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Based on interview and record review, the hospital failed to ensure the general consent form was completed correctly for three of the six patient records reviewed on the medical-surgical units (Patients 20, 23, and 96). This could potentially result in the patients not exercising their rights. In addition, the hospital failed to ensure two of four surgical patients reviewed (Patients 44 and 47) were provided with accurate information and were informed of the name of the surgeon who would be performing the surgical procedure. This resulted in the potential for patients not being allowed to make an informed decision regarding surgery.

Findings:

1. On 11/15/10, a review of the hospital's general consent showed the form included permission to have the hospital's medical personnel perform exams and treatment, take clinical photographs, allow for observation of the patient during treatment and procedures by medical staff and students, release to the public basic patient information, financially obligate the patient for costs, and allow for the release of information to payers sources, such as Medicare or insurance companies. The form also informed patients the hospital had a safe. Patients were notified the hospital was therefore not responsible for items not placed in the safe.

a. On 11/15/10 at 1430 hours, Patient 96 was interviewed and spoke clear unaccented English. After interview, the patient's medical record was reviewed. The general consent found in the medical record was in Spanish. Patient 96 was re-interviewed and was asked if he read Spanish and the patient stated, no.

b. On 11/15/10 at 1445 hours, review of the medical record for Patient 20 showed the general consent form was not signed.

c. On 11/15/10 at 1535 hours, Patient 23's medical record was reviewed. The consent form was witnessed, timed and dated but there was no patient signature found on the consent.

The Clinical Nursing Director and the Assistant Nursing Director, who were present during the reviews, confirmed these consent forms were incorrect.


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2. Patient 44 was interviewed at 0905 hours on 11/16/10, in the pre-operative area. Patient 44 stated she signed a consent form in the physician's office for MD D to perform the procedure. The surgical procedure for Patient 44 was observed at 1100 hours. The physician performing the surgery was not the physician listed on the informed consent. The physician performing the surgery was identified as the "surgeon of the day 2."

When interviewed on 11/18/10 at 1110 hours, the Medical Director of the Operating Room stated that documented informed consent was required in order to indicate the correct physician performing the procedure.

3. Patient 47 was interviewed at approximately 0930 hours on 11/16/10. When asked, Patient 47 stated she was unaware of the name of the surgeon who would be performing her surgical procedure. The patient stated she had signed forms for the consent, but was not informed of the name of the operating surgeon.

Based on interview and record review, the hospital failed to ensure advanced directives were addressed for three of six patients reviewed on the medical-surgical unit (Patients 20, 23, and 96). This could potentially result in the hospital not complying with patient wishes regarding end of life care.

Findings:

On 11/15/10, a review of the hospital's general consent form showed a section pertaining to advanced directives. The first line of the section was "Brochure on Patient Self Determination Act to Patient" with a check box. The second line was "Patient has Advance Directive" with yes, no or unknown check boxes. The third line showed "If yes, copy placed on chart (checkbox), or advised patient to provide copy to physician (checkbox)."

1. Patient 20 was interviewed on 11/15/10 at 1445 hours. The patient stated during the interview she was unaware of advanced directives.

A review of the patient's chart showed the general consent, which included advanced directive information, was not signed by the patient. However, the "Brochure on Patient Self Determination Act to Patient" box was checked and the "Patient has Advance Directive" was checked as no.

2. Patient 96's medical record was reviewed on 11/15/10. On the second line of the Advance Directive section written as "El paciente tiene Instruccion Anticipada:" (Patient has Advanced Directive) the no box was checked. During a subsequent interview on 11/15/10 at 1430 hours, the patient stated he did not read Spanish.

3. Patient 23's medical record was reviewed on 11/15/10 at 1535 hours. The general consent showed, in the Advance Directive section, that a Brochure on Patient Self Determination Act was provided to the patient. The no box on the third line was checked indicating the patient did not have an advance directive. However, the patient had not signed the general consent form, although it had a witnesses signature and was timed and dated.

The Clinical Nursing Director and the Assistant Nursing Director, who were present during the reviews, confirmed these consents were incorrect.

Based on observation, interview and record review, the hospital failed to ensure the patient's right to privacy was maintained for four of 105 sampled patients (Patients 2, 4, 95 and 98). For Patients 2, 4, and 95, discussions with their physicians in the Emergency Psychiatric Department were not conducted in private. The physician for Patient 98 discussed his medical diagnosis in front of a visitor. This resulted in PHI (Protected Health Information) being shared with non-authorized individuals.

Findings:

1. On 11/15/10 at 1015 hours, a tour of the Emergency Psychiatric Department was conducted. Staff reported the census to be 21 patients. Gurneys were lined up side by side on two sides of the room, spaced approximately twelve inches apart. Many of the gurneys were occupied with patients. Physicians or psychiatrists were observed interviewing patients about PHI at the foot of the guerney.

The Emergency Psychiatric Department had bays numbered 9, 10, 11, and 12 which contained eleven patient gurneys occupied by five patients. Additionally, only one privacy curtain was observed between bays 9 and 10. There were no other privacy curtains found in the Psychiatric Emergency Department.

a. Patient 2 was interviewed on 11/15/10 at 1020 hours. She stated when the psychiatrist came to talk to her he discussed her case while standing at the foot of her gurney. The patient stated the psychiatrist discussed her medication changes or additions. The patient stated this was done routinely.

b. Patient 4 was interviewed on 11/15/10 at 1030 hours. The patient stated the psychiatrist discussed his case while standing at the foot of the gurney. When asked, the patient stated the psychiatrist did not meet with him privately.

c. Patient 95 was interviewed on 11/15/10 at 1035 hours. The patient stated she was uncomfortable regarding her location. The patient stated, "look where I am at!" The patient then stated the psychiatrist discussed her case while standing at the end of her gurney.

An interview with the attending psychiatrist was conducted on 11/15/10 at 1050 hours. He was asked about patient privacy and where medical residents and medical students interviewed the patients. The attending psychiatrist stated they had one interview room and tried to use it as often as possible.


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2. Review of the hospital's P & P for PHI, effective 9/25/08, showed the hospital would limit the disclosure of PHI to the minimum necessary. Written authorization would be required before disclosing PHI for purposes other than treatment, payment or healthcare operations.

On 7/19/10, the Department was notified of an information breach that occurred on 7/12/10. During an interview on 11/18/10, the HIPAA Regulatory Compliance Officer stated Patient 98 had reported that MD E had discussed the patient's HIV (Human Immunodeficiency Virus,a lentivirus that causes acquired immunodeficiency) status in front of a visitor who was unaware of the patient's condition. According to the privacy officer, MD E verified this had occurred.

On 11/19/10, review of the hospital's investigation of the event corresponded with the findings discussed in the interview with the HIPAA Regulatory Compliance Officer.

Based on observation, interviews and review of hospital policies, the hospital failed to ensure a safe environment due to:

* A security door alarm system failed for one of three door alarms tested on one nursing unit which potentially resulted in a 16 year old patient (Patient 79) leaving the hospital unescorted. The patient had a recent positive PPD (test for tuberculosis) with the potential for transmission of a highly contagious disease and was at risk for a metabolic crisis as a result of untreated diabetes.

* A laboratory cart was left unattended in the Psychiatric Emergency Department which could potentially result in psychiatric patients obtaining needles and glass tubes.

* Multiple oxygen cylinders were observed not secured properly which could potentially result in a cylinder falling, releasing pressure and becoming a projectile object.

* Used urinals were observed on over bed tables next to lunch trays (for four unsampled patients) which could potentially result in an emotionally unsafe environment with regard to dignity and respect.

* Policies and procedures for the control and reporting of OR temperatures and humidity were not developed and implemented which could potentially result in microorganism growth, increased risk of dust contamination, and increased risk for fire.

* The manufacturer's recommendations for the correct proportions of disinfection and cleaning products were not followed per the hospital's policy and procedures to ensure that surgical instruments and the surgical environment were safe for patients.

Findings:

1. On 11/18/10 at 1310 hours, a tour of the 8A and B medical floors was conducted accompanied by the Director of the unit.

Observation of a west facing door on the 8B unit showed the door had an electronic alarm attachment. The door was centrally located west of the main nursing station. The staff was asked to activate the door alarm as a test. The door alarm activated when the door was opened.

The 8B unit was connected to the 8A unit by a conjoined hallway system. There was no door dividing the units. Staff, visitors, and patients could move freely from one unit to the other without interruption.

The 8A medical floor had a door located at the west end of the unit. The door was equipped with an electronic alarm unit attached to the top of the door. The door was tested and the alarm system failed to activate. When asked, the Director of the unit stated she did not know why the alarm had failed. The Director was asked where the stairwell led. She stated the stairwell led to the first floor of the hospital.

Another door centrally located on unit 8A was observed with a exit sign above the door. There was no alarm attachment observed on the door. The door was tested and there was no alarm activation. The Unit Director was asked where the exit door led. She stated the door lead to a stairwell to the first floor of the hospital.

On 11/18/10, medical record review was conducted for Patient 79. The patient was admitted on 9/14/10 at 0239 hours, to the 8B medical unit. A medical screening examination showed Patient 79 had a diagnosis of increased blood glucose levels, asthma and panic attacks. Nursing documentation dated 9/14/10, showed Patient 79 had received insulin medication at 0706 hours, had vital signs taken at 0730 hours, and was reported missing at 0945 hours.

An interview with the Plant Operations Manager was conducted on 11/18/10, at 1330 hours. The Manager was asked about the door on the 8A unit with an electronic door alarm attachment that failed to alarm when tested. The Manager stated the alarm required batteries for power and the batteries in the alarm did not work. The Manager stated there had been no preventive maintenance done on the door. When asked the reason for the alarm doors on the 8A and 8B units, the Manager stated the alarms were to alert staff of someone exiting the unit.

2. During the tour of the Psychiatric Emergency Department on 11/15/10 at 1015 hours, a phlebotomist lab cart was observed unattended and unsecured in a patient care area.

Interview with the phlebotomist was conducted on 11/15/10 at 1035 hours. The phlebotomist stated the cart contained needles, glass tubes and other blood draw equipment.

On 11/18/10 at 0935 hours, an interview with the Manager of the Psychiatric Emergency Department was conducted. The Manager stated such equipment should not be left unattended.

3. The National Fire Protection Association (NFPA) Standards 99 for Health Care Facilities showed documentation that oxygen cylinders must be secured in racks or by chains.

On 11/15/10 at 1000 hours, the Psychiatric Emergency Triage area was toured. Found in a room identified as 'Decontamination Room Only', an oxygen cylinder was observed laying on its side and was not secured. A staff member accompanying the tour picked up the cylinder and stated, "this should not be here like this."


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4. An initial tour of Pulmonary Function Test (PFT) Laboratory was conducted on 11/15/10 at 1500 hours, accompanied by RN JJ, RN KK and PFT 1. An E-cylinder oxygen tank was observed lying on the floor of Sleep Room-1. A cage, used to securely store oxygen tanks was located beside the E-tank but had not been used.

5. On 11/15/10 at 1137 hours, a portable oxygen cylinder was noted lying unsecured on the floor outside the entrance to the main OR.

6. On 11/15/10 at 1130 hours, during the initial tour of the fourth and fifth floor ICUs, accompanied by RN JJ, RN KK and the respective charge nurses, a patient in ICU-4A was observed with a half-full urinal sitting on the patient's overbed table. A staff person was observed to enter the room and empty the urinal. The staff person replaced the urinal on the overbed table. When the staff person noticed the surveyor watching the room the urinal was then hung on the side rail of the patient's bed.

During tour of ICU-4B, two other ICU patients were observed to have urinals on their overbed tables. In some cases the urinals were placed beside the patients' lunch trays while the patients were eating. When the situation was pointed out to RN JJ, she asked the nurses assigned to the patients to remove the urinals.

Further tour of ICU-5A revealed another urinal placed on the overbed table sitting beside a patient's finished lunch tray.


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7. The hospital failed to ensure that policies and procedures for the control and reporting of temperature and humidity were developed and implemented. Cross Reference A 726 #1 and 2.

8. The hospital failed to ensure correct proportions of disinfection and cleaning products were dispensed per policy and procedure and manufacturer's recommendation in order to ensure surgical instruments and the surgical environment were safe for patient care. Cross reference A 951 # 1, 2, 3, and 5.

9. The hospital failed to ensure infusion pumps were properly cleaned. Cross Reference A 749 #2.

Based on interviews, and review of selected documents supplied by the hospital, the hospital failed to measure, analyze and track quality indicators for 24 of the 24 operating rooms, one cystoscopy room, two labor and delivery operating rooms, five endoscopy rooms, two cardiac catheterization rooms, instrument processing and sterilizing areas, patient recovery areas and two interventional radiology rooms, in order to assess and track temperature and humidity. This could lead to an unsafe environment for patient care due to the increased risk of fire and/or bacterial growth.

Findings:

AORN guidelines, dated 2010, for Safe Environment of Care Recommendation V, showed the temperature in the operating room should be maintained between 68 to 73 degrees F. The relative humidity should be maintained between 30-60% within the perioperative suites, including operating rooms, recovery areas, cardiac catheterization labs, endoscopy rooms, instrument processing rooms and sterilization areas. Low humidity increases the risk of electrostatic change which poses a fire hazard in an oxygen rich environment or when flammable agents are in use, and also increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored or procedures performed.

On 11/18/10, the relative humidity and temperature reports for the 24 operating rooms were reviewed for the time period of 9/1/10 through 11/18/10. Eighteen of the 24 operating rooms were documented as out of range for either temperature, humidity or both. Cross reference A 951

Interviews were conducted on 11/18/10 at 1110 hours with the Medical Director of the Operating Room and the Nursing Director of Surgical Services. The Medical Director of the Operating Room stated that he was unaware of the AORN standards for temperature and humidity recommendations for a safe environment. The Medical Director stated he had not been informed the temperature and humidity in the ORs had been out of range. He stated he was also unaware that low humidity increased the risk of dust contamination or was a fire hazard. The Nursing Director of Surgical Services stated Facilities personnel were to inform the surgical department if any of the OR suites were out of range for temperature and humidity. She stated she had never been informed that the temperature and humidity had been out of range.

On 11/18/10 at 0930 hours, the Director of Facilities was interviewed along with the Director of Patient Safety. Both stated the facility engineers monitored the OR temperature and the humidity and if the readings were out of range the cause was investigated. When asked, no written documentation was provided to show the OR staff had been informed of the out of range readings for temperature and humidity in the ORs. In addition, the staff was unable to provide a written policy and procedure to show a process was in place for the reporting of out of range temperatures and humidity in high risk areas.

The Epidemiologist of in-patient surgical services was interviewed at 1000 hours on 11/17/10. She stated the infection control committee met quarterly and reviewed the temperature and humidity logs. The Epidemiologist was asked to produce minutes for this review. Review of the committee minutes dated 8/19/10, showed documentation the "Water surveillance and OR Temperature/Humidity report not available."

Based on interviews and a review of the medical record for one of four sampled surgical patients (Patient 45) the hospital failed to ensure a medical history and physical examination had been performed within 24 hours of admission to the hospital. This could lead to a patient having surgery who might be unstable for the procedure.

Findings:

The medical record for Patient 45 was reviewed on 11/16/10. The patient was admitted on 11/16/10 and was scheduled for surgery the same day. Review of the Day Surgery Focused History and Physical Exam dated 11/16/10, showed no documentation a review of the patient's vital signs had been completed and pertinent laboratory or x-rays reports, if any, had been reviewed. The area to show the History and Physical was reviewed and signed by the attending physician prior to the surgical procedure was blank.

Based on interview and medical record review, the hospital failed to ensure care plans for one of six sampled patients on the medical surgical units (Patient 12) were developed to address the patient's risk of infection, the use of a special diet, and psychosocial issues related to a possible diagnosis of leukemia (a cancer of the blood or bone marrow). A lack of comprehensive care plan development may result in patient interventions not developed and/or assessed which can further compromise the patient's medical status.

Findings:

Patient 12 was interviewed on 11/15/10 at 1445 hours. The patient stated she had been admitted to the hospital for anemia (low red blood cell count) and had undergone a bone marrow biopsy today.

Patient 12's medical record was reviewed on 11/15/10. The patient was admitted to the hospital on 11/12/10. Review of the H&P dated 11/12/10, showed the patient was severely anemic with a hemoglobin (a protein in red blood cells that carries oxygen) of 5.1 gm/dl (normal value is 12.1 - 15.1 gm/dl) thought to be due to a malignant process. In addition, the patient was also documented as neutropenic (abnormally low number of white blood cells) and thrombocytopenic (abnormally low number of platelets which assist in clotting of the blood) due to a malignant process. The physician documented a potential diagnosis of leukemia. The proposed plan included to monitor for any fever and/or source of infection and offer support and any needed counseling with social worker or chaplain regarding the leukemia diagnosis.

Patient 12's medical record was reviewed with RN A on 11/15/10 at 1445 hours. When asked to state the nursing concerns for the patient, RN A stated, due to a possible diagnosis of leukemia, Patient 12 was on a neutropenic diet. The RN stated this diet was used for people with weakened immune systems to protect them from bacteria and other harmful organisms found in some food and drinks such as uncooked fruits and vegetables. Review of the Interdisciplinary Patient Care Plan did not show the pre-printed care plan problem areas for nutrition, infection and psychosocial had been initiated with stated interventions and desired outcomes. When asked to review the plan of care for Patient 12, the RN confirmed there were no care plans to address the use of a neutropenic diet, a risk of infection, or the potential need for psychosocial support due to a leukemia diagnosis. When asked if the risk of infection was a nursing concern, the RN stated it was, that the patient wore a mask when leaving her room to protect her from other people's possible germs.

Based on interview, the hospital failed to ensure four out of eight nurses interviewed (RNs KK, V, F, and the Nurse Manager for Labor and Delivery) had the competencies required to care for patients receiving paralytic agents. This could potentially result in the failure of the nurses to recognize and intervene for patients with the signs and symptoms of Malignant Hyperthermia (an inherited disease that causes a rapid rise in body temperature (fever) and severe muscle contractions when the affected person receives general anesthesia agents).

Findings:

According to Lexicomp On-line, the use of Succinylcholine (suxamethonium, a paralytic agent) may be associated with acute onset of Malignant Hyperthermia.

United States Pharmacopeia (USP) 2006: The Interdisciplinary Safe Medication Use Expert Committee of the USP has recommended the following: Hospitals, clinics, and other practice sites should institute special safeguards in the storage, labeling, and use of these agents and should include these safeguards in staff orientation and competency training. Healthcare professionals should be on high alert (especially vigilant) whenever a neuromuscular-blocking agent (NMBA) is stocked, ordered, prepared, or administered.

1. During a tour of the ED Resuscitation unit on 11/16/10 at 0915 hours, RN V was asked what drugs were used during intubation (inserting a breathing tube for a patient). RN V stated Succinylcholine (suxamethonium a paralytic agent) and etomidate (a sedative). When asked to name adverse effects of Succinylcholine, RN V did not include Malignant Hyperthermia. When asked what Malignant Hyperthermia was, the RN stated it was an effect caused by psychiatric drugs such as Haldol.

2. A review of practices with the use of Succinylcholine was conducted in the ICU:

a. RN JJ was interviewed in the ICU on 11/17/10 at 1530. RN JJ stated etomidate and Succinlycholine were some of the agents used to intubate patients in the ICU. The RN noted Malignant Hyperthermia as a potential side effect. When asked, RN JJ stated she had not received training on Malignant Hyperthermia at this hospital but at a previous place of employment.

b. On 11/17/10 at 1540 hours, in the medical ICU, RN KK stated etomidate and Succinlycholine were some of the agents used to intubate patients in the ICU. RN KK did not identify Malignant Hyperthermia as a side effect of Succinlycholine.


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c. RN II was interviewed on 11/17/10 at 1550 hours. The RN stated she assisted with the intubation of patients in the ICU and confirmed the medication Succinylcholine was sometimes used for this. When asked, the RN stated she was aware of the complication of Malignant Hyperthermia but had not received education at this hospital.

3. A tour of the two OR suites in the L&D unit was conducted on 11/15/10 at 1145 hours, accompanied by the Clinical Director of Women's and Children's Services and the Nurse Manager of L&D. The staff confirmed general anesthesia was occasionally used during a C-section (surgical delivery of a baby). When asked about the availability of chilled saline for the treatment of Malignant Hyperthermia, The staff stated, to their knowledge there was no chilled saline stored on the L&D Unit.

a. A follow up interview was conducted with the Nurse Manager of L&D on 11/16/10 at 0840 hours. The Nurse Manager stated chilled saline was available along with a cart containing medications for the treatment of Malignant Hyperthermia in the Anesthesia Work Room, located adjacent to the L&D OR suites. When asked, the Nurse Manager stated she became aware of the saline's location following our interview the previous day. The Nurse Manger stated there had been no training for the staff regarding Malignant Hyperthermia.

b. During an interview with RN F on 11/16/10 at 0855 hours, the RN stated she had worked in the L&D unit at the hospital for eight years. The RN stated she had not received education regarding Malignant Hyperthermia as a side effect of certain anesthetic agents. The RN stated she had only learned today of the location of the chilled saline and the Malignant Hyperthermia cart.

Based on interview and medical record and document review, the hospital failed to administer continuous IV insulin infusions as ordered by the physician for two of two sampled patients (Patients 104 and 105). This resulted in the patients receiving an incorrect insulin dose.

Findings:

The medical records for Patient 104 and Patient 105 were reviewed with PH 1 on 11/16/10 at 1430 hours. The preprinted form "Adult Insulin (Regular) Continuous Infusion for Hyperglycemia in Critical Patients" was completed by the prescribing physicians for both patients. The following order to start a continuous infusion of insulin (hormone to control blood sugar level) was dated 11/10/10:

Initiate IV (intravenous) regular insulin continuous infusion:
If blood glucose results (mg/dl), then give:
121-150, one unit per hour
151-200, two units per hour
201-250, three units per hour
251-300, four units per hour
Greater than 300, five units per hour.

Perform fingerstick (or blood glucose) test every two hours.

Adjust IV regular insulin continuous infusion according to the following:

If blood glucose result is between 90-120, check fingerstick (or blood glucose) every one hour times two. If fingerstick (or blood glucose) is 90-120 mg/dl, decrease regular insulin continuous infusion at half of the current rate.
If blood glucose decreases by 100 mg/dl or more in one hour from the immediate prior result and the blood glucose is less than 120 mg/dl, discontinue IV regular insulin continuous infusion and notify physician.

If blood glucose result is between 121-200, increase IV regular insulin continuous infusion by 0.5 unit per hour. If blood glucose decreases by 100 mg/dl or more in one hour from the immediate prior result and the blood glucose is greater than 120 mg/dl, decrease regular insulin continuous infusion at half of the current rate.

If blood glucose result is between 201-250, increase IV regular insulin continuous infusion by one unit per hour. If blood glucose decreases by 100 mg/dl or more in one hour from the immediate prior result and the blood glucose is greater than 120 mg/dl, decrease regular insulin continuous infusion at half of the current rate.

If blood glucose result is greater than 250, if blood glucose is not trending down from the immediate prior result, increase IV regular insulin continuous infusion by two units per hour.

a. For Patient 104, the following discrepancies were identified from medical record review:

On 11/10/10 at 1600 hours, the blood glucose result was 249 mg/dl. The insulin infusion rate remained unchanged at nine units per hour; per the physician's order, the insulin infusion rate should have been decreased by one half;

On 11/11/10 at 0400 hours, the blood glucose result was 97 mg/dl. The next blood glucose was measured two hours later instead of the one hour according to the physician's order;

On 11/11/10 at 1800 hours, the blood glucose result was 130 mg/dl. The insulin infusion rate remained unchanged at 3.5 units per hour; per the physician's order, the insulin infusion rate should have been increased by 0.5 units per hour;

On 11/12/10 at 0028 hours, the blood glucose result was 126 mg/dl. The insulin infusion rate remained unchanged at two units per hour. per the physician's order, the insulin infusion rate should have been increased by one unit per hour;

b. For Patient 105, the following discrepancies were identified from medical record review:

On 11/10/10 at 1800 hours, the blood glucose result was 297 mg/dl. The insulin infusion rate was increased by only one unit instead of two units per hour;

On 11/11/10 at 0000 hours, the blood glucose result was 207 mg/dl. The insulin infusion rate was increased by only 0.5 units instead of one unit per hour;

On 11/11/10 at 0800 hours, the blood glucose result was 233 mg/dl. The insulin infusion rate was increased by only 0.5 units instead of one unit per hour;

On 11/13/10 at 0800 hours, the blood glucose result was 196 mg/dl. The insulin infusion rate increased by one unit instead of 0.5 units per hour;

On 11/13/10 at 1400 hours, the blood glucose result was 141 mg/dl. The insulin infusion rate remained unchanged at 21.5 units per hour; per the physician's order, the insulin infusion rate should have been increased by 0.5 units.

On 11/13/10 at 2000 hours, the blood glucose result was 221 mg/dl. The insulin infusion rate was increased by only 0.5 units instead of one unit per hour.

When asked, PH 1 acknowledged the insulin infusion rate adjustment was not made according to the physician's preprinted insulin infusion order. PH 1 stated the rate adjustment instruction was very confusing. For example, PH 1 stated he was not able to clearly understand the instruction, when the blood glucose result was between 90-120, "If blood glucose decreases by 100 mg/dl or more in one hour from the immediate prior result and the blood glucose is less than 120 mg/dl, discontinue IV regular insulin continuous infusion and notify physician." PH 1 stated the parameters were very confusing and needed to be addressed.

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

* The general consent form was completed correctly for three of the six patients (Patients 20, 23, and 97) reviewed on the medical-surgical units.

* Two of four sampled surgical patients (Patients 44 and 47) were provided with accurate information and were informed of the name of the surgeon who would be performing their surgical procedure.

* One of four surgical patients reviewed (Patient 45) had documentation the vital signs, laboratory results or x-rays were reviewed prior to surgery. This could potentially result in an unstable patient having surgery.

Findings:

1. On 11/15/10, a review of the hospital's general consent form showed the form included permission to have the hospital's medical personnel perform exams and treatment, take clinical photographs, allow for observation of the patient during treatment and procedures by medical staff and students, release to the public basic patient information, financially obligate the patient for costs, and allow for the release of information to payers sources, such as Medicare or insurance companies. The form also informed patients the hospital had a safe. Patients were notified the hospital was therefore not responsible for items not placed in the safe.

a. On 11/15/10 at 1430 hours, Patient 96 was interviewed. The patient spoke clear unaccented English. After the interview, the patient's medical record was reviewed. The general consent found in the medical record was in Spanish. Patient 96 was re-interviewed and was asked if he read Spanish and the patient stated, no.

b. On 11/15/10 at 1445 hours, Patient 20 was interviewed. Review of the patient's medical record showed the general consent form was not signed.

c. On 11/15/10 at 1535 hours, Patient 23's medical record was reviewed. The consent form was witnessed, timed and dated but there was no patient signature found on the consent.

The Clinical Nursing Director and the Assistant Nursing Director, who were present during the reviews, confirmed the three consent forms were incorrect.


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2. Review of the medical record showed Patient 45 was admitted to the hospital on 11/16/10. There was no documentation to show vital signs had been completed and pertinent laboratory or x-rays reports had been reviewed. There was no documentation to show an attending physician had reviewed the "focused history and physical examination" prior to the surgical procedure.

Based on interviews and medical record review, the hospital failed to ensure two of four sampled surgical patients (Patients 44 and 47) had been provided with accurate information and had been informed of the name of the surgeon who would be performing the surgical procedure. This could lead to inaccurate information regarding the medical care for the patient.

Findings:

1. Patient 44 was interviewed at 0905 hours on 11/16/10, in the pre-operative area. Patient 44 stated she signed a consent form in the physician's office for MD D to perform the procedure. The surgical procedure for Patient 44 was observed at 1100 hours. The physician performing the surgery was not the physician listed on the informed consent. The physician performing the surgery was identified as the "surgeon of the day 2."

When interviewed on 11/18/10 at 1110 hours, the Medical Director of the Operating Room stated documented informed consent was required in order to indicate the correct physician performing the procedure.

2. Patient 47 was interviewed at approximately 0930 hours on 11/16/10. When interviewed, Patient 47 was unaware of the name of the surgeon who would be performing her surgical procedure. The patient stated she had signed forms for the consent, but was not informed of the name of the operating surgeon.

Based on interview and medical record review, the hospital failed to ensure weights were accurately recorded in the medical record for two of the two patients (Patients 74 and 75) reviewed for weights. This had the potential to jeopardize the patients' medical care. In addition, a speech therapy evaluation was not completed as ordered for one patient (Patient 76). There was no documentation to show the order was discontinued. This resulted in the potential for the patient not to receive an appropriate diet consistency which increased his risk for choking on food or liquids and contributed to the patient eating a decreased amount.

Findings:

1. Patient 74 was admitted 11/13/10. The MAR dated 11/14/10, showed the patient's height as 5 feet 7 inches and weight as 120 pounds. The Interdisciplinary Assessment and Discharge Planning form dated 11/13/10, showed the height as 5 foot 7 inches. The patient's weight was documented as 145 pounds, lined through, and rewritten as 125 pounds above. The Nursing Care and Treatment Flow Sheet initiated 11/14/10, showed the weight as 113 pounds. RN AA stated the weight of 113 pounds was obtained on 11/16/10, when weekly weights were taken.

RN CC and RN F were interviewed on 11/17/10 at 1015 hours. RN CC stated nursing staff was expected to report weight differences and the weight would be rechecked if there was a weight difference. In addition, RN CC and RN F stated the admission weight could have been "stated" by the patient. Both RNs stated the weights on the care plans and treatment flow sheets should be patient weights taken on the unit scale.

RN CC reviewed the medical record on 11/17/10 at 1030 hours. The RN was not able to locate documentation the admission weight was verified or the 11/16/10, weight of 113 pounds had been rechecked. In addition, RN CC was unable to locate documentation of the weight loss or the notification of the physician.

Review of the Patient Assessment/ Reassessment Nursing Services Policy on 11/17/10 at 1445, hours showed "the assessment process includes a collection of objective and subjective data that focuses on patient's physical, psychosocial, spiritual, and developmental needs."

2. Patient 75 was admitted 11/9/10. Medical record review on 11/17/10 at 1400 hours, showed the Admitting Orders dated 11/8/10, documented the patient's weight as 160 pounds and height as 5 foot 2 inches. Review of the Nursing Care and Treatment Flowsheet initiated on 11/9/10, showed a weight of 140 pounds and height of 4 foot 10 inches. Review of the Nursing Care and Treatment Flow Sheet, Psychiatric Hospital, form initiated on 11/14/10, showed a weight of 144 pounds. The Interdisciplinary Assessment and Discharge Planning Psychiatry form showed the weight and height sections were not filled in.

RD F acknowledged that the correct weight and height were essential to assess the nutrition status and the weight loss for Patient 75.

3. Medical record review for Patient 76 was initiated on 11/17/10. Patient 76 was admitted to the hospital on 10/25/10. Review of the physician's orders dated 10/26/10, showed a diet order for dysphagia (softer texture diet for patients with a problem swallowing) and a consult for a speech evaluation. Review of the clinical record did not show documentation a speech evaluation had been completed.

An interview was conducted with RD C on 11/17/10 at 1610 hours. RD C stated there were only two speech therapists at the hospital.

During an interview with RN HH at approximately 1615 hours, the RN was asked how speech therapy consults were ordered. RN HH stated the order was entered in the electronic system and the information was passed on to the next shift. RN HH stated the speech therapists usually came in to see the patient the next day. The speech therapists documented in the electronic record and talked to nursing about the evaluation.

An interview was conducted with ST A on 11/18/10 at 1410 hours. ST A stated their practice was to see inpatient consults within 24 hours. The ST stated if they received more than 10 per day then they may have to push one back. If a patient consult was delayed, the ST stated this was documented in the chart and the consult would be completed as soon as possible. ST A stated the inpatient consults were their first priority. ST A stated they had never received a request for a consult for Patient 76 until last night. ST A stated the order was written in October but she thought the consult was later discontinued, but this was never written in the orders.

Based on observation, interview, and medical record review, the hospital failed to provide adequate levels of pharmaceutical services that assured the safety of medication usage, the appropriate storage of medications, the minimization of drug errors and the ability to adequately account for prescription drugs utilized within the hospital as evidenced by failure to:

* Ensure pharmacists reviewed all new non-emergent medication orders for appropriateness before administration to patients. Cross Reference A 500.

* Ensure the rapid and proper treatment of Malignant Hyperthermia, a potentially fatal medical emergency. Cross Reference A 500.

* Ensure the safe use of fentanyl patches, a potent opoid narcotic analgesic. Cross Reference A 500.

* Ensure preprinted orders for medications were clear and complete for the nursing staff. Cross Reference A 404.

* Ensure complete listings of medications on the portable emergency carts and containers; and ensure the presence of necessary medications in the carts. Cross Reference A 500.

* Account for all controlled substance (e.g., narcotic analgesics, sedatives) usage in the operating room areas. Cross Reference A 494.

* Follow-up on all discrepancies from AMDs (automated medication dispensing) cabinets located throughout the hospital. Cross Reference A 493.

* Follow-up on non-reviewed medication orders to ensure the medications were appropriate for the patient and had been ordered by the physician. Cross Reference A 493.

* Check AMD cabinets during nursing unit inspections in order to remove expired and deteriorated medications. Cross Reference A 493.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality pharmaceutical services in a safe environment.

Based on observation, staff interview, medical record review and review of hospital documents, the hospital failed to provide sufficient pharmacist staff in order to:

* Follow-up on all discrepancies from AMD cabinets to determine the reasons for the discrepancies which potentially included medication errors;

* Ensure new medication orders from nonprofiled AMD cabinets were reviewed by pharmacists. (Non profiled AMDs do not require a physician's order and a review of that order by a pharmacist prior to dispensing).

* Check AMD cabinets during ward inspections to ensure proper placement of medications and to remove expired and deteriorated medications;

* Ensure accountability of controlled substances (narcotic analgesics, sedatives) in the OR areas.

* Follow-up on overrides from the AMD cabinets (medications dispensed prior to a review by a pharmacist) to determine whether a prescriber's orders for these medications existed and whether the medications were appropriate for the patients.

* Follow-up on returned doses of medications to ensure they were not doses that were overlooked by the nursing staff.

These failures placed patients at increased risk for potential adverse effects attributable to inappropriate medication therapy, medication errors.

Findings:

1. PH 1 was interviewed on 11/15/10 at 1130 hours. PH 1 stated the hospital utilized automated drug dispensing cabinets for dispensing medications. The AMD cabinets contained computers which were connected electronically to the pharmacy computer system. New medication orders were electronically sent to the pharmacy where a pharmacist reviewed them. The AMD cabinets were "profiled" when a pharmacist was required to review the new medication orders before authorizing the nurse, via the computer, to remove the ordered dose to be administered to a patient. Pharmacists reviewed new medication orders for safety considerations such as order completeness, toxicities, errors, allergies, and appropriateness. PH 1 stated AMD cabinets in Labor and Delivery, Post Anesthesia Recovery, Operating Rooms, the Emergency Department, Radiology, and procedural areas such as Cardiac Catheterization were not profiled. A pharmacist was not required to review new medication orders when a AMD cabinet was not profiled.

At 1145 hours on 11/15/10, PH 1 discussed "discrepancies" associated with AMD cabinets. Discrepancies occurred when the count or number of a particular medication in a drawer in the AMD cabinet was incorrect. This could have occurred, for example, when a nurse removed too many doses, too few doses, or the wrong medication, or when there was drug diversion. It also could have occurred if the person who was re-stocking the AMD cabinet entered an incorrect number of doses in the computer. Removal of too many doses, too few doses, and the wrong medication could have been detrimental to patients' health if they received these incorrect numbers of doses or the wrong medication.

PH 1 stated the hospital pharmacy department did not follow-up on all of the drug discrepancies from the AMD cabinets due to a lack of pharmacy staff. PH 1 stated pharmacy personnel only followed-up on controlled substances (for example, morphine, sedatives) discrepancies. Follow-up included a determination of why the discrepancy occurred. The reason for the discrepancy included a determination of whether a medication error had occurred. PH 1 stated the hospital did not produce discrepancy reports for non-controlled drugs.

2. PH 1 was interviewed at 1145 hours on 11/15/10. PH 1 stated pharmacists did not check AMD cabinets when they conducted their ward inspections. She stated the pharmacy department did not have enough staff pharmacists to conduct this task. PH 1 stated pharmacists did not check the placement of medications in "matrix" drawers in the AMD cabinets. Matrix drawers contained many different medications and doses and allowed nurses to inadvertently remove the wrong medication after opening the drawer.

3. PH 1 was interviewed on 11/16/10 at 0900 hours. PH 1 was asked whether pharmacy checked to ensure all of the controlled substances used in the operating rooms were accounted for, either through administration to patients and/or waste. PH 1 stated pharmacy personnel checked to ensure that all of the controlled substances were reconciled for about 25 cases (surgeries) per day. PH 1 stated there were more than 25 cases per day but there was insufficient pharmacy staff to reconcile all controlled substances for every case.

4. PH 1 was interviewed on 11/15/10 at 1130 hours. PH 1 stated the hospital's AMD cabinets dispensed about 6000 doses of medication a day and about two percent of those medications were dispensed by the computer's "override" function. Overrides occurred when a dose of medication for a new physician order was removed by a nurse from a profiled AMD cabinet before a pharmacist had reviewed the order. Examination of the hospital's "AMD Medications Override" report for October, 2010, showed there were 1,294 override doses that month, or 2.1 % of the 61,657 total doses dispensed. Override drug examples included: morphine (a narcotic for pain); furosemide (to increase urine flow); ondansetron (for nausea and vomiting); lorazepam (a sedative); meglumine-sodium diatrizoate (diagnostic agent), propofol (a sedative); ziprasidone (antipsychotic); docusate (for constipation); acetaminophen (Tylenol, for fever and pain); and levofloxacin (antibiotic).

During a follow up interview with PH 1 on 11/16/10, PH 1 stated the pharmacy department did not receive override reports from the non-profiled AMD areas. On 11/17/10 at 1015 hours, PH 1 stated the hospital did not follow-up on all of the overrides to determine whether prescribers' orders existed for the medications.

5. The DOP and PH 1 were interviewed on 11/15/10 at 1155 hours. Both staff stated drugs returned to the pharmacy from the nursing units were not reviewed by a pharmacist in order to ensure the returned dose had not been overlooked during the administration of drugs to the patient. It was stated that a shortage of staff kept this process to identify potential medication errors from occurring.

6. On 11/16/10, a review of the hospital's personnel vacancy report indicated that 20 Pharmacist positions and 14 Pharmacy Technician positions were not filled. On interview the DOP indicated these positions had been frozen due to budgetary considerations.

Based on staff interview, the hospital failed to reconcile the use of all controlled substances (for example, narcotic analgesics, sedatives) in the operating room areas. This resulted in the hospital being unable to determine whether drug diversion or medication errors had occurred with these medications.

Findings:

During an interview on 11/16/10 at 0900 hours, PH 1 was asked whether pharmacy personnel accounted for the use of all of the controlled substances used in the operating rooms, either through administration to patients and/or waste. PH 1 stated pharmacy personnel checked to ensure that all of the controlled substances were reconciled for about 25 cases (surgeries) per day. PH 1 indicated there were more than 25 cases per day. The PH stated there was insufficient pharmacy staff to reconcile all controlled substances for every case.

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Based on observation, interviews, and medical record review the hospital failed to:

* Ensure pharmacists reviewed all new medication orders before administration to patients;

* Ensure complete listings of medications on portable emergency carts and containers and the presence of necessary medications within them, which prevents healthcare workers from quickly knowing what is in the cart during an emergent event;

* Ensure the rapid and proper treatment of Malignant Hyperthermia, a potentially fatal medical emergency;

* Ensure the safe use of the fentanyl transdermal system (patch), a potent opioid narcotic analgesic;

* Ensure pre-printed orders for medications were clear and complete for nursing staff;

* Ensure final sealing of the crash cart trays were performed by the pharmacist;

* Ensure doses of drugs returned to the pharmacy from the nursing units were reviewed by a pharmacist in order to ensure the returned dose was not overlooked during medication administration. Missed doses of drugs could keep the patient from receiving appropriate levels of therapy which could lead to a longer hospital stay.

These failures placed patients at increased risk for potential adverse effects attributable to: overrides and discrepancies associated with AMD drug dispensing cabinets which potentially placed patients at risk for adverse effects from medication errors; inadequate treatment during medical emergencies; and potential overdoses of opioid analgesics.

Findings:

1. PH 1 was interviewed on 11/15/10 at 1130 hours. PH 1 stated the hospital utilized ADM (automated drug dispensing) cabinets for dispensing medications. AMD cabinets contained computers which were connected electronically to the pharmacy computer system. New medication orders were electronically sent to the pharmacy where a pharmacist reviewed them. The AMD cabinets were "profiled" when a pharmacist was required to review the new medication orders before authorizing a nurse, via the computer, to remove the ordered dose to be administered to a patient. Pharmacists reviewed new medication orders for safety considerations such as order completeness, toxicities, errors, allergies, and appropriateness. PH 1 stated AMD cabinets in Labor and Delivery, Post Anesthesia Recovery, Operating Rooms, the Emergency Department, Radiology, and procedural areas such as Cardiac Catheterization were not profiled. A pharmacist was not required to review new medication orders when an AMD cabinet was not profiled. In these cases nurses removed doses of medications without a pharmacist's review of the new order. PH 1 stated the hospital AMD cabinets dispensed about 6000 doses a day and about two percent were by the computer's "override" function (medications dispensed prior to a review by a pharmacist). Overrides occur when a dose of medication from a new order is removed by a nurse from a profiled AMD cabinet before a pharmacist reviewed the order.

Examination of the hospital's "AMD Medications Override" report for October, 2010 showed there were 1,294 overrides that month or 2.1 % of the 61,657 total doses dispensed. Override drug examples for October, 2010, included: morphine (a narcotic for pain); furosemide (to increase urine flow); ondansetron (for nausea and vomiting); lorazepam (a sedative); meglumine-sodium diatrizoate (diagnostic agent); propofol (sedative); ziprasidone (antipsychotic); docusate (for constipation); acetaminophen (Tylenol, for fever and pain); and levofloxacin (antibiotic).

During an interview on 11/17/10 at 1015 hours, PH 1 stated the hospital did not follow-up on all of the overrides to determine whether physicians' orders existed for the medications.

During an interview on 11/15/10 at 1145 hours, PH 1 discussed "discrepancies" associated with AMD cabinets. Discrepancies occurred when the count, or the number of a particular medication in a drawer in the AMD cabinet was incorrect. This could have occurred, for example, if a nurse removed too many doses, too few doses, or the wrong medication, or when there was drug diversion. It also could have occurred if the person who was re-stocking the AMD cabinet entered an incorrect number of doses in the computer. PH 1 stated the pharmacy department did not follow-up on all of the drug discrepancies from the AMD cabinets due to lack of pharmacy staff. PH 1 stated pharmacy personnel only followed-up on controlled substances (for example, morphine, sedatives) discrepancies. She said the hospital did not produce discrepancy reports for non-controlled drugs. Follow-up included a determination of why the discrepancy occurred. Among reasons for the discrepancy was a determination of whether a medication error had occurred.

2. On 11/15/10 at 1400 hours, a portable emergency cart in the Pediatric Emergency Department (number 28440) was examined with PH 1. The list of medications on the outside cover did not include the following medications which were found in the cart:

One normal saline (salt) solution, 250 ml (milliliter)
One normal saline irrigation solution, 500 ml
One normal saline irrigation solution, 1000 ml
One 5% dextrose (sugar) solution, 1000 ml
Six normal saline syringes, 10 ml
One Dopamine (raises blood pressure) container 400 mg (milligrams)/250 ml.

PH 1 stated the hospital had over 100 portable emergency carts and all were stocked identically. PH 1 stated pharmacists did not place the seals on all of the medications in the carts.

The California Code of Regulations, Title 22, 70263 (f)(2) reads, "The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within."

3. a. On 11/15/10 at 1518 hours, the Malignant Hyperthermia emergency cart was delivered to the Emergency Department from the Operating Room area. Malignant Hyperthermia is a rare medical emergency attributable to the use of Succinylcholine (muscle blocking agent) and inhalation anesthetics (such as Halothane). It is important to have medications immediately available for treatment. PH 1 said a pharmacy technician checked the contents of the cart daily but a pharmacist only checked the contents once a month. The cart was observed to have a combination lock. PH 1 stated anesthesiologists and pharmacy personnel had the combination. There was no seal attached by a pharmacist to be broken in order to access the contents of the medications on the cart.

b. On 11/16/10 at 0845 hours, the Malignant Hyperthermia emergency cart in the Labor and Delivery area was inspected with Staff 5. The cart, located in the locked anesthesia work room, was not locked. There was no seal attached by a pharmacist to be broken in order to access the contents of the medications on the cart.

MD F provided the Malignant Hyperthermia policy (" Malignant Hyperthermia Protocol ") on 11/17/10 at 1035 hours. It did not contain a complete list of the medications in the Malignant Hyperthermia emergency cart and MD F said the policy had not been approved by the hospital's Pharmacy and Therapeutics Committee.

4. Review of the P&P Emergency Medications, number 230, showed for areas that were not on the Emergency Crash Cart Exchange Program (Network Policy 920), new crash cart locks will be issued as follows: Each area will initially receive 10 locks and a log sheet. Unit staff other than pharmacists were permitted to seal and lock some of the emergency carts in the hospital.

a. On 11/16/10 at 1545 hours, emergency drug containers ["Emergency Box" (" Angio Only" )"] were observed in Interventional Radiology and at 1605 hours, in Computerized Tomography. Medications in the boxes included albuterol (to improve breathing), epinephrine (for allergic reactions), and diphenhydramine (antihistamine). RN LL stated the medications were obtained from the pharmacy and nursing placed the lock or seal on the containers themselves.

During an interview with PH 1 on 11/17/10 at 1000 hours, the PH stated the emergency drug boxes and their contents had not been approved by the hospital's Pharmacy and Therapeutics Committee.

b. During an interview with PH 1 on 11/18/10 at 0905 hours, PH 1 stated pharmacists did not seal (with a breakaway lock) the emergency cart in the AIDS (autoimmune deficiency syndrome) clinic after replacing the medications. PH 1 stated pharmacy personnel gave a new box (drug supply) and a seal for it to a nurse from the clinic.

5. RN JJ and MD I were interviewed along with PH 1 in a medication room in the Emergency Department on 11/15/10 at 1445 hours. Observation of the refrigerator in the medication room showed more than 10 containers of Succinylcholine, a muscle relaxing paralyzing agent which can cause Malignant Hyperthermia. Malignant Hyperthermia is a rarely occurring medical emergency requiring early recognition and treatment. RN JJ and MD I were asked how to treat a case of Malignant Hyperthermia. RN JJ said she did not know. MD I said she would have to "look it up" and subsequently said she would call anesthesia.

On 11/15/10 at 1455 hours, PH 1, RN JJ, and MD I were asked to obtain the Malignant Hyperthermia emergency cart which should contain all of the drugs, including dantrolene, a muscle relaxant, recommended by the Malignant Hyperthermia Association of the United States (MHAUS). MHAUS has published the standards of practice for treating Malignant Hyperthermia ("Drugs, Equipment, and Dantrolene - Managing MH," 1/27/10). The cart arrived at the door of the medication room in the Emergency Department at 1518 hours, 23 minutes after it was requested. MHAUS has recommended "The full 36 vials of dantrolene should be available within five minutes of the diagnosis of MH." ().

On 11/17/10 at 1035 hours, MD F provided the hospital's current P&P for treating Malignant Hyperthermia, "Malignant Hyperthermia Protocol." MD F also provided a revised version, " Malignant Hyperthermia Management in Anesthesia Cases." MD F said both P&Ps had not been approved by the hospital's Pharmacy and Therapeutics Committee. The current policy read, "The following precautions should be taken in order to detect MH (Malignant Hyperthermia) in its early stages, when it is usually amenable to treatment without sequelae." The policy was "..intended as a guide for anesthesia practitioners and other health care professionals to be prepared to recognize, treat and prevent Malignant Hyperthermia." The policy, developed by anesthesiology, showed "All operating room and PACU personnel should be trained in the recognition and treatment of MH." The policy also documented, "MH is life threatening in susceptible individuals. The MH syndrome describes a rapidly occurring chain of events.." and "There is an approximate 50% mortality rate."

6. The manufacturers of fentanyl patches are required to include an FDA (US Food and Drug Administration) approved boxed warning with each package. The boxed warning refers to the requirement that patients be opioid (narcotic analgesic) tolerant before applying a patch. This warning reads, "Fentanyl transdermal system should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg [micrograms]/hour. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer: at least 60 mg [milligrams] of morphine daily; or at least 30 mg of oral oxycodone daily; or at least 8 mg of oral hydromorphone daily; or an equianalgesic dose of another opioid." Oxycodone, morphine, and hydromorphone are all narcotic type analgesic pain relievers. The boxed warning pointed out that "Because serious or life-threatening hypoventilation could occur, fentanyl transdermal system is contraindicated in patients who are not opioid tolerant." (Hypoventilation is a decrease in respirations).

On 11/16/10 at 1445 hours, PH 2, PH 3, PH 4, and the DOP were interviewed. The question asked regarded the use of a fentanyl (a narcotic analgesic) transdermal system (patches) which were applied to the skin for pain relief. PH 2 stated pharmacists usually do not talk to patients to determine whether they are opioid tolerant. PH 2 stated they usually checked only with the nurse. When PH 3 was asked about the process for reviewing orders for the appropriateness of fentanyl patches, PH 3 did not mention that he checked for opioid tolerance. PH 3 stated he checked to ensure the fentanyl patch order was signed. When asked, PH 4 was unable to relate the specifications for being opioid tolerant.

The medical records for nine patients who had received fentanyl patches over the previous 90 days were reviewed with PH 1 on 11/16/10 and 11/17/10. Patients 99 and 100 were found not opioid tolerant. The patients did not receive sufficient doses of opioids for a week or longer to become opioid tolerant.

On 11/17/10 at 1545 hours, the physicians caring for Patients 99 and 100, MD G and MD H, were interviewed. Both physicians agreed their patients did not meet the FDA approved requirements listed in the boxed warning to be opioid tolerant.

7. On 11/16/10 at 1400 hours, 12 different preprinted orders which contained medications were reviewed with PH 1 and the DOP. Seven of the 12 orders sheets were found to contain unclear or incomplete directions for nursing staff. Examples included: the names of medications did not list both generic and brand names (Interventional Radiology Thrombolytic Infusion Therapy Order Set); the nurse was to determine if a patient had a history of heparin (anticoagulant) induced decrease in platelets or an allergy to dalteparin or heparin (anticoagulants)(MICU Daily Order Set); the nurse was to determine whether a patient had a hypersensitivity (Adult Chemotherapy Physician's Orders); an order to infuse one liter of solution after chemotherapy "as tolerated" without defining "as tolerated" (Adult Chemotherapy Intravenous Hydration); and morphine sulfate to be given prn (as needed) for a procedure/dressing change and haloperidol (antipsychotic) prn for agitation, without defining agitation or specifically when the morphine was needed (Burn Center Adult Pain/Agitation Orders).

8. During an interview with the DOP and PH 1 on 11/15/10 at 1155 hours, they stated doses of drugs returned to the pharmacy from the nursing units were not reviewed by a pharmacist in order to ensure the returned dose had not been overlooked during the administration of drugs to the patient. The DOP stated a shortage of pharmacy staff kept this process from happening.


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9. According to the California Code of Regulations, Title 22, Section 70263(f)(2), "The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs ..."

During an inspection of the drug storage in the Pediatric ICU with RN LL on 11/17/10 at 1130 hours, three sets of emergency medication trays were observed stored in the overhead cupboard where an emergency crash cart was located. The trays were sealed in plastic wrap. RN LL stated the trays were prepared at Ward Services.

During an interview on 11/17/10 at 1500 hours, RPH 6A stated emergency medication trays were prepared for emergency crash carts at Ward Services. RPH 6A stated a pharmacy technician picked the medications to be included in the tray and a pharmacist then checked to ensure the correct medications and the correct amount were in the trays. RPH 6A stated the trays were taken by a pharmacy technician from the second floor where the trays were prepared, to the fifth floor, where sealing of the tray took place. RPH 6A stated, no pharmacist was present on the fifth floor while the sealing of the tray took place. RPH 6A stated the final sealing was not done by the pharmacist but rather by a pharmacy technician.

10. According to California Code of Regulations, Title 22, Section 70263(f)(2), "..The contents of the (emergency drug supply) container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within."

During an inspection of the medication room in the Pediatrics Unit on the eighth floor with RN MM on 11/17/10 at 1200 hours, an Extravasation (refers to the leakage of infused substances from the vein into the surrounding tissue) Kit containing medications needed to manage extravasations was observed. The following medications were observed contained in the kit:

One injectable vial of hydrocortisone 100 mg/ 2 ml;
One injectable vial of sodium bicarbonate 50 milliequivalent/ 50 ml;
Two injectable vials of sodium thiosulfate 10 percent 10 ml.

Further inspection revealed the content list and the extravasation management guidelines were located inside the kit. It was not possible to know the contents unless the kit was opened.

During an interview on 11/17/10 at 1500 hours, RPH 6A confirmed the content list for the Extravasation kit was not readily visible.

11. According to the nationally recognized pharmacy organization, American Society of Health-Systems Pharmacists (ASHP) publication entitled, ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals:

"Optimizing Medication Therapy, An important aspect of pharmaceutical care is optimizing medication use. This must include processes designed to ensure safe and effective use of medications and increase the probability of desired patient outcomes. The pharmacist, in concert (along) with the medical and nursing staff, must develop policies and procedures for ensuring the quality of medication therapy ...

Medication orders. All prescribers medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed. Any questions regarding the order must be resolved with the prescriber at this time, and a written notation of these discussions must be made in the patient's medical record or pharmacy copy of the prescriber's order. Information concerning changes must be communicated to the appropriate health professional."

During an inspection of the Pharmacy Department on 11/15/10 at 1130 hours, AMD technology was observed to be utilized by the pharmacy staff for processing and profiling the physician's orders in the pharmacy system. AMD technology allowed the pharmacy staff to view scanned images of physician orders for processing in the order of receipt. Priorities could be assigned based on the urgency of the orders.

Upon further inspection of the order line up in the AMD technology, on the top of the priority screen were observed several orders that were assigned on hold. The top four orders were selected for review with RPH 6B:

a. A physician's order for calcitriol (Vitamin D supplement) 0.25 mg by mouth daily, written on 11/10/10 for Patient 101.

b. A physician's order for Robitussin (cough syrup) 10 mg every 4 hours as needed, written on 11/11/10 for Patient 6.

c. A physician's order for phytonadione 1 mg by mouth daily, written on 11/10/10 for Patient 103.

d. A physician's order for Ranexa 500 mg by mouth twice a day, written on 11/12/10 for Patient 103.

RPH 6B stated the above physician orders were on line up in the AMD technology because the orders were incomplete. The RPH stated the orders required further clarification to be processed for dispensing to the patients. RPH 6B looked at each scanned order and explained that: calcitriol did not come in the strength of 0.25 mg; Robitussin could not be dispensed because it did not come in 10 mg strength; phytonadione's lowest strength available was 5 mg and it was a non-formulary drug (a drug not approved by the Pharmacy and Therapeutics Committee for use by the patients in the hospital); and Ranexa 500 mg was a non-formulary drug and the pharmacy did not carry it. RPH 6B was asked to state the follow up done by the pharmacy regarding these physicians' orders as they had been ordered three to five days prior. RPH 6B, after reviewing the scanned orders, was unable to state if nursing or the prescribing physicians were contacted by the pharmacy department.

The Assistant Director of Pharmacy (ADOP) was interviewed on 11/16/10 at 1200 hours. The ADOP confirmed that the above medications for the four patients were not dispensed due to the need for further clarification. The ADOP confirmed there was no documentation of nursing or physician contact for clarification The ADOP confirmed a patient might suffer as a result of the delay in getting the necessary medications. The ADOP, when following up on the non-formulary drugs for the above patients stated one patient had been discharged. The other patient used his/her own supply of Ranexa 500 mg. In addition, when asked, the ADOP was unable to confirm the non-formulary Medication Request forms had been completed for approval of the medications phytonadione and Ranexa to be used in the hospital for these patients.

Based on staff interview, observations, and review of hospital documents, the hospital failed to ensure unusable medications and biologicals were not available for patient use when expired medications were found stored in the main pharmacy and on one nursing unit. In addition, intravenous solutions and irrigation solutions were observed stored in warmers outside the temperature range and for the length of time recommended by the manufacturer, in the OR and on the L&D unit. This resulted in the potential for patients to receive potentially deteriorated medications and intravenous and irrigation solutions which could have had a detrimental effect on the patients' health.

Findings:

1. On 11/16/10 at 1020 hours, the ORs Core Area B was visited with RN KK. The warmer in the area was observed to contain three -1000 ml bags of lactated ringers IV solution (an electrolyte solution). The front of the warmers provided a gauge reading of the temperatures within. The warmer with the IV solutions registered a temperature of 129 degrees F. One bag was not labeled with the date it was placed in the warmer. The other two bags were dated with a felt pen. RN KK said she could not guarantee the temperature range and said that was why she limited the time in the warmer to three days.

RN KK provided the hospital's P&P for the warming cabinets, "Equipment: Warming Cabinet for blankets." The P&P showed "Per the manufacturer of the solutions, solutions can be warmed to temperatures not exceeding 150 degrees and for a period no longer than 72 hours -or- Solutions can be warmed to temperatures not exceeding 104 degrees Fahrenheit and for a period no longer than 30 days. RN KK also provided a letter from Baxter dated 11/15/10, which read, "IV solutions of volumes 150 ml or greater can be warmed in their plastic overpouches to temperatures not exceeding 40 degrees Centigrade (104 degrees F) and for a period no longer than 14 days."


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2. During an inspection of the medication room in the Orthopedics Unit with RN C on 11/17/10 at 1100 hours, eight 85 gram tubes of wound gels were observed to have an expiration of 10/10. RN C confirmed the tubes were expired and should have been removed from the medication room.

3. During an inspection of the Narcotic Room of the Pharmacy Department with RPH 6C on 11/16/10 at 1330 hours, nine expired 30-ml syringes of morphine sulfate (narcotic pain medication) PCA (Patient Controlled Analgesia) were observed in a black file cabinet. The expired medications were mixed with boxes of controlled medications that were not expired. RPH 6C confirmed the expired controlled medications were mixed with non-expired medications.



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4. A tour of the two OR suites in the L&D Unit was conducted on 11/15/10 at 1145 hours, accompanied by the Clinical Director of Women's and Children's Services and the Nurse Manager of L&D. Liter bottles of sterile water were stored in a warming unit located in the room between the two OR suites. Two bottles of sterile water were observed labeled with the date 10/25. When asked how long sterile water bottles were kept in the warming unit, the Nurse Manager stated the bottles were stored for two weeks only. She further stated the two bottles should be discarded.

Based on closed medical record review and hospital document review, the hospital failed to provide radiological services within acceptable standards of practice when an accurate ultrasound report of the anatomical site of the testicular tumor of one patient (Patient 94) was not provided for consultation and guidance to the surgical staff. This resulted in a wrong site surgery and the need for Patient 94 to undergo extensive chemotherapy for metastatic testicular cancer. Cross Reference A 529.

The cumulative effect of this systemic problem resulted in the hospital's inability to ensure the provision of quality patient care in a safe environment.

Based on a review of the closed medical record for Patient 94 and the results of an internal investigation, the hospital failed to ensure the radiological service provided an accurate report of the anatomical site of the patient's testicular tumor in order to provide accurate consultation and guidance to the surgical staff, which resulted in a wrong site surgery and the need for the patient to undergo extensive chemotherapy for metastatic testicular cancer.

Findings:

Patient 94, came to the hospital on 3/15/10, with a five month history of "worsening scrotal swelling." Patient 94 was seen approximately five months earlier at another hospital and was told this was a hydrocele (a fluid filled collection in the scrotal sac).

Patient 94 was evaluated at the hospital on 3/15/10, and was found to have bilateral testicular swelling. An ultrasound examination performed on 3/15/10, showed evidence of a large hydrocele as well as a mass in the left testis. The formal ultrasound report, dated 3/16/10, indicated that the complex mass was in the "left" testis. The report showed: "The testis and epidiymis are normal on the right. There is no right-sided intrascrotal mass." The side of the tumor was, in fact, in the right testis.

Patient 94 was consented for a left radical orchiectomy.(a major surgical procedure in which the testicle is removed and the regional lymph nodes explored and removed surgically). According to the operative report: the right testicle appeared normal on the ultrasound. Patient 94 had a CT of his chest, abdomen and pelvis which showed multiple small left periaortic lymph nodes (a group of lymph nodes that lie in front of the lumbar vertebrae near the aorta which receive drainage from the lower gastrointestinal tract and the pelvic organs). Tumor markers showed an elevation of the LDH to 3700 (normal is less than 35 and an elevation to this level is suggestive of tumor disease spread), with a normal beta hCG and AFP. (The beta hCG and AFP are blood tests to determine if a tumor is present and secreting these chemicals into the blood stream of the patient). According to the CT scan report, "Several borderline sized left periaortic lymph nodes, indeterminate for metastasic disease" was reported.

Patient 94 was admitted to the hospital on 3/15/10, for the left sided surgical procedure. The pathology report revealed: "Intratubular germ cell neoplasia is not identified. Hydrocele sac is present. No evidence of malignancy is identified, left testis."

The discharge summary dated 3/17/10, for Patient 94 showed the patient tolerated the surgical procedure without difficulty and was scheduled for follow up in the "urology clinic in 1-2 weeks for a post-op check as well as a discussion of the results of his CT scan and pathology for further treatment options." The report also showed: "This discharge plan was discussed with the attending physician who agrees with the plan."

According to the internal investigation performed at the hospital Patient 94 "missed appointments on 5/12/10, and 5/28/10."

Patient 94 returned to the emergency department on 6/25/10, complaining of swelling of the left testicle and worsening pain. A 20 cm x 15 cm mass was noted. The right testis was "hard" to palpation. Patient 94 was scheduled for an ultrasound and blood work. A CT scan of the abdomen and pelvis were ordered and a follow up appointment given for the urology clinic.

Patient 94 was again evaluated in the urology clinic on 6/26/10 with a complaint of swelling and pain in the left scrotal sac and a large right testicle. An ultrasound examination of the scrotal area was performed that demonstrated evidence of " a diffusely enlarged right testicle with areas of abnormal internal ultrasound (this finding is very suggestive of cancer), and a large right lower quadrant abdominal mass adjacent to the bladder and right hydroureter (dilatation of the right urine collecting tube connecting the kidney to the bladder, indicating partial obstruction due to tumor compression). Patient 94 stated that he had lost 65 pounds in weight over the past 1-2 months. A CT scan was performed that revealed evidence of "a large abnormal mass replacing the right testis, right external iliac nodal mass and extensive retroperitoneal and pelvic lymph node disease (this represents lymph node extension of cancer spread in areas behind the abdomen). There was evidence of right-sided urinary tract obstruction secondary to tumor compression of the collecting system. Tumor markers were again found to be elevated when compared with values from the prior admission with LDH >5000 and bHCG elevated to 210 (this represents further growth and spread of cancer from the testis tumor).

Patient 94 returned to the operating room on 6/26/10, and a right radical orchiectomy was performed. A right ureteral stent (a tube device to promote urinary drainage) was inserted. The pathology report demonstrated evidence of a pure Seminoma (a malignant testicular tumor).

The medical record showed on 7/3/10, a discussion was conducted with Patient 94 and his family "regarding the surgical error" and medical problems since the wrong site surgical procedure. Patient 94 is now undergoing extensive chemotherapy for metastatic testicular cancer.

On 11/17/10, at approximately 0930 hours, the hospital presented a review of the hospital's internal investigation of the wrong site testicular tumor surgery. Actions had been put into place to improve physician trainee oversight by the attending physicians with increased surveillance for elevated tumor markers found in the lab work for tumor patients. In addition a monthly review was now being conducted of patients being evaluated for malignant disease, including special evaluation of patients who were being followed at the time of physician trainee rotations to other departments.

Based on observation, staff interview and document review the hospital failed to have a qualified full-time employee who served as the Director of Food and Dietetic Services to ensure safe food handling practices as evidenced by: lack of effective cleaning and sanitation of the cook chill tumbler; lack of documentation of dish machine temperatures; and lack of maintaining the cleanliness of two of two plastic transport carts and 5 cutting boards. These deficiencies in safe food handling practices were a potential source for food borne illness for patients.

Findings:

1. On 11/15/10, starting at 1100 hours, the following was observed in the kitchen:

a. Two white and three red cutting boards had yellow brown stains and visible cuts on the surface. The rough and stained cutting board surfaces were not cleanable and presented a potential for food borne illness from microorganisms in the cutting board crevices. During an interview on 11/15/10 at 1100 hours, RD A confirmed the cutting boards needed to be replaced.

b. The cook chill tank had visible food debris and mineral buildup approximately one inch wide on the interior surface. The cook chill tank was used to cook and chill products used for patient and staff food.

Review of the Job Cleaning Schedule on 11/16/10 at 1500 hours, showed the cook chill tank was descaled on 11/12. Review of the manufacturer's cleaning instructions on 11/16/10 at 0900 hours, showed the "best time to clean is shortly after each use."

2. On 11/15/10 at 1130 hours, the dish machine temperature log was reviewed. The log showed no documentation of wash, rinse and final rinse temperatures on the evening shift for 11/11, 11/12, 11/13, 11/14, and 11/15/10. There was no temperature documentation for noon on 11/14/10.

During an interview with RD A on 11/15/10 at 1130 hours, the RD stated the wash, rinse, and final rinse temperatures were to be recorded at the start of each meal.

3. On 11/15/10 at 1130 hours, there were two white plastic food transport carts observed in the kitchen. Both carts were black stained and deeply scratched. The surfaces appeared unclean and were being used to transport food.

Based on interview, review of medical records, and review of the hospital's P&Ps, the hospital failed to ensure clinical oversight for:

* Two of 105 sampled patients (Patient 74 and 75) did not receive accurate weights and heights;

*One of 105 sampled patients (Patient 40) did receive a physician ordered nutrition consult;

*One of 105 sampled patients (Patient 40) did not receive the correct diet according to the physician's order resulting in the patient receiving a strict diet that prohibited certain nutrients that were needed for healing.

*One of 105 sampled patients (Patient 76) received food from home without following hospital policy which had the potential for food bourne illness.

Findings:

1. Patient 74 was admitted 11/13/10. The MAR dated 11/14/10, showed the patient's height as 5 feet 7 inches and weight as 120 pounds. The Interdisciplinary Assessment and Discharge Planning form dated 11/13/10, showed the height as 5 foot 7 inches. The patient's weight was documented as 145 pounds, lined through, and rewritten as 125 pounds above. The Nursing Care and Treatment Flow Sheet, Psychiatric Hospital, form initiated 11/14/10, showed the weight as 113 pounds. RN AA stated the weight of 113 pounds was obtained on 11/16/10, when weekly weights were taken.

RN CC and RN F were interviewed on 11/17/10 at 1015 hours. RN CC stated nursing staff was expected to report weight differences and the weight would be rechecked if there was a weight difference. In addition, RN CC and RN F stated the admission weight could have been "stated" by the patient. Both RNs stated the weights on the care plans and treatment flow sheets should be patient weights taken on the unit scale.

RN CC reviewed the medical record on 11/17/10 at 1030 hours. The RN was not able to locate documentation the admission weight was verified or the 11/16/10, weight of 113 pounds had been rechecked. In addition, RN CC was unable to locate documentation of the weight loss or the notification of the physician.

Review of the Patient Assessment/ Reassessment Nursing Services Policy on 11/17/10 at 1445 hours, showed "the assessment process includes a collection of objective and subjective data that focuses on patient's physical, psychosocial, spiritual, and developmental needs."

There was no policy regarding the recording of patient's weight or the verification of the accuracy of documented weights. There was no policy directing staff when a patient had a weight loss and what staff would be notified.

2. Patient 75 was admitted 11/9/10. Medical record review on 11/17/10 at 1400 hours, showed the Admitting Orders dated 11/8/10, documented the patient's weight as 160 pounds and height as 5 foot 2 inches. Review of the Nursing Care and Treatment Flowsheet, Psychiatric Hospital, form initiated on 11/9/10, showed a weight of 140 pounds and height of 4 foot 10 inches. Review of the Nursing Care and Treatment Flow Sheet, Psychiatric Hospital, form initiated on 11/14/10, showed a weight of 144 pounds. The Interdisciplinary Assessment and Discharge Planning Psychiatry form showed the weight and height sections were not filled in.

RD F acknowledged that the correct weight and height were essential to assess the nutrition status and the weight loss for Patient 75.

3. Review of the medical record was conducted on 11/16/10 for Patient 40. Patient 40 was admitted to the hospital on 11/4/10. Review of the physician's orders dated 11/4/10, showed an order for a nutrition consult for diet recommendations and an order for a vegan, no wheat diet. Review of the physician's orders dated 11/15/10, showed an order for a regular diet. Review of the electronic computer system dated 11/16/10 at 0751 hours, showed a regular diet order, vegetarian by patient request. Review of the nutrition assessment notes dated 11/9/10, showed Patient 40 was on a vegan, and no wheat diet by his request however will eat wheat due to the importance of an adequate diet for healing. The RD recommended to discontinue the wheat restriction.

a. There was no documentation of a nutrition consult in the nutrition assessment. Review of the electronic record showed a nutrition consult was ordered on 11/4/10 at 1023 hours.

An interview was conducted with RN EE on 11/16/10 at 1130 hours, regarding how nutrition consults are generated in the hospital. RN EE stated nutrition consults are put in the computer system and nursing can also call or page the RD.

An interview was conducted with RD E on 11/16/10 at 1150 hours. RD E stated she was not aware a consult was put in the computer system for Patient 40. RD E stated she did an assessment on Patient 40 because the patient had been admitted for five days. RD E stated, according to their policy they see all patients by the fifth day unless something had triggered them to see the patient before then.

Review of the hospital's P&P titled Nutrition Assessment, Intervention, Monitoring and Evaluation, showed RDs will see patients based on Guidelines for Further Prioritization. Review of the RDs Guidelines for Further Prioritization, showed physician referrals would be seen within 24 hours.

Lack of the nutrition assessment in a timely manner resulted in a delayed nutrition intervention which reduced the time for healing.

b. An observation of the lunch tray delivery for Patient 40 was conducted on 11/16/10. Review of the diet card for Patient 40, showed a Vegetarian diet, no milk or dairy, no eggs or poultry items, and no wheat products. An observation of the lunch tray, showed Patient 40 received the following food items for lunch on 11/16/10: white rice; mixed vegetables; peanut butter and honey sandwich on white bread; apple; and fruit punch juice.

An interview was conducted with the Hospitality Supervisor on 11/16/10 at 1440 hours. The Supervisor was asked why Patient 40 received a vegetarian and no wheat diet even though the diet order was just for vegetarian. The Hospitality Supervisor stated the diet office likely saved the previous diet pattern which was created by the RD that included no wheat.

An interview was conducted with RD E on 11/16/10 at 1515 hours. RD E stated Patient 40 was on a special meal pattern which she created. The RD said the diet office apparently continued using the old diet pattern even though the diet order now just said vegetarian.

Review of the vegetarian menu for 11/16/10, showed for lunch, buttered bowtie pasta with marinara sauce would be served.

An interview was conducted with RD B on 11/17/10 at 1400 hours. RD B stated the buttered bowtie pasta with marinara sauce was substituted for vegetable lasagna. RD B stated Patient 40 did not receive what was on the menu because he was also getting no wheat products.

4. Review of the medical record was initiated on 11/17/10 for Patient 76. Patient 76 was admitted to the hospital on 10/25/10. Review of the physician's orders dated 10/26/10, showed a diet order for dysphagia (softer texture diet for patients with a problem swallowing). Review of the nutrition notes dated 11/9/10, showed according to nursing the patient preferred food brought in by the family. The RD stated there were soft fruits, Twinkies, and Coke at the bedside. The RD interventions showed the patient had been eating food from outside of the hospital and to allow food from home. The RD plan of care showed for the physician to allow food from home or outside of the hospital.

An interview was conducted with RD G on 11/17/10 at 1600 hours. RD G stated she did not educate the patient or family on appropriate foods to be brought from home. The RD stated she should have done so and documented this in the RD notes.

An interview was conducted with RN HH on 11/17/10 at 1605 hours, regarding Patient 76 receiving food from home. RN HH stated a physician's order was required for food to be brought from home for a patient. RN HH stated it was the first time she had cared for the patient and she was not sure how long the patient had received food from outside the hospital. RN HH stated she had also seen chili at the patient's bedside that was not from the hospital.

Review of the hospital's P&P titled Food Brought in to Patients from the Outside, showed the following: nursing will fax the order for "food from home" to the diet office and the physician was to write the order that a modified diet was okay; and a RD/dietetic technician/diet assistant/hospitality assistant would provide the patient a handout discussing the proper handling procedures for foods brought from home to encourage safe food handling.

Based on observation, staff interview, and document review the hospital failed to serve the menu for the diabetic diets, pediatric diets and the serving sizes as specified on the menu at the hospital's off site campus. When diets are not served as approved by the dietitian and the diet manual there is the potential that the medical care of patients requiring therapeutic diets would be compromised.

Findings:

On 11/17/10 at 1145 hours, the tray line at the Augustus-Hawkins campus was observed:

1. Review of the lunch menu dated 11/17/10, for a consistent carbohydrate diet specified a three ounce serving of meat loaf. The patient tray card showed the "diabetic 1800 calories" diet specified a meat serving of two ounces.

RD E confirmed on 11/17/10 at 1200 hours, the menu and the patient tray card did not match.

2. Review of the lunch menu dated 11/17/10, showed a menu for the 13-18 years age group, however, the patient was identified on the census as age 12. The RD stated that the menu and the patient tray tags did not match.

3. During the trayline observation the corn, spinach, and green beans were served with a slotted spoon. Chef 2 stated there were not enough four ounce serving scoops available for use in order to accurately measure all the four ounce portions as specified on the menu.

4. During the trayline one tray card specified a two ounce serving of meat loaf. The patient was served ? piece of meat loaf. There was no verification of the weight of the piece of meatloaf. The staff was requested to weigh the ? slice of meat loaf which was just under three ounces.

5. The weight of the meat loaf served was four ounces. The menu dated 11/17/10, specified a three ounce serving. RD E acknowledged the serving of meat loaf and the menu should be served as specified.

Based on observation and staff interview, two hydrocollators (a liquid heating apparatus used to heat and store hot packs) and a patient refrigerator in the Rehabilitation Department were found past the due date for biomedical inspection. In addition, a patient refrigerator in Sleep Room-1 was found in need of defrosting. Hospital equipment must be maintained to ensure acceptable level of safety and quality.

Findings:

1. On 11/16/10 at 1000 hours, during the initial tour of the Rehabilitation Department accompanied by RN JJ, RN KK and PT 1, two hydrocollators in the PT/OT Department were found past the due date for a biomedical safety inspection. The hydrocollator in the OT department was last inspected on 10/08, and was due for a safety inspection on 1/13/10. The hydrocollator in the PT Department was last inspected on 10/08, and was due for safety inspection on 9/09. The refrigerator in the OT Department used to store patient food was last inspected in 8/09, and was due for a safety inspection in 8/10. PT 1 confirmed the need for a safety inspection by the due date.

2. On 11/15/10 at 1500 hours, during the initial tour of Sleep Room 1 in the PFT (Pulmonary Function Testing) Laboratory accompanied by RN JJ, RN KK and PFT 1, the refrigerator for patient food was found in need of defrosting. PFT 1 confirmed the required maintenance in order to ensure a level of safety and quality.

Based on interviews, a tour of the hospital and a review of documents supplied by the hospital, the hospital failed to ensure all the operative suites contained a mechanism to evaluate and regulate temperature and humidity control. No documentation was provided by the hospital to show out of range temperatures and humidity were reported to the Director of Perioperative Services Out of range temperatures and humidity had the potential for increase in bacterial growth and fire hazard. In addition, the hospital failed to ensure one refrigerator used for the storage of breast milk was maintained at temperatures specified on the refrigerator log forms and in hospital policy. There was no documentation on the refrigerator log form to show the recommended temperature for the storage of breast milk and the temperature ranges documented on the log form for nourishments were not as recommended by the US Food Code, 2009.

Findings:

1. The AORN Guidelines, dated 2010, for Safe Environment of Care Recommendation V, shows the temperature in the operating room should be maintained between 68 to 73 degrees F. The relative humidity should be maintained between 30-60% within the perioperative suites, including operating rooms, recovery areas, cardiac catheterization labs, endoscopy rooms, instrument processing rooms and sterilization areas. High humidity and temperature increase the risk of microbial growth in areas where sterile supplies are stored or procedures performed. Low humidity increases the risk of electrostatic charge which poses a fire hazard in an oxygen rich environment or when flammable agents are in use and increases the potential for dust.

a. A tour of the hospital was conducted on 11/16/10 at 0900 hours. Observation of OR #3 did not show a temperature or humidity gauge. When interviewed, the Nursing Director for Perioperative Services stated temperature and humidity levels were monitored by Facilties Management personnel. The Director stated the 24 OR suites did not contain a mechanism to monitor temperature or humidity. The Director stated Facilities Management personnel monitored the levels on a daily basis and would notify the OR nursing staff if the temperature or humidity readings were out of range. The Director stated surgical services included trauma and cardiovascular surgical procedures which were performed 24 hours per day, 7 days per week. The Director stated she was unaware of any instances when Facilities Management personnel had notified the OR staff of temperature or humidity values being out of range.


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b. A tour of the L&D OR suites was conducted on 11/15/10 at 1135 hours, accompanied by the Clinical Director of Women's and Children's Services and the Nurse Manager of L&D. When asked how humidity and temperatures were monitored in the OR suites, the Nurse Manager stated the hospital had a centralized system for monitoring. The Nurse Manager stated there was no digital read out of measurements for temperature or humidity in the OR suites. She stated if there was a problem the alarms would sound in the centralized area and the unit would be notified by Facilities Management personnel.

The relative humidity reports for 24 of 24 hospital ORs were reviewed for the time period 9/1/10 through 11/18/10. Documentation showed 17 of the 24 ORs had relative humidity levels out of range (Rooms 2, 3, 4, 5, 10, 12, 14, 15, 17, 18, 19, 20, 21, 22, 23, 24 and 25).

The temperature reports for 24 of 24 hospital ORs were reviewed for the time period 9/1/10 through 11/18/10. Documentation showed 11 of 24 ORs had temperature levels out of range (Rooms 1, 10, 12, 14, 15,17, 18, 21, 22, 23 and 24).

Interviews were conducted with the Medical Director of Operating Rooms and the Nursing Director of Surgical Services on 11/18/10 at 1110 hours. The Medical Director stated he was not aware of the AORN standards for the temperature and humidity for a safe environment. The Medical Director stated he had not been informed of the out of range temperatures and humidity. The Nursing Director of Surgical Services stated Facilities Management personnel were to inform the surgical department of any OR suites with temperatures and humidity were out of range. The Nursing Director stated she had never been informed of the out of range temperatures and humidity.

The Director of Facilities Management was interviewed along with the Director of Patient Safety on 11/18/10 at 0930 hours. They stated the facility engineers monitored OR temperatures and humidity. The staff stated, should the readings be out of range, an investigation as to the cause would result. When asked, no written documentation was provided to show the OR staff had been informed of the out of range readings in the OR suites. When asked to produce a written policy and procedure for out of range temperature and humidity, the staff were unable to do so.


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2. On 11/16/10 at 1100 hours, the half sized breast milk refrigerator/freezer, #19791, was observed in the pantry of unit 8 C. The refrigerator/freezer was labeled "Breast Milk Only." A significant ice build up was observed in the open freezer ice compartment. The temperature of the refrigerator was observed as 32 degrees F. There was no documentation the buildup of ice in the interior ice compartment had been reported to Facilities Management.

The Refrigerator Maintenance Logs for September, October and November 2010, were reviewed with RN EE. The log forms showed documentation the storage of "Biological at 36-46 degrees F." The log also showed to "record malfunctioning refrigerator in log and steps taken to correct." The refrigerator logs documented temperatures from 34 degrees F to 32 degrees F during the three months. There was no documentation the out of range refrigerator temperatures had been reported to Facilities Management or to the RN unit manager. RN EE stated that she was unaware the refrigerator was not in temperature for "Biological."

Review of the Breast Milk Management and Storage Policy addendum B-2 on 11/17/2010 at 1630 hours, showed "fresh breast milk can be stored in the refrigerator for 24 hours at 39 degrees F." RN EE stated she was not aware of the storage temperature for breast milk.

In addition the refrigerator temperature log showed "Nourishments were to be held at 45 degrees F or below." The US Food Code 2009, for food safety and prevention of growth of microorganisms recommends 41 degrees or below.

Based on observation, interview, and medical record review, the hospital failed to provide an infection control program to prevent and control infections and communicable diseases and provide a sanitary environment by failing to:

* Ensure there was a system in place in Surgical Services to track the locations of the surgical instrument trays. This resulted in the hospital being unable to identify a surgical infection event related to surgical instruments. Cross Reference to A 951 #2b.

* Ensure disinfection solutions were mixed in correct proportions per P&P and the cleaning products were used per manufacturers recommendations to ensure surgical instruments were safe for patient care. Cross Reference A 951 #1.

* Ensure there was a process to monitor the water temperature in machines used to wash surgical instruments which could potentially result in surgical infections. Cross Reference A 951 #1b.

* Ensure surgical instrument washers were cleaned and descaled according to manufacturer's recommendations which could potentially result in the machines inability to clean surgical instruments. Cross Reference A 951 #1c.

* Ensure the surgical environment was cleaned appropriately per P&P and the guidelines provided by the manufacturer for the use of the cleaning products. Cross Reference A 951 #5.

* Ensure biological indicators for surgical instrument sterilization were used according to manufacturer's recommendations. Cross Reference A 951 #2a.

* Ensure surgical equipment and supplies were not stored next to an open drain. Cross Reference A 951 #6.

* Ensure infusion pumps were cleaned appropriately per P&P and the guidelines provided by the manufacturer for the use of the cleaning products.
Cross reference A 749 #2.

* Ensure temperature and humidity variances in the OR were addressed and corrected. Cross Reference A 951 #7.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of patient care in a safe environment.

Based on observation, interview and record review, the hospital failed to ensure the infection control program developed a system for surveillance of staff practices in all areas of the hospital to ensure:

* Surgical instruments trays were tracked.

* Hospital equipment was sanitary.

* Surgical environment was cleaned appropriately per P&P and the guidelines provided by the manufacturer for the use of the cleaning products.

* Biological indicators for surgical instrument sterilization were used according to manufacturer's recommendations.

* Methods used to clean surgical suites were correct.

* The policies and procedures for aseptic IV administration were used.

* Surgical equipment and supplies were not stored next to an open drain.

* Temperature and humidity variances in the OR were addressed and corrected.

* Staff followed the hospital's policy and procedure for hand hygiene

* An EVS staff member was informed a room had been used for airborne isolation prior to cleaning.

These findings had the potential to create an unsafe environment for patient care and the spread of infectious diseases.

Findings:

An interview with the hospital ICP (Infection Control Preventionist) RNs and the physician Epidemiologist was conducted with the survey team on 11/16/10 at 1300 hours. The ICP RNs stated each of RNs were assigned oversight of different areas of the hospital. When asked, the ICP RN assigned to the OR stated direct surveillance rounds were no longer conducted by the ICP RN in the OR suites.The OR managment team made their own rounds. Direct oversight of the sterile processing areas was the responsibility of the CS Manager.

1. There was no system in place in Surgical Services to track the OR locations of the surgical instrument trays. This resulted in the hospital being unable to identify a surgical infection event related to surgical instruments. Cross Reference A 951 #2b.

Interviews with the Director of Clinical Equipment Operations showed that CNA 1 was to wear PPE. The directions for use of the disinfectant showed that the surfaces of the pumps were to remain visibly wet for three (3) minutes. The manufacturer's directions for the disinfectant solution was to use 1/2 ounce of the product to one (1) gallon of water. The manufacturer of the pain pump did not recommend the use of a disposable wipe for cleaning.

2. In the central sterile processing department disinfection solutions were not mixed in correct proportions per the P&P and the manufacturers' recommendations to ensure surgical instruments were safe for patient care. Cross Reference A 951 #1a, 3a, and 3b.

3. The biological indicator read time for sterility of instruments was not done according to the manufacturer's recommendations which could potentially result in unsterile instruments. Cross Reference A 951 #2a.

4. The area for the cleaning of the hospital infusion pumps (electronic pumps used to control the rate of infusions, for example IVs) was observed on 11/15/10 at 1510 hours. CS A was observed cleaning the infusion pumps without PPE (personal protective equipment such as gloves, mask and gown) or a hair net. CS A was observed to clean three different pumps, an IV infusion pump, a patient controlled analgesia pump and a feeding pump. CS A used the same cleaning cloth in a sequential manner without changing the cloth or gloves. CS A was observed to add 1 capful of disinfectant to an un-measured amount of water. CS A cleaned the infusion pain pump with a disposable disinfectant wipe.

5. There was a no mechanism to monitor the water temperature in machines used to wash surgical instruments which could potentially result in surgical infections. Cross Reference A 951 #1b.

6. The surgical instrument washers were not cleaned and descaled according to the manufacturer's recommendations which could potentially result in the machines inability to clean surgical instruments. Cross Reference A 951 #1c.

7. OR staff was not observed to use proper techniques for hand hygiene, changing of gloves and handling of equipment when cleaning the OR which could potentially result in infections. Cross Reference A 951 #5.

8. Temperature and humidity variances outside the range of safety in OR areas were not identified and corrected which could potentially result in infection and dust contamination Cross Reference A 951 #7.

9. A CRNA and an anesthesiologist were not observed to clean IV ports prior to injections which could potentially result in disease causing microorganisms being injected into the patient. Cross Reference A 951 #4.

10. Sterile equipment and supplies were observed stored next to an open drain which could potentially result in contamination of the equipment and supplies. Cross Reference A 951 #6.


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11. Review of the hospital's P & P "Guidelines for Hand Hygiene" effective date 10/09, showed hands would be cleaned after removal of gloves.

On 11/15/10 at 1100 hours, RN U was observed caring for a patient in the ED resuscitation unit. RN U removed his gloves and put on new gloves without performing hand hygiene between the two actions.


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12. During an observation of the ICU on 11/17/10 at 1545 hours with RN II, EVS A was observed terminally cleaning room 130. EVS A wore a mask and gloves as she wiped down the bed and the equipment in the room. A cart containing PPE supplies for use in an isolation room was observed outside the door of the room, however there was no signage on the door to indicate the room had been used for isolation. On interview, EVS A stated she wore the mask while cleaning the room because she dusted high surfaces. When asked if the patient who was discharged from the room had been on isolation, EVS A stated no, she had not been told the patient was on isolation for an infection. EVS A showed the surveyor her pager which showed the room requested to be cleaned was "dirty." EVS A stated, if the patient had been on isolation she would have worn a mask, gown and gloves to protect herself.

RN II was interviewed on 11/17/10 at 1550 hours. The RN stated Patient 80 had been in room 130. She stated the patient had a severe cough and had been placed on airborne isolation precautions for possible TB. The RN stated the patient required a negative pressure room (a room which minimizes the escape of microbes from the room of a patient infected by TB or any other microbe that can spread through the air) for airborne isolation and was transferred. The RN stated the sign to indicate the use of airborne isolation was removed from the room and was transferred with the patient. RN II stated nursing had been using full PPE, gowns, mask and gloves, while caring for Patient 80. When asked how the EVS staff were notified of the need to use PPE while cleaning isolation rooms, RN II stated the EVS Supervisor had been notified by phone the room to be cleaned was an airborne isolation room.


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13a. On 11/15/10 at 1130 hours, during the initial tour of the fourth and fifth floor ICUs, accompanied by RN JJ, RN KK and respective charge nurses, a half-full urinal was observed in ICU-4A sitting on the patient's overbed table. A staff person was observed to enter the room and empty the urinal. The staff person replaced the urinal on the overbed table. When the staff person noticed the surveyor watching the room the urinal was then hung on the side rail of the patient's bed.

b. During tour of ICU-4B, two other ICU patients were observed to have urinals on their overbed tables. In some cases the urinals were placed beside the patients' lunch trays while the patients were eating. When the situation was pointed out to RN JJ, she asked the nurses assigned to the patients to remove the urinals.

c. Further tour of ICU-5A revealed another urinal placed on the overbed table sitting beside a patient's finished lunch tray.

Based on interviews, a review of minutes of the medical staff, hospital documents and a tour of the hospital, the hospital failed to ensure surgical services were provided in an organized, safe environment as evidenced by:

* Staff were unaware of and were not observed to use the correct proportions of cleaning product for the prewashing of surgical instruments. This resulted in the potential for tissue injury to a patient if chemical residue remained on the instruments from a too high concentration of cleaner used, or the potential for the spread of infection if a too low concentration was used. Cross Reference A 951 #1a and 3a.

* There was a no mechanism to monitor the water temperature in machines used to wash surgical instruments which could potentially result in continued contamination. Cross Reference A 951 #1b.

* The surgical instrument washers were not cleaned and descaled according to manufacturer's recommendations which could potentially result in the machines inability to clean surgical instruments. Cross Reference A 951 #1c.

* The biological indicator read time for sterility of instruments was not done according to manufacturer's recommendations which could potentially result in unsterile instruments. Cross Reference A 951 #2a.

* There was no mechanism to track the distribution of surgical instrument trays used for OR procedures in order for the hospital to be able to identify surgical infections related to contaminated surgical instrument lots. Cross Reference A 951 #2b.

* OR staff did not use techniques to prevent the recontamination of surfaces when cleaning the OR, which could potentially result in infections. Cross Reference A 951 #5.

* Sterile equipment and supplies were stored next to an open drain which could potentially result in contamination of the equipment and supplies. Cross Reference A 951 #6.

* Temperature and humidity variances in the OR areas were not identified and corrected which could potentially result in infection, fire, and dust contamination. Cross Reference A 951 #7.

This cumulative effect of these systemic problems resulted in the hospitals failure to deliver surgical services in a safe environment.

Based on observation, interview and record review the hospital failed to ensure the surgical services of the hospital were provided to maintain standards of patient care as evidenced by:

* Staff were unaware of and were not observed to use the correct proportions of cleaning product for the prewashing of surgical instruments. This resulted in the potential for tissue injury to a patient if chemical residue remained on the instruments from a too high concentration of cleaner used, or the potential for the spread of infection if a too low concentration was used.

* There was a no mechanism to monitor the water temperature in machines used to wash surgical instruments which could potentially result in surgical infections.

* The surgical instrument washers were not cleaned and descaled according to manufacturer's recommendations which could potentially result in the machines ability to clean surgical instruments.

* The biological indicator read time for sterility of instruments was not done according to manufacturer's recommendations which could potentially result in unsterile instruments.

* There was no mechanism to track the distribution of surgical instrument trays used for OR procedures in order for the hospital to be able to identify surgical infections related to contaminated surgical instruments lots.

* A CRNA and an Anesthesiologist did not clean IV ports prior to IV injections which could potentially result in disease causing microorganisms being injected into the patient.

* OR staff did not use techniques to prevent the recontamination of surfaces when cleaning the OR, which could potentially result in infections.

* Electrical safety checks were not current on two decontamination machines which could potentially result in electrical safety hazard.

* Sterile equipment and supplies were stored next to an open drain which could potentially result in contamination of the equipment and supplies.

* Temperature and humidity variances in OR areas were not identified and corrected which could potentially result in infection, fire, and dust contamination.

Findings:

1. A tour of the central sterile processing department was conducted on 11/15/10 at 1115 hours.

a. The decontamination machine was inspected. Interviews were conducted concurrently with Technician 1 and Technician 2. The manufacturer's directions called for 25 cc of the cleaning product for every two gallons of water. Technician 1 stated he was unaware of the directions for use. Technician 1 stated he placed 300 cc of the product into an unmeasured amount of water and then placed dirty surgical instruments into the decontamination machine for a prewash cleaning. Technician 2 stated his practice was to place 60 to 90 cc of the product into an unmeasured amount of water. Technician 2 stated each technician processing the surgical instruments used a different technique and placed a different amount of the product in the decontamination machine for the processing of surgical instruments.

During further interview, Technician 1 and Technician 2 stated the solutions for the decontamination machine should be changed weekly. A review of the log for this machine showed that the solutions for the machine should be changed daily. When reviewed, the log for the machine for the month of November, 2010, showed that the solutions were changed on November 1, 6, 7, and 15. There was no written documentation to show the solution was changed daily after processing of the dirty instruments.

b. An observation of the central processing washers showed two long tunnel shaped washing machines used for washing surgical instrument trays following decontamination. According to the CDC Guidelines for sterilization and disinfection in healthcare facilities, 2008, washer-sterilizers are modified steam sterilizers that clean by filling the chamber with water and detergent through which steam passes to provide agitation. Instruments are subsequently rinsed and subjected to a short steam-sterilization cycle. The machines require water temperature to 285 degrees F. Observation of the two washers did not show a mechanism to measure the water temperature. During an interview with the Nursing Director of Surgical Services she stated "the washing machines will automatically shut down if the water temperature is below 180 degrees F." When asked, the Director was unable to provide documentation of this feature.

c. Four vertical surgical instrument washers were observed.

The washers had cleaning maintenance logs to show documentation of the daily cleaning of the washers. Review of the November, 2010, log showed documentation dated 11/1, 11/6, 11/7, 11/8 and 11/15/10, of the cleaning of the washers. There were no entries for the remaining 10 days to show the washers were cleaned daily.

The Weekly Descaling Maintenance logs dated October, 2010, showed no documentation of descaling for six of the six washers. When interviewed, the Sterile Processing Supervisor stated that these maintenance procedures might have been performed without the logs being filled in.

d. A review of the Cart Washers Daily Cleaning log showed the large surgical carts used to transport surgical trays and instruments were to be washed on a daily basis. Review of the log dated November, 2010, showed documentation the carts were cleaned on 11/2, 11/3, and 11/14/10. There were no entries for the remaining 12 days to show the carts were cleaned daily.

e. Technician 2 stated the ultrasonic cleaners were to be cleaned on a daily basis. A review of the log for the ultrasonic machines dated November, 2010, showed documentation of cleaning on 11/1, 11/6, 11/7, 11/8 and 11/15/10. There were no entries for the remaining 10 days to show the machines were cleaned.

f. Review of the manufacturer's recommendation showed the solution in the ultrasonic cleaners should be between 65-70 degrees F. Observation of the machines did not show a mechanism to verify temperatures or a log of the temperatures of the machine. When asked, Technician 2 stated that he did not monitor the temperature of the solution used in the ultrasonic cleaner.

g. Two surgical instrument decontamination machines were observed to lack electrical safety inspection stickers. One machine had not been inspected since 8/5/07, and the second machine had not been inspected since 11/6/07. When interviewed, the Director of Surgical Services produced the P&P for electrical equipment management, dated 9/5/08. When reviewed, the Director of Perioperative Services stated the policy was unclear and did not specify a mechanism for periodic inspection to ensure electrical safety.

2. A tour of the central sterile processing department was conducted on 11/15/10 at 1410 hours.

a. The manufacturer's instructions for the biological indicators (placed inside the packaging of a surgical instrument tray before placing in an autoclave) showed it should be read three hours after its removal from the autoclave. Review of the Load Control Record form, used to monitor sterile processing, showed documentation on 11/6/10, load #2 was placed into the autoclave at 0859 hours, and removed at 0954 hours. The biological indicator result for this load was negative (a negative reading indicated that the load was sterile and the biological indicator was inactivated). The time the indicator was read was not documented on the form. When asked, the Director of Perioperative Services was unable to show the form contained an area for documentation of the time the biological indicator was read.

b. A tour of the storage area for sterile instrument trays showed 37 identical sterile surgical instrument trays. A copy of the delivery inventory records for surgical trays and peel packs was requested from the Nursing Director of Surgical Services. The Director stated there was no process in place to track each of the instrument trays to the OR suites. When asked how the location of the tray could be determined in the event of an adverse sterile processing outcome, the Director stated they would not be able to determine the location of a tray and/or on which patient the instruments had been used.

3. On 11/15/10 at 1530 hours, a tour of the OR decontamination work area was conducted.

a. During an interview with Technician 4 she stated she added two pumps of the enzyme product (a product used to decontaminate surgical instruments) to an un-measured amount of water. Technician 4 stated that she filled the water to a line in the sink but stated she did not know the amount of water the sink contained.

Review of the manufacturer's guideline for the product showed one pump (each pump of the product was 15 cc) of product was to be added to one gallon of water. The Nursing Director of Surgical Services confirmed Technician 4 was using the incorrect amount of solution to decontaminate the surgical instruments.

b. Review of the hospital's P&P for the solution used to remove rust, pitting, stains and corrosion from stainless steel surgical instruments showed one part of the product was to be mixed with seven parts of hot water. The policy required the solution container be labeled with the date the solution was mixed.

During an interview, Technician 3 was unable to identify the date the solution was prepared or the concentration of the solution being used for the cleaning of the surgical instruments.

4. On 11/17/10 at 1025 hours, anesthesia services were observed for Patient 44. CRNA C and Anesthesiologist X were observed to administer medications via a port in the IV tubing. CRNA C and Anesthesiologist X were not observed to clean the port prior to administering the intravenous medication on five occasions.

The P&P for port cleaning prior to injection of IV medications by anesthesia providers required cleaning of the injection port with an alcohol wipe.

5. An observation of OR #3 was conducted during a tour of the OR suites on 11/16/10 at 1145 hours.

a. Two EVS staff were performing cleaning and disinfection procedures between surgical cases. EVS C was observed cleaning the operating room table and mattress, the trash cans, and the back tables in the operating room, including the surgical sponge rack. EVS 1 was observed to use the same cleaning cloth for all surfaces during the cleaning procedure. EVS C was observed to clean the floors and then wipe the surfaces of the operating room table and IV poles, cleaning from the bottom to the top. The surfaces cleaned remained wet with cleaning solution for 1-1.5 minutes, using the operating room clock. Review of the manufacturer's directions showed all surfaces to remain wet with the cleaning solution for 10 minutes.

b. EVS B was observed entering OR #3 wearing gloves. EVS B proceeded to pick up the tubing of a machine used to prevent lower extremity blood clots, which was laying on the blood stained floor. EVS B was observed to pick up the tubing and throw it over the anesthesia machine, recontaminating the machine.

c. EVS B began cleaning the floor of the operating room using a wet vacuum machine. EVS B was wearing gloves. EVS B was observed leaving OR #3 wearing the same gloves and exiting the operating room corridor by a door at the end of the hallway. EVS B then re-entered the surgical suite, wearing gloves and entered OR #3 without changing gloves or performing hand hygiene.

6. A tour of the OR suites was conducted on 11/15/10 at 1520 hours. An open, uncovered medium pressure steam drain pipe was observed dripping water into an uncovered waste water drain. There was evidence of discoloration around the drain that appeared to be rust colored. A sterile instrument and surgical supplies cart was observed adjacent to, and within inches of, the open waste water drain. When interviewed the Director of Perioperative Services stated the close proximity of the surgical supply cart to the waste water drain could pose a contamination hazard to these supplies.

7. The AORN Guidelines, dated 2010, for Safe Environment of Care Recommendation V, shows the temperature in the operating room should be maintained between 68 to 73 degrees F. The relative humidity should be maintained between 30-60% within the perioperative suites, including operating rooms, recovery areas, cardiac catheterization labs, endoscopy rooms, instrument processing rooms and sterilization areas. High humidity and temperature increase the risk of microbial growth in areas where sterile supplies are stored or procedures performed. Low humidity increases the risk of electrostatic charge which poses a fire hazard in an oxygen rich environment or when flammable agents are in use and increases the potential for dust.

a. The relative humidity reports for 24 of 24 hospital ORs were reviewed for the time period 9/1/10 through 11/18/10. Documentation showed 17 of the 24 ORs had relative humidity levels out of range (Rooms 2, 3, 4, 5, 10, 12, 14, 15, 17, 18, 19, 20, 21, 22, 23, 24 and 25).

For example, review of hospital humidity logs showed for OR #2, from 1500 hours on 10/27 until 1700 hours on 10/28/10, the relative humidity was measured between 16 to 19.4 %. For OR# 4, from 1500 hours on 10/27/10, until 0700 hours on 10/28/10, the relative humidity was between 16.8 to 19.9%. For OR #20, from 0500 hours on 10/11/10 until 0300 hours on 10/14/10 the relative humidity was between 62.9 to 73.3 %. For OR #23, from 1000 hours on 9/2/10, until 1100 hours on 9/3/10, the relative humidity was above the normal range.

b. The temperature reports for 24 of 24 hospital ORs were reviewed for the time period 9/1/10 through 11/18/10. Documentation showed 11 of 24 ORs had temperature levels out of range (Rooms 1, 10, 12, 14, 15,17, 18, 21, 22, 23 and 24).

The hospital's temperature logs showed for OR #23, from 2400 hours on 11/16/10, until 0800 hours on 11/16/10, the temperatures were elevated and out of range with readings of 81.9 degrees F to 76.1 degrees F. At 2100 hours on 11/16/10 until 0700 hours on 11/17/10, the temperature readings were elevated with readings up to 82.7 degrees F. For OR #12, on 9/2/10 at 1000 hours, the temperature log showed 80.6 degrees F. For OR #1, a temperature of 80.5 degrees was recorded on 11/8/10 at 0400 hours. For OR #14, a temperature of 81.4 degrees was recorded on 11/17/10 at 1430 hours and for OR #17, a temperature of 78.2 degrees was recorded during the same hours.

Interviews were conducted with the Medical Director of Operating Rooms and the Nursing Director of Surgical Services on 11/18/10 at 1110 hours. The Medical Director stated he was not aware of the AORN standards for the temperature and humidity for a safe environment. The Medical Director stated he had not been informed of the out of range temperatures and humidity. The Medical Director stated he was not aware low humidity was a risk for increased dust contamination or was a fire hazard. The Nursing Director of Surgical Services stated Facilities Management personnel were to inform the surgical department of any OR suites with temperatures and humidity were out of range. The Nursing Director stated she had never been informed of the out of range temperatures and humidity.

The Director of Facilities Management was interviewed along with the Director of Patient Safety on 11/18/10 at 0930 hours. They stated the facility engineers monitored OR temperatures and humidity. The staff stated, should the readings be out of range, an investigation as to the cause would result. When asked, no written documentation was provided to show the OR staff had been informed of the out of range readings in the OR suites. When asked to produce a written policy and procedure for out of range temperature and humidity, the staff were unable to do so.

The Epidemiologist of Inpatient Surgical Services was interviewed at 1000 hours on 11/17/10. She stated the infection control committee met quarterly and reviewed the temperature and humidity logs. The Epidemiologist was asked to produce minutes for this review. Review of the committee minutes dated 8/19/10, showed documentation the "Water surveillance and OR Temperature/Humidity report not available."

Based on a review of the medical record for one of four sampled surgical patients (Patient 45), the hospital failed to ensure a medical history and physical examination had been performed within 24 hour of admission to the hospital. This could lead to a patient having surgery who might be unstable for the procedure.

Findings:

The medical record for Patient 45 was reviewed on 11/16/10. The patient was admitted on 11/16/10 and was scheduled for surgery the same day. Review of the Day Surgery Focused History and Physical Exam dated 11/16/10, showed no documentation a review of the patient's vital signs had been completed and pertinent laboratory or x-rays reports, if any, had been reviewed. The area to show the History and Physical was reviewed and signed by the attending physician prior to the surgical procedure was blank.

Based on interviews and medical record review, the hospital failed to ensure two of four sampled surgical patients (Patients 44 and 47) had properly executed surgical consents. Patient 44's consent form listed the wrong surgeon and Patient 47 was unaware who was performing the surgery. This resulted in the patients not being allowed to make an informed decision regarding surgery.

Findings:

1. Patient 44 was interviewed at 0905 hours on 11/16/10, in the pre-operative area. Patient 44 stated she signed a consent form in the physician's office for MD D to perform the procedure. The surgical procedure for Patient 44 was observed at 1100 hours. The physician performing the surgery was not the physician listed on the informed consent. The physician performing the surgery was identified as the "surgeon of the day 2."

When interviewed on 11/18/10 at 1110 hours, the Medical Director of the Operating Room stated that documented informed consent was required in order to indicate the correct physician performing the procedure.

2. Patient 47 was interviewed at approximately 0930 hours on 11/16/10. When asked, Patient 47 stated she was unaware of the name of the surgeon who would be performing her surgical procedure. The patient stated she had signed forms for the consent, but was not informed of the name of the operating surgeon.