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6655 ALVARADO ROAD

SAN DIEGO, CA 92120

PATIENT RIGHTS: INFORMED DECISION

Tag No.: A0132

Based on observation, interview and record review, the hospital failed to ensure that staff in the Same Day Surgery unit, validated the Advance Directive/Durable Power of Attorney for Healthcare for Patient 33, when obtaining a telephone consent for a surgical procedure from a family member and prior to the surgical procedure. In addition, the hospital's Advance Directive policy and procedure indicated that the hospital did not honor Advance Directives in the outpatient settings.

Findings:

On 6/12/12 at 1:15 P.M., a tour was conducted of the Same Day Surgery Unit with the Nursing Director of Medical Surgical (NDMS) and the Nursing Director of Surgical Services (NDSS).

On 6/12/12 at 1:45 P.M., Patient 33 was observed sleeping on a gurney in the recovery room area of the same day surgery unit. Per Registered Nurse (RN) 34, Patient 33 was non-verbal and had undergone a pacemaker generator change procedure that morning.

A review of Patient 33's medical record was conducted, with RN 34 and the Manager of the SDS unit and revealed an authorization for and consent to surgery form, for the placement of a new pacemaker generator. The consent form documented that a phone consent was obtained from the patient's son. The consent was witnessed by 2 RNs.

RN 34 was unsure if Patient 34 had an Advance Directive. RN 34 stated that 2 other nurses had checked the patient in for surgery. Further review of the medical record revealed no Advance Directive form to indicate that the son who had signed the surgical consent form was, in fact, the Durable Power of Attorney for Healthcare.

The Admission/Registration form contained a section entitled "Advance Directive." The question "does the patient have an advance directive" was left blank. Furthermore, the Admission/Registration form contained the name of another son as "the person to notify."

The SDS Manager stated that Patient 34 had been transferred to the hospital for the procedure from a long term care facility. Patient 34 was an outpatient. The Admission Record from the long term care facility had been sent to the hospital with the patient. Per the Admission Record, the son who had signed the consent form was identified as the Power of Attorney for Healthcare, but the NDSS acknowledged that hospital staff should not rely on that information, and should confirm and obtain a copy of the patient's Advance Directive/Durable Power of Attorney for Healthcare.

On 6/13/12 at 10:00 A.M., an interview was conducted with RN 35 who had co-witnessed Patient 33's surgical consent. Per RN 35, she was unaware that the patient was arriving from a nursing home. Per RN 35, she spoke with the patient's son via telephone and confirmed that he was the patient's son, but did not ask if he had the Power of Attorney for Healthcare or request a copy of the patient's Advance Directive.

On 6/13/12, the hospital's Advance Directive policy, dated 3/2009, was reviewed. Per the policy, when a patient was transferred from another health care facility, the admitting nurse or designee was required to ask the facility if the patient had an Advance Directive and request a copy if the document was available. That information was to be documented on the Admitting worksheet. In addition, the policy documented that "the hospital does not honor Advance Directives in outpatient settings."

On 6/13/12 at 10:15 A.M., a joint interview was conducted with the Chief Nursing Officer (CNO), the Admissions Director, the Nurse Manager of Telemetry, the Chief Financial Officer, the Director of Case Management (DCM), and the End of Life Specialist (ELS). The DCM acknowledged that hospital staff should have obtained a copy of Patient 33's Advance Directive and confirmation of Durable Power of Attorney for Healthcare. The leadership team was informed by the surveyor that Advance Directives were to be honored in both inpatient and outpatient settings. The team acknowledged their understanding of that information.

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on observation, interview and record review, the hospital failed to ensure that 2 patients (11, 32), who were assessed as high fall risks, received care in a safe setting, when fall safety precautions were not implemented by staff. When Radiology Technician (RT) 32 transported Patient 31 back to her room following a procedure, he failed to turn on the patient's bed alarm and complete the required documentation pertaining to fall safety. In addition, a Certified Nursing Assistant (CNA) did not activate the bed alarm for Patient 11.

Findings:

1. On 6/11/12 at 10:30 A.M. a tour of the telemetry unit was conducted with Charge Nurse (CN) 31 and the Nursing Director Medical Surgical (NDMS). On 6/11/12 at 10:55 A.M., RT 32 was observed transporting Patient 31 in a wheelchair back to her room following a procedure in the radiology department. RT 32 assisted the patient back into her bed, raised the bed side rails, and left the room. According to CN 31, Patient 31 was a high fall risk patient. Patient 31's bed alarm had not been activated by RT 32 upon his exit of the patient's room. In addition, RT 32 had not completed a yellow colored "Fall Risk Documentation" form hung on the wall of the patient's room. The form contained elements pertaining to fall safety interventions and signatures that staff were to complete.

On 6/11/12 at 11:00 A.M., RT 32 was interviewed. RT 32 stated that he had received training in fall safety. RT 32 was asked to verbalize what precautions he would implement after returning a high fall risk patient back to their room. RT 32 did not verbalize activation of a patient's bed alarm or the completion of the "Fall Risk Documentation" form.

On 6/11/12 at 11:10 A.M., Patient 31's medical record was reviewed. Per a History and Physical, dated 6/8/12, Patient 31 was admitted to the hospital following a complaint of chest pain and dizziness. The patient's past medical history included dementia.

On 6/11/12, the hospital's "Falls Reduction" policy and procedure, dated 3/12, was reviewed. Per the policy, all patients identified as a high risk for falls were to have their bed alarm activated. In addition, high fall risk patients were to have a yellow "Fall Risk Documentation" form in the room that would be filled out by all clinical staff before leaving the room.

On 6/11/12 at 11:15 A.M., CN 31 and the MSND stated that RT 32 should have activated Patient 31's bed alarm and completed the "Fall Risk Documentation" form prior to exiting the patient's room.



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2. A tour of the 3rd floor North Medical/Surgical Unit was conducted on 6/11/12 at 9:55 A.M. On 6/11/12 at 9:58 A.M., a high fall risk log was observed posted on Patient 11's door with all the elements listed such as alarm activated, magnet on door, non-skid socks on, etc. with check marks. However, the patient's bed alarm was observed to be "off." According to certified nursing assistant (CNA) 11, who was assigned as the patient's sitter, she turned the bed alarm off because the patient was getting aggravated when the alarm goes off. CNA 11 also indicated that she was constantly watching the patient while she sat outside the patient's room. However, a few seconds later, CNA 11 was observed inside another patient's room, leaving Patient 11 unattended with a bed alarm that was turned-off. Patient 11 was observed sitting at the edge of the bed. According to charge nurse (CN) 11, CNA 11 was assigned as a sitter for both Patient 11 and another patient in the next room. CN 11 acknowledged that the bed alarm should have been turned-on.

An interview with registered nurse (RN) 11 was conducted on 6/11/12, at 10:45 A.M. RN 11 indicated that Patient 11 was confuse and was high risk for falls. RN 11 indicated that the patient's bed alarm should have been turned-on. RN 11 stated that she was not aware that CNA 11 turned-off the bed alarm.

A review of the hospital's policy and procedure (P&P) titled, "Falls Prevention and Resource Policy," was conducted on 6/11/12 3:50 P.M. The P&P indicated that, "3. All patients identified as high risk for falls will have the following measures initiated: Place a yellow colored fall armband on the patient's wrist; Place fall prevention instructions across from patient in patient room; No slip/skid socks applied; Bed alarm activated, etc."

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on observation, interview and record review, the hospital failed to ensure that pain assessments and reassessments were performed, for 3 of 20 sampled patients (21, 22, 33).

Findings:

1. On 6/12/12 at 1:15 P.M., a tour was conducted of the Same Day Surgery Unit with the Nursing Director of Medical Surgical (NDMS) and the Nursing Director of Surgical Services (NDSS).

On 6/12/12 at 1:45 P.M., Patient 33 was observed sleeping on a gurney in the recovery room area of the same day surgery unit. Per Registered Nurse (RN) 34, Patient 33 was non-verbal and had undergone a pacemaker generator change procedure that morning.

A review of Patient 33's medical record was conducted with RN 34. Per a History and Physical report, dated 5/11/12, Patient 33 could not speak and was partially paralyzed from a stroke. Per the Procedure Sedation Post-Procedure form, RN 34 had taken the patient's vital signs every 15 minutes beginning at 1:10 P.M. The most recent recorded vital signs were recorded at 2:10 P.M. There was no documentation on the post procedure form concerning pain assessments. RN 34 acknowledged that there were no documented pain assessments. RN 34 stated that usually patients receive an injection of lidocaine (a local anesthetic agent) intraoperatively and don't experience much pain.

The NDSS stated that the hospital's policy was that pain assessments were performed with vital signs. The NDSS acknowledged that the post procedure form/tool that the SDS RNs used to document did not contain a pain assessment element. The NDSS acknowledged that pain assessments should have been performed and documented for Patient 33.


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2. A review of Patient 21's medical record was conducted on 6/11/12, at 2:12 P.M. Patient 21 was seen at the hospital's Emergency Department (ED) on 6/11/12, because of a fall, hip and back pain per the Facesheet. According to a physician's order dated 6/11/12 at 8:55 A.M., hydrocodone-acetaminophen (NORCO- pain medication) 5-325 mg (milligrams) oral tablet, one tablet to be administered to Patient 21 once stat (immediately).

A review of Patient 21's Medication Administration Record (MAR) dated 6/11/12 at 8:55 A.M., indicated that NORCO 5-325 mg tablet was administered to Patient 21.

A review of Patient 21's nursing assessments titled, "ED - Pain Management," was conducted on 6/11/12. A nursing note dated 6/11/12 at 8:56 A.M., indicated that Patient 21 verbalized aching pain in his right hip, lower back area and scored the pain at an 8 out of 10 (severe pain). A nursing note dated 6/11/12 at 9:00 A.M., indicated that Patient 21 was medicated. There was no documented evidence to show that Patient 21's pain was reassessed after the pain medication was administered.

An interview and joint record review with Registered Nurse (RN) 21 was conducted on 6/11/12 at 3:20 P.M. RN 21 stated that when pain medications were administered, his practice was to reassess the patient's pain within 1 hour from the administration of oral pain medication. He stated that there was no documented evidence to show that Patient 21's pain was re-assessed after the administration of the NORCO 5-325 mg oral tablet for pain this morning.

A review of the hospital policy entitled, "Pain Assessment and Management Standards," review date of 5/10, was conducted on 6/14/12. The policy indicated under re-assessments, that the health care team will ensure that patient's pain was evaluated and managed appropriately within timeframes following interventions. Per the same policy, it indicated that pain re-assessment will be performed 60 minutes after an oral dose of pain medication was administered.

An interview and joint record review with the Nursing Director of the ED (NDED) was conducted on 6/14/12 at 9:21 A.M. The NDED showed that a pain reassessment was performed on Patient 21 however, the pain reassessment was documented on 6/11/12 at 4:16 P.M. She acknowledged that there was no documented evidence in the medical record to show that Patient 21's pain reassessment was performed within 1 hour after administration of the pain medication in accordance with the hospital's policy.

3. A review of Patient 22's medical record was conducted on 6/12/12 at 2:10 P.M. Patient 22 was admitted to the hospital on 6/12/12 per the Facesheet. According to the Operative Report dated 6/12/12, Patient 22 underwent back surgery. A physician's order dated 6/12/12 at 5:30 P.M., indicated that oxycontin (pain medication) 30 mg (milligrams) orally every 12 hours for pain.

A review of Patient 22's Medication Administration Record (MAR) was conducted on 6/13/12. The MAR indicated that oxycontin 30 mg tablet was administered to Patient 22.

According to Patient 22's Pain Flowsheet, on 6/12/12 at 8:40 P.M., Patient 22 had verbalized aching pain in his head and his pain level was a 4 out of 10 (moderate pain). Per the Flowsheet, Patient 22 was medicated. There was no documented evidence to show that the pain was reassessed after the administration of the pain medication.

A review of the hospital policy entitled "Pain Assessment and Management Standards," review date of 5/10, was conducted. The policy indicated that under re-assessments, the health care team will ensure that patient's pain was evaluated and managed appropriately within timeframes following interventions. Per the same policy, it indicated that pain re-assessment will be performed 60 minutes after an oral dose of pain medication was administered.

An interview and joint record review with the Nursing Director of Critical Care (NDCC) was conducted on 6/13/12 at 1:33 P.M. The NDCC acknowledged that there was no documented evidence in the medical record to show that Patient 22's pain reassessment was performed after the administration of pain medication in accordance with the hospital's policy.

NURSING CARE PLAN

Tag No.: A0396

Based on observation, interview and record review, the hospital failed to implement their "Falls Prevention and Resource Policy," for 2 of 20 sampled patients (11, 21). Patient 11's nursing care plan related to his high fall risk status was not followed. Patient 21's fall risk assessment was inaccurate because it did not reflect a history of a fall. In addition, the facility failed to ensure that physician's orders pertaining to 1:1 sitter and an order for protein supplement was followed, for 2 of 28 sampled patients (11, 41). The hospital also failed to individualize Patient 41's nutrition care plan. Lastly, a registered nurse was not able to verbalize the correct positioning of the head of the bed when feeding a patient who was at risk for aspiration.

Findings:

1. A tour of the 3rd floor North Medical/Surgical Unit was conducted on 6/11/12 at 9:55 A.M. On 6/11/12 at 9:58 A.M., a high fall risk log was observed posted on Patient 11's door with all the elements listed such as alarm activated, magnet on door, non-skid socks on, etc. with check marks. However, the patient's bed alarm was observed to be "off." According to an interview conducted with certified nursing assistant (CNA) 11, who was assigned as the patient's sitter, turned the bed alarm off because the patient was getting aggravated when the alarm goes off. CNA 11 also indicated that she was constantly watching the patient while she sat outside the patient's room. However, a few seconds later, CNA 11 was observed inside another patient's room, leaving Patient 11 unattended with a bed alarm that was turned "off." Patient 11 was observed sitting at the edge of the bed. According to charge nurse (CN) 11, CNA 11 was assigned as a sitter for both Patient 11 and another patient in the next room. CN 11 acknowledged that the bed alarm should have been turned "on."

An interview with registered nurse (RN) 11 was conducted on 6/11/12, at 10:45 A.M. RN 11 indicated that Patient 11 was confused and was a high risk for falls. RN 11 indicated that the patient's bed alarm should have been turned "on." RN 11 stated that she was not aware that CNA 11 turned off the bed alarm.

A review of the hospital's policy and procedure (P&P) titled, "Falls Prevention and Resource Policy," was conducted on 6/11/12 at 3:50 P.M. The P&P indicated that, "3. All patients identified as high risk for falls will have the following measures initiated: Place a yellow colored fall armband on the patient's wrist; Place fall prevention instructions across from patient in patient room; No slip/skid socks applied; Bed alarm activated, etc."

2. A tour of the 3rd floor North Medical/Surgical Unit was conducted on 6/11/12 at 9:55 A.M. On 6/11/12 at 9:58 A.M., a high fall risk log was observed posted on Patient 11's door with all the elements listed such as alarm activated, magnet on door, non-skid socks on, etc. with check marks. However, the patient's bed alarm was observed to be "off." According to certified nursing assistant (CNA) 11, who was assigned as the patient's sitter, she turned the bed alarm off because the patient was getting aggravated when the alarm goes off. CNA 11 also indicated that she was constantly watching the patient while she sat outside the patient's room. However, a few seconds later, CNA 11 was observed inside another patient's room, leaving Patient 11 unattended with a bed alarm that was turned off. Patient 11 was observed sitting at the edge of the bed. According to charge nurse (CN) 11, CNA 11 was assigned as a sitter for both Patient 11 and another patient in the next room.

Patient 11's medical record was reviewed on 6/11/12 at 10:08 A.M. Patient 11 was admitted to the hospital on 6/9/12 with diagnoses that included alcohol withdrawal and delirium tremens per the History and Physical.

A review of the physician's order, written on 6/11/12 at 4:18 A.M. indicated that Patient 11 was supposed to have a 1:1 sitter. This physician's order was not followed since the sitter assigned to Patient 11 was also assigned to another patient.

On 6/11/12 at 10:25 A.M., charge nurse (CN) 11 stated that she just spoke to Patient 11's physician and that the physician indicated that 1:1 sitter was not necessary for Patient 11. However, CN 11 acknowledged that the order should have been clarified sooner and while the order was not clarified, the order for 1:1 sitter should have been followed.

3. An interview with registered nurse (RN) 13 was conducted on 6/11/12, at 1:45 P.M. RN 13 was asked what she would do when feeding a patient who was at risk for aspiration. RN 13 stated that she would position the head of the bed at 45 degrees and stated high Fowler's position (the upper half of the patient's body is between 60 degrees and 90 degrees in relation to the lower half of their). RN 13 verbalized two conflicting answers. The question was asked again at what degree should the head of the bed be when feeding a patient at risk for aspiration. RN 13 stated at 45 degrees. RN 13 also stated that the head of the bed should remain at 45 degrees for 30 minutes after the patient finished eating.

An interview with the Director of Telemetry (DOT) was conducted on 6/12/12 at 9:28 A.M. The DOT stated that the head of the bed should be at 90 degrees when feeding a patient at risk for aspiration.

A review of the facility's Dysphagia (difficulty swallowing) policy and procedure attachment indicated the following: "Speak with nurse before giving any food or drink; Feed only when awake, alert and attentive; Sit fully upright at 90 degrees to eat and drink; Remain seated upright for 30 minutes after meals; Do not lower the head of the bed below 45 degrees."



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4. A review of Patient 21's medical record was conducted on 6/11/12 at 2:12 P.M. Patient 21 was seen at the hospital's Emergency Department (ED) on 6/11/12 because of a fall, hip and back pain per the Facesheet. According to the ED - Patient Screens titled, "Fall Risk Factors," it indicated that Patient 21 did not have a history of a fall in the past 30 days. Per a nursing assessment under pain location dated 6/11/12, a nursing note indicated that Patient 21 had "Right hip and low back pain s/p (status post) fall on Friday."

An interview and joint record review with Registered Nurse (RN) 21 was conducted on 6/11/12 at 3:20 P.M. RN 21 agreed that Patient 21 sustained a fall within the past 30 days. He stated that Patient 21's fall risk assessment should have reflected the history of a fall.

A review of the hospital's policy entitled "Falls Prevention and Resource Policy," review date of 3/12, was conducted. The policy indicated that in the ED, patients will be assessed for risk and all assessments will be documented in the record. Per the same policy, "The RN will assess the fall risk factors, ie (example): history of falls, ...." The fall policy's interventions included the implementation of the following: yellow armband applied, nonskid slippers on and direct visualization from the staff.

Inaccurate fall risk assessments by the RNs had the potential for the required interventions to not be implemented and ensure patient safety, per the facility policy.

An interview with the Nursing Director of the ED (NDED) was conducted on 6/14/12 at 9:21 A.M. The NDED acknowledged that Patient 21's fall risk assessment should have reflected a history of fall in accordance with the hospital's policy.



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5. On 6/11/12 at 1:35 P.M., Patient 41's medical record was reviewed. Patient 41 was admitted to the hospital on 6/7/12, with a diagnosis that included hypoproteinemia [low levels of protein in the blood] and malnutrition with a stage II bedsore (partial thickness loss of dermis presenting as a shallow ulcer with a red/pink wound bed) in the right heel, according to the history and physical.

On 6/8/12, the physician wrote an order for "Beneprotein [a protein supplement] 2 scoops po [by mouth] 4 times daily."

Registered Nurse (RN) 42 was asked where the administration of Beneprotein for Patient 41 would be documented. RN 42 asked, "Is there an order for Beneprotein?" RN 42 stated that if there was an order for Beneprotein, the order should have been faxed to the pharmacy department. RN 42 stated the pharmacy department would then include the Beneprotein order on the patient's medication administration record (MAR). RN 42 stated if the Beneprotein was on the MAR, that was the place where it would have been documented.

RN 42 verified that he was the nurse responsible for taking care of Patient 41 at that time. RN 42 reviewed the physician's orders and verified that there was a physician's order for Beneprotein 2 scoops po 4 times daily. RN 42 verified that the Beneprotein order was faxed to the pharmacy department, however the Beneprotein order was not on the MAR. RN 42 acknowledged that he was unaware of the physician order to give Patient 41 Beneprotein 4 times daily. RN 42 looked at the yellow nursing kardex that was in Patient 41's medical record that indicated that Patient 41 should have received Beneprotein, 2 scoops 4 times a day, and stated, "I have not had time to look at the kardex or the medical record." RN 42 reviewed Patient 41's medical record and could not find any documentation that Patient 41 had ever received the protein supplement, 3 days after it had been ordered.

During the interview above, the Director of Food and Clinical Nutrition Services was present, and stated that the Food and Nutrition Department was responsible to send up the protein supplement on the meal tray. The Director of Food and Clinical Nutrition Services stated that the hospital no longer carried Beneprotein, and the house approved formulary substitute was Prostat.

On 6/11/12 at 4:09 P.M., the Director of Pharmacy stated she reviewed the Beneprotein order, and the MAR for Patient 41, and stated, "We did not enter." The Director of Pharmacy verified that once the faxed Beneprotein order was received, that a pharmacist should have entered it onto the MAR in accordance with hospital policy.

A review of Patient 41's Graphic Record which had a location for nursing to document "meal %, Snack % and Supplement%", was blank under snack and supplement from 6/8/12 - 6/11/12.

According to Patient 41's "Risk for impaired skin integrity" care plan, " ...Educate/Encourage increased protein, adequate calories, hydration & supplements as ordered."

Nursing staff failed to ensure that a physician's order for a protein supplement was encouraged, and administered, to Patient 41 in accordance with the care plan. RN 42 failed to ensure that Patient 41's yellow nursing kardex was reviewed when assigned to care for Patient 41. On 6/12/12 at 9:58 A.M., RN 43 verified that nursing staff should be reading the yellow nursing kardex which was a tool to direct nursing on patient care, and should be ensuring the care plans are specific to the patient.

Patient 41's Patient Care Management Report under the category of Nutrition included, but not limited to, the following: "Outcome: Tolerating tube feedings -Active, If calorie intake insufficient, discuss potential need for TPN/tube feeding with physician, Active; Assessment Nutrition-calorie count." The designated "Active" status was supposed to address a current problem. The Director of Food and Clinical Nutrition Services reviewed the interdisciplinary nutrition care plan and acknowledged that the above were not applicable to this patient. Patient 41's interdisciplinary nutrition care plan lacked the detailed nutrition interventions that were ordered and applicable for Patient 41 which included Ensure with every meal, ordered on 6/8/12, and Beneprotein 2 scoops po 4 times daily, verified by RN 42 on 6/11/12.

The hospital's policy and procedure entitled Interdisciplinary Plan For Patient Care indicated, "Provide an individualized plan of care for the patient in an interdisciplinary, collaborative manner."

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on interview and record review, the facility failed to ensure that a pain medication was administered as ordered for, 1 of 27 sampled patients (12).

Findings:

Patient 12's medical record was reviewed on 6/11/12 at 2:35 P.M. Patient 12 was admitted to the hospital on 6/8/12, with diagnoses that included osteoporosis (the thinning of bone tissue and loss of bone density over time) and a recent L4 (lower back) compression fracture, per the History and Physical.

A review of the physician's order dated 6/9/12, indicated an order for Tylenol 650 milligrams (mg) every 6 hours as needed (PRN) for mild pain (level 1-3). The order also indicated to give Vicodin (pain medication) 5/500 1 tab every 4 hours PRN for moderate pain (level 4-6). There was no medication ordered to address severe pain.

A review of Patient 12's Pain Flowsheet indicated that on 6/9/12 at 11:44 A.M., and at 10:03 P.M., Patient 12 complained of a back pain at a level of "8" (severe pain) and was given 1 tablet of Vicodin in both occasions. However, the order for Vicodin was to be given for moderate pain and not severe pain.

An interview with registered nurse (RN) 14 was conducted on 6/11/12, at 2:58 P.M. RN 14 stated that the physician's order for Vicodin was for moderate pain. RN 14 acknowledged that the physician's order was not followed as ordered.

PHARMACY ADMINISTRATION

Tag No.: A0491

Based on observation, interview and document review, the hospital failed to follow its policies and procedures pertaining to: the comparison of refrigerator and freezer temperatures with a known standard thermometer, storage of a medication at the recommended temperature, falls reduction, medication auto substitution, and medication reconcilation. In addition, the hospital failed to have a complete and comprehensive listing of medications that should not be crushed, per its Policy and Procedure titled, "Crushing Oral Dosage Forms."


Findings:

1. On June 11, 2012 at 1:20 pm, the Director of Pharmacy (DOP) presented a policy titled "Storage of Medications." The policy indicated, "Refrigerator and freezer thermometer temperatures are compared for accuracy with a known standard thermometer (e.g., a reference thermometer in the hospital laboratory, or equivalent) semi-annually." The DOP was not able to provide documentation that a comparison of refrigerator temperatures with a reference thermometer had been performed. At this same time, during an interview with Pharmacy Technician 1 (RxTech1), who was knowledgeable about the Automated Dispensing Cabinet (ADC), "Smart Remote Manager" (technology that connects refrigerators to the centralized ADC system) stated that, the comparison of displayed refrigerator temperatures versus a known standard thermometer was never conducted.

2. On June 11, 2012, during a tour of the Pharmacy with the Director of Pharmacy (DOP), a fluid warming cabinet was observed that contained Mannitol (an injectable solution used to help increase urine output) in 50 milliliter (ml) bottles, as well as 500 ml and 1000 ml bags. The bottles and bags did not have notations on them as to when they were placed into the warming cabinet. The Food and Drug Administration (FDA) approved drug information states that this solution should be stored at 20 to 25 degrees Centigrade (C) equivalent to 68 to 77 degrees Fahrenheit (F). The FDA approved drug information also states that the solutions may be warmed to 77 degrees F in the event that mannitol crystals are found in the solutions. This higher temperature will facilitate the conversion of crystals back into solution. The observed temperature of the warming cabinet was 100 degrees F based on the installed cabinet thermometer.

During an interview with the Director of Pharmacy (DOP) at this time, she stated that she was unsure of the solution's stability at 100 degrees F. and uncertain when these solutions were placed in this warmer. The DOP was unable to provide stability documentation for these solutions at this elevated temperature. The DOP stated that these solutions would be removed from this warmer and another used in the hospital, and that, FDA information would be adhered to pending review of the literature related to temperature excursions of mannitol outside of the approved labeling.

3. During a review conducted on 6/11/12, of the Hospital-Wide Policy and Procedure titled "Falls Reduction,", dated 3/2012, the director of Pharmacy stated that, the Pharmacy specified parts of the procedure were not followed as written. The policy indicates: "A. Initial Assessment/Screening: ... 3. Pharmacy will assess if a patient is on medication that had the potential to increase the risk for falls or the risk for injury should a fall occur."

The Director of Pharmacy (DOP) stated that, retrospective review of patient medications is performed when orders are entered or a patient medication profile is reviewed, but that initial screening formerly took place by a Pharmacist that was stationed on the patient care area. These Pharmacists, who care for patients on specific patient care areas, are no longer available at the facility. The DOP stated that if a patient is followed for a particular medication protocol such as warfarin, (a drug that decreases the ability of blood to clot), the pharmacist would notify the nurse of such risk if found.

During chart reviews conducted for Patient 1 on 6/12/12, on the Medical Unit at 10:00 A.M., and for Patient 2 on 6/12/12, at 1:40 P.M. on the Acute Rehabilitation Unit, there was no written documentation found in the chart indicating that the Pharmacy performed an initial screening for falls.

4. During a medication pass observation in the medical intensive care unit on 6/12/12 at 9:45 A.M., Registered Nurse 1 (RN1) was observed preparing medications for Patient 3, by crushing the medications so that they could be delivered to the patient by an oral gastric tube (a tube that enters the mouth and terminates in the stomach). One of the medications was phenytoin sodium sustained release. The product was labeled as a "Kapseal?" equivalent (a sustained release product). This product was immediately confiscated by the Director of Pharmacy (DOP) who opened the phenytoin capsule: in it was found what appeared to be a tablet. Review of the patient's Medication Administration Record indicated that, 4 doses of this product were given between 6/7/12 and 6/12/12. A new order was then provided that changed the once a day dosing of the sustained released product to twice daily dosing of the immediate acting liquid form of the generic product.

A review of the Policy titled, "Crushing Oral Dosage Forms," took place on 6/12/12 at 10:00 A.M. The policy stated that, " Pharmacy will make available to the nursing staff an up-to-date list of medications that should not be crushed and/or chewed." The list titled: "Oral Dosage Forms That Should Not Be Crushed," was last updated in March, 2012. Each page of this 16 page document was branded with "ISMP " (Institute for Safe Medication Practices). The list made no reference to phenytoin sodium either as a generic or as a trade name product (Dilantin?).


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5. On 6/11/12 at 11:10 A.M., Patient 31's medical record was reviewed. Per a History and Physical, dated 6/8/12, Patient 31 was admitted to the hospital following a complaint of chest pain and dizziness.

A physician's order, dated 6/10/12, prescribed Vicodin 5/500 ( 5 milligrams (mg.) hydrocodone and 500 mg. acetaminophen) by mouth every 4 hours as needed for moderate pain. A review of Patient 31's Medication Administration Record (MAR) revealed that Norco (5 mg. hydrocodone and 325 mg. acetaminophen) had been substituted for the physician's Vicodin order. However, there was no documented information in the patient's medical record concerning the substitution of Norco for Vicodin.

On 6/11/12 the hospital's policy and procedure entitled "Auto Substitution," dated 11/10, was reviewed. Per the policy, Norco was listed as an approved therapeutic substitution for Vicodin. However, per the policy, when the pharmacist approved and entered a substitution into the patient's medication profile, the pharmacist was required to fill out a preprinted "Therapeutic Interchange Order Sheet," sign it, and place it in the physician's order section of the patient's medical record. There was no such form in Patient 31's record.

On 6/11/12 at 11:30 A.M., the Nursing Director of Medical Surgical (NDMS) acknowledged that the form should have been completed by the pharmacist and placed in the patient's record, in accordance with hospital policy and procedure.


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6. A review of Patient 21's medical record was conducted on 6/11/12, at 2:12 P.M. Patient 21 was seen at the hospital's Emergency Department (ED) on 6/11/12, because of a fall, hip and back pain, per the Facesheet.
There was no documented evidence to show that the physician reconciled Patient 21's medications upon admission, as the "Medication comparison completed" section, did not have a physician's signature, date or time.

An interview with Registered Nurse (RN) 21 was conducted on 6/11/12, at 3:20 P.M. RN 21 stated that patient's medication reconciliation forms were completed as soon as possible. He stated that the physician's signature, date and time indicated that the medications were reconciled by the physician.

A review of the hospital's policy entitled "Medication Reconciliation," revision date of 7/2011, was conducted on 6/13/12. The policy's purpose indicated that, "Medication reconciliation process includes the comparison of the medications the patient is taking prior to hospitalization with the medications the facility will provide." Per the policy, this process occurred to avoid the occurrence of adverse medication and disease events, transcription errors, omission, duplication of therapy, contraindications, and drug to drug or drug to disease interactions. The policy stipulated that upon admission or entry to the facility, the nurse or healthcare provider will obtain a complete list of the current medications which included name, dose, route, frequency, last dose taken and the purpose of the medication. According to the policy, the hospital's Medication Reconciliation Form will contain all this information and the physician's signature, date and time in the Medication comparison completed section indicated that the medications were reconciled.

An interview and joint record review with the Nursing Director of the ED (NDED) was conducted on 6/14/12 at 9:28 A.M. The NDED acknowledged that Patient 21's Medication Reconciliation Form was not completed in accordance with the hospital's policy.

7. A review of Patient 23's medical record was conducted on 6/11/12, at 1:40 P.M. Patient 23 was admitted to the hospital's Emergency Department (ED) on 6/11/12, due to a migraine (recurrent throbbing headache) and nausea, per the Facesheet. There was no documented evidence to show that the physician reconciled Patient 23's medications upon admission, as the "Medication comparison completed" section did not have a physician's signature, date or time.

An interview with Registered Nurse (RN) 21 was conducted on 6/11/12, at 3:20 P.M. RN 21 stated that patient's medication reconciliation forms were completed as soon as possible. He stated that the physician's signature, date and time indicated that the medications were reconciled by the physician.

A review of the hospital's policy entitled "Medication Reconciliation," revision date of 7/2011, was conducted on 6/13/12. The policy's purpose indicated that, "Medication reconciliation process includes the comparison of the medications the patient is taking prior to hospitalization with the medications the facility will provide." Per the policy, this process occurred to avoid the occurrence of adverse medication and disease events, transcription errors, omission, duplication of therapy, contraindications, and drug to drug or drug to disease interactions. The policy stipulated that upon admission or entry to the facility, the nurse or healthcare provider will obtain a complete list of the current medications which included name, dose, route, frequency, last dose taken and the purpose of the medication. According to the policy, the hospital's Medication Reconciliation Form will contain all this information and the physician's signature, date and time in the Medication comparison completed section indicated that the medications were reconciled.

An interview and joint record review with the Nursing Director of the ED (NDED) was conducted on 6/14/12 at 9:28 A.M. The NDED acknowledged that Patient 23's Medication Reconciliation Form was not completed in accordance with the hospital's policy.

8. A review of Patient 24's medical record was conducted on 6/11/12, at 12:18 P.M. Patient 24 was admitted to the hospital's Emergency Department (ED) on 6/11/12, for left groin (the area between the abdomen and the thigh on either side of the body) pain, per the Facesheet. Patient 24's Medication Reconciliation Form did not contain the dose, route and frequency of the two medications listed. There was also no documented evidence to show that the physician reconciled Patient 24's medications upon admission, as the "Medication comparison completed" section did not have a physician's signature, date or time.

An interview with Registered Nurse (RN) 21 was conducted on 6/11/12 at 3:20 P.M. RN 21 stated that patient's medication reconciliation forms were completed as soon as possible. He stated that the physician's signature, date and time indicated that the medications were reconciled by the physician.

A review of the hospital's policy entitled "Medication Reconciliation," revision date of 7/2011, was conducted on 6/13/12. The policy's purpose indicated that, "Medication reconciliation process includes the comparison of the medications the patient is taking prior to hospitalization with the medications the facility will provide." Per the policy, this process occurred to avoid the occurrence of adverse medication and disease events, transcription errors, omission, duplication of therapy, contraindications, and drug to drug or drug to disease interactions. The policy stipulated that upon admission or entry to the facility, the nurse or healthcare provider will obtain a complete list of the current medications which included name, dose, route, frequency, last dose taken and the purpose of the medication. According to the policy, the hospital's Medication Reconciliation Form will contain all this information and the physician's signature, date and time in the Medication comparison completed section indicated that the medications were reconciled.

An interview and joint record review with the Nursing Director of the ED (NDED) was conducted on 6/14/12 at 9:28 A.M. The NDED acknowledged that Patient 24's Medication Reconciliation Form was not completed in accordance with the hospital's policy.

9. A review of Patient 25's medical record was conducted on 6/12/12, at 3:12 P.M. Patient 25 was admitted to the hospital on 6/12/12 for a right temporal artery biopsy (an examination of tissue removed from a living body to discover the presence, cause or extent of a disease), per the Facesheet. There was no documented evidence to show that the physician reconciled Patient 25's medications upon admission, as the "Medication comparison completed" section did not have a physician's signature, date or time.

An interview with Registered Nurse (RN) 21 was conducted on 6/11/12, at 3:20 P.M. RN 21 stated that patient's medication reconciliation forms were completed as soon as possible. He stated that the physician's signature, date and time indicated that the medications were reconciled by the physician.

A review of the hospital's policy entitled "Medication Reconciliation," revision date of 7/2011, was conducted on 6/13/12. The policy's purpose indicated that, "Medication reconciliation process includes the comparison of the medications the patient is taking prior to hospitalization with the medications the facility will provide." Per the policy, this process occurred to avoid the occurrence of adverse medication and disease events, transcription errors, omission, duplication of therapy, contraindications, and drug to drug or drug to disease interactions. The policy stipulated that upon admission or entry to the facility, the nurse or healthcare provider will obtain a complete list of the current medications which included name, dose, route, frequency, last dose taken and the purpose of the medication. According to the policy, the hospital's Medication Reconciliation Form will contain all this information and the physician's signature, date and time in the Medication comparison completed section indicated that the medications were reconciled.

An interview and joint record review with the Nursing Director of the ED (NDED) was conducted on 6/14/12 at 9:28 A.M. The NDED acknowledged that Patient 25's Medication Reconciliation Form was not completed in accordance with the hospital's policy.

DELIVERY OF DRUGS

Tag No.: A0500

Based on observation, interview and document review, the facility failed to stock a Malignant Hyperthermia Cart (a cart which contains medications and supplies used to treat Malignant Hyperthermia (MH): an emergency condition which may arise given certain triggering anesthetic medications), that meets professional standards of practice.

Findings:

The Malignant Hyperthermia Association of the United States (MHAUS) is a professional association that provides information related to MH for both professionals and the public. "Malignant Hyperthermia (MH) is an inherited muscle disorder triggered by certain types of anesthesia that may cause a fast-acting life-threatening crisis. The incidence of MH is low, but, if untreated, the mortality rate is high" (taken from the MHAUS web site at www.mhaus.org).

From the MHAUS Medical Professional's Frequently Asked Questions on their website, MHAUS recommends that the following medications be stocked on the MH cart: "dantrolene (36 vials) ... furosemide (to increase urine output), dextrose (a sugar used by the body for energy), calcium chloride (a chemical used in muscle contraction and other biological processes) ... [and] antiarrhythmics " (medications that help provide a normal heart rhythm)."

During an observation of the Operating Rooms conducted on 6/11/12, the MH Cart was inspected with both the Director of Pharmacy (DOP) and the Director of the OR (DOR). Twelve vials of dantrolene (a drug used to treat MH) were available on the cart (the remaining 24 vials were in the pharmacy) and furosemide, dextrose and lidocaine were found in an Automated Dispensing Cabinet adjacent to the MH Cart.

The current documents in use by the facility, "Dantrolene Sodium IV - Use and Preparation," reviewed by the facility on April, 2012, and, "Suggested Contents for a Malignant Hyperthermia (MH) Cart," from "Perioperative Standards and Recommended Practices 2011 Edition," were provided by the DOR and DOP. In the latter document, it is also recommended that Furosemide, Calcium Chloride, Lidocaine and Dextrose all be stored on the cart, as is recommended by MHAUS. The DOR stated that the cart would be updated per the MHAUS recommendations immediately.

ACCESS TO LOCKED AREAS

Tag No.: A0504

Based on interview and document review, the facility failed to ensure that only authorized personnel have access to locked areas that contained medications and medical supplies.

Findings:

On 6/11/12, a list of all Automated Dispensing Cabinet (ADC) users was provided by the Director of Pharmacy (DOP). The DOP then provided a list obtained from Human Resources of all personnel who had terminated employment with the facility during the months of April and May. Comparison of these lists demonstrated that 4 of 36 (12.5%) former employees continued to have access to the ADC's. During an interview conducted with the DOP on 6/11/12, the DOP stated that these former employees should have been removed from the ADC active status.

On 6/11/12, the Policy and Procedure titled, "Automated Medication Dispensing System," was provided by the DOP. The document stated that, "The Pharmacy will be notified immediately by Human Resources in writing (includes e-mail) when an employee terminates. The Pharmacy will immediately revoke or change user privileges upon written/e-mailed notification from the Nursing Director." There was no indication from the DOP that notification had been provided by the Nursing Director for those employees who terminated but were yet found to have active ADC profiles.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observation, interview and record review, the Director of Food and Clinical Nutrition Services failed to ensure that, thawed chicken was prepared or discarded in a timely manner, to ensure food quality and safety.

Findings:

On 6/11/12 at 9:56 A.M., inside a walk-in refrigerator, was a large stainless steel pan that held a cardboard box. The cardboard box had a hand written date that indicated "6/14/12." Inside the box, were blue bags that were unsealed with thawed chicken. The cardboard box had a manufacturer's label that indicated "40 lbs of chicken," when shipped. The pan contained approximately a ?" to 1" thick of chicken liquids. According to the requisition order, the chicken was portioned into 3-10 oz portions.

According to the Executive Chef, in the presence of the Director of Food and Clinical Nutrition Services, the chicken was received frozen and directly placed into the walk-in refrigerator on 6/4/12. The Executive Chef stated that he determined the use by date of 6/14/12, to allow the frozen chicken up to three days to thaw inside the refrigerator, and then would allow an additional seven days in its thawed state before it would either need to be prepared, or discarded. At that time, the Director of Food and Clinical Nutrition Services did not confirm that was a safe food handling practice. The Executive Chef stated that he would do research to determine if it took 3 days to thaw the 3-10 oz sizes of chicken that were shipped at a total of 40 lbs at a time, and to determine if allowing an additional 7 days after the chicken thawed was a safe food handling practice that maintained quality.

On 6/11/12 at 3:34 P.M., the Executive Chef and Director of Food and Clinical Nutrition Services stated that, keeping thawed chicken in the refrigerator for up to 7 days, "was wrong and we need to implement a new policy."

The hospital's procedure entitled Infection Control - HACCP [hazard analysis critical control point] - Food Procurement and Storage (#: IC -5.0; last revised 9/03), indicated, "...Frozen food that has been thawed shall be cooked or processed before it may be refrozen." The Director of Food and Clinical Nutrition acknowledged the procedure lacked detailed direction to dietary staff in regard to how long a thawed potentially hazardous food could be stored in the refrigerator .

According to the United States Department of Agriculture, once raw chicken had thawed it could be kept in the refrigerator an additional day or two before cooking.

DIETS

Tag No.: A0630

Based on interview and patient menu nutrient analysis review, the hospital failed to ensure that a comprehensive nutrient analysis was conducted, for the patient non-select menus to ensure the menu provided met the nutritional needs of the patients, in accordance with recognized dietary practices.

Findings:

On 6/11/12 at 12:03 P.M., the hospital's menu analysis was reviewed with the Director of Food and Clinical Nutrition Services. The nutrient analysis was conducted for all of the most commonly ordered diets, however, all of the diets that were analyzed lacked analysis of the following items that are in the RDA [recommended dietary allowances]/RDI's [dietary reference intake], and are available from nutrition data basis: pantothenic acid (Vitamin B 5), Vitamin B12 (cobalamin), Vitamin D (upper safe limits have been established),Vitamin E (upper safe limits have been established and should be included in a menu analysis), folacin, selenium, zinc and magnesium.

The Director of Food and Clinical Nutrition Services verified that the patient menus, including therapeutic diets, had not had a complete analysis in accordance with the RDA's/RDI's of the Food and Nutrition Board of the National Research Council, from those which are available in nutrition data bases.

The national standards for the RDA's or RDI's were developed to "provide health professionals...references for planning for the nutrient needs of individuals and groups of people." (Institute of Medicine of the National Academies, 2006).

The hospital's procedure entitled Menu Planning To Accommodate Patient Needs For [name of hospital] (Procedure #: TX-23;last revised 9/04) indicated, " It is the responsibility of Food & Nutrition Services to provide nutritionally adquate meals to all patients..., Nutritional preferences and needs of patients/residents are met in accordance with the physicians orders based on the Diet Manual, and as far as the diet permits, meet the Recommended Dietary Allowances of the Food and Nutrition Board, National Research Council, 1989."

FIRE CONTROL PLANS

Tag No.: A0714

Based on interview and policy review, the hospital failed to ensure that Operating Room (OR) staff were able to verbalize the location of the emergency gas shut off valves in case of a fire or disaster. Two out of the 4 OR staff did not know the location of the emergency gas shut off valves.

Findings:

An interview with the OR scrub technician (ORT 21) was conducted on 6/12/12 at 1:29 P.M. ORT 21 was not able to verbalize the location of the gas shut off valve when asked if there was fire or an emergency, how would you turn off the gas in the operating rooms.

An interview with ORT 22 was conducted on 6/12/12 at 1:35 P.M. When asked if he knew how to turn off the gas in the OR, he was not able to verbalize the location of the emergency gas shut off valves.

An interview with Charge Nurse (RN) 22 was conducted on 6/12/12 at 1:59 P.M. RN 22 stated that all OR staff should have been able to verbalize where the emergency gas shut off valves were located in the OR in case of a fire or disaster. She stated that all staff were trained upon hire and annual re-education pertaining to emergency gas shut off valves and fire safety were required.

A review of the hospital's policy entitled, "Surgery Fire Safety and Responsibilities," revision date of 5/2012, was conducted on 6/13/12. The policy indicated that all staff in the OR will be familiar with fire prevention and fire response plans and shall participate in department specific fire safety education and drills. Per the same policy, all staff should be able to verbalize the location of gas shut off valves as they received this information in orientation and is an important aspect of their annual competency assessment.

An interview with the Nursing Director of the OR (NDOR) was conducted on 6/14/12 at 10:15 A.M. The NDOR acknowledged that the OR staff should have been able to verbalize the location of the emergency gas shut off valves in the OR in accordance with the hospital policy.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on observation, interview and document review, the hospital failed to ensure that carbon dioxide (CO2) cylinders were safely stored in a closet located in the Operating Room (OR).

Findings:

A tour of the OR was conducted with the Charge Nurse (RN 22) and the Nursing Director of the OR (NDOR), on 6/12/12 beginning at 9:12 A.M. A closet was observed containing 4 large carbon dioxide cylinders. The closet door read "CO2 Storage Room." Three of the four CO2 cylinders were not securely chained in the closet.

An interview with the NDOR was conducted on 6/12/12 at 9:33 A.M. The NDOR stated that the CO2 cylinders should have been securely chained in the closet. She stated that the OR staff was not responsible for the CO2 cylinders, it was the Engineering department staff who were responsible for the maintenance of the CO2 Storage Room closet.

An interview with the corporate office engineer was conducted on 6/13/12, at 1:25 P.M. He stated that the hospital did not have a policy that demonstrated the safe storage of CO2 cylinders. He explained that the hospital had a policy on how to store medical gases (Oxygen and Nitrous Oxide). He stated that medical gas cylinders will be checked and recorded daily. He also stated that each individual cylinder will be chained at all times. He acknowledged that the CO2 cylinders in the OR closet should have been securely chained.

INFECTION CONTROL PROFESSIONAL

Tag No.: A0748

Based on observation, interview and document review, the facility failed to fully implement their policy related to Infection Control. In addition, the facility failed to ensure that disinfecting agents were followed, per the manufacturer's guidelines.

Findings:

1. On 6/12/12, during a Medication Pass Observation, Registered Nurse 1 (RN1) was observed to be wearing a disposable isolation gown (a cover that is placed over the outer clothing that protects the outer clothing from being contaminated). The gown was not tied to prevent it from falling off of her shoulders. Consequently, this gown fell in such a way that it only covered her forearms while she performed actions on Patient 3 exposing the rest of her uniform. Patient 3 was in isolation with contact precautions.

During an interview with the Director of Pharmacy (DOP), she stated that RN1 should have been properly attired to make any contact with this isolated patient.

A review of the facility's policy and procedure titled Infection Control indicated that, "General Procedures: 3. Wear a gown when indicated by the specific isolation precaution category."



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2. A tour of the 3rd floor South Medical/Surgical Unit was conducted on 6/11/12 at 2:05 P.M. On 6/11/12 at 2:08 P.M., registered nurse (RN) 12 was observed going inside a patient's room, that had a signage "contact precaution," posted outside the room, without wearing a gown. According to RN 12, she always wore a gown when entering a patient's room on isolation precaution. However, RN 12 could not explain why she did not wear a gown that day.

An interview with the Infection Preventionist (IP) was conducted on 6/13/12 at 9:30 A.M. The IP stated that all staff should be wearing a gown when entering a room with contact precaution signage posted outside the room.

A review of the hospital's policy and procedure titled Infection Control was conducted on 6/13/12 at 3:45 P.M. The policy indicated that for Contact Precautions, "3. Gown is to be donned prior to entering room of any patient in contact isolation and removed immediately prior to exiting the room."

3. An interview with registered nurse (RN) 13 was conducted on 6/11/12 at 1:10 P.M. RN 13 was asked what she would use to disinfect a walker that she used on a patient that had methicillin resistant staphylococcus aureus (MRSA - a bacterium responsible for several difficult-to-treat infections in humans). RN 13 stated that she would disinfect the walker using the Super Sani-Cloth. When asked about the contact time (the amount of time the surface needed to be wet with disinfectant for maximum effectiveness), RN 13 stated that she would wipe the walker with the super sani-cloth for 1 minute and another minute to dry. For clarification, RN 13 was asked what if the surface of the walker was dry after 1 minute and 20 seconds, RN 13 stated that it was "Ok."

A review of the Super Sani-Cloth label indicated that the contact time for the disinfectant was 2 minutes.

An interview with the Infection Preventionist (IP) was conducted on 6/13/12 at 9:30 A.M. The IP stated that staff should follow manufacturer's guidelines. The IP stated that the contact time for Super Sani-Cloth was 2 minutes. The IP stated that she was not aware that manufacturer's guidelines for contact times were not being followed.

4. An interview with housekeeper 11, using a translator, was conducted on 6/11/12 at 2:20 P.M. Housekeeper 11 stated that she used the disinfectant called "Retaliate" (Brand name of a disinfectant) to disinfect all patient rooms except rooms occupied by patients with C. difficile (a bacteria that causes severe diarrhea). Housekeeper 11 also stated that after disinfecting the mattress surface, she would make the bed when the mattress was dry. When asked what the contact time (the amount of time the surface needed to be wet with disinfectant for maximum effectiveness) was for "Retaliate," housekeeper 11 stated "5 minutes." When asked what she would do if the mattress surface dried in 3 minutes, housekeeper 11 stated that she would then make the bed.

The manufacturer's guideline for "Retaliate" was reviewed on 6/11/12, at 4:00 P.M. Per the guidelines, the contact time for "Retaliate" was 10 minutes

An interview with the Infection Preventionist (IP) was conducted on 6/13/12 at 9:30 A.M. The IP stated that staff should follow manufacturer's guidelines. The IP stated that the contact time for "Retaliate" was 10 minutes. The IP stated that she was not aware that manufacturer's guidelines for contact times were not being followed.



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5. A tour of the OR (Operating Room) was conducted with the Charge Nurse (RN 22) and the Nursing Director of the OR (NDOR) on 6/12/12 beginning at 9:12 A.M.

An interview with the OR attendant (ORA 21) was conducted on 6/12/12, at 10:05 A.M. He stated that the disinfectant used to wipe down beds, tables, equipment, counter tops and surfaces in the OR was called "Retaliate" (brand name for a disinfectant). When asked what the contact time (the amount of time the surface needed to be wet with disinfectant for maximum effectiveness) was for "Retaliate," ORA 21 stated "5 minutes."

An interview with RN 22 was conducted on 6/12/12 at 1:59 P.M. RN 22 stated that "Retaliate" was the disinfectant used in the OR. She stated that the required contact time was 10 minutes per manufacturer's guidelines.

The manufacturer's guideline for "Retaliate" was reviewed on 6/12/12. Per the guideline, the contact time required for the disinfectant to be effective was 10 minutes.

An interview with the Infection Preventionist (IP) was conducted on 6/13/12 at 9:30 A.M. The IP stated that staff should follow manufacturer's guidelines. She stated that she was not aware that OR staff were not following required contact times for the disinfectant used in the OR.

On 6/13/12 at 2:42 P.M., a Quality Assessment and Performance Improvement (QAPI) group interview was conducted. The IP was present. The IP was asked what the hospital's surgical site infection rate was. The IP stated that the number of surgical site infections were "not where she wanted them to be." She acknowledged that there were opportunities for additional monitoring of OR practices that had the potential to impact infection control. Those opportunities included additional monitoring and oversight pertaining to the implementation of required contact times of disinfectants used in the OR by staff.

6. General observations were conducted in the Operating Room (OR) on 6/12/12 beginning at 1:20 P.M. An interview with OR scrub technician (ORT 21) was conducted on 6/12/12 at 1:44 P.M. ORT 21 stated that the disinfectant he used to wipe down equipment in the OR was called "Retaliate" (brand name of disinfectant). He stated that he would apply the disinfectant onto equipment and surfaces for 5 minutes and left to air dry.

An interview with RN 22 was conducted on 6/12/12 at 1:59 P.M. RN 22 stated that "Retaliate" was the disinfectant used in the OR. She stated that the required contact time (the amount of time the surface needed to be wet with disinfectant for maximum effectiveness) was 10 minutes per manufacturer's guidelines.

The manufacturer's guideline for "Retaliate" was reviewed on 6/12/12. Per the guideline, the contact time required for the disinfectant to be effective was 10 minutes.

An interview with the Infection Preventionist (IP) was conducted on 6/13/12 at 9:30 A.M. The IP stated that staff should follow manufacturer's guidelines. She stated that she was not aware that OR staff were not following required contact times for the disinfectant used in the OR.

On 6/13/12 at 2:42 P.M., a Quality Assessment and Performance Improvement (QAPI) group interview was conducted. The IP was present. The IP was asked what the hospital's surgical site infection rate was. The IP stated that the number of surgical site infections were "not where she wanted them to be." She acknowledged that there were opportunities for additional monitoring of OR practices that had the potential to impact infection control. Those opportunities included additional monitoring and oversight pertaining to the implementation of required contact times of disinfectants used in the OR by staff.

7. General observations were conducted in the Operating Room (OR) on 6/12/12 beginning at 1:20 P.M. An interview with the OR scrub technician (ORT 22) was conducted on 6/12/12 at 1:48 P.M. ORT 22 stated that when disinfecting equipment in the OR, he used a disinfectant called "Retaliate." He stated that he would apply the disinfectant on the surfaces or equipment for 5 minutes and allowed to air dry.

An interview with RN 22 was conducted on 6/12/12 at 1:59 P.M. RN 22 stated that "Retaliate" was the disinfectant used in the OR. She stated that the required contact time (the amount of time the surface needed to be wet with disinfectant for maximum effectiveness) was 10 minutes per manufacturer's guidelines.

The manufacturer's guideline for "Retaliate" was reviewed on 6/12/12. Per the guideline, the contact time required for the disinfectant to be effective was 10 minutes.

An interview with the Infection Preventionist (IP) was conducted on 6/13/12 at 9:30 A.M. The IP stated that staff should follow manufacturer's guidelines. She stated that she was not aware that OR staff were not following required contact times for the disinfectant used in the OR.

On 6/13/12 at 2:42 P.M., a Quality Assessment and Performance Improvement (QAPI) group interview was conducted. The IP was present. The IP was asked what the hospital's surgical site infection rate was. The IP stated that the number of surgical site infections were "not where she wanted them to be." She acknowledged that there were opportunities for additional monitoring of OR practices that had the potential to impact infection control. Those opportunities included additional monitoring and oversight pertaining to the implementation of required contact times of disinfectants used in the OR by staff.

8. General observations were conducted in the Operating Room (OR) on 6/12/12 beginning at 1:20 P.M.

An interview with an OR Registered Nurse (RN 23) was conducted on 6/12/12 at 1:51 P.M. RN 23 stated that the disinfectant used in the OR was called "Retaliate." She stated that when she wiped down surfaces or equipment, she applied "Retaliate" (disinfectant) on for 2 minutes and left to air dry.

An interview with RN 22 was conducted on 6/12/12 at 1:59 P.M. RN 22 stated that "Retaliate" was the disinfectant used in the OR. She stated that the required contact time (the amount of time the surface needed to be wet with disinfectant for maximum effectiveness) was 10 minutes per manufacturer's guidelines.

The manufacturer's guideline for "Retaliate" was reviewed on 6/12/12. Per the guideline, the contact time required for the disinfectant to be effective was 10 minutes.

An interview with the Infection Preventionist (IP) was conducted on 6/13/12 at 9:30 A.M. The IP stated that staff should follow manufacturer's guidelines. She stated that she was not aware that OR staff were not following required contact times for the disinfectant used in the OR.

On 6/13/12, at 2:42 P.M., a Quality Assessment and Performance Improvement (QAPI) group interview was conducted. The IP was present. The IP was asked what the hospital's surgical site infection rate was. The IP stated that the number of surgical site infections were "not where she wanted them to be." She acknowledged that there were opportunities for additional monitoring of OR practices that had the potential to impact infection control. Those opportunities included additional monitoring and oversight pertaining to the implementation of required contact times of disinfectants used in the OR by staff.