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 670029 (X3) Date Survey Completed 03/15/2011
Name of Provider or Supplier First Surgical Hospital Street Address, City, State 4801 Bissonnet Blvd, Bellaire, 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)
A0043 GOVERNING BODY
CFR(s): 482.12

The hospital must have an effective governing body legally responsible for the conduct of the hospital as an institution. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body.


This CONDITION is not met as evidenced by:
FACTS: First Street Hospital has added seven out-patient emergency centers that are classified as Provider Based Entities (PBE) with CMS. The seven centers are as follows: Bellaire: effective date of PBE 9/1/10 Memorial Heights: effective date of PBE 9/1/10 St Michaels Sugarland: effective date of PBE 9/1/10 St. Michaels Westheimer: effective date of PBE 9/1/10 St. Michaels Woodlands: effective date of PBE 9/1/10 Preferred: effective date of of PBE 1/3/11 River Oaks: effective date of PBE 10/18/10 Based on observation, interview, and record review the Governing Body failed to ensure that policies were adhered to per the policies and procedures established by the Governing Board: 1) Two Emergency room Medical Directors mis-represented the out-patient emergency center / hospital as a "Free Standing Emergency Center" to other hospitals (Physician ID#'s 58 and 62) 2) One Emergency room Medical Director was not forthright with another hospital when asked if he had a "Transfer agreement with any hospitals." (Physician ID# 58) 2) Four indigent emergency room patients were inappropriately transferred to other hospitals (Patient ID#'s 10, 15, 35, 41) 3) One of seven out-patient emergency room laboratories failed to meet Federal Laboratory requirements (no CLIA certificate: Clinical Laboratory Improvement Amendments at the Bellaire Emergency Center) 4) The Governing Body failed to obtain a laboratory contract between Bellaire Emergency Center and hospital ID# 90. 5) Infection control activities at 3 out-patient emergency rooms were not integrated with the hospital. Three locations were using autoclaves to sterilize instruments without implementing quality controls. (St Michael's Sugar Land, Westheimer, and the Woodlands) Findings include: Record review of a policy titled "Performance Improvement Plan" dated 4/2009 stated "Governing Board: The Governing Board has the ultimate responsibility for establishing policy, maintaining safe qaultiy patient care, and providing for the management, planning, and maintenance of the Performance Improvement Plan. The Board is responsible for the Hospital and its Medical Staff providing quality medical care that meets the needs of the community." (HOSPITAL MIS-REPRESENTATION) Two Emergency room Medical Directors mis-represented the out-patient emergency center / hospital as a "Free Standing Emergency Center" to other hospitals (Physician ID#'s 58 and 62). Medical Director ID# 58 also told a County Hospital that Bellaire emergency room was not contracted with any hospital to receive patients. Patient ID# 1 Record review of a Memorandum of Transfer form for patient ID# 1 dated 2/5/11 stated the patient was transferred to the County Hospital (ID# 88). The Memorandum of Transfer form stated River Oaks Emergency Center was a "Free Standing Emergency Medical Care Facility." The form did not reflect the fact that the emergency room is an out-patient department of First Street Hospital. Review of hospital transfer tapes from the County Hospital (ID# 88) revealed the following conversation between the Medical Director (ID# 62) of River Oaks Emergency Center and the hospital transfer center regarding patient ID# 1: The Medical Director (ID# 62) told the County hospital "This is River Oaks Emergency Center free standing emergency room." The transfer center then asks "and what is the nature of the transfer?" The Medical Director stated "Patient with severe dehydration." The transfer center proceeds to ask "And you are transferring for? and the Medical Director stated "Higher level of care and patient request." Record review of a contract titled "Emergency Room Department Management Agreement" stated "This Emergency Room Department Management Agreement is dated October 1, 2010 and is between River Oaks Emergency Management and First Street Hospital........Manager is engaged in the business of providing certain administrative and management services to hospital-based off-campus emergency room departments." The management contract was signed by the Medical Director of River Oaks emergency center (ID# 62) and dated 8/5/10. The same Medical Director told the County Hospital transfer center the facility was a "Freestanding Emergency Room." Patient ID# 19 Record review revealed this patient was seen on 12/13/10 at River Oaks Emergency Center. The Memorandum of Transfer form stated River Oaks Emergency Center was a "Free Standing Emergency Medical Care Facility." The Memorandum of Transfer form stated the patient was transferred to Hospital #88 with a diagnoses of "acute appendicitis." Review of hospital transfer tapes from Hospital ID# 87 revealed the following conversation between the ER Medical Director (ID# 62) of River Oaks Emergency Center and the hospital transfer center regarding patient ID# 19: The Medical Director told the transfer center surgeon "I am one the emergency room doctors at River Oaks Emergency free standing emergency department. I have a patient for you with appendicitis." Patient ID# 35 Record review of a Memorandum of Transfer form for patient ID# 35 dated 9/23/10 stated the patient was transferred to the County Hospital (ID# 88). Review of hospital transfer tapes from the County Hospital (ID# 88) revealed the following conversation between the Medical Director (ID# 58) of Bellaire Emergency Center and the hospital transfer center regarding patient ID# 35: The Medical Director (ID# 58) told the transfer center "I am trying to initiate a transfer, we are a free standing emergency room and I have a patient with appendicitis." The transfer center then asks "you are a freestanding, what is the name of your hospital?" The Medical Director replied "Bellaire Emergency Center." The transfer center then asks "are you contracted with any hospital to receive patients from you all? and the Medical Director replied "We are not officially contracted with any hospital." The surgeon (ID# 86) at the County Hospital then gets on the line and the Medical Director tells him "I am at one of the free standing emergency rooms in Bellaire." The surgeon then ask "you are a free standing emergency room there?" The Medical Director replied "Yea, Yea, So, I will get the ambulance and we will transfer him to the emergency room there." The Physician Chairman (ID# 59) of the hospital acknowledged 3/14/11 at 8 a.m. the out-patient emergency departments were previously functioning as unlicensed emergency rooms and he thought the physicians at the centers were in the habit of identifying themselves as "Free Standing Emergency Centers." Record review of a contract titled "Emergency Room Department Management Agreement" stated "This Emergency Room Department Management Agreement is dated June 7th, 2010 and is between Bellaire Emergency Center and First Street Hospital........Manager is engaged in the business of providing certain administrative and management services to hospital-based off-campus emergency room departments." The management contract was signed by the Medical Director of Bellaire emergency center (ID# 58) and dated 6/9/10. The same Medical Director told the County hospital "We are not officially contracted with any hospital." (INAPPROPRIATE PATIENT TRANSFERS) Four indigent emergency room patients were inappropriately transferred to other hospitals for higher level of care. (Patient ID#'s 10, 15, 19, 35). Record review of a policy titled "Emergency Medical Treatment and Active Labor Act (EMTALA) dated 5/2010 stated "Screening within the off-campus locations sahll be within the location's capabilities and available personnel. If the patient's condition is outside the scope of services available, the off-campus location shall arrange patient transportation.........Patients shall be routinely shall be routinely transferred to facilities where transfer agreements have been established, or the patient's choice." Record review of emergency room patient transfers for patient ID#'s 10, 15, 35 and 41 revealed each patient was seen in out-patient provider based emergency departments and each was diagnosed with appendicitis. Each patient was indigent with no insurance and all were transferred to other hospitals for higher level of care / surgical intervention. In each case, the hospital had the capability and the capacity to care for these patients but the out-patient emergency centers did not consult with the hospital prior to the transfers. The Chief Executive Officer (CEO) acknowledged 3/11/11 at 4:30 p.m. that it is sometimes in the best interest of the patients to be transferred to the closest hospital in the area of town. The CEO stated the hospital has never received a patient admission from any of the seven out-patient emergency rooms. The CEO provided documentation that 536 emergency room patients had been transferred to other hospitals from September 2010 to February 2011. Record review of a policy titled "Emergency Department Scope of Service" dated 12/09 stated "Emergency Department patients are evaluated for response to treatment and are either admitted, transferred for further treatment that requires a higher level of care or is not provided by First Street Hospital......." Record review of a policy titled "Scope of Services" dated 07/2010 stated "Perioperative Services - Surgery: Surgical services include a full range of general surgical procedures as well as surgical specialties.........The primary focus of service is to provide surgical support for in-patients and out-patients." Patient ID# 10: Record review revealed this patient was seen 10/22/10 at St. Michaels Emergency Room Westheimer. The face sheet stated the patient was unemployed with no insurance. The Memorandum of Transfer form stated the patient was transferred to Hospital #90 with a diagnoses of Appendicitis. The Memorandum of Transfer stated the patient was being transferred for "Medical necessity / Upgrade in care." The patient record failed to document if the emergency room contacted First Street Hospital prior to transferring the patient to another hospital. First Street Hospital had the capability and the capacity to care for patient # 10. Record review of the surgery on-call schedule dated 10/22/10 revealed a general surgeon (ID# 57) was on-call at First Street Hospital. Review of the general surgeon's credential file revealed one of the approved delineation of privileges was "appendectomy." Record review of the daily Census on 10/22/10 revealed the hospital had a census of 2 in-patients with a total capacity of 5 beds. Patient ID# 15: Record review revealed this patient was seen on 12/26/10 at St. Michaels Emergency Room Woodlands. The face sheet stated the patient was uninsured. The Memorandum of Transfer form stated the patient was transferred to Hospital # 89 with a diagnoses of Appendicitis. The Memorandum of Transfer stated the patient was being transferred for "Medical necessity / Upgrade in care." The patient record failed to document if the emergency room contacted First Street Hospital prior to transferring the patient to another hospital. First Street Hospital had the capability and the capacity to care for patient # 15. Record review of the surgery on-call schedule dated 12/26/10 revealed a general surgeon (ID# 54) was on-call at First Street Hospital. Interview 3/15/11 at 10 a.m. with the Chief Executive Officer (ID# 50) revealed the hospital had no in-patients on 12/26/10 and 19 beds available. The CEO stated the hospital completed construction on an expansion 12/20/10 and added 14 additional beds to the existing 5 beds for a total of 19 beds. Record review of a "Patient Transfer Agreement" between Hospital ID# 89 and St. Michael's Emergency Room Woodlands dated 11/10/10 stated "Woodlands Freestanding Emergency Center doing business as St. Michael's Emergency Room is a Texas free-standing emergency center." The transfer agreement was signed by the Medical Director (ID# 81) of St. Michael's Emergency Centers and not by an administrative representative from First Street Hospital. Interview 3/11/11 at 3 p.m. with the Transfer Coordinator / Director of Trauma Services at Hospital ID# 89 revealed the hospital was not aware that St. Michael's Emergency Room was an out-patient emergency department of First Street Hospital. The Transfer Coordinator stated that St. Michael's Emergency Center presented themselves to the hospital as a "Free Standing Emergency Room." Patient ID# 19: Record review revealed this patient was seen on 12/13/10 at River Oaks Emergency Center. The face sheet stated the patient was uninsured. The Memorandum of Transfer form stated River Oaks Emergency Center was a "Free Standing Emergency Medical Care Facility." The Memorandum of Transfer form stated the patient was transferred to Hospital #87 with a diagnoses of "acute appendicitis." The Memorandum of Transfer form did not state the reason for the transfer. The patient record failed to document if the emergency room contacted First Street Hospital prior to transferring the patient to another hospital. First Street Hospital had the capability and the capacity to care for patient # 19. Record review of the surgery on-call schedule dated 12/13/10 revealed a general surgeon (ID# 57) was on-call at First Street Hospital. Record review of the daily Census on 12/13/10 revealed the hospital had a census of 4 in-patients with a total capacity of 5 beds. The patient record failed to document if the emergency room contacted First Street Hospital prior to transferring the patient to another hospital. Patient ID# 35: Record review revealed this patient was seen on 9/23/10 at Bellaire Emergency Center. The face sheet stated the patient was uninsured. The Memorandum of Transfer form stated the patient was transferred to the County Hospital (ID# 88) for "Medical Necessity / Upgrade in care and Patient Request." Per telephone interview 3/16/11 at 3 p.m. with patient ID# 35 revealed the patient did not request to be transferred to the county hospital, that the emergency room made all the arrangements. Review of the transfer tapes from the county hospital for patient ID# 35 revealed the Medical Director (ID# 58) of Bellaire emergency room telling the County hospital transfer center "I am trying to initiate a transfer, we are a free standing emergency room and I have a patient with appendicitis." The transfer center then asks "what is the name of your hospital?" and the Medical Director replies "Bellaire Emergency Center." The transfer center then asks if the Medical Director contacted any other hospital and the Medical Director stated "no, you are the first one." The transfer center then asks "are you contracted with any hospital to receive patients from you all?" The Medical Director replies "We are not officially contracted with any hospital." The patient record failed to document if the emergency room contacted First Street Hospital prior to transferring the patient to the County hospital. First Street Hospital had the capability and the capacity to care for patient ID# 35. Record review of the surgery on-call schedule dated 9/23/10 revealed a general surgeon (ID# 57) was on-call at First Street Hospital. Record review of the daily census on 9/23/10 revealed the hospital had a census of 4 in-patients with one bed available. Record review of a policy titled "Patient Transfer Policy" dated 8/29/06 stated "Introduction: The Governing Board of First Street Hospital, after consultation with the Medical Staff, has adopted the following policy according to rules adopted by the Texas Department of State Health Services regarding the evaluation, treatment, and transfer of patients from this hospital to another hospital in a medically appropriate manner......The transfer of a patient may not be predicated upon arbitrary, capricious, or unreasonable discrimination based upon race, religion, national origin, age, gender, physical condition or economic status." The policy further stated "Administrative Protocols: If a patient has an emergency condition which has not been stabilized or when stabilization of the patient's vital signs is not possible because the hospital or emergency department does not have the appropriate equipment or personnel to correct the underlying process, evaluation and treatment shall be performed and transfer shall be carried out as quickly as possible." The hospital had previously performed an appendectomy. Record review of the medical record revealed Patient ID# 41 was admitted to the hospital on 1/25/11. A general surgeon's (ID# 57) operative note dated 1/27/11 stated a laparoscopic appendectomy was performed. (FEDERAL LABORATORY REQUIREMENTS) Observation 3/10/11 at 3 p.m. at Bellaire Emergency Center revealed a laboratory with testing equipment. No CLIA certificate was posted. (Clinical Laboratory Improvement Amendments) The Medical Director (ID# 58) of Bellaire Emergency center acknowledged 3/11/11 at 8:50 a.m. the center did not have a CLIA certificate. The Medical Director stated that the center performs laboratory work onsite for "Internal reasons only." The Medical Director further stated that all laboratory studies are sent out to Hospital ID# 90. The Chief Executive Officer (CEO) acknowledged 3/10/11 at 3 p.m. the hospital just realized two weeks ago that Bellaire Emergency Room did not have a CLIA certificate. The CEO could not locate a contract with Hospital ID# 90 to perform laboratory studies for Bellaire emergency center. Interview 3/11/11 at 9 a.m. with the Medical Laboratory Director (ID# 82) revealed he was aware that Bellaire emergency center did not have a CLIA certificate. The Laboratory Director stated he was not really aware of the arrangements between the out-patient emergency rooms and the hospital because he primarily oversees the Hospital laboratory. Record review of a policy titled "Clinical Laboratory Scope of Services" dated 11/30/06 stated "The responsibilities of the Medical Laboratory Director will include: assuring compliance with the applicable regulations." The Centers for medicare and Medicaid web page regarding "Clinical Laboratory Improvement Amendments (CLIA)" stated "CLIA requires all entities that perform even one test, including waived tests.......to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program." Record review of patient ID# 48 revealed he was treated at Bellaire emergency room on 3/9/11. The record revealed laboratory studies were performed at Bellaire emergency center without a CLIA certificate. Laboratory studies included Comprehensive Metabolic panel, complete blood count, and a urinalysis. INFECTION CONTROL Infection control activities at 3 out-patient emergency rooms were not integrated with the hospital. Three locations were using autoclaves without implementing quality controls. (St Michael's Sugar Land, St. Michaels Westheimer, and St. Michaels Woodlands) Observation 3/11/11 at 11:55 a.m. at St. Michaels Emergency center Woodlands revealed an autoclave in the laboratory room. Interview 3/11/11 at noon with the emergency room technician (ID# 49) revealed the autoclave is used to sterilize surgical instruments for suturing. The technician stated the center does not maintain logs of quality assurance testing for the autoclave and the center did not have a policy for operational standards, such as temperature monitoring or monthly spore testing. Observation 3/15/11 at 10:30 a.m. at St. Michaels Emergency center Westheimer revealed an autoclave in a storage room. Interview 3/15/11 at 10:35 a.m. with an emergency room technician (ID# 84) revealed the autoclave is used to sterilize surgical instruments for suturing. The technician stated the center does not maintain logs of quality assurance testing for the autoclave and the center did not have a policy for operational standards, such as temperature monitoring or monthly spore testing. Observation 3/11/11 at 3:00 p.m. at St. Michaels Emergency center Sugar Land revealed an autoclave in the laboratory room. Interview 3/11/11 at 3:15 p.m. with the nurse (ID# 48) on duty at St. Michaels Sugar Land revealed the autoclave is used to sterilize instruments for suturing. The nurse stated the center does not maintain logs of quality assurance testing for the autoclave. Record review of a hospital policy titled "Infection Control for Sterile Processing" dated 12/2009 stated "Sterilizer logs, chart / chemical / biological tests, and spore test shall be maintained as required......Recording charts and gauges: shall be examined by the sterilizer operator at the beginning and end of each cycle (temperature and pressure). Records shall be maintained per hospital / regulatory requirements." The Infection Control nurse (ID# 61) at the hospital stated she has never been to any of the out-patient emergency centers and was not aware the centers were using autoclaves to sterilize instruments. Record review of a policy titled "Surveillance" dated 1/12/2009 stated "Surveillance requires a constant flow of information to the Infection Control Practitioner. Information is usually acquired by: Rounds also ensure that environmental and engineering controls are in place and properly utilized."