HospitalInspections.org

Based on observations and staff interview the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure that expired supplies were not available for patient use.

The findings were:

1. Expired Laboratory Supplies
A tour of the pre-operative patient care area on 12/12/2011 at approximately 2:15 PM with the Director of Surgical Services revealed that in the pre-operative area there was a cupboard with laboratory test tubes. There were approximately 20 yellow laboratory tubes that had a manufacturer's expiration date of 11/2011 that were available in the cupboard for patient use. The date on the tubes was confirmed by the Pre-operative/Post-operative Nurse Manager.

A tour of the infusion center patient care area on 12/13/2011 at approximately 9:45 AM with the Director of Surgical Services revealed that in one of the patient rooms, a drawer contained laboratory tubes for patient laboratory draws. Thirteen lavender laboratory tubes were found that had a manufacturer's expiration date of 11/2011. The date on the tubes was confirmed by the Infusion Center Nurse Manager.

2. Expired Glucometer Controls
A facility policy titled "Ancillary blood glucose monitoring: Accu-Chek inform" last revised 6/22/2011 stated the following, in pertinent parts:
"...All units providing the service of Accu-Chek Inform blood glucose monitoring shall comply with the established quality control measures...
Quality Control Guidelines
1. Two levels of Roche Diagnostics Quality Control material will be run on each day that patient testing is to be done, on each Accu-Chek Inform Glucose Meters....
2. Storage of Controls and Test Strips
2.1 Glucose Control Solutions must be stored at room temperature. Do not refrigerate or freeze. Glucose Control Solutions are stable for three months after opening or until the expiration date that is printed on the vial, whichever comes first. The date opened, expiration date, and user's initials must be written on the vial label.
2.2 Any outdated Glucose Control Solutions must be discarded..."

A tour of the outpatient eye surgery center that functioned as an outpatient department of the hospital on 12/13/2011 at approximately 10:40 AM revealed that the glucose control solutions available for use had written indication that the bottles were opened on 9/6/2011 and were to be discarded 12/6/2011. The manager of the surgery center confirmed that the glucose control solutions were labeled to be discarded on 12/6/2011. S/he confirmed with the nurse on duty that the control solutions labeled to be discarded on 12/6/2011 were used on 12/13/2011 for the quality control check.

Cross reference tag A0505 for findings related to the hospital's failure to ensure that outdated and unusable drugs were not available for patient use.

Based on credential file review, review of the facility's medical staff delineation of privileges sets, and staff interview the facility failed to ensure that practitioners were granted specific privileges when placed on the medical staff. Specifically, the facility failed to delineate what tasks/activities/procedures the practitioners were granted privileges to do.

The findings were:

Review of the provided delineations of privileges for the various medical specialty areas of the medical staff revealed the following, in pertinent parts:

"Classification of Privileges in the Department of Medicine.
Each staff physician will be classified as having certain professional privileges, as outlined below. You are asked to request the privileges you deem appropriate to your training and skills. The requests will be reviewed by various committees and final decision will be made by the Board, upon recommendation of the Medical Executive Committee. It is understood that any physician may take appropriate emergency action in a situation where, in the best judgement of the attending physician, such immediate action is necessary for the patient's welfare.

Class of Privileges (PLEASE CIRCLE the group you are requesting.)

CLASS 1 Competent to handle all medical conditions of mild to moderate degree. Physicians in this class are required to request consultation in all cases in which doubt exists as to the diagnosis, or in cases in which improvement in the patient's condition is not soon apparent.
CLASS 2 Competent to handle medical conditions and consultations of greater severity or complexity, requiring specialized knowledge. This category will generally include physicians certified by or with training and experience required for certification by the American Board of Internal Medicine. Such physicians will be expected to request consultation when hazardous treatment procedures are contemplated; when unexpected complications arise; in cases in which treatment response seems unduly delayed.
CLASS 2A Competent to handle medical conditions, but no consultations, of greater complexity. This category may include physicians who are certified by the American Board of Family Practice, and who furthermore have demonstrated sufficient postgraduate training and competence in the management of more complex illnesses in the field of internal medicine. Such physicians will be expected to request consultation when hazardous treatment procedures are contemplated; when unexpected complications arise; in cases in which treatment response seem unduly delayed.
CLASS 3 Competent to handle the most difficult procedures and conditions in certain areas requiring unusually specialized knowledge. Generally comparable to certification by, or with training and experience required for certification by a specialty board. This includes the following categories:
Allergy/Immunology
Cardiovascular Diseases
Dermatology
Endocrinology
Gastroenterology
Hematology/Oncology
Infectious Disease
Nephrology
Neurology
Psychiatry
Pulmonary Diseases
Rheumatology
Toxicology..."
Attached to the Medical delineation of privileges were additional specialty privileges, including
"General Procedures", which included the following:
"Arterial Puncture, Arthrocentesis, Lumbar Puncture, Paracentesis, Skin Biopsy, Subclavian Catheterization, Thoracentesis..."
"Cardiovascular Procedures..."
"Endocrinology Procedures..."
"Gastroenterology..."
"Nephrology..."
"Neurology..."
"Psychiatry Procedures..."
"Pulmonary Procedures..."
"Rheumatology..."
"Sedation Analgesia (For Non-Anesthesiologists)..."
"Moderate Sedation Analgesia..."
"If you wish to perform any procedure not listed on this form, please contact your department chairman or the medical staff office..."

The additional sets of delineated privileges, which all included "core" or "block" privileges, were also reviewed:
"Emergency Medicine Physician (EP) Core Privileges," "Anesthesia Privileges," "Radiology Privileges," "Pathology Privileges," "Certified Registered Nurse Anesthetist," "Physician Assistant," "Nurse Practitioner/Clinical Nurse Specialist," "Certified Nurse Midwife," "Orthopedic (Surgery) Clinical Privileges," "Surgery - General, Colorectal and Pediatric," "Cardiovascular and Thoracic Surgery Privileges," "Oral and Maxillofacial Surgery Clinical Privileges," "Ophthalmology Clinical Privileges," "Otolaryngology Clinical Privileges," "Podiatry Privileges," "Urology Clinical Privileges," "Vascular Surgery Privileges," "Internal Medicine," "Cardiology," "Dermatology," "Endocrinology," "Hematology," "Infectious Disease," "Nephrology," "Neurology," "Psychiatry," "Pain Management," "Physical Medicine and Rehabilitation," "Rheumatology."

Review on 12/15/11 of the privilege delineation sets revealed that they all started with a large description of "core" or "block" privileges, which were presented in such a format that there was no way to select or delete components of the "core" or "block" privileges to accommodate the skills and needs/wishes of the individual physician as required. Some delineation sets also had additional groupings of other privileges, some were listed as a group allowing no choice, and some were provided in a "menu" format that allowed for individual choice.

An interview with the Associate Chief Nursing Officer conducted on 12/14/2011 at approximately 4:15 PM revealed that the Clinical Administrator on Duty (CAD) utilized a computer program to review the privileges granted to practitioners when necessary to ensure that surgeons had privileges to perform specific procedures. S/he was asked to retrieve the privileges for a specific surgeon. S/he was able to utilize a software system which contained scanned copies of the sheet(s) of paper that were filled out by practitioners when applying for inclusion on the medical staff. The plastic surgeon reviewed at that time had been granted the privileges of "Cosmetic Surgery" and "Reconstructive Surgery". The privileges were not specified any further than those two categories and did not list any specific procedures that would be included under those broad categories. The medical staff office staff member stated that the information obtained was the same in both systems.

An interview with the hospital's Director of Medical Staff on 12/15/2011 at approximately 7:50 a.m. confirmed that the Medical Staff Office staff and the hospital's staff had access to the system that was described the Associate Chief Nursing Officer. S/he confirmed that the hospital granted "core privileges" and did not further specify privileges for most practitioners.

A subsequent interview with the hospital's Director of Medical Staff and the corporate Director of Credential Support Center conducted on 12/15/2011 at approximately 9:23 AM revealed that the hospital and the governing body were unaware of a need to grant specific privileges rather than groups or more general privileges.

Based on staff interviews, tour observations and review of facility policies/procedures, the facility failed to assure that unauthorized individuals could gain access to or alter patient medical records. Specifically, the following areas failed to maintain adequate security and confidentiality of patient medical records:
1. The HIM (Health Information Management) office during off business hours failed to be secured when housekeeping cleaned the area.
2. The laboratory/pathology department failed to secure anatomical reports during off hours when housekeeping cleaned the area.
3. The outpatient eye surgery center that functioned as an outpatient department of the hospital failed to secure patients' medical records when the department was not staffed.

The findings were:

The facility's policy and procedure entitled "Record Confidentiality and Safeguarding" stated the following in pertinent part:
"4. Record Access:
4.1. Access to areas housing medical records shall be limited to the HIM Department personnel. The sole exception to this policy shall be the nursing personnel designated by Nursing Administration, and at times in which the HIM department is not staffed.
4.2. The front door to the HIM Department is secured by badge swipe access. The back door is locked at all times.
4.3. Only designated hospital staff have access to HIM (e.g., Director of Health Information Management, designated HIM staff, Physicians, Nurse Managers.)"

During the tour, an interview was conducted with the HIM Manager on 12/12/11 at approximately 3:00 p.m. regarding the security of medical records and when housekeeping comes into the area. The Manager stated that housekeeping comes in between five and six and they use a badge access. There might be medical records personnel in the department when housekeeping are doing the cleaning, but there are times when no one would be in the HIM department. Furthermore, housekeeping does not turn in their badges when they leave so they have access to medical records anytime of the day or night. The Manager agreed that this was not good practice and did not assure the confidentiality of medical records.


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On 12/12/11 at approximately 11:30 a.m., during a tour of the laboratory area with the department manager, it was determined that
pathology reports were stored in unsecured files in the pathology area. The manager stated that patient anatomical reports were considered a part of the medical record. S/he stated that the manager of the medical records department was aware that the patients' anatomical reports were maintained in the pathology area of the laboratory department. S/he stated that the records were maintained in compliance with all state and federal requirements. S/he stated that the pathology area was locked at night, but that hospital housekeeping crews had access to that area during off hours when pathology/laboratory staff were not present in that area. S/he stated that the records were not secured during off hours in locked shelving or file cabinets.


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A tour of the outpatient eye surgery center that functioned as an outpatient department of the hospital on 12/13/2011 at approximately 11:00 AM revealed that the center kept the medical records of patients on a shelf overnight. The manager of the surgery center stated that overnight, the center was cleaned by a housekeeping employee, sometimes unsupervised. Furthermore, s/he stated that the records were not secured overnight from unauthorized access. S/he stated that the center had cabinets that could lock, but that the center did not currently utilize them for record storage.

Based on tour of the facility, staff interviews, and review of policies/procedures, the facility failed to ensure drugs were stored in accordance with accepted professional principles and in accordance with their own policies and procedures. Specifically, the facility did not monitor refrigerator temperatures consistently. The hospital did not indicate what actions were taken when temperatures were found to be out of range. This failure created the potential for a negative outcome.

The findings were:

A facility policy titled: "Refrigerators" last revised 9/23/2011 stated the following, in pertinent parts:
"...3. Refrigerator temperature checks shall be completed and logs maintained by the department in which they are located...
5. Medications (See Refrigeration of Medications policy in Medication Management Chapter.
6. Any refrigerator noted out of temperature range or to be malfunctioning shall be reported immediately to Plant Operations and noted on the log..."

A facility policy titled: "Refrigeration of Medications, Patient Food, and Human Milk" last revised 12/21/2010 stated the following, in pertinent parts:
"...Purpose: To provide for proper storage of drugs, patient foods and human milk requiring controlled temperature storage and to alert the appropriate staff when a storage refrigerator is outside of the acceptable temperature range...
3.2 Nursing Staff shall be responsible for checking medication storage requirements and for storing them properly while they are on the unit...
6. Temperatures must be maintained as follows:
Medication Refrigerators: 35 to 46 degrees F...
7. All refrigerators must be monitored to assure appropriate temperatures are maintained.
7.1. Refrigerators and freezers containing pharmaceuticals, patient food or human milk are monitored either via an electronic - computer network system linked to the Pyxis Med station or a manual temperature log...
7.3 Medications, Food or Human milk storage refrigerators and freezers which are not monitored by the electronic system will be monitored by the department in which they are located and shall maintain and complete logs of daily refrigerator temperature checks.
7.4. Any refrigerator noted out of temperature range or to be malfunctioning shall be reported immediately to Plant Operations and noted on the log...
7.7 If the temperature in a medication refrigerator cannot be brought into the appropriate range within 6 hours, or if the temperature has dropped below freezing the Plant Operations Engineer will contact the Pharmacy...to notify Pharmacy staff of the incident...
7.13 Manual refrigerator logs will be maintained on the unit for a minimum of 12 months..."

A tour of the facility's outpatient Post-Anesthesia Care Unit (PACU) on 12/12/2011 at approximately 2:22 p.m. revealed that the outpatient PACU had a medication refrigerator that was not connected to the computer monitoring system. On the front of the refrigerator there was a magnetic clip with temperature log sheets. Additionally there was a clipboard on top of the medication refrigerator with temperature log sheets. A closer review of the temperature log sheets revealed that the logs on the front of the refrigerator and on top of the refrigerator were both for recording the temperature of the medication refrigerator. Furthermore, the temperature log sheets were for the same months of October, November, and December 2011. The PACU's Nurse Manager stated that the temperature logs on the clipboard on top of the medication refrigerator were completed by the outpatient PACU staff while the temperature logs on the front of the medication refrigerator were maintained by the pharmacy staff. The temperature log maintained by the pharmacy did not have recorded readings for the following dates in December: 12/3, 12/4, 12/6, 12/10, and 12/11. The temperature log had a temperature of 32 degrees F logged on 12/1 and a temperature of 33 degrees F on 12/9, but did not have any documentation of corrective action where documentation was to be placed on the temperature log form. The temperature log maintained by the PACU did not have recorded readings for the following dates in December: 12/3, 12/4, 12/10, and 12/11. The temperature log had a temperature of 34 degrees F logged on 12/1, but did not have any documentation of corrective action where documentation was to be placed on the temperature log form.

An interview with a staff pharmacist on 12/12/2011 at approximately 2:42 p.m. revealed that the pharmacy department was in the process of ensuring that the temperature of the medication refrigerator was monitored daily. S/he stated that the facility had discovered that the refrigerator was not being monitored on days when the surgical department did not utilize the outpatient PACU. S/he stated that the facility was in the process of purchasing a new device that would be placed in the refrigerator that could track the temperature over a month-long period. However, s/he stated that the new devices were not currently in place.

Based on observations, staff interviews, and review of the hospital's policies/procedures the hospital failed to ensure that all outpatient departments adhered to the hospital's policies for medication storage and disposal.

A hospital policy titled "Expiration Dating (Beyond Use Dating) for Injectable Medications in Vials and Ampuls" last revised 1/3/2011 stated the following, in pertinent parts:
"...The maximum period in which a solution containing a preservative may be used once the stopper has been punctured will be 28 days unless the manufacturer specifies a Beyond Use Date (BUD) that is shorter unless contamination is evident or suspected...
1.2.3. Vials containing preservative - BUD of 28 days with the following exceptions...
1.2.3.3. Vial should be labeled with BUD and discarded at expiry. Vials not labeled with BUD will be discarded immediately..."

A hospital policy titled "Warming IV and Irrigation Fluids" last reviewed 9/27/2010 stated the following, in pertinent parts:
"...Procedure
Pour Fluids:
1. For warmed pour fluids, these bottles can be stored in a warming cabinet at a temperature not to exceed 110 degrees F (43 degrees C) no longer than 14 days...
3. Pour fluid bottles must be dated, stored and rotated according to manufacturers' instructions to ensure the integrity of the fluids.
4. All pour fluids bottles that have been warmed for 14 days will be discarded.
Bagged Fluids:
1. Bagged fluids in the overwrap may be in a warming cabinet with a temperature not to exceed 110 degrees F (43 degrees C) no longer than 14 days...
3. Bagged fluids must be dated, stored and rotated according to manufacturers' instructions to ensure the integrity of the fluids.
4. All bagged fluids that have been warmed for 14 days will be discarded..."

A tour of the Family Medicine clinic that served as an outpatient department of the hospital on 12/13/2011 at approximately 12:35 p.m. with the clinic's Operations Manager revealed that the clinic administered medications occasionally which included the use of multidose vials. A vial of Novolog insulin was found in the clinic's medication refrigerator. The vial had written indication on the bottle that it had been opened on 11/19/2011 and was to be discarded on 12/19/2011. The written indication was not consistent with the hospital's policy to discard multidose medication vials after 28 days. A vial of tuberculin skin testing solution was found in the clinic's refrigerator that had written indication that it had been opened on 10/10/2011 and was to be discarded 11/10/2011. The bottle had a manufacturer's direction that the solution be discarded 30 days after being opened. The vial remained available for patient use beyond the manufacturer's recommended beyond use date. A vial of 2% Lidocaine was found in a drawer that had written indication that it had been opened on 12/1/2011 and was to be discarded 1/1/2012. The written indication was not consistent with the hospital's policy to discard multidose medication vials after 28 days.

A tour of the hospital's Post-Anesthesia Care Unit on 12/12/2011 at approximately 2:00 p.m. with the Director of Surgical Services revealed that the department utilized a warming cabinet for intravenous fluids. The cabinet contained nine bags of normal saline solution that had written indication that the bags needed to be removed from the cabinet on 1/1/2012 (19 days after the date of the observations). The staff of the Post-Anesthesia Care Unit (PACU) as well as the PACU's Nurse Manager were asked what the facility's policy on the storage of fluids in the warming cabinets. They were initially unable to state what the policy was, but were able to confirm that the facility's policy was that fluid was to be removed from the cabinet after 14 days. The PACU's Nurse Manager confirmed that the written indication on the nine bags of normal saline solution was inconsistent with the facility's policies.

A tour of the hospital's Obstetrical Surgical area on 12/12/2011 at approximately 3:55 p.m. with the Obstetrical Technician revealed that a warming cabinet in the surgical area contained both intravenous fluids and pour fluids. None of the fluids were dated in accordance with the facility's policy. The obstetrical technician stated that the anesthesia staff stocked the fluids in the warmer and confirmed that the fluids did not have a written indication when they were placed in the warmer or when the fluids needed to be removed from the warmer.


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On 12/13/11 at approximately 9:30 a.m., during a tour of the main medication room for the medical/telemetry unit the patient individual medication drawers were inspected and revealed the following:

Examination of the drawer for patient room 404 revealed a previously opened multiple dose vial of Heparin that had no label of when the vial had been opened, initials of the staff member who had opened the vial, or the date that the vial would reach the 28-day after opening date that required the vial to be discarded, per facility policy/procedure. The clinical pharmacist stated that the medication should have been labeled at the time of opening, so that the 28-day discard date would have been determined to ensure that the medication did not reach a patient after the exceed the "beyond use date" (BUD). S/he removed and discarded the medication, after it was presented to her.

Examination of the drawer for patient room 423 revealed that it contained a patient's own outpatient prescription bottle containing Warfarin. The bottle was not labeled with a bar code and evidence that it had been inspected by the pharmacy and approved for hospital administration. The clinical pharmacist stated that the medication should not have been stored in the patient medication drawer on the unit unless it was inspected, barcoded and approved for use in the hospital per a physician order. S/he stated that it appeared to be a patient's prescription bottle brought in at the time of admission. S/he stated that the medication should have been sent home with family or sent to the pharmacy for storage until discharge.

Examination of the drawer for patient room 426 revealed a previously opened multiple dose vial of Heparin that had no label of when the vial had been opened, initials of the staff member who had opened the vial, or the date that the vial would reach the 28-day after opening date that required the vial to be discarded, per facility policy/procedure. The clinical pharmacist stated that the medication should have been labeled at the time of opening, so that the 28-day discard date would have been determined to ensure that the medication did not reach a patient after the exceed the "beyond use date" (BUD). S/he removed and discarded the medication, after it was presented to her.

Examination of the drawer for patient room 440 revealed that it contained a plastic bag containing five bottles of the patient's own medications from home. The bag contained one prescription bottle of Metoprolol ER 25 mg, and four over-the-counter bottles for a multivitamin, famotidine, aspirin 81 mg and NAC (N-acetyl cysten). The patient's nurse was questioned why the medications were in the medication drawer, since they contained no evidence of a bar code or inspection/approval by pharmacy. S/he stated that the medications were not being administered to the patient and that s/he would send them home with the patient's spouse that day. The clinical pharmacist stated that the medications should not have been stored in the patient medication drawer on the unit unless it was inspected, barcoded and approved for use in the hospital per a physician order. S/he stated that the medication should have been sent home with family or sent to the pharmacy for storage until discharge.

During the inspection of the medication room, a plastic grocery bag was found stored on the top of the medication refrigerator, behind two large bottles of liquid nutritional supplements. The unlabelled bag contained a ripped paper bag that contained what appeared to be 14 sample boxes containing bottles of Aciphex 20 mg. No nursing staff on the unit knew who the samples belonged to or how long they had been stored on top of the refrigerator. The clinical pharmacist stated that the hospital did not allow sample medications. S/he stated that s/he had no explanation for why the apparent samples were found in the medication room. S/he theorized that the medications were probably samples brought in by a patient at the time of admission, but they should have been labelled and sent home with family or sent to the pharmacy for storage until discharge. S/he removed and discarded the medication, after it was presented to her.

The findings were confirmed with the nursing manager for the unit, the assistant director of nursing and the clinical pharmacist for the unit.

Based on facility tours, staff interviews and facility documents, the facility failed to maintain medical equipment to ensure an acceptable level of safety and quality. Specifically, there was equipment that did not have timely preventive maintenance performed and equipment that had incorrect due dates for the next scheduled preventive maintenance.

The findings were:

A tour was conducted on 12/12/11 of surgical services beginning at approximately 1:30 p.m. In the PACU (Post Anesthesia Care Unit) there was a "fluid warmer" that had a preventive maintenance sticker that was due 9/11 and a Ethicon Endo Surgery UC (Electrosurge) that had a preventive maintenance sticker due 12/7/11. Further observations in PACU and sterile processing revealed there were approximately 11 to 12 SCD (Sequential Compression Device) pumps that were all due for preventive maintenance in 11/11.

An interview was conducted with the Director of Biomed on 12/14/11 at approximately 9:00 a.m. The Director stated that the fluid warmer was a Tier 2 item and Biomed had a two month window to perform preventive maintenance. A history of the equipment was supplied by the Director and the fluid warmer was on a "could not locate" list and continued to be overlooked. However, after being located by a surveyor during the survey process, preventive maintenance was performed on 12/13/11. The history log for the Electrosurge revealed that preventive maintenance had been performed on 12/7/11; however, the technician had failed to put a new sticker on the equipment.

The interview was continued with the Director regarding the SCD pumps. The Director stated there are 200 SCD pumps located throughout the facility and they are on a two year cycle for preventive maintenance and are all due in 11/12 not 11/11. It had been determined by the facility during the time that maintenance had been performed on the pumps in 2010 that they would be phased out of service by 9/11. The Director stated that s/he made an error in judgement and had the technicians put the due date of 11/11 on every pump because all the pumps were supposed to be gone before that due date. The Director further stated that s/he regretted this decision and all the SCD pumps should have been tagged with the correct due date of 11/12 rather than the incorrect due date of 11/11. The facility has set 2/2012 as the next date when the pumps are to be phased out.


19816


On 12/13/11 at approximately 11 a.m., during a tour of the intensive care unit with the nurse manager and the assistant director of nursing, the #3 crash cart was inspected. Inspection of the defibrillator revealed that it contained a note stating "requisition sent to Biomed(ical Engineering) 12/10 to check for low battery print out." The nurse manager and the assistant director of nursing confirmed that the defibrillator should have been switched out for a working replacement, rather that leaving the defibrillator on the cart, since the performance of the machine was in question. They stated that they would address the situation immediately to ensure that a working replacement was placed on the cart and the other defibrillator removed to Biomedical Engineering.

During a tour of an equipment storage area on the unit, two portable pulse oxygen monitors were found stored in a cabinet. One of the monitors had been inspected on 12/10 and was due to be inspected 12/11. The other monitor had not been inspected since 12/08. The findings were confirmed with the nurse manager and the assistant director of nursing. They stated that the monitor with an old inspection date would be brought to the attention of Biomedical Engineering that day for inspection.

Based on tour of the facility, staff interviews, and review of policies/procedures, the facility failed to ensure that proper temperature controls were utilized in pharmaceutical storage areas. Specifically, the facility did not monitor refrigerator temperatures consistently. The hospital did not indicate what actions were taken when temperatures were found to be out of range. This failure created the potential for a negative outcome.

The findings were:

A facility policy titled: "Refrigerators" last revised 9/23/2011 stated the following, in pertinent parts:
"...3. Refrigerator temperature checks shall be completed and logs maintained by the department in which they are located...
5. Medications (See Refrigeration of Medications policy in Medication Management Chapter.
6. Any refrigerator noted out of temperature range or to be malfunctioning shall be reported immediately to Plant Operations and noted on the log..."

A facility policy titled: "Refrigeration of Medications, Patient Food, and Human Milk" last revised 12/21/2010 stated the following, in pertinent parts:
"...Purpose: To provide for proper storage of drugs, patient foods and human milk requiring controlled temperature storage and to alert the appropriate staff when a storage refrigerator is outside of the acceptable temperature range...
3.2 Nursing Staff shall be responsible for checking medication storage requirements and for storing them properly while they are on the unit...
6. Temperatures must be maintained as follows:
Medication Refrigerators: 35 to 46 degrees F...
7. All refrigerators must be monitored to assure appropriate temperatures are maintained.
7.1. Refrigerators and freezers containing pharmaceuticals, patient food or human milk are monitored either via an electronic - computer network system linked to the Pyxis Med station or a manual temperature log...
7.3 Medications, Food or Human milk storage refrigerators and freezers which are not monitored by the electronic system will be monitored by the department in which they are located and shall maintain and complete logs of daily refrigerator temperature checks.
7.4. Any refrigerator noted out of temperature range or to be malfunctioning shall be reported immediately to Plant Operations and noted on the log...
7.7 If the temperature in a medication refrigerator cannot be brought into the appropriate range within 6 hours, or if the temperature has dropped below freezing the Plant Operations Engineer will contact the Pharmacy...to notify Pharmacy staff of the incident...
7.13 Manual refrigerator logs will be maintained on the unit for a minimum of 12 months..."

A tour of the facility's outpatient Post-Anesthesia Care Unit (PACU) on 12/12/2011 at approximately 2:22 p.m. revealed that the outpatient PACU had a medication refrigerator that was not connected to the computer monitoring system. On the front of the refrigerator there was a magnetic clip with temperature log sheets. Additionally there was a clipboard on top of the medication refrigerator with temperature log sheets. A closer review of the temperature log sheets revealed that the logs on the front of the refrigerator and on top of the refrigerator were both for recording the temperature of the medication refrigerator. Furthermore, the temperature log sheets were for the same months of October, November, and December 2011. The PACU's Nurse Manager stated that the temperature logs on the clipboard on top of the medication refrigerator were completed by the outpatient PACU staff while the temperature logs on the front of the medication refrigerator were maintained by the pharmacy staff. The temperature log maintained by the pharmacy did not have recorded readings for the following dates in December: 12/3, 12/4, 12/6, 12/10, and 12/11. The temperature log had a temperature of 32 degrees F logged on 12/1 and a temperature of 33 degrees F on 12/9, but did not have any documentation of corrective action where documentation was to be placed on the temperature log form. The temperature log maintained by the PACU did not have recorded readings for the following dates in December: 12/3, 12/4, 12/10, and 12/11. The temperature log had a temperature of 34 degrees F logged on 12/1, but did not have any documentation of corrective action where documentation was to be placed on the temperature log form.

An interview with a staff pharmacist on 12/12/2011 at approximately 2:42 p.m. revealed that the pharmacy department was in the process of ensuring that the temperature of the medication refrigerator was monitored daily. S/he stated that the facility had discovered that the refrigerator was not being monitored on days when the surgical department did not utilize the outpatient PACU. S/he stated that the facility was in the process of purchasing a new device that would be placed in the refrigerator that could track the temperature over a month-long period. However, s/he stated that the new devices were not currently in place.

Based on observations during tour, staff interviews and facility documentation, the infection control officer failed to mitigate risks contributing to healthcare-associated infections including the monitoring of compliance with policies and procedures, requiring the proper use of detergents and/or germicides used in endoscopy high-level disinfection in accordance with manufacturer's guidelines and terminal cleaning of the obstetrical surgical areas.

The findings were:

1. Endoscopy scope cleaning:

On 12/13/2011 at approximately 10:05 a.m., a tour of the area utilized to clean endoscopy scopes with a nurse that was responsible for cleaning the scopes revealed that the scopes were precleaned with a detergent. The nurse stated that the scopes are placed in the sink and the sink is then filled in order to cover the scope allowing 1-2 inches of water above the scope and then three squirts of the enzymatic detergent was then added to the water. When asked if s/he had an ability to measure the amount of water added to the sink, s/he stated that it was approximately three gallons of water, but confirmed that there was not a way to measure the amount of water. The nurse stated that the instructions on the enzymatic detergent stated to add one squirt of enzymatic detergent to each gallon of water.

An interview with the Director of Surgical Services on 12/13/2011 at approximately 10:30 a.m. revealed that the amount of water had been measured previously and the sink had been marked to indicate where three gallons of water would reach. S/he stated that the line was present three weeks prior to the observations on 12/13/2011. A subsequent observation with the Director of Surgical Services of the sink used for precleaning of endoscopes on 12/13/2011 at approximately 11:30 a.m. revealed that the line was not present.

2. Terminal cleaning of obstetrical surgical areas

A policy from the hospital's contracted housekeeping service titled "Surgical/Invasive Areas and Delivery Rooms - Terminal Cleaning at the end of each day" stated the following, in pertinent part: "...Surgical and invasive procedure rooms and scrub/utility areas should be terminally cleaned daily. Terminal cleaning of operating and invasive procedure rooms should be done at the end of each day when the scheduled procedures are completed or should occur each 24-hour period during the regular work week. Unused rooms should be cleaned once during each 24-hour period during the regularly scheduled work week..."

An interview with the obstetrical technician during a tour of the surgical suites used for obstetrical surgeries conducted on 12/12/2011 at approximately 3:55 p.m. revealed the suites were not routinely terminally cleaned on a daily basis. S/he stated s/he thought the rooms were terminally cleaned "every couple of months."

A subsequent interview with the Director of Women's Services on 12/14/2011 at approximately 8:45 a.m. revealed the surgical suites used for obstetrical surgeries were expected to be terminally cleaned every day procedures are performed in the rooms. S/he stated s/he would have the Manager of Housekeeping provide the cleaning log and explain the process to the surveyor.

An interview with the Manager of Housekeeping conducted on 12/14/2011 at approximately 10:52 a.m. revealed the surgical suites for obstetrical surgeries were to be terminally cleaned Monday through Friday. S/he stated it was expected that the housekeeping personnel would document the terminally cleaning in the log provided for staff to do so. A review of the log with the Housekeeping Manager revealed the log indicated that on 12/9/2011 only one of the three surgical suites were terminally cleaned. The log for the month of October indicated that on 10/4, 10/5, 10/6, 10/11, 10/14, 10/19, 10/26, 10/27, and 10/28 only one of the three surgical suites were terminally cleaned. The log also indicated that on 10/7 and 10/13 only two of the three surgical suites were terminally cleaned.

Based on credential file review, review of the facility's Medical Staff Bylaws, Rules/Regulations, and staff interview the facility failed to ensure surgical privileges were delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The facility failed to ensure the surgical service was able to maintain a roster of practitioners specifying the specific surgical privileges of each practitioner. Specifically, the facility granted general "core privileges" that only specified the type of practitioner (such as General Surgery, Orthopedic Surgery, etc.) category.

The findings were:

Cross Reference to A 0355: Medical Staff Privileging - for findings related to the facility's failure to ensure practitioners were granted specific privileges when placed on the medical staff. Specifically, the facility failed to delineate what tasks/activities/procedures the practitioners were granted privileges to do.

An interview with the Director of Surgical Services and the Operating Room Manager conducted on 12/12/2011 at approximately 1:15 p.m. revealed the operating room staff would contact the medical staff office or the Clinical Administrator on Duty (CAD) to inquire about what privileges a surgeon had been granted if there was any question if a surgeon was able to perform a procedure in the operating room.

An interview with the Associate Chief Nursing Officer conducted on 12/14/2011 at approximately 4:15 p.m. revealed the CAD utilized a computer program to review the privileges granted to practitioners when necessary to ensure surgeons had privileges to perform specific procedures. When asked to retrieve the privileges for a specific surgeon, it was revealed that the system was not currently available due to downtime. The medical staff office staff member present was also unable to access the system. S/he was able to utilize another system that was available which contained scanned copies of the sheet(s) of paper that were filled out by practitioners when applying for inclusion on the medical staff. The plastic surgeon that was reviewed at that time had been granted the privileges of "Cosmetic Surgery" and "Reconstructive Surgery". The privileges were not specified any further than those two categories and did not list any specific procedures that would be included under those broad categories. The medical staff office staff member stated that the information obtained was the same in both systems.

An interview with the hospital's Director of Medical Staff on 12/15/2011 at approximately 7:50 a.m. confirmed that the Medical Staff Office staff and the hospital's staff had access to the system that was described the Associate Chief Nursing Officer. S/he confirmed that the hospital granted "core privileges" and did not further specify privileges for most practitioners.

A subsequent interview with the hospital's Director of Medical Staff and the corporate Director of Credential Support Center conducted on 12/15/2011 at approximately 9:23 a.m. revealed that the hospital and the governing body were unaware of a need to grant specific privileges rather than groups or more general privileges.


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Based on observations and staff interview the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure that expired supplies were not available for patient use.

The findings were:

1. Expired Laboratory Supplies
A tour of the pre-operative patient care area on 12/12/2011 at approximately 2:15 PM with the Director of Surgical Services revealed that in the pre-operative area there was a cupboard with laboratory test tubes. There were approximately 20 yellow laboratory tubes that had a manufacturer's expiration date of 11/2011 that were available in the cupboard for patient use. The date on the tubes was confirmed by the Pre-operative/Post-operative Nurse Manager.

A tour of the infusion center patient care area on 12/13/2011 at approximately 9:45 AM with the Director of Surgical Services revealed that in one of the patient rooms, a drawer contained laboratory tubes for patient laboratory draws. Thirteen lavender laboratory tubes were found that had a manufacturer's expiration date of 11/2011. The date on the tubes was confirmed by the Infusion Center Nurse Manager.

2. Expired Glucometer Controls
A facility policy titled "Ancillary blood glucose monitoring: Accu-Chek inform" last revised 6/22/2011 stated the following, in pertinent parts:
"...All units providing the service of Accu-Chek Inform blood glucose monitoring shall comply with the established quality control measures...
Quality Control Guidelines
1. Two levels of Roche Diagnostics Quality Control material will be run on each day that patient testing is to be done, on each Accu-Chek Inform Glucose Meters....
2. Storage of Controls and Test Strips
2.1 Glucose Control Solutions must be stored at room temperature. Do not refrigerate or freeze. Glucose Control Solutions are stable for three months after opening or until the expiration date that is printed on the vial, whichever comes first. The date opened, expiration date, and user's initials must be written on the vial label.
2.2 Any outdated Glucose Control Solutions must be discarded..."

A tour of the outpatient eye surgery center that functioned as an outpatient department of the hospital on 12/13/2011 at approximately 10:40 AM revealed that the glucose control solutions available for use had written indication that the bottles were opened on 9/6/2011 and were to be discarded 12/6/2011. The manager of the surgery center confirmed that the glucose control solutions were labeled to be discarded on 12/6/2011. S/he confirmed with the nurse on duty that the control solutions labeled to be discarded on 12/6/2011 were used on 12/13/2011 for the quality control check.

Cross reference tag A0505 for findings related to the hospital's failure to ensure that outdated and unusable drugs were not available for patient use.

Based on credential file review, review of the facility's medical staff delineation of privileges sets, and staff interview the facility failed to ensure that practitioners were granted specific privileges when placed on the medical staff. Specifically, the facility failed to delineate what tasks/activities/procedures the practitioners were granted privileges to do.

The findings were:

Review of the provided delineations of privileges for the various medical specialty areas of the medical staff revealed the following, in pertinent parts:

"Classification of Privileges in the Department of Medicine.
Each staff physician will be classified as having certain professional privileges, as outlined below. You are asked to request the privileges you deem appropriate to your training and skills. The requests will be reviewed by various committees and final decision will be made by the Board, upon recommendation of the Medical Executive Committee. It is understood that any physician may take appropriate emergency action in a situation where, in the best judgement of the attending physician, such immediate action is necessary for the patient's welfare.

Class of Privileges (PLEASE CIRCLE the group you are requesting.)

CLASS 1 Competent to handle all medical conditions of mild to moderate degree. Physicians in this class are required to request consultation in all cases in which doubt exists as to the diagnosis, or in cases in which improvement in the patient's condition is not soon apparent.
CLASS 2 Competent to handle medical conditions and consultations of greater severity or complexity, requiring specialized knowledge. This category will generally include physicians certified by or with training and experience required for certification by the American Board of Internal Medicine. Such physicians will be expected to request consultation when hazardous treatment procedures are contemplated; when unexpected complications arise; in cases in which treatment response seems unduly delayed.
CLASS 2A Competent to handle medical conditions, but no consultations, of greater complexity. This category may include physicians who are certified by the American Board of Family Practice, and who furthermore have demonstrated sufficient postgraduate training and competence in the management of more complex illnesses in the field of internal medicine. Such physicians will be expected to request consultation when hazardous treatment procedures are contemplated; when unexpected complications arise; in cases in which treatment response seem unduly delayed.
CLASS 3 Competent to handle the most difficult procedures and conditions in certain areas requiring unusually specialized knowledge. Generally comparable to certification by, or with training and experience required for certification by a specialty board. This includes the following categories:
Allergy/Immunology
Cardiovascular Diseases
Dermatology
Endocrinology
Gastroenterology
Hematology/Oncology
Infectious Disease
Nephrology
Neurology
Psychiatry
Pulmonary Diseases
Rheumatology
Toxicology..."
Attached to the Medical delineation of privileges were additional specialty privileges, including
"General Procedures", which included the following:
"Arterial Puncture, Arthrocentesis, Lumbar Puncture, Paracentesis, Skin Biopsy, Subclavian Catheterization, Thoracentesis..."
"Cardiovascular Procedures..."
"Endocrinology Procedures..."
"Gastroenterology..."
"Nephrology..."
"Neurology..."
"Psychiatry Procedures..."
"Pulmonary Procedures..."
"Rheumatology..."
"Sedation Analgesia (For Non-Anesthesiologists)..."
"Moderate Sedation Analgesia..."
"If you wish to perform any procedure not listed on this form, please contact your department chairman or the medical staff office..."

The additional sets of delineated privileges, which all included "core" or "block" privileges, were also reviewed:
"Emergency Medicine Physician (EP) Core Privileges," "Anesthesia Privileges," "Radiology Privileges," "Pathology Privileges," "Certified Registered Nurse Anesthetist," "Physician Assistant," "Nurse Practitioner/Clinical Nurse Specialist," "Certified Nurse Midwife," "Orthopedic (Surgery) Clinical Privileges," "Surgery - General, Colorectal and Pediatric," "Cardiovascular and Thoracic Surgery Privileges," "Oral and Maxillofacial Surgery Clinical Privileges," "Ophthalmology Clinical Privileges," "Otolaryngology Clinical Privileges," "Podiatry Privileges," "Urology Clinical Privileges," "Vascular Surgery Privileges," "Internal Medicine," "Cardiology," "Dermatology," "Endocrinology," "Hematology," "Infectious Disease," "Nephrology," "Neurology," "Psychiatry," "Pain Management," "Physical Medicine and Rehabilitation," "Rheumatology."

Review on 12/15/11 of the privilege delineation sets revealed that they all started with a large description of "core" or "block" privileges, which were presented in such a format that there was no way to select or delete components of the "core" or "block" privileges to accommodate the skills and needs/wishes of the individual physician as required. Some delineation sets also had additional groupings of other privileges, some were listed as a group allowing no choice, and some were provided in a "menu" format that allowed for individual choice.

An interview with the Associate Chief Nursing Officer conducted on 12/14/2011 at approximately 4:15 PM revealed that the Clinical Administrator on Duty (CAD) utilized a computer program to review the privileges granted to practitioners when necessary to ensure that surgeons had privileges to perform specific procedures. S/he was asked to retrieve the privileges for a specific surgeon. S/he was able to utilize a software system which contained scanned copies of the sheet(s) of paper that were filled out by practitioners when applying for inclusion on the medical staff. The plastic surgeon reviewed at that time had been granted the privileges of "Cosmetic Surgery" and "Reconstructive Surgery". The privileges were not specified any further than those two categories and did not list any specific procedures that would be included under those broad categories. The medical staff office staff member stated that the information obtained was the same in both systems.

An interview with the hospital's Director of Medical Staff on 12/15/2011 at approximately 7:50 a.m. confirmed that the Medical Staff Office staff and the hospital's staff had access to the system that was described the Associate Chief Nursing Officer. S/he confirmed that the hospital granted "core privileges" and did not further specify privileges for most practitioners.

A subsequent interview with the hospital's Director of Medical Staff and the corporate Director of Credential Support Center conducted on 12/15/2011 at approximately 9:23 AM revealed that the hospital and the governing body were unaware of a need to grant specific privileges rather than groups or more general privileges.

Based on staff interviews, tour observations and review of facility policies/procedures, the facility failed to assure that unauthorized individuals could gain access to or alter patient medical records. Specifically, the following areas failed to maintain adequate security and confidentiality of patient medical records:
1. The HIM (Health Information Management) office during off business hours failed to be secured when housekeeping cleaned the area.
2. The laboratory/pathology department failed to secure anatomical reports during off hours when housekeeping cleaned the area.
3. The outpatient eye surgery center that functioned as an outpatient department of the hospital failed to secure patients' medical records when the department was not staffed.

The findings were:

The facility's policy and procedure entitled "Record Confidentiality and Safeguarding" stated the following in pertinent part:
"4. Record Access:
4.1. Access to areas housing medical records shall be limited to the HIM Department personnel. The sole exception to this policy shall be the nursing personnel designated by Nursing Administration, and at times in which the HIM department is not staffed.
4.2. The front door to the HIM Department is secured by badge swipe access. The back door is locked at all times.
4.3. Only designated hospital staff have access to HIM (e.g., Director of Health Information Management, designated HIM staff, Physicians, Nurse Managers.)"

During the tour, an interview was conducted with the HIM Manager on 12/12/11 at approximately 3:00 p.m. regarding the security of medical records and when housekeeping comes into the area. The Manager stated that housekeeping comes in between five and six and they use a badge access. There might be medical records personnel in the department when housekeeping are doing the cleaning, but there are times when no one would be in the HIM department. Furthermore, housekeeping does not turn in their badges when they leave so they have access to medical records anytime of the day or night. The Manager agreed that this was not good practice and did not assure the confidentiality of medical records.


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On 12/12/11 at approximately 11:30 a.m., during a tour of the laboratory area with the department manager, it was determined that
pathology reports were stored in unsecured files in the pathology area. The manager stated that patient anatomical reports were considered a part of the medical record. S/he stated that the manager of the medical records department was aware that the patients' anatomical reports were maintained in the pathology area of the laboratory department. S/he stated that the records were maintained in compliance with all state and federal requirements. S/he stated that the pathology area was locked at night, but that hospital housekeeping crews had access to that area during off hours when pathology/laboratory staff were not present in that area. S/he stated that the records were not secured during off hours in locked shelving or file cabinets.


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A tour of the outpatient eye surgery center that functioned as an outpatient department of the hospital on 12/13/2011 at approximately 11:00 AM revealed that the center kept the medical records of patients on a shelf overnight. The manager of the surgery center stated that overnight, the center was cleaned by a housekeeping employee, sometimes unsupervised. Furthermore, s/he stated that the records were not secured overnight from unauthorized access. S/he stated that the center had cabinets that could lock, but that the center did not currently utilize them for record storage.

Based on tour of the facility, staff interviews, and review of policies/procedures, the facility failed to ensure drugs were stored in accordance with accepted professional principles and in accordance with their own policies and procedures. Specifically, the facility did not monitor refrigerator temperatures consistently. The hospital did not indicate what actions were taken when temperatures were found to be out of range. This failure created the potential for a negative outcome.

The findings were:

A facility policy titled: "Refrigerators" last revised 9/23/2011 stated the following, in pertinent parts:
"...3. Refrigerator temperature checks shall be completed and logs maintained by the department in which they are located...
5. Medications (See Refrigeration of Medications policy in Medication Management Chapter.
6. Any refrigerator noted out of temperature range or to be malfunctioning shall be reported immediately to Plant Operations and noted on the log..."

A facility policy titled: "Refrigeration of Medications, Patient Food, and Human Milk" last revised 12/21/2010 stated the following, in pertinent parts:
"...Purpose: To provide for proper storage of drugs, patient foods and human milk requiring controlled temperature storage and to alert the appropriate staff when a storage refrigerator is outside of the acceptable temperature range...
3.2 Nursing Staff shall be responsible for checking medication storage requirements and for storing them properly while they are on the unit...
6. Temperatures must be maintained as follows:
Medication Refrigerators: 35 to 46 degrees F...
7. All refrigerators must be monitored to assure appropriate temperatures are maintained.
7.1. Refrigerators and freezers containing pharmaceuticals, patient food or human milk are monitored either via an electronic - computer network system linked to the Pyxis Med station or a manual temperature log...
7.3 Medications, Food or Human milk storage refrigerators and freezers which are not monitored by the electronic system will be monitored by the department in which they are located and shall maintain and complete logs of daily refrigerator temperature checks.
7.4. Any refrigerator noted out of temperature range or to be malfunctioning shall be reported immediately to Plant Operations and noted on the log...
7.7 If the temperature in a medication refrigerator cannot be brought into the appropriate range within 6 hours, or if the temperature has dropped below freezing the Plant Operations Engineer will contact the Pharmacy...to notify Pharmacy staff of the incident...
7.13 Manual refrigerator logs will be maintained on the unit for a minimum of 12 months..."

A tour of the facility's outpatient Post-Anesthesia Care Unit (PACU) on 12/12/2011 at approximately 2:22 p.m. revealed that the outpatient PACU had a medication refrigerator that was not connected to the computer monitoring system. On the front of the refrigerator there was a magnetic clip with temperature log sheets. Additionally there was a clipboard on top of the medication refrigerator with temperature log sheets. A closer review of the temperature log sheets revealed that the logs on the front of the refrigerator and on top of the refrigerator were both for recording the temperature of the medication refrigerator. Furthermore, the temperature log sheets were for the same months of October, November, and December 2011. The PACU's Nurse Manager stated that the temperature logs on the clipboard on top of the medication refrigerator were completed by the outpatient PACU staff while the temperature logs on the front of the medication refrigerator were maintained by the pharmacy staff. The temperature log maintained by the pharmacy did not have recorded readings for the following dates in December: 12/3, 12/4, 12/6, 12/10, and 12/11. The temperature log had a temperature of 32 degrees F logged on 12/1 and a temperature of 33 degrees F on 12/9, but did not have any documentation of corrective action where documentation was to be placed on the temperature log form. The temperature log maintained by the PACU did not have recorded readings for the following dates in December: 12/3, 12/4, 12/10, and 12/11. The temperature log had a temperature of 34 degrees F logged on 12/1, but did not have any documentation of corrective action where documentation was to be placed on the temperature log form.

An interview with a staff pharmacist on 12/12/2011 at approximately 2:42 p.m. revealed that the pharmacy department was in the process of ensuring that the temperature of the medication refrigerator was monitored daily. S/he stated that the facility had discovered that the refrigerator was not being monitored on days when the surgical department did not utilize the outpatient PACU. S/he stated that the facility was in the process of purchasing a new device that would be placed in the refrigerator that could track the temperature over a month-long period. However, s/he stated that the new devices were not currently in place.

Based on observations, staff interviews, and review of the hospital's policies/procedures the hospital failed to ensure that all outpatient departments adhered to the hospital's policies for medication storage and disposal.

A hospital policy titled "Expiration Dating (Beyond Use Dating) for Injectable Medications in Vials and Ampuls" last revised 1/3/2011 stated the following, in pertinent parts:
"...The maximum period in which a solution containing a preservative may be used once the stopper has been punctured will be 28 days unless the manufacturer specifies a Beyond Use Date (BUD) that is shorter unless contamination is evident or suspected...
1.2.3. Vials containing preservative - BUD of 28 days with the following exceptions...
1.2.3.3. Vial should be labeled with BUD and discarded at expiry. Vials not labeled with BUD will be discarded immediately..."

A hospital policy titled "Warming IV and Irrigation Fluids" last reviewed 9/27/2010 stated the following, in pertinent parts:
"...Procedure
Pour Fluids:
1. For warmed pour fluids, these bottles can be stored in a warming cabinet at a temperature not to exceed 110 degrees F (43 degrees C) no longer than 14 days...
3. Pour fluid bottles must be dated, stored and rotated according to manufacturers' instructions to ensure the integrity of the fluids.
4. All pour fluids bottles that have been warmed for 14 days will be discarded.
Bagged Fluids:
1. Bagged fluids in the overwrap may be in a warming cabinet with a temperature not to exceed 110 degrees F (43 degrees C) no longer than 14 days...
3. Bagged fluids must be dated, stored and rotated according to manufacturers' instructions to ensure the integrity of the fluids.
4. All bagged fluids that have been warmed for 14 days will be discarded..."

A tour of the Family Medicine clinic that served as an outpatient department of the hospital on 12/13/2011 at approximately 12:35 p.m. with the clinic's Operations Manager revealed that the clinic administered medications occasionally which included the use of multidose vials. A vial of Novolog insulin was found in the clinic's medication refrigerator. The vial had written indication on the bottle that it had been opened on 11/19/2011 and was to be discarded on 12/19/2011. The written indication was not consistent with the hospital's policy to discard multidose medication vials after 28 days. A vial of tuberculin skin testing solution was found in the clinic's refrigerator that had written indication that it had been opened on 10/10/2011 and was to be discarded 11/10/2011. The bottle had a manufacturer's direction that the solution be discarded 30 days after being opened. The vial remained available for patient use beyond the manufacturer's recommended beyond use date. A vial of 2% Lidocaine was found in a drawer that had written indication that it had been opened on 12/1/2011 and was to be discarded 1/1/2012. The written indication was not consistent with the hospital's policy to discard multidose medication vials after 28 days.

A tour of the hospital's Post-Anesthesia Care Unit on 12/12/2011 at approximately 2:00 p.m. with the Director of Surgical Services revealed that the department utilized a warming cabinet for intravenous fluids. The cabinet contained nine bags of normal saline solution that had written indication that the bags needed to be removed from the cabinet on 1/1/2012 (19 days after the date of the observations). The staff of the Post-Anesthesia Care Unit (PACU) as well as the PACU's Nurse Manager were asked what the facility's policy on the storage of fluids in the warming cabinets. They were initially unable to state what the policy was, but were able to confirm that the facility's policy was that fluid was to be removed from the cabinet after 14 days. The PACU's Nurse Manager confirmed that the written indication on the nine bags of normal saline solution was inconsistent with the facility's policies.

A tour of the hospital's Obstetrical Surgical area on 12/12/2011 at approximately 3:55 p.m. with the Obstetrical Technician revealed that a warming cabinet in the surgical area contained both intravenous fluids and pour fluids. None of the fluids were dated in accordance with the facility's policy. The obstetrical technician stated that the anesthesia staff stocked the fluids in the warmer and confirmed that the fluids did not have a written indication when they were placed in the warmer or when the fluids needed to be removed from the warmer.


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On 12/13/11 at approximately 9:30 a.m., during a tour of the main medication room for the medical/telemetry unit the patient individual medication drawers were inspected and revealed the following:

Examination of the drawer for patient room 404 revealed a previously opened multiple dose vial of Heparin that had no label of when the vial had been opened, initials of the staff member who had opened the vial, or the date that the vial would reach the 28-day after opening date that required the vial to be discarded, per facility policy/procedure. The clinical pharmacist stated that the medication should have been labeled at the time of opening, so that the 28-day discard date would have been determined to ensure that the medication did not reach a patient after the exceed the "beyond use date" (BUD). S/he removed and discarded the medication, after it was presented to her.

Examination of the drawer for patient room 423 revealed that it contained a patient's own outpatient prescription bottle containing Warfarin. The bottle was not labeled with a bar code and evidence that it had been inspected by the pharmacy and approved for hospital administration. The clinical pharmacist stated that the medication should not have been stored in the patient medication drawer on the unit unless it was inspected, barcoded and approved for use in the hospital per a physician order. S/he stated that it appeared to be a patient's prescription bottle brought in at the time of admission. S/he stated that the medication should have been sent home with family or sent to the pharmacy for storage until discharge.

Examination of the drawer for patient room 426 revealed a previously opened multiple dose vial of Heparin that had no label of when the vial had been opened, initials of the staff member who had opened the vial, or the date that the vial would reach the 28-day after opening date that required the vial to be discarded, per facility policy/procedure. The clinical pharmacist stated that the medication should have been labeled at the time of opening, so that the 28-day discard date would have been determined to ensure that the medication did not reach a patient after the exceed the "beyond use date" (BUD). S/he removed and discarded the medication, after it was presented to her.

Examination of the drawer for patient room 440 revealed that it contained a plastic bag containing five bottles of the patient's own medications from home. The bag contained one prescription bottle of Metoprolol ER 25 mg, and four over-the-counter bottles for a multivitamin, famotidine, aspirin 81 mg and NAC (N-acetyl cysten). The patient's nurse was questioned why the medications were in the medication drawer, since they contained no evidence of a bar code or inspection/approval by pharmacy. S/he stated that the medications were not being administered to the patient and that s/he would send them home with the patient's spouse that day. The clinical pharmacist stated that the medications should not have been stored in the patient medication drawer on the unit unless it was inspected, barcoded and approved for use in the hospital per a physician order. S/he stated that the medication should have been sent home with family or sent to the pharmacy for storage until discharge.

During the inspection of the medication room, a plastic grocery bag was found stored on the top of the medication refrigerator, behind two large bottles of liquid nutritional supplements. The unlabelled bag contained a ripped paper bag that contained what appeared to be 14 sample boxes containing bottles of Aciphex 20 mg. No nursing staff on the unit knew who the samples belonged to or how long they had been stored on top of the refrigerator. The clinical pharmacist stated that the hospital did not allow sample medications. S/he stated that s/he had no explanation for why the apparent samples were found in the medication room. S/he theorized that the medications were probably samples brought in by a patient at the time of admission, but they should have been labelled and sent home with family or sent to the pharmacy for storage until discharge. S/he removed and discarded the medication, after it was presented to her.

The findings were confirmed with the nursing manager for the unit, the assistant director of nursing and the clinical pharmacist for the unit.

Based on facility tours, staff interviews and facility documents, the facility failed to maintain medical equipment to ensure an acceptable level of safety and quality. Specifically, there was equipment that did not have timely preventive maintenance performed and equipment that had incorrect due dates for the next scheduled preventive maintenance.

The findings were:

A tour was conducted on 12/12/11 of surgical services beginning at approximately 1:30 p.m. In the PACU (Post Anesthesia Care Unit) there was a "fluid warmer" that had a preventive maintenance sticker that was due 9/11 and a Ethicon Endo Surgery UC (Electrosurge) that had a preventive maintenance sticker due 12/7/11. Further observations in PACU and sterile processing revealed there were approximately 11 to 12 SCD (Sequential Compression Device) pumps that were all due for preventive maintenance in 11/11.

An interview was conducted with the Director of Biomed on 12/14/11 at approximately 9:00 a.m. The Director stated that the fluid warmer was a Tier 2 item and Biomed had a two month window to perform preventive maintenance. A history of the equipment was supplied by the Director and the fluid warmer was on a "could not locate" list and continued to be overlooked. However, after being located by a surveyor during the survey process, preventive maintenance was performed on 12/13/11. The history log for the Electrosurge revealed that preventive maintenance had been performed on 12/7/11; however, the technician had failed to put a new sticker on the equipment.

The interview was continued with the Director regarding the SCD pumps. The Director stated there are 200 SCD pumps located throughout the facility and they are on a two year cycle for preventive maintenance and are all due in 11/12 not 11/11. It had been determined by the facility during the time that maintenance had been performed on the pumps in 2010 that they would be phased out of service by 9/11. The Director stated that s/he made an error in judgement and had the technicians put the due date of 11/11 on every pump because all the pumps were supposed to be gone before that due date. The Director further stated that s/he regretted this decision and all the SCD pumps should have been tagged with the correct due date of 11/12 rather than the incorrect due date of 11/11. The facility has set 2/2012 as the next date when the pumps are to be phased out.


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On 12/13/11 at approximately 11 a.m., during a tour of the intensive care unit with the nurse manager and the assistant director of nursing, the #3 crash cart was inspected. Inspection of the defibrillator revealed that it contained a note stating "requisition sent to Biomed(ical Engineering) 12/10 to check for low battery print out." The nurse manager and the assistant director of nursing confirmed that the defibrillator should have been switched out for a working replacement, rather that leaving the defibrillator on the cart, since the performance of the machine was in question. They stated that they would address the situation immediately to ensure that a working replacement was placed on the cart and the other defibrillator removed to Biomedical Engineering.

During a tour of an equipment storage area on the unit, two portable pulse oxygen monitors were found stored in a cabinet. One of the monitors had been inspected on 12/10 and was due to be inspected 12/11. The other monitor had not been inspected since 12/08. The findings were confirmed with the nurse manager and the assistant director of nursing. They stated that the monitor with an old inspection date would be brought to the attention of Biomedical Engineering that day for inspection.

Based on tour of the facility, staff interviews, and review of policies/procedures, the facility failed to ensure that proper temperature controls were utilized in pharmaceutical storage areas. Specifically, the facility did not monitor refrigerator temperatures consistently. The hospital did not indicate what actions were taken when temperatures were found to be out of range. This failure created the potential for a negative outcome.

The findings were:

A facility policy titled: "Refrigerators" last revised 9/23/2011 stated the following, in pertinent parts:
"...3. Refrigerator temperature checks shall be completed and logs maintained by the department in which they are located...
5. Medications (See Refrigeration of Medications policy in Medication Management Chapter.
6. Any refrigerator noted out of temperature range or to be malfunctioning shall be reported immediately to Plant Operations and noted on the log..."

A facility policy titled: "Refrigeration of Medications, Patient Food, and Human Milk" last revised 12/21/2010 stated the following, in pertinent parts:
"...Purpose: To provide for proper storage of drugs, patient foods and human milk requiring controlled temperature storage and to alert the appropriate staff when a storage refrigerator is outside of the acceptable temperature range...
3.2 Nursing Staff shall be responsible for checking medication storage requirements and for storing them properly while they are on the unit...
6. Temperatures must be maintained as follows:
Medication Refrigerators: 35 to 46 degrees F...
7. All refrigerators must be monitored to assure appropriate temperatures are maintained.
7.1. Refrigerators and freezers containing pharmaceuticals, patient food or human milk are monitored either via an electronic - computer network system linked to the Pyxis Med station or a manual temperature log...
7.3 Medications, Food or Human milk storage refrigerators and freezers which are not monitored by the electronic system will be monitored by the department in which they are located and shall maintain and complete logs of daily refrigerator temperature checks.
7.4. Any refrigerator noted out of temperature range or to be malfunctioning shall be reported immediately to Plant Operations and noted on the log...
7.7 If the temperature in a medication refrigerator cannot be brought into the appropriate range within 6 hours, or if the temperature has dropped below freezing the Plant Operations Engineer will contact the Pharmacy...to notify Pharmacy staff of the incident...
7.13 Manual refrigerator logs will be maintained on the unit for a minimum of 12 months..."

A tour of the facility's outpatient Post-Anesthesia Care Unit (PACU) on 12/12/2011 at approximately 2:22 p.m. revealed that the outpatient PACU had a medication refrigerator that was not connected to the computer monitoring system. On the front of the refrigerator there was a magnetic clip with temperature log sheets. Additionally there was a clipboard on top of the medication refrigerator with temperature log sheets. A closer review of the temperature log sheets revealed that the logs on the front of the refrigerator and on top of the refrigerator were both for recording the temperature of the medication refrigerator. Furthermore, the temperature log sheets were for the same months of October, November, and December 2011. The PACU's Nurse Manager stated that the temperature logs on the clipboard on top of the medication refrigerator were completed by the outpatient PACU staff while the temperature logs on the front of the medication refrigerator were maintained by the pharmacy staff. The temperature log maintained by the pharmacy did not have recorded readings for the following dates in December: 12/3, 12/4, 12/6, 12/10, and 12/11. The temperature log had a temperature of 32 degrees F logged on 12/1 and a temperature of 33 degrees F on 12/9, but did not have any documentation of corrective action where documentation was to be placed on the temperature log form. The temperature log maintained by the PACU did not have recorded readings for the following dates in December: 12/3, 12/4, 12/10, and 12/11. The temperature log had a temperature of 34 degrees F logged on 12/1, but did not have any documentation of corrective action where documentation was to be placed on the temperature log form.

An interview with a staff pharmacist on 12/12/2011 at approximately 2:42 p.m. revealed that the pharmacy department was in the process of ensuring that the temperature of the medication refrigerator was monitored daily. S/he stated that the facility had discovered that the refrigerator was not being monitored on days when the surgical department did not utilize the outpatient PACU. S/he stated that the facility was in the process of purchasing a new device that would be placed in the refrigerator that could track the temperature over a month-long period. However, s/he stated that the new devices were not currently in place.

Based on observations during tour, staff interviews and facility documentation, the infection control officer failed to mitigate risks contributing to healthcare-associated infections including the monitoring of compliance with policies and procedures, requiring the proper use of detergents and/or germicides used in endoscopy high-level disinfection in accordance with manufacturer's guidelines and terminal cleaning of the obstetrical surgical areas.

The findings were:

1. Endoscopy scope cleaning:

On 12/13/2011 at approximately 10:05 a.m., a tour of the area utilized to clean endoscopy scopes with a nurse that was responsible for cleaning the scopes revealed that the scopes were precleaned with a detergent. The nurse stated that the scopes are placed in the sink and the sink is then filled in order to cover the scope allowing 1-2 inches of water above the scope and then three squirts of the enzymatic detergent was then added to the water. When asked if s/he had an ability to measure the amount of water added to the sink, s/he stated that it was approximately three gallons of water, but confirmed that there was not a way to measure the amount of water. The nurse stated that the instructions on the enzymatic detergent stated to add one squirt of enzymatic detergent to each gallon of water.

An interview with the Director of Surgical Services on 12/13/2011 at approximately 10:30 a.m. revealed that the amount of water had been measured previously and the sink had been marked to indicate where three gallons of water would reach. S/he stated that the line was present three weeks prior to the observations on 12/13/2011. A subsequent observation with the Director of Surgical Services of the sink used for precleaning of endoscopes on 12/13/2011 at approximately 11:30 a.m. revealed that the line was not present.

2. Terminal cleaning of obstetrical surgical areas

A policy from the hospital's contracted housekeeping service titled "Surgical/Invasive Areas and Delivery Rooms - Terminal Cleaning at the end of each day" stated the following, in pertinent part: "...Surgical and invasive procedure rooms and scrub/utility areas should be terminally cleaned daily. Terminal cleaning of operating and invasive procedure rooms should be done at the end of each day when the scheduled procedures are completed or should occur each 24-hour period during the regular work week. Unused rooms should be cleaned once during each 24-hour period during the regularly scheduled work week..."

An interview with the obstetrical technician during a tour of the surgical suites used for obstetrical surgeries conducted on 12/12/2011 at approximately 3:55 p.m. revealed the suites were not routinely terminally cleaned on a daily basis. S/he stated s/he thought the rooms were terminally cleaned "every couple of months."

A subsequent interview with the Director of Women's Services on 12/14/2011 at approximately 8:45 a.m. revealed the surgical suites used for obstetrical surgeries were expected to be terminally cleaned every day procedures are performed in the rooms. S/he stated s/he would have the Manager of Housekeeping provide the cleaning log and explain the process to the surveyor.

An interview with the Manager of Housekeeping conducted on 12/14/2011 at approximately 10:52 a.m. revealed the surgical suites for obstetrical surgeries were to be terminally cleaned Monday through Friday. S/he stated it was expected that the housekeeping personnel would document the terminally cleaning in the log provided for staff to do so. A review of the log with the Housekeeping Manager revealed the log indicated that on 12/9/2011 only one of the three surgical suites were terminally cleaned. The log for the month of October indicated that on 10/4, 10/5, 10/6, 10/11, 10/14, 10/19, 10/26, 10/27, and 10/28 only one of the three surgical suites were terminally cleaned. The log also indicated that on 10/7 and 10/13 only two of the three surgical suites were terminally cleaned.

Based on credential file review, review of the facility's Medical Staff Bylaws, Rules/Regulations, and staff interview the facility failed to ensure surgical privileges were delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The facility failed to ensure the surgical service was able to maintain a roster of practitioners specifying the specific surgical privileges of each practitioner. Specifically, the facility granted general "core privileges" that only specified the type of practitioner (such as General Surgery, Orthopedic Surgery, etc.) category.

The findings were:

Cross Reference to A 0355: Medical Staff Privileging - for findings related to the facility's failure to ensure practitioners were granted specific privileges when placed on the medical staff. Specifically, the facility failed to delineate what tasks/activities/procedures the practitioners were granted privileges to do.

An interview with the Director of Surgical Services and the Operating Room Manager conducted on 12/12/2011 at approximately 1:15 p.m. revealed the operating room staff would contact the medical staff office or the Clinical Administrator on Duty (CAD) to inquire about what privileges a surgeon had been granted if there was any question if a surgeon was able to perform a procedure in the operating room.

An interview with the Associate Chief Nursing Officer conducted on 12/14/2011 at approximately 4:15 p.m. revealed the CAD utilized a computer program to review the privileges granted to practitioners when necessary to ensure surgeons had privileges to perform specific procedures. When asked to retrieve the privileges for a specific surgeon, it was revealed that the system was not currently available due to downtime. The medical staff office staff member present was also unable to access the system. S/he was able to utilize another system that was available which contained scanned copies of the sheet(s) of paper that were filled out by practitioners when applying for inclusion on the medical staff. The plastic surgeon that was reviewed at that time had been granted the privileges of "Cosmetic Surgery" and "Reconstructive Surgery". The privileges were not specified any further than those two categories and did not list any specific procedures that would be included under those broad categories. The medical staff office staff member stated that the information obtained was the same in both systems.

An interview with the hospital's Director of Medical Staff on 12/15/2011 at approximately 7:50 a.m. confirmed that the Medical Staff Office staff and the hospital's staff had access to the system that was described the Associate Chief Nursing Officer. S/he confirmed that the hospital granted "core privileges" and did not further specify privileges for most practitioners.

A subsequent interview with the hospital's Director of Medical Staff and the corporate Director of Credential Support Center conducted on 12/15/2011 at approximately 9:23 a.m. revealed that the hospital and the governing body were unaware of a need to grant specific privileges rather than groups or more general privileges.


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