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Based on interview, documentation in 2 of 2 patient medical records reviewed (Patients 1 and 2), and review of policies and procedures, it was determined the hospital failed to ensure that patient nursing care needs related to hypertension management, vital signs and other assessments were supervised and managed by the RN in accordance with appropriate assessments, physician orders, physician notification and hospital policies and procedures.

Findings included:

1. The medical record for Patient 1 was reviewed. The record reflected the patient presented to the hospital's labor and delivery department on 05/29/2015 at 2301 with a diagnosis of chronic hypertension and preeclapsia. On 06/01/2015 the patient experienced a sudden onset of shortness of breath and required oxygen for treatment of pulmonary edema. On 06/02/2015 the patient delivered a newborn by cesarean section and was transferred to the MBU.

Physician orders dated 06/02/2015 at 0227 reflected that the physician was to be notified if the patient's temperature was greater than 38 degrees C; heart rate greater than 120 or less than 60; systolic BP greater than 150 or less than 90; diastolic BP greater than 90 or less than 50, and oxygen saturation less than 93 percent.

The VS flowsheet documentation on 06/02/2015 at 0603 reflected the patient's BP was elevated at 153/73. There was no documentation reflecting that the physician was notified of the elevated blood pressure. The next BP was not documented until 06/02/2015 at 0701.

The VS flowsheet documentation on 06/02/2015 at 1627 reflected the patient's BP was elevated at 160/68. There was no documentation reflecting that the physician was notified of the elevated blood pressure.

The VS flowsheet documentation on 06/02/2015 at 1800 reflected the patient's BP was elevated at 155/74. There was no documentation reflecting that the physician was notified of the elevated blood pressure. The next BP was not documented until 1900.

The VS flowsheet documentation on 06/02/2015 at 1908 reflected the patient's oxygen saturation was low at 89 percent and there was no documentation to reflect that the RN notified the physician of the low oxygen saturation level.

The VS flowsheet documentation on 06/02/2015 at 1926 reflected the patient's BP was elevated at 169/86. The next BP documented at 1943 reflected the patient's BP was elevated at 153/76. The next BP documented at 1946 reflected the patient's BP was elevated at 158/77. There was no documentation reflecting that the physician was notified of the elevated blood pressures.

The VS flowsheet documentation on 06/03/2015 reflected the patient's BP at 0031 was elevated at 182/76. There was no documentation reflecting that the physician was notified of the elevated blood pressure. The next BP was not documented until 0415 and was also elevated at 189/69.

The VS flowsheet documentation on 06/03/2015 at 0439 reflected the patient's BP was elevated at 176/62 and temperature was elevated at 39.1 degrees C (102.4 degrees F).

Physician notes dated 06/03/2015 at 0510 reflected "Notified by RN of patient being febrile with elevated BP. On review of patient's vitals in chart, appears she had a severe range BP at 0331 which the MD was not notified of, nor was it repeated...At 0415, BPs were again noted to be severe range: 189/60 with manual repeat of 176/62. She at this time was noted to be febrile to 39.1 with with new onset tachycardia. Additionally, her O2 saturations decreased to the 70s...She is currently febrile, tachycardic and with severe range BPs." This was the first documentation reflecting that the RN notified the physician of the patient's elevated BPs and temperature.

On 06/03/2015 at 0852 the VS flowsheet documentation reflected the patient's BP was elevated at 155/72. The next BP was not documented until 1158 and was elevated at 197/73. Also at 1158, the patient's temperature was elevated at 39.3 degrees C (102.7 degrees F). There was no documentation to reflect that the RN notified the physician of the patient's elevated BPs until 1159 and that note reflected "[Physician] paged regarding fever and VS." An additional RN note dated "6/3/2015 1:58" reflected "At 1158 patient complained of feeling feverish and unwell. Temp was 39.3 patient chilled. Complaining of increased lower abdominal pain. HR increased to 110s and 120s with movement. RR increased to 22-24...BP 197/73 repeat manual BP found to be 210/60. Call to [Physician] to inform of [patient] status then rapid response called to bedside...[patient] transfer to ICU..."

The record reflected the patient was transferred to the CVICU on 06/03/2015 at 1310 because of ongoing hypertension with SBP greater than 200, fever and a concern for endometriosis.

The VS flowsheet documentation on 06/04/2015 at 0000 reflected the patient's temperature was elevated at 39.7 C (103.5 F). The next temperature was not documented until 0400 and was also elevated at 39.3 C (102.7 F). There was no documentation to reflect that the physician was notified of the patient's elevated temperature.

The VS flowsheet documentation on 06/04/2015 at 0300 reflected the patient's BP was elevated at 184/94; at 0315 elevated at 202/79; and at 0330 elevated at 125/103. There was no documentation to reflect that the physician was notified of the elevated BPs until 0330 and that note reflected "CVI notified of high SBP" and did not include documentation that the physician was notified of the patient's elevated DBP of 125/103 documented at 0330.

Physician notes dated 06/04/2015 at 1411 reflected "[Patient] continues to require ongoing management f (sic) her BP with IV [medication]. She has ongoing fever and requires close observation and management. She requires ongoing ICU level of care..."

The VS flowsheet documentation on 06/05/2015 at 1200 reflected the patient's BP was elevated at 158/77. There was no documentation to reflect that the physician was notified and the next BP was not documented until 1300.

The physician discharge summary dated 06/12/2015 at 1317 reflected the patient experienced persistent severe blood pressures, fever, tachycardia, and pneumonia during his/her hospitalization. The patient was discharged on 06/12/2015.

2. The medical record for Patient 2 was reviewed. The record reflected the patient was admitted to the hospital on 06/15/2015 at 0548 with diagnoses of epilepsy and seizures. The patient underwent a surgical procedure that involved a craniotomy and placement of subdural electrode grids.

The record reflected the patient was transferred to the neuro ICU on 06/15/2015 at 1352.

Physician orders with a "Start Date/Time" of 06/15/2015 at "02:30 PM" reflected that the physician was to be notified if the patient's temperature was greater than 38.3 degrees C; respiratory rate greater than 24 or less than 8; and ICP greater than 20.

Physician orders with a "Start Date/Time" of 06/15/2015 at "03:00 PM" reflected that vital signs were to be performed every 1 hour.

The VS flowsheet documentation on 06/16/2015 at 0000 reflected that the physician was notified of "...new onset [left] eye blurriness. MD at bedside assessing [patient]..." Two hours later on 06/16/2015 at 0200, the VS flowsheet documentation reflected the patient's respiratory rate was 5. There was no documentation that the physician was notified of the patient's low respiratory rate.

In addition, although there were orders to notify the physician if the patient's ICP was greater than 20, there was no documentation reflecting that the patient's ICP was checked or documentation describing why the ICP was not checked and documented as ordered.

3. The medical records for Patients 1 and 2 were reviewed with an RN on 07/27/2015 beginning at 1100. These findings were confirmed during an interview with the RN during the record review.

4. A policy titled "NPEOC: Adult Critical Care Standard of Care" dated "Effective Date: 12/06/2013" reflected the following: "...Assess for complex care needs, intervene as needed and initiate appropriate referrals...Pulse, Resp, BP, BP Mean are monitored and documented Q 2 hours or more frequently as indicated by patient condition..."

Based on observation, interview and review of policies and procedures, it was determined that the hospital failed to ensure that medications available for patient use in the OR were labeled and managed appropriately in accordance with hospital policies and procedures.
* Intravenous medications were not appropriately labeled when they were transferred from their original container to a secondary container in accordance with hospital policies and procedures; and
* MDVs were not managed and dated in accordance with hospital policies and procedures.

Findings included:

1. During observation of a surgical procedure in OR 16 with the Division Director of Perioperative Services on 07/24/2015 the following observations were made:

* At 0840, a 1000 mL IV bag of 0.9 percent Normal Saline solution was observed available for use with the Division Director of Perioperative Services and the Purfusionist. The bag had a label affixed that read: "Heparin" followed by a blank line and then "Units/ml." The label also read "Date" followed by a blank line; "Time" followed by a blank line; and "Int" followed by a blank line. There was no information on the bag to indicate the strength or dose of the Heparin medication, the date or time it was added to the IV bag, and the identification of the individual who prepared the medication in the bag. At the time of the observation, the Purfusionist confirmed that Heparin had been added to the IV bag, and the Division Director of Perioperative Services acknowledged that the Heparin label was not complete.

* The policy and procedure titled "Labeling of Medications, Medication Containers and other Solutions in Procedural Settings" dated "Effective Date: 10/23/2013" reflected "Medications and solutions to be labeled...The following medications will be labeled when removed from their original packaging and not immediately administered to a patient...Prescription medications or any other product designated by the FDA as a medication...IV solutions...A label will be applied to the medication container when a medication or solution is removed from its original packaging and not immediately administered...Labels will include the following information at a minimum...Name of medication or solution...Strength of medication or solution...Quantity or volume...Diluent and volume...Expiration date, if not used within 24 hours...Expiration time, when the expiration occurs in less than 24 hours..."

Refer to Tag A749, CFR 42 CFR 482.42(a)(1) Infection Control Program, which reflects the hospital's failure to ensure MDVs were managed and dated in accordance with hospital policies and procedures.

Based on observation, interview, and review of policies and procedures, it was determined the hospital failed to implement its policies and procedures for infection prevention in the following areas:
* MDVs were not managed and dated in accordance hospital policies and procedures in the OR;
* Hazardous waste (sharps containers) were not managed in accordance with hospital policies and procedures in the SPD;
* Sterile processing and disinfection processes were not managed in accordance with hospital policies and procedures in the SPD; and
* Isolation Precautions were not fully implemented in accordance with hospital policies and procedures.

Findings included:

1. In OR 16 on 07/24/2015 at 0735 an open multi-dose vial of injectable Lidocaine HCl 10 mg/ml was observed on the anesthesia cart with the Division Director of Perioperative Services. The vial had no date or time to indicate when it was opened. This was confirmed with the Anesthesiologist at 0740 and he/she indicated that the vial should have been discarded.

* The hospital policy titled "Safe Administration Practices in Use of Single and Multidose Medications" dated "Effective Date: 11/7/2012" reflected the following: "...The beyond use date (BUD) for an opened multiple dose medication administered by intravenous injection, injection used for inhalation, subcutaneous, intramuscular, or intradermal will be 28 days...the expiration date will be written on the medication container when the container is initially opened."

2. A tour of the decontamination area of the SPD was conducted with the Division Director of Perioperative Services and the Manager of SP beginning on 07/24/2015 at 0900. The following observations were made:

* At 0915, a large sharps container was observed available for use near a work area. The container was over filled and had multiple contaminated items protruding from an opening at the top of the container. This was confirmed with the Manager of SP at the time of the observation.

* During an interview conducted on 07/24/2015 at 1540 the RN Professional Practice Leader stated that sharps containers should be replaced when they are 3/4 full.

* The hospital policy titled "Needles and Sharps Management" dated "Effective Date: 06/08/2013" reflected the following: "...Full sharps containers: A sharps container is considered to be "full" when the fill line on the label is reached and/or when approximately 3/4 full...OHSU Healthcare workforce members are responsible for adhering to the provisions of this procedure...Individual departments are responsible for assuring timely change out of full sharps containers...Needles or sharps must not be "forced" into the containers...All full containers are to be placed in black bulking containers labeled "sharps" for transport to disposal sites..."

* At 0920, a tray containing surgical instruments was observed near the OR elevator. During an interview conducted with the Manager of SP at the time of the observation, he/she indicated that the surgical instruments had been transported in the elevator from the OR to the decontamination area in order to be cleaned and sterilized. The manager stated that the hospital's process for cleaning surgical instruments included that the instruments be sprayed with an enzymatic solution prior to arrival to the decontamination area. He/she confirmed that the surgical instruments in the tray had not been sprayed with an enzymatic solution and stated that they should have been.

* A hospital Standard Operating Procedures document titled "Transporting and Receiving of Contaminated Instruments to the Decontamination Room" dated "Date Created/Revised: 06/29/2014" reflected the following: "This document serves as instruction to perform the job function of: Transporting and Receiving of Contaminated Instruments to the Decontamination Room...Soiled instruments will be sprayed with a pre-enzyme cleaner by the OR staff at the Spraying Station located outside the designated Dirty Elevator in the OR, to keep them moist prior to transport to SPD."

* The hospital policy titled "Sterilization Procedures" dated "Effective Date: 6/17/2014" reflected the following: "...Preparation of Items For Sterilization...Cleaning...Articles requiring packaging and sterilization must be absolutely clean. All bio-burden in which microorganisms may find favorable conditions for continued life and growth must be removed using mechanical action combined with water and detergent...Preliminary cleaning of items should be done immediately after use, such as simple rinsing or using enzymatic cleaner applied by soaking or using a squirt bottle..."

3. During a tour of the supplies storage area of the SPD on 07/24/2015 at 1015, a wrapped sterile pack containing surgical instruments was observed. The pack had a label affixed that read "07/18/2015 11:13PM" and "Syntheses Troch Fix Nail (TFN) Locking - SOR IMP502140 - 001." The pack was not labeled with the sterilizer used to sterilize the instruments and the sterilizer load number. This was confirmed during an interview conducted with the Manager of SP at the time of the observation. The manager indicated that the hospital did not routinely label sterile packs with the sterilizer used and the sterilizer load number.

* The hospital policy titled "Sterilization Procedures" dated "Effective Date: 6/17/2014" reflected "...Each item sterilized internally by OHSU Healthcare must have a label identifying the...sterilizer number and load number..."

4. A tour of the General Medicine unit was conducted with the Manager of Regulatory Affairs beginning on 07/27/2015 at 1330. The following observations were made:

* At 1400, the outside of patient room 03 was observed and a "Contact Precautions" sign was posted. The sign reflected the following instructions: "...Staff: In addition to standard precautions, EVERY time you enter the room: Hand Hygiene: Before and after patient contact...Gloves: Remove gloves before exiting room. A RN was observed in the room. He/she handled and touched the patient with gloved hands. He/she removed the gloves and exited the room. He/she did not perform hand hygiene before exiting the room.

In addition, two physicians were observed to walk into the patient's room to the bed area. Although the physicians were holding gloves in their hands, one of the physicians had not donned the gloves, and the other physician had only one glove donned.

* The hospital policy titled "Transmission-based Isolation Precautions" dated "Effective Date: 12/16/2013" reflected the following: Transmission-based isolation precautions, Airborne, Contact, Contact Plus, and Droplet, are to be used for patients known or suspected to be infected or colonized with highly transmissible or epidemiologically important pathogens for which additional precautions beyond Standard Precautions are needed to interrupt transmission in hospitals and clinics...Contact Precautions...Gloves and gowns are both required at all times, upon room entry...Perform hand hygiene with an antimicrobial agent after removing gloves and before leaving room."