Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391
Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 670031 (X3) Date Survey Completed 02/02/2017
Name of Provider or Supplier St Luke's Patients Medical Center Street Address, City, State 4600 East Sam Houston Parkway South, Pasadena, TX
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID Prefix Tag Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)
A2407 STABILIZING TREATMENT
CFR(s): 489.24(d)(1-3)

(1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual's behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual's behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual's written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both.


This STANDARD is not met as evidenced by:
Based on record review, and interview, the facility failed to provide stabilizing treatment for a patient determined by the facility to have a medical emergency condition when he presented to the Emergency Room and was diagnosed with gas gangrene of his left leg. The facility failed to utilize its available specialized services to treat the patient. Citing one (1) patient named in a complaint Patient #1. Findings: Medical Record Review for Patient #1: Review of demographic data for Patient #1 revealed he was admitted to the Emergency Room (ER) on 1/18/2017 at 2140 hours. He was unemployed and had no insurance. He was listed as Self Pay. Review of Triage Nurses notes dated 1/18/2017 at 2242 revealed Patient (#1) Thirty four (34) year old male presented to the ER with wound, edema and purulent drainage to left foot. The patient gave history he had toes amputated in 2012. He reported a wound to the bottom of his foot for a week. Patient (#1) states "I don't have insurance so I have not been to a doctor". There was documentation that vital signs were within normal limits and oxygen (o2) saturation on room air was 97%. Pain scale was 10/10, blood pressure 137/60, Temperature 99.9, Respiratory Rate 19 breath per minute (bpm), Pulse Rate 102 beats per minute (bpm). Oxygen saturation by pulse oximetry 97% room air. Review of Physician's notes dated 1/18/2017 revealed documentation the physician saw the patient "on arrival in triage room 5". (A time of day was not documented). The notes documented that 34 year old Patient (#1) arrived at the Emergency Room at Hospital C on 1/18/2017 at 2140 with complaints of left foot pain, swelling and purulent discharge for the past week. The patient also gave history of having recent black stools. He had past history of Diabetes and hypertension and surgical history of Trans Metatarsal Amputation (TMA) of left foot in 2012. Rectal Guaiac was negative, scant brown stool. Laboratory tests: white blood cell count 26.1 Hemoglobin 6.1, hematocrit 18.1, glucose 258, Blood Urea Nitrogen (BUN) 12 and Sodium 122. Clinical Impression: Gas Gangrene, Osteomyelitis, Anemia, GI Bleed, Hypernatremia. Disposition: Transfer. X-ray report dated 1/18/2017 at 23:09 revealed the following information: Impression: Status Post amputation of the forefoot with new extensive osseous destruction of the cuneiforms, talus, calcaneus compatible with osteomyelitis. Marked associated soft tissue gas and swelling could be due to soft tissue spread of infection. The report was signed and dated 1/19/2017 at 12:14 am. Review of physician's certification notes dated 1/19/2017 revealed the reason for transfer was for a higher level of care, surgical debridement and GI work up. Summary of Risk to Transfer: motor vehicle accident, death. Risk if the individual is not transferred: death, sepsis, loss of limb. The patient was transferred from the facility on 1/19/2017 at 0220. There was no documentation that ER Physician A51 requested specialized on call physicians available at Hospital C for consultation or to treat the patient. Patient #1 was transferred to Hospital Q without needed stabilizing treatment. Transfer Center Recordings: Review of recorded conversation from the transfer center between Dr. A51, ER physician at Hospital C, and Dr. B52, on call Surgeon at Hospital Q, revealed Dr. A51 gave Dr. B52 a history of the patient's condition and stated he was making the request for the transfer because Hospital C did not have Podiatrist, and he did call his surgeon who said he would take a look at the patient "tomorrow". Dr. A51 stated it was his "feeling that the patient was not going to get anything done tonight". He stated Hospital C was a small hospital and did not have surgical room open at that hour of night and the patient needed higher level of care for his condition. The following information revealed the facility did have functional on call services for physicians and emergency surgical services at Hospital C on 1/18/2017 when Patient #1 required emergency services. Review of Facility Policy/Procedure (Hospital C): Review of the facility's Surgery Call Process Policy/Procedure effective August 2016 revealed the following information: "The surgery call schedule will contain a minimum of one Registered Nurse and one Certified Surgical Technologist. Normal operating hours are Monday - Friday 0630 -1700. 0n Call will begin at 1700 and additionally there will be a surgical call team covering all weekends and holidays. Weekend and Holidays will consist of 24 hour coverage starting at 0700 until 0700 the following morning". Review of the facility's operating room schedule from November 2016 through January 2017 revealed there were adequate on call staff on the schedule. On 1/18/2017, when Patient #1 required surgical services at Hospital C, there was one (1) Registered Nurse, one (1) Certified Surgical Technologist and one (1) Anesthesiologist on the OR call schedule. Review of the facility's physician on call schedule from November 2016 through January 2017 revealed there were adequate on call physicians on the schedule for the four (4) specialty areas including General Surgery provided at the facility. The facility listed five (5) General Surgeons on the facilities on call schedule. Review of the facility's Operating Room after hours activities from November 2016 through January 2017 revealed the following information: In November 2016 there were six (6) after hours surgeries including weekends and nights. In December 2016 there were six (6) cases and in January 2017 eight (8) cases. After hours cases conducted on the night shift in January 2017 revealed the following information: 1/19/2017 case done at 8:00pm 1/22/2017 done at 10:29 pm 1/23/2017 done at 0400 am 1/29/2017 done at 11:13 pm. Review of Medical Staff Bylaws Rules and Regulations dated 1/31/2017 revealed the following information: On-Call Responsibilities: "All Members of the Medical Staff shall be available on a rotational schedule as Recommended by the Medical Executive Committee and approved by the Board of Managers to provide medical care or consultation to any patient in the Emergency Department who is found by the Emergency Physician on duty to require such care. If assigned to Emergency Department call, the Practitioner on call in each specialty is to be available to render such service in the Emergency Department as may be needed". Review of facility's Emergency Medical Policy/Procedure: Review of the facility's Policy/Procedure titled Medical Screening, Stabilization and Transfer of Individual with Emergency Medical Conditions dated January 2016 gave the following information: Individuals Who Have An Emergency Medical Condition: "When it is determined that an individual has an Emergency Medical Condition, Hospital C shall: Within the capability of staff and facilities available at Hospital C stabilize the individual to the point where the individual is either "stable for discharge" or "stable for transfer" as defined in section IV. G and Section IV.H; or Provide for an appropriate transfer of the unstabilized individual to another medical facility in accordance with these procedures". Review of the facility's Transfer of Individual with Emergency Medical Conditions Policy/Procedure dated January 2016 gave the following information: "To stabilize" or "stabilize", or "stabilized" means: With respect to an Emergency Medical Condition, that the individual is provided with such medical treatment as is necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the patient from Hospital C; or With respect to a pregnant woman who is having contractions and who cannot be transferred before delivery without a threat to the health or safety of the woman or the unborn child, that the woman has delivered the child and placenta". On-Call Physicians: "Hospital C shall maintain an on-call list of physicians, including sub-specialists that are available for duty, to screen, examine and treat patients with potential Emergency Medical Condition. If an on-call specialist, or sub-specialist, is not available, the Emergency Department Physician, or his designee, shall attempt to obtain the services or another appropriate specialist or sub-specialist, from the hospital's medical staff through working with the President, or administrator on call, as deemed appropriate and in accordance with pertinent Medical Staff Or Patient Medical Care Policy." Medical Record from Hospital Q: Review of Medical Record for Patient #1, from Hospital Q, revealed Patient #1 arrived at Hospital Q on 1/19/2017 at 0302. Review of physical examination documentation revealed the following information: Abdomen soft non-tender, TMA stump with distal wound (about 4 cm in diameter) with active pus extrusion. Marked edema and tenderness elicited on palpation. Vital signs Blood Pressure 128/66 Pulse 105(bpm). Temperature 101 degrees Fahrenheit O2 saturation 98% on room air. Surgery assessment and plan: Diabetic foot ulcer with likely wet gangrene. Signs of systemic infection including fevers and tachycardia. Operating Room (OR) 1/19/2017 for left lower Below the Knee Amputation (BKA) Guillotine (first stage, needed immediately) would need formal BKA later. Broad spectrum antibiotics, Intravenous Fluids, Nothing by Mouth. Interviews with Hospital C staff: During an interview on 2/1/2017 at 11:00 am with Staff D54, Registered Nurse Director of the Emergency Room (ER) at Hospital C, he stated the ER had four (4) dedicated on call services. General Surgery, Internal Medicine, Orthopedics and Invasive Cardiology (Cardiac Cauterization only). He stated amputations are procedures that are done at the hospital. These services are available twenty four (24) hours a day seven (7) days a week. In addition, the Operating Room (OR) IS available 24/7 on an on call basis. During an in person interview on 2/2/2017 at 11:10 am in the hospital's conference room with Dr. A51, he stated he did not call Dr. E55, on call surgeon, to see the patient and maybe that was the reason he did not document that he talked to the doctor. He stated the decision to transfer was his, because he felt the patient needed more services than could be provided at Hospital C. During an interview on 2/2/2017 at 10:15 am with Dr. E55, Surgeon at Hospital C, he stated he was on call on 1/18/2017 through 1/19/2017 and was available for calls. The physician stated he was never called to see Patient (#1) nor for a consultation about the patient. According to Physician E55, a patient with Gas Gangrene has an emergency medical condition and, if he was called, he would have come to see the patient. During a telephone interview on 2/2/2017 at 9:15 am with Dr. F56, Medical Director for the ER, he stated he was aware of the details of the case. He stated Dr. A51 called him regarding the Patient (#1), stating the patient had Gas Gangrene, low hemoglobin levels, gastric involvement and thinks the patient would be better served if he was transferred to a tertiary facility for a higher level of care. The Medical Director stated he was in agreement with the decision to transfer. During a follow up telephone interview on 2/8/2017 at 8:30 am with Staff C53, Chief Nursing Officer at Hospital C, regarding Operating Room (OR) services at the facility, she stated the OR is staffed with Nurses and Technicians for services 24/7. The staffs are on call from 5:00 pm until 6:00 am seven (7) days a week.