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Based on interview and medical record review, the governing body failed to ensure that the medical staff approved hospital guidelines for insulin infusion before the guideline was used in the hospital's intensive care unit for one of 75 sampled patients (Patient 70). The medical staff failed to be accountable to the governing body when it failed to ensure oversight for one of 73 sampled patients (Patient 66) who received a fentanyl patch, in violation of its own policies and procedures for the administration of a controlled substance.

Findings:

1. On 12/14/10 at 1506 hours, review of Patient 70's medical record revealed a physician completed a preprinted guideline and order sheet for insulin infusion. There was no form number or date of approval by the hospital at the bottom of the sheet. The order was written on 12/9/10 at 0435 hours to maintain insulin infusion based on blood glucose (BG). Insulin 100 units was mixed in a 100 milliliter bag of normal saline to give a concentration of 1 unit/milliliter. The blood glucose goal was 70 -130 milligrams/deciliter and the nurse used a chart which was part of the guideline to adjust the insulin dose based on the blood glucose result. RN 31 was asked how a nurse would adjust the dose of insulin for Patient 70. She stated the dose was based on the glucose level and the current insulin dose the patient received.

On 12/15/10 at 0820 hours, Pharmacist 2 was interviewed and stated, "Pharmacy was not involved in reviewing this guideline. It was written 3 years ago." Pharmacist 2 was not sure whether the guideline was approved by the hospital's Pharmacy and Therapeutics Committee ( a function of the medical staff in California). California Code of Regulations, Title 22, 70263(c)(1) stated, "A pharmacy and therapeutics committee, or a committee of equivalent composition, shall be established. The committee shall consist of at least one physician, one pharmacist, the director of nursing service or her representative, and the administrator or his representative. The committee shall develop written policies and procedures for establishment of safe and effective systems for procurement, storage, distribution, dispensing and use of drugs and chemicals. The pharmacist in consultation with other appropriate health professionals and administration shall be responsible for the development and implementation of procedures. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate."

On 12/15/10 at 1357 hours, MD 5 stated she developed the insulin infusion guideline that was ordered for Patient 70. She could not remember when it went in to effect but thought it was around 5 years ago. The guideline was reviewed by the endocrine department but she could not remember if other departments reviewed it. The guideline was not approved by the hospital's Pharmacy and Therapeutics committee and did not receive a form number.

On 12/16/10 at 0805 hours, the DOP stated the guideline was approved by the P&T committee. However, further research of the P&T committee meeting minutes failed to show documentation the guideline was approved.

2. The medical staff failed to ensure their preprinted fentanyl patch order sheet was accurately completed and intern physicians were provided training on the contraindications described in the black box warning when prescribing fentanyl patches. The pharmacy department did not have a procedure in place to prevent the inappropriate dispensing of fentanyl patch for Patient 66. The physician's order was not investigated or clarified by the pharmacist. Patient 66, became lethargic, confused, and disoriented as a result of being over medicated. See A500, #1.

Based on record review, observations and interviews, the governing body failed to ensure oversight of three services provided under contract (housekeeping, dialysis, and pharmacy sevices). These practices could result in an unsafe environment for patient safety.

Findings:

1. On 12/13/10, a tour of the cath lab (cardiac catheterization laboratory) was performed. Housekeeper 6 was observed cleaning the cath lab following a cardiac catheterization procedure. The housekeeper failed to remove the mattress from the procedure table and when wiping the surface of the mattress and the table, one quick wipe was performed. By actual timing, the surface remained wet for approximately 30 seconds. The manufacturer's guidelines required that the surfaces remain wet for 3 minutes. Housekeeper 6 seemed unaware that all surfaces required prolonged contact with the product to ensure safe disinfection of all surfaces and heart monitor leads.

2. On 12/14/10 at 0830 hours, a tour of the operating room area was conducted. During the tour, Housekeeper 4 and Housekeeper 5 were observed cleaning Operating Room 6 following a surgical procedure. Wiped surfaces were dry in less than three minutes. A review of the manufacturer's guidelines for the disinfectant product indicated that the surfaces must remain wet for ten minutes to be effective.


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3. On 12/16/10, the personnel record for Housekeeper 4 and 5 were reviewed. The record included a form titled "Orientation /Reorientation Attestation Form." The form had instructions for the employees to complete and mail in to their supervisor. The form was signed by Housekeepers 4 and 5, dated 10/21/10, and had thirty questions which were answered.

A review of the questions showed incorrect answers. The first sample question was regarding "When an event notification should be completed," which was answered by Housekeeper 4 as "when a patient expresses a desire to be married in the hospital." The second sample question was concerning the actions to be taken for a sentinel event of a near miss which was answered by Housekeeper 5 as to report it to "The Los Angeles Police Department." These forms were not corrected or scored. An additional concern was situational questions that were not applicable to housekeepers, such as questions concerning medication administration.

During an interview on 12/16/10 at 1020 hours, the Director of Environmental Services was unable to answer why the orientation forms were not graded.


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4. The contracted dialysis services' Procedural Manual for Dialysate Additives; Section 4, Page 9, showed, the correct amount of potassium or calcium should be placed into a graduated cylinder (laboratory equipment to measure accurate liquid volume) to have a precise measurement for patient safety. The amount specified to increase the electrolyte level by 1 meq/liter was 50 cc of electrolyte per gallon of acid concetrate.

On 12/14/10 at 0830 hours, observation of the storage rooms containing dialysis supplies was done with RN 27. Bottles of liquid potassium and calcium were observed in a supply cart used by the dialysis nurses, however, there was no graduated cylinder noted to measure the liquid potassium and calcium accurately.

On 12/14/10 at 1040 hours, an interview was conducted with the dialysis nurse, RN 29. When asked about measuring the liquid potassium and calcium, RN 29 stated the nurses used the small plastic medication cups kept in stock on each cart. The plastic cups each held 30 cc of liquid. The nurses added 45 ml of the potassium or calcium to a gallon container to increase the total amount of the electrolyte. He added that 45 was one and one-half medication cups of liquid potassium.

The contracted service did not follow their policy and procedure to use a graduated cylinder and to add the correct amount of electrolyte to the gallon containers of acid concentrate in order to provide safe, accurate and effective patient care.

5. During review of the contracted dialysis service personnel files on 12/14/10, it was observed the contracted companies had not provided the hospital with documentation of demonstrated skills, signed by a qualified trainer, to reflect the competency of the nursing personnel who provided dialysis treatments to the hospital's patients.

On 12/15/10 at 1150 hours, an interview and review of the personnel files was done with the Contracted Services Director who was responsible for the content of the personnel files. The lists given to them by the contracted dialysis service did not reflect the type of skills to show the nurses were qualified to perform dialysis treatments for the patients, or the service personnel who serviced the dialysis machines had received training by the machine manufacturer as being competent to service the dialysis machines.


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6. On 12/13/10 at 0935 hours during interview, the DOP stated that hospital staff had not visited or observed the contract pharmacy that prepared sterile products for patient use for six to seven years. He stated that they relied on reports submitted by the contract pharmacy. These reports were not verified and the supplied product not tested for sterility by the hospital. He further stated that the contract pharmacy's reports were not part of the QAPI tracking/trending process.

Based on record review and interview, the hospital failed to ensure a consent form presented to one of 75 sampled patients (Patient 14) for signature was in the language spoken and understood by the patient. The failure could result in the patient signing for a procedure the patient did not want/need.

Findings:

On 12/13/10 at 1150 hours, an interview was conducted with dialysis nurse, RN 11, and Patient 14. The patient spoke and understood English, which was confirmed by RN 11. During review of the patient's medical record, a consent form for blood transfusion was found signed by the patient. The consent form was in a language which the patient did not speak or understand. When the patient was asked by RN 19, the Charge Nurse, if he understood the language the consent form was written in, the patient told RN 19 "no."

Based on interview and record review, the hospital failed to provide informed consent regarding administration of antipsychotic (psychotropic) medications. Seven of seven medical records (Patients 1, 2, 34, 67, 72, 73, 74) reviewed in the Psychiatric Emergency Department (PED) showed no documentation of informed consent for administration of psychotropic medications. This practice could result in not providing the necessary information to the patient or his/her representative in order to make informed decisions regarding his/her care.

Findings:

On 12/15/10, a review of the hospital P&P titled: Patients Consents for Psychotropic Drugs, showed psychiatric patients, particularly those who may be involuntarily detained for evaluation and treatment under California law, were informed as to the risks, benefits and alternatives of treatment with psychotropic drugs. The policy revealed that prior to administration of psychotropic medications; the prescribing physician was to inform the patient or his/her representative of their right to refuse medication and to provide the patient with the risk and benefits of therapy. The P&P added the type, range, frequency, amount, the use of PRN (as needed), route (by mouth or by injection), and duration of taking psychotropic medications required informed consent.

Review of Patient 1's medical record on 12/15/10 showed Haldol (a psychotropic medication) was ordered to be administered on an as needed basis for psychotic symptoms. The record failed to show an informed consent for the medication Haldol was obtained.

Further medical record review of Patients 2, 34, 67, 72, 73, and 74 on 12/15/10 showed psychotropic medications (Ativan, Zyprexa, Risperdal, Restoril) were ordered on a PRN basis, however, there was no informed consent documented for these medications.

In an interview with RN 27, conducted on 12/15/10 at 1330 hours, it was stated patients who have a PRN (as needed) order for psychotropic medications did not require an informed consent. Informed consent was only needed for psychotropic medications ordered on a routine schedule.

Interviews with 3 psychiatrists were conducted. MD 3, interviewed on 12/15/10 at 0900 hours, acknowledged informed consent was required for all psychotropic medications regardless of their administration schedule. MD 4, interviewed on 12/15/10 at 1000 hours, stated consent was not required if the psychotropic medications were part of the emergency dosing procedure which included PRN medication orders for agitation. MD 4 stated only routinely scheduled antipsychotic medication required informed consent. MD 11, interviewed on 12/15/10 at 1015 hours, stated informed consent was required in most cases unless an emergency situation made it impossible to obtain an informed consent. It was added staff confusion might have existed when PRN medications were written for agitation which could have been interpreted as an emergency dose. He stated some clarification and education were required of staff.

Based on observation and record review, the hospital failed to provide privacy for four of 18 patients (Patients 8, 72 and two unsampled patients) in the ED. The hospital failed to ensure privacy for patients in the Psychiatric ED. This resulted in a violation of the patients' rights.

Findings:

1. On 10/5/10, a confidential complainant notified the Department of a violation of privacy. According to the complaint, while in the ED on 10/3/10, MD 10 told Patient 72 to take off her top in the hallway of the ED.

On 12/13/10, a review of Patient 72's medical record showed Patient 72 was in the ED on the date described in the complaint. MD 10 was the MD caring for the patient, and the patient had a condition that would require lifting or removal of the patient's gown.

On 12/13/10 at 1500 hours, the main ED area was observed. Instead of one patient in each patient bay there were two. There were also three patients lying on gurneys in the hall and patients in chairs. There were no curtains or screens between the patients in chairs, the patients doubled up in the single patient bays, or around the patients in the hall on gurneys.

During the observation, an unidentified nurse had an unsampled male patient remove his shirt in full view of other patients and another nurse started an IV on a patient. Patient 8, a young female patient, was asked by CNA 3 to lift her gown in the front so he could reach under and apply electrode patches to monitor the heart. There was no attempt to provide privacy for the patients.


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2. On 12/13/10 at 0900 hours, a tour of the PED was conducted. The Director of Psychiatry was in accompaniment. The PED consisted of two rooms opposite each other with a nursing station in between the two rooms. Patients could be observed through plexiglass windows located on both sides of the nursing station. Each room had a separate door leading to the room from the nursing station. Each room had a nursing staff member stationed inside the room. The PED Manager stated one room currently had 10 patients and the other room had 15 patients.

The room on the left from the entrance was designated the Blue Room, the room on the right the Pink Room. The Blue Room had 4 hospital beds and an assortment of chairs and couches. Some patients were occupying the beds and others were lying down on the couches. Other patients were observed sitting asleep in the chairs. Two patients were sitting on the floor.

Patients and staff were observed in each room. A psychiatrist was observed talking to a patient in the Blue Room. A nurse was observed to be bringing medication into the Blue Room and administered it to a patient located there. There was no area in the Blue Room to have a private conversation.

The Pink Room was observed with staff members sitting at tables near the entrance to the room. Patients in the Pink Room were observed laying down on the couches, chairs, and sitting on the floor. There were no privacy curtains in the Pink Room. There was no location in the Pink Room where one could have a private conversation.

On 12/13/10 at 0930 hours, an interview with psychiatrist MD 2 was conducted. He was asked about how the psychiatrist goes about interviewing patients and maintaining confidentiality. He stated the room is small, and patients with a high elopement potential must remain in the room. He stated considering the size and the number of patients the PED sees, he and the staff do the best they can to maintain confidentiality and privacy for the patients there.

An interview with the PED Manager was conducted on 12/13/10 at 1030 hours. The Manager was asked about the PED bed capacity and she replied it was twelve. She stated PED runs over capacity on a daily basis.

Based on observation and staff interview, the hospital failed to ensure the ED developed a fire evacuation plan that addressed the overcrowded ED. This could potentially result in patient/visitor/staff injury or death. The hospital failed to ensure needles and syringes were stored securely in the ED. This could potentially result in inappropriate access of these items by unlicensed staff and members of the general public.

Findings:


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1. On 12/13/10 at 0900 hours, a tour of the main ED was conducted. In Patient Bays 1A and 1B, instead of one patient per bay there were two lined up in a linear fashion. The Nursing Director of the ED stated the ED had severe space issues and needed to double patients up in order to handle the ED patient volume. When asked if ED staff members were trained in fire safety regarding evacuation of patients with the overcrowding, the director said no.

On 12/13/10 at 1500 hours, the ED was toured again. At this time, five bays were doubled up with patients and there were three patients on gurneys in the hallway. At various times eight to ten staff members were in the hallway and three people were lined up in the hall outside the rest room.

On 12/13/10 at 1445 hours, RN 20 was asked if she had received fire safety training specific to the ED and stated she had not. CNA 4 was asked if he had received fire training specific to the ED and stated he had not.

2. On 12/13/10 at 0900 hours, a tour of Room 2B124 in the ED showed the room was used primarily for gynecology patients. There were 10 butterfly IV needles, 4 IV catheters, and 9 needles with syringes in an unsecured neonatal kit. Against the wall in between ED Bays 2 A and 2 B was an unlocked cart with over 50 each of 18 gauge, 20 gauge and 22 gauge IV catheters. The unsecured storage of needles was verified with the ED nurse manager.

Based on interviews, observation and record review, the hospital QAPI:
* Failed to monitor the effectiveness of their contracted services (pharmacy, housekeeping, and dialysis services) to ensure the personnel were competent in performing the required tasks which could affect quality and safety of patient care.
* Failed to ensure the insulin order set had been approved by the Pharmacy and Therapeutics committee of the hospital. This could lead to unsafe administration of insulin and adverse patient reaction to the medication.
* Failed to ensure disinfection procedures were monitored and evaluated. This could lead to ineffective disinfection in patient care areas.
* Failed to ensure the contracted dialysis services provided proof of the maintenance done on the hemodialysis machines used for patient treatments.
* Failed to ensure the ED had developed a fire evacuation plan that addressed the overcrowded ED. This could potentially result in patient/visitor/staff injury or death.
* Failed to ensure needles and syringes were stored securely in the ED. This could potentially result in inappropriate access of these items by unlicensed staff and the general public.
* Failed to ensure informed consent regarding administration of antipsychotic (psychotropic) medications. This practice could result in not providing the necessary information to the patient or his/her representative in order to make informed decisions regarding his/her care.

Findings:

1. On 12/13/10 at 0935 hours during interview, the DOP stated the hospital staff had not visited or inspected the contract pharmacy that prepared sterile products for patient use for six to seven years. The department relied on reports submitted by the contract pharmacy. These reports were not verified or the supplied product tested for sterility by the hospital. It was further stated the contract pharmacy's reports were not part of the QAPI process.

2. On 12/14/10 at 1506 hours, review of Patient 70's medical record revealed a physician completed a preprinted guideline and order sheet for insulin infusion. There was no form number or date of approval by the hospital at the bottom of the sheet.

On 12/15/10 at 0820 hours, Pharmacist 2 was interviewed and stated, "Pharmacy was not involved with reviewing this guideline. It was written 3 years ago." Pharmacist 2 was not sure whether the guideline was approved by the hospital's Pharmacy and Therapeutics Committee

On 12/15/10 at 1357 hours, an Physician MD 5 stated she developed the insulin infusion guideline that was ordered for Patient 70. She could not remember when it went in to effect but thought is was around 5 years ago. The guideline was reviewed by the Endocrine Department but she could not remember if other departments reviewed it. The guideline was not approved by the hospital's P&T committee and did not receive a form number.

On 12/16/10 at 0805 hours, during an interview with the DOP, who thought the guideline was approved by the P&T committee. Further research of the committee meeting minutes showed no documentation the guideline was approved. See A500 #2.

3. On 12/13/10, a tour of the cath lab (cardiac catheterization laboratory) was performed. Housekeeper 6 was observed cleaning the cath lab, following a cardiac catheterization procedure. The housekeeper failed to remove the mattress from the procedure table and when wiping the surface of the mattress and the table, one quick wipe was performed. By actual timing, the surface remained wet for approximately 30 seconds. The manufacturer's guidelines required that the surfaces remain wet for 3 minutes. Housekeeper 6 seemed unaware that all surfaces required prolonged contact with the product to ensure safe disinfection of all surfaces and heart monitor leads. See A749 #1.

4. On 12/14/10 at 0830 hours, a tour of the operating room area was conducted. During the tour, Housekeeper 4 and Housekeeper 5 were observed cleaning Operating Room 6 following a surgical procedure. Wiped surfaces were dry in less than three minutes. A review of the manufacturer's guidelines for the disinfectant product indicated that the surfaces must remain wet for ten minutes to be effective. See A749 #2.

5. During review of the contracted dialysis service personnel files on 12/14/10, it was observed the contracted companies had not provided the hospital with documentation of demonstrated skills, signed by a qualified trainer, to reflect the competency of the nursing personnel who provided dialysis treatments to the hospital's patients. There was no information supplied to the hospital by the contracted companies that showed the training and qualifications for the personnel responsible for servicing of the dialysis machines.

On 12/15/10 at 1150 hours, an interview and review of the personnel files was done with the Contracted Services Director who was responsible for the content of the personnel files. The lists given to them by the contracted dialysis service did not reflect the type of skills to show the nurses were qualified to perform dialysis treatments for the patients, or the service personnel had received training by the machine manufacturer as being competent to service the dialysis machines.


6. Review of seven of seven medical records located in the PED showed no documentation of informed consent for administration of psychotropic medications which could potentially result in patients receiving medications against their decisions. See A131.

During a meeting held with the hospital's Quality Committee on 12/15/10 the above items were discussed and they had not been self-identified as areas of patient safety and/or quailty of care concern.

Based on observation, record review and staff interview, for 10 of 75 sampled patients the hospital:

* Failed to ensure Patient 48 was supervised appropriately when the patient was witnessed smoking in a wheelchair with an oxygen tank attached to the back of the chair. Smoking beside flammable gases such as oxygen could cause fire and explosion.
* Failed to ensure the RN verified the patient had given informed consent prior to administration of antipsychotic (psychotropic) medications which can potentially deprive the patient/representative of the ability to make informed decisions (Patients 1, 2, 34, 67, 72, 73, 74).
* Failed to ensure the RN followed the a policy and procedure for blood sugar monitoring which could result in high or low blood sugars for patients (Patient 65).
* Failed to ensure one patient (Patient 31) was assessed with regard to their fluid status and needs which could possibly result in the patient becoming fluid overloaded.

Findings:

1. On 12/15/10, the hospital's P&P on No Smoking, under Procedure, letter B. stated smoking was prohibited near any area on the grounds of the Medical Center where flammable liquids, gases, and combustible materials were stored.

On 12/15/10 at 1330 hours, Patient 48 was observed through the transparent glass door of the cafeteria, smoking at the designated smoking patio in front of the hospital building. Patient 48 was sitting on the wheelchair with an oxygen tank attached behind the wheelchair. Assistant Hospital Administrator (AHA) 1 was notified at 1340 hours. The oxygen tank was removed from the wheelchair by AHA 1.

On 12/15/10 at 1500 hours, RN 12 was identified to be assigned to care for Patient 48 and was interviewed. She stated she was not aware Patient 48 was out smoking in the patio using a wheelchair with an oxygen tank behind. RN 12 added visitors assisting patients to smoke usually grab any available wheelchairs, with or without an oxygen tank.

2. On 12/15/10 at 0900 hours, during observation of a medication pass for Patient 31 by RN 12, a sign was observed above Patient 31's bed identifying the patient was to receive only a certain amount of fluids. It was observed the patient had a 500 ml plastic bottle of drinking water on the bedside stand. On the over-bed table were four bottles of dietary supplement drink. Each of the four bottles contained 8 ounces of fluid which was equal to a total of approximately 944 ml of fluid. The patient's nursing assistant was also observed bringing in a pitcher of water for the patient that was placed on the over-bed table with the dietary supplement drinks.

Review of Patient 31's chart showed a physician's order for the patient to receive a total of 1.5 liters of fluid (1500 ml) per day.

During an interview with RN 12 on 12/15/10 at 0920 hours, the RN was asked about the fluid restriction sign above Patient 31's bed. RN 12 stated she was not aware of the sign or if the patient was on fluid restriction. After checking the physician's order, RN 12 acknowledged the patient was on fluid restrictions and removed the extra fluids from the bedside.

On 12/16/10 at 1200 hours, an interview was done with the unit's RN Director, RN 10. It was stated the day nurse who was taking over the care of the patients visited each patient's room with the night nurse to have a full report of each patient's status. The RN Director added that Patient 31's fluid restriction status should have been included during the change of shift report.

3. Seven of seven medical records (Patients 1, 2, 34, 67, 72, 73, 74) reviewed in the Psychiatric Emergency Department (PED) showed no documentation of informed consent for administration of psychotropic medications. See A131.


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4. On 12/16/10, review of the hospital's policy and procedure for blood glucose monitoring showed that the physician should be immediately notified of a critical patient test result. A high critical test result was defined in the policy and procedure as above 450mg/dL.

On 12/16/10, the medical record for Patient 65 was reviewed. The patient came to the ED on 10/13/10 and was triaged at 0837 hours (triage is a process of determining the priority of patients' treatments based on the seriousness of their illness). The assessment of RN 23, the triage nurse, showed the patient complained of nausea and vomiting, with rapid breathing and had been out of diabetic medication for four days. Written by hand was a blood sugar of high value over 450mg/dL. However, there was no documentation the test was immediately reported to an MD. MD 12 wrote orders, dated 10/13/10 at 0910 hours, for further laboratory tests and an IV infusion.

Further review of Patient 65's medical record showed, at 1115 hours, the patient was found down in the bathroom and had no palpable pulse. A code blue (an emergency code for immediate resuscitation) was called. Resuscitative measures were conducted but failed. Patient 65 was pronounced dead at 1150 hours. A laboratory test performed during the code showed the patient's blood sugar was 1100mg/dl.

On 10/13/10 at 1215 hours, MD 12 wrote in the "Assessment/Medical Decision Making" section of the physician record that Patient 65 was never seen after being called at 9am, 10am, and 10:30 am. Also noted were that preliminary orders were written based on Patient 65's chief complaint.

On 12/16/10 at 0845 hours, the ED Nurse Manager stated that, after triage, Patient 65 was placed in a chair in the main ED and a nurse was assigned. The patient was told to stay in the chair. However, the MD started to look for Patient 65 at 0900 hours who was not found in the chair.

During an interview with MD 13 on 12/16/10 at 0930 hours, it was stated that an investigation of the events showed the patient was brought back to the main ED immediately and placed in a chair. The patient was called numerous times and did not respond. When asked about nurse's initiating treatment for high blood sugar, for example obtaining further laboratory tests, MD 3 stated there was no protocol in place in the ED for the triage nurse to implement any actions for elevated blood sugars.

Based on record review and staff interview, the care plan for Patient 36 regarding pressure ulcers was not written in a timely manner. The practice could result in communication failure as to the ongoing assessment of patient's needs and responses to interventions and should be initiated from the time of admission to discharge.

Findings:

On 12/15/10, record review of Patient 36 revealed the hospital's Pressure Sore Risk Assessment tool (Braden Scale) was used on an unknown date to assess Patient 36's skin status. Patient 36 was assessed as being bedfast and with limited mobility, with probable inadequate nutrition and potential problem for shear and friction and had a total score of 13 points for both day shift and night shift. Per instruction of the Braden Scale for a score of 13 points or less, the Pressure Sore/Ulcer Prevention and Management Protocol should be implemented.

Further review of the Pressure Ulcer Staging/Description record revealed Patient 36 had zero skin issues at 0800 hours on the unknown date, but sacrum redness by 2400 hours. On 3/26/10, it was documented on the nursing flow sheet Patient 36 had rashes on both thighs and back despite being turned to the side to relieve the pressure. There was no other intervention noted. Review of the nursing care plan regarding the patient's skin status was found blank.

On 12/15/10 at 1530 hours, RN 30, Assistant Manager of ICU who reviewed the electronic records with the surveyor, acknowledged the skin care problem was evident; however, the written care plan for care interventions was not initiated.

Based on observation, interview and medical record review, the hospital failed to administer insulin (medication to treat high blood glucose) doses according to physician orders for one of 75 sampled patients (Patient 70). Missed doses or administering extra doses of insulin can potentially impact Patient 70 by allowing blood glucose levels to remain too high or too low affecting the brain, heart, kidneys, and circulation. In addition, the medication administration for oneof 75 sampled patients (Patient 31) was not documented per facility policy which could result in the patient not receiving an ordered medication..

Findings:

1. On 5/14/10 at 1506 hours, review of Patient 70's medical record revealed a physician completed a preprinted guideline and order sheet for insulin infusion. There was no form number or date of approval by the hospital at the bottom of the sheet. The order was written on 12/9/10 at 0435 hours to maintain insulin infusion based on blood glucose. Insulin 100 units was mixed in a 100 ml bag of normal saline to give a concentration of 1 unit/ml. The blood glucose goal was 70-130 mg/dL and the nurse used a chart which was part of the guideline to adjust the insulin dose based on the blood glucose result. RN 31 was asked how a nurse would adjust the dose of insulin for Patient 70. She stated the dose was based on the glucose level and the current insulin dose the patient received.

On further review of Patient 70's documented insulin doses, on 12/12/10 at 0100 hours, the blood glucose level was 100 mg/dL. According to the guideline, the insulin dose should not be increased; however, the insulin dose was increased from 12 units to 16 units/hour without a physician order. On 12/12/10 at 0500 hours, the blood glucose level was 265 mg/dL. The insulin, according to the guideline, should have been increased by 3 units/hour, but this was not done. On 12/12/10 at 0700 hours, the blood glucose was 191 mg/dL and according to the guideline, the dose should have been increased by 2 units per hour, but was not done.


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2. Review of the hospital's Policy 246 for Medication Administration; Version 5, showed the nurse should observe the patient take their medications, and the medications were to be documented on the medication administration record after they were given.

On 12/15/10 at 0850 hours, during observation of Patient 31's medication pass, RN 12 had shown the surveyor a paper cup containing several pills the patient was to be given at 0900 hours. RN 12 went directly to Patient 31's room to administer the medications. RN 12 then reviewed the MAR where the time the medications were given was to be documented. During the MAR review it was noted a liquid medication had been documented as given at 0900 hours, however, there was no liquid medication administered to Patient 31 during the medication pass. RN 12, while placing back the liquid medication in the patient's drawer of the medication cart, stated she would give it to the patient later though the medication was already documented as given in the MAR. At 0945 hours, RN 12 was asked if the medication had been given to the patient, and she stated she had offered the medication to the patient, but the patient had refused to take it.

During an interview, the Nursing Director (RN 10) for that patient care area on 12/16/10 at 1200 hours, stated the nurses were to sign for the medications after they were given to ensure a medication dose was not missed.

Based on interview and medical record review, the facility failed to ensure updated information regarding changes in the surgical status for one of 75 sampled patients (Patient 13) had been documented to ensure the patient received appropriate and safe care.

Findings:

On 12/13/10 at 1005 hours, during medical record review and a concurrent interview, Patient 13's medical record showed a surgical consent signed by the patient on 12/9/10 and a pre-surgical assessment dated 12/12/10. The assessment had been completed related to a surgical procedure scheduled for 12/13/10. The patient's nurse, RN 16, stated the surgery was never scheduled because the surgeons were available only on Tuesdays and not on 12/13 which was a Monday. She added the surgeons were contacted to confirm the surgery was not scheduled for 12/13/10.

On 12/14/10 at 0910 hours, a review of the electronic documentation, with RN 27 and the RN Director (RN10), showed the physicians and other staff members treating the patient acknowledged the patient was scheduled for surgery on 12/13/10 including the pre-surgical preparations which were implemented by the night shift on 12/12/10. However, there was no documentation on whether the patient's surgery was ever cancelled and/or if the physicians had been contacted to confirm the surgical services could not be provided.

Based on record review and interview, the hospital failed to ensure a consent form presented to one of 75 sampled patients for signature was in the language spoken and understood by the patient (Patient 14). The failure could result in the patient signing for a procedure the patient did not want/need. the hospital failed to ensure seven of 75 sampled patients had accurate and complete documentation of informed consent for medications resulting in the potential for medications to be given against a patient's wishes.

Findings:

1. On 12/13/10 at 1150 hours, an interview was conducted with dialysis nurse RN 11, and Patient 14. The patient spoke and understood English, which was confirmed by RN 11. During review of the patient's medical record, a consent form for blood transfusion was found signed by the patient. The consent form was in a language which the patient did not speak or understand. When the patient was asked by RN 19, the Charge Nurse, if he understood the language the consent form was written in, the patient told RN 19 "no."

2. On 12/15/10, a review of the hospital P&P titled: Patients Consents for Psychotropic Drugs, showed psychiatric patients, particularly those who may be involuntarily detained for evaluation and treatment under California law, were informed as to the risks, benefits and alternatives of treatment with psychotropic drugs. The policy revealed that prior to administration of psychotropic medications; the prescribing physician was to inform the patient or his/her representative of their right to refuse medication and to provide the patient with the risk and benefits of therapy. The P&P added the type, range, frequency, amount, the use of PRN (as needed), route (by mouth or by injection), and duration of taking psychotropic medications required informed consent.

Review of Patient 1's medical record on 11/12/10 showed Haldol (a psychotropic medication) was ordered to be administered on an as needed basis for psychotic symptoms. The record failed to show an informed consent for the medication Haldol was obtained.

Further medical record review of Patients 2, 34, 67, 72, 73, and 74 on 12/15/10 showed psychotropic medications (Ativan, Zyprexa, Risperdal, Restoril) were ordered on a PRN basis, however, there was no informed consent documented for these medications.

In an interview with RN 27, conducted on 12/15/10 at 1330 hours, it was stated patients who have a PRN (as needed) order for psychotropic medications did not require an informed consent. Informed consent was only needed for psychotropic medications ordered on a routine schedule.

Based on interview and document review, the hospital failed to ensure two of five patients (Patient 32 and 53) reviewed for nutritional status had weights recorded in a timely manner which could compromise the patient's medical care.

Findings:

1. Patient 32's medical record was reviewed on 12/15/10 at 0930 hours. Patient 32, a diabetic, per H&P, was admitted on 11/27/10 with a weight of 69.4 kilograms. The weight on 12/13/10 was 80.3 kilograms. (One kilogram equals 2.2 pounds).

RN 17 stated that patients were weighed on admission and per MD orders. It was stated the hospital did not have a policy to weigh patient during their hospital stay or to direct staff to verify significant weight gains or losses. Per nursing notes, there was no documentation of notification of the physician or RD of this significant weight gain.

The standards of practice by Clinical Nutrition Management, stated that weight and accuracy was important for the assessment of a patient's nutritional status. It was further stated that weight monitoring was relevant for patients hospitalized for long periods of time and those with medical conditions like diabetes.

2. Patient 53's medical record was reviewed 12/16/10 at 0930 hours. Patient 53 was admitted on 12/8/10 with a weight of 91.5 kilograms.

Review of nursing notes and the patient's weight history on 12/16/10 at 0930 hours showed no recorded patient weight since admission.

A Nutritional Assessment, dated 12/13/10, showed Patient 53 was assessed at level one (high nutritional risk) secondary to being NPO (nothing by mouth) for 5 days. The RD recommendation was to check the patient's weight. RD 3 stated that when she recommended weight monitoring she had to ask nursing or notify the physician to order weight verification.

CNM (Clinical Nutrition Manager) acknowledged that patients' weights were an important part of nutritional assessments and should be taken on a regular and ongoing period.

Based on observation, interview, medical record, document review and policy and procedure review, the hospital failed to ensure pharmaceutical services carried out its full and complete oversight that meets the needs of the patients in the hospital.

Findings:

1. Pharmaceutical services failed to ensure their preprinted fentanyl patch order sheet was accurately completed and intern physicians were provided training on the contraindications described in the black box warning when prescribing fentanyl patches. The Pharmacy Department did not have a procedure in place to prevent the inappropriate dispensing of fentanyl patch; therefore, an order was not investigated or clarified by the pharmacist. As a result, Patient 66, became lethargic, confused, and disoriented as a result of being over medicated. See A500, #1.

2. Pharmaceutical services failed to ensure pharmacy technicians who compounded sterile intravenous medications were competent in aseptic technique and passed their annual competency examinations. See A501.

3. Pharmaceutical services failed to ensure the designated hospital committees' approval of the insulin (injectable medication to treat high blood sugar) IV infusion guideline before it was routinely used in the ICU. See A500, #2.

4. Pharmaceutical services failed to ensure that insulin doses administered to patients were in accordance with physician orders. See A405.

5. Pharmaceutical services failed to provide the oversight and documentation to follow the flow of non-controlled (prescription medications that do not fall under the category of highly abused or highly addictive) medications from their entry into the hospital through dispensation and administration to patients throughout the hospital. See A491, #1.

6. Pharmaceutical services failed to ensure that expired intravenous antibiotics (medications to treat infection) were not available for patient use. See A505.

7. Pharmaceutical services failed to ensure that patients received all doses of albuterol and Atrovent inhalers (medications used to aid in breathing) that were ordered by the physician and doses administered were documented on the medication administration record (MAR) per hospital policy. See A491, #2.

8. Pharmaceutical services failed to ensure that pharmacy staff were aware of the hospital's policy and procedure entitled, "Patients Own Medications" and the DOP was aware of the procedure for approving patient's own medications for use in the hospital. See A491, #3.

9. Pharmaceutical services failed to list the contents of the emergency medications on the outside of the adult emergency crash cart located in the ED and outpatient clinics, and failed to include the earliest expiration date of any drugs within. See A500, #3; #8.

10. Pharmaceutical services failed to ensure that the ED medication order review process provided the necessary information to evaluate the medication order and prevent medication adverse effects that could be harmful to the patients. See A500, #4.

11. Pharmaceutical services failed to ensure that medications returned to the pharmacy in the patient's medication cassette drawer were followed up on to determine why they were not given. See A500, #5.

12. Pharmaceutical services failed to ensure that the laminar flow hood (hood where intravenous medications were compounded, requiring a sterile environment) was free from microorganisms (germs) that could infect the patient and cause harm. See A500, #6.

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

Based on observation, interview and document review, the hospital failed to ensure medications were being administered according to accepted professional principles. The pharmacy services failed to:
* Provide the oversight and documentation to follow the flow of non-controlled (prescription medications that do not fall under the category of highly abused or highly addictive) medications from their entry into the hospital through dispensation and administration to patients throughout the hospital. This could result in poor tracking and control over drugs.
* Ensure Patient 36 received all doses of albuterol and Atrovent inhalers (used to aid in breathing) per documentation that were ordered by her physician. The doses administered were not documented on her medication administration record (MAR) per hospital policy.
* Ensure patients' own medications brought into the hospital were reviewed and approved in accordance with the hospital's policy and procedure entitled, "Patients Own Medications." Failure to follow P&P could lead to adverse effects of medications.
* Ensure medications were documented after they were given. Documenting medications as given before administration could potentially result in medication errors.

Findings:

1. On 12/13/10 at 1432 hours, during a tour of the emergency department's medication room, an ADC (automated drug cabinet to store medications) was being utilized by RN 13. RN 13 was removing ciprofloxacin (an antibiotic to treat infections) 500 milligrams for a patient. During the removal, a pop up screen appeared on the ADC requesting a number of tablets to be removed. RN 13 entered one tablet to be removed and removed the one tablet. During this process, there was no documentation required to ensure the count for ciprofloxacin in the drawer was accurate. RN 13 stated that the part of the process for documenting the quantity of ciprofloxacin was accurate, and was turned off. If this part was left on, and the count was inaccurate, a discrepancy report would be created and would need to be investigated. RN 13 referred to the hospital's policy as "auto-resolved." RN 13 further stated that nurses do not need to count and document the balance of tablets or capsules stored in the drawer. Without this accountability, nursing staff may remove more medication than ordered since there was no oversight by the pharmacy department. There was no discrepancy report created to track and determine the count was accurate; and if not accurate, there was no system to notify the pharmacy department for follow up.

ASHP (American Society of Health-System Pharmacists) guideline on standard of practice stated in their article entitled, ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals, 1995, "The pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital for inpatient and ambulatory patients. Failure to provide any of these services may compromise the overall quality of pharmaceutical care."

On 12/13/10 at 1522 hours, the DOP stated "auto-resolved" is the policy throughout the hospital. "All non-controlled prescription medications do not require nursing to count the tablets." Counting tablets would ensure the medications were removed accurately.

2. On 12/15/10 at 1005 hours, during record review of Patient 36's chart, there were orders for Albuterol Metered Dose Inhaler 2 puffs every six hours and for Atrovent Metered Dose Inhaler 2 puffs every six hours. On the MAR for 12/14/10, only three doses (instead of four) were charted for both medications. RN 19 looked for documentation that the doses were administered for the dates of 12/12/10 and 12/13/10. RN 19 was unable to find any documentation on the MAR that doses were administered for those dates.

On 12/15/10, the policy and procedure entitled, "Medication Administration" stated on page 5, medications were to be documented on the MAR after they were given.

On 12/15/10 at 1304 hours, the Respiratory Manager stated he was aware that documentation of metered dose inhalers were missing on the MAR. He stated, "Once the dose was administered, it should be immediately documented on the MAR." The Respiratory Manager was unable to find the MAR documentation that the inhalers were administered to Patient 36 on 12/12/10 and 12/13/10.

3. On 12/13/10 at 1551 hours, during an interview with the DOP, it was stated medications brought into the hospital for patients' own use were to be identified by the pharmacist or physician. Once identified, the DOP was unaware of documentation that was required to verify the process was done and to notify the nursing staff that the medication was approved for use.

On 12/16/10, review of the hospital's P&P entitled, "Patients Own Medications" revealed on page 3 the following, "The medication must be contained in its original prescription container that identifies the name, strength, dose, route of administration, and directions for use of that medication. It must be positively identified by a pharmacist or physician. If identified by the pharmacy, a pharmacist will place a self-adhesive sticker (initial & date) on the medication container verifying such check."

4. On 12/15/10 at 0850 hours, during observation of Patient 31's medication pass, RN 12 documented a liquid medication as given at 0900 hours, however, there was no liquid medication noted that was administered to Patient 31 during the medication pass at 0900 hours.

Based on interviews and observation, the hospital failed to ensure that drugs and biologicals had been stored, controlled and distributed in a manner consistent with applicable standards of practice. This could lead to unsafe storage, distribution and administration of drugs and biologicals:
* Medical record review revealed that one patient (Patient 66) received fentanyl patch not in accordance with manufacturer's dosing guidelines and contraindications. The practice could lead to life-threatening emergencies due to over medication.
* Patient 70 received insulin doses without prior hospital approval of the insulin (injectable medication to treat patients with high blood sugar) intravenous infusion guideline being routinely used in the intensive care unit (ICU).
* There was no list of contents of all the emergency medications posted on the outside of the adult emergency medication cart located in the ED and outpatient clinics in accordance with State law. The list did not include the earliest expiration date of any drugs within the crash cart.
* The ED medication order review process did not provide the necessary information to evaluate the medication order and prevent medication adverse effects that could be harmful to the patients.
* Medications returned to the pharmacy in the patient's medication cassette drawer were not followed up on to determine why they were not given.
* The laminar flow hood, hood where intravenous medications were compounded and required to be a sterile environment, was not free from microorganisms (germs) that could infect the patient and cause harm.
* Breast milk was being stored in a medication refrigerator which provided the potential for contamination of the medications.

Findings:

1. On 12/15/10 at 1441 hours, review of Patient 66's medical record revealed the patient was admitted to the hospital on 12/11/10. The patient received orders for fentanyl patch 25 micrograms every 72 hours and Dilaudid (a potent narcotic pain medication) 2 milligrams every four hours as needed for breakthrough pain. The first fentanyl patch was administered on 12/11/10 at 2245 hours.

The black box warning (BBW) for fentanyl patch was to alert the prescriber that the medication should only be prescribed in patients who have demonstrated opioid tolerance, and who required a total daily dose at least equivalent to a fentanyl 25 mcg/hr (mcg/hr) patch. Patients who were considered opioid tolerant were those who have been taking, for a week or longer, at least 60 mg of oral morphine daily, or an equianalgesic (of equal pain-relieving capability) dose of another opioid. Due to life-threatening hypoventilation (decreased rate of breathing) that could occur, fentanyl patch was contraindicated in patients who were not opioid tolerant.

On 12/14/10 at 2335 hours, Patient 66 was found to be lethargic, able to move her hands but was not able to speak as per nursing notes at this time. MD 11 was called immediately to the bedside. MD 11 charted that Patient 66, "Responded to painful stimuli by opening eyes, able to identify herself, but could not answer other orientation questions. Fentanyl patch was held. Likely due to oversedation." The patient's respiratory rate was 18 and oxygen saturation was 95%.

On 12/15/10, review of Patient 66's medical record was performed to determine her narcotic usage prior to admission. The history and physical, dated 12/11/10 did not include narcotic medications on the list of medications Patient 66 took prior to admission. On 12/15/10 at 1510 hours, RN 10 stated that the medication reconciliation sheet had all the medications the patient took prior to admission. Review of the medication reconciliation sheet revealed Patient 66 did not take narcotic pain medications prior to admission. According to the BBW, Patient 66 was not considered opioid tolerant and should not have received fentanyl patch.

On 12/16/10 at 0910 hours, an interview was performed with the physician (MD 6) who prescribed the fentanyl patch for Patient 66. MD 6 stated her physician orders needed to be approved/countersigned by the supervising physician for the reason that MD 6 was an intern physician. MD 6 further stated, "Since the hospital did not have a Lidocaine patch which the patient was on prior to admission, she switched her to a fentanyl patch." Lidocaine patch was a local anesthetic patch and a non narcotic medication and was unrelated to a narcotic medication. MD 6 was asked if she was aware of the black box warning for fentanyl patch. The reply was, "What is a black box warning?"

On 12/16/10 at 0927 hours, the DOP stated that Pharmacist 3 verified the fentanyl patch order for Patient 66 on 12/11/10. Pharmacist 3 was interviewed on 12/27/10 at 1415 hours. During the telephone interview, Pharmacist 3 stated that when a patient entered the hospital and the physician checked off the, "Continuation of chronic pain regimen box," on the preprinted order sheet, Pharmacist 3 admitted the patient was not verified for opioid tolerance. Pharmacist 3 added, "That was the responsibility of the physician."

The hospital did not have policies or procedures in place to ensure intern physicians received appropriate training before prescribing BBW drugs, including fentanyl patch. The hospital did not have a system in place where newly admitted patients on fentanyl patch orders were verified for opioid tolerance by the pharmacists before the patch was dispensed and administered.

2. On 12/14/10 at 1506 hours, review of Patient 70's medical record revealed a physician completed a preprinted guideline and order sheet for insulin infusion. There was no form number or date of approval by the hospital at the bottom of the sheet. The order was written on 12/9/10 at 0435 hours to maintain insulin infusion based on blood glucose (BG). Insulin 100 units was mixed in a 100 ml bag of normal saline to give a concentration of 1 unit/ml. The blood glucose goal was 70-130 mg/dL and the nurse used a chart which was part of the guideline to adjust the insulin dose based on the blood glucose result. RN 31 was asked how a nurse would adjust the dose of insulin for Patient 70. She stated the dose was based on the glucose level and the current insulin dose the patient received. On further review of Patient 70's documented insulin doses, on 12/12/10 at 0100 hours, the blood glucose level was 100 mg/dL. According to the guideline, the insulin dose should not be increased; however, the insulin dose was increased from 12 units to 16 units/hour without a physician order. On 12/12/10 at 0500 hours, the blood glucose level was 265 mg/dL. The insulin, according to the guideline, should have been increased by 3 units/hour, but was not done. On 12/12/10 at 0700 hours, the blood glucose was 191 mg/dL and according to the guideline, the dose should have been increased by 2 units per hour, but was not done.

On 12/15/10 at 0820 hours, Pharmacist 2 was interviewed and stated, "Pharmacy was not involved with reviewing this guideline. It was written 3 years ago." Pharmacist 2 was not sure whether the guideline was approved by the hospital's Pharmacy and Therapeutics (P&T) committee. California Code of Regulations, Title 22, 70263(c)(1) states, "A pharmacy and therapeutics committee, or a committee of equivalent composition, shall be established. The committee shall consist of at least one physician, one pharmacist, the director of nursing service or her representative, and the administrator or his representative. The committee shall develop written policies and procedures for establishment of safe and effective systems for procurement, storage, distribution, dispensing and use of drugs and chemicals. The pharmacist in consultation with other appropriate health professionals and administration shall be responsible for the development and implementation of procedures. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate."

On 12/15/10 at 1357 hours, MD 5 stated she developed the insulin infusion guideline that was being ordered for Patient 70. She could not remember when it went in to effect but thought is was around 5 years ago. The guideline was reviewed by the Endocrine Department but she could not remember if other departments reviewed it. The guideline was not approved by the hospital's P&T committee and did not receive a form number.

On 12/16/10 at 0805 hours, during an interview, the DOP stated he thought the guideline was approved by the P&T committee. Further research of the committee meeting minutes showed no documentation that the guideline was approved.

3. On 12/13/10 at 1434 hours, during a tour of the emergency department (ED), the adult code blue crash cart was noted to be missing a list of all the contained emergency medications on the outside of the cart. After further search, a list was found attached to the underside of the medication box but not visible from the outside of the cart. The list did not include two intravenous medications, i.e., dextrose 5% in water and normal saline. In addition, there was no documentation on the outside of the cart when the first medication located inside the cart expired.

California Code of Regulations, Title 22, 70263(f)(2) states, "The emergency drug supply shall be stored in a clearly marked portable container which is sealed by a 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."


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4. On 12/13/10 at 1005 hours, in an interview with Pharmacist 2, it was stated that all medication orders administered in the Emergency Department were being reviewed by a pharmacist the following day. It was also stated the reviewing pharmacist did not look at the patient's medical record during the review process. The pharmacist's review included therapeutic appropriateness of a patient's medication regimen; appropriateness of the drug, dose, frequency, route and method of administration; or variation from organizational criteria for use in their review process. The review process did not provide the necessary information to evaluate the medication order and could lead to exposure of the patient to harmful drug therapy.

In an interview with the ED Charge Nurse (RN 33) on 12/13/10 at 1315 hours, it was stated only twenty-percent of the medications ordered in the ED were of an emergent nature, requiring immediate administration. RN 33 further stated eighty percent of the orders were not being reviewed by a pharmacist to minimize the occurrence of adverse (bad) events prior to the first dose of medications being administered.

Per the American Society of Health-System Pharmacists that published Minimum Standard for Pharmacies in Hospitals, dated September 22, 1995, it stated, "All prescribers' medication orders (except in emergency situations) must be approved for appropriateness by a pharmacist before a first dose was dispensed." The hospital's practice did not meet this standard.

5.On 12/13/2010 at 1015 hours, inspection of the medication drawers that were returned to the pharmacy every 24 hours indicated there were doses of drugs that were not administered to the patients. The pharmacy utilized a 24-hour drawer exchange system to provide drugs for patients when these drugs were not in the ADC at the nursing units. There was no documentation why the doses of drugs had not been administered. Pharmacist 2 stated the staff did not inquire why returned medications were not administered to the patients. He added they did not have enough staff to perform this function.

6. On 12/13/10 at 1035 hours, a pharmacy technician was observed mixing an intravenous solution in a laminar flow hood (LFH). The LFH provides a clean area where these solutions must be prepared to maintain sterility (free from germs) of the solutions. A white milky substance was observed growing on the screen covering the inside back wall of the LFH. Air flowed through the screen and could disperse any contaminants growing there. The DOP was asked for sterility data on the observed LFH. The DOP stated these tests were not being performed as their clinical laboratory would not perform the testing for them. A laboratory culture (test to determine germs) was requested. The preliminary report on 12/14/10 from the hospital's clinical laboratory indicated "Gram positive cocci observed, fastidious growth observed." The final report supplied by the facility indicated "Staphylococcus Epidermis" was present in the LFH thereby negating the use of the hood as a "clean" area.
Some gram positive cocci are germs that can cause disease. Staphlococus Epidermis is a bacteria that does not normally cause disease but may in immune comprised populations.



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7. On 12/15/10 at 10:30 a.m., the breast milk freezer was inspected. The RN manager identified the breast milk stored in the freezer had been placed temporarily in the medication refrigerator. Two bottles and two syringes of breast milk were noted in the medication refrigerator. The medication refrigerator was solely for the storage of medications and could not be used for food items due to the potential of cross contamination of the medications.


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8. On 12/17/10 at 1000 hours, a tour of the outpatient clinics was conducted. Inspection of the emergency crash carts in 7 clinics ( Medical/Surgical, Pediatric, ENT, Orthopedic, Outpatient Surgical Same Day, OB/GYN, and Primary Care) and the Psychiatric ED showed no pharmaceutical inventory lists on the outside of the emergency crash carts.

Interview with the Director of the Clinics was conducted on 12/17/10 at 1015 hours. She was asked about the emergency crash carts. She stated she was not aware a list was required on the outside of the cart for the medications contained within the cart.

Based on observation, interview and document review, the hospital failed to ensure that three
of 13 pharmacy technicians received annual competency evaluations for aseptic technique (a germ-free manner) in compounding intravenous medications (Pharmacy Techs 1, 3 and 4). One of the three pharmacy technicians (Pharmacy Tech 3) had not had annual competency evaluations in over five years.

Findings:

On 12/13/10 at 1058 hours, during a tour of the main pharmacy, Pharmacy Tech 1 was observed compounding intravenous medications using the laminar flow hood designed to ensure sterility. The DOP stated that all the Pharmacy Technicians working in the sterile compounding areas had been assessed for competencies on aseptic technique on an annual basis. Review of Pharmacy Tech 1's employee folder revealed the latest annual aseptic competency quiz was on 12/8/09.

On 12/14/10 at 1341 hours, during an interview with the HR (Human Resource) Manager, it was stated that all competency quiz results were filed in the employee personnel file. The HR Manager stated she would review all the Pharmacy Technician files for their annual aseptic technique competencies and would report back. At 1357 hours, Pharmacist 1 stated, "Pharmacy Technicians were supervised by different supervisors, so not all competency training was consistent. Five technicians were under me and two other pharmacists supervised the rest." On 12/15/10 at 1334 hours, the HR Manager produced the files for 13 Pharmacy Technicians. She stated three of the 13 Pharmacy Technicians did not take the last annual aseptic competency quiz (Pharmacy Technicians: 1, 3, and 4). Pharmacy Technician 3 was found with no annual quiz taken in over five years.

Based on observation and interview, the hospital failed to remove expired medications found in the main pharmacy and in the emergency department. The medications were available for patient use despite the potential for contamination and loss of potency.

Findings:

1. On 12/13/10 at 1023 hours, during a tour of the main pharmacy, ceftriaxone 1 gram, an injectable antibiotic to treat infections, was stored in the main pharmacy after it was previously opened on 12/10/10.

On 12/13/10 at 1026 hours, the DOP stated he was aware of the single use vial being used over again. The DOP approved the storage since it was stored in the pharmacy's refrigerator so it was safe to administer again.

Documented by the manufacturer on ceftriaxone's label was the following, "Single use vials." Per the manufacturer, single use vials were intended to be used only once since they do not contain a preservative to ensure sterility for future use. Single dose vials were to be used only once. If there was any left over after the first use, it was not safe to administer again even if it was stored in the pharmacy's refrigerator.

2. On 12/13/10 at 1419 hours, while touring the emergency department (ED), cefotetan 2 grams, an injectable antibiotic to treat infections, was found to have expired the previous day (12/12/10) and was still available in the ED refrigerator for patient use.

Based on observation, staff interview and document review, the hospital failed to have a qualified full-time Director of Food and Dietetic Services responsible for daily management of the dietitic services. As a result, the hospital failed to ensure safe food handling practices as evidenced by:

* Disaster/emergency water supply was not stored in an approved building.
* Ice machines were not sanitized as specified by the manufacturer.
* There was no documentation of cool down logs per department policy; and
* Staff was not able to demonstrate knowledge of internal cook temperatures.

These unsafe food handling practices were potentials for food borne illnesses and inability to supply water in times of disasters for patients and staff.

Findings:

On 12/13/10 at 0900 hours, during the kitchen tour, the following were observed:

1. There was one pan of roast beef in the walk-in refrigerator. Staff stated that the roast beef was cooked on Saturday, 12/11/10, to be served Sunday and Monday.

Review of the Food Temperature Monitoring Chart, showed the cooling section was not completed on the following dates: 11/6/10, 11/13/10, 11/20/10, 11/27/10, and 12/4/10. Only the date 12/11/10 was filled in. Chef 1 was not able to explain why the cool down log was not documented to ensure the cooling process was followed to prevent the growth of microorganisms and food borne illnesses. Chef 1 acknowledged that the cool down logs had not been reviewed to ensure the cooks properly documented the cooling process.

2. The refrigerator that was marked "Flower Refrigerator" was at the center section of a three door roll with exposed food in the two other sections. The exposure of the food to flowers could potentiate cross contamination from flowers that were not completely separated from food storage.

On 12/15/10 at 1000 hours, the hospital's policy stated, "Maintains supply of New Mom Flower vases in Flower Refrigerator." The policy did not specify a refrigerator that was completely separated from food storage.

3. One potted plant was observed in the serving area of the cafeteria. The insects from the potted plant could potentiate contamination of food.

4. Five pint cartons of chocolate milk were found marked with "Best by 12/12/10" and were stored in the bin with milk dated, 12/19/10.

Chef 1 acknowledged the chocolate milk with the expired date should have been discarded and not stored with milk of later dates.

Review of the policy titled, "Production, Purchasing, and Storage #B006, stated that products past the "sell by or use by" dates should not be served to patients.

5. The emergency water supply was stored in a warehouse across the parking lot. The CNM acknowledged that the warehouse was not licensed and not an approved building by OSHPD (Office of Statewide Healthplanning and Development) which placed the stored disaster/emergency water supply at risk of being unavailable if this building was destroyed during a disaster.

6. Cook 1 was asked about the internal cook temperature for poultry. She stated 155 degrees Fahrenheit (F) at first, then stated 175 degrees F, then changed to 160 degrees F, and later acknowledged, "I am not sure."

On 12/13/10, review of the Cook 1 personnel file on job specific competencies dated 1/14/10, no. 5 showed, "Correctly identified the internal cook temperature of chicken at 165 degrees F."

7. On 12/13/10 at 1310 hours, the kitchen bin ice machine was reviewed and Chef 1 stated that the dietary staff was responsible for cleaning and sanitizing the bin. He stated that the staff used a quaternary ammonia sanitizer.

On 12/14/10 at 1300 hours, review of the manufacturer's directions on sanitizing showed, "Dilute IMS-II sanitizer or a 5.25.percent sodium hypochlorite solution with water." The hospital was observed not using the correct sanitizing solution as specified by the manufacturer.

Based on interview, review of the clinical record, and review of the hospital's policies and procedures, the hospital's dietitian failed to ensure clinical oversight of one of five (Patient 32) patient charts reviewed for nutrition care. This could result to potential neglect of the nutritional aspects of patient care.

Findings:

Patient 32's medical record was reviewed on 12/15/10 at 0930 hours. The patient, a diabetic, was admitted on 11/27/10. Patient 32's weight on admission was 69.4 kilograms (1 kilogram equals 2.2. pounds).

The Nutrition Assessment, dated 12/10/10, stated, diet was consistent carbohydrate, 2 gram sodium. The nutrition assessment failed to assess patient education needs for the consistent carbohydrate or 2 gram sodium diets.

On 12/15/10 at 0930 hours, RD 2 stated she had not documented any patient education assessment for either diet restriction but that she should have noted information for the patient's diet knowledge.

On 12/16/10, review of the Assessment/MNT (Medical Nutrition Treatment) intervention policy #D006, showed, "Assessment of patient nutritional needs utilizing the established nutritional assessment guidelines and assessment of patient educational needs on previous and current knowledge regarding their diet and nutrition."

Based on observation and staff interview, the hospital failed to ensure supplies and equipment were updated and stored to ensure an acceptable level of safety and quality:

* The pharmacy laminar flow hood used for compounding intravenous medications was not maintained sterile as required by standards of practice. The laminar flow hood could harbor infectious germs and contaminate intravenous medications.
* A box of expired red top laboratory tubes was found available for patient use in the ICU supply room. The expired laboratory tubes could interfere with the accuracy of laboratory results.
* Expired disinfectants in the MRI supply room were available for cleaning of the MRI table between patients and were stored with food items and clean medical supplies. This created the potential for accidental ingestion of the disinfectants and possible contamination of medical supplies.
* The MRI fire extinguisher was not inspected the last 2 months. Required regular inspection of fire extinguisher ensured availability of the equipment when needed.
* The printer of the washer to clean endoscopic equipment was broken for an unknown period of time. The machine to determine leaks in endoscopic equipment was also out of printing paper to record viability of the equipment.
* The Psychiatric ED (PED) failed to be large enough to maintain privacy and provide sleeping accomodations for the average daily patient census.

Findings:

1. On 12/13/10 at 1035 hours a pharmacy technician was observed mixing an intravenous solution in a laminar flow hood (LFH). The LFH provides a clean area where these solutions must be prepared to maintain their sterility (no germs). A white milky substance was observed growing on the screen covering the inside back wall of the LFH. Air flows through this screen and could disperse any contaminants growing there. The DOP was asked for sterility data on the observed LFH. It was stated they do not perform these tests any more as their clinical laboratory would not perform the testing for them. A laboratory culture test to determine sterility was requested. The preliminary report on 12/14/10 from the hospital's clinical laboratory indicated "Gram positive cocci, fastidious growth observed." A final report supplied by the facility indicated "Staphylococcus Epidermis" to be present in the LFH, thereby negating the use of the hood as a "clean" area.

2. On 12/13/10 at 1405 hours, during the ICU tour accompanied by RN 30, a box of expired red laboratory tubes was found in the supply room available for patient use. RN 30 responded by disposing of the box of expired laboratory tubes and ensured the remaining boxes of laboratory tubes were up to date.

3. a. On 12/14/10 at 1500 hours, during the initial tour of the Magnetic Resonance Imaging (MRI) area accompanied by the Unit Manager, the clean storage room for medical supplies was found to have janitorial supplies such as a floor mop, broom, and toilet supplies. On the right side of the second upper shelf, expired liquid disinfectants, dated 10/2010, were stored beside office paper supplies, coffee filters and powdered coffee creamer. On the right side of the shelf were medical supplies for patient use.

On 12/14/10 at 1510 hours, the Unit Manager acknowledged the different kinds of liquid disinfectants were expired and were to be thrown away. The janitorial supplies were kept behind the door because there was no place else to keep the supplies including the coffee filters and creamer.

b. In the same area, the fire extinguisher located before the entrance door to the MRI examining room was noted to miss two months of inspection. The notice attached to the equipment stated, "Periodic inspections must be performed at regular intervals." The equipment was checked every month from January to October 2010 but none for November and December 2010.

On 12/14/10 at 1515 hours, the Unit Manager stated she would notify the Maintenance Operator.

5. On 12/14/10 at 1330 hours, during the initial tour of the Gastrointestinal Laboratory RN 31 stated the printer of the washer to clean the endoscope equipment was broken. CNA 1, in-charge of cleaning the equipment, was unable to determine how long the printer had been non-functional. The other machine to detect leaks on endoscope equipment was also out of paper to record the viability of the endoscope equipment.

MD 14 could not believe there was no printed proof that the endoscope equipment went through leak detecting tests to assure quality and safety.

6. On 12/13/10 at 0900 hours, a tour of the PED was conducted. The Director of Psychiatry was in accompaniment. The PED consisted of two rooms opposite each other with a nursing station in between the two rooms. Patients could be observed through plexiglass windows located on both sides of the nursing station. Each room had a separate door leading to the room from the nursing station. Each room had a nursing staff member stationed inside the room. One room had a census of ten patients and the other room had a census of fifteen patients for a total of twenty-five. The approved patient bed capacity for the PED was twelve.

The room on the left from the entrance was designated the Blue Room, the room on the right the Pink Room. The Blue Room had 4 hospital beds and an assortment of chairs and couches. Some patients were occupying the beds and others were lying down on the couches. Other patients were observed sitting asleep in the chairs. Two patients were sitting on the floor.

Patients and staff were observed in each room. A psychiatrist was observed talking to a patient in the Blue Room. A nurse was observed to be bringing medication into the Blue Room and administered it to a patient located there. There was no area in the Blue Room to have a private conversation.

The Pink Room was observed with staff members sitting at tables near the entrance to the room. Patients in the Pink Room were observed laying down on the couches, chairs, and sitting on the floor. There were no privacy curtains in the Pink Room. There was no location in the Pink Room where one could have a private conversation.

An interview with the PED Manager was conducted on 12/13/10 at 1030 hours. The Manager was asked about the PED bed capacity and she replied it was twelve. She stated PED runs over capacity on a daily basis. She stated the patients who are there overnight will have a mattress to sleep on. She stated mattresses are brought by environmental services staff (EVS) each evening for patient ' s to sleep on. The mattresses are placed on the floor. The manager stated patients are also brought to the sixth floor in-patient psychiatric unit where patients may sleep on a mattress in the day room.

Based on interviews, observation and a tour of the hospital, the hospital failed to ensure a sanitary environment to avoid transmission of infection and communicable diseases. The deficient practices could lead to spread of infections in the hospital.

Findings:

1. The hospital failed to ensure that appropriate disinfection procedures between patient procedures were performed in the cardiac catheterization laboratory. See A749, #1.

2. The hospital failed to ensure that operating rooms had been disinfected in a manner consistent with manufacturer's recommendations for the product being used to clean and disinfect surfaces between patient procedures. See A749, #2.

3. The hospital failed to ensure the pharmacy maintained a sterile laminar flow hood for compunding intravenous medications. See A500, #6.

4. The hospital failed to ensure that ice machines had been disinfected in accordance with manufacturer's rcommendations. See A620 #7 and 749 #6.

5. The hospital failed to have a mechanism in place 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. See A749 #3.

6. The hospital failed to ensure surgical areas and supplies were cleaned in accordance with manufacturer recommendations and standards of practice. See A951.

7. The hospital failed to ensure hand hygiene was performed in the ED and isolation procedures were followed on the medical surgical floor. See A749 #4.

8. The hospital failed to ensure the Infection Control Officer provided oversight in dietary services to ensure the meat cooling process was followed per department policies. See A 749 #7.

9. The hospital failed to ensure GI laboratory personnel followed the manufacturer's recommended dilution ratio for effective cleaning of endoscopes using medical enzyme detergents. See A749, #5.

The cummulative effect of these deficient practices resulted in the inability of the hospital to provide quality health care in a safe environment.

Based on observation, interviews, and record review, the infection control officer:

* Failed to ensure a sanitary environment was maintained in the cardiac catheterization laboratory and the operating room.
* Failed to ensure there was a 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.
* Failed to ensure that the laminar flow hood in the pharmacy had been maintained in a clean manner to prevent contamination of intravenous solutions and medications.
* Failed to ensure the GI (Gastrointestinal) Laboratory followed the manufacturer's recommendation for effective disinfection of endoscopic equipment to ensure prevention of infection.
* Failed to ensure the manufacturers' directions on maintenance of ice machines were followed which could potentially contribute to development of microorganisms in unsanitized ice machines.
* Failed to ensure hand hygiene was performed in the ED and isolation procedures were followed on the medical surgical floor. This could potentially lead to the spread of infection.


Findings:

1. On 12/13/10, a tour of the cath lab (cardiac catheterization laboratory) was performed. Housekeeper 6 was observed cleaning the cath lab, following a cardiac catheterization procedure. The housekeeper failed to remove the mattress from the procedure table and when wiping the surface of the mattress and the table, one quick wipe was performed. By actual timing, the surface remained wet for approximately 30 seconds. The disinfectant product manufacturer's guidelines required that the surfaces remain wet for three minutes. Housekeeper 6 seemed unaware that all surfaces required prolonged contact with the product to ensure safe disinfection of all surfaces.

2. On 12/14/10 at 0830 hours, a tour of the operating room area was conducted. During the tour, Housekeeper 4 and Housekeeper 5 were observed cleaning the OR (operating room) following a surgical procedure. Wiped surfaces were dry in less than 3 minutes. A review of the manufacturer's guidelines for the disinfectant product indicated that the surfaces must remain wet for 10 minutes to be effective.

An interview was conducted with members of the infectious disease department on 12/16/10 at approximately 1130 hours. The infectious disease physician and the Infection Control Practitioner stated that direct observation of cleaning practices in the OR were not indicated since there were no surgical infection outcomes related to this.

3. On 12/14/10, at 1100 hours, the sterile processing area was toured and the CS (Central Service) Supervisor was interviewed, along with the OR Nursing Director. Multiple sets of instruments trays were observed. According to the CS Supervisor, instrument trays were placed on carts to be sent to the various OR rooms according to the surgery and the instruments needed. Both the CS Supervisor and the OR Director stated there were no logs to track or inventory surgical trays or instruments from sterilization to the operating room. There was no policy or procedure in place to track or trace the instruments to the specific operating room suite, or to determine which patients the trays had been used on in the event of a failed sterilization of a load of surgical instrument trays and/or packages.

4. On 12/13/10 at 1035 hours a pharmacy technician was observed mixing an intravenous solution in a laminar flow hood (LFH). A white milky substance was observed growing on the screen covering the inside back wall of the LFH. Air flows through this screen and could disperse any contaminants growing there. The DOP was asked for sterility data on the observed LFH and he stated that they did not perform these tests any more as their clinical lab would not perform the testing for them. A laboratory culture test was requested and a preliminary report on 12/14/10 from the hospital's clinical lab indicated "Gram positive cocci and fastidious growth observed." A final report supplied by the facility indicated "Staphylococcus Epidermis" to be present in the LFH thereby negating the use of the hood as a "clean" area.


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5. The CDC Guideline for Disinfection and Sterilization in Health Facilities, 2008, show "As with all chemicals, enzymes must be rinsed from the equipment or adverse reactions could result. Enzyme solutions should be used in accordance to manufacturer's instructions, which include proper dilution of the enzymatic detergent and contact with equipment for the amount of time specified on the label. Detergent enzymes could result in asthma or other allergic effects in users."

On 12/14/10 at 1330 hours, during the initial tour of the GI Lab, CNA 1 was asked to demonstrate how the endoscope equipment was being cleaned and disinfected for future use. She began by disconnecting the parts of the scopes and placing them in the sink, filled the sink with water until all the parts of the scopes were completely immersed in water. CNA 1, then, applied 3 "squirts" of medical enzyme detergent and allowed the equipment to soak in the sink for 30 minutes before rinsing.

Review of the manufacturer's recommendation on using the medical enzyme detergent stated the dilution for effective cleaning consisted of 1 ounce of the detergent to a gallon of water. When the amount of water in the sink was measured by CNA 1 by the gallons, there were 2 extra gallons of water for the amount of detergent used.

On 12/14/10 at 1500 hours, CNA 1 and MD 14 acknowledged that eyeing the level of water in the sink to be diluted by a "few squirts" of detergent was an inaccurate way of achieving the proper dilution.

6. On 12/13/10 at 1315 hours, and throughout the survey, the cleaning and sanitizing of approximately 20 ice machines was investigated. The ice machines were located hospital wide in medical units, kitchens and cafeterias and used for patients and the public.

On 12/15/10 at 1100 hours, the shoot ice machine in the Labor and Delivery pantry was inspected. The two clear plastic shoots had visible buildup of white and black substance inside. Staff confirmed the presence of the white substance with a paper towel wiped on the inside of the tubes.

During a meeting with Facilities 1 on 12/13/10 at 1300 hours, the preventive maintenance for all hospital ice machines was reviewed. There were approximately 20 ice machines from two manufactures. Facilities 1 stated the ice machines were cleaned with a descaling product and the parts were rinsed with water. He stated he did not feel it was necessary to sanitize the parts.

Review of both manufacturers' manuals on 12/13/10 at 1300 hours showed specific requirements for cleaning and sanitizing the internal parts of the ice machines. Facilities 1 confirmed that the hospital was not following the manufacturer's recommendations.

On 12/15/10 at 0900 hours, The Infection Control Practitioner was asked if the ice machine cleaning and sanitizing policies had been reviewed as part of the hospital wide infection control program. RN 14 stated the ice machines had not been reviewed by the infection control committee. Further review of the Infection Control Plan on 12/15/10 at 0900 hours showed the infection control plan goals were "for surveillance, prevention and control of infections including many components, in both direct patient care and patient care support areas." However, there was no plan for hospital wide oversight of departments like the food and dietetic services.

7. On 12/14/10, there was one pan of roast beef in the walk-in refrigerator. Staff stated the roast beef was cooked on Saturday, 12/11/10, to be served for Sunday, 12/12/10 and Monday, 12/13/10.

On 12/15/10, review of the Food Temperature Monitoring Chart showed the cooling section was not completed on 11/6/10, 11/13/10, 11/20/10, 11/27/10, and 12/4/10. The cooling log was filled in only on 12/11/10. Chef 1 was not able to explain why the cool down log was not documented to ensure the cooling prevented the growth of microorganisms and food borne illnesses. Chef 1 acknowledged that he had not reviewed the cool down logs to ensure the cooks properly documented the cooling process.

There was no infection control oversight of the Food and Nutrition department's HACCP (Hazards Analysis Critical Control Points) program implementation.


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8. Review of the hospital's policy and procedure "Hand Hygiene in Healthcare Settings" revised 4/10, showed hand hygiene was to be done before and after patient contact.

On 12/13/10 at 1510 hours, CNA 1 was observed touching a patient, then touching a cart. CNA 1 then went into a room and obtained a blanket and placed it on the patient. The CNA then went to an empty clean gurney and moved it to a new location. The CNA did not remove his gloves or perform hand hygiene between any of these activities.

9. On 12/14/10, review of the hospital's Infection Control P&P, #1889; Version 1, on Isolation Procedure; Removing PPE, showed people were to remove PPE (Personal Protective Equipment) at the doorway or in an anteroom before leaving the room. The procedure was for people to remove their respirator/mask outside of the room. The front of the respirator/mask and the outside of the gloves were contaminated and should be discarded in a waste container.

a. On 12/13/10 at 1140 hours, a housekeeping staff was observed leaving an isolation room wearing a gown, mask and gloves. The housekeeper walked over and discarded the PPE in the trash container at the main hallway. The housekeeper then pushed the trash container down the hallway. She did not wash her hands after removing the isolation clothing.

On 12/13/10 at 1420 hours, during an interview RN 28 stated staff could wear masks out of an airborne isolation room and place them in the trash containers outside of the isolation room. However, observation of the isolation room area showed there was no trash container available outside of the airborne isolation room. A staff member was observed removing the mask and taking it over to the nurses' station to dispose of it.

b. On 12/14/10 at 1300 hours, a staff member was observed coming out of a contact isolation room wearing a blue gown. The staff member did not have a mask or gloves on. The staff member went to the isolation supply cart and took some supplies. As the staff member was removing the supplies, another staff member dressed in a yellow gown partially stepped out of the door and asked the staff member in the blue gown to bring the chart on top of the supply cart. The staff member re-entered the contact isolation room with the patient's chart.

c. During observation of a contact isolation room on 12/14/10 at 1350 hours, a staff member was observed leaving the isolation room wearing her mask. During an interview with RN 15, she verified the staff member was a respiratory therapist.

On 12/15/10 at 0810 hours, during an interview with the Infection Control Physician and the Infection Control Practitioner, they acknowledged a trash container should be available for the placement of masks outside an airborne isolation room. Gowns, masks and gloves should be removed before leaving a contact isolation room and medical records should not be taken into isolation rooms.

Based on observation, interview and record review, the hospital failed to ensure surgical service areas and supplies were cleaned in accordance with manufacturer's recommendations and accepted standards of practice. This could potentially result in the spread of infection or patient injury.

Findings:

1. On 12/14/10, at 1050 hours, CS Tech 1 was observed cleaning surgical instruments prior to washing and sterilization procedures. When interviewed, CS Tech 1 stated that he estimated the dilution of the enzymatic agent and water for enzymatic cleaning of the surgical instruments. A review of the manufacturer's recommendation for the enzymatic product showed that it was to be mixed as 1 ml of product to16 ml. of water.

2. At 1100 hours on 12/14/10, the sterile processing area was toured and the Central Supervisor was interviewed, along with the OR Nursing Director. Both stated that there was no mechanism to track or inventory surgical trays or instruments following sterilization. Both stated that the trays were stored in a storage area and sent to an operating room upon request, however, there was no policy or procedure in place to track or trace the instruments to the specific operating room suite, or to determine who had received the trays in order to track instrument tray loads to patients/surgical procedures.

3. On 12/14/2010 at 0830 hours, a tour of the operating room area was conducted. During the tour, Housekeeper 4 and Housekeeper 5 were observed cleaning the operating room following a surgical procedure. Wiped surfaces were dry in less than 3 minutes. A review of the manufacturer's guidelines for the disinfectant product indicated that the surfaces must remain wet for 10 minutes to be effective.



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4. On 12/14/10, Operating Room 6 had a stool with adhesive tape across the seatl and a patient warming machine with tape holding the tubing to the machine. The OR Director stated the tape on the stool was so the physician didn't slide off.

5. The 2010 edition of the AORN's Perioperative Standards and Recommended Practices, under the section titled Recommended Practices for Cleaning and Care of Surgical Instruments and Power Equipment, showed instruments should be kept in the open and unlocked position.

On 12/14/10 at 0850 hours, a tour of the OR area was conducted. Packaged sterilized instruments were inspected and one pair of face lift scissors and one pair of iris scissors were found in the closed position. These were shown to the OR Director who confirmed the scissors should be in the open position.