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Based on observation, interview, and review of SA licensing records it was determined that the CAH failed to ensure that all operations were approved as required by the State of Oregon hospital licensing requirements.
* OAR 333-515-0050, OAR 333-535-0000, and OAR 333-675-0000 require that a hospital submit building construction plans to the SA, the Oregon hospital licensing authority, for review and approval prior to building construction or alterations and prior to expansion of existing services. Such areas may not operate until approval to commence services is received from the SA. The CAH lab had been expanded without the required SA building plans review and approval.

Findings include:

1. During observations in the laboratory on 06/29/2016 at 1115 with the Laboratory Manager he/she stated that a lab remodel/expansion had been completed in March or April of 2016. Observations revealed that approximately half of a wall in the original lab space had been removed and a second space added through and on the other side of that open wall. The second space also contained a smaller office type room. Items observed in the new space included, but were not limited to, a large rack of supplies, multiple refrigerators, lab equipment, the microbiology hood, a MedicaPro laboratory water system installed into exposed plumbing. In one corner of the new space on a shelf adjacent to the handwashing sink was a counter that contained numerous containers of beverages and food.

During interview with the Laboratory Manager at that time he/she confirmed that walls and plumbing had been altered during the remodel. He/she also confirmed that the counter observed with food and beverages on it was the staff food area.

The review of Oregon hospital licensing records maintained by the SA revealed no evidence that the CAH had initiated the SA building plans review process for the expansion of the lab.

Based on observation, interview, and review of policies and procedures it was determined that the CAH failed to ensure the facility was arranged to ensure adequate and appropriate space for the provision of services:
* ED triage was in a space not afforded visual or auditory privacy;
* Potentially infectious waste was disposed of in public/patient toilets; and
* Separation of sterile/clean and contaminated/dirty supplies and instruments was not maintained.

Findings include:

1. A tour of the ED and pre-op/PACU unit was conducted with the CNO on 06/28/2016 beginning at 1215. Observations revealed that the ED triage area was located in the open corridor inside the ED and pre-op/PACU unit, between the door from the ED/Surgical Services registration/waiting room and the pre-op/PACU rooms. The area was in the corridor used by other patients and visitors to the ED and surgical services units, and there were no provisions for visual or auditory privacy.

2. Refer to Tag C278, CFR 485.635(a)(3)(vi), Patient Care Policies related to control of infections and communicable diseases. Findings 1, 2, and 3 reflect the lack of adequate space to conduct tasks and procedures in a manner to ensure cross-contamination and infection prevention.

Based on observation, interview, review of PM documentation and policies and procedures, it was determined that the CAH failed to ensure that all patient care equipment had been maintained to ensure an acceptable level of safety and quality: All patient care equipment was not incorporated into the CAH inventory and there was lack of PM documentation.

Findings include:

1. On 06/29/2016 at 1025 observations in the Outpatient Rehabilitation Department revealed the following:
* A ProStride Treadmill had no identifiable inventory/property # and no evidence of PMs;
* A SciFit Treadmill, PMH inventory/property #0641, had no identifiable evidence of PMs;
* An Empi Select TENS unit had no identifiable inventory/property # and no evidence of PMs;
* An Empi Continuum Neuromuscular Device unit had no identifiable inventory/property # and no evidence of PMs; and
* An electronic Omron BP device had no identifiable inventory/property # and no evidence of PMs.

On 06/29/2016 at 1115 observations in the Laboratory revealed the following:
* A LifeLoc Professional Breath Alcohol Tester had no identifiable inventory/property # and no evidence of PMs.

2. During interview with the Facilities Manager and Biomedical Supervisor on 06/30/2016 at 1105 they confirmed that the above equipment and devices had not been incorporated into the St. Charles Prineville inventory and there were no records of PM activity for those.

Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure that all staff were trained to ensure the safety of patients in non-medical emergencies.

Findings include:

1. Refer to the applicable findings identified on the attached Life Safety from Fire SOD.

Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure compliance with applicable Life Safety from Fire codes.

Findings include:

1. Refer to the applicable findings identified on the attached Life Safety from Fire SOD.

29708

Based on observation, interview, review of TB testing documentation for 7 of 7 temporary staffing agency personnel (Staff #s 14, 15, 16, 17, 18, 19, and 20), and review of policies and procedures it was determined the CAH failed to fully develop and implement policies and procedures for infection prevention in the following areas:
* Management and storage of ED and pre-op/PACU soiled materials and potentially infectious waste/bodily fluids;
* Storage of clean ED and surgical services patient care supplies;
* Separation of dirty/contaminated and sterile/clean instruments/supplies;
* Use of disinfectants and detergents in accordance with manufacturer instructions;
* Provisions for hand hygiene;
* Management of sterilization processes;
* Use of endoscope reprocessing equipment and disinfectants in accordance with manufacturer instructions;
* Monitoring of temperature, humidity and airflow;
* Labeling of injectable medications;
* Storage of staff food in the lab; and
* TB evaluation and screening for contracted personnel.

Findings included:

1. A tour of the ED and pre-op/PACU unit was conducted with the CNO on 06/28/2016 beginning at 1215. Observations reflected that the surgical services pre-op/PACU rooms were contained within the ED area and not within the surgical suite. The ED had 14 rooms in total arranged around a central nurses station located in the center. During interview with the CNO at that time he/she stated that Rooms 1 through 9 were ED treatment/exam rooms. The CNO stated that Rooms 1 through 5 were intended to be used for surgical services pre-op/PACU but that "generally" only Rooms 1 through 3 had been used for that. He/she described Room 10 as the trauma room, Room 11 as the negative pressure/AII room, and Rooms 12 through 14 as ED rooms designed to meet inpatient specifications for observation patients or "boarding" patients before admission to the inpatient unit on the second floor.

During interview with the CNO at that time he/she stated that there were "concerns" about the sharing of space between surgical services and ED as usually those departments are separated. He/she stated that the only "soiled utility" area was in the decontamination room and indicated they were planning to remodel that room to improve its functionality. He/she stated that potentially infectious waste/bodily fluids from the ED and surgical services pre-op/PACU was disposed of in the toilet in the one public bathroom on the unit, located next to Room 5. He/she indicated that at times staff used the patient toilets inside of Rooms 11 - 14, as those rooms were designed to inpatient specifications and included toilet rooms. The CNO stated that Room 5 was also used by patients for UA specimen collection. The CNO confirmed at that time that there were no written policies and procedures for management and storage of potentially infectious waste/bodily fluids in the shared space that lacked a soiled utility room. He/she acknowledged that "practice deviates with staff."

Observations on 06/28/2016 between 1215 and 1300 confirmed that:
* There was no room designated as a soiled utility or soiled hold room.
* There was no clean utility room and patient supplies were stored in unlocked carts in open spaces under the nurse's station countertop facing the hallway. The supplies were unsecured and were accessible to patients and visitors.
* There was one public bathroom located in the hallway next to Room 5. A supply of UA specimen containers was observed on a shelf in the room.
* There were no observations on the unit of "clinical flush-rim sinks", or "hoppers", designed for emptying bedpans and disposing of potentially infectious waste/bodily fluids.

* During an interview with the IP on 06/30/2016 at 1130 he/she acknowledged the CAH had not developed and implemented a policy and procedure for storage and disposal of potentially infectious waste/bodily fluids in the ED shared with surgical services pre-op/PACU.

2. On 06/29/2016 at 1030 a cart with five drawers was observed located next to the decontamination room in the ED and surgical services pre-op/PACU unit. The top of the cart had a label affixed to it that read "Dirty Dirty Dirty Instrument Drop Off" with two arrows pointing down towards the drawers. Although the label on top of the cart indicated the drawers were for "dirty" instruments, another label was attached to the top drawer that read "Clean Tub Only." It was not clear what that meant. The second drawer was labeled "Dirty Emergency Department" and had a red covered container inside it that contained numerous contaminated surgical scissors and other sharp instruments.

A sign posted on the wall above the cart read "'Clean' instruments only! Please place 'dirty' instruments in appropriate drawers below." Observed under the sign on the wall and placed on top of the cart was a red plastic covered container had no visible markings or labels. Placed on top of that container was an uncovered blue plastic basin. Inside the blue basin were observed sterile packs of surgical instruments. Also observed on top of the cart was an uncapped spray bottle of Pre-Klenz gel, used for pre-cleaning contaminated instruments.

Dirty, contaminated, sterile and clean supplies and instruments were co-mingled on the cart. The signage and labeling was not clear and did not ensure the integrity of the sterile instruments. In addition, the cart was located in a public corridor and was not secured to prevent access by visitors and patients.

* The p/p titled "Instrument Reprocessing for SC Prineville" with effective date "Not Approved Yet" was reviewed and reflected the following: "...Contaminated instrument shall be placed in biohazard containers and immediately sprayed with a gel surfactant that is "free rinsing" and compatible with washers and detergents. This initiates the cleaning process at the point of use and keeps instruments moist until transport without the use of water which would add to the weight during transport...Bins shall be transported from the clinical department 1-2 times per day for reprocessing...When bins are received in the decontamination area, instruments will be examined for bioburden...The presence of biofilm would interfere with the effectiveness of sterilization...Bins shall be cleaned in the automated washer and returned to the clinical department...Sterilized instruments will be returned to the clinical department within 48 hours..." The p/p was not approved and did not address the practice whereby clean and contaminated instruments/supplies were stored in and/or on an unlocked cart in a public hallway outside the decontamination area.

* During an interview with the IP on 06/30/2016 at 1130 he/she acknowledged it was not acceptable for clean and dirty instruments/supplies to be stored in the same cart.

3. During tour of the decontamination room on 06/29/2016 beginning at 1135 with the OR Manager, the following observations were made:

* The only sink observed in the room was used for cleaning surgical instruments. The faucet on the sink had a dispensing unit attached to it. The dispensing unit had a hose connected to it. The other end of the hose was attached to a 5-gallon container of Prolystica detergent underneath the sink. During an interview at the time of the observation, the OR Manager stated the dispensing unit on the faucet was used to dilute the Prolystica detergent. He/she stated that the detergent should be diluted to 1/8 to 1/2 ounce detergent per one gallon of water in accordance with manufacturer instructions. However, the OR Manager stated he/she did not know how or if the detergent or the dispensing unit was monitored and/or maintained to ensure the detergent was diluted appropriately.

* The decontamination room had no provisions for hand hygiene, including no handwashing sink and no other hand hygiene supplies. This was confirmed with the OR Manager at the time of the observation.

* During an interview on 06/30/2016 at 1650 the IP stated he/she contacted the manufacturer of the Prolystica detergent dispensing unit on the decontamination room sink faucet. The IP stated that information from the manufacturer indicated that the unit was inaccurate and varied depending on the amount of water pressure used. The IP stated the CAH should have been checking the dilution of the detergent but acknowledged that they had not.

4. During an interview with the Surgical Tech on 06/29/2016 at 1205 he/she stated the CAH had two steam sterilizers that were used for sterilizing surgical instruments. The Surgical Tech stated the CAH policy was that a BI was to be performed with every load of instruments that were sterilized.

* Review of "3M Steam Sterilization" records provided for "Sterilizer 1" reflected 20 sterilizer loads were performed from 04/25/2016 through 06/23/2016. Review of BI records reflected no BI results were documented for two of those loads on 05/13/2016 and 05/27/2016. During an interview on 06/29/2016 at 1205, the Surgical Tech confirmed that the BI records were not complete.

* The p/p titled "Sterilization - 3M Attest Biological Indicator, Incubation and Interpretation of Results," effective 01/02/2015 reflected "Load control is the process by which a load is monitored and released based on the results of the biological indicator. If all the spores are killed on the biological indicator, then you have assurance that the sterilization process was effective. Positive biological indicator results indicate that the sterilization process was not effective at killing spores...All biological indicator results...must be included in the sterilization records..."

5. During a tour of the endoscope reprocessing area with the OR Manager and the Surgical Tech on 06/29/2016 beginning at 1215 the following observations were made:

* An AER was observed. The AER had two wall mounted water purification filters attached to it. The cover piece on the front of the two filters had one manufacturer label and two pieces of tape affixed to it. The label reflected the "...Minimum Replacement Frequency Carbon Filter: Semi-Annually 0.2 Micron Filter Semi-Annually." One of the pieces of tape was hand written and reflected "Filters To Be Changed Annually" The other piece of tape was also hand written and reflected "Changed 4-15." It was unclear when the filters were last changed, and there was no documentation or other evidence to reflect the filters were changed in accordance with manufacturer recommendations.

* The AER was observed to have a container of Cidex OPA-C disinfectant concentrate connected to it. The container had no date on it or other evidence of when it was opened. These observations were confirmed with the Surgical Tech at the time of the observations. Manufacturer instructions for the Cidex OPA-C concentrate were reviewed and reflected "Storage Conditions and Expiration Date...Once opened, the unused portion of the concentrate may be stored in the original container, connected to the machine, for up to 80 days."

6. The p/p titled "Infection Prevention HVAC Monitoring," effective 04/13/2016 reflected "...The HVAC system is intended to reduce the amount of environmental contaminates (e.g., microbial-laden skin squames, dust, lint) in the surgical suite, procedure room...and Central Processing...All areas in use will monitor and record at a minimum once daily on a Room Environmental Tracking Log...temperature, humidity, and pressure in each of the OR rooms...central processing...procedural rooms...Temperature...Operating rooms...will be maintained between 68-78 [degrees] F...Central Processing and Decontaminations: 72-78 [degrees] F...Procedural rooms including endoscopy units: 68-73 [degrees] F...Relative Humidity...All areas: OR rooms...Central Processing, and Procedural rooms will maintain relative humidity between 20-60%...Pressure (airflow direction)...The airflow direction (i.e., pressure relationship of one area to adjacent areas) should be designed and engineered to minimize the flow of contaminates from clean to less-clean areas...OR rooms...Clean areas of Central Processing should have positive pressure...Decontamination areas will be negative to adjacent areas...Procedural rooms (especially where bronchoscopies are performed) will be negative to adjacent areas...Prineville...OR staff will check temperature and humidity before the beginning of the first case and enter it in the log. If temperature and humidity are not within the range, OR staff will notify Facilities and Infection Prevention...Document on log sheet when Facilities notified...Record on log sheet when temperature, humidity, or pressure returned to normal...If after making all possible adjustments and the levels are still not within the acceptable range within 45 minutes, make the following notifications...Notify the Manager or Supervisor...Notify Director of Infection Prevention 24/7..."

* Temperature and air pressure logs for the decontamination area for June 2016 were reviewed. Entries for temperature and air pressure were recorded for 20 days between 06/01/2016 and 06/29/2016. For all 20 days, the Airflow was recorded as "N/A." There was no other documentation reflecting the airflow was monitored or recorded. In addition, for 19 out of 20 days recorded, the temperature was outside the required range. Examples included but were not limited to the following:
On 06/02/2016 at 0610 the temperature was recorded 70.9 [degrees] F;
On 06/10/2016 at 0604 the temperature was recorded 70.8 [degrees] F;
On 06/23/2016 at 0608 the temperature was recorded 70.8 [degrees] F; and
On 06/29/2016 at 0615 the temperature was recorded 71.0 [degrees] F.
Although the log had a space for each day that read: "Action Taken (document when Facilities called: Date/Time when conditions returned to normal)," there was no documentation related to actions taken to correct the temperatures.

* Similar findings were identified during review of temperature and air pressure logs for "Sterile Core." Entries were recorded for 20 days between 06/01/2016 and 06/29/2016. For all 20 days, the Airflow was recorded as "N/A." There was no other documentation reflecting the airflow was monitored or recorded. In addition, for all 20 days recorded, the temperature was outside the required range. Examples included but were not limited to the following:
On 06/06/2016 at 0615 the temperature was recorded 65.6 [degrees] F;
On 06/10/2016 at 0605 the temperature was recorded 65.7 [degrees] F;
On 06/23/2016 at 0608 the temperature was recorded 66.1 [degrees] F; and
On 06/27/2016 at 0640 the temperature was recorded 67.8 [degrees] F.

* There was no documentation of temperature, humidity, or airflow monitoring logs for any of the areas required in the CAH's policy and procedure prior to June 2016. This was confirmed during an interview with the OR Manager on 06/29/2016 at 1100.

7. The restricted areas of the surgical services department was toured with the OR Manager on 06/29/2016 beginning at 1025. In OR 1 the following observations were made in relation to injection practices:

* In OR 1, a syringe with clear liquid inside it was observed on the anesthesia cart. The syringe was labeled as Fentanyl, a narcotic analgesic/anesthetic. The label contained a handwritten entry that read "6/29." It was not clear what that notation was. At the time of the observation the CRNA acknowledged that the time the medication was drawn up into the syringe was not recorded on the label.

* The p/p titled "Medication Administration in the Operating Room," effective 07/10/2014 reflected "...Medications and solutions both on and off the sterile field are labeled even if there is only one medication being used...Labeling must occur when any medication or solution is transferred from the original packaging to another container by a physician or caregiver and not immediately administered...Medication or solution labels include the medication name, strength, amount (if not apparent from the container), and expiration time...Medication and/or containers (e.g., syringes...if they contain medications) must be labeled at all times..."

8. In the laboratory on 06/30/2016 at 1230 a counter in laboratory work space was observed to contain numerous containers of food and beverages, including opened and uncovered beverages and an uncovered tray of cut up vegetables.

* During interview with the Laboratory Manager at that time he/she confirmed that the counter observed with food and beverages on it was the staff food area.

9. The policy and procedure titled "Caregiver Health - Tuberculosis (TB) Evaulation (sic) and Screening" reflected the TB screening was "to ensure quality and safe Infection Prevention practices for SCHS caregivers, volunteers, and students." It stipulated that "An evaluation for M. tuberculosis is required within the first seven days of employment for all caregivers and volunteers...Those who have not had a history of a positive tuberculin test shall have either a two-step tuberculin skin test applied and interpreted within the last year or a blood assay test for M. tuberculosis." The policy and procedure defined "Two-step testing" as "A procedure used for the baseline testing...If the initial tuberculin test result is classified as negative, a second test is repeated 1 - 3 weeks later..."

Documentation in personnel records of contracted Staff #s 14, 15, 16, 17, 18, 19, and 20 contained evidence of a negative tuberculin skin test. However, there was no evidence for any of those staff that the "two-step" testing had been conducted that included a second tuberculin skin test.

In addition, the documentation of the tuberculin skin test in three of the personnel records was incomplete or reflected the test was not read timely:
* Staff 19 - The "TB Skin Test" record reflected that skin test was administered on 12/16/2015, however the time was not specified. The documentation reflected that the skin test was to be read with in "48 - 72 hours after administration." The record reflected that the site of the skin test was observed on 12/20/2015, again the time was not specified. That exceeded the 72 hour limit on reading the result.
* Staff 16 - A "Family Health Associates" letterhead had the following handwritten note that was dated 04/14/2015: "Neg PPD Nov 2014." There was no evidence that the test had been conducted appropriately as it lacked the lot # and expiration date of the tuberculin used; the date and time of the test; the arm the test was administered on; and the date and time the test was read.
* Staff 17 - A "Family Health Associates" letterhead had the following typewritten note that was dated 05/11/2015: "[Staff 17's] TB skin Test was neg on 5/8/15." There was no evidence that the test had been conducted appropriately as it lacked the lot # and expiration date of the tuberculin used; the date and time of the test; the arm the test was administered on; and the time the test was read.

Review of a document titled "Onboarding requirements for Non-SCHS Personnel" reflected "St. Charles health System, Inc.'s onboarding policies are intended to keep our patients, visitors, staff, and contractors safe." The document identified "Tier 1" Non-SCHS personnel as "Personnel who will be physically present at a St. Charles facility, and who will be participating in direct patient care activities." A list of those categories of personnel followed and included: "Agency personnel (temporary employment services, nurse or allied heath staffing agencies)" and "Travel nurses or similar temporary caregivers." The document contained a list of paperwork and documents to be obtained from the "contractor and its employees." There were no documents or paperwork related to TB evaluation and screening.

Based on documentation for 3 of 3 blood transfusions in 2 of 2 medical records reviewed (Patients 16 and 17) it was determined that the CAH failed to ensure that the documentation of transfusion vital signs was accurately documented.

Findings include:

1. The medical record of Patient 17 reflected he/she received a blood transfusion that was started on 05/20/2016 at 1326 and was stopped at 1726. The "Transfusion Record" contained spaces for vital signs to be recorded during the transfusion to monitor the patient's condition. The time of the "Post Transfusion" vital signs was not clear as the time recorded had been altered by a writeover.

Patient 17 received a second blood transfusion that was started on 05/20/2016 at 2017 and was stopped on 05/21/2016 at 0030. The "Transfusion Record" reflected that the times of four sets of vital signs during the transfusion were not clear as the original times written had been altered. A BP reading and an oxygen saturation level reading were also not clear as the original entries had been altered by writeovers.

2. The medical record of Patient 16 reflected he/she received a blood transfusion that was started on 05/26/2016 at 0202 and was stopped at 0602. The "Transfusion Record" contained spaces for vital signs to be recorded during the transfusion to monitor the patient's condition. The pulse recorded at 0502 was not clear as it had been altered by a writeover.

29708

Based on observation, interview, documentation in 1 of 1 medical record of a surgical patient (Patient 12) reviewed for appropriate informed consent that addressed the individuals who participated in the surgical procedure, it was determined the CAH failed to ensure the patient's medical record contained an appropriately executed informed consent reflecting that the student PA would be participating in patient's procedure.

Findings include:

1. An observation of a surgical procedure was made in OR1 with the OR Manager on 06/29/2016 at 1045. A student PA was observed and was participating in the procedure. The PA was observed assisting the physician by making contact with the patient's surgical site using surgical instruments such as forceps and retractors.

* The medical record of Patient 12, the patient who had the surgical procedure above, was reviewed. The record reflected the patient was admitted on 06/29/2016 at 0855 with a diagnosis of chronic cholecystitis.

An operative report electronically signed by the physician and dated 06/29/2016 at 0631 was reviewed and reflected the patient underwent a laparoscopic cholecystectomy procedure under general anesthesia on 06/29/2016.

A "Patient Informed Consent" form for the surgical procedure was reviewed. The form was signed by the patient on 06/29/2016 at 0916. The top portion of the form reflected "...I authorize my Physician/Credentialed Provider...and his/her designated assistants to perform the following treatment or procedure: Laparoscopic Cholecystectomy...For the purpose of advancing medical education, I consent to the admittance of observers in the operating room." There was no other information on the form related to the "designated assistants" or that a student PA would be participating by performing hands on tasks during the procedure.

The record also contained two "Patient Consent For Educational Observer/Industrial Representative During Operation, Treatment, or Procedure" forms related to the patient's 06/29/2016 surgical procedure. Both of the forms were dated 06/29/2016 at 1023. The forms identified two other individuals who observed the surgical procedure, but did not include any information about the student PA.

There was no documentation in the medical record reflecting an informed consent was executed informing the patient that a student PA would be participating in his/her surgical procedure.

* An interview was conducted with the QIC on 06/30/2016 at 1500. Patient 12's medical record was reviewed with the QIC during the interview. The QIC confirmed there was no informed consent or other documentation in the medical record reflecting the patient was informed that a student PA would be participating in the patient's surgical procedure.