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Based on interview and record review, it was determined the medical staff failed to be accountable to the governing body for the provision of services for 1 of 1 Patient [Patient #1] by Resident Physician and Supervising Physician, which resulted in Patient #1 requiring a Left Below the Knee Amputation on 12/23/09.

Findings Included:

The Operative Report dated 08/29/08 reflected, "Left Total Knee Arthroplasty...complications none...patient is a 51-year-old female with chronic history of left knee pain and degenerative joint disease which failed conservative treatment...Surgeon [Resident Physician, Staff #7] and Supervising M.D. #11] present for all important portions of case..."[signed by Supervising Physician Staff #11].

The general care flowsheet dated 08/29/08 timed at 11:30 AM reflected, "received patient from RR [Recovery Room]...at 12:30 PM notified MD [Medical Doctor] about patient c/o [complaining of] pain and burning sensation to left leg..."

The staff progress note [documented by Medical Student #10] dated 08/30/08 timed at 8:31 AM reflected, "Patient has diffuse numbness of L [Left] LE [Lower Extremity]. Unable to wiggle toes or dorsiflex ankle...toes warm...good cap refill....monitor for end of nerve block and resumption of motor sensory activity of LLE [Left Lower Extremity]..."

The Staff progress note [documented by Resident Physician, Staff #7] dated 08/30/08 timed at 11:00 AM reflected, "agree with above...monitor nerve function for return..."

The general care flowsheet dated 08/30/08 timed at 4:00 PM reflected, "Toes warm to touch patient unable to wiggle toes, MD aware...patient complains of pain, medicated...at 21:15 feels tingling in left foot continue to monitor..."

The Staff progress note [documented by Medical Student #10] dated 08/31/08 timed at 8:36 [unknown time whether AM or PM] reflected, "Patient states that her foot has a burning sensation on medial plantar surface and that she is still unable to move toes or ankle...monitor for resumption of LLE motor function..."

The Staff progress note [documented by Resident Physician, Staff #7] dated 08/31/08 untimed reflected, "Agree..."

The Staff progress note dated 08/31/08 timed at 2:45 PM documented by a nurse reflected, "Noted decreased sensation to toes. Positive sensation to heel through mid foot...MD aware of decrease sensation and pain..."

The Staff progress note dated 09/01/08 timed at 1:00 PM [documented by Resident Physician, Staff #7] called to evaluate patient with persistent LLE pain...LLE positive for swelling, tight compressible compartments...concern for compartment syndrome...to OR [Operating Room].

No documentation was found from 08/29/08 to 08/31/08 indicting the supervising physician assessed Patient #1's condition and/or the resident physician's medical record entries.

The Intra-operative report dated 09/01/08 timed at 01:15 AM reflected, "Left Leg Compartment...procedure Fasciotomy left leg...at 02:14 PT [Patient] admitted to OR #18 as emergent case secondary to LLE compartment syndrome..."

The first operative report dated 09/01/08 reflected, "Compartment fasciotomy of the left leg...findings...a deep posterior compartment with patchy necrosis, no posterior tibial pulse by Doppler...status post total knee arthroplasty approximately 2 days...following the procedure, the patient was unable to dorsiflex or plantarflex her ankle or her toes...the patient had new onset paresthesias in sural saphenous distribution...patient taken to operating room for compartment fasciotomy...the posterior tibial artery was identified and there was no pulse palpable...all 4 fasciotomy sites were taken both proximally and distally...at this point there was concern the patient had a vascular injury as we could not obtain posterior tibial, dorsalis pedis or posterior pulses..."

The 09/01/08 general care flowsheet timed at 8:00 AM reflected, "Toes cold/vascular resident at bedside dopplering pulses unable to hear...patient has consented for OR...at 08:15 NPO [Nothing by mouth] for OR....at 9:30 AM off floor to OR..."

A second Operative Report dated 09/01/08 reflected, "High grade Left Popliteal Artery Injury...operation performed...left lower extremity arteriogram and left femoral artery to posterior tibial artery with vein....left lower extremity arteriogram demonstrated acute and abrupt cut-off height demonstrating high-grade injury of the left popliteal artery behind the knee with no identifiable run off on the angiogram....there was a weak monophasic signal in the posterior tibial artery at the end of the case...disposition....poor prognosis for bypass as well as limb salvage due to late grade of ischemia..."

The 09/01/08 nurses note timed at 8:00 PM reflected, "Pulse on LLE [Left Lower Extremity] not palpable. Foot warm...at 2400 ...no change in pulse...on 09/2/08 at 06:00 AM doctor...at bedside with vascular. Stated vascular may just wash out fasciotomy versus AKA [Above Knee Amputation]...No other changes."

The 09/02/08 Operative Report reflected, "Irrigation and debridement of left lower leg...vascular surgery was consulted..."

The 09/05/08 Operative Report reflected, "Debridement and irrigation and application of VAC [vacuum] wound dressing..."

The 09/08/08 Operative Report reflected, "Irrigation and debridement of the left leg and application of vacuum dressing to the left leg..."

The 09/12/08 Operative report reflected, "closure of the lateral wound, split-thickness skin graft to the medial wound and application of vacuum-assisted closure dressing to the medial wound..."

The Discharge Summary dated 09/19/08 reflected, "Patient continued to work with physical therapy and subsequently cleared physical therapy. The VAC [vacuum] dressing was taken down on 09/17/08 and there was evidence of good healing of the skin graft, which appeared to have taken well...the lateral fasciotomy site continued to perform well without erythema, induration, or exudate...patient was discharged home on 09/19/08..."

The 12/23/09 Operative Report reflected, "Postoperative left total knee arthroplasty infection...operation performed amputation of lower extremity...this 52 year old female has had a very long and complicated course in regards to her left total knee arthroplasty...her last procedure consisted of a free flap to cover her total knee arthroplasty that was performed by plastics and was doing well up until 3 days ago when the patient was taken back to OR by plastic service and an infection was noted....recommendation was an amputation...."

On 12/10/10 at 9:25 AM, [M.D. #18] was interviewed.[ M.D. #18] stated the hospital did not recognize Patient #1's case as a concern until the article in the local newspaper appeared in 2010. [M.D. #18] stated Patient #1's case was being reviewed and the peer review process was in progress. [M.D. #18] stated the hospital failed to identify the connection between the multiple surgeries Patient #1 underwent and the initial surgery performed 08/29/08.

On 12/30/10 at 1:00 PM [Staff #4] stated this event was missed by the hospital.

On 12/31/10 at 10:45 AM [Staff #1] was interviewed. Staff #1 stated communication and policy revisions on resident supervision had been done over the last two years. [Staff #1] stated the event was not identified after the surgical event and the surgical complications Patient #1 sustained.

On 12/31/10 at 1:15 PM [ Resident Physician, Staff #7] was interviewed. [Resident Physician, Staff #7] stated he notified the supervising physician of Patient #1's medical changes but did not document it.

On 01/26/11 at approximately 4:30 PM [Staff #1] was asked to provide Resident Physician supervision policy for 2008. A hand written faxed response dated 01/26/11 timed at 19:22 PM reflected, "No formal policy and procedure for Resident Supervision in 2008 for...hospital..."

The public verification/physician profile for [Resident Physician, Staff #7] reflected, "Physician in Training Permit begin date 07/01/08 to 06/30/12."

The Texas Occupations Code Section 155.105. entitled, "Physician in Training Permit"
(b) A physician-in training permit does not authorize the performance of a medical act by permit holder unless act is performed: 1) as a part of graduate medical education training program; and 2) under supervision of a physician.

Based on interview and record review, it was determined the hospital failed to identify a medical error which occurred when 1 of 1 Patient [Patient #1] had a Left Total Knee Replacement on 08/29/08. Patient #1 sustained a Popliteal Artery Injury. The injury required Patient #1 to endure multiple surgical procedures and/or complications related to the surgery which resulted in a Left Below the Knee Amputation on 12/23/09.

Findings Included:

The Operative Report dated 08/29/08 reflected, "Left Total Knee Arthroplasty...complications none...patient is a 51-year-old female with chronic history of left knee pain and degenerative joint disease which failed conservative treatment...Surgeon [Resident Physician, Staff #7] and [Supervising M.D. #11] present for all important portions of case..."

The general care flowsheet dated 08/29/08 timed at 11:30 AM reflected, "received patient from RR [Recovery Room]...at 12:30 PM notified MD [Medical Doctor] about patient c/o [complaining of] pain and burning sensation to left leg..."

The staff progress note [documented by Medical Student #10] dated 08/30/08 timed at 8:31 AM reflected, "Patient has diffuse numbness of L [Left] LE [Lower Extremity]. Unable to wiggle toes or dorsiflex ankle...toes warm...good cap refill....monitor for end of nerve block and resumption of motor sensory activity of LLE [Left Lower Extremity]..."

The Staff progress note [documented by Resident Physician, Staff #7] dated 08/30/08 timed at 11:00 AM reflected, "agree with above...monitor nerve function for return..."

The general care flowsheet dated 08/30/08 timed at 4:00 PM reflected, "Toes warm to touch patient unable to wiggle toes, MD aware...patient complains of pain, medicated...at 21:15 feels tingling in left foot continue to monitor..."

The Staff progress note [documented by Medical Student #10] dated 08/31/08 timed at 8:36 [unknown time whether AM or PM] reflected, "Patient states that her foot has a burning sensation on medial plantar surface and that she is still unable to move toes or ankle...monitor for resumption of LLE motor function..."

The Staff progress note [documented by Resident Physician, Staff #7] dated 08/31/08 untimed reflected, "Agree..."

The Staff progress note dated 08/31/08 timed at 2:45 PM documented by a nurse reflected, "Noted decreased sensation to toes. Positive sensation to heel through mid foot...MD aware of decrease sensation and pain..."

The Staff progress note dated 09/01/08 timed at 1:00 PM [documented by Resident Physician, Staff #7] called to evaluate patient with persistent LLE pain...LLE positive for swelling, tight compressible compartments...concern for compartment syndrome...to OR [Operating Room].

No documentation was found from 08/29/08 to 08/31/08 indicting the supervising physician assessed Patient #1's condition and/or the resident physician's medical record entries.

The Intra-operative report dated 09/01/08 timed at 01:15 AM reflected, "Left Leg Compartment...procedure Fasciotomy left leg...at 02:14 PT [Patient] admitted to OR #18 as emergent case secondary to LLE compartment syndrome..."

The first operative report dated 09/01/08 reflected, "Compartment fasciotomy of the left leg...findings...a deep posterior compartment with patchy necrosis, no posterior tibial pulse by Doppler...status post total knee arthroplasty approximately 2 days...following the procedure, the patient was unable to dorsiflex or plantarflex her ankle or her toes...the patient had new onset paresthesias in sural saphenous distribution...patient taken to operating room for compartment fasciotomy...the posterior tibial artery was identified and there was no pulse palpable...all 4 fasciotomy sites were taken both proximally and distally...at this point there was concern the patient had a vascular injury as we could not obtain posterior tibial, dorsalis pedis or posterior pulses..."

The 09/01/08 general care flowsheet timed at 8:00 AM reflected, "Toes cold/vascular resident at bedside dopplering pulses unable to hear...patient has consented for OR...at 08:15 NPO [Nothing by mouth] for OR....at 9:30 AM off floor to OR..."

A second Operative Report dated 09/01/08 reflected, "High grade Left Popliteal Artery Injury...operation performed...left lower extremity arteriogram and left femoral artery to posterior tibial artery with vein....left lower extremity arteriogram demonstrated acute and abrupt cut-off height demonstrating high-grade injury of the left popliteal artery behind the knee with no identifiable run off on the angiogram....there was a weak monophasic signal in the posterior tibial artery at the end of the case...disposition....poor prognosis for bypass as well as limb salvage due to late grade of ischemia..."

The 09/01/08 nurses note timed at 8:00 PM reflected, "Pulse on LLE [Left Lower Extremity] not palpable. Foot warm...at 2400 ...no change in pulse...on 09/2/08 at 06:00 AM doctor...at bedside with vascular. Stated vascular may just wash out fasciotomy versus AKA [Above Knee Amputation]...No other changes."

The 09/02/08 Operative Report reflected, "Irrigation and debridement of left lower leg...vascular surgery was consulted..."

The 09/05/08 Operative Report reflected, "Debridement and irrigation and application of VAC [vacuum] wound dressing..."

The 09/08/08 Operative Report reflected, "Irrigation and debridement of the left leg and application of vacuum dressing to the left leg..."

The 09/12/08 Operative report reflected, "closure of the lateral wound, split-thickness skin graft to the medial wound and application of vacuum-assisted closure dressing to the medial wound..."

The Discharge Summary dated 09/19/08 reflected, "Patient continued to work with physical therapy and subsequently cleared physical therapy. The VAC [vacuum] dressing was taken down on 09/17/08 and there was evidence of good healing of the skin graft, which appeared to have taken well...the lateral fasciotomy site continued to perform well without erythema, induration, or exudate...patient was discharged home on 09/19/08..."

The 12/23/09 Operative Report reflected, "Postoperative left total knee arthroplasty infection...operation performed amputation of lower extremity...this 52 year old female has had a very long and complicated course in regards to her left total knee arthroplasty...her last procedure consisted of a free flap to cover her total knee arthroplasty that was performed by plastics and was doing well up until 3 days ago when the patient was taken back to OR by plastic service and an infection was noted....recommendation was an amputation...."

On 12/10/10 at 9:25 AM, [M.D. #18] was interviewed.[ M.D. #18] stated the hospital did not recognize Patient #1's case as a concern until the article in the local newspaper appeared in 2010. [M.D. #18] stated Patient #1's case was being reviewed and the peer review process was in progress. [M.D. #18] stated the hospital failed to identify the connection between the multiple surgeries Patient #1 underwent and the initial surgery performed 08/29/08.

On 12/30/10 at 1:00 PM [Staff #4] stated this event was missed by the hospital.

On 12/31/10 at 10:45 AM [Staff #1] was interviewed. [Staff #1] stated communication and policy revisions on resident supervision had been done over the last two years. [Staff #1] stated the event was not identified after the surgical event and the surgical complications Patient #1 sustained.

On 12/31/10 at 1:15 PM [ Resident Physician, Staff #7] was interviewed. [Resident Physician, Staff #7] stated he notified the supervising physician of Patient #1's medical changes but did not document it.

On 01/26/11 at approximately 4:30 PM [Staff #1] was asked to provide Resident Physician supervision policy for 2008. A hand written faxed response dated 01/26/11 timed at 19:22 PM reflected, "No formal policy and procedure for Resident Supervision in 2008 for...hospital..."

The Hospital Bylaws with a revision date of 03/25/08 reflected under section 7 entitled, "Quality and Risk Management Committee" the following: "The Quality and Risk Management Committee shall consist of a Chairman and two other Board members. Administration will provide...reports on performance improvement and quality and risk management activities...these reports will address such issues as clinical safety, compliance, regulatory and accreditation activities..." Noted the hospital was unaware of Patient #1's case until if was brought to the hospitals attention through the media.

Based on interview and record review, the hospital failed to maintain complete medical records for 1 of 1 patients [Patient #1] treated and discharged after 09/19/08. The medical record entries were not complete, dated, timed, and/or authenticated according to hospital policy.

Findings Included:

1) Patient #1's surgery procedure notes dated 08/29/08 to 09/12/08 reflected the following:

The 08/29/08 note reflected, "Diagnosis: Arthritis Left Knee." The note documented no entry time.

The 09/01/08 note reflected, "Diagnosis: Compartment Syndrome Left Leg." The note documented no entry time. A second 09/01/08 note reflected, "Diagnosis Ischemic Left Leg, S/P [Status Post] L [Left] Total Knee Replacement." No entry time was documented.

The 09/08/08 note reflected, "Diagnosis: Complex wounds L [Left] leg secondary to Fasciotomies and Vascular repair." The note documented no entry time.

The 09/12/08 note reflected, "Diagnosis: Wounds of L [Left] leg S/P [Status Post] Fasciotomy. The note documented no entry time.

2) The 09/01/08 Intensive Care Unit Progress note under the section entitled, "Resident Documentation" reflected a time of "22:00." The Resident documentation reflected, "51 year old F [Female] S/P [Status Post] TKA [Total Knee Arthroplasty] 08/29/08 for Osteoarthritis, complicated by L [Left] LE [Lower Extremity] Compartment syndrome S/P [Status Post] L [Left] LE [Lower Extremity] fasciotomy 09/01/08...patient lost left lower extremity pulse..." The section of the document entitled, "Attending Documentation" reflected no documentation.

3) The Operative Reports dated 08/29/08 to 09/12/08 reflected the following:

The Operative Report dated 08/29/08 was dictated by [Resident Physician #7] at "09:16:40." [Supervising Physician #11] signed the dictated report. No date and time was documented.

The Operative Report dated 09/01/08 was dictated by [Resident Physician #14] at "03:36:25." [Supervising Physician #13] signed the dictated report. No date and time was documented.

The Operative Report dated 09/02/08 was dictated by [Resident Physician #16 ] at "18:19:21." [Supervising Physician #15] signed the dictated report. No date and time was documented.

The Operative Report dated 09/05/08 was dictated by [Resident Physician #17] at "19:27:59." [Supervising Physician #15] signed the dictated report. No date and time was documented.

The Operative Report dated 09/08/08 was dictated by [Resident Physician #14] at "22:50:15." [Supervising Physician #11] signed the dictated report. No date and time was documented.

The Operative Report dated 09/12/08 was signed by [Supervising Physician #15] but no date and time was documented.

4) The Discharge Summary dated 09/19/08 was dictated by [Resident Physician #17] at "11:01:00." [Supervising Physician #11] signed the report but did not date and time the entry.

5) The "Physician" order signature was not timed and dated for the following dates:

The 09/3/08 verbal order timed at 7:00 AM and the 09/03/08 verbal order timed at 10:20 AM.

6) The "Physicians Orders" were not dated, timed and authenticated by the nurse for the following dates:

09/01/08 timed at 3:30 PM order, the 09/04/08 order timed at 7:00 AM, and the 09/04/08 order timed at 10:00 AM.

7) The surgical consent dated 08/24/08 timed at 11:00 AM reflected, [Resident Physician, Staff #7] signed the consent along with Patient #1. After the surgery was performed on 08/29/08 the consent form reflected, no signature of "surgeon of record [to be signed after procedure]..."

On 12/30/10 at approximately 3:30 PM [Staff #2] verified the above medical record entries did not have dates, times and written authentication.

The Hospital Health and Hospital System Rules and Regulations with a revision date of 08/22/06 reflected under section two, "All entries in the medical record shall be authenticated, dated, and timed by the individual who is responsible for ordering, providing, or evaluating the services furnished..."

The policy entitled, "Transcription of Provider Orders" with a revision date of 11/08 reflected, "All orders must be verified and signed by a registered nurse...the nurse shall verify each set of physician's/other provider's orders shall have full signature, title and ID # of the nurse who checked them, as well as the date and time.