews, the facility failed to ensure that the medical record for Sample Patient #1 was complete and contained identification and social data, evidence of properly executed informed consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient for an Emergency Department visit on 7/27/10. The provider (Staff #7) failed to document the visit and the patient was released by the provider before the full assessment, including the nursing assessment could be completed. Since there was not record of the patient's 7/27/10 visit, the subsequent providers on 7/28/10 (Staff #9) and on 7/29/10 (Staff #3) did not have access to previous assessment data that could have been helpful in determining a differential diagnosis. The failure may have contributed to the negative outcome for sample patient #1. In addition, there was no documentation of the outpatient clinic visit on 7/29/10, other than a face sheet, a consent form and a super-bill with a diagnosis of "Arterial Compromise of Right Hand." The patient was sent out urgently, but there was no record of the provider's assessment of the patient or the two dressing changes required while the patient was in the clinic prior to transfer.

The findings were:

1. Medical Record Review: Sample Patient #1

Review of the medical record on 8/30/10 revealed that the record contained no documentation of an ED visit that the patient made on post-surgical day five (7/27/10). Per staff interviews, the patient was seen by a physician assistant (PA) on the evening of 7/27/10 in the Emergency Department. Review of the Emergency Department Log on 8/31/10 revealed that sample patient #1 was not entered into the log for a visit on 7/27/10.


2. Staff Interviews:

An interview conducted on 8/31/10 at approximately 10:35 a.m. with the nurse working in the ED that day on 7/27/10 revealed the following findings:

S/he stated the patient (Sample Patient #1) came into the ED and was placed in an overflow room in the outpatient surgery area around the corner from the ED, since the two bays and the exam room were already full with other patients. S/he stated that the PA had been called from the outpatient clinic to see patients in the ED, since s/he was the provider on-call for the ED that day. S/he ran into the patient (#1) in the hallway and followed her/her into the room. The nurse went to the nurse's station to enter the patient into the computer and start the record. S/he stated s/he took out a new ED packet and wrote the patient's name on the record. The PA called the nurse and asked him/her for a pair of scissors to cut through the patient's dressings at the thumb areas to loosen the tension on the dressing. S/he provided the scissors and left again. Soon after that s/he saw the PA showing the patient out of the ED. The PA allegedly told the nurse that the patient was leaving and that s/he did not need to enter the patient into the system. The nurse stated that s/he had not assessed the patient, had not yet entered the patient into the ED log or the electronic part of the system to generate a visit number. The PA had no written documentation of the patient assessment. S/he stated s/he shredded the paperwork, which only had the patient's name on it. When asked what s/he would have assessed had s/he had the chance, s/he stated s/he would have checked capillary refill, pulses, vital signs, measure blister on hand and observe skin temperature. S/he also stated: "I knew s/he came in and had a blister on his/her finger and s/he was a diabetic and I was concerned and wanted to look at it."

On 8/31/10 at approximately 2:50 p.m., the PA was interviewed and revealed the following findings:

The PA stated: "I was 1st assistant in surgery and saw him/her 24 hours post-op with a fever (s/he thought it was 101.4). S/he was a smoker and I made the diagnosis of atelectasis."

S/he stated s/he then saw the patient briefly 7/27/10 for a small blister that s/he thought was from dressing irritation. S/he stated that s/he followed all of the orthopedic surgeon cases and frequently saw blistering in the recovery period after fractures and other orthopedic trauma and surgery. The PA showed on his/her own hand that the blister was on the skin on the webbed area between the thumb and the index finger. S/he showed the blister was round and looked about the size of a half-dollar. S/he stated the patient complained of numbness, difficulty moving fingers, but the PA stated s/he had good capillary refill. S/he stated that s/he did not "pop the blister" (as had been reported in the medical record by the next physician to see the patient on 7/28/10). The PA stated s/he released the pressure of the bandage. S/he stated: "I did not think his/her swelling of the fingers was anything unusual for this kind of surgery. I did not suspect any circulatory compromise at this time." The PA acknowledged that s/he did not document his/her findings at the time of the visit and since s/he told the nurse that s/he did not need to enter the patient in the record and sent the patient home before the nurse could do a nursing assessment, there was no way to establish or validate his/her findings and they were not available for other later providers on subsequent visits on 7/28/10 and 7/29/10.

3. Review of Emergency Department Policy/Procedure:

Review on 8/31/10 of the policy/procedure "Emergency Room Admission and Discharge Policies" revealed the following, in pertinent parts:

"...Admission Medical Screening:
1. All individuals presenting to the (facility) ED will be evaluated by a physician or certified physician's assistant (PAC), FNP (family nurse practitioner) or on call provider (OCP) and treated or stabilized as appropriate to their condition as consistent with resources generally available for such treatment or stabilization at (the facility).
2. An RN (registered nurse) will perform the initial triage assessment on all patients presenting to the (facility) ED, and these findings will be given to the on call provider (OCP). The detail and nature of the information will be dictated by the particular circumstances of the situation.
...Medical Record:
1. An emergency department record is filled out for every person seeking treatment through the ED.
...Record Maintenance;
...2. Each ED admission is recorded in the ED log..."