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Based on interview and record review, the hospital failed to ensure that informed consent was obtained prior to a bronchoscopy, for 1 of 6 sampled bronchoscopy patients (42). There was no documented evidence to show that the informed consent process was conducted prior to Patient 42's bronchoscopy on 1/23/12, at Hospital B.

Findings:

A review of Patient 42's medical record was conducted on 1/23/12, beginning at 3:49 P.M. Patient 42 was admitted to Hospital B on 1/15/12, with diagnoses that included chronic obstructive pulmonary disease, per the facesheet.

According to Patient 42's Procedure Report, dated 1/23/12, and dictated by Physician 41, a bronchoscopy was performed for diagnostic and therapeutic purposes. The Report indicated that, "the procedure was discussed with (family member--FM 41), who was unable to come on the day of the procedure to sign the consent, and he agreed on signing the consent afterward, and he will come to sign it at the bedside." Per the Procedure Report, this information was communicated to Patient 42's nurse.

An interview and joint record review with Registered Nurse (RN 41) was conducted on 1/24/12 at 10:45 A.M. RN 41 stated that she did not participate in the informed consent process, and she did not confirm that informed consent was obtained prior to Patient 41's bronchoscopy on 1/23/12.

A review of the hospital's policy entitled "Physician Documentation Requirements," effective date of 1/12, was conducted. The policy's purpose stipulated that, "To provide guidelines for the medical staff on their role and responsibilities for documenting clinical information in a manner that contributes to patient safety and ensures compliance with regulatory requirements."

The policy under informed consent, indicated that the following elements were required documentation in the patient record by the physician, when informed consent was obtained:

-The nature of the proposed care, treatment, services and anticipated recuperation.
-Potential benefits, risks, or side effects, including potential problems that might occur during recuperation.
-The likelihood of achieving care and treatment goals.
-Reasonable alternatives to the proposed care, treatment and service.
-The relevant risks, benefits, and side effects related to alternatives including the possible results of not receiving care, treatment and services. -When indicated, any limitations on the confidentiality of information learned from or about the patient.
-The consequences of refusing the suggested procedure.

An interview and joint record review with Physician 41, was conducted on 1/24/12 at 2:00 P.M. Physician 41 stated that prior to performing Patient 42's bronchoscopy on 1/23/12, he had talked to FM 41 via the telephone and discussed the following informed consent items: the need for the procedure, the nature, benefits and risks. He stated that he documented this process on Patient 42's dictated procedural note, dated 1/23/12, which was dictated on 1/24/12 in the A.M. He acknowledged that at the time of this interview, there was no documented evidence to show that the informed consent process was performed, in accordance with the hospital's policy.

An interview with FM 41, was conducted on 1/25/12 at 8:20 A.M. FM 41 stated that he was Patient 42's son who has made medical decisions for Patient 42, when the patient was unable to make medical decisions or consent to procedures. He stated that on 1/24/12, at approximately 11:00 A.M., he received a phone call from Physician 41, at which time the risks, benefits and consent for a bronchoscopy, was discussed with him. He stated that Physician 41 discussed that Patient 42's bronchoscopy was performed yesterday (1/23/12), to follow-up on the lung abscess. FM 41 stated that, he informed Physician 41 that he will be at the hospital that afternoon and will sign the documents then.

A follow-up review of Patient 42's medical record, was conducted on 1/25/12 at 8:35 A.M. A Consent To Surgery Or Special Diagnostic Or Therapeutic Procedures form, was found completed and signed on 1/24/12 at 7:40 P.M.

An interview with the Associate Vice President (AVP) was conducted on 1/26/12 at 9:40 A.M. The AVP stated that, the hospital's policy pertaining to the informed consent process was clear, in that the informed consent was obtained prior to the procedure, with the exceptions of emergencies.

Based on interview, record and document review, Hospital A failed to ensure that attempts were made to obtain a copy of 3 of 54 (32, 33, 34) sampled patient's Advance Directives. In addition, Hospital A failed to ensure accurate information related to the three patient's Advance Directives, was documented in their respective medical records.

Findings:

1. A review of Patient 32's medical record was conducted on 1/23/12 at 2:45 P.M. Patient 32 was admitted to Hospital A on 1/19/12, for treatment of a fractured right hip that she sustained after falling at home. According to the Emergency Department Nursing Flowsheet, Patient 32 had an Advance Directive (a legal document, signed by a competent person to provide guidance for medical and health care decisions, in the event a person becomes incompetent to make such decisions), and the family was instructed to bring in a copy of her Advance Directive to place on her medical record while she was an inpatient. After Patient 32 was admitted to Hospital A, a Nursing Admission Assessment was performed by a Registered Nurse. According to the Nursing Admission Assessment section of Patient 32's medical record, Patient 32 had no Advance Directive. And, there was no copy of an Advance Directive on Patient 32's medical record. Clarification regarding the Advance Directive could not be obtained from Patient 32 because she had been discharged the morning of 1/23/12.

A review of the hospital's policy and procedure, dated 5/11, and entitled "Advance Health Care Directives" indicated that, "It is the policy for (the hospital) to respect and encourage patient self-determination in decisions regarding their health care...Advance Directives are recognized in all settings and will be honored as incorporated in the patient's treatment plan...The status of an individual's Advance Directive will be addressed on admission...Ask adult patient whether he/she has a written Advance Directive. If yes, ask him/her to provide copy for their medical record...Alert staff to the presence of an Advance Directive: Indicate presence of an Advance Directive in the plan of care for communication to the care team."

An interview was conducted on 1/26/12 at 11:20 A.M. with the Director of Risk Management (DRM). The DRM acknowledged that the nursing staff failed to follow the hospital's policy and procedure on the management of Advance Directives.

2. Patient 33 was admitted to Hospital A on 1/22/12, after being brought to the Emergency Department by the paramedics for episodes of dizziness, according to the Admission Face Sheet. A review of Patient 33's medical record was conducted on 1/23/12 at 2:10 P.M. According to the Emergency Department Nursing Flowsheet, Patient 33 had an Advance Directive (a legal document, signed by a competent person to provide guidance for medical and health care decisions, in the event a person becomes incompetent to make such decisions). It was also documented on the Nursing Flowsheet that Patient 33's Advance Directive was at her home. However, there was no documentation that Patient 33 was instructed to have a copy of her Advance Directive brought to the hospital to be placed on her medical record. After Patient 33 was admitted to Hospital A, a Nursing Admission Assessment was performed by a Registered Nurse (RN). According to the Nursing Admission Assessment section of Patient 33's medical record, Patient 33 had no Advance Directive. And, there was no copy of an Advance Directive on Patient 33's medical record.

A review of the hospital's policy and procedure, dated 5/11, and entitled "Advance Health Care Directives" indicated that "It is the policy for (the hospital) to respect and encourage patient self-determination in decisions regarding their health care...Advance Directives are recognized in all settings and will be honored as incorporated in the patient's treatment plan...The status of an individual's Advance Directive will be addressed on admission...Ask adult patient whether he/she has a written Advance Directive. If yes, ask him/her to provide copy for their medical record...Alert staff to the presence of an Advance Directive: Indicate presence of an Advance Directive in the plan of care for
communication to the care team."

On 1/23/12 at 2:20 P.M., the Charge RN verified with Patient 33 that she did, in fact, have an Advance Directive which was at home. The Charge RN acknowledged that Patient 33 was alert and oriented. The Charge RN further stated that if a patient has an Advance Directive someone should have asked her to have a copy brought to the hospital.

An interview was conducted on 1/26/12 at 11:20 A.M., with the Director of Risk Management (DRM). The DRM acknowledged that the nursing staff failed to follow the hospital's policy and procedure on the management of Advance Directives.

3. Patient 34 was admitted to Hospital A on 12/16/11, for the treatment of a fractured humerus, according to the Admission Face Sheet. A review of Patient 34's medical record was conducted on 1/26/12 at 11:15 A.M. According to the Emergency Department Nursing Flowsheet, Patient 34 had an Advance Directive (a legal document, signed by a competent person to provide guidance for medical and health care decisions, in the event a person becomes incompetent to make such decisions). It was also documented on the Nursing Flowsheet that Patient 34's Advance Directive was at her home. However, there was no documentation that Patient 34 was instructed to have a copy of her Advance Directive brought to the hospital to be placed on her medical record. After Patient 34 was admitted to Hospital A, a Nursing Admission Assessment was performed by a Registered Nurse (RN). According to the Nursing Admission Assessment section of Patient 34's medical record, Patient 34 had no Advance Directive. And, there was no copy of an Advance Directive on Patient 34's medical record. Clarification regarding the Advance Directive could not be obtained from Patient 34 because she had been discharged.

A review of the hospital's policy and procedure, dated 5/11, and entitled "Advance Health Care Directives" indicated that "It is the policy for (the hospital) to respect and encourage patient self-determination in decisions regarding their health care...Advance Directives are recognized in all settings and will be honored as incorporated in the patient's treatment plan...The status of an individual's Advance Directive will be addressed on admission...Ask adult patient whether he/she has a written Advance Directive. If yes, ask him/her to provide copy for their medical record...Alert staff to the presence of an Advance Directive: Indicate presence of an Advance Directive in the plan of care for
communication to the care team."

An interview was conducted on 1/26/12 at 11:20 A.M. with the Director of Risk Management (DRM). The DRM acknowledged that the nursing staff failed to follow the hospital's policy and procedure on the management of Advance Directives.

Based on observation, interview and record review, the hospital did not maintain one patient's (52) right to personal privacy in accordance with hospital policies, as he was rolled down a hallway in a bed. Patient 52's blanket was down around his lower legs, his gown was up, and his left thigh was exposed. Patient 52 was physically and mentally unable to cover himself on his own. The hospital's failure to ensure the personal privacy of Patient 52 placed him, and potentially other patients, at risk for a loss of dignity. The patient census was 302.

Findings:

On 1/23/12 at 3:50 P.M., Patient 52 was being rolled in a bed down a corridor of the 11th floor by a patient transporter (Transporter 69). As he was rolled past the surveyor, Patient 52 was not completely covered. Administrative Director of Pharmacy (ADM 57) and Senior System Director of Pharmacy (ADM 58) were walking with the surveyor at the time. A blanket was down around his lower legs and his gown was raised which exposed approximately 12 inches of his left thigh. Administrative Director of Pharmacy (ADM 57) told Transporter 69 to cover Patient 52. An interview with the Transporter and patient was deferred so as not to interrupt care.

On 1/23/12 at 3:56 P.M. in an interview, a Registered Nurse, 11th Floor (RN 68) said Patient 52 was her patient and had just returned from Radiology. She explained that Patient 52 was confused and aphasic (unable to speak). She said she noticed that he tugs at his gown and exposes his legs. She explained that when she sees this behavior she says, "Let's cover you up."

On 1/23/12 at 4:00P.M. in an interview, ADM 58 said "I saw his gown up. I saw his thigh ...nothing else."

On 1/23/12 at 4:05 P.M. in an interview, ADM 57 said, "I did not see any private parts. I would not see it as a gross violation of his dignity. You lose your dignity when you come to a hospital. "

On 1/25/12 at 10:27 A.M. in an interview, the Director of Patient Logistics (Director 73) said, "[Transporter 69] was taking Patient 52 back to his room from Radiology. Director 73 said the hospital's investigation showed Patient 52 was "very agitated and going through alcohol withdrawal." She elaborated, "We expect transporters to maintain privacy at all times, including physical self."

On 1/25/12 at 10:27 A.M. in an interview conducted with the Director of Risk Management (ADM 61), ADM 61 said in reference to Patient 52, "We have to take extra precautions for someone who's confused. He can't speak and can't act for himself." In the same interview, Chief Nurse Operating Executive (ADM 67) said it is a Service Standard of the hospital to create a clean, safe, private environment and to respect the dignity of all patients. She said staff receives two hours of training on hospital standards and core values including personal privacy, but not all staff had completed training.

A review of Attachment A of the hospital's policy, Patient Rights and Responsibilities, Approved Model Content Access to (Hospital A's) Care and Services, Patient Rights and Responsibilities shows patients should expect, "Respect for your personal privacy."

A review of the hospital's Position Description and Performance Evaluation of Transporter/Lift Team showed under the subheading, Safety/Security, that the transporter staff, "Maintains privacy of patient's physical self and medical record."

Based on observation, interview and record review, the hospital failed to maintain confidentiality for one patient (56), in a patient care area of a Surgical Intensive Care Unit (SICU). Registered Nurse (RN 60) failed to log out of a computer before leaving it unattended. The computer was opened to a page of Patient 56's Medication Administration Record (MAR) (confidential information) and was visible to passersby during visiting hours. The hospital's failure denied Patient 56's right to confidential treatment of the patient's medical records. The hospital census was 302 patients.

Findings:

On 1/24/12 at 3:00 p.m. during a tour of SICU, a computer outside the room of Bed 10, was observed unattended. The computer was opened to a page of Patient 56's Medication Administration Record (MAR). Patient 56's name and her routine medications were visible to passersby during visiting hours.

A record review of the Inpatient Face Sheet, dated 1/23/12, showed Patient 56 was admitted on 1/19/12, with a diagnosis of rectal cancer. A History and Physical, dated 1/21/12 at 8:53 A.M., showed that she was admitted through the Emergency Department with severe pain in the rectal area with drainage and required emergency surgery.

On 1/24/12 at 3:02 P.M. in an interview, the Surgical Intensive Care Unit (SICU), Registered Nurse Manager (RN 59), said that Registered Nurse (RN 60) was Patient 56's nurse. The manager looked around the unit and indicated that he did not see RN 60. RN 59 acknowledged that confidential patient information was visible on the computer screen and could be visible to persons who walked by the computer screen. SICU staff said the "print screen" function was not available on the computer with wheels but they provided a copy of the MAR which included five routine medications administered or scheduled to be administered between 1/24/12 at 7:00 A.M. through 1/25/12 at 6:59 A.M.

On 1/24/12 at 3:06 P.M., during an interview with RN 60, she acknowledged that she left the MAR screen on Patient 56's MAR visible because she had to go to the restroom and did not have a chance to log out.

On 1/25/12 at 10:27 A.M. during an interview, the Director of Risk Management (ADM 61) provided and discussed the hospital's policy regarding, Confidentiality of Information (Patient, Financial, Employee, and Other Sensitive and Proprietary Information (dated 11/10). A review of the policy showed that every employee who had access to Confidential Information was responsible for following all hospital, "policies and to safeguard all Confidential Information." The policy defined "Confidential Information" to include Personal Health Information and patient records. The policy described Inappropriate Disclosure of Protected Health Information as, "disclosing confidential information, regardless of intent, in verbal written or electronic form ...in a setting where information can be read or transferred from an unattended computer monitor ... " The policy described Protected Health Information (PHI) as, "any information, including demographic information, collected from an individual that (a) is created or received by a health care provider, health plan, employer or health care clearinghouse; and (b) relates to the past, present or future physical or mental health or condition of an individual, the provision of healthcare to an individual and identifies the individual or with respect to which there is a reasonable basis to believe that the information can be used to identify the individual."

On 1/26/11 at 2:00 P.M., during the surveyor exit conference, a hospital administrator asked the surveyor for clarification as to whether the circumstances of the disclosure (provision of access to the confidential information) were potentially allowable under the hospital's policies. ADM 61 told him, "No" and explained that the disclosure occurred in a setting where information could be read from an "unattended" computer monitor.

Based on observation, interviews and document reviews, the hospital failed to maintain an effective data-driven quality assessment and performance program, as evidenced by:

1. The hospital quality program failed to account for missing and extra medications that could indicate that a patient received too much, missed a dose, or were given the wrong medication, when a 30 day audit revealed 2,836 of 2,836 missing and extra medications, were not accounted for by the hospital (See A267, A500).

2. The hospital quality program failed to ensure bacterial/fungal testing of the pharmacy sterile compounding area in order to maintain sterility of intravenous (IV) preparations, when IV hoods were not tested monthly for bacteria and fungus for over 8 years (See A267, A500).

3. The hospital quality assurance program failed to identify and reduce medication errors to ensure safe use of medications, when nurses administered and monitored insulin infusions to 3 of 5 patients in Hospital A (53, 54, 55) in a manner not in accordance with the medical staff approved protocol (See A266, A405).

The cumulative effects of these systemic problems resulted in the hospital's inability to maintain an effective quality assessment and performance improvement program, in accordance with the statutorily mandated Conditions of Participation for Quality Assessment and Performance Improvement Program.

Based on interview and record review, Hospital A's quality assurance program failed to identify and reduce medication errors to ensure the safe use of medications, when nurses administered and monitored insulin infusions to 3 of 5 patients in Hospital A (53, 54, 55), in
a manner not in accordance with the medical staff approved protocol.

Findings:

The Hospital A's insulin protocol, Insulin Infusion Orders" (revised 11/11) were reviewed, and showed instructions for nursing to adjust insulin infusion rates for patients according to a medical staff approved protocol.

On 1/24/12 at 2:29 P.M. in the Surgical Intensive Care Unit (SICU) of Hospital A, Patient 53's insulin protocol was reviewed with SICU Registered Nurse (RN 72). RN 72 discussed discrepancies in what the protocol (Physicians Orders) called for and what was actually documented by nursing staff as follows:

"On 1/23/12 at 12:30 A.M. Patient 53's blood glucose was 91 and the nurse went to 1 unit per hour. According to the protocol, Patient 53 should have been rechecked at 1:30 A.M., but he was actually checked at 3:00 A.M., one and a half hours later than required by the protocol."

"On 1/23/12 at 3:00 A.M., Patient 53's blood glucose was 125 and he was changed to a rate of 2.4 per hour. According to the protocol, he should have been rechecked at 4:00 A.M., 1 hour later, but he was actually checked at 5:00 A.M. This was an hour later than required by the protocol."

After the surveyor discussed the findings of non-adherence to the protocol, the surveyor requested the hospital to provide documentation for patients currently receiving insulin infusions via the protocol.

On 1/25/12 at 10:57 A.M., Medication Safety Officer 1 (MSO 63) provided patient records for Patient 53, Patient 54 and Patient 55. The surveyor demonstrated incidents of non-adherence to the protocol, ie, failure to follow the Physicians Orders, as follows:

1. On 1/14/12 at 9:00 A.M., Patient 54 had a blood glucose drawn 1 hour later than required by the protocol.

2. On 1/17/12 at 2:30 P.M., Patient 54 had a blood glucose drawn 2 hours later than required by the protocol.

3. On 1/17/12 at 5:30 P.M., Patient 54 had a blood glucose drawn 1.5 hours later than required by the protocol.

4. On 1/18/12 at 2:30 P.M., Patient 54 had insulin infusing at the wrong rate. Medication administration records showed the rate was 0.9 units per hour when it should have been 0.6 units per hour.

5. On 1/18/12/ at 3:30 P.M., Patient 54 had insulin infusing at the wrong rate. Medication administration records showed the rate was 1.2 units per hour when it should have been 0.8 units per hour.

6. On 1/19/12 at 3:00 A.M., Patient 54 had a blood glucose drawn 1 hour later than required by the protocol.

7. On 1/19/12 at 11:0 P.M., Patient 55 had insulin infusing at the wrong rate. Medication administration records showed the rate was 6.8 units per hour when it should have been 8.5 units per hour.

8. On 1/22/12 at 9:10 P.M., Patient 53 had a blood glucose drawn 2 hours and 40 minutes later than required by the protocol.

9. On 1/23/12 at 12:30 A.M., Patient 53 had a blood glucose drawn 1.5 hours later than required by the protocol.

10. On 1/23/12 at 12: 30 A.M., Patient 53 had insulin infusing at the wrong rate. Medication administration records showed the rate was 1 unit per hour when it should have been 2.5 units per hour.

11. On 1/23/12 at 3: 00 A.M., Patient 53 had a blood glucose drawn 1 hour later than required by the protocol.

12. On 1/23/12 at 9:45 A.M., Patient 53 had insulin infusing at the wrong rate. Medication administration records showed the rate was 0.4 units per hour when it should have been turned off.

A record review of the patients' charts showed no documentation that these deviations from the insulin protocol were necessary. MSO 63 said the hospital's investigation showed that all errors were a combined result of inattention by nurses during shift change or choosing the wrong rate from a column on a chart during insulin adjustments. MSO 63 elaborated that the hospital had a process change of insulin protocols around November 2011.

On 1/26/12 at 11:20 A.M. in an interview, RN 65 acknowledged that she made a mistake when looking at the wrong column on the adjustment chart. She explained, "I've been trained. It was confusing in the beginning ...it was overwhelming in the beginning." She elaborated, "Every time we do a rate change we do a double check." She clarified that for insulin, because it is a high risk medication, a second nurse comes behind and checks the first nurse's rate calculation.

On 1/26/12 at 11:30 A.M. in an interview, RN 66 said she apparently made a mistake in adjusting Patient 54's insulin infusion and stated, "I don't remember."

The above instances were due to non-adherence to the hopsital's Insulin Protocal during insulin adjustment changes, and each of these insulin adjustments were double checked by a second nurse.

Based on interview and document review, the hospital failed to measure, analyze, and accurately track quality data in order to improve hospital performance as evidence by:

1. The hospital quality program failed to account for missing and extra medications that could indicate that a patient received too much, missed a dose, or were given the wrong medication when a 30 day audit revealed 2,836 of 2,836 missing and extra medications were not accounted for by the hospital.

2. The hospital quality program failed to ensure bacterial/fungal testing of the pharmacy sterile compounding area in order to maintain sterility of intravenous (IV) preparations when IV hoods were not tested monthly for bacteria and fungus for over 8 years.

Findings:

1. During an interview conducted on 01/24/12 at 3:15 P.M, the Director of Pharmacy (DOP) stated Pharmacy did not review the missing or extra medications (aka discrepancies) found in the Automated Dispensing Cabinet (ADC- computerized drug storage devices). The DOP stated that misuse was primarily the cause of the discrepancies. She acknowledged that administering too much, missing a dose, or giving the wrong medication could be a cause of the discrepancies.

During an interview conducted on 01/25/12 at 2:15 P.M., the Pharmacy Administrator stated that the pharmacy could not account for the discrepancies. He acknowledged that some of the discrepancies could be medication errors. He also said that he could generate a discrepancy report. These discrepancies were not reviewed for medication errors by the hospital quality program.

A review of the ADC generated discrepancy report listed discrepancies, excluding narcotics, over the period from 12/26/11 to 01/24/12, which indicated there were 2,836 discrepancies. Each discrepancy had one or more extra doses; or one or more missing doses. One example of one discrepancy indicated 937 missing doses of Insulin. Insulin is a medication used for diabetes and when giving incorrectly can cause death or serious injury.

During an interview conducted on 01/26/12 at 10:46 A.M., Admin 1 and Admin 2 stated that they had oversight of the hospital's quality program. Admin 1 and Admin 2 both stated that they had not reviewed quality data that identified medication discrepancies as an issue.

The hospital did not provide evidence that the hospital's quality program addressed or acted upon the 2,836 discrepancies.

2. During an interview conducted on 01/25/12 at 2:15 P.M., the Director of Pharmacy (DOP) stated that bacterial and fungal sample testing for the sterile compounding hoods, were not being done. The DOP also stated that she did not know that bacterial and fungal testing was not being completed routinely. She acknowledged that contamination could occur in the IV (intravenous) hoods, and in order to ensure product sterility, periodic testing would be necessary.

The hospital did not provide any documentation that bacterial and fungal sample testing was done for any of their sterile compounding hoods, in which IV medications were being prepared.

A review of the document entitled "IV Hood Location," indicated that the following IV Hoods were located throughout the hospital:

Laminar Air Flow Hood-Main Pharmacy
Laminar Air Flow Hood-Main Pharmacy
Laminar Air Flow Hood-Pharmacy Satellite
Germfree Glove Box-Pharmacy Satellite
Germfree Glove Box-Pharmacy Satellite
Laminar Air Flow Hood-Main Pharmacy
Biological Safety Cabinet (Chemo Hood) -Main Pharmacy

During an interview conducted on 01/26/12 at 12:10 P.M., Admin 3 stated that there was no testing of the IV hoods as far back as 2004. She stated that there were no test results and that the testing may not have been done prior to 2004.

During an interview conducted on 01/26/12 at 10:46 A.M., Admin 1 and Admin 2 stated that they had oversight of the hospital quality program. Admin 1 and Admin 2 both stated that they were not aware that testing was not being done.

The hospital's quality program had not analyzed data for bacterial and fungal contamination in the IV hoods for over 8 years. There were thousands of IV medications prepared during this time in the IV hoods without bacterial and fungal testing results. It is not known if these products were being prepared in a contaminated environment.

Based on interviews and document reviews, the hospital failed to maintain an organized nursing service that meets the needs of the patients as evidenced by:

1. Hospital B, failed to the ensure safe use of medications, when a nurse administered intravenous Oxytocin (a pituitary hormone that stimulates the contraction of uterine muscle) without the physician's orders (see A 405, finding 1).

2. Hospital A, failed to ensure the safe use of medications, when nurses administered and monitored Insulin (a hormone that lowers the level of glucose in the blood) infusions to 3 of 5 patients in Hospital A (53, 54, 55), in a manner not in accordance with the medical staff approved protocol (see A 405, finding 3).

3. Hospital B, failed to ensure the safe use of medications, when a nurse failed to administer intravenous fluids in accordance with the physician's orders (see A 405, finding 2).

4. Hospital A, failed to ensure the safe use of medications, when a nurse administered potassium chloride (medication to correct potassium/body salt deficiency) oral solution to Patient 51, without measuring it in an oral syringe in accordance with hospital policies (see A 405, finding 4).

5. Hospital A, failed to ensure the safe use of medications, when a nurse administered insulin to Patient 51, without labeling the syringe in accordance with hospital policies (see A 405, finding 5).

6. Hospital A, failed to ensure the safe use of medications, when a nurse administered medications to Patient 51, without discussing the function of the medications with her: letrozole (medication to treat breast cancer), venlafaxine (an antidepressant) and renexa (medication to treat chronic chest pain) in accordance with hospital policies (see A 405, finding 6).

7. Hospital A, failed to ensure the safe use of medications, when a nurse administered morphine (narcotic/opiate pain reliever) to Patient 51, without conducting a subjective pain assessment in accordance with hospital policies (see A 405, finding 7).

The cumulative effects of these systemic problems, resulted in the hospital's inability to provide nursing services and care in a safe and effective manner, in accordance with the statutorily mandated Conditions of Participation for Nursing Services (see A 405).

Based on observation, interview and record review, the hospital failed to ensure that nursing staff at Hospital A implemented Patient 23's physical therapy (PT) plan of care. There was no documented evidence that nursing staff increased Patient 23's frequency of ambulation, in accordance with physician's orders and the PT plan of care.

Findings:

On 1/23/12 at 10:24 A.M., an observation and interview was conducted with Patient 23 and his wife. Patient 23 was in bed and wore an oximyzer mustache cannula (a cannula that improves respiratory efficiency over a regular nasal cannula). Patient 23 was admitted to Hospital A on 1/11/12, and underwent a heart valve replacement on that date. The patient and his wife verbalized he would be discharged today (1/23/12) to an acute rehabilitation facility. Patient 23 and his wife stated that the "nurses are supposed to walk me in the afternoon and they are not doing it." The patient stated that the nurses "rushed" him when they had walked him, and his oxygen levels dropped, and then they put him back to bed. Patient 23 stated that "I didn't get PT over the weekend." Patient 23 and his wife were concerned because they knew that his physician wanted him to walk more often.

A record review was conducted on 1/23/11 at 10:50 A.M. A review of physician's orders related to the PT plan of care revealed the following:

On 1/13/12, a Nurse Practitioner (NP) prescribed PT once a day, 5days per week. The therapy included gait and stairs training. On 1/13/12, an order documented that it was "ok" to accept oxygen saturation levels 85% or higher in order to get the patient out of bed. On 1/17/12, NP 24 ordered "aggressive PT." On 1/20/12, NP 24 wrote another order to "ambulate TID (3 times/day ) nursing or PT." An additional order was written on 1/21/12, to increase ambulation to 4 times per day.

On 1/23/12 at 11:05 A.M., an interview was conducted with Physical Therapy Assistant (PTA) 22. PTA 22 stated that she worked with Patient 23 three times in the past week. PTA 22 stated that Patient 23's oxygen levels dropped when he walked, but he recovered after frequent rest breaks. PTA 22 stated that the nurses should be walking the patient more often, too. PTA 22 stated that she communicated that to the nursing staff.

On 1/23/12 at 1:00 P.M., an interview was conducted with NP 24. NP 24 stated that she wrote an order for "aggressive" PT, because she was concerned that Patient 23 was "not receiving the amount of PT that she would have liked." NP 24 wanted the patient up and walking more frequently than what occurred.

A review of PT notes revealed that an initial PT evaluation of Patient 23 was conducted on 1/13/12. On 1/17/12, PTA 22 documented that the patient refused PT in the morning due to fatigue, and was unavailable in the afternoon due to a procedure. Patient 23 ambulated with PTA 22 on 1/18/12, 1/19/12, and 1/20/12 (which was on a Friday). PT notes revealed that at times the patient's oxygen levels dropped, but after a short period he recovered. There was no documented evidence of any further PT sessions over the weekend, on 1/21/12 and 1/22/12.

There was no documentation in the nurses notes to indicate that the nursing staff provided additional ambulation sessions for the patient, and assessed his response or progess.

There was no documented evidence in the clinical record that Patient 23 was ambulated 4 times per day by nursing and/or PT staff in accordance with the PT plan of care and physician orders.

Based on interview and record review, the hospital failed to ensure that pain medications were administered as ordered by the physician, for 2 of 54 sampled patients (1, 41).

Findings:

1. A closed record review of Patient 1's medical record was conducted on 1/24/12 at 2:45 P.M. Patient 1 was admitted to Hospital B on 12/15/11, per the facesheet. A review of the physician's order sheet, dated 12/16/11, indicated an order for morphine sulfate (narcotic pain medication) 2 mg (milligrams) IV (intravenous) for moderate (4-6) pain, every 2 hours as needed.

A review of Patient 1's electronic pain assessment record was conducted and indicated that, the patient complained of severe low back pain on 12/17/11 at 11:00 P.M. According to the electronic medication administration record, the patient was given 2 mg of morphine sulfate for the complaint of back pain.

Further review of Patient 1's medical record failed to reveal documented evidence that the patient's physician was informed, that the patient complained of severe pain, and that, the order for the morphine sulfate was specifically ordered to be administered for moderate pains. There was no documented evidence to show that the nurse who administered the morphine sulfate informed the physician that the pain medication was given to the patient for severe pain, and not moderate pain, which was contrary to the physician's specific order.

A joint record review and interview with the clinical nurse specialist (CNS) was conducted on 1/24/12 at 3:15 P.M. The CNS acknowledged that the physician's order was not followed when the nurse administered the morphine sulfate for severe pain, when the order was specifically ordered to be given for moderate pain. The CNS stated that the nurse should have called Patient 1's physician to clarify the order.


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2. A review of Patient 41's medical record was conducted on 1/24/12 at 2:41 P.M. Patient 41 was admitted to the hospital on 1/24/12, with a diagnosis that included thyroidectomy (surgical removal of the thyroid gland), per the facesheet.

According to Patient 41's Anesthesia PACU (post-anesthesia care unit) Orders, dated 1/24/12, intravenous pain medication was ordered. The order read: Fentanyl (a medication used to relieve pain) 25 mcg (micrograms) for moderate pain and 50 mcg for severe pain IVP (intravenous push) every 5 minutes PRN (as needed) for pain to a maximum dose of 200 mcg.

Patient 41's medication administration record (MAR) dated 1/24/12, was reviewed and indicated that pain medication was administered as follows:
11:20 A.M. - 50 mcg of Fentanyl intravenously for a pain score of 6;
11:45 A.M. - 50 mcg of Fentanyl intravenously for a pain score of 5;
12:05 P.M. - 50 mcg of Fentanyl intravenously for a pain score of 5.

An interview and joint record review was conducted with Registered Nurse (RN 42) on 1/24/12 at 3:10 P.M. RN 42 stated that she used the unit's Verbal Descriptor Scale (VDS) to determine Patient 41's pain status. According to the VDS, moderate pain was equivalent to pain scores of 4-6. RN 42 agreed that Patient 41 was given 50 mcg of Fentanyl for moderate pain scores when the physician's orders instructed to give 25 mcg for moderate pain. She acknowledged that she was not following the physician's orders as written.

A review of the PACU's VDS was conducted on 1/24/12. The VDS listed word descriptors to include the following:
"No Pain" ................. 0 Pain
"Mild" ...................... 1-3 Pain rating
"Moderate" ............... 4-6 Pain rating
"Severe" ................... 7-10 Pain rating

An interview with the surgery manager was conducted on 1/24/12 at 3:30 P.M. The surgery manager stated that, the unit's VDS was used to assess pain scores to help the nursing staff administer pain medications in accordance with the physician's orders. She stated that, RN 42 did not follow the physician's orders when she administered 50 mcg of Fentanyl 3 times for moderate pain instead of severe pain.

A review of the hospital's policy entitled "Medications: Orders, Administration, and Documentation," effective date of 10/11, was conducted on 1/26/12. The policy indicated that its purpose was to promote the safe administration of medications. Per the policy, "Medications are administered in accordance with the written order of a licensed independent practitioner (LIP)."

Based on interview and document review, the hospital failed to ensure the administration of medications in accordance with hospital policy as evidence by:

1. Hospital B failed to ensure the safe use of medications when a nurse administered intravenous Oxytocin (a pituitary hormone that stimulates the contraction of uterine muscle) without a physician's orders.

2. Hospital B failed to ensure the safe use of medications when a nurse incorrectly calculated the rate and administered intravenous fluids not in accordance with physician's orders.

3. Hospital A failed to ensure the safe use of medications when nurses administered and monitored Insulin (a hormone that lowers the level of glucose in the blood) infusions to 3 of 5 patients in Hospital A (53, 54, 55), in a manner not in accordance with the medical staff approved protocol.

4. Hospital A failed to ensure the safe use of medications when a nurse administered potassium chloride (blood chemical/electrolyte similar to salt) oral solution to Patient 51, without measuring it in an oral syringe in accordance with hospital policy.

5. Hospital A failed to ensure the safe use of medications when a nurse administered Insulin to Patient 51 without labeling the syringe in accordance with hospital policy.

6. Hospital A failed to ensure safe use of medications when a nurse administered medications to Patient 51, without discussing the function of medications: Letrozole (used to treat breast cancer), Venlafaxine (an antidepressant) and Ranexa (used to treat chronic chest pain) in accordance with hospital policy.

7. Hospital A failed to ensure the safe use of a medication when a nurse did not monitor morphine's effect on the patient's pain in accordance with hospital policy.

Findings:

1. According to the Institute of Safe Medication Practice (ISMP), a nationally recognized medication resource which focuses on medication error prevention and safe medication use, indicated in the entitled document ISMP's List of High Alert Medications, "High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope you will use this list to determine which medications require special safeguards to reduce the risk of errors." The list includes intravenous Oxytocin a medication primarily used to induce labor and to control postpartum bleeding.

According to Lexicomp Online, a nationally recognized medication information resource, indicates for Oxytocin "An infusion pump is required for administration ...Postpartum bleeding ...10-40 units by I.V. infusion in 1000ml ...high doses or hypersensitivity to oxytocin may cause uterine hypertonicity, spasm ...or rupture of the uterus ...intravenous preparations should be administered by adequately trained individuals familiar with its use and able to identify complications ...adverse reactions ...arrhythmias, hypertensive episodes ...postpartum hemorrhage, uterine rupture ...subarachnoid hemorrhage ...coma ...and death ..."

An observation on 01/25/12 at 10:58 A.M., in the Post Anesthesia Care Unit (PACU) of Hospital B revealed that Patient 81 was receiving intravenous (IV) Oxytocin 10mg. The Oxytocin was not being administered via an IV pump. The Oxytocin was running via gravity drip into Patient 81.

During an interview on 01/25/12 at 10:58 A.M., Nurse 1 stated that the Oxytocin did not have to be run through an IV pump. She also stated that there were no physician's orders to administer the Oxytocin. She said there were no transfer orders written for Oxytocin.

A review of Patient 81's clinical record indicated Patient 81 was on IV Oxytocin 30mg (milligrams) in the Operating Room to reduce postpartum bleeding. There were no transfer orders written for Oxytocin.

According to the hospital policy entitled Orders, Licensed Independent Practitioners, Physician and Allied Health Professional, for Hospital Services (ID: MER-FW-PC-3133) indicated "Transfer from One Level of Care to another Level of Care ...All orders are discontinued automatically ...When the patient is being transferred to a different level of care with the hospital, all orders must be rewritten."

According to the hospital policy the Oxytocin would have been discontinued unless orders were rewritten. The nurse administered a high alert medication without a physician's orders.

2. An observation on 01/25/12 at 10:58 A.M. in the PACU Patient 81's intravenous (IV) fluid was not running on an IV pump. It was observed to be infucsing at a rate of 15 drops/min. The rate was 60 ml/hr (calculated as 1 ml/min multiplied by 60 min).

A review of Patient 81's clinical record indicated physician's orders for IV fluids to be administered at a rate of 125 ml/hr.

During an interview on 01/25/12 at 10:58 A.M., RN1 stated she was the registered nurse taking care of Patient 81. RN1 stated that she observed 15 drops/min and that the tubing used was 15 drops/ml. She incorrectly said that the rate would then be 125 ml/hr.

RN1 administered IV fluids at slower than half the physician prescribed rate. RN1 did not administer IV fluids as written by the physician.

3. Insulin infusions are a type of intravenous medication used to control blood sugar levels. The Institute of Safe Medication Practices lists insulin as a High Alert Medication. High alert medications are those that bear a heightened risk of causing significant harm when used in error (www.ismp.org ).

The hospital's insulin protocol, Insulin Infusion Orders "(revised 11/11) showed instructions for nursing to adjust insulin infusion rates for patients according to a medical staff approved protocol.

On 1/24/12 at 2:29 P.M. in Surgical Intensive Care Unit (SICU), Patient 53's insulin protocol was reviewed with Registered Nurse, SICU (RN 72). RN 72 discussed discrepancies in what the protocol (Physicians Orders) called for and what was actually documented by nursing staff as follows:

"On 1/23/12 at 12:30 A.M. Patient 53's blood glucose was 91 and the nurse went to 1 unit per hour. According to the protocol, [Patient 53] should have been rechecked at 1:30 A.M. but he was actually checked at 3:00 A.M., one and a half hours later than required by the protocol."

"On 1/23/12 at 3:00 a.m., Patient 53's blood glucose was 125, and he was changed to a rate of 2.4 per hour. According to the protocol, he should have been rechecked at 4:00 a.m., 1 hour later, but he was actually checked at 5:00 a.m. This was an hour later than required by the protocol."

After the surveyor discussed findings of non-adherence to the protocol, she requested the hospital to provide documentation for patients currently receiving insulin infusions via the protocol.

On 1/25/12 at 10:57 A.M., Medication Safety Officer (MSO 63) provided patient records for Patient 53, Patient 54 and Patient 55. MSO 63 demonstrated the following incidents of non-adherence to the protocol, ie, failure to follow the Physicians Orders, as follows:

1. On 1/14/12 at 9:00 A.M., Patient 54 had a blood glucose drawn 1 hour later than required by the protocol.

2. On 1/17/12 at 2:30 P.M., Patient 54 had a blood glucose drawn 2 hours later than required by the protocol.

3. On 1/17/12 at 5:30 P.M., Patient 54 had a blood glucose drawn 1.5 hours later than required by the protocol.

4. On 1/18/12 at 2:30 P.M., Patient 54 had insulin infusing at the wrong rate. Medication administration records showed the rate was 0.9 units per hour when it should have been 0.6 units per hour.

5. On 1/18/12/ at 3:30 P.M., Patient 54 had insulin infusing at the wrong rate. Medication administration records showed the rate was 1.2 units per hour when it should have been 0.8 units per hour.

6. On 1/19/12 at 3:00 A.M., Patient 54 had a blood glucose drawn 1 hour later than required by the protocol.

7. On 1/19/12 at 11:0 P.M., Patient 55 had insulin infusing at the wrong rate. Medication administration records showed the rate was 6.8 units per hour when it should have been 8.5 units per hour.

8. On 1/22/12 at 9:10 P.M., Patient 53 had a blood glucose drawn 2 hours and 40 minutes later than required by the protocol.

9. On 1/23/12 at 12:30 A.M., Patient 53 had a blood glucose drawn 1.5 hours later than required by the protocol.

10. On 1/23/12 at 12: 30 A.M., Patient 53 had insulin infusing at the wrong rate. Medication administration records showed the rate was 1 unit per hour when it should have been 2.5 units per hour.

11. On 1/23/12 at 3: 00 A.M., Patient 53 had a blood glucose drawn 1 hour later than required by the protocol.

12. On 1/23/12 at 9:45 A.M., Patient 53 had insulin infusing at the wrong rate. Medication administration records showed the rate was 0.4 units per hour when it should have been turned off.

A record review of the patients' charts showed no documentation that these deviations from the insulin protocol were necessary. MSO 63 said the hospital's investigation showed that all errors were a combined result of inattention by nurses during shift change or choosing the wrong rate from a column on a chart during insulin adjustments. She also stated that the hospital had a process change of the insulin protocols around November 2011.

On 1/26/12 at 11:20 A.M., in an interview conducted with RN 65, she acknowledged that she made a mistake when looking at the wrong column on the adjustment chart. RN 65 explained, "I've been trained. It was confusing in the beginning ...it was overwhelming in the beginning." She elaborated, "Every time we do a rate change we do a double check." She clarified that for insulin, because it is a high risk medication, a second nurse comes behind and checks the first nurse's rate calculation.

On 1/26/12 at 11:30 A.M., in an interview conducted with RN 66, she said she apparently made a mistake in adjusting Patient 54's insulin infusion but stated, "I don't remember."

4. On 1/24/12 at 9:16 A.M. during a medication pass observation, RN 64 poured potassium chloride solution, 20 milliequivalents per 15 milliliters, into a 1 ounce graduated plastic medicine cup. RN 64 poured from the stock bottle to the cup an amount which was between one-third and one-half of the total cup volume. RN 64 said, "I should have got a syringe. There is no measurement (on the plastic cup) between 10 and 15 (milliliters.)" After acknowledging that the measurement could not be accurate, and that she knew she should have used an oral syringe, RN 64 administered the medication to Patient 51 from the plastic cup.

A review of the hospital's policy, Medications: Orders, Administration, and Documentation (10/11) showed, "Liquid medications will be prepared using an oral syringe to ensure accuracy of dose to be administered."

5. On 1/24/12 at 9:16 A.M. during a medication pass observation in the Medication Room, RN 64 showed the surveyor a stock bottle of Lispro (an insulin used to lower blood glucose). RN 64 did not label the syringe before taking it to Patient 51's room where she administered it into the patient's abdomen.

A review of the hospital's policy, Medications: Orders, Administration, and Documentation (10/11) indicated, "Medication labeled (medication name and dose) throughout process from preparation to administration. Labeling must occur when any medication or solution is transferred from the original packaging to another container i.e. insulin."

6. On 1/24/12 at 9:16 A.M. during a medication pass observation, RN 64 administered medications to Patient 51 in the following order: Letrazole 25 milligrams by mouth ; Venlafaxine 75 milligrams by mouth; and Ranexa 500 milligrams by mouth.
Letrazole had an additional cautionary label which indicated, "Special Handling." RN 64 said, "I don't know what it if for." RN 64 told Patient 51 that Venlafaxine was "a psych med" and that Ranexa was, "for your tummy ...I don't know if that's diabetic ... "

On 1/24/12 at 9:39 A.M. after the medication pass, RN 64 was unable to locate drug information on the medications Letrazole, Venlafaxine or Ranexa without assistance. She discussed all the drug information references available to her: She said referring to Mosby's, a nursing information source, "We don't have a book." She said, "The hospital has Micromedex (subscription drug database), but I don't really utilize that. It's not my favorite. "She repeated, "They don't have Mosbys now." A co-worker came over and showed her how to access the online Mosby's, another subscription drug information database.

A review of the hospital's policy, titled Medications: Orders, Administration, and Documentation (10/11), indicated, "Discuss with the patient the name and function of each medication if there is no one else in the room. If there are visitors present, ask the patient if it is okay to discuss the medications. RN 64 had no explanation as to why she was unable to discuss Patient 51's mediations with her except for stating, "I don't know what they are for."

7. On 1/24/12 at 9:16 A.M., during a medication pass observation, RN 64 administered Morphine 4 milligrams to Patient 51. After administering 16 medications to Patient 51, at 9:37 A.M., RN 64 asked Patient 51, "What is your pain level?" When she did not get an answer right away, RN 64 said, "Your pain was 10 out of 10 the last time I checked. What is it, about a seven?" Patient 51 thought about the suggestion and said, "No. It's 8."

A review of the hospital's policy, "Medications: Orders, Administration, and Documentation" indicated instructions for nurses under the subsection "monitoring," about "Gathering the patient's own perceptions about side effects, and when appropriate, perceived efficacy, for example the effectiveness of pain medication."

On 1/25/11 at 10:00 A.M. in an interview, the Chief Nurse Operating Executive (ADM 67) stated that, RN 64 had received a written warning related to her skills regarding intravenous medications, prior to the survey. She said that the nursing managers did their own skills assessments and were surprised that RN 64 did not know the uses for the medications she was passing. ADM 67 said, "It's basic nursing. References were available and RN 64 had numerous documented training encounters." ADM 67 further stated, "The patients come first, her patients were immediately reassigned to other staff members."

Based on interview and record review, the hospital failed to ensure that the nursing staff implemented its Universal Protocol policy and procedure, which included the completion of a Pre-Procedural/Pre-Operative Checklist, for 1 of 6 sampled bronchoscopy patients (42). There was no documented evidence in Patient 42's medical record, to indicate that a Pre-Procedural/Pre-Operative Checklist was completed for a bronchoscopy that was performed on 1/23/12 at Hospital B.

Findings:

A review of Patient 42's medical record was conducted on 1/23/12, beginning at 3:49 P.M. Patient 42 was admitted to Hospital B on 1/15/12, with diagnoses that included chronic obstructive pulmonary disease, per the facesheet. According to Patient 42's Procedure Report, dated 1/23/12, a bronchoscopy was performed for diagnostic and therapeutic purposes. There was no documented evidence found in the medical record to show that a Pre-Procedural/Pre-Operative Checklist was completed for the bronchoscopy.

A review of the hospital's form entitled "Pre-Procedural/Pre-Operative Checklist" (front page) and the "Universal Protocol Checklist" (back page) was conducted on 1/24/12. The form contained the following patient information to be completed prior to the procedure:
(Front page contents)
Allergy alert band on patient
Consent for anesthesia has been validated
Pre-Anesthesia Health History completed
History and Physical (H&P) is on the chart
Transmission Based Precautions in place (options listed)
Hand off Report provided
Blood Sugar
NPO (nothing by mouth) status
IV (intravenous) patency
Central Line Access or Dialysis Access
Catheters
Ostomies/Drains/Tubes
Pressure Ulcer present
Loose teeth identified
Jewelry/valuables removed
Pre-procedure medications administered as ordered.
(Back page contents)
Universal Protocol Checklist, Patient Verification and Marking
Visible red stop sign noted on the upper left hand corner of the form
Patient identified using two identifiers
Patient, procedure and site are verified with: the following listed- consent, physician's order, history & physical.
Signatures, printed names, initials, dates and times for all involved
with patient before, during and after the procedure.

An interview and joint record review with RN 41 was conducted on 1/24/12 at 10:45 A.M. RN 41 was able to verbalize most of the required patient information to complete the form. However, she stated that she did not complete Patient 42's Pre-Procedural/Pre-Operative Checklist, nor the Universal Protocol Checklist, for the bronchoscopy in accordance with the hospital's policy and procedure.

A review of the hospital's policy entitled "Universal Protocol," effective date of 2/10, was conducted. The policy's purpose was to establish and implement processes to confirm the correct patient and to verify the correct procedure, prior to initiating a surgical or invasive procedure which includes the following:
patient identification, pre-procedure verification process, site marking requirements and time out. According to the policy, it indicated that "Before a surgical or invasive procedure may be performed, a process for confirmation of patient identification and procedure verification must be completed." In addition, the policy indicated that the "time-out" will be documented in the medical record using a universal protocol checklist.

An interview with the intensive care unit (ICU) manager was conducted on 1/24/12 at 11:32 A.M. The ICU manager stated that the nursing staff were expected to complete the Pre-Procedural/Pre-Operative Checklist and the Universal Protocol Checklist, in accordance with the hospital's policy. She acknowledged that there was no documented evidence in Patient 41's medical record to show that when the bronchoscopy was performed on 1/23/12, the checklists were completed.

Based on interview and record review, the facility failed to ensure that its policy and procedure pertaining to physician documentation requirements, was implemented at Hospital A. Medical Doctor (MD) 21 failed to document the year in which, and time, that a History and Physical (H&P) was performed. In addition, MD 21 failed to document the time that a pre-procedure order set was prescribed.

Findings:

On 1/24/12 at 10:30 A.M., a tour was conducted of the cardiac catheterization laboratory's (cath lab) pre and post procedure area.

An interview and medical record review was conducted with Registered Nurse (RN) 21 on 1/24/12 at 11:00 A.M. Per RN 21, Patient 22 underwent a heart cath procedure with stent placement, performed by MD 21, on that same in the morning. MD 21 documented that the H&P was completed on "1/19." The H&P did not contain a year or time to indicate when the H&P was performed. MD 21 also failed to document the time that the "Cardio Vascular Lab Pre-Procedure Orders" were prescribed.

A policy entitled "Physician Documentation Requirements," dated "1/12," was reviewed on 1/24/12. Per the policy, "all patient medical record entries must be legible, complete, dated, timed and authenticated in written or electronic form by the person responsible for providing or evaluating the service consistent with the hospital policies and procedures."

On 1/24/12 at 11:30 A.M., an interview was conducted with the Director of Risk Management (DRM) who confirmed that, MD 21 did not follow the hospital's policy and procedure pertaining to medical records documentation requirements.

Based on interviews and document reviews, the hospital failed to ensure the provision of pharmaceutical services and care that meets the needs of the patients, as evidenced by:

1. Hospital B, failed to account for missing and extra medications that could indicate that a patient received too much, missed a dose, or were given the wrong medication when a 30 day audit revealed 2,836 of 2,836 missing and extra medications, were not accounted for by the Pharmacy (see A500).

2. Hospital B, failed to implement a policy to ensure the sterility of intravenous (IV) preparations, when IV hoods were not tested monthly for bacteria and fungus for over 8 years (see A500).

3. Hospital A, failed to ensure the safe use of medications, when nurses administered and monitored insulin infusions to 3 of 5 patients in Hospital A (Patient 53, Patient 54, and Patient 55), not in accordance with the medical staff approved protocol (see A 405, finding 3).

4. Hospital B, failed to ensure the safe use of medications, when a nurse administered intravenous Oxytocin without the physician's orders (see A405).

5. Hospital B, failed to ensure the safe use of medications, when a nurse administered intravenous fluids not in accordance with the physician's orders (see A405).

6. Hospital A, failed to ensure the safe storage of medications,when the hospital did not keep drugs in a secure locked area, in one patient care area (Surgical Intensive Care Unit). The hospital's failure placed patients at risk for potential adverse events from a loss of control of the drug supply (see A502).

7. Hospital A, failed to ensure the safe storage of medications, when one of four fluid warmers in the Operating Room (Warmer between Operating Rooms 1&2), showed bottles of irrigation solutions that had been stored out of range for 7 of 25 days in January 2012. The hospital's failure to maintain an effective system to detect and remove compromised Sodium Chloride 0.9% irrigation solution (a salt/electrolyte solution) had the potential to cause medication administration errors (wrong strength or dose) for surgical patients (see A505).

8. Hospital A, failed to develop a system that would ensure that all medications would be discontinued after a reasonable time established by the medical staff. The hospital's failure to have a policy which applied to all classes of drugs, had the potential for a medication regimen to be continued longer than necessary for all patients, which exposed them to preventable adverse events (see A 507).

The cumulative effects of these systemic problems, resulted in the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner, in accordance with the statutorily mandated Conditions of Participation for Pharmaceutical Services.

Based on observation, interview and document review, the hospital failed to deliver pharmaceutical services to meet the needs of the patients, when medications where not controlled and distributed in accordance with standards of practice or federal or state law.

1. Hospital B Pharmacy failed to account for missing and extra medications that could indicate that a patient received too much, missed a dose, or were given the wrong medication when a 30 day audit revealed 2,836 of 2,836 missing and extra medications that were unaccounted for by the Pharmacy.

2. Hospital B Pharmacy failed to implement policy to ensure sterility of intravenous (IV) preparations when IV hoods were not tested monthly for bacteria and fungus for over 8 years.

Findings:

1. According to the American Society of Health-System Pharmacists, a nationally recognized professional organization, in the titled document Minimum Standard for Pharmacies in Hospitals indicated "The pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital ..."

An automated dispensing cabinet (ADC) is a computerized medication dispensing machine. The ADC is similar to a vending machine in that the user enters what they want and the machine opens dispensing the product. There are several different types of ADCs. The hospital had some ADCs with several open pockets for the user to pick the product from one of the pockets.

During an interview conducted on 01/24/12 at 3:15 P.M., the Director of Pharmacy (DOP) stated Pharmacy did not review the missing or extra medications (aka discrepancies) found in the ADC. She stated that misuse was primarily the cause of the discrepancies. She acknowledged that administering too much, missing a dose, or giving the wrong medication could be a cause of the discrepancies.

ADC medication discrepancies are when the count of the medication is different from what is expected. This occurs from misuse of the ADC when medications are not correctly placed, taken, or entered into the computer. Discrepancies also occur when there are medication errors, for example a patient could receive an extra dose and the ADC would show a missing dose. A patient receiving a missing dose the ADC would indicate an extra dose. If a patient receiving a wrong medication then one of the ADC pockets would have an extra dose and another pocket would have a missing dose.

During an interview conducted on 01/25/12 at 2:15 P.M., the Pharmacy Administrator stated that the pharmacy could not account for the discrepancies. He acknowledged that some could be medication errors. He also said that he could generate a discrepancy report; these discrepancies were not reviewed for medication errors by the pharmacy.

A review of the ADC generated discrepancy report listed discrepancies (excluding narcotics) over the period from 12/26/11 to 01/24/12, indicated there were 2,836 discrepancies. Each discrepancy had one or more extra doses; or one or more missing doses. One example of one discrepancy indicated 937 missing doses of Insulin. Insulin is a medication use for diabetes and when giving incorrectly can cause death or serious injury.

The hospital did not provide evidence that the pharmacy could account for 2,836 out of 2,836 discrepancies.

2. According to the United States Pharmaceopedia 797 Pharmaceutical Compounding (USP 797) page 3730 under the entitled section Appendix I. Principal Competencies, Conditions, Practices, and Quality Assurances That Are Required and Recommended in USP Chapter 797 indicates "Surface sampling (testing for bacteria/fungus) shall be performed in all ISO classified areas (referring to sterile compounding hood) on a periodic basis and can be accomplished using contact plates and/or swabs and shall be done at the conclusion of compounding ...Environmental sampling data shall be collected and reviewed on a routine basis as a means of evaluating the overall control of the compounding environment."

According to the hospital policy entitled IV Compounding (ID MER-FW-MM-3239) indicated "Air quality in the buffer zone is checked monthly by using growth plates in the work area and comparing the number of Colony Forming Units (CFU's)[CFU would indicate bacterial and/or fungal growth] with a baseline value. Action may be warranted if a significant increase in CFU's becomes apparent. Growth plates are placed in the back right and left of each PEC (referring to IV hoods)."

The hospital did not provide any documentation that bacterial/fungal sample testing was done for any of their sterile compounding hoods in which IV medications were being prepared.

During an interview on 01/25/12 at 2:15 P.M., the DOP stated that bacterial/fungal sample testing for the sterile compounding hoods were not being done. She also stated that she did not know that bacterial/fungal testing were not being completed routinely. She further stated and acknowledged that, contamination could occur in the IV hoods, and in order to ensure product sterility periodic testing would be necessary.

A review of the document entitled IV Hood Location indicated that the following IV Hoods were located throughout the hospital:

Laminar Air Flow Hood-Main Pharmacy
Laminar Air Flow Hood-Main Pharmacy
Laminar Air Flow Hood-Pharmacy Satellite
Germfree Glove Box-Pharmacy Satellite
Germfree Glove Box-Pharmacy Satellite
Laminar Air Flow Hood-Main Pharmacy
Biological Safety Cabinet (Chemo Hood) -Main Pharmacy

An interview was conducted on 01/26/12 at 12:10 P.M. with Admin 3, who stated that there was no testing of the IV hoods as far back as 2004. She stated that there were no bacterial/fungal testing results and testing may not have been done prior to 2004.

The hospital did not test for bacterial and fungal contamination in the IV hoods for over 8 years. There were thousands of IV medications prepared during this time in the IV hoods without bacterial/fungal testing results. It is unknown if these products were being prepared in a contaminated environment.

Based on observation and interview, the hospital failed to keep drugs in a secure locked area, in the SICU (Surgical Intensive Care Unit). The hospital's failure to keep drugs secure placed patients at risk for potential adverse events from a loss of control of the drug supply.

Findings:

On 1/24/12 at 2:29 P.M., during a tour of SICU, an unlocked cart was observed outside the room of bed number 14. The cart contained 18 vials of Normal Saline 0.9% (a body chemical/salt) for Injection, 10 milliliters.

On 1/24/12 at 3:00 P.M., during a tour of SICU, an unlocked cart was observed outside the room of bed number 12. The cart contained 11 vials of Normal Saline 0.9% for Injection 10 milliliters.

On 1/24/12 at 2:29 P.M., during a tour of SICU, an unlocked cart was observed outside the room of bed number 11. It contained 13 vials of Normal Saline 0.9% for Injection 10 milliliters.

On 1/24/12 at 2:29 P.M., during a tour of SICU, an unlocked cart was observed outside the room of bed number 10. It contained 18 vials of Normal Saline 0.9% for Injection 10 milliliters.

On 1/24/12 at 3:02 P.M. in an interview, Registered Nurse Manager (RN 59) of the SICU, stated that he placed the vials in the carts about 45 days prior, for the convenience of the nursing staff. RN 59 indicated that the pharmacy staff did not know they were stored in the carts because he didn't tell them.

Based on observation, interview and record review, Hospital A failed to take action when one of four fluid warmers in the Operating Room (Warmer between Operating Rooms 1&2), showed bottles of irrigation solutions that had been stored out of range, for 7 of 25 days in January 2012. The hospital's failure to maintain an effective system to detect and remove compromised Sodium Chloride 0.9% irrigation solution (electrolyte/body chemical), that had the potential to cause medication administration errors (wrong strength or dose) for surgical patients.

Findings:

On 1/25/12 at 8:00 A.M., during a tour of the Operating Room, an inspection of the fluid warmer between Operating Room 1 and Operating Room 2 showed sterile hydration and irrigation solutions that were stored at 105 degrees Fahrenheit. An inventory of the contents of the fluid warmer is as follows:

Sodium Chloride 0.9% 1000 milliliters, 11 bags
Lactated Ringers 1000 milliliters, 7 bags
Sodium Chloride 0.9% 3000 milliliters, 1 bag
Sodium Chloride 0.9% 500 milliliters, 6 bags
Sodium Chloride 0.9% 1000 milliliters, 6 bags
Sterile Water for Irrigation 500 milliliters, 7 bottles
Sterile Water for Irrigation 1000 milliliters, 6 bottles

A review of the January 2012, Daily Temperature Monitoring Log, for Fluid Warmers 1&2 indicated, "Maintain at or below 104 degrees Fahrenheit." The following entries showed a daily temperature of 105 degrees Fahrenheit, as documented by Operating Room staff : 1/5/12, 1/9/12, 1/10/12, 1/13/12, 1/23/12, 1/24/12, and 1/25/12. There were no entries under the heading, "Action Taken for Temperatures out of Range."

When a bottle of electrolyte solution is heated, water evaporates, and causes the solution to concentrate. When a bottle's labeled concentration is more dilute than the actual product altered by evaporation, it is compromised. A review of the hospital's policy, Medications: Orders, Administration, and Documentation (dated 10/11) showed, " Medications are stored under necessary conditions to ensure stability (heat, cold and light issues)." The policy further indicated, "Medications that require warming will be kept at 30 degrees to 40 degrees Celsius (84 degrees to 104 degrees Fahrenheit)."

On 1/25/12 at 8:00 A.M. in an interview conducted with Operating Room staff and the Administrative Director of Pharmacy (ADM 57), ADM 57 stated the solutions were not usable. ADM 57 also stated, "I am surprised we were not notified ... this has been out of range for three days." ADM 57 explained that Operating Room staff usually notifies the Pharmacy Department whenever they notice a warmer is out-of-range. That way, he said, "Engineering can make an adjustment to bring the warmers into range."

On 1/25/12 at 2:30 P.M., ADM 57 explained that a pharmacist inspects the Operating Room warmers every 30 days as part of the unit inspection and documents the findings electronically in a software program called VeriForm.

A review of VeriForm records showed that Staff Pharmacist (RPH 74) inspected the Operating Room warmers on 1/12/12. Item number 22 on the inspection checklist showed, "Log sheet (warmer) is present and completed? Temperatures out of range have corrective action noted." RPH 74 documented "non-compliance" on the report with comments, "Warmer between Rm 7/8 missed a log entry on 1/11/12." There was no documentation that temperatures were out of range for the warmer between Operating Rooms 1&2 on 1/5/12, 1/9/12, or 1/10/12. There was no documentation that corrective action was taken for temperatures that were noted to be out of range.

Based on policy and procedure review, and interview of two pharmaceutical services administrators, the hospital failed to develop a system that would ensure that all medications would be discontinued after a reasonable time established by the medical staff. The hospital's failure to have a policy which applied to all classes of drugs had the potential for a medication regimen to be continued longer than necessary for all patients, which exposed them to preventable adverse events.

Findings:

A review of the hospital's policy, Medications: Orders, Administration, and Documentation (10/11) showed, "The physician will be notified that a drug with a pharmacy determined stop date is due to be reordered; the drug will not be discontinued automatically unless specifically ordered by the attending physician."

The policy showed an exception for psychiatric medications, "All medications ...will have a 30 day soft stop date except for Behavioral Health Outpatient." The policy showed exceptions for a non-steroidal anti-inflammatory (Ketorolac) and intravenous nutrition compounds, "The following medications will be automatically discontinued (hard stop) Ketorolac will have a 5 day stop date. TPN/PPN (Total Peripheral Nutrition/ Peripheral Nutrition) will have a 24 hour stop date." The policy showed an exception for Emergency Department Holding Admission Orders.

On 1/24/11 at 11:10 A.M. in an interview, Senior System Director of Pharmacy and Administrative Director of Pharmacy (ADM 58) explained that a "soft stop" would initiate a process to notify a physician that a patient had orders for a particular medication for 30 days. He acknowledged that the hospital's process for a soft stop would not initiate a process to automatically discontinue the medication without prescriber intervention.

On 1/24/11 at 11:15 a.m. in an interview, (ADM 57) explained each report was patient specific and listed medications that were due to be renewed for that patient and the reports provided prompts for the physician to renew or discontinue the medication or to continue it for a period of time specified by the physician. He said "Soft stop is an acceptable procedure ...just have to follow through." ADM 57 acknowledged that "soft stops" would not automatically stop in the computer without staff intervention, since stopping the order (hard stop) depended upon receipt of a returned report filled out by the physician.

The hospital's use of a "soft stop" only served as a reminder to the physician to either re-order or stop the medication but it did not meet the requirement of actually stopping or discontinuing the medication.

Based on observation, interview and record review, Hospital A failed to ensure that potentially hazardous foods, such as pasta and leftovers, were cooled down safely.

Findings:

On 1/23/12 at 9:30 A.M. at Hospital A, in the walk-in refrigerator was a pan of cooked noodles that was 4" deep by approximately 12" in length, a pan of cooked steak, and a 4" deep by 12" pan of cooked ziti pasta. Dietary Supervisor (DS 111) stated that the cooked steak was leftover from the patient trayline on Sunday, 1/22/12, the pan of cooked noodles was cooked at the hospital on 1/22/12, and the cooked ziti pasta was cooked that morning on 1/23/12.

The cool-down log was requested for the pan of cooked noodles, the leftover steak and the ziti pasta that was cooked in the morning. The FSD (food service director), and DS 112, reviewed the CHILL BLASTER TEMPERATURE LOG, and stated that the above items were not cooled down. When the FSD was asked if she thought the pasta should have been cooled down, she replied that she did not consider pasta to be a potentially hazardous food. However, according to standards of practice in the foodservice industry, cooked pasta to be served on another day would be considered a PHF (capable of supporting microbial growth), and should be cooled down, per the FDA Food Code.

Cook 113 stated that he was the person who cooked the ziti pasta in the morning on 1/23/12 to be served to patients on 1/24/12. Cook 113 stated that he cooled down the ziti pasta by running cool water over the pasta, and then placed it in the walk-in refrigerator at 6:00 A.M. on 1/23/12. He stated that he had not checked the temperature of the ziti pasta after placing in the walk-in refrigerator. He further stated that he cooked a variety of pastas almost daily, and that was his usual cool down practice. Cook 113 stated that he never would go back in the walk-in refrigerator to check the temperature of the pasta, and that he did not document cool-down measures on a log.

On 1/23/12 at 9:50 A.M., Cook 113 was requested to check the temperature of the cooked ziti pasta that was in the walk-in refrigerator and it was 65 degrees F, 3 hours and 50 minutes later after the initial cool-down period. The FSD, and Dietary Supervisor 112 instructed Cook 113 to remove the cooked ziti pasta from the walk-in refrigerator and place it in the chill blaster.

On 1/23/12 at 10:10 A.M, dietary supervisor 112 stated, "The pan of spaghetti noodles will be tossed." When DS 112 was asked what the leftover steak would be used for, she stated, "It could be used for retail in case we run out of something." Even though the FSD and DS 112 previously acknowledged that the leftover steak from patient trayline had not been cooled down safely.

On 1/23/12 at 10:30 A.M., the FSD informed the surveyor that the cooked ziti pasta that was now in the chill blaster did not "reach 41 degrees F or less and it was thrown out too." At that time, the FSD further stated that the leftover steak had been thrown away.

On 1/24/12 at 1:45 P.M. at Hospital B, in the walk-in refrigerator was a pan with cooked ribs with a sticker label that indicated "use by 1/27/12." According to FSD 114, "The ribs are leftovers from the cafeteria." The cool down log was requested for the leftover ribs.

At that time, FSD 114 provided the January 2012 COOLING LOG, which did not contain the ribs. FSD 114 acknowledged that the leftover ribs had not been cooled down to ensure food safety. FSD 114 further stated that pasta was sometimes cooked a day in advance of serving and "that should be on there (on the cool down log)."

A review of Hospital B's COOLING LOG for November 2011, December 2011, and January 2012, indicated that out of the 12 documented times in which cool down occurred, 11 out of 12 times were done incorrectly.

On 1/25/11 at 7:55 A.M., at Hospital B, prep cook 115 stated that she was responsible for completing the COOLING LOG. Prep cook 115 stated, "I would cut the meat more and then continue to cool the meat if it was not down to 70 degrees F after 2 hours." According to standards of practice in the foodservice industry, the potentially hazardous food should have been re-heated, or discarded if it had not reached 70 degrees F, per the FDA Food Code 2009.

According to the hospital's policy and procedure entitled : FOOD SAFETY, PREPARATION AND SERVICE POLICY (Approved: 7/11) : "Foods are kept safe from contamination and bacteria build-up during thawing, preparing, cooking, holding, cooling and re-heating..., Cooling; 1. Food must be cooled to 41 degrees F or lower in less than six hours total after cooking or hot holding. Foods are cooled in two stages: from 140 - 70 degrees F in two hours and from 70-41 degrees F in four hours for a total of six hours cooling time."

Excessive time for cooling of potentially hazardous foods has been consistently identified as one of the leading contributing factors to foodborne illness. The initial 2-hour cool is a critical element of this cooling process, per the FDA Food Code 2009.

Based on observation, interview and record review, the hospital failed to ensure that dietitians included an individualized comprehensive nutrition assessment, for patients on a diabetic diet.

Findings:

On 1/23/12 at 3:20 P.M., Patient 116's medical record was reviewed. Patient 116 was admitted to Hospital A on 1/13/12. According to Patient 116's history and physical, past medical history included insulin-dependent diabetes mellitus.

The Manager of Clinical Nutrition stated that according to Patient 116's medical record, the physician prescribed a 2 gm sodium, 1800 calorie ADA (American Diabetic Association) diet. The Manager of Clinical Nutrition stated that the hospital's approved definition of a diabetic diet, whether it was written as a specific calorie level or not, was consistent carbohydrate (CHO) with 4-5 servings of CHO per meal, with three meals a day."

The Manager of Clinical Nutrition reviewed Patient 116's medical record and stated that a comprehensive nutrition assessment had not been completed, because the patient was determined to be "low-risk."

Earlier in the day on 1/23/12 at Hospital A, during lunch trayline, Patient 116's menu indicated "large portions." The Manager of Clinical Nutrition acknowledged that large portions was not part of the diet order, and she placed a call to a diet clerk to learn that large portions was a preference of the patient. When asked how the dietitian assessed whether the diet being provided to the patient was appropriate for that individual patient without completing a nutrition assessment, she stated, "By blood sugars. If the patient has a blood sugar greater than 180 gm/dl then the nurse will trigger the food and nutrition department for a dietitian consult. She further added that, diet clerks could increase the protein being provided to meet the patient's large portion request, while still complying with the diabetic diet of 4-5 CHOs per meal, per day.

According to Patient 116's medical record, the patient was 5 '11", and weighed 275 lbs.
Patient 116 had requested large portions and was on a therapeutic diabetic diet. An individualized nutrition assessment, including a patient specific estimation of caloric needs had not been determined, to assess whether the hospital's CHO counting meal pattern of 4-5 CHO per meal per day met the patient's individualized nutritional needs. She further added that the diabetic diet of 4-5 CHO per meal, per day provided 1800 to 2000 calories a day.

When the Manager of Clinical Nutrition was asked if there could be different carbohydrate counting meal patterns depending on an individual's height and weight, she said yes, and provided a "Diabetic Diet Guidelines" form, that did significantly change the carbohydrate counting meal pattern and allotment based on different caloric levels.
However, the Manager of Clinical Nutrition stated that the form was not really implemented, and that the diabetic diet provided to patients with a variety of diabetic diet orders, despite orders that may specify a specific caloric level, was 4-5 carbohydrates per meal per day.

On 1/23/12 at 3:46 P.M., Patient 119's medical record was reviewed. Patient 119 was admitted to Hospital A on 1/20/12. According to Patient 119's history and physical, the patient had a blood glucose level over 600 when admitted.

On 1/21/12 according to Admission Holding Orders in the Emergecy Department (ED,) the physician prescribed a 2000 calorie diabetic diet. On 1/21/12, there was a physician's order for a nutrition consult and for diabetes education.

The Manager of Clinical Nutrition reviewed Patient 119's nutrition evaluation form and stated that diabetic diet education was provided to Patient 119 by a dietitian (RD) on 1/21/12. According to the evaluation note completed by the RD on 1/21/12, the RD determined that Patient 119 was a level of care for nutrition of "moderate" risk, and should be followed up by the RD. The nutrition evaluation, dated 1/21/12 completed by the RD, did not contain the patient's weight, height or estimated nutritional needs. When the Manager of Clinical Nutrition was asked how the dietitian determined if the therapeutic diet prescribed for the patient was appropriate to meet the patient's estimated nutritional needs, she stated, "We educate on 4-5 CHO's per meal. Acute care is more general. I would expect that to occur in an outpatient setting."

The hospital's Diet Order Paramenters definitions of therapeutic diets was reviewed and indicated, "DIABETIC; Consistent CHO with 60-75 gm (4-5 CHO servings) per meal unless otherwise ordered."

When a physician prescribes a diabetic diet, the hospital provides the patient between 1800 to 2000 calories that incorporate 4-5 CHO per meal per day, according to the Manager of Clinical Nutrition. If a patient's nutritional needs are more or less than provided by the hospital's diabetic diet, individualized adjustments may be required to be in accordance with physician's goals, especially as it relates to weight loss goals.

The hospital chose an acceptable system of consistent carbohydrate counting for the therapeutic diabetic diets which may meet the needs of the majority of patients requiring a diabetic diet. However, the dietitian did not gather pertinent patient data, and complete a comprehensive nutrition assessment, which was necessary to determine if recommending a modification in a diabetic diet was necessary to meet the patient's individualized nutrition needs. If a patient's nutritional needs are more or less than provided by the 4-5 CHO per meal for 3 meals a day, individualized adjustments may necessitate a recommendation to the physician to modify the therapeutic diabetic diet order, per the American Diabetes Association, Clinical Diabetes, January 2004, vol 22 no. 1 39-41.

Based on observation, interview and menu review, Hospital A failed to ensure that one patient (116) received large portions as specified on the patient's menu.

Findings:

On 1/23/12 at Hospital A, during lunch trayline, Patient 116's menu indicated "large portions." A dietary employee working on trayline placed the patient's selected entree on the plate which was tuna salad, with one serving size of tuna. Dietary Supervisor (DS 117) checked the lunch tray and verified it was accurate in accordance with the selections on the menu, and placed the dome lid on the plate to load onto the meal delivery cart. DS 117 was asked if Patient 116 should have received large portions, and she stated, "Oh, yes." DS 117 acknowledged that Patient 116 had not received large portions as indicated on the menu.

The Food Service Director (FSD) stated that diet clerks are trained with the knowledge and skills to check menus for accuracy, to ensure that selections are provided in accordance with the physician's order. The FSD stated that dietary staff who work on trayline should follow the directions on the menu.

On 1/23/12 at 3:20 P.M., Patient 116's medical record was reviewed. According to the physician's orders, the patient was on a 2gm sodium, 1800 calorie ADA (American Diabetic
Association) diet. The patient was 5'11" and weighed 275 lbs. According to the Clinical Nutrition Manager who reviewed Patient 116's medical record and spoke with a diet clerk, large portions were at the patient's request. The Clinical Nutrition Manager stated that she would have expected DS 117 to provide large portions, in the form of another serving of tuna salad as indicated on the menu, in order to meet Patient 116's special request for large portions.

Based on observation, interview and policy review, the hospital failed to ensure that preventative maintenance (PM) stickers were placed on equipment, and that the PM stickers contained accurate information related to safety maintenance checks, in accordance with their policy and procedure at Hospital B. Patient care items and equipment were found in the special care nursery, endoscopy department and the operating room without PM stickers or without accurate information on the stickers. In addition, Hospital B failed to ensure that the ice-machines were sanitized in accordance with the hospital's preventative maintenance procedures which included following manufacturer's guidelines.

Findings:

1. On 1/25/12 at 9:45 A.M., a tour of the hospital's special care nursery was conducted with the Director of Maternal Child (DMC) and Director of Patient Safety (DPS). A neonatal transporter bed with a built-in ventilator was observed stored with other patient care items. The PM sticker located on the neonatal transporter bed read "Test Date 7/10 and Due Date 7/11."

A review of the hospital's policy entitled "Medical Equipment, Preventative Maintenance, Labeling," effective date of 1/17/12, was conducted on 1/25/12. The policy stipulated that "All medical equipment serviced by the Engineering Department, Biomedical Engineering Department or outside vendor will have a PM label. Per the same policy, it indicated that "The label will be annotated with the month/year the item of medical equipment was PM'd last and the month/year it is due for PM again. The tech that PM'd the piece of equipment or the vendor name will be identified on the PM label."

An interview with the lead biomedical engineer (LBE) was conducted on 1/25/12 at 11:20 A.M. The LBE stated that preventative maintenance on the infant transport system was performed on 6/17/11. He acknowledged that the PM sticker did not contain accurate information to reflect that the PM was completed timely.

2. On 1/25/12 at 11:00 A.M., a tour of the hospital's endoscopy department was conducted with the charge nurse (RN 3) and the Director of Patient Safety. The following patient care items were observed. A mobile endoscopy cart had a PM sticker which indicated that the test was done on 3/2011, and was due for another preventative maintenance check on 5/2011. There was no PM sticker found on a Hoyer lift (patient care item) stored in the endoscopy procedure room.

A review of the hospital's policy entitled "Medical Equipment, Preventative Maintenance, Labeling," effective date of 1/17/12, was conducted on 1/25/12. The policy stipulated that "All medical equipment serviced by the Engineering Department, Biomedical Engineering Department or outside vendor will have a PM label. The same policy indicated that, "The label will be annotated with the month/year the item of medical equipment was PM'd last and the month/year it is due for PM again. The tech that PM'd the piece of equipment or the vendor name will be identified on the PM label."

An interview with the lead biomedical engineer (LBE) was conducted on 1/26/12 at 9:05 A.M. The LBE stated that preventative maintenance was performed on the mobile endoscopy cart on 3/23/11 and on the Hoyer lift on 5/24/11. He acknowledged that the PM sticker found on the mobile endoscopy cart did not contain accurate information related to its PM status and that a PM sticker was not placed on the Hoyer lift in accordance with the hospital's policy.

3. On 1/25/12 at 11:25 A.M., a tour of the hospital's endoscopy decontamination room was conducted with the charge nurse (RN 3) and the Director of Patient Safety. A leak testing device (a crucial part of proper scope cleaning and disinfection) used on endoscopes was observed without a PM sticker.

A review of the hospital's policy entitled, "Medical Equipment, Preventative Maintenance, Labeling," effective date of 1/17/12, was conducted on 1/25/12. The policy stipulated that "All medical equipment serviced by the Engineering Department, Biomedical Engineering Department or outside vendor will have a PM label. The same policy indicated that, "The label will be annotated with the month/year the item of medical equipment was PM'd last and the month/year it is due for PM again. The tech that PM'd the piece of equipment or the vendor name will be identified on the PM label."

An interview with the lead biomedical engineer (LBE) was conducted on 1/26/12 at 9:05 A.M. The LBE stated that preventative maintenance was performed on the leak testing device on 4/15/11. He acknowledged that a PM sticker was not placed on the leak testing device in accordance with the hospital's policy.

4. On 1/25/12 at 2:25 P.M., a tour of the hospital's operating rooms with the Surgery Manager and the Director of Patient Safety was conducted. A waste management system was observed by the bed in the operating room that was being set up for a surgical procedure. The waste management system had a PM sticker that read "Test Date-12/09" and "Due date-6/10."

A review of the hospital's policy entitled "Medical Equipment, Preventative Maintenance, Labeling," effective date of 1/17/12, was conducted on 1/25/12. The policy stipulated that "All medical equipment serviced by the Engineering Department, Biomedical Engineering Department or outside vendor will have a PM label. Per the same policy, it indicated that "The label will be annotated with the month/year the item of medical equipment was PM'd last and the month/year it is due for PM again. The tech that PM'd the piece of equipment or the vendor name will be identified on the PM label."

An interview with the lead biomedical engineer (LBE) was conducted on 1/26/12 at 9:05 A.M. The LBE stated that the preventative maintenance was performed on 12/11, and was due for the next PM on 6/12. He acknowledged that the waste management system did not have a PM sticker in place to show the PM status of the patient care equipment.


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5. On 1/24/11 at 2:55 P.M., at Hospital B, Engineering Employee (EE 118) stated that he was one of the people responsible for maintenance of the ice-machine located in the kitchen, as well as the ice-machines in the pantries located near the nursing stations.

EE 118 was asked to bring in the actual products used on the ice-machine in the kitchen during the interview. EE 118 brought a de-scale product designed for ice-machines. During an interview with EE 118, in the company of the manager of engineering for Hospital B, Food Service Director 114, and the Manager of Clinical Nutrition, EE 118 stated that the only product used inside of the top part of the ice-making apparatus was the de-scale product.

At that time, the preventative maintenance (PM) for the ice-machine located in the kitchen was reviewed. According to the PM, dated 10/27/11, for the ice-machine in the kitchen (Control # 339433), the procedures on the PM indicated, "CLEAN AND SANITIZE THE ICE DISPENSER WATER SYSTEM AT LEAST TWICE A YEAR." The PM included the specific product to use in order to complete the sanitizing step for the ice-machine, after the cleaning had been completed. EE 118 had the PM in front of him when he verified that he was the person that had signed the PM, dated 10/27/11, as completed.

When EE 118 was asked if he sanitized the ice-machine, he stated, "No, it's really not needed because the de-scale product works very well." EE 118 further added that he used the de-scale product on all of the ice-machines at Hospital B, and that, the de-scale product did not include a sanitizing component.

According to the manufacturer's guidelines for the ice-machine located in the kitchen, there should have been a cleaning procedure, as well as a sanitizing procedure. The manufacturer's guidelines of the ice-machine indicated for the sanitizing procedure, "Dilute IMS-II Sanitizer or a 5.25% Sodium Hypochlorite Solution with water (add .5 fl.oz. to 1 gal. of water)."

According to the standards of practice in the food service industry it would be expected that the manufacturer's guidelines would be followed, per the FDA Food Code 2009.

Based on observation, interview and record review, the hospital failed to ensure that Infection Control policies and procedures, were implemented by staff at Hospital A. Environmental Service and Nursing staff were unable to verbalize infection control procedures and manufacturer's recommended guidelines pertaining to disinfectant contact time, in an effort to prevent patient hospital acquired infections.

Findings:

On 1/23/12 at 9:30 A.M., a tour was conducted of the telemetry unit with the Unit Supervisor (US) and Charge Nurse (CN). According to the US, 6 patients on the unit were on special infection control precautions in order to prevent the transmission of infection or disease. Those 6 patient diagnoses included: MRSA (Methicillin resistant staphylococcus aureus-a bacteria responsible for difficult to treat infections in humans), ESBL (Extended spectrum beta lactamase- an infection where many antibiotics don't work), and Scabies (an skin infestation with a mite).

On 1/23/12 at 9:45 A.M., an interview was conducted with Environmental Service staff (EVS) 21, who was assigned to the telemetry unit on that day. EVS 21 stated that he used "Blue Skiies" (brand name) cleaner when he cleaned equipment and beds in patient rooms. EVS 21 was unable to verbalize if the cleaning product had a specific contact time (the amount of time the product is to remain on a surface per manufacturer recommendation in order to ensure disinfection).

On 1/23/12 at 10:00 A.M., an interview was conducted with EVS 22, who was regularly assigned to the telemetry unit. EVS 22 was unable to verbalize the name of the disinfectant products that she used to clean the patient rooms. She stated that she was not aware of any specified contact times required by the manufacturers of those products.

On 1/23/12 at 10:10 A.M., an interview was conducted with the Manager of Environmental Services (MES). Per the MES, Blue Skiies was used for routine cleaning and disinfection purposes, but another product called Dispatch was used to disinfect rooms and equipment for patients with C-difficile infections (Clostridium difficile-a bacterial infection which can produce severe diarrhea and colon inflammation). Per the MES, the contact time for Blue Skiies was 10 minutes, and the contact time for Dispatch was 5 minutes. The MES acknowledged that EVS staff should have known the required contact times for the disinfectant products for infection control purposes.

On 1/23/12 at 2:00 P.M., a tour and joint interview was conducted on the trauma unit with the Trauma Charge Nurse (TCN) and the Trauma Nurse Supervisor (TNS). According to the TNS, nurses used a product called "CaviWipes" to routinely clean and disinfect patient rooms and equipment. The TNS stated that the contact time for the CaviWipe product was 5 minutes. Per the TNS, a different cleaning product with bleach (name not given) was used to disinfect rooms and equipment for patients with C-difficile infections. Per the TNS, the contact time for the bleach product was 10 minutes.

On 1/24/12, the manufacturer's labels with recommended guidelines for the use of the Blue Skiies, CaviWipes, and Dispatch products were reviewed. The manufacturer's directions gave the following contact times for the products: Blue Skiies-10 minutes; Dispatch (bleach product)-5 minutes; and CaviWipes-3 minutes.

On 1/24/12, a review of the hospital's "Standard Precautions and Transmission Based Precautions" policy was conducted. Per the policy, "Patient care items that come in contact with intact skin and are not disposable or single use items are to be cleaned with a California EPA (Environmental Protection Agency) registered hospital approved disinfectant......Follow equipment manufacturer's recommendations for type of product to use and directions for use."

On 1/24/12 at 1:00 P.M. a joint interview was conducted with the Infection Control Chairman, the Infection Control Coordinator, the Director of Quality, the Director of Risk Management and the Chief Nursing Officer. The Infection Control Coordinator acknowledged that staff had some "educational needs" concerning the use and contact times of the various disinfectant products.

Based on observation, interview and record review, the hospital failed to ensure that clean supplies were not stored in the dirty area of the decontamination room, of the endoscopy department at Hospital B. Several washers and buttons for endoscopes (an instrument that can be introduced into the body to give a view of its internal parts), colonoscopes (a flexible tube that provides an inside look at your colon and rectum) and bronchoscopes (a slender tubular instrument used to examine the bronchial tubes of the lung), were observed hanging on a rack on the side of the room used for cleaning contaminated instruments.
Findings:
On 1/25/12 at 11:25 A.M., a tour of the endoscopy's decontamination room was conducted with the charge nurse (RN 3) and the Director of Patient Safety. There were 2 endoscope washers, one colonoscope washer, 3 bronchoscope washers and button attachments that were hanging on a rack in the dirty area.
A joint observation and interview with the endoscopy technician (ET) was conducted on 1/25/12 at 11:25 A.M. The ET stated that when the high level disinfection of the scopes was completed, she removed the washers and button attachments from the scopes and hung them on the rack located on the side referred to as the "dirty" area. She stated that she had been working in endoscopy for 10 years and her practice has been the same. She agreed that clean items should not be stored with dirty items or on the dirty side.
An interview with RN 3 and the Director of Patient Safety (DPS) was conducted on 1/25/12 at 11:40 A.M. They both agreed that the clean items should not have been stored on the side of the room that was identified as "dirty." They both acknowledged that the practice posed a risk for cross-contamination or transmission of organisms among the clean and dirty items and supplies in the room.

Based on interview and record review, the hospital failed to ensure that staff at Hospital A implemented its policy and procedure pertaining to patient and family education. There was no documented evidence that Patient 23's family member, was consistently and adequately included in the educational process.

Findings:

On 1/23/12 at 10:24 A.M., an observation and interview was conducted with Patient 23 and his wife. Patient 23 was in bed and wore an oximyzer mustache cannula (a cannula that improves respiratory efficiency over a regular nasal cannula). A healing incisional wound was observed over the patients sternum (breast bone). Patient 23 was admitted to Hospital A on 1/11/12, and underwent a heart valve replacement on that date. After surgery the patient was in the Intensive Care Unit (ICU), and then was transferred to the telemetry unit on 1/17/12. The patient and his wife verbalized that he would be discharged today (1/23/12) to an acute rehabilitation facility. According to Patient 23 and his wife, they had not received any discharge teaching.

A record review was initiated on 1/23/12 at 10:45 A.M. The Nursing Patient Teaching Summary Reports from 1/11/12 through 1/23/12 were reviewed. There was documented evidence that while the patient was in the ICU, teaching was conducted by the nursing staff with the patient and family. However, after the patient's transfer to the telemetry unit on 1/17/12, there was no documented evidence by nursing staff, that the patient's family or wife had been involved with any teaching pertaining to wound care, safety, infection control, diet, activity, pain management, or respiratory and cardiovascular management.

A review of the "Patient and Family Education" policy and procedure, dated 10/09, was reviewed on 1/23/12. Per the policy, the purpose of patient and family education was to plan, support, and provide accurate, consistent understandable information to patients and their families about the healthcare environment or treatment. Per the policy, "all patients and their families will be provided with education and/or training as appropriate. Education is interactive when appropriate, promoting patient/family involvement in their own care and in the educational process."

On 1/23/12 at 1:10 P.M., an interview was conducted with Registered Nurse (RN) 24, who acknowledged that there was no documented evidence that nursing staff on the telemetry unit had included Patient 23's wife in any educational activities to include discharge teaching.

Based on interview and document review, the hospital failed to ensure that its procedures pertaining to the patient choice process for skilled nursing facility (SNF) selection, was implemented by Case Manager 22 at Hospital A. Case Manager 22 instructed Patient 23's family member to ask other hospital staff for reviews and suggestions concerning SNF selection.

Findings:

A record review was initiated on 1/23/12 at 11:15 A.M. Patient 23 was admitted to Hospital A on 1/11/12, and underwent heart valve replacement surgery on that same date, per a History and Physical (H&P) dated 1/11/12.

A review of the Case Manager (CM) notes, dated 1/18/12, revealed that Patient 23's family member expressed concerns about a previous SNF that Patient 23 had been transferred to. It was the patient's and family member's wishes for Patient 23 to not return to that particular SNF. Per the documentation by CM 22, the patient and family member asked questions about other SNFs. Per the notes, CM 22 told the patient and family member that he could not supply reviews about other SNFs, but he suggested that they talk with other members of the hospital staff, such as physicians, nurses, or physical therapy and occupational therapy staff to get "reviews" on other SNFs.

On 1/23/12 at 11:20 A.M., an interview was conducted with the Case Management Supervisor (CMS). The CMS stated that CM 22 should not have directed the patient or family member to other hospital staff for "reviews" regarding SNFs, as it was not the process or procedure.

On 1/23/12 at 11:25 A.M., a joint interview was conducted with CM 22 and the CMS. CM 22 stated that in recent meetings the CMS said it was "ok" to tell patients and families to talk with other hospital staff for SNF reviews.

A review of a document entitled "Case Management Patient Choice Process for SNF Selection," was conducted on 1/23/12. Per the document, if patients were undecided about which SNF to select, CMs could offer a tour, print updated information from the Medicare website or provide additional brochures, laptop displays, or computer print outs. The procedure and process did not include referring patients to other hospital staff for "reviews" of other SNFs.

On 1/24/12 at 12:00 P.M., an interview was conducted with the Director of Risk Management (DRM) who confirmed that CM 22 had not followed the hospital procedure pertaining to the patient choice process for SNF selection.

Based on observation, interview and record review, Hospital B failed to ensure that their pediatric crash cart contained all the emergency supplies that were listed on their inventory list, in accordance with their policy and procedure.

Findings:

On 1/23/12 beginning at 11:12 A.M., an audit of the Emergency Department's (ED) pediatric crash cart was conducted with Registered Nurse (RN 44). The following emergency supplies were not found:

1 Umbilical Catheter Insertion Tray (a set of supplies for the insertion of an indwelling tube that is placed into the umbilical artery or vein for the care of the neonates)
1 TLCL (triple lumen catheter) 5.0 Fr (French) Catheter Insertion Tray (triple access into the central venous system reducing the need for painful venipunctures)
1 3.5 mm (millimeter) Cricothyrotomy (an emergency incision into the larynx, performed to open the airway in a person who needs relief from an upper airway obstruction) Kit
1 4.0 mm Cricothyrotomy Kit

A review of the ED's pediatric crash cart inventory list was conducted with RN 44. The following emergency supplies were listed on the inventory: an umbilical catheter insertion tray, TLCL (triple lumen catheter) 5.0 Fr Catheter Insertion Tray, 3.5 mm Crichothyrotomy Kit and 4.0 mm Crichothyrotomy Kit.

An interview with RN 44 was conducted on 1/23/12 at 12:10 P.M. RN 44 stated that the following emergency supplies were not found in the pediatric crash cart: an umbilical catheter insertion tray, TLCL 5.0 Fr Catheter Insertion Tray, 3.5 mm Cricothyrotomy Kit and a 4.0 mm Cricothryrotomy Kit as listed on the hospital's inventory list.

An interview with the ED manager (EDM) was conducted on 1/23/12 at 12:45 P.M. The EDM acknowledged that the cart should have contained all the emergency supplies listed on its inventory list. The EDM stated that if there was a change in the use of an emergency supply, the inventory list should have been corrected to reflect the change. She further acknowledged that the hospital's new policy related to code carts and emergency medication kits, was not applicable to the use of the old pediatric crash carts.

A review of the facility's policy entitled "Emergency Drugs And Crash Cart," approval date of 9/09, was conducted. The policy indicated that code carts were checked daily by the charge nurse, lead registered nurse (RN) or the designated RN/LVN (licensed vocational nurse). Per the same policy, it stipulated that "During any inspection/check, if any equipment is in non-working order, missing any items, items not specified on the check list are present, or if any item has expired, complete a Code Blue Discrepancy Report and return the code cart to central services."

Based on observation, interview and record review, the hospital failed to communicate a change in process related to the management of pediatric airways in an emergency. Hospital B's Emergency Department (ED) decided that cricothyrotomy (an incision made through the skin and cricothyroid membrane to establish an airway during life-reatening situations such as airway obstructions) kits, were no longer going to be utilized in the unit. However, the nursing staff were not informed nor re-educated of this change in process.

Findings:

On 1/23/12 beginning at 11:12 A.M., an audit of the Emergency Department's (ED) pediatric crash cart was conducted with Registered Nurse (RN 44). According to the cart's inventory list, a 3.5 mm (millimeter) cricothyrotomy kit and 4.0 mm cricothyrotomy kit should have been found in the bottom drawer among the universal equipment listed.

An interview with RN 44 was conducted on 1/23/12 at 12:10 P.M. When RN 44 was asked to explain the management of pediatric airway emergencies, related to the use of cricothyrotomy kits, she stated that she knew the kits were available and located in the pediatric crash cart. She stated that she was not aware that the ED was no longer using cricothyrotomy kits.

During an interview with the ED manager (EDM) on 1/23/12 at 12:45 P.M., the EDM stated that in December 2011, the decision was made to discontinue the use of cricothyrotomy kits in the ED. She explained that the remaining cricothyrotomy kits were expiring that month and replacement kits were not ordered. She stated that there was no plan discussed nor implemented to address the the discontinuation of cricothyrotomy kits used in the ED among the nursing staff.

An interview and joint observation was conducted with RN 45 on 1/23/12 at 2:20 P.M. RN 45 stated that cricothyrotomy kits were used on the pediatric population for the management of their upper airway obstruction emergencies. He stated that as the nurse, his role was to assist the physician with emergency supplies when emergency procedures were performed. He stated that the ED's cricothyrotomy kit was located in the procedure cart in a box that was locked. He showed the surveyor the procedure cart and the locked box that contained the expired cricothyrotomy kit. RN 45 stated that he did not know that cricothyrotomy kits were longer used in the ED.

A follow-up interview with the ED manager (EDM) was conducted on 1/23/12 at 2:55 P.M. The EDM acknowledged that the decision to no longer use cricothyrotomy kits, was not communicated to the ED nursing staff. She stated that the nursing staff should have been informed of this change.

Based on observation, interview and record review, Hospital A failed to ensure that its policies and procedures pertaining to rehabilitation inpatient prioritization and chain of command, were implemented by Physical Therapy Assistant (PTA) staff for one patient (23). When Patient 23's physical therapy plan of care was not implemented per physician orders, there was no documented evidence that PTA 22, attempted to resolve the concern with the patient's nurse, or that she involved a supervisor or charge nurse in accordance with policies and procedures.

Findings:

On 1/23/12 at 10:24 A.M., an observation and interview was conducted with Patient 23 and his wife. Patient 23 was in bed and wore an oximyzer mustache cannula (a cannula that improves respiratory efficiency over a regular nasal cannula). Patient 23 was admitted to Hospital A on 1/11/12, and underwent a heart valve replacement on that date. The patient and his wife verbalized he would be discharged today (1/23/12) to an acute rehabilitation facility. Patient 23 and his wife stated that the "nurses are supposed to walk me in the afternoon and they are not doing it." The patient stated that the nurses "rushed" him when they had walked him, and his oxygen levels dropped, and then they put him back to bed. Patient 23 stated that "PT came by this morning, but I didn't get PT over the weekend." Patient 23 and his wife were concerned because they knew that his physician wanted him to walk more often.

A record review was conducted on 1/23/11 at 10:50 A.M. A review of physician orders related to the PT plan of care revealed the following:
On 1/13/12, a Nurse Practitioner (NP) prescribed PT once a day, 5days per week. The therapy included gait and stairs training. On 1/13/12, an order documented that it was "ok" to accept oxygen saturation levels 85% or higher in order to get the patient out of bed. On 1/17/12, NP 24 ordered "aggressive PT." On 1/20/12, NP 24 wrote another order to "ambulate TID (3 times/day) nursing or PT." An additional order was written on 1/21/12, to increase the patient's ambulation to 4 times per day.

On 1/23/12 at 11:05 A.M., an interview was conducted with PTA 22. PTA 22 stated that she worked with Patient 23 three times in the past week. PTA 22 stated that Patient 23's oxygen levels dropped when he walked, but he recovered after frequent rest breaks. PTA 22 stated that the nurses should be walking the patient more often, too. PTA 22 stated that she communicated that to the nursing staff.

On 1/23/12 at 1:00 P.M., an interview was conducted with NP 24. NP 24 stated that she wrote an order for "aggressive" PT, because she was concerned that Patient 23 was "not receiving the amount of PT that she would have liked." NP 24 wanted the patient up and walking more frequently than what occurred.

A review of PT notes revealed that an initial PT evaluation of Patient 23 was conducted on 1/13/12. On 1/17/12, PTA 22 documented that the patient refused PT in the morning due to fatigue, and was unavailable in the afternoon due to a procedure. Patient 23 ambulated with PTA 22 on 1/18/12, 1/19/12, and 1/20/12 (which was on a Friday). PT notes revealed that at times the patient's oxygen levels dropped, but after a short period he recovered. There was no documented evidence of any further PT sessions over the weekend, on 1/21/12 and 1/22/12.

There was no documentation in the nurses notes to indicate that the nursing staff provided additional ambulation sessions for the patient, and assessed his response or progess.

There was no documented evidence in the clinical record that Patient 23 was ambulated 4 times per day by nursing and/or PT staff, in accordance with the PT plan of care and physician's orders.

On 1/24/12 the "Rehabilitation Inpatient Prioritization" policy, dated 1/10, was reviewed. Per the policy, "the patient's Registered Nurse will be notified when service is unable to be provided and documentation made in the patient's medical record."

There was no documentation in Patient 23's medical record by PTA 22 that she had expressed her concerns to the nursing staff and requested increased assistance from nursing to ambulate the patient.

On 1/24/12 , the "Chain of Command" policy, dated 5/09, was reviewed. Per the policy, " if issue resolution is not achieved, the individuals involved are encouraged to involve the next level of authority." Per the policy, the next level of authority involved the Supervisor or Charge Nurse. There was no evidence that PTA 22 involved the Supervisor or Charge Nurse to ensure that Patient 23's Physical Therapy plan of care was implemented, in an effort to achieve an optimal patient outcome and goals pertaining to mobility and functional capacity.

On 1/26/12 at 11:20 A.M., an interview was conducted with the Chief Nursing Officer (CNO). Per the CNO, PT staff should have communicated to the Charge Nurse all concerns pertaining to the implementation of Patient 23's PT plan of care.