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Based on facility tours and staff interviews, the facility failed to maintain a safe environment to protect the health and safety of patients.
This failure contributed to the potential for patient injury due to improperly stored supplies and the use of expired supplies during patient procedures.

FINDINGS:

1. The facility failed to ensure oxygen tanks were secured.

a) On 05/29/13 at 1:30 p.m., a tour of the facility's Emergency Department was conducted with the facility's Director of Nursing (DON). During the tour, a storage room was viewed and contained 3 oxygen tanks that were standing upright on the floor and not secured in any fashion.

b) During the tour, an interview was conducted with the facility's DON. The DON stated that it was his/her expectation that oxygen tanks would be secured at all times as they were a potential hazard when not secured.

2. The facility failed to ensure that supplies used during patient procedures were not expired.

a) On 05/29/13 at 1:30 p.m., a tour of the facility's Emergency Department (ED) was conducted with the facility's Director of Nursing (DON).

The shelving units in ED Trauma Room A were viewed and contained 3 culture swabs with manufacturer's expiration dates of 03/2013 and 2 packages of skin prep with manufacturer's expiration dates of 07/2010. The facility's Director of Nursing (DON) verified the manufacturer's expiration dates and immediately discarded the items.

The crash cart in ED Trauma Room A was viewed and contained the following expired supplies: 2 intubation kits with manufacturer's expiration dates of 05/2005 and 07/2010, and 1 tracheostomy tube with a manufacturer's expiration date of 04/2012. The facility's Director of Nursing (DON) verified the manufacturer's expiration dates and immediately discarded the items.

The crash cart in ED Trauma Room B was viewed and contained the following expired supplies: 1 Medivac tubing connector with a manufacturer's expiration date of 06/2011, 1 Neonate speci-cath with a manufacturer's expiration date of 04/2012, 1 Alaris connector with a manufacturer's expiration date of 04/2013, 1 sterile scalpel kit with a manufacturer's expiration date of 01/2012, 2 arterial blood gas kits with manufacturer's expiration dates of 03/2012, 1 umbilical vessel catheter with a manufacturer's expiration date of 10/2011, 4 Broselow pediatric emergency kits containing airways and masks with manufacturer's expiration dates of 11/2011 and 03/2010, 3 green Broselow emergency kits with manufacturer's expiration dates of 08/2010, 1 orange Broselow emergency kit with a manufacturer's expiration date of 12/2012, 1 blue Broselow emergency kit with a manufacturer's expiration date of 05/2011, 1 8.0-sized tracheostomy tube with a manufacturer's expiration date of 06/2012, and 1 package of 2.0 Ethilon sutures with a manufacturer's expiration date of 01/2013. The facility's Director of Nursing (DON) verified the manufacturer's expiration dates and immediately discarded the items.

b) On 05/29/13 at 3:00 p.m., a tour of the facility's Operating Rooms was conducted with the facility's Operating Room (OR) Manager.
The facility's Malignant Hyperthermia kit was viewed and contained the following expired items; 9 blue lab specimen tubes with manufacturer's expiration dates of 04/2013, and 6,24 gage IV catheters with manufacturer's expiration dates of 04/2013. The facility's OR Manager verified these expiration dates and immediately discarded the items.

The facility's anesthesia cart in Operating Room #1 was viewed and contained the following expired items; 4,24 gage intravenous (IV) catheters with manufacturer's expiration dates of 11/2011 and 04/2013, 1,22 gage IV catheter with a manufacturer's expiration date of 04/2013, and 1 nasal airway with a manufacturer's expiration date of 01/2013. The facility's OR Manager verified these expiration dates and immediately discarded the items.

The facility's anesthesia cart in Operating Room #2 was viewed and contained the following expired items; 3,22 gage IV catheters with manufacturer's expiration dates of 03/2012, 3,24 gage IV catheters with manufacturer's expiration dates of 08/2004 and 02/2008, 2 lavender lab specimen tubes with manufacturer's expiration dates of 01/2007 and 07/2008, 3,22 IV catheters with manufacturer's expiration dates of 05/2010, 2 adjustable nasal airways with manufacturer's expiration dates of 01/2013, 21 sterile tongue depressors with manufacturer's expiration dates of 01/2005 and 02/2008, 1 tracheostomy tube with a manufacturer's expiration date of 03/2012, and 4 IV spikes with manufacturer's expiration dates of 04/2011. The facility's OR Manager verified these expiration dates and immediately discarded the items.

During the tour, the facility's OR Manager stated the anesthesia crash carts were monitored by anesthesia staff. The OR Manager stated it was his/her expectation that expired items would be discarded and not be stored in the anesthesia carts.

c) On 05/30/13 at 10:30 a.m., a tour of the facility's Medical Surgical unit was conducted with the facility's Medical Surgical Nurse Manager.

The Medical Surgical Unit's pediatric crash cart was viewed and contained the following expired items; 6 green lab specimen tubes with manufacturer's expiration dates of 04/2013 and 03/2012, 1 endotracheal tube with a manufacturer's expiration date of 08/12, 1 endotracheal tube stylet with a manufacturer's expiration date of 03/2012, and 1 pediatric capnography monitor with a manufacturer's expiration date of 03/2011. The facility's Medical Surgical Nurse Manager verified these expiration dates and immediately discarded the items.

Based on observations, staff interviews, and facility document review, the facility failed to ensure that contracted services furnished the agreed upon services.

This failure led to preventative maintenance not being performed on multiple types of equipment used for patient care.

FINDINGS:

1. The facility did not ensure that preventative maintenance was performed on its equipment.

a) On 05/29/13 at 10:30 a.m., a tour of the facility's Emergency Department (ED) was conducted with the facility's Director of Nursing (DON).

In the ED, a Bipap machine was viewed and contained a sticker that documented that preventative maintenance had last been performed on 05/2011. The facility's DON verified this finding.

b) On 05/30/13 at 10:00 a.m., a tour of the facility's Labor and Delivery unit and Nursery was conducted with the facility's DON.

In the facility's Labor and Delivery unit, an ultrasound machine was viewed and contained a sticker that documented that preventative maintenance had last been performed on 03/2012. The facility's DON verified this finding.

In the facility's Nursery, an infant warmer was viewed and contained a sticker that documented the last preventative maintenance had been performed on 07/2011. The facility's DON verified these findings.

c) On 05/30/13 at 10:30 a.m., a tour of the facility's Medical Surgical Unit was conducted with the Medical Surgical Manager.

In the Medical Surgical storage room, a sequential compression device was viewed and contained a sticker that documented the last preventative maintenance had been performed on 05/2011. The Medical Surgical Manager verified this finding.

d) On 05/30/13, the facility's contracted services list was viewed and contained an agreement with a vendor to provide yearly preventative maintenance on hospital equipment used for patient care. The agreement between the facility and the vendor was listed as being active on the contract list and was to automatically renew annually. The facility's DON verified this was the vendor the facility currently used and stated it was his/her expectation that all preventative maintenance would be conducted on annual basis as per the contract, and that preventative maintenance dates would be accurately documented on all pieces of equipment.

Based on document review and interviews, the facility failed to ensure that the Governing Body assumed full responsibility for all activities in the facility including the safety of patients and the quality of patient care provided by staff.

This failure created the potential for negative outcomes to patients who received care at the facility.

FINDINGS:

1. The Governing Body was not made aware of drug diversion, which the facility determined occurred over a 6 month period, through an investigation initiated on 03/11/13.

a) On 05/28/13 at 3:40 p.m., review was conducted of the facility's policy titled, "Board Roles and Responsibilities," dated 05/29/12, which stated, "The Board has the final legal and regulatory responsibility for everything that goes on in the organization, especially the quality of services provided by all individuals who perform their duties in the organization's facilities or under its sponsorship. To exercise this quality oversight responsibility the Board will: Review and carefully discuss quality reports which provide comparative statistical data about the organizations' services, and set measurable policy targets to ensure continual improvement in quality performance." Review of the Governing Body Bylaws, stated under Section 4, General Duties, that the Board is responsible for, "a. Quality of care/Customer service." The Bylaws also stated the Chief Executive officer (CEO) "shall serve as the Board's representative in the day-to-day management and operation of the facility. The Chief Executive Officer shall report to the Board."

b) On 05/28/13 at 2:34 p.m., internal facility documents from 10/01/12 through 05/27/13 were reviewed. A document dated 02/26/13 stated, "multiple narcotics removed from Pyxis on override." The follow-up to this statement indicated that an investigation was started by the facility related to events which occurred on 03/11/13. Further review of internal facility documents revealed that on multiple dates from 10/01/12 through 05/27/13, a Registered Nurse (RN) accessed patient medications in the Pyxis system through override of the system. Some dates listed were 01/04/13, 02/26/13, and 03/06/13, and the medications involved were narcotics. Documentation revealed that on 01/04/13, an RN removed hydromorphone by override for a patient with no scheduled facility visit. On 02/26/13, "multiple narcotics" were removed by override of the Pyxis system. On 03/06/13, "pain medications," were removed by RN override of the Pyxis system for a patient who was not registered at the facility. In addition to the override of the Pyxis system for narcotics, documentation was found stating that on 01/08/13, 2 syringes with partial doses of hydromorphone were found in the medication room of the medical/surgical unit Pyxis area. Facility documentation was reviewed which stated that on 01/11/13, a dose/vial of Neulasta, 6 milligrams, was "missing" from the Pyxis refrigerator, with a cost of $2049.70/dose.

c) On 05/29/13 at 9:10 a.m., an interview was conducted with the facility's Director of Nursing (DON), who stated that drug diversion by a staff RN had occurred in the facility. The DON stated a staff medical/surgical RN was found incapacitated in the staff lounge on 03/11/13 and was admitted to the facility as a patient. The DON stated an investigation was initiated and it was determined that the RN had been involved in the diversion of narcotics for approximately 6 months, beginning in October, 2012. The DON stated that through overrides of the medical /surgical Pyxis sysyem to obtain narcotics, through putting patients into the facility's electronic system who were not admitted and were not scheduled to receive outpatient treatments, and through the falsification of physician orders for narcotics, drug diversion of patient medications had occurred. The DON stated the event was reported to the State Board of Nursing, the Board of Pharmacy, the local police, and the Drug Enforcement Administration, but was not reported to the Colorado Department of Public Health and Environment as an occurrence, as required under general licensure regulations.

d) On 05/29/13, documentation was provided by the DON that described findings of the facility's investigation. In a letter to the Department of Regulatory Agencies (DORA), the DON stated that on 3/11/13, it was determined the RN removed, "over 600 mg of Demerol and 4 mg of Dilaudid," on this date for a patient who was fraudulently registered and was not present in the facility. Empty vials of Demerol and a syringe with an attached needle were found on the RN's person. The RN tested positive for the presence of opiates. The DON provided a document that s/he helped to compile that showed at least 5 patients (Sample Patients #2, #5, #21, #22, and #23) who received care at the facility from October, 2012 through March, 2013 and whose medical records supported drug diversion activity. It was determined that at least 188 doses of hydromorphone and 89 doses of meperidine were diverted by the RN from October, 2012 through March 11, 2013. The DON stated the facility could not be certain that the medical record review captured all drug diversion activity by the RN.

e) On 05/30/13, review of meeting minutes for the facility's Board of Directors and the facility's Clinical Quality Committee was conducted for meetings held from 05/01/12 through 05/28/13. Minutes from the Board of Director meetings dated 03/26/13 and 04/30/13 contained no mention of drug diversion or the facility's investigation and/or findings. Meeting minutes from the Clinical Quality Committee from 03/25/13, 04/22/13, and 05/20/13 contained no mention of drug diversion or the facility's investigation and/or findings.

f) On 05/31/13 at 2:04 p.m., an interview was conducted with the facility's Chief Operating Officer (CEO). The CEO confirmed the facility's Governing Body was the Board of Directors. When asked if and when the Board of Directors was informed of the drug diversion from 03/11/13 and the facility's investigation and actions regarding findings, the CEO stated the Board had not been informed, but that s/he would inform the Board today. When asked how the Board of Directors, the party responsible for the functioning of the facility, including quality of patient care, could be responsible if uninformed of such activities as drug diversion, the CEO stated s/he did not know. The CEO confirmed that the Board of Directors had ultimate responsibility for the functioning of the facility and that the s/he was responsible for the day-to-day functioning of the facility. When asked if the drug diversion had been discussed in Clinical Quality Committee meetings the CEO stated it had not. When asked if and when the physicians who had orders falsified by the RN had been notified, the CEO stated, "I do not know the answer to that."

Based on document review and interviews, the facility failed to ensure that physicians reviewed patient medical records on a periodic basis.

This failure created a situation in which medical records for patients who received outpatient services were not audited by physicians, or other facility staff, which allowed for the falsification of physician verbal orders.

FINDINGS:

1. There were no requirements by the facility that physicians review or audit their own medical records, or any percent of medical records, for accuracy of the content of records, including the authentication of verbal orders.

a) On 05/29/13 through 05/31/13, the facility's Director of Nursing (DON), the facility's Director of Quality, and the Manager of Health Information Management were asked for policies related to the auditing of patient medical records. Staff explained that facility policies were currently being reviewed and some policies were being purged as they were not applicable to the facility. A policy titled, "Quality Improvement, Health Information Management," was presented by the Manager of HIM as the guide to ensure the accurateness and completeness of patient medical records. This policy contained no written expectation that physicians would review the medical records of their own patients for completeness or accuracy, but instead stated that the review of patient medical records would be conducted by HIM staff. The policy stated that a 10% sampling of one area of medical records (in-patient, out-patient, Emergency Department, etc.) would be conducted each month.

b) On 05/31/13, review of the facility's Medical Staff Bylaws and Rules and Regulations was conducted. The facility document titled, "General Rules and Regulations for the Medical Staff," dated 07/29/13, contained the statement, "A member of the medical staff shall be responsible for the medical care and treatment of each patient in (the facility), for the prompt completeness and accuracy of those portions of the medical record for which he is responsible and for providing..." The documents contained no further written expectation that physicians would provide auditing or review of their patients' medical records for completeness and accuracy. The Medical Staff Rules and Regulations also stated, "All verbal orders shall be transcribed in the proper place in the medical record, shall include date, time, name, and signature of the person transcribing the order and the name of the practitioner, and shall be countersigned by the prescribing practitioner within twenty-four (24) hours."

c) On 05/29/13 at 10:30 a.m., an interview was conducted with the facility's DON and the facility's Director of Quality. The DON stated that during the facility's investigation regarding diverted drugs, it was determined that orders for narcotics had been hand written and falsified by a Registered Nurse (RN). The patient medical records involved were for Sample Patient #5 and Sample Patient #21. The DON stated that both patients were in the facility to receive outpatient infusion/hydration therapy in the chemotherapy/infusion room located on the medical/surgical floor. Review of the medical record for Sample Patient #5 revealed a handwritten, verbal order from a facility physician on 02/07/13 stating, "Dilaudid, 1-2 mg IV Q 1 hr prn pain." A second handwritten, verbal order from 02/25/13 stated, "May try Demerol 75 mg IV Q2 hrs prn pain." Both orders were signed by the same RN. Neither order was signed/authenticated by the patient's physician as of 05/29/13. Review of the medical record for Sample Patient #21 revealed a handwritten, verbal order from 01/23/13 stating, "May give Dilaudid 1-2 mg IV Q1 hr prn pain from cancer/chemo while in outpatient." The order was written by the same staff RN. The verbal order was not signed/authenticated by the patient's physician as of 05/29/13.

d) On 05/31/13 at 11:10 a.m., an interview with the facility's Manager of Heath Information Management (HIM) was conducted. The Manager confirmed that review of the facility's patient medical records was conducted by the HIM department staff and that incomplete records would be sent to physicians to be completed per the Medical Staff Bylaws and Rules and Regulations. The HIM Manager stated that for patients who receive treatments in the facility's outpatient chemotherapy/infusion room, located on the medical/surgical floor, the physicians have access to sign off on verbal orders electronically and have been instructed to sign these orders within 24 hours, per the facility's Medical Staff Rules and Regulations.

e) On 05/31/13 at 2:04 p.m., an interview was conducted with the facility's Chief Operating Officer (CEO). When asked if and when the physicians who had orders falsified by the RN had been notified, the CEO stated, "I do not know the answer to that." The CEO stated s/he had not informed the physicians of the falsification of orders and assumed that they had not been informed. The CEO stated s/he had not informed the Board of Directors or the facility's medical staff of the issues regarding around the diversion of drugs that had occurred from October, 2012 through March, 2013. The CEO confirmed that the falsified orders for narcotics for Sample Patients #5 and #21 were not signed/authenticated by their physicians. The CEO could offer no explanation of why the orders were not signed/authenticated by the physicians within 24 hours, per facility policy, or why the falsified medication orders were not identified as such by the physicians and questioned further.

Based on observations, staff interviews, and facility document review, the facility failed to maintain proper storage of drugs and biologicals.

This failure had the potential for expired or improperly stored medications to be administered to the facility's patients.

FINDINGS:

1. The facility stored intravenous fluids and sterile water in fluid warmers but did not monitor how long the fluids were stored.

a) On 05/29/13 at 1:30 p.m., a tour of the facility's Emergency Department (ED) was conducted with the facility's Director of Nursing (DON). During the tour, the facility's ED fluid warmer was viewed and contained 4, one-liter bottles of sterile water and 7, one-liter bags of intravenous (IV) fluid. None of the bottles of sterile water or bags of IV fluid contained dates to indicate when they had been placed in the warmer.

During the tour of the ED, the DON stated that it was facility policy to keep the fluids in the warmer for a maximum of two weeks. The DON stated that ED staff went through the fluids so quickly that there was no reason to date the bottles or bags because they would use them before two weeks. The DON was unable to state how staff would know when the IV fluids and sterile water had been placed in the warmer without the items being dated.

b) On 05/31/13 the manufacturer's instructions for warming IV fluids were viewed. The manufacturer's instructions stated, "Solutions can be warmed in their overpouches to temperature not exceeding 45 degrees Celsius (113 degrees Fahrenheit) for a period no longer than 14 days." The facility's DON verified this was the current policy.

2. The facility did not ensure expired medications were removed from patient care areas.

a) On 05/29/13 at 3:00 p.m., the facility's Operating Rooms were toured with the facility's Operating Room (OR) Manager.

The anesthesia cart in OR #1 was viewed and contained the following expired medications; 1 vial of Epinephrine with a manufacturer's expiration date of 01/2013, and 1 vial of Phenylephrine with a manufacturer's expiration date of 04/2013. The facility's OR Manager verified these findings and immediately discarded the items.

The anesthesia cart in OR #2 was viewed and contained the following expired medications; 4 vials of Oxytocin with a manufacturer's expiration date of 04/2013, 2 vials of Robinul with a manufacturer's expiration date of 04/2005, and 1 vial of Epinephrine with a manufacturer's expiration date of 03/2013. The facility's OR Manager verified these findings and immediately discarded the items.

b) During the tour of the OR#1 and OR#2, an interview was conducted with the OR Manager. The OR Manager stated the anesthesia carts were monitored by the anesthesiologists and that it was his/her expectation that expired medications would be discarded and not stored in the anesthesia carts.

c) On 05/31/13, the facility's policy, "Storage of Drugs," was viewed and stated, "Expired, damaged, contaminated, or recalled drugs will not be available for use." The facility's Director of Nursing (DON) verified this was the current policy.

Based on observations, facility document review, and staff interviews, the facility failed to ensure that facility practices were performed in a manner that would prevent communicable diseases.

This failure contributed to the potential for patients and staff to be exposed to potentially infectious agents.

FINDINGS:

1. The facility did not ensure that cleaning solutions were properly diluted to ensure effective cleaning and disinfection of sterile equipment used during patient procedures.

a) On 05/29/13 at 3:00 p.m., the facility's sterile instrument cleaning area was viewed with the facility's Operating Room (OR) Manager and an OR staff member. There were 3 sinks positioned in a row in the sterile instrument cleaning area. The OR staff member stated the first sink was for soaking and cleaning sterile instruments, the second sink was for rinsing the sterile instruments, and the third sink was for cleaning endoscopes.

The OR staff member stated s/he always used the first sink to clean sterile instruments and that s/he cleaned the surgical instruments in a cleaning solution that s/he mixed. The OR staff member stated that s/he mixed, "seven capfuls", of the cleaning solution labeled, "Endozyme," in an unknown amount of water that s/he estimated was, "seven gallons." S/he stated there was no marking on the first sink to indicate how many gallons it could hold, but that s/he, "eye-balled it," with the endoscope sink's water line, on the third sink, which s/he believed to represent 7 gallons.

The OR staff member then read the manufacturer's instructions on the "Endozyme" bottle, which stated,"to add 1/2 ounce of Endozyme per gallon of water." The OR staff member then filled the third sink with water using a 1/2 gallon measuring cup. The line on the third sink, which the OR staff member had estimated was 7 gallons, was measured to actually hold 8 gallons. The facility's OR staff member was unable to verbalize how s/he was able to comply with the manufacturer's instructions without knowing the exact amount of water contained in the sink.

b) On 05/31/13 at 11:30 p.m., the facility's policy,"Central Services: Sterilization of Endoscopes" was reviewed. The OR Manager stated this policy was the same that was used for cleaning sterile instruments. The policy stated to clean devices, "using approved enzymatic cleaner, according to manufacturer's recommendations". The facility's OR Manager verified this was the current policy.

2. The facility failed to ensure that patient care items were not stored on the floor.

a) On 05/29/13 at 1:30 p.m., the facility's Radiology department was toured with the facility's Director of Nursing (DON) and the Radiology Department manager.

The facility's X-ray room #1 was viewed and contained 1 pillow and 2 positioning devices on the floor. The Radiology Department manager stated these items were stored on the floor, but were not used for patient care. The Radiology Manager questioned why these items were in X-ray room #1 and confirmed that these items could be used for positioning patients.

The facility's X-ray room #2 was viewed and contained 2 1-gallon jugs of water on the floor. The Radiology Department manager stated these jugs were used to position patients during procedures and were stored on the floor.

b) On 05/29/13 at 3:00 p.m., the facility's Operating Room (OR) was toured with the facility's OR Manager.

The facility's Operating Room #2 was viewed and contained a donut-shaped, basketball-sized, yellow device that was laying on the floor. The OR Manager stated this device was used to position the patient's head during operating procedures.

c) On 05/30/13 at 10:00 a.m., a tour of the facility's Labor and Delivery Unit was conducted with the facility's Director of Nursing (DON) and a staff nurse. The Labor and Delivery unit's storage room was viewed and contained a bag of stuffed animals stored directly on the floor. The Labor and Delivery staff nurse verified the stuffed animals were normally stored on the floor.

d) During tours of the facility units, interviews were conducted with the facility's DON. The DON stated it was his/her expectation that patient care items would not be stored on the floor.

3. The facility did not ensure all food items were properly labeled.

a) On 05/30/13 at 10:30 a.m., a tour of the Medical Surgical unit was conducted with the facility's Medical Surgical Nurse Manager and the refrigerator used to store patient food items was viewed. The refrigerator contained multiple containers of soup, ice cream, and sandwiches with no patient names or dates to indicate when the items expired or to whom they belonged.

b) During the tour, the facility's Medical Surgical Nurse Manager was interviewed. The facility's Medical Surgical Nurse Manager was unable to state how s/he could positively identify food items, their owners, or their expiration dates if they were not labeled.

c) On 05/31/13 at 9:00 a.m., the facility's policy, "Food Protection," was viewed and stated, "Food in unmarked containers or packages or for which the time has expired will be discarded." The facility's Director of Nursing verified this was the facility's current policy.

4. The facility did not ensure expired items were not provided for patient and staff consumption.

a) On 05/29/13 at 1:30 p.m., a tour of the facility's Emergency Department (ED) was conducted with the facility's Director of Nursing (DON).

The ED patient refrigerator was viewed and contained the following expired items; 10 cartons of orange juice with a manufacturer's expiration date of 03/2013, 1 carton of milk with a manufacturer's expiration date of 05/07/13, and 3 single serving containers of yogurt with a manufacturer's expiration date of 05/07/13. The facility's DON verified the manufacturer's expiration dates and immediately discarded the items.

b) On 05/30/13 at 10:00 a.m., a tour of the facility's Labor and Delivery Unit was conducted with the facility's Director of Nursing (DON) and a staff nurse. The Labor and Delivery unit's patient refrigerator was viewed and contained 3 single serve containers of yogurt with manufacturer's expiration dates of 05/07/13. The facility's DON verified the manufacturer's expiration dates and immediately discarded the items.

c) During the tour of the Labor and Delivery unit, the facility's DON was interviewed and stated it was his/her expectation that expired food items would be discarded and not stored in patient refrigerators.

d) On 05/31/13 at 9:00 a.m., the facility's policy, "Food Protection," was viewed and stated, "Food in unmarked containers or packages or for which the time has expired will be discarded." The facility's DON verified this was the facility's current policy.

5. The facility did not ensure that breast milk was stored separately from other food items.

a) On 05/30/13 at 10:00 a.m., a tour of the facility's Labor and Delivery Unit was conducted with the facility's Director of Nursing (DON) and a staff nurse. The Labor and Delivery unit's patient refrigerator was viewed and contained a sign that stated, "Breast Milk," on the outside of the freezer. The inside of the freezer contained no breast milk, but did not contain multiple frozen patient food items.

b) During the tour of the Labor and Delivery unit, the Labor and Delivery staff nurse was interviewed and stated that when the facility needed to store breast milk for a patient, the breast milk was stored in the patient food refrigerator, along with the patient food items.

Based on document review and interview, the facility failed to ensure that an admitted inpatient, Sample Patient #6, received ordered diagnostic testing in the licensed facility.

This failure created the potential for negative patient outcome(s).

FINDINGS:

1. The facility took Sample Patient #6 to a clinic, that was not an outpatient clinic of the facility's, for a diagnostic test that should have been performed in the patient's room of the inpatient unit.

a) On 05/20/13 at 11:14 a.m., review of a facility document dated 01/30/13 was conducted and reviewed with the facility's Director of Quality regarding the care of Sample Patient #6. The document stated that on this date, Sample Patient #6, who was an inpatient of the facility, was taken by wheelchair to a clinic located in the same building as the facility. The document stated there were issues with the transfer of the patient from the wheelchair to the table where the patient was to receive an echocardiogram. Documentation revealed that facility staff had to be "called back down to provide assistance" for the transfer of the patient from the wheelchair to the diagnostic table, that the patient was in pain, and that the patient "should have stayed in bed" and the diagnostic should have been provided in the patient's room. The document stated, as follow up by a facility Director, that "cardiac clinic techs are not always amenable to coming to the unit to do the these ECHOs..."

b) On 05/29/13 at 11:14 a.m., an interview was conducted with the facility's Chief Financial Officer (CFO), who stated the clinic where Sample Patient #6 received the diagnostic test on 01/30/13 was not under the facility's license so is not an outpatient clinic of the facility. The CFO stated the clinic where the patient received the diagnostic test, per contract, was to provide services to patients who were admitted, inpatients in the facility, in patient rooms.

c) On 05/31/13 at 9:30 a.m., an interview was conducted with the facility's DON who stated the facility did not have a policy or procedure for taking admitted, incenter patients to the adjacent specialty clinics that were not part of the licensed facility.

d) On 05/31/13 at 1:19 p.m., an interview was conducted with the facility's DON who confirmed that Sample Patient #6 was taken to the cardiac clinic on 01/30/13 for a diagnostic that could have been performed at the patient's bedside. The DON stated that per the Governing Body Bylaws, the cardiac clinic and other specialty clinics, were to provide diagnostics in patient rooms for admitted, incenter patients. The DON stated that technicians from these "specialty clinics" were, by contract, to provide services in patients' rooms. The DON stated that taking patients out of the facility to the specialty clinics for diagnostic testing was rare. The DON confirmed that the specialty clinics were not under the facility's license and so were not outpatient clinics of the facility. The DON could not confirm the emergency response training, specifically the type of CPR training, that staff at the specialty clinics possessed as these were not employees of the licensed facility. The DON stated the facility would immediately stop sending admitted, incenter patients to the specialty clinics, and would adhere to the contract between the facility and the clinics.

e) On 05/30/13 at 2:53 p.m., review of the medical record for Sample Patient #6 was conducted. The record stated the patient was 79 years of age, was, "weak and falling at home," had painful, peripheral neuropathy, and congestive heart failure. A physician order date 01/30/13 was noted in the medical record which stated, "Echo today." The medical record was reviewed by the Director of Quality, who stated the expectation for inpatients of the facility was that services provided by the specialty clinics would be provided in patients' rooms.

Based on observations and staff interviews, the facility failed to ensure that radiological procedures were performed in a manner that protected both staff and patients from infectious agents.

This failure contributed to patients and staff being exposed to potential infectious agents.

FINDINGS:

1. The facility stored patient care items on the floor and below the sink in the Radiology department.

a) On 05/29/13 at 1:30 p.m., the facility's Radiology department was toured with the facility's Director of Nursing (DON) and the Radiology Department manager.

The facility's X-ray room #1 was viewed and contained 1 pillow and 2 positioning devices on the floor. The Radiology Department manager stated these items were normally stored on the floor, but were not used for patient care.

The facility's X-ray room #2 was viewed and contained 2 1-gallon jugs of water on the floor. The Radiology Department manager stated these jugs were used to position patients during procedures and were always stored on the floor.

The facility's mammography room was viewed and the following items were viewed in a cabinet below the sink: 2 rolls of paper toweling, 1 box containing several 30 gage needles, and 4 boxes of patient marking kits. The facility's Radiology Department manager verified these findings and stated these items were normally stored below the sink.

b) During the tour, the facility's DON stated that it was his/her expectation that no items would be stored on the floor or kept below sinks.

Based on interviews and document review, the facility failed to supervise and evaluate the nursing care for patients who received outpatient services in the facility's chemotherapy/infusion department.

This failure created a situation in which a staff Register Nurse diverted drugs over a period of approximately 6 months.

FINDINGS:

1. The facility did not supervise the patient care provided by a staff Registered Nurse (RN) who provided care to patients receiving outpatient hydration therapy.

a) On 05/28/13 at 2:34 p.m., internal facility documents were reviewed that captured overrides of the facility's Pyxis system for narcotics for patients who received outpatient hydration therapy. A facility document dated 01/04/13 stated that on this date, a staff RN removed hydromorphone by override of the Pyxis system for a patient with no scheduled visit (Sample Patient #2). A staff pharmacist discovered the override and initiated the documentation of the event. A facility document dated 02/26/13 stated that multiple narcotics were removed from the Pyxis system by override by a staff RN on this date to be administered to Sample Patient #5. A staff pharmacist discovered the override and initiated documentation of the event. A facility document dated 03/06/13 stated that narcotics were removed from the Pyxis system on this date, by override, for a patient who was not registered at the facility to receive treatment/care (Sample Patient #5). The same staff RN was documented as overriding the Pyxis system on each of the 3 dates. The document dated 01/04/13 showed followup by the RN Director of the Medical/Surgical unit with the RN on 01/07/13, 3 days after the override. The document dated 02/26/13 showed followup by the RN Director of the Medical /Surgical unit with the RN on 03/11/13, 13 days after the override of the Pyxis for narcotics. The document dated 03/06/13 showed followup by the facility's Director of Quality on 04/17/13, 43 days after the override of the Pyxis for narcotics.

b) On 05/29/13 at 10:30 a.m., an interview was conducted with the facility's Director of Nursing (DON). The DON stated there was a room located on the inpatient medical/surgical floor where patients received chemotherapy treatments and other infusions. S/he stated the facility had been without a chemotherapy nurse for approximately 1 year, but the infusion room continued to be used for chemotherapy patients who needed hydration therapy. The DON stated these patients received chemotherapy infusions at another location, outside of the licensed facility. The Director stated the facility's Medical /Surgical RN staff provided the hydration treatments, as they were trained and qualified to do so. S/he stated the RN staff would "float" between providing hydration treatments to outpatients in the infusion room and helping with care of inpatients, as both were located in the same area.

c) On 05/30/13 at 2:07 p.m., an interview was conducted with the facility's RN Medical/Surgical Director. The previous documents of overrides of the Pyxis system by the RN who was determined to have diverted drugs was discussed with the Director. The Director confirmed that the RN would spend his/her scheduled time with patients who received hydration therapy in the outpatient room and in between these scheduled patients, the RN would "step out" to help with inpatients. The Director stated the RN was on the schedule to work in the outpatient room and therefore s/he was not the supervisor of this nurse. The Director stated the supervisor of the chemotherapy/infusion outpatient department was the RN Emergency Department Director. The RN Medical/Surgical Director confirmed that s/he had followed up with the RN after override of the Pyxis, on 01/07/13 and on 03/11/13, but could not explain why she conducted the follow up as s/he was not the RN's supervisor when this nurse worked the outpatient infusion room. When asked since the diversion of drugs was discovered, who was now responsible for the supervision of RNs who were scheduled to work in the infusion room providing hydration therapy, the Director stated s/he was not certain.

d) On 05/31/13 at 12:09 p.m., an interview was conducted with the facility's DON who also functiond as the RN Director of Emergency Services. The DON stated that during the time the staff RN was diverting drugs in the outpatient chemotherapy/infusion room, the RN was under the supervision of the facility's RN Medical/Surgical Director. The DON stated that s/he, himself/herself, was the Director responsible for the chemotherapy/infusion room during the time that diversion of drugs occurred. The DON stated the RN would contact both Directors when s/he was working the infusion room, for different reasons. The DON stated the RN, who was determined to have diverted drugs, was unsupervised at the time by any facility Director and stated this was an area that was identified by staff as needing correction. The DON stated that since the drug diversion was discovered by the facility, both RNs and facility Directors currently understood the lines of supervision of nursing staff. The DON was informed that the RN Medical/Surgical Director was not certain of who would supervise an RN providing hydration therapy to patients in the outpatient chemotherapy/infusion department. The DON could not provide documentation that showed this issue had been corrected by the facility.

Based on document review and interviews, the facility failed to ensure that medications were administered by nursing staff in accordance with signed/authenticated verbal orders from physicians.

This failure created a situation in which orders for narcotics were falsified by a staff Registered Nurse.

FINDINGS:

1. The facility did not respond to its own internal processes for the override of the Pyxis system in which a Registered Nurse (RN) obtained narcotics by the falsification of verbal's orders on 2 occasions. The falsified verbal orders remained unsigned by the facility's physicians.

a) Cross Reference Fed-C-0296: There was lack of supervision of nursing staff who worked in the outpatient chemotherapy/infusion room. Deficiency Fed-C-0296 also addresses the facility's use of event reporting by the pharmacy department regarding overrides of the Pyxis system that were not adequately followed up on by facility Directors/Managers (3 overrides of the Pyxis system from 01/14/13 through 03/06/13 for narcotics by the same staff RN). Supervisors of nursing staff remain uninformed of which Directors are responsible for the supervision of RNs in each area of the facility, including outpatient units.

b) Cross Reference Fed-C-0259: There were no requirements by the facility that physicians review or audit their own medical records, or any percent of medical records, for accuracy of content of records, including the authentication of verbal orders. The facility's requirement that physician verbal orders be authenticated within 24 hours was not adhered to. The requirement that verbal orders be electronically authenticated within 24 hours by physicians who have patients receiving outpatient infusions on the Medical/Surgical unit was not adhered to.

Based on facility medical record review, facility document review, and staff interview, the facility failed to ensure that verbal physician orders were signed by the physician within 24 hours of the order being transcribed by facility nursing staff.

This failure led to orders not being authenticated in a timely manner and the possibility for medication orders to be written without a physician's knowledge.

FINDINGS:

1. The facility failed to ensure that the physician orders were authenticated within 24 hours in 3 (Sample Patients # 5, 11, and 21) out of 23 patient medical records reviewed.

a) On 05/31/13, a review of 23 patient medical records was conducted and revealed that in 3 patient medical records, that physician verbal orders had not been authenticated and signed by the physician within 24 hours.

Sample Patient #5's medical record was reviewed and contained verbal physician orders for narcotics on 02/07/13 and 02/25/13. Neither verbal order contained any authentication by the ordering physician and contained no physician signature.

Sample Patient #11's medical record was reviewed and contained multiple verbal physician orders from 03/09/13. The orders were documented as electronically signed by the ordering physician on 03/25/13, which was 16 days after they were transcribed into the patient medical record by the Registered Nurse (RN).

Sample Patient #21's medical record from 01/23/13 was reviewed and contained verbal physician orders for a narcotic pain medication. The verbal order did not contain any documentation of authentication of the orders by the physician.

b) On 05/31/13 at 11:30 p.m., the facility's medical records were reviewed with the facility's Health Information Management (HIM) Manager. The HIM Manager reviewed the medical records for Sample Patients #5, #11, and #21. The HIM Manager verified that there was no physician signature for verbal orders for Sample Patients #5 and #21, and that the verbal orders for Sample Patient #11 were signed 16 days after the orders were transcribed by nursing staff. The HIM Manager stated it was his/her expectation that all verbal physician orders be signed within 24 hours.

c) On 05/31/13 at 12:00 p.m., the facility's Medical Staff rules titled, "General Rules and Regulations for the Medical Staff," was reviewed. The medical staff rules stated,"All verbal orders shall be transcribed in the proper place in the medical record, shall include date, time, name, and signature of the person transcribing the order and the name of the practitioner, and shall be countersigned by the prescribing practitioner within twenty-four (24) hours." The facility's Director of Nursing (DON) verified these were the current medical staff rules.

Based on document review and interviews, the facility failed to ensure that individuals who were part of the facility's quality assurance program were informed of, and involved in, patient care service issues and patient safety issues.

This failure created the potential for negative patient outcomes due to lack of the responsible committee, the quality committee, being uninformed of potential patient care and safety issues.

FINDINGS:

1. The facility's Clinical Quality Committee was not informed of drug diversion discovered in the facility from an investigation initiated on 03/11/13.

a) On 05/28/13 at 3:40 p.m., a review was conducted of the facility's Governing Body Bylaws, which stated under Article VIII, Committees, Section 1., "Committees of the Board shall be classified as standing and special, and shall be advisory to the Board." The Bylaws also stated, "The Chief Executive Officer shall serve as an ex-officio member of each committee appointed by the Board, unless otherwise designated in these bylaws or by the Board."

b) On 05/30/13, review of meeting minutes from the facility's Clinical Quality Committee was conducted for meetings held from 05/01/12 through 05/28/13. Minutes from the Clinical Quality Committee meeting dated 01/28/13 stated, "The data on Pyxis overrides supports a sustained, slight downward trend. Order entry errors remain very low." Minutes from the Clinical Quality Committee meeting dated 03/25/13 stated, "Pharmacy: Items are Pyxis overrides. We are trending down, and hitting below target. Pharmacy Order Entry Errors, keeping errors down." Minutes from the Clinical Quality Committee meeting dated 04/22/13 stated, "4Q13 Pyxis overrides are trending down (4.17%) and order entry errors are down (0.09%). Minutes from the Clinical Quality Committee meeting dated 05/20/13 stated, "Pyxis overrides and pharmacist order entry errors have not been calculated yet." Meeting minutes from the Clinical Quality Committee from 03/25/13, 04/22/13, and 05/20/13 contained no mention of the facility's investigation or findings related to a drug diversion investigation initiated by the facility staff on 03/11/13, which was found to be related to Pyxis overrides by a staff Registered Nurse (RN), Pyxis medications obtained by an RN for patients who were not admitted to the facility, and narcotics obtained by an RN through falsification of physician orders. In addition, meeting minutes from the facility's Quality Council were reviewed for meetings held from 05/01/12 through 05/28/13. Minutes from meetings held on 03/20/13 and 05/15/13 contained no mention of drug diversion or the facility's investigation or findings.

c) On 05/31/13 at 2:04 p.m., an interview was conducted with the facility's Chief Executive Officer (CEO).The CEO confirmed that s/he attended quality meetings held by the facility. When asked if the drug diversion had been discussed in Clinical Quality Committee meetings or Quality Council meetings, the CEO stated it had not. It was reviewed with the CEO that the drug diversion by an RN that had been discovered by the facility created patient safety and patient care issues. The CEO confirmed that these were issues that should be discussed in quality meetings. The CEO stated a member of the Board of Directors attended quality meetings and was responsible for reporting quality issues to the Board of Directors. The CEO could not explain how quality issues, specifically the findings of the drug diversion investigation, could have been shared with the facility's Board of Directors if it was not discussed in quality meetings. It was reviewed with the CEO that statements documented in quality meetings since the drug diversion was discovered, regarding override of the Pyxis system simply stated that overrides were, "trending down," or were "hitting below target." When asked if and when the physicians who had orders falsified by the RN had been notified, the CEO stated, "I do not know the answer to that." The CEO stated s/he had not informed the physicians of the falsification of orders and assumed that they had not been informed. The CEO stated s/he had not informed the Board of Directors or the facility's medical staff of the issues discovered around the diversion of drugs that had occurred from October, 2012 through March, 2013.