HospitalInspections.org

Based on interview and record review the Hospital failed to have an effective Governing Body. The Governing Body failed to ensure the hospital ' s Policies and Bylaws were adhered to as follows:

1) Failed to ensure that the Medical Staff is accountable to the Governing Body for the quality of care provided to patient ID# 9. The Governing Body failed to conduct physician peer reviews on two physicians (ID# 56 and 62) that prescribed narcotic orders for patient ID# 9 resulting in the death of the patient as a result of "combined sedative effects."

(Cross reference deficiency A0263 - Quality Assessment)


2) Failed to provide supervision of nursing care by a Registered Nurse as per hospital policy

(Cross reference deficiency A0385 - Nursing Services)


3) Failed to provide pharmaceutical services to meet the needs of patient
ID# 9

(Cross reference deficiency A0490 - Pharmaceutical Services)

4) Failed to provide Emergency Services to meet the emergency needs of patients in accordance with acceptable standards of practice.

(Cross reference deficiency A1100 - Emergency Services)


Findings include:

Patient ID# 9
Medical record review revealed this was a 51 year old male that was admitted to the hospital for back surgery on 1/27/11. According to the consent form and operative report dated 1/27/11 the patient had the following surgical procedure: " Transforaminal Interbody Lumbar Fusion." The surgeon was physician ID# 62 and the "assistant" was physician ID# 56 according to the operative report.

Record review of a history and physical dated 1/29/11 for patient ID# 9 written by the surgeon (ID# 62) caring for this patient stated " I received a phone call earlier this afternoon that the patient had coded on the floor and cardiopulmonary resuscitation (CPR) had been initiated. He had been transferred to a Northeast Hospital for further resuscitation. Unfortunately, he was not resuscitated. "

Record review of the autopsy report for patient ID# 9 dated 3/31/11 stated
"Cause of death: Hypertensive cardiovascular disease complicated by combined sedative effects of fentanyl, diazepam, diphenhydramine, and hydrocodone with diffuse alveolar damage and acute bronchopneumonia. Manner of Death: Accidental. "

The Medical Record for patient ID# 9 showed that the Surgeon (ID# 62) consulted a Pain Specialist physician (ID# 56) on 1/28/11 due to the patients continued complaint of pain after surgery. The Pain Specialist Physician called in verbal telephone orders on 1/28/11 to adjust narcotic pain medication and Central Nervous System Depressants without evaluating the patient on 1/28/11.

Review of the physician orders for patient ID# 9 revealed the patient had concurrent orders for a total of Nine different "Central Nervous System Depressants" at the time of his death. (Hydrocodone, Morphine, Valium, Dilaudid, Fentanyl, Neurotin, Wellbutrin, Benadryl, and Soma)

Interview 7/15/11 at 1:30 p.m. with the Medical Director (ID# 73) revealed he was notified about the death of patient ID# 9 on 1/29/11. The Medical Director stated that the case was discussed in a Quality Assurance meeting but nothing was formally documented. The Medical Director stated there were several concerns relating to the patient's death. One concern was about a a pain medicine physician (ID# 56) being consulted and calling in verbal telephone orders for pain medication and not physically evaluating patient ID# 9 on 1/28/11. Another concern was " a nurse medicating the daylights out of this guy. " The Nurse was suspended.

The Medical Director stated he had not seen the autopsy report. The Medical Director further stated that physician / nurse peer reviews for the two physicians (ID# 58 and 62) and nurse (ID# 96) caring for patient ID# 9 have not been done to date because they are still awaiting the toxicology reports to see if the patient died of a narcotic overdose or aspiration. The Medical Director stated he was not aware the hospital received the autopsy / toxicology report on May 15th, 2011 per the Administrator and was not aware the findings showed accidental death due to combined sedative effects.

The Medical Director also stated "he did not initially know that an LVN (Licensed Vocational Nurse) was caring for patient ID# 9 when he coded and thought that was an isolated incident" (having only an LVN in the hospital as nursing staff). The Medical Director stated that during a Quality Assurance meeting it was discussed changing the rule to having two Registered Nurses on the floor at all times. The Medical Director was not aware the current practice of the hospital remains with staffing only a Licensed Vocational Nurse at times to care for patients without a Registered Nurse available in the hospital to supervise care.


Record review of Governing Body Bylaws (no date) revealed the following:
" The Governing Body of the Facility, hereto referred as the Board of Manager, shall assume full legal responsibility for governing the organizations total operations to support safe and quality patient care, treatment and services.....Medical Director: The Medical Director shall be responsible for the professional and ethical standards of the Medical Staff and shall be the liaison with the Medical Staff."

Further review of the Governing Body Bylaws in section 7.3 titled " Committees " stated the following: " 7.3.5: Provide ongoing review of information available regarding the competence of Medical Staff Members and Allied Health Professionals. 7.3.10: Review and access the quality of care provided by Medical Staff Members. 7.3.11: Serve as the peer review committee when required under applicable State Law and perform all duties associated therewith."

Record review of the only Medical Executive Meeting held in 2011 on April 18th revealed discussion in the meeting minutes that stated "Incident reports binder and discussion." An incident report for patient ID# 9 stated "Peer review was performed on this case on February 10th, 2011, in the absence of the toxicology report and the autopsy. This review is preliminary and should be followed up on when the autopsy is received."

Physician peer reviews were not conducted for the two physicians (Physician ID#'s 56 and 62) caring for patient ID# 9 per interview with the Administrator on 7/13/11 at 1:40 p.m. The Administrator stated the hospital was awaiting the autopsy report they received on 5/15/11 before conducting physician peer reviews. The Administrator stated the case of patient ID# 9 was discussed in the Medical Executive Meeting but nothing was formally written in the minutes.


NURSING
Record review of a policy titled " Plan For the Provision of Care " (no date) stated " Experienced Registered Nurses who are Team Leaders work to address department specific issues and are present 24 hours during the week, 24 hours on holidays, and 24 hours on weekends. " Further review of a policy titled "Assignment of Care" (no date) stated "Purpose: To establish a guideline for making patient care assignments. Unit will be staffed according to the following census: 1 - 3 in-patients / observation patients will be cared for by (1) RN (Registered Nurse). Patient ID# 9 was the only in-patient on 1/29/11 and was being cared for by a Licensed Vocational Nurse at the time of his arrest.


PHARMACY
Record review of patient ID# 9's medical record reflected there were physician orders for a total of Nine Central Nervous System depressants at the time of patient ID# 9 ' s death. The autopsy report showed the patient died accidentally as a result of "combined sedative effect."

Although the Consultant Pharmacist (ID# 67) was aware of the amount of narcotics and Central Nervous System depressants prescribed to this patient, the pharmacist stated 7/13/11 at 2:20 p.m. no formal recommendations were made to the hospital after the death of patient ID# 9. Also the pharmacy nurse (ID# 76) acknowledged 7/14/11 at 11 a.m. that she reviewed the medical record of patient ID# 9 and identified errors relating to medication administration but no recommendations were made by the pharmacy staff, only a report of the errors was submitted to Administration.

Record review of a document titled "Pharmacy Requirements When a Patient is Admitted to the In-patient Unit" (no date) stated "When a patient is admitted to the in-patient unit - records need to be completed and interactions checked before any medications are administered........All this needs to be done because we do not have a Full Time Pharmacist and Pharmacy. The Pharmacist comes in once a week and reviews all the patient charts and pharmacy."

EMERGENCY SERVICES
The Code record dated 1/29/11 for patient ID# 9 reflected that the Emergency Room Physician and a Paramedic responded to the code on the nursing unit and left the emergency room unattended. The Emergency Room Physician (ID# 66) stated 7/15/11 at 3:25 p.m. she instructed the staff to call " 911 " to get more help " and to transfer the patient to a higher level of care. The hospital did not address the need for more staffing or the need to stabilize the patient before calling "911." No patients were in the emergency room at the time of the code.

The Ambulance record for patient ID# 9 dated 1/29/11 stated that when the paramedics arrived (ten minutes after the patient was found unresponsive) the patient was found cyanotic (blue), the breathing tube was not properly inserted, the intravenous line was not functional and the patient was bleeding onto the floor from the intravenous line. The hospital did not address the need for inservices / competencies regarding code situations.

Based on interview and record review the hospital failed to have an effective quality assessment and performance improvement program. The Quality Assurance program failed to identify problems and take corrective actions associated with patient ID# 9 ' s death.

(Cross reference deficiency A0043 - Governing Body)

(Cross reference deficiency A0385 - Nursing Services)

(Cross reference deficiency A0490 - Pharmaceutical Services)

(Cross reference deficiency A1100 - Emergency Services)


Findings Include:

The Medical Record of Patient ID# 9 reflected that this was a 51 year-old patient that had back surgery on 1/27/11. Two days after surgery on 1/29/11 the patient was found unresponsive and had a cardiac arrest, was transferred to another hospital and was pronounced dead at the emergency room of the receiving hospital.

Review of Quality Assurance meeting minutes dated 4/18/2011, a summary of the Incident and a Root Cause Analysis for patient ID# 9 provided by the Administrator revealed the following problems were not identified by the Quality Assurance committee regarding patient ID# 9's death on 1/29/11, therefore no actions were taken to prevent a similar occurrence:

1) The Medical Record for patient ID# 9 showed that the Surgeon (ID# 62
consulted a Pain Specialist physician (ID# 56) on 1/28/11 due to the patients continued complaint of pain after surgery. The Consultant Pain Specialist Physician called in verbal telephone orders on 1/28/11 to adjust narcotic pain medication and Central Nervous System Depressants without coming to the hospital and evaluating the patient on 1/28/11.


2) There were physician orders for a total of Nine Central Nervous System depressants at the time of patient ID# 9 ' s death according to physician orders. The autopsy report showed the patient died accidentally as a result of "combined sedative effect." Physician peer reviews were not conducted for the two physicians (Physician ID#'s 56 and 62) caring for patient ID# 9 per interview with the Administrator on 7/13/11 at 1:40 p.m. The Administrator stated the hospital was awaiting the autopsy report they received on 5/15/11 before conducting physician peer reviews.

3) Although the Consultant Pharmacist (ID# 67) was aware of the amount of narcotics and Central Nervous System depressants prescribed to this patient, the pharmacist stated 7/13/11 at 2:20 p.m. no formal recommendations were made to the hospital after the death of patient
ID# 9. Also the pharmacy nurse (ID# 76) acknowledged 7/14/11 at
11 a.m. that she reviewed the medical record of patient ID# 9 and identified errors relating to medication administration but no recommendations were made by the pharmacy staff, only a report of the errors was submitted to Administration. The "Pharmacy medication report on patient ID# 9" failed to address the following:
A) The excessive amounts of Central Nervous System Depressants administered to the patient during his stay in the hospital from 1/27/11 to 1/29/11 until his death.
B) The duplication of narcotic pain orders (Morphine and Hydrocodone)


4) The Code record dated 1/29/11 for patient ID# 9 reflected that the Emergency Room Physician and the Paramedic responded to the code on the nursing unit and left the emergency room unattended. The Emergency Room Physician (ID# 66) stated 7/15/11 at 3:25 p.m. she instructed the staff to call " 911 " to get more help " and to transfer the patient to a higher level of care. The hospital did not address the need for more staffing or the need to stabilize the patient before calling "911."

5) The Ambulance record for patient ID# 9 dated 1/29/11 stated that when the paramedics arrived (ten minutes after the patient was found unresponsive) the patient was found cyanotic (blue), the breathing tube was not properly inserted, the intravenous line was not functional and the patient was bleeding onto the floor from the intravenous line. The hospital did not address the need for inservices / competencies regarding code situations.

6) Staffing roster on 1/29/11 showed that a Licensed Vocational Nurse (LVN) was assigned as the only staff nurse in the hospital when the patient arrested. Review of the LVN ' s personnel file showed this nurse was an agency nurse and her personnel file did not reflect any documentation of the hospital providing orientation. The hospital did identify the agency LVN sent to cover the shift on 1/29/11 was not familiar with the hospital. The hospital's corrective action stated "assure staff is competent and qualified for the type of patient care needed." Record review of 3 additional agency LVN personnel files (ID#'s 97, 98, 99) revealed they have worked at the hospital since the incident on 1/29/11 (May, June, and July 2011) and their personnel files also lacked documentation of hospital orientation. The Hospital has not ensured that current agency Licensed Vocational Nurses working in the hospital have documentation of orientation.


7) Nursing records and staffing reports reflected that on 1/29/11 at 7 a.m. a Licensed Vocational Nurse (LVN ID# 70) was the only staff nurse in the hospital assigned to care for this in-patient (ID# 9). Patient ID# 9 was the only in-patient in the hospital on 1/29/11. A Registered Nurse was not available in the hospital on 1/29/11 to supervise patient care. The Medical Director stated 7/15/11 at 1:30 p.m. that during a Quality Assurance meeting it was discussed changing the rule to having two Registered Nurses on the floor at all times but no changes were made to staffing patterns. The Medical Director was not aware the current practice of the hospital remains with staffing only a Licensed Vocational Nurse at times to care for patients without a Registered Nurse available in the hospital to supervise care. The only staff on duty 1/29/11 when patient ID# 9 was found unresponsive was an emergency room physician, a paramedic, a Licensed Vocational Nurse and a security guard. The hospital has not changed its staffing practices since the death of patient ID# 9.

Record review of a policy titled "Job Description - Licensed Vocational Nurse" dated 6/10/10 stated "Under the general supervision of the Registered Nurse staff, nurse provides direct nursing care in accordance with established policies and procedures of the hospital."

Record review of a policy titled "Assignment of Care" (no date) stated "Purpose: To establish a guideline for making patient care assignments. Unit will be staffed according to the following census: 1 - 3 in-patients / observation patients will be cared for by (1) RN (Registered Nurse). Patient ID# 9 was the only in-patient on 1/29/11.

8) Interview 7/15/11 at 1:30 p.m. with the Medical Director (ID# 73) revealed he was notified about the death of patient ID# 9 on 1/29/11. The Medical Director stated there were several concerns relating to the patient's death. One concern was about " a nurse (ID# 96) medicating the daylights out of this guy. " Record review of a "Summary of Incident" for patient ID# 9 revealed that Registered Nurse ID #96 was suspended on 2/1/11. The hospital did not conduct a nursing peer review of this nurse.

Record review of the Governing Body Bylaws (no date) in section 7.3 titled
" Committees " stated the following: " 7.3.5: Provide ongoing review of information available regarding the competence of Medical Staff Members and Allied Health Professionals. 7.3.10: Review and access the quality of care provided by Medical Staff Members. 7.3.11: Serve as the peer review committee when required under applicable State Law and perform all duties associated therewith."

Record review of a policy titled "Performance Improvement Risk Management / Patient Safety Plan" (no date) stated "Purpose: In accordance with mission, vision, and values, Humble Surgical Hospital is committed to providing high quality healthcare services in a safe environment." A section titled "Medical Executive Committee" stated "The Medical Executive Committee, composed of elected / appointed Medical Staff leaders and Administration, meets to provide oversight for all medical care rendered to patients at Humble Surgical Hospital. Medical staff peer review activities are performed according to Bylaws." Another section titled "Intense Analysis" stated "When indicated, an intense analysis is performed to identify processes needing improvement and to minimize the occurrence / recurrence of adverse outcomes....Some examples of processes and events requiring analysis include.........Sentinel Events."

On page 16 of the Performance Plan it stated "When addressing sentinel events, root cause analysis and near misses, patient notification of events, etc., reporting must be completed within 45 days of the event." The Root Cause Analysis for patient ID# 9 failed to identify the above listed problems.

Based on interview and record review the Hospital failed to ensure nursing services were supervised by a Registered Nurse in the Emergency Department and the In-patient medical / surgical unit.

Findings include:

Nursing records and staffing reports reflected that on 1/29/11 from 7 a.m. to
1 p.m. a Licensed Vocational Nurse (LVN ID# 70) was the only staff nurse in the hospital assigned to care for this one in-patient (ID# 9). A Registered Nurse was not available in the hospital on 1/29/11 to supervise the LVN.

The Administrator confirmed 7/13/11 at 1:40 p.m. the hospital was only staffed with an LVN, Physician, Paramedic and Security Guard on 1/29/11.

Nursing notes by the LVN on 1/29/11 at 12:40 p.m. stated " Wife alerted writer patient had urinated on self, BP 128/68, Heart rate 70, difficulty arousing patient, sternal rubs attempted without response, Emergency room physician notified of non-response. See Code Record. " The " Cardiopulmonary Resuscitation Record " revealed the code team consisted of a physician (ID# 66), a paramedic (ID# 68), and the LVN (ID# 70). A Registered Nurse was not available in the hospital to supervise the code of this patient.

Record review of a policy titled "Assignment of Care" (no date) stated "Purpose: To establish a guideline for making patient care assignments. Unit will be staffed according to the following census: 1 - 3 in-patients / observation patients will be cared for by (1) RN (Registered Nurse). Patient ID# 9 was the only in-patient on 1/29/11.

The Administrator (ID# 60) acknowledged 7/12/11 at 12 noon the Hospital occasionally staffs the in-patient unit with an LVN (Licensed Vocational Nurse). The Administrator stated a Registered Nurse is always on-call. The Administrator further stated that the Emergency Room is staffed with a physician and a paramedic.

Review of staffing records for May, June, and July 2011 revealed LVN's were assigned to care for in-patients without Registered Nurse supervision.

The Director of In-Patient Services (ID# 59) confirmed 7/15/11 at 2 p.m. that
the following dates had one Licensed Vocational Nurse assigned to work the medical surgical unit with a Registered Nurse on-call.

Review of documentation from a contracted staffing agency confirmed the dates and times of assigned contracted LVN's from the staffing agency. Also, the daily hospital Census reports listed the census for each day.

Dates of In-Patient Medical/Surgical Unit staffing with an LVN as the only nurse on a shift to care for patients each day:
05/06/2011 (LVN # 99 was assigned to care for three observation patients)
05/09/2011 (LVN # 99 was assigned to care for three observation patients)
05/13/2011 (LVN # 99 was assigned to care for one in-patient and one observation patient)
05/16/2011 (LVN # 99 was assigned to care for three observation patients)
05/17/2011 (LVN # 99 was assigned to care for one in-patient)
05/19/2011 (LVN # 99 was assigned to care for one in-patient)
05/27/2011 (LVN # 98 was assigned to care for one observation patient)
06/09/2011 (LVN # 98 was assigned to care for one observation patient)
06/13/2011 (LVN # 98 was assigned to care for three observation patients)
06/14/2011 (LVN # 98 was assigned to care for one observation patient)
06/17/2011 (LVN # 98 was assigned to care for three observation patients)
07/01/2011 (LVN # 97 was assigned to care for two in-patients)
07/02/2011 (LVN # 97 was assigned to care for two in-patients)
07/03/2011 (LVN # 97 was assigned to care for one in-patient)
07/12/2011 (LVN # 97 was assigned to care for one in-patient)
07/13/2011 (LVN # 97 was assigned to care for four in-patients)

Record review of a policy titled "Job Description - Licensed Vocational Nurse" dated 6/10/10 stated "Under the general supervision of the Registered Nurse staff, nurse provides direct nursing care in accordance with established policies and procedures of the hospital."

EMERGENCY ROOM

The Administrator (ID# 60) acknowledged 7/12/11 at 12 noon that the Hospital and the Emergency Room is only staffed with a physician and a paramedic in the evenings and on weekends if there are no in-patients in the hospital. The Administrator stated that a Registered Nurse is always on-call.

Record review of emergency room patient record #'s 1, 2, 3, 6, 7, and 8 revealed only a paramedic and a physician treated these patients. A nurse was not available to supervise care.

ER Patient ID# 1 was treated 3/27/11
ER Patient ID# 2 was treated 3/20/11
ER Patient ID# 3 was treated 2/5/11
ER Patient ID# 6 was treated 10/10/10
ER Patient ID# 7 was treated 2/5/11
ER Patient ID# 8 was treated 4/17/11

The Nursing ER Director (ID# 59) verified a Registered Nurse was not in the hospital when ER patient #'s 1, 2, 3, 6, 7, and 8 presented to the emergency room. The Nursing Director further stated that a Registered Nurse is always on-call but the hospital does not have a policy or protocol defining how soon the RN would need to respond to the hospital if notified.

Based on interview and record review the hospital failed to meet the emergency needs of patients in accordance with acceptable standards of practice. The Hospital failed to:

1) Provide Registered Nurse supervision of care for patients presenting to the emergency room
2) Provide adequate staffing in the emergency department (the ER was left unattended when an in-patient coded on the nursing unit on 1/29/11.)
3) Provide competent emergency room staff
4) Provide stabilization of a patient's condition before calling "911."
5) Provide on-call schedule of surgeons for the emergency department

Findings include:

The Administrator (ID# 60) acknowledged 7/12/11 at 12 noon the Hospital staffs the Hospital / Emergency room with a physician and a paramedic when there are no in-patients in the hospital. The Administrator stated a Registered Nurse is always on-call.

A Code record dated 1/29/11 for patient ID# 9 reflected that the Emergency Room Physician and the Paramedic responded to the code on the nursing unit and left the emergency room unattended (no patients were currently in the ER at the time of the code.)

The Emergency Room Physician (ID# 66) stated 7/15/11 at 3:25 p.m. she instructed the staff to call " 911 " to get more help " and to transfer the patient to a higher level of care. The hospital did not address the need for more staffing or the need to stabilize the patient before calling "911."

The Administrator confirmed 7/13/11 at 1:40 p.m. the hospital was only staffed with an LVN, Physician, Paramedic and Security Guard on 1/29/11.

The Ambulance record for patient ID# 9 dated 1/29/11 stated that when the paramedics arrived (ten minutes after the patient was found unresponsive) the patient was found cyanotic (blue), the breathing tube was not properly inserted, the intravenous line was not functional and the patient was bleeding onto the floor from the intravenous line. The hospital did not address the need for inservices / competencies regarding code situations.

The Emergency Room Physician (ID# 66) acknowledged 7/15/11 at 3:25 p.m. that "during the code of patient ID# 9 intubation was unsuccessful twice and the third time she was successful placing the breathing tube but it must have become dislodged during cardiopulmonary resuscitation."

Record review of emergency room patient record #'s 1, 2, 3, 6, 7, and 8 revealed only a paramedic and a physician treated these patients.

ER Patient ID# 1 was treated 3/27/11
ER Patient ID# 2 was treated 3/20/11
ER Patient ID# 3 was treated 2/5/11
ER Patient ID# 6 was treated 10/10/10
ER Patient ID# 7 was treated 2/5/11
ER Patient ID# 8 was treated 4/17/11

The Nursing ER Director (ID# 59) verified a Registered Nurse was not in the hospital when ER patient #'s 1, 2, 3, 6, 7, and 8 presented to the emergency room. The Nursing Director further stated that a Registered Nurse is always on-call but the hospital does not have a policy or protocol defining how soon the RN would need to respond to the hospital if notified.

Interview 7/15/11 at 3 p.m. with the Administrator revealed the Emergency Department does not maintain any on-call schedules for surgeons. The Administrator stated the only call schedule is a back-up emergency room physician schedule.

The Emergency Room Physician (ID# 101) on duty 7/15/11 acknowledged at 3:15 p.m. that the emergency room does not have an on-call schedule for surgeons at Humble Surgical Hospital. The ER Physician stated that all surgeries at Humble Surgical Hospital are scheduled and elective and if any patients presented to the emergency room requiring emergency surgery they would be transferred to another hospital.

Record review of a policy titled "EMTALA, Stabilization and Transfer Policy" (no date) stated "Policy: The Emergency Department will adhere to the EMTALA Patient Transfer Policy and any applicable laws of EMTALA."
(Emergency Medical Treatment and Active Labor Act (EMTALA)


Federal Tag A2404
?489.24(j)(1)
Each hospital must maintain an on-call list of physicians on its medical staff in a manner that best meets the needs of the hospital's patients who are receiving services required under this section in accordance with the resources available to the hospital, including the availability of on-call physicians.

Based on record review and interview the facility failed ensure 12 of 36 medical records reviewed were accurate and completed in a timely manner. (Patient #'s 1, 3, 5, 8, 9, 11, 26, 27, 31, 32, 33, 36).

Findings include:
Patient ID # 1 was seen in the emergency department on 3/27/11. The emergency room physician record was not signed by a physician.
Patient ID #3 was seen in the emergency department on 2/5/11. A physician order for a Stat X-ray was ordered but the order was not timed. Further, the nursing notes stated a nurse gave Tylenol but the medication administration record did not reflect Tylenol as being administered to the patient.
Patient ID # 5 was seen in the emergency department on 6/11/11. The medical record did not have any discharge instructions.
Patient ID # 8 was seen in the emergency room on 4/17/11. The medical record did not have a nursing triage sheet.
Patient ID # 9 was admitted to the hospital on 1/27/11 and had surgery. The operative report dated 1/27/11 was not signed by a physician. A telephone order for Dilaudid on 1/28/11 was not signed by a physician.
Patient # 11 had an outpatient procedure done on 6//20/11. The operative report was not signed at the time of this review.
Patient # 26 had a procedure on on 5/3/11. The operative report was not signed at the time of this review.
Patient # 27 had an outpatient procedure done on 5/24/11. There was no operative report in his chart at the time of review.
Patient # 31 had an outpatient procedure done on 6/10/11. The operative report was not signed at the time of review.
Patient # 32 had an outpatient procedure done on 5/16/11. There was no operative report in the chart at the time of review.
Patient # 33 had an outpatient procedure done on 6/28/11. The operative report was not signed at the time of review.
Patient # 36 had a procedure done on 4/17/11. The operative report was not signed at the time of review.

Review of facility's medical record policy titled "Medical Records Completion Requirements" Policy number RC 01. (no date) Policy states "It is the policy of the medical staff to maintain complete medical records on all of the hospital's patients, including but not limited to each patient's history and physical examination, operative notes, discharge summaries, and a comprehensive audit of all the patients medical records to ensure that they are complete." # 4 states " Medical records must be completed and signed within thirty (30) days of discharge".

Interview with Employee # 100 medical record person on 7/14/11 at 230 PM revealed that the facility is aware of the incomplete medical records and the physicians involved have been notified.

Based on interview and record review the Hospital failed to provide pharmaceutical services to meet the needs of patient ID# 9.

Findings include:

The Medical Record of Patient ID# 9 reflected that this was a 51 year-old patient that had back surgery on 1/27/11. Two days after surgery on 1/29/11 the patient was found unresponsive, had a cardiac arrest, was transferred to another hospital and was pronounced dead at the emergency room of the receiving hospital. The autopsy report showed the patient died accidentally as a result of "combined sedative effect."

Record review of patient ID# 9's medical record reflected there were physician orders for a total of Nine Central Nervous System depressants at the time of patient ID# 9 ' s death (Hydrocodone, Morphine, Valium, Dilaudid, Fentanyl, Neurotin, Wellbutrin, Benadryl, and Soma). Narcotics were ordered by intravenous pump infusion, by patch to absorb into the body, intravenously, intramuscularly, and orally.

Hydrocodone: Opiate Narcotic Analgesic
Morphine: Potent Opiate Analgesic
Valium: Benzodiazepine (muscle relaxant)
Dilaudid: Potent Opiate Analgesic
Fentanyl: Potent Narcotic Analgesic
Neurotin: Used to relieve pain
Wellbutrin: Depression
Benadryl: Sleep or itching
Soma: Muscle Relaxant


Interview 7/13/11 at 2:20 p.m. with the Consultant Pharmacist (ID# 67) revealed he reviewed patient ID# 9's medication profile on 1/28/11 (the day before patient ID# 9 died). No concerns were noted. The Pharmacist stated that after his review of the patient record a Consultant Pain Specialist Physician called in verbal telephone orders on 1/28/11 for medication changes. The Pharmacist had left the hospital on 1/28/11 before the new orders were called in.

The Pharmacist stated he did not personally review the medical record for patient ID# 9 after his death but the nurse (ID# 76) assigned to the pharmacy reviewed the medication orders. The Pharmacist stated that he did review the report of the pharmacy nurse but he did not make any formal recommendations to the Governing Body. The Consultant Pharmacist stated he visits the hospital once per week, the minimum Licensure requirements of the Texas State Board of Pharmacy for Hospitals.

The pharmacy nurse (ID# 76) acknowledged 7/14/11 at 11 a.m. that she reviewed the medical record of patient ID# 9 and identified several errors relating to medication administration but no recommendations were made by the pharmacy staff, only a report of the errors was submitted to Administration.

Record review of a "Pharmacy medication report on patient ID# 9" stated "The following errors were found after review of the medication record:"

-Lactated Ringers solution not documented on the medication administration record. Not sure when it was discontinued but was told that the Lactated Ringers was discontinued and the Patient Controlled Anesthesia was the only fluid going. Orders were Lactated Ringers at 90 ml per hour to convert to saline lock when tolerating well.

-Pepcid 20 mg was ordered IV or PO every 12 hours....None was ever documented as being given on the medication administration record....

-Valium 5 mg PO / IV was written but both IV and PO were written on the same line on the medication administration record so when times were recorded it was not clear which route was given until you compare with narcotic sign out record...the IV route was given until you compare with narcotic sign out record....the IV line was crossed out which would show po but narcotic records show it was given IV the first 3 doses.....

-Reglan 10 mg po three times daily ordered times three doses on 1/27/11 was shown to have only received one dose at 6 a.m. on 1/28/11.

-Colace 100 mg po twice daily orders were written on 1/27/11 but the medication administration record shows no colace was ever given. It is on the medication administration record to be given as ordered but none documented.

-Dulcolax 10 mg po every night was ordered unless loose stools and is written on the medication administration record to be given at bedtime but no documentation that any dulcolax was ever given.

-Benadryl 25 mg or 50 mg po ordered on 1/27/11 every 6 hours as needed for itching / sleep....when written on the medication administration record the dosages should be on two separate lines indicating if 25 mg or 50 mg was given...documentation on the medication administration record that benadryl was given but dosage amount not documented ....was 25 mg given or 50 mg given?

-Ambien 10 mg po at bedtime ordered on 1/27/11 and written that way on the medication administration record but no ambien was given or signed out on the in-patient narcotic sheet.

-Vicodin Extra Strength (7.5mg / 325 mg - hydrocodone) ordered on 1/27/11 to give 1 or 2 tabs every 4 to 6 hours as needed for moderate pain. We do not carry the Extra Strength (7.5 mg) Vicodin....we only have 5 mg / 500 mg Vicodin. When written on the medication administration record it was written as we have it (5 mg / 500 mg) but the surgeon should have been notified of the dosage we carry and written as an order that the dosage was OK.....can not find where surgeon was ever contacted...therefore orders were not carried over to medication administration record correctly. Also the 1 or 2 tabs were on the same line and there is no documentation if one or two tabs were given. If you go to the narcotic record you then find out two tabs were given...not documented on the medication administration record.

-Norco 10 / 325 administer 1 or 2 tabs ordered on 1/27/11 every 4 to 6 hours as needed for moderate pain. The one or two tabs were written on the same line on the medication administration record so when Norco was given there is no record if one or two tabs were given. You have to look on the narcotic sign out record to find out that 2 tabs were always given.

-Orders written on 1/27/11 to continue home meds.....meds were not brought in by family until 1/28/11 and were identified in the pharmacy and returned to in-patient area and locked up in patient drawer. Meds were given as ordered 1/28/11 except Zyrtec was listed to be given at bedtime but it was given at 12:00....not sure if this was because he did not receive it the night before because he had not brought in home meds until 1/28/11. On 1/29/11 the medication administration record shows that 5 home meds were to be given at 0900 but no documentation was made if meds were given that morning.

-On 1/28/11 orders from the Consultant Pain Specialist at 1:30 p.m. for Soma 350 mg three times daily. The medication administration record show it was given at 2 p.m. but the next two doses were circled and were not given according to the medication administration record and narcotic sign out record...The 10 p.m. dose circled states held because patient sleeping however medication administration record shows patient did receive Norco po and Morphine 10 mg IM at the same time at 10 p.m.

-Neurontin 600 mg po four times daily ordered on 1/28/11 by the Pain Specialist and patient received dose at 3:15 p.m. and 9 p.m. but no doses are documented as being given on the morning of 1/29/11 as was ordered.

-Dilaudid Patient Controlled Analgesia pump was ordered at 1:30 p.m. to be decreased to 1/2 the previous amount and shows this was done between 3:45 p.m. and 4 p.m. on 1/28/11. (over two hours later)

-The Norco order on 1/28/11 to be given if OK with the Pain Management Physician was continued but no orders seen from the Pain Management Physician to continue the Norco was OK and it was given until 6 a.m. on 1/29/11.

-On 1/28/11 at 11:30 p.m. the patient was ordered to have have Valium 5 mg po but Valium 10 mg IV was signed out and documented on the narcotic sheet as given but not shown on the medication administration record.


The above "Pharmacy medication report on patient ID# 9" failed to address
1) The excessive amounts of Central Nervous System Depressants administered to the patient during his stay in the hospital from 1/27/11 to 1/29/11 until his death.
2) The duplication of narcotic orders

Review of the medication list for patient ID# 9 revealed the following Central Nervous Depressants were administered to the patient:

1/27/11
1:00 p.m. Dilaudid Patient Controlled pump started
1:40 p.m. Valium 5 mg IV
1:40 p.m. Benadryl 25 mg po
5:30 p.m. Morphine 10 mg IM
5:30 p.m. Vicodin 10 mg po
7:00 p.m. Norco 20 mg po
7:30 p.m. Benadryl 25 mg po
7:40 p.m. Valium 5 mg IV
8:30 p.m. Morphine 10 mg IM
11:30 p.m. Morphine 10 mg IM

1/28/11
12 a.m. Norco 20 mg po
1:00 a.m. Valium 5 mg IV
2:30 a.m. Morphine 10 mg IM
3:00 a.m. Benadryl 25 mg po
4:00 a.m. Norco 20 mg po
6:00 a.m. Morphine 10 mg IM
7:00 a.m. Valium 5 mg IV
9:00 a.m. Norco 20 mg po
10:00 a.m. Morphine 3 mg IV
10:00 a.m. Robaxin 750 mg po
11:25 a.m. Valium 5 mg po
12:00 p.m. Wellbutrin XL 300 mg po
2:00 p.m. Soma 350 mg po
3:15 p.m. Neurontin 600 mg po
3:35 p.m. Valium 5 mg po
4:00 p.m. Duragesic Patch 50 mcg applied
4:00 p.m. Dilaudid pump rate decreased
4:35 p.m. Morphine 3 mg IV
6:00 p.m. Norco 20 mg po
7:00 p.m. Benadryl 25 po
7:00 p.m. Morphine 10 mg IM
7:30 p.m. Morphine 3 mg IV
7:30 p.m. Valium 5 mg po
9:00 p.m. Neurontin 600 mg po
10:00 p.m. Morphine 10 mg IM
10:00 p.m. Norco 20 mg po
10:30 p.m. Morphine 3 mg IV
11:00 p.m. Valium 5 mg po

1/29/11
1:00 a.m. Benadryl 25 mg po
1:00 a.m. Morphine 10 mg IM
1:30 a.m. Morphine 3 mg IV
2:00 a.m. Norco 20 mg po
3:30 a.m. Valium 5 mg po
4:00 a.m. Morphine 10 mg IM
4:30 a.m. Morphine 3 mg IV
6:00 a.m. Norco 20 mg po


Record review of the physician orders for patient ID# 9 revealed a duplication of narcotic orders as follows:

Physician Orders 1/27/11 at 11:30 a.m.:

-"Valium 5 mg PO / IV every 6 hours as needed" (the physician did not mark if he wanted the Valium administered orally or intravenously, so therefore the nursing staff gave Valium both ways (orally and intravenously) at intervals of less than 6 hours apart) The Physician order also did not stipulate the reason to give this medication, the order stated "as needed."

-Vicodin (hydrocodone) 7.5 mg, 1 - 2 tabs every 4 - 6 hours as needed for moderate pain or for break through pain

-Norco 10 mg (generic hydrocodone) 1 - 2 tabs every 4 - 6 hours as needed for moderate pain or for break through pain

-Morphine 10 mg IM every 3 - 4 hours as needed for severe pain or for break though pain

Physician Orders 1/28/11 at 9:45 a.m.:

-Morphine 3 mg IV every 3 - 4 hours as needed for break though pain

(The Morphine was ordered intramuscularly and intravenously and was a duplication of a narcotic order for "break through pain." The hydrocodone was ordered in a brand name form and generic form and was also a duplicate narcotic order)

Record review of a document titled "Pharmacy Requirements When a Patient is Admitted to the In-patient Unit" (no date) stated "When a patient is admitted to the in-patient unit - records need to be completed and interactions checked before any medications are administered........All this needs to be done because we do not have a Full Time Pharmacist and Pharmacy. The Pharmacist comes in once a week and reviews all the patient charts and pharmacy."

Record review of a contract between the hospital and the consultant pharmacist dated 7/1/10 stated "Services: The services to be provided will include review of medication records, orders and Quality Assurance as required by the Texas State Board of Pharmacy, compliance with Medicare Regulations, Inservices and, if desired, the establishment of a formulary for the hospital."

Based on observation, interview, and record review revealed the hospital failed to ensure the following:

1) Multi-dose vials of medications that had been previously opened were not dated as to when they were first opened in operating room number ' s 4 and 5.
2) Single dose vials of medication that had been previously opened were not discarded in operating room number ' s 4 and 5.
3) Expired medications were not removed from stock in operating room #5

Findings include:

Observation 7/13/11 at 1 p.m. revealed the following medications:


OR # 4 Inside the Anesthesia drug cart.

1 - Nimbex 5 ml single dose vial (neuromuscular blocking drug or skeletal
muscle relaxant) The vial had been previously opened.

1 - Rocuronium 5 ml single dose vial (provide skeletal muscle relaxation during surgery or mechanical ventilation). The vial had been previously opened.
1 - Etomidate 10ml single dose vial (a short-acting, hypnotic nonbarbiturate IV agent for induction of general anesthesia). The vial had been previously opened.
2 - Esmolol HCL 10 ml single dose vial (Short-term management of supraventricular tachyarrhythmias and noncompensatory sinus tachycardia). The vial had been previously opened.
OR # 4 Inside a locked drawer
1 - Dexamethasone multi-dose vial (This medication is a corticosteroid hormone. It decreases your body's natural defensive response and reduces symptoms such as swelling and allergic-type reactions). The vial had been previously opened and was not dated as to when it was first opened.

OR # 5 Inside the Anesthesia drug cart:
4 vials Neo-Synephrine 10 mg/ml (This medicine may used to treat very low blood pressure or serious heart problems such as irregular heartbeat). The vial had been previously opened and was

1 vial Phenylephrine Hydrochloride Solution opened 2/23/11
1 vial Phenylephrine Hydrochloride Solution expired 06/2011

1 vial - Nimbex 2mg/ml (Used as an adjunct to general anesthesia, or sedation to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation). The vial had been previously opened and was labeled single dose vial.

6 vials -Hydrochloride 20mg/ml 1 ml (single dose) expired 3-2011 (Directly relaxes vascular smooth muscle to cause peripheral vasodilation, decreasing arterial BP and peripheral vascular resistance).

1 pre filled syringe- 50% Magnesium Sulfate 5grams/10ml expired 1 May 2011. (Indicated for immediate control of life threatening convulsions in the treatment of severe)

1 -Marican 0.25% multi-dose vial (Used to prevent or relieve pain, used after surgery to relieve pain). The vial had been previously opened and was not dated as to when it was first opened.
1 - Prefilled syringe -Epinephrine1:10,000 1 mg (0.1mg/ml) expired April 2011 (Drug of choice for treating bronchoconstriction and hypotension resulting from anaphylaxis as well as all forms of cardiac arrest. Rapid injection produces a rapid increase in systolic pressure, ventricular contractility, and heart rate)

OR # 5 Inside a locked drawer.

1 Vial - Dexamethasone Sodium Phosphate 4mg/ml multi-dose vial (used to treat conditions such as arthritis , blood/hormone/immune system disorders, allergic reactions, certain skin and eye conditions, breathing problems, certain bowel disorders, and certain cancers). The vial had been previously opened and was not dated as to when it was first opened.

Record review of a policy titled " Medication Management Dating of Sterile Containers " (no date) stated " Single Dose Vials: Discard 24 hours after opening. " The policy further stated " Multiple dose vials: Discard 28 days after opening. Must be labeled with date, time and initials of person opening. "

The Operating Room Nursing Director (ID# 93) stated 7/13/11 at 1 p.m. that only the contract anesthesia personnel have the combination number for the anesthesia carts.

Based upon observations, interviews and record reviews the hospital failed to maintain a clean/sanitary environment.

Heavy build-up [1/8 inch] of dust/lint on horizontal surfaces in the following areas. (Medical/Surgical Unit patient rooms 6 of 6, Emergency Department treatment room, Operating rooms 2, 3, 4, 5 of 6, Pre-Operative area beds 2, 3, 4, 5. PACU (Post Anesthesia Care Unit) - bed 5 & 7, on top of blanket warmer.

Finding Include:

During tour of hospital the following were observed on 07/12/2011 at 1200 PM:

Pre-operative area with nursing director (#61) Room #s 2, 3, 4, 5 were observed to have heavy dust / lint build-up (1/8 inch) on the horizontal surfaces of the cardiac monitors, paper towel/sharp dispensers, wall mounted suction canisters, TV and underneath the stretchers.

PACU (Post Anesthesia Care Unit) with nursing director (#64) on 07-12-2011 at 1215 PM. Surveyor observed heavy dust / lint build-up (1/8 inch) on top horizontal surface of blanket warmer located in rear of area unit. Room # ' s 5 & 7 - Observed by surveyor dust on wall suction canister tops, top of cardiac monitors, on top of black box medication box mounted on walls for patients and the bottom of stretchers.

Medical / Surgical Unit (In-Patient Unit- 1-6 rooms) All rooms were found to have dust / lint build-up (1/8 inch) on top of cardiac monitors, pictures frames, top of lights above the beds, window blinds, window seals, and white writing boards mounted on the wall in patient rooms.

Emergency Room #1 was found to have heavy dust / lint build-up on top of wall mounted procedure lamp used for suturing patients.

Operating Room # ' s 5 of 6 were observed with employee (#65). All operating suites observed were found to have heavy dust / lint build-up (1/8 inch) on horizontal anesthesia gas cart, anesthesia column for gas and electric outlets, white writing boards mounted on walls, wall mounted x-ray viewing lamp, return air vent and the top of the suction canisters.

Review of Humble Surgical Hospital Policy: Infection Control - Housekeeping in the Surgical Suites. Policy Number IC 14. (no date) Policy stated the following:
"Purpose: To ensure a safe environment for patients and personnel. To maintain a clean orderly Operating Suite. To provide timely turnover in achieving a pathogen-free environment. Policy: A daily routine will be followed to assure optimum control of environment. Procedure: General Duties (f) Damp dust all flat surfaces, (h) Check operating Room tables; spot lights and room for cleanliness each morning before opening supplies. C. Terminal Daily Cleaning (b) Wash overhead surgical lights using disinfectant.

The Administrator acknowledged 7/13/11 at 2 p.m. the hospital has recently changed contract cleaning services.

The Infection Control nurse (ID# 64) stated 7/14/11 at 1:30 p.m. the hospital does not conduct surveillance rounds of the environment.