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Based on interview and record review the facility failed to develop a comprehensive, individualized care plan for six of 13 patients' care plans reviewed (Patients #12, #14, #56, #57, #58, and #59). The facility census was 666.

Findings included:

1. Review of a facility policy titled, "Interdisciplinary Care Planning (ICP) and Pathways," revised 06/12, showed the following:
-The ICP is developed and updated based upon the admission assessment, and any changes in condition;
-The ICP identifies individual patient care needs;
-The ICP identifies treatment goals, and patient specific interventions;
-The ICP is appropriate to the patient's physiological, and psychosocial needs, strengths, limitations and goals;

Record review of facility's policy titled, "Care Plan/Nursing Process: Inpatient and Outpatient" dated 05/06/11, showed the following:
- The Care Plan identifies the patient's individual needs, treatment goals and objectives, patient specific interventions and timelines for goals to be met.
- Will be reviewed with the patient and/or family every 24 hours;
- Initiated within 12 hours of admission and reflects the individualized needs identified during the assessment including but not limited to Medical and Discharge goals.

2. Review of Patient #14's History and Physical (H&P), dated 06/14/12, showed the patient was admitted on that date with a diagnosis of post cardiac arrest. The patient had an orange-sized pressure sore on the coccyx area (tailbone).

Review of laboratory results dated 06/28/12, showed the patient had an infection in the bloodstream called Acinebactor, which is resistant to multiple antibiotics.

Observation on 07/10/12 at 9:30 AM showed the patient was in contact isolation.

Review of the patient's medication administration records from 06/30/12 through 07/10/12, showed the patient received Colymycin, Micafungin and Tigecycline (antibiotics) for infection.

Review of the patient's care plan, last updated 07/10/12, showed staff failed to identify the patient's infection as a problem, with a goal and interventions to resolve.

During an interview on 07/10/12 at 9:30 AM, Staff A, Registered Nurse RN, confirmed there was no care plan addressing the Patient #14's infection.

3. Observation on 07/11/12 at 1:25 PM on the orthopedic surgical unit showed Patient #56 sitting upright in a chair with a wound dressing covering the right knee.

During an interview on 07/11/12 at 1:25 PM Patient #56 stated that she was not aware of the staff's goal of care and that she did not remember discussing a plan but that her goal was to return home able to take care of herself in her own home and to have a better level of comfort and mobility after knee surgery.

Review of the H&P for Patient #56 showed:
-The patient was 81 years old;
-Was admitted to the facility on 07/09/12 for right total knee arthroplasty (a surgical knee joint replacement) procedure;
- Had a history significant for an oophorectomy (surgical procedure for removal of the ovaries) in 1963; and
-Had impaired blood sugar levels (a type of pre diabetes with high blood sugar levels);

Record review of the Physician Assessment and Plan for Patient #56 showed staff was to monitor blood pressure (BP), blood sugar (BS) and renal (kidney) function. The Plan also directed staff to provide routine post-operative nursing care for a total knee replacement.

Record review of the care plan for Patient #56 showed no individualized patient specific interventions for the following identified problems:
-Monitoring the blood sugar;
-Wound care after the knee surgery;
-Mobility Goals to increase her level of independence following surgery: Walking, Climbing stairs, toilet transfers, shower/tub transfer;
-Fall/Trauma/Injury Risks; and
-Discharge needs.

Review of the Care Plan section located in the electronic medical record for Patient #56 showed an obstetrics Care Plan titled "Hypertensive Disorder (high blood pressure) in Preg, (pregnancy) includes HELLP (H (hemolysis, which is the breaking down of red blood cells, EL (elevated liver enzymes) and LP (low platelet count) (a group of symptoms that occur in pregnant women which causes severe bleeding problems) (obstetrics')".

Record review of the medical record for Patient #56 showed no medical diagnosis of pregnancy. Pregnancy was an unlikely problem for the 81 year old patient admitted for knee replacement surgery.

4. Record review of Patient #57's H&P dated 07/10/12 and nurse's notes showed:
-The patient was pregnant, with a gestation (length of pregnancy) of 33 weeks and five days of an expected 40 week gestation;
-Was taking medication during the pregnancy for high blood pressure;
-Had a medical diagnosis of type one insulin dependent diabetes (must inject insulin daily for survival, not controlled by diet or oral medications) for 16 years and utilized an insulin pump for continuous insulin infusion with unstable blood sugar levels;
-The physician's plan was to perform a c-section (surgical procedure to deliver the infant and avoid natural labor and childbirth) the same day due to risks associated with high blood pressure and high blood glucose levels "in light of severe preeclampsia" (condition of pregnancy which includes symptoms of high blood pressure, protein in the urine and can be life threatening to mother and infant if untreated); and
-Nurse Notes dated 07/11/12 showed "Orders to d/c (discontinue) Foley catheter (catheter inserted into the bladder for urine collection)".

Record review of Patient #57's Care Plan showed no identified patient specific problems for high blood pressure, Foley catheter need, placement or care; or blood sugar monitoring and associated interventions for diabetes.

During an interview on 7/11/12 at 1:15 PM, Staff RR, RN, stated that the patient (#57) was "not doing well" and shouldn't have visitors. Staff RR stated that all patients have their blood pressure monitored regularly and verified the absence of a care plan for high blood pressure or blood sugar monitoring.

5. Record review of the H&P showed Patient #58 was admitted to the facility on 07/11/12 for induction (to begin or speed up) of childbirth/labor.
The patient had hypertension (elevated blood pressure) and hidradenitis suppurativa (chronic inflammation of the glands located under the arms, breasts, genitals and anus) with abscesses (infections of tissue marked by a collection of pus surrounded by inflamed tissue) on and off since 2002. The patient was being treated with medications for both conditions at the time of admission.

Record review of the medication administration record (MAR) for Patient #58 showed the patient was receiving Penicillin and Clindamycin (antibiotics) and high blood pressure medication, Labetalol.

Record review for Patient #58 showed no Care Plan for the problems of high blood pressure and infection.

6. Record review for Patient #59 showed a sixteen year old admitted to the facility on 05/05/12 from a pediatric rehabilitation hospital for evaluation of vomiting with a history significant for mental retardation, healing burn wounds and skin graft donor sites.

Record review of the Care Plan for Patient #59 showed no patient specific individualized interventions for the following problems:
-Speech Language Dysphasia (impairment of the power of expression by speech or writing);
-Discharge needs;
-Skin integrity impairment; and
-Risk factors - fair complexion with blonde/red hair).

Observation on 07/11/12 from approximately 9:45 AM until 10:45 AM showed the patient laying in bed with eyes open, alert, with a right wrist and hand brace in place. The patient had dark brown skin, dark brown hair, dark brown eyes and had visible healing wounds throughout the facial area, neck, arms, chest, thighs and legs. Wound dressings were observed on the right wrist and hand.

During an interview on 07/11/12 at 10:45 AM, Staff TT, RN, Manager of the General Pediatrics Unit, verified the absence of individualized care planning for Patient #59.

7. Observation on 07/11/12 at 1:05 PM showed Staff P, RN removed a urinary indwelling catheter from Patient #12.

During an interview on 07/11/12 at 1:05 PM, Staff P stated that Patient #12 had a surgical heart valve repair during her current admission and that most heart patients get indwelling urinary catheters.

Record review for Patient #12 showed no Care Plan for the indwelling urinary catheter.

8. During an interview on 07/12/12 at 12:30 PM, Staff GGG, RN, Supervisor of Information Systems, stated that all Care Plans are expected to be individualized to the patient's specific needs and that the documentation should reflect the policy expectations. Staff GGG verified missing documentation and inappropriate care plan interventions for Patient #12, Patient #56, Patient #57, Patient #58, and Patient #59.

9. Record review of care planning in-service modules on 07/12/12, titled "Epic Care Planning Upgrade January 2011 Labor Birth and Recovery" and "Simplified Care Planning" showed instruction for nursing staff to individualize and customize the Care Plan interventions based on the individual needs of the patient.




17863

Based on observation, interview and record review, the facility failed to follow professional standards of care and facility policy regarding patient care and assessment for four patients (#52, #53, #54 and #55) of four patients observed with known risks during treatment. This had the potential to affect all dialysis patients in the facility. The facility census was 666.

Findings included:

1. Record review of the Centers of Medicare and Medicaid Services document titled, "ESRD [End Stage Renal Disease] Basic Technical Surveyor Training Interpretive Guidance, Interim Final Version 1.1" dated October 3, 2008 gives the following guidance:
- Patients must be in view of staff during Hemodialysis treatment to ensure patient safety;
- Each patient, including his/her face, vascular access site, and bloodline connections, must be able to be seen by a staff member throughout the dialysis treatment, (video surveillance will not meet this requirement);
- Allowing patient to cover access sites and line connections provides an opportunity for accidental needle dislodgement or a line disconnection to go undetected which could result in exsanguinations [bleeding out] and death in minutes.

Record review of the facility policy titled, "Clinical Procedures" dated 09/11, gave the following direction to clinical staff in the Dialysis (Hemodialysis) Unit:
- Purpose: Ensure patient safety and extend the use of the patient's vascular access;
- Access and connections are visible at all times.

Dialysis is a specialized treatment that requires visual contact with the patient and the patient's access site at all times throughout dialysis treatment as a standard of practice. Dialysis access is an entranceway into the patient's bloodstream that lies completely beneath the patient's skin. The access is usually in the arm, but sometimes in the leg, and allows blood to be removed from the patient, circulated through tubing into a machine where unwanted blood components are removed, then returned through tubing back into the patient. This can be done quickly, efficiently, and safely. However, venous pressure alarms that are part of this system are not consistently reliable in detecting venous disconnections before a significant amount of blood is lost. Therefore, the patient should not be placed alone where the access site cannot be seen by staff trained to watch for problems, such as rooms which do not permit ongoing observation of the blood lines. In the majority of these cases, the venous pressure alarm on the dialysis machine fails to detect the event until significant blood loss had occurred. Episodes of blood loss can occur that if not detected or stopped can result in hospital admission or death of the patient.

2. Observation on 07/11/12 at 9:07 AM showed four patients in the Dialysis Unit. The dialysis unit was shaped in a semi- U design. The nurses' station was in the middle of the room with two isolation (isolation refers to the precautions that are taken in the hospital to prevent the spread of an infectious agent from an infected or colonized [where there is a presence of bacteria without causing disease in a person] patient to susceptible persons) rooms on either side and four patient rooms divided by curtains to the front of the nurses' station. Patient #53 was in isolation room #3; Patient #54 was in isolation room #8; Patients #52 and #55 were side by side in rooms #5 and #6 directly in front of the nurses' station. There was a large glass window overlooking room #8 approximately 3 feet by 4 feet covered by a large printer approximately 2 feet wide by 4 feet high and a poster over the bottom of the window, leaving approximately 8 inches by 10 inches viewing space into room #8. All patients could not be visualized by staff from the nurses' station throughout their dialysis treatment, a period usually of more than two hours.

3. During an interview on 07/11/12 at 9:07, Staff A, Registered Nurse (RN), Intensive Care and Dialysis Unit Manager, stated that the Dialysis Unit is staffed with three RN's and the staff to patient ratio is 2:1 (two patients for every one nurse).

4. Observations on the dialysis unit for 07/11/12-07/12/12 showed Staff HHH, RN, remained in the nurses' station behind the computer and did not participate in direct contact or monitoring of any of the dialysis patients.

5. Observations on 07/11/12 at 9:10 AM showed Staff JJ, RN, in Patient
#53's room with the curtain drawn. Staff KK, RN, was in Patient #52's room with all three curtains drawn.

6. During an interview on 07/11/12 at 9:20 AM Staff A, RN, Intensive Care and Dialysis Unit Manager, stated "they [the nurses] don't have to have direct sight [of the patients], all the nurses listen for the alarms". Staff A stated that she didn't know if the alarms could be turned off or the volume adjusted.

7. Observation on 07/11/12 at 1:20 PM showed Staff JJ coming out of room #3 and preparing to go into room #8. Both patients were currently receiving dialysis treatments and Patient #53 in room #3 did not have the access site exposed when the nurse left the room. Staff JJ stated, "I would say that we don't have to observe the patient at all times". Staff JJ entered room #8 with Patient #54 and stated that the access site was not visible unless you were standing over the patient.

8. Observation of Patient #54 on 07/11/12 at 1:25 PM from the nurses' station showed that neither the patient's face nor access site could be seen from the viewing window at the nurses' station.

9. Observation on 07/11/12 at 1:25 PM showed Staff KK, RN, and Staff A, RN, Nurse Manager, in Patient #55's room with the curtains partially drawn. The patient's blood pressure (BP) reading on the monitor was 53/30 which was an extremely low blood pressure and indicates a life-threatening situation (normal BP is 120/80 and low normal BP is 110/75.) Neither Staff KK nor Staff A attempted to call for assistance during that time. Patient #54 was currently receiving dialysis treatment in room #8 and was not visible to any of the nurses at that time.

10. Observation on 07/11/12 at 1:34 PM showed Patient #54 in room #8 still unattended. The patient's dialysis machine alarm sounded and remained sounding until 1:43 PM before Staff JJ entered the room. The patient's blood pressure reading was 83/47 which was very low and could indicate weakness or fainting status.

11. During an interview on 07/11/12 at 1:45 PM Staff JJ stated that the patient assignments are always divided two to one (two patients for every nurse) and that if there are two patients in isolation one nurse would have both of those patients even though the isolation rooms are located at either end of the unit. Staff JJ stated that the other nurse would have the non-isolation patients. She stated the situation was not the best but that was how it turns out sometimes.

12. During an interview on 07/11/12 at 3:45 PM Staff D, Director of Accreditation and Licensure, stated that the facility didn't have a policy stating the criteria chosen as the nationally accepted internal standards for the Hemodialysis Unit.

A facility must follow nationally accepted standards of practice in patient care and should state which nationally accepted standards of practice they are going to follow in the policies and procedures to ensure continuity of care and written guidelines.

13. Record review of the facility policies for the Dialysis Unit showed no policy that addressed required staffing for the unit.

Based on observation, interview, record review and policy review, the facility failed to ensure medical records at one (Infusion Room) of 22 off-site outpatient facilities were secured from unauthorized access. This had the potential to affect the confidentiality of all outpatient medical records stored in the off-site medical record storage room. The main hospital census was 666. The outpatient facility Infusion Room sees an average of 15 patients per day.

Findings included:

1. Record review of the facility's policy titled "Offsite Storage" revised on 06/29/12, showed direction for all paper-based medical records to be stored at a [facility] specified off-site storage facility.

Record review of the facility's policy titled "Safeguards: Protecting Patient Information" dated 04/21/05 showed that the facility was to protect the privacy and security of patient information in compliance with federal, state, and other applicable laws governing access to protected health information.

2. During an interview on 07/11/12 at approximately 2:50 PM, Staff AAA, Supervisor of Infusion Room stated that the Infusion Room (part of the outpatient facility) staff stored patients' medical records in a medical records storage room in a physician clinic that adjoined the outpatient facility. Staff AAA stated the Infusion Room records are stored in the physician clinic because the physician's associated with the Infusion Room wanted to have quick access to the paper records if needed.

3. Observation on 07/11/12 at approximately 3:15 PM showed a medical records storage room located in a physicians clinic that adjoined the outpatient facility. The storage room was accessible by keyed entry and contained medical records from the Infusion Room, a department within the outpatient facility along with medical records of patients not associated with the facility outpatient department.

4. During an interview on 07/11/12 at 3:35 PM, Staff YY, Pre-Certification Coordinator of the adjoining physicians clinic (not a part of the Infusion Room outpatient clinic) stated that when medical records staff leave or are not available, staff members from all areas of the physician clinic are able to obtain a key from the radiology department and access the medical records storage room.

5. During an interview on 07/11/12 at approximately 2:55 PM, Staff G, Director of Accreditation stated that he was unaware outpatient medical records were stored in the adjoining clinic and explained that all medical records should be stored electronically and then destroyed, and not stored in paper form.

6. During an interview on 07/12/12 at 12:45 PM, Staff E, Executive Director of Health Information Services stated that:
-He was not aware the outpatient facility medical records were stored in paper form at the physician clinic which adjoined the outpatient facility.
-The outpatient facility records should not be stored in paper form at the physicians clinic. The records should be scanned electronically and then destroyed.
-Only staff authorized to obtain and store medical records should have access to the outpatient medical records.
-Physician clinic staff were not authorized to have access to the outpatient facility's medical records.

Based on interview, record review and policy review the facility:
-Failed to provide adequate oversight of Class 3 narcotic medication (subject to addiction or abuse) when it allowed Emergency Department (ED) Registered Nurses (RN's) to administer these medications without a complete or direct physician order to seven patients (#21, #24, #25, #68, #69, #19 and #70) of seven records reviewed for pain management;
-Allowed ED nursing staff to give medications based on a protocol, which had not been approved by the Medical Executive Committee or the Pharmacy and Therapeutics Committee and
-Based on observation, interview and policy review the facility failed to label medications with the patients' name, date dispensed, drug name, strength of the medication and directions for use for two patients (#6 and #11) of two patients observed. Without each medication being labeled separately it would be impossible to scan the medication for identifying the correct patient or be sure the medication was intended for that patient before administration of the mediation.

The ED had an average of 220 patient visits per day. The facility census was 666.

The severity and cumulative effect of these practices resulted in the facility's non-compliance with 42 CFR 482.25 Condition of Participation: Pharmaceutical Services.

Please see citations at A0491 and A0505.


29511

Based on interview, record review and policy review the facility failed to provide adequate oversight of Class 3 narcotic medication (subject to addiction or abuse) when it allowed Emergency Department (ED) Registered Nurses (RN's) to administer these medications without a complete or direct physician order to seven patients (#21, #24, #25, #68, #69, #19 and #70) of seven records reviewed for pain management. The ED has an average of 220 patient visits per day. The facility census was 666.

Findings included:

1. Review of facility Adult Emergency Medicine policy titled "Medication Administration Protocol" #4.76, revised 08/11, showed:
-These guidelines will outline immediate interventions for patients in the triage area and the ED for the management of pain;
-Pain medication will be given per guidelines;
-Musculoskeletal- Pain Scale 6-10 (a pain rating system) - give Hydrocodone/Acetaminophen (a medication for pain) 975 mg (milligrams, a unit of measure) (Norco- also called Vicodin) PO (by mouth) one time only;
-Suspected fracture- Pain scale rating 6-10 - give Hydrocodone/Acetaminophen 975 mg (Norco) PO (by mouth) one time only;
-Suspected fracture- Pain scale rating 6-10 needing interventions such as surgery, moderate sedation- give Morphine (pain medication) 2 mg slow IV push (administer through intravenous sight) one time only.

Review of facility policy number 200.38 titled, "Medication Management: Prescribing" revised 2/2009 showed:
-Medication can only be administered upon the order of an individual who has been assigned clinical prescribing privileges;
-Each order will include the date written or accepted verbally, either the generic or brand name of the medication, dose, frequency of use and route of administration.
-Prescribers may request initiation of pre approved protocols. These typically include detailed medication and dosing information which must also be specified by the prescriber at the initiation of such orders.

2. Review of Omnicell (medication dispensing system located in triage area)"transaction by item" report showed nine Hydrocodone with Acetaminophen 5/325 mg tablets (5 milligrams of Hydrocodone and 325 mg of acetaminophen) were dispensed to seven different patients from 07/05/12 to 07/10/12.

3. Review of medical record for Patients #21, #24, #25, #68, and #69 showed each patient received one tablet of Hydrocodone and acetaminophen 5/325 while in ED triage or waiting room with no corresponding physician order prior to administration of the medication.

4. Further review of Patient #24's medical record showed that patient left the ED without being seen after receiving medication but prior to ever being evaluated by an ED physician.

5. Review of medical record showed Patient #19 received two tablets of Hydrocodone and acetaminophen 5/325 while in ED triage or waiting room with no corresponding physician order prior to administration of the medication.

6. Review of medical record showed Patient #70 received two tablets of Hydrocodone and acetaminophen 5/325 while in ED triage or waiting room with the ordering physician listed as (Facility Name) Staff JJJ Protocol. Staff JJJ was not the physician of record for this patient.

7. During an interview on 07/10/12 at 9:15 AM Staff X, ED triage RN, stated that Vicodin (Hydrocodone with acetaminophen) is frequently given in triage. Staff X stated that the RN assesses the patient and based on symptoms and pain scale an order for the medication is entered under the Staff JJJ protocol. Staff X stated that either the ED physician that eventually examines the patient or Staff JJJ will sign the order. Staff X stated that only one dose can be given. Staff X stated that it is not necessary to call and get an order because "we have the protocol".

8. During an interview on 07/09/12 at 2:30 PM Staff W, ED Director, stated a protocol initiated in triage or the waiting room directs the nurse to administer Vicodin, based on pain scale assessment, prior to evaluation by a physician to help manage patients pain. Once the patients pain scale and allergies are assessed the RN can administer one dose of Vicodin. The RN places an order based on the protocol and either the ED physician that takes care of the patient or Staff JJJ will sign the order. Staff W stated that they don't want patients to wait while they are in pain.

9. Review of facility policy number 200.83 titled, "Protocol" revised 5/2012 showed:
-Protocols are evaluated and approved by the Medical Executive Committee and/or the Pharmacy and Therapeutic Committee when content includes medications.
-All approved protocols are available via the Medical Center's Intranet

10. Review of the facility's intranet listing of protocols that have been approved by Medical Staff does not include Emergency Department Medication Administration Protocol.

11. During an interview on 07/11/12 at 10:05 AM Staff FF, Director of Pharmacy, stated that the ED Medication Protocol does not include a dose for the Hydrocodone- it comes in 5 mg, 7.5 mg or 10 mg tablets and that 975 mg of acetaminophen means the RN would need to give three tablets (325 mg each). Staff FF stated that the protocol order is confusing and could lead to errors. Staff FF stated that the ED triage RN should not be administering medication without an order from the ED physician, especially a Class 3 drug. Staff FF stated that he has previously advised the ED that the pharmacy does not support this practice.

12. During a concurrent interview on 07/11/12 at 10:05 AM Staff LL, Vice President of Performance/Operations, stated that this ED protocol has not been approved by the Medical Executive Committee or the Pharmacy and Therapeutics Committee.

Based on observation, interview and policy review the facility failed to ensure medications were secured in a manner to avoid tampering or potential harmful use for one patient (#6) of two patients observed. This had the potential to affect all patients in the facility.
The facility also failed to secure medication designated for disposal. This failure had the potential to allow unauthorized persons access to medication designated for prescription use only. This failure occurred in the GI (gastrointestinal) Lab. The GI Lab performs about 50 procedures a day. The facility census was 666.

Findings included:

1. Review of facility policy 200.63 titled, "Medication Storage and Security Prior to Administration" dated 02/15/2010 showed the following:
-Pharmacy provides for safe distribution, storage and security of medications between delivery to the patient care area, or an individual healthcare provider prior to medication administration.
-Nursing is responsible for the appropriate drug waste disposition and documentation.
-Medications may be designated for additional security precautions related to medication distribution and wastage.
-Pharmacy identifies the best method of distribution and storage to ensure the security and integrity of medication prior to administration. Any drug received from the Pharmacy is administered or placed in an approved storage area as soon as possible.
-Drugs should never be left unattended or in unsecured storage in the patient's room or treatment room.
-If any portion of the medication remains following patient administration, that portion will be disposed of in the appropriate waste container.

2. Observation on 07/09/12 at 2:56 PM showed a plastic see-through stationary box (referred to as a bread box by facility staff) containing medications in Patient #6's room. The box had a combination touch pad locking system but the box was unlocked and contained two medications: Travatan ophthalmic solution 0.004% (used for the treatment of glaucoma, a disease of the optic nerve that is progressive and may eventually lead to blindness) and Advair 250/50 (an inhaler used for the treatment of chronic obstructive pulmonary disease, including chronic bronchitis, emphysema, or both).

3. During an interview on 07/09/12 at 3:17 PM, Staff D, Registered Nurse (RN), Nurse Manager, stated that the bread box couldn't be opened because they lock automatically.

4. Observation on 07/09/12 at 3:20 PM showed Staff D opened the bread box in Patient #6's room and stated, "it wasn't locked". Staff was not observed checking the box for medications that may have been missing.

5. During a concurrent interview on 07/11/12 at 10:00 AM, with Staff FF, Director of Pharmacy and Staff LL, Vice President of Performance and Operations, Staff FF stated that all medications in the bread box should be secured with the locking mechanism. He stated that the boxes do not lock automatically and the knob must be turned to the locking position to secure the medications. He stated that this was a new process for the facility and the bread boxes had only been in use a couple of weeks. Staff LL stated that the bread boxes were new and that she agreed the medications should be locked.

6. Record review of vendor policy, specific to this facility, MSL-11-001 titled "Pharmaceutical and Dual Waste Pickups" revised 12/21/11 showed direction that if the bin [container with medications to be discarded] is at least ½ (half]) full it will be collected.

7. Observation in the GI Lab procedure Room #2 on 07/12/12 at 9:55 AM showed that five bottles and syringes of Propofol (an intravenous, IV, medication used for anesthesia to keep patients sedated during procedures) had been discarded into a black bin with an unsecured lid. The bin sat on the floor, unsecured, with a lift up lid. The bins were labeled with the name of the vendor authorized to dispose of the discarded medications. The medication name was visible on the bottles. The syringes contained a milky white substance consistent with the appearance of Propofol.

8. Observation in the GI Lab procedure Room #7 on 07/12/12 at 10:05 AM showed that four bottles and syringes of Propofol had been discarded into a black bin with an unsecured lid. The bin sat on the floor, unsecured, with a lift up lid. The bins were labeled with the name of the vendor authorized to dispose of the discarded medications. The medication name was visible on the bottles. The syringes contained a milky white substance consistent with the appearance of Propofol.

9. During an interview on 07/12/12 at 10:10 AM Staff LLL, Director of GI Lab, stated that the medications in the bins were Propofol. Staff LLL stated that the bins were specifically for medication and were removed by a contracted vendor. Staff LLL stated that the bins were easily accessible, "the lids just lift up," and that she agrees this could be an opportunity for drug diversion.

10. During an interview on 07/12/12 at 10:40 AM Staff MMM, Anesthesiologist, stated that the bins are provided specifically to discard drugs. Staff MMM stated that controlled substances (narcotics) can't be disposed of in the bins. Staff MMM stated, "We were told we can't throw medications into the trash can and we can't put drugs like Propofol down the drain so we got the bins." Staff MMM stated that Propofol has become the drug of choice for these types of procedures (GI).

11. During an interview on 07/12/12 at 12:30 PM Staff FF, Director of Pharmacy, stated that he agrees with the potential for drug diversion and the need to make the containers secure. Staff FF stated that the facility experienced a drug (Propofol) diversion from the intensive care unit within the last year. Staff FF stated that he recognizes that Propofol is at high risk for abuse but is not a controlled substance. Staff FF stated that Propofol can't be wasted (poured) down the drain because its high lipid (fat) concentration could damage municipal filtration systems. Staff FF stated that the EPA (Environmental Protection Agency) has also advised against it and that's why the facility contracted with this vendor for medication disposal.




29511

Based on observation, interview and policy review the facility failed to:
- Label multi-dose medications/vials with the patients' name, date dispensed, drug name and strength, and directions for use for two patients (#6 and #11) of two patients observed. Without each medication being labeled separately it would be impossible to scan the medication for identifying the correct patient or be sure the medication was intended for that patient before administration of the mediation.
- Label opened multi-dose medications in one (unit 3B) of one medication room, with the date opened and the initials of the staff member who opened the medication and
- Follow the facility's policy and procedure for sample medications in one (unit 3B) of one medication room. These failures had the potential to affect all patients in the facility. The facility census was 666.

Findings included:

1. Record review of the facility's policy and procedure titled, "Medication Storage and Security Prior to Administration" dated 02/10, showed the unauthorized storage, distribution, administration or use of any portion of a drug product to any individual other than the intended patient will be in direct violation of this policy.

2. Observation on 07/09/12 at 2:56 PM showed a plastic see-through box (referred to as a bread box by facility staff) containing medications in Patient #6's room. The box contained two medications. The medications did not contain the name of a patient, date dispensed, drug name and strength, and directions for use.

During an interview on 07/09/12 at 2:56 PM, Patient #6 stated she had no idea those medications were in there but wanted to use them and had never seen anyone get them out of the box.

3. During an interview on 07/09/12 at 3:17 PM, Staff D, RN, Nurse Manager, stated that frequently used patient medications are contained in the bread boxes in each patient room.

4. During an interview on 07/10/12 at 9:22 AM, Staff O, RN, opened the bread box of Patient #11 which contained five medications including an insulin (a hormone that lowers the level of glucose [a type of sugar] in the blood) multi-dose pen. None of the medications were labeled with the patient's name, date dispensed or directions for use.

5. During an interview on 07/11/12 at 10:00 AM, Staff FF, Director of Pharmacy, stated that all medications in the bread box should be labeled with the patient's name, date dispensed and directions for use and secured. He stated he couldn't understand why the medications in the bread box were not labeled.

During an interview on 07/11/12 at 2:20 PM, Staff FF stated that the reason the medications were not labeled in the bread box was a carousel (a system of medication distribution in the pharmacy) issue with labeling. He stated that all the medications for the bread box were being placed in a large bag with required patient labeling attached to the outside of the bag by the Pharmacy Technicians. Staff FF stated he has since discovered that the medications are being placed in the bread box without the bag and labeling and the bags are being discarded and he was unaware of this procedure until now.

Without each medication being labeled separately it would be impossible to scan the medication for identifying the correct patient or be sure the medication was intended for that patient before administration of the medication.

6. Observation on 07/09/12 at 2:00 PM in the medication room on 3B (Neurological Surgical Unit) showed three ceiling to floor unlocked cabinets with a large multi-dose bottle of non-aspirin medication that had been opened but did not contain the date it was opened and the initials of the staff member that opened the medication. It could not be determined when the medication should be discarded.

7. Record review of the facility's policy and procedure titled, "SAMPLE MEDICATION POLICY" dated 08/11, gave the following direction regarding sample medications:
- The use of sample medication is prohibited in the hospital pharmacy or ambulatory care areas;
- Hospital Pharmacy Department and Ambulatory Care Areas do not stock or dispense sample medication.

8. Observation also showed an unopened physician sample of Enablex (a prescription medication approved for the treatment of overactive bladder) 15 mg (milligrams) containing seven tablets.

9. During an interview on 07/09/12 at 2:00 PM, Staff C, Registered Nurse (RN), Nurse Manager, stated that the Enablex must be for the nurses' use and that it should not have been stored in the cabinet.

Based on observation, interview and record review the facility failed to discard expired blood collection and culture tubes in the Emergency Department (ED), in one of three medication storage rooms observed and failed to discard expired alcohol based hand sanitizers found in seven of seven storage cabinets in an outpatient facility's infusion room. Failure to remove expired supplies from stock has the potential to expose patients to unsterile, unstable supplies which could cause infection or inaccurate test results.

The facility also failed to maintain food storage areas and equipment to ensure quality and safety of foods. The facility census was 666.

Findings included:

1. Review of facility policies titled, "Expiration of Blood Collection Tubes," dated 10/08/08, and "Expiration of Products," dated 11/01/10, showed the following:
-The expiration date indicates the shelf life of the product as determined by the manufacturer;
-Products must be used by the expiration date;
-Tubes must be used by the expiration date to assure accurate draws and test reliability; and
-Tubes must be discarded on the last day of the indicated expired month.

2. Observation on 07/09/12 at 2:15 PM, showed approximately 63 gold blood collection tubes stored in the medication room on the neuro/trauma intensive care unit (ICU) that had expired the last day of April, 2012. Staff failed to discard these tubes, rendering them accessible for patient use.

During a concurrent interview, the Registered Nurse (RN) manager, Staff A, of the neuro/trauma ICU stated that the tubes were delivered to the unit from an unknown source, and the nurses on the unit stocked them. Staff A confirmed the tubes had expired.

3. Observation on 07/09/12 at 2:00 PM in the Emergency Department (ED) in the Triage Area showed the following supplies:
-68 Gold Top blood specimen tubes with acid/citrate/dextrose additive (keeps specimen from deteriorating) with a manufacturers' expiration date 03/12;
-32 Gray Top blood specimen tubes with a Sodium Chloride buffer additive (keeps specimen stable) with a manufacturers' expiration date of 05/12; and
-Two Anerobic culture specimen collection tubes that contained an additive to keep sample from breaking down with a manufacturers' expiration dates of 07/10 and 09/10.

4. During an interview on 07/09/12 at 2:15 PM Staff W, ED Director, stated that these items are not used very often in the triage area. Staff W stated that the ED technicians are responsible to check for expired supplies but "everybody should be checking."

5. Observation on 07/11/12 at approximately 2:30 PM of an outpatient facility's Infusion Room cabinets showed seven storage cabinets (containing patient items such as gowns, towels, and supplies) each contained one expired alcohol based hand sanitizer, Lot #C091691 with an expiration date of 09/11.

During an interview at the time of the observation, Staff AAA, Supervisor of the Outpatient Infusion Room stated that she was responsible for periodically (once a month) checking for expired supplies in the infusion room and that she must have overlooked the expired hand sanitizer.

6. Review of the US Department of Health and Human Services (USDHHS), Public Health Service (PHS), Food and Drug Administration (FDA), 2005 Food Code showed the following direction in Chapter 3-305.11 Food Storage. Food shall be protected from contamination by storing in a clean, dry location, where not exposed to splash, dust or other contamination and at least six inches above the floor.

Record review of the facility's policy titled, "Storage - Dry Goods, Formulas and Groceries" reviewed 04/11 showed the following direction:
-Facility dietary staff to store all dry packed and canned foods on racks or shelves at least six inches above the floor.
-Facility dietary staff shall keep the storage area clean.

7. Observations on 07/10/12 in the main hospital kitchen at 10:55 AM showed shelving in the dry food storeroom soiled with spills from food crumbs spilled from twenty five pound sacks of brown rice, and bread crumbs.

During an interview on 07/10/12 at 10:55 AM Staff J, Chef confirmed the dry food storeroom shelving (where staff stored sacks of brown rice and bread crumbs) should be cleaned.

8. Observations on 07/10/12 in a main hospital kitchen walk-in refrigerator at 10:59 AM showed staff stored foods under a condenser fan blade guard covered with gray lint and unknown debris thick enough to pull a one half inch by one eighth inch wad of the debris off of the surface.

During an interview on 07/10/12 at 10:59 AM Staff J confirmed the condenser fan blade guard was soiled and should be cleaned daily.

9. Observations on 07/10/12 at 11:00 AM in a second walk-in refrigerator showed staff stored a ten pound case of bacon on a soiled floor and three cases of yogurt (each case had six thirty-two ounce containers), on the soiled floor.

During an interview on 07/10/12 at 11:00 AM Staff J confirmed the case of bacon and the three cases of yogurt were stored on the floor and should be up on shelving.

10. Review of the USDHHS, PHS, FDA, 2005 Food Code showed the following direction in Chapter 4-601.11 Equipment, food contact surfaces, non-food contact surfaces and utensils shall be clean to sight and touch.

11. Observations on 07/10/12 in the main hospital kitchen from 10:40 AM through 11:15 AM showed the following:
-Floor of the elevator used to transport food deliveries from the dock to the kitchen was heavily covered with food dry food spills, a dried, discarded apple core and blackened unknown debris.
-Two walls of the elevator used to transport food deliveries from the dock to the kitchen with approximate one foot circular, dried tomato spatters (seeds stuck to the walls).
-A table mounted can opener with metal can shavings imbedded into blackened tar like debris on the blade, gears behind the blade and on the metal plate holding the can opener to the table.

During an interview at the time of the observation, Staff J confirmed the walls and floor of the elevator used to transport foods from the dock to the kitchen should be cleaned and the table mounted can opener should be cleaned.

12. Observation on 07/10/12 at 11:15 AM in the main kitchen showed staff failed to clean a two door reach-in refrigerator splashed with red gelatin on the shelves, interior surface of the doors and on the gaskets of the doors.

During an interview on 07/10/12 at 11:15 AM Staff J confirmed the two door reach-in refrigerator was soiled with red gelatin splashes and should be cleaned.

13. Observation on 07/10/12 at 11:35 AM in the Heart Hospital kitchen showed dietary staff failed to clean a table mounted can opener with metal can shavings imbedded into blackened tar like debris on the blade, gears behind the blade and on the metal plate holding the can opener to the table.

During an interview on 07/10/12 at 11:35 AM Staff J confirmed the table mounted can opener was soiled and should be cleaned.












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Based on observation, interview and record review the facility failed to:
-Apply personal protective equipment (PPE-gowns, gloves, and masks used to ensure infection control) appropriately for four patients (#12, #14, #52 and #53) of eight patients observed for infection control measures;
-Ensure staff washed/sanitized hands after contamination, or between glove changes for three (Patients #11, #14, and #34) of five patients observed for infection control measures;
-The facility failed to ensure a sanitary environment was maintained when approximately 70 linen hampers with rusted casters/legs were not cleaned, repaired or replaced in operating rooms. Rusted equipment in the Operating Room (OR) rendered that equipment to be functionally non-cleanable and become a source of contaminants and a source to transmit infections. The facility census was 666.

Findings included:

1. Review of facility policies titled, "Hand Hygiene," revised 02/12, "Barrier-Personal Protective Equipment," dated 11/83, and "Infectious Diseases & types of Precautions," reviewed 10/11, showed the following:
-Hospital personnel shall perform hand hygiene after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient, and after removing gloves;
-Hand sanitizer (alcohol-based) can be used if hands are not visibly soiled, between glove changes;
-Change gloves during patient care if moving from a contaminated body site to a clean body site;
-Do not wash gloves;
-Hand hygiene must be used when caring for a patient in contact isolation, and all persons entering the room must wear gown and gloves;
-Acinebactor, a multi-drug resistant bacteria, requires the patient be in contact isolation.

2. Review of Patient #14's History and Physical (H&P), dated 06/14/12, showed the patient was admitted on that date with a diagnosis of post cardiac arrest. The patient had an orange-sized pressure sore on the coccyx area (tailbone).

Review of laboratory results dated 06/28/12, showed the patient had an infection in the bloodstream called Acinebactor, which is resistant to multiple antibiotics.

Observation on 07/10/12 at 9:30 AM, showed the following:
-The patient was in contact isolation;
-During a dressing change on the pressure sore, Registered Nurse (RN) Staff R, put sterile gloves on over contaminated standard gloves, rather than take the standard gloves off, sanitize and donn (apply) the sterile gloves per facility policy/philosophy;
-Physician S, an infectious disease physician, came into the patient's room to examine the patient with a gown on; however, failed to tie the back of the gown, allowing the ties to dangle on the bed, bed frame, patient, and other inanimate objects.

3. Review of Patient #34's H&P, dated 05/25/12, showed the patient was admitted on 05/26/12 with second degree burns on 34.25% of his body. The patient was in strict, contact isolation per the burn unit.

During an observation and concurrent interview on 07/11/12 at 9:00 AM, RN Staff II stated that Patient #34 developed pressure sores on his heels from wearing specialized boots (designed to prevent pressure sores). Staff II failed to wash/sanitize her hands between glove changes, during dressing changes on the patient's heels, even though she contaminated her hands by touching various inanimate objects (bed, tubing, bedside table, etc.).

4. During an interview on 07/11/12 at 9:44 AM, the clinical supervisor of the burn unit, RN Staff HH stated she expected the nurses to sanitize or wash hands when changing gloves, or going from dirty to clean.

5. Observation on 07/10/12 at 8:50 AM showed Staff O, RN, donn PPE and gloves to administer medications to Patient #11 on contact precautions. Staff O typed on the computer keyboard then placed pill between her fingers and placed the medication on the patients tongue. She handed Patient #11 a drink to swallow the medication then went over to the computer and typed on the keyboard. Staff O then removed her gloves, did not perform hand hygiene and went to the patient's door requesting medication cups. Without performing hand hygiene she donned a new pair of gloves, typed on the computer keyboard, broke a large pill in half with her gloved hands and put each half pill on the patient's tongue. Wearing the same gloves Staff O injected intravenous (in the vein) medication and again typed on the computer keyboard. Staff O removed her gloves and did not perform hand hygiene but went to the door and requested a syringe. She then donned a new pair of gloves without performing hand hygiene and mixed an IV medication for injection into the IV tubing. Staff O removed her gloves the third time without performing hand hygiene and went to the door and asked for a cup of ice. She put on a new pair of gloves without performing hand hygiene and handed the ice to the patient.

6. Observation on 07/10/12 at 1:14 PM showed Staff QQ, Housekeeper, inside Patient #12's room wearing PPE and cleaning the room. The housekeeping cart with cleaning supplies was outside the room in the hall in front of the patient's door. Staff QQ was observed exiting the door of the patient's room wearing PPE seven times to retrieve items off of the housekeeping cart and replacing them while wearing the same PPE. When Staff QQ had finished cleaning the patient's room she removed the PPE and pushed the cart with contaminated items on it down the hall.

7. Record review of Patient #53's Dialysis Kardex (trademark for a card-filing system that allows quick reference to the particular needs of each patient for certain aspects of nursing care) dated 06/27/12 showed the patient had been diagnosed with the highly contagious C-diff (a bacteria that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon, is difficult to contain and highly contagious) and sepsis (refers to a bacterial infection in the bloodstream or body tissues).

Observation on 07/11/12 at 9:27 AM showed Staff PP, Medical Doctor (MD), proceed to enter Patient #53's room without donning PPE. Staff JJ, RN, stopped the physician and explained the patient was on contact isolation. Staff PP donned gloves and gown but failed to tie the gown in back allowing the ties to dangle on the bed, bed frame, patient, and other inanimate objects.

During an interview on 07/11/12 at 10:55 AM, Staff M, RN, Executive Director of Quality Assurance and Infection Control, stated, "Yes, I saw that [the physician who did not tie the PPE gown in Patient #53's contact isolation room]".

8. Record review of the Centers of Medicare and Medicaid Services document titled, "ESRD [End Stage Renal Disease] Basic Technical Surveyor Training Interpretive Guidance, Interim Final Version 1.1" dated October 3, 2008 gives the following guidance:
- CDC RR-5 as Adopted by Reference 42 CFR 494.30 (a)(1)(i)
Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood).

9. Observation on 07/11/12 at 9:07 AM showed Staff KK, RN, on the Dialysis Unit initiating dialysis for Patient #52. Staff KK was not wearing PPE for protection during the initiation phase of hemodialysis treatment (a medical procedure that uses a special machine to filter waste products from the blood.)

10. Review of the AORN (Association of Perioperative Registered Nurses) Perioperative Standards and Recommended Practices, May 2009, showed: "A safe, clean environment should be reestablished after each surgical procedure. Routine cleaning and disinfection reduces the amount of dust, organic debris and microbial load in the environment. Following scientifically based recommendations for cleaning and disinfection practice in health care organizations helps to reduce infections associated with contaminated items."

Review of the facility policy OR-73 titled "Sanitation Guidelines in the Operating Room" reviewed 10/10 showed:
-The cleanliness of the Operating Room is maintained through consistent cleaning according to established routines;
-Objects that become contaminated are cleaned with approved disinfectant;
-Cycle cleaning (cleaning that is done on regular schedule whether visibly soiled or not) includes cleaning of hampers.

11. Observation in Operating Room #3 on 07/11/12 at 4:15 PM showed three laundry hampers with rust covered casters. Each hampers had four casters and the rust continued up the legs where the casters attach to the hampers. Hampers were made of stainless steel. Casters scraped with fingernail caused visible rust particles.

During an interview on 07/11/12 at 4:15 PM Staff KKK, Director of surgical Services, stated that there has been discussion about the rusty carts and the facility is currently evaluating products that may not be susceptible to rusting. Staff KKK stated that most of the linen hampers throughout the surgical area (28 rooms, two or three hampers per room) are rusted and in the same condition. Staff KKK stated that the operating rooms are "flooded" (floors cleansed with copious amount of water/cleaner) during the overnight cleaning and that's what causes the rust on the casters. Staff KKK stated that rust would prevent the hampers from being cleaned properly.

During an interview on 07/12/12 at 9:35 AM Staff FFF, Manager of Environmental Services, stated that rust is a problem because it cannot be cleaned properly. Staff FFF stated that the operating room floors are flooded during terminal (all surfaces cleaned) cleaning at night. Staff FFF stated that all of the laundry hampers in the surgical suites have the same problem (rust) because of the flooding.






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