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Based on review of documentation in 3 of 3 PA credentialing records (#s 4, 5, and 10) and other documentation, and review of State of Oregon Medical Board OARs it was determined that the CAH failed to ensure that the PA's credential records clearly delineated the type of supervision required by the PA's designated supervising physician in accordance with the Oregon Medical Board PA supervision requirements.

Findings include:

1. The current rules of the Oregon Medical Board at OAR 847-050-0010(10)(a)(b)(c) define supervision as it is related to the physician and PA relationship:
"(10) 'Supervision' means the routine review by the supervising physician or designated agent, as described in the practice agreement or Board-approved practice description of the medical services provided by the physician assistant. The supervising physician or designated agent and the physician assistant must maintain direct communication, either in person, by telephone, or other electronic means. There are three categories of supervision:
(a) 'General Supervision' means the supervising physician or designated agent is not on-site with the physician assistant, but must be available for direct communication, either in person, by telephone, or other electronic means.
(b) 'Direct Supervision' means the supervising physician or designated agent must be in the facility when the physician assistant is practicing.
(c) 'Personal Supervision' means the supervising physician or designated agent must be at the side of the physician assistant at all times, personally directing the action of the physician assistant."

The current rules of the Oregon Medical Board at OAR 847-050-0037(3) contain additional language related to PA supervision:
"(3) The type of supervision and maintenance of supervision provided for each physician assistant must be described in the practice agreement or Board-approved practice description."

2. Review of the hospital's medical staff credentialing records for PA 4 revealed a hospital board appointment letter dated 10/09/2015. The letter reflected that a list of privileges granted was included. The attached privileges included, but were not limited to the following:
* Replace/exchange/removal of drains, may include simple suture
* Application of Splints/Braces
* Nail Removal
* Drainage of Subungual hematoma
* I&D of palpable superficial mass
* Simple removal of foreign body in subcutaneous tissue, nose, or ear
* Corneal foreign body removal
* Women's Healthcare Core-Outpatient
* Administer local anesthesia injections
* Suturing minor wounds/lacerations
* Simple/selective debridement, which includes the removal of devitalized tissue from an open wound using high pressure waterjet, scissors, scalpel or forceps without intent to excise subcutaneous or deeper tissue layers
* Wound care management including wound closure and performance of topical or field infiltration of anesthetic solution, and select & apply appropriate wound dressing including liquid/spray occlusive material (doesn't include wound VAC or sharp debridement)
* Administer digital blocks
* Bursa aspiration or injection of Knee
* Bursa aspiration or injection of Elbow
* Bursa aspiration or injection of Shoulder

Review of the CAH's website on 05/05/2016 revealed that the identical privileges list was published on the CAH's webpage for Professional Staff Privileges for PA 4.

Although two "Supervising Physicians" were identified by name on the privileges list, there was no documentation on the list or in any other documents in the PA's credentialing record as to what type of supervision ("general," "direct," or "personal") the supervising physicians had determined was indicated or required for each or all of those privileges.

3. Review of the hospital's medical staff credentialing records for PA 5 revealed a hospital board appointment letter dated 12/11/2015. The letter reflected that a list of privileges granted was included. The attached privileges included, but were not limited to the following:
* Anoscopy
* Application of splints and braces
* Drainage of Subungual Hematoma
* Arthrocentesis or injection of Shoulder

Review of the CAH's website on 05/05/2016 revealed that the identical privileges list was published on the CAH's webpage for Professional Staff Privileges for PA 5.

Although two "Supervising Physicians" were identified by name on the privileges list, there was no documentation on the list or in any other documents in the PA's credentialing record as to what type of supervision ("general," "direct," or "personal") the supervising physicians had determined was indicated or required for each or all of those privileges.

4. Review of the hospital's medical staff credentialing records for PA 10 revealed a hospital board appointment letter dated 02/12/2016. The attached privileges included, but were not limited to the following:
* Replace/exchange/removal of drains, may include simple suture
* Application and removal of splints, casts, and braces
* Reduction of closed fracture and joint dislocation, metacarpal, and carpometacarpal, tarsal, and ankle, phalangeal and radial head; shoulder; hip
* Aspiration or injection of joint or bursa
* Administer local anesthesia injections
* Suturing minor wounds/lacerations
* Incision and drainage of palpable superficial mass
* Simple removal of foreign body in subcutaneous tissue, nose, or ear
* Simple/selective debridement, which includes the removal of devitalized tissue from an open wound using high pressure waterjet, scissors, scalpel or forceps without intent to excise subcutaneous or deeper tissue layers
* Wound care management including wound closure and performance of topical or field infiltration of anesthetic solution, and select & apply appropriate wound dressing including liquid/spray occlusive material (doesn't include wound VAC or sharp debridement)
* Administer digital blocks

Review of the CAH's website on 05/05/2016 revealed that the identical privileges list was published on the CAH's webpage for Professional Staff Privileges for PA 10.

There was no supervising physician identified on the privileges list and there was no documentation on the list or in any other documents in the PA's credentialing record as to what type of supervision ("general," "direct," or "personal") a supervising physician had determined was indicated or required for each or all of those privileges.

A document titled "Pre-Submission Review and Confirmation Practice Agreement" was reviewed. The form identified a supervising physician and included an "Attestation/Certification Statement." However, the form was incomplete as the statement "I attest to all of the above to confirm that I understand my responsibilities as a supervising physician" was not checked in the box provided.

5. No additional information related to the type of supervision indicated and provided for the CAH's individual PAs was provided during the survey.

Based on observation, interview, and review of documents it was determined that the hospital failed to ensure it complied with State licensing requirements for hospitals:
* The CAH provided hospital rehabilitation services to inpatients, in a vacated, formerly licensed and Medicare certified SNF attached to the CAH, without the the required State licensing building plans review;
* The CAH respiratory therapy department had been relocated without the required State licensing building plans review; and
* The CAH provided hospital outpatient services to patients in spaces that it shared with non-hospital providers and therefore had not ensured CAH control over those spaces, to include continuous compliance with hospital regulatory requirements.

Findings include:

1. A tour of the rehab department was conducted on 05/04/2016 beginning at 1200 with numerous staff including the Rehab Manager, Manager of Patient Safety & Quality, and COO/CNO. The rehab department was located in a dining room at the end of a hallway on a unit that was attached to the CAH. The Rehab Manager stated that the unit was previously a SNF that had been vacated. He/she stated the CAH began using the vacated SNF dining room for CAH inpatient rehab services in November 2014. The hallway leading from the CAH to the rehab department contained 15 vacated SNF resident rooms, utility rooms, bathrooms, and a shower room. Some of the rooms were being used for CAH office space. However most rooms were disorganized and cluttered with CAH equipment and supplies. Examples included, but were not limited to the following:
* "SNF" room 104 contained numerous equipment and supplies including two ladders, an electric bed, carpet maintenance equipment, a metal shelving unit on wheels, privacy screens, an oxygen concentrator, a computer on wheels with a sign attached to it that read "this computer is broken," and a large dietary food warming unit.
* "SNF" room 105 contained numerous equipment and supplies including a desk, office equipment, chairs, a metal shelving unit on wheels, a Geri-chair, a mechanical lift and two IV pumps. The COO/CNO stated the IV pumps were new and were ready to put into service at the CAH.
* "SNF" room 107 had CAH IC training supplies in it, and a computer on wheels.
* "SNF" room 108 had yellow tape across the doorway that read "Caution - Do Not Enter" and a sign on the door that read "Isolation Room Keep Out". The room had an air purification unit inside it.
* "SNF" room 110 contained an electric bed, a large dietary food warming unit, and a large shelving unit.
* "SNF" room 115 had a bed and other furniture in it. The Manager of Patient Safety & Quality stated the room was an on-call physician sleep room.
* In the hallway near the entry to the rehab department (formerly the SNF dining room), an EZ Lift bariatric scale was observed. The scale had a sign on it that read "Do not throw out. Please return to storage rm across from ED 8 when possible..."
* The COO/CNO stated the various "SNF" rooms were used to store CAH equipment that was usable and also "out of service" items. He/she stated "Its a combination of both."

Observation of the CAH rehab department reflected it was in a dining room at the end of the "SNF" unit and CAH patients and staff accessed it via the SNF hall that was attached to the CAH. The rehab department contained numerous rehab equipment items including a Sci-Fit Step machine; a standing frame; training stairs; parallel bars; wheelchairs; walkers; a kitchen area with cupboards; a sink and countertop; stove; and an island with an attached table.

An interview was conducted on 05/04/2016 at 1735 with the CFO, COO/CNO, Quality and Risk Management Coordinator, and Manager of Patient Safety & Quality. They confirmed that the area where CAH rehab services were provided was in the dining room of a previously licensed and Medicare certified SNF. They stated that the SNF was closed and vacated May 2014 and the CAH began providing inpatient rehab services in the "SNF" dining room November 2014. The CFO stated he/she did not know if the CAH had gone through State hospital building plans review process.

2. A tour of an outpatient clinic in a MOB attached to the CAH was conducted on 05/04/2015 beginning at 1145 with the Clinical Educator, who confirmed at that time that the outpatient clinic was a hospital operation and service. The Clinical Educator stated that "It's hard to tell sometimes what is hospital" and acknowledged that it "get's confusing." As surveyor observations were being made of various clinic operations with the Clinic Charge RN, at approximately 1210 it was reported that the outpatient clinic in which observations were being made was in fact, not part of the hospital, but was a separately Medicare certified RHC.

As the tour continued on 05/04/2016 at 1300, staff present including the Clinic Manager, the Clinic Charge RN, a Nursing Supervisor, and the Clinical Educator, confirmed that RHC and other non-hospital providers had operations in spaces throughout the MOB that were not clearly separated from the CAH operations. The CAH staff present were not all clear on where the physical spaces and separation of hospital and non-hospital services were. The group planned to work on a map of the MOB to designate the locations of hospital versus RHC versus other non-hospital, independent providers.

During further tour of the CAH outpatient clinic areas in the MOB on 05/04/2016 at 1430 an area of the clinic was observed that was described as CAH cardiology services commingled with RHC services. Staff present during the tour indicated the bathroom, linen, and utility spaces were shared. Another area of the MOB observed was described as CAH oncology and RHC urology services. Staff present during the tour indicated the oncology and urology exam rooms and support spaces were shared between the hospital and non-hospital providers.

Throughout the survey two undated versions of CAH campus maps, that included the attached MOBs were provided to health and OSFM surveyors. Those versions contained significant differences. Examples include, but are not limited to:
* In one version the medical records department was located in the space that the other version reflected was the pharmacy;
* In one version the CNA training room was located in the space that the other version reflected was the respiratory therapy department; and
* In one version an attached non-hospital SNF was located in the space that the other version reflected was CAH rehabilitation services.

An enlarged, detailed map of the MOB was provided on 05/05/2016 at 0930 by the CFO who indicated that he/she had drawn it to reflect where the CAH services overlapped or were shared with non-hospital services. Examples include, but are not limited to:
* The map reflected, as observed on the 05/04/2016 tour, that on the second floor of the MOB there was an area where there were nine exam rooms in a horseshoe configuration around a nurses station, bathrooms, utility and storage areas. The hospital rooms were not contiguous and separate from the RHC rooms. The rooms were observed to be commingled and beginning at one side of the horseshoe there were two RHC rooms, three hospital rooms, two RHC rooms, and two hospital rooms, in that order to the other end of the horseshoe.
* The map further reflected, as observed on the 05/04/2016 tour, that on the first floor of the MOB there were shared CAH and non-hospital independent provider spaces. The CAH anti-coagulation clinic was in a space shared with non-hospital independent contractors. The hospital oncology clinic and the RHC urology clinic shared spaces that included exam rooms 3 and 4 that were used by both clinics on different days of the week.

3. Review of SA Health Facilities Licensing and Certification and its Facilities Planning and Safety Unit records reflected that the hospital had not submitted building plans for review, and building plans review had not been conducted, for conversion of the former SNF to a hospital rehabilitation department. In addition, the SA's records lacked evidence of the building plans review for the respiratory therapy department that had been relocated into a space formerly used as a CNA training room.





29708

37081


Based on observation, interview, and review of policies and procedures to was determined that the CAH failed to develop and implement policies and procedures to ensure that a manual jet ventilator available for emergency use had been identified, inventoried, and maintained.

Findings Include:

1. During observation of the "Difficult Airway Cart" in the surgical services department on 05/05/2016 at 1130 a manual jet ventilator was observed. The device did not have an inventory tag, a preventive maintenance sticker, or any other identifying information.

2. During interview with a CRNA at the time of the observation he/she stated that he/she had not seen the manual jet ventilator used during his/her employment at the CAH. The CRNA indicated that he/she was not aware of any policies and procedures for the use and operation of the device.

3. The policy and procedure titled "High-frequency jet ventilator use," revised 04/05/2016, was reviewed. It was specifically for the use and operation of automated jet ventilators. No policies and procedures were provided related to the use and operation of manual jet ventilators.

4. During an interview with the Regional Director of Clinical Engineering and the Biomed Department Manager on 05/06/2016 at 1030 regarding the manual jet ventilator the Biomed Department Manager stated "I didn't even know we had it." The Regional Director responded, "Neither did I." No inventory or preventive maintenance records were provided.

37081

Based on observation and review of policies and procedures and other documents, it was determined that the CAH failed to fully implement its policies and procedures to ensure that all patients were provided with a complete and accurate description of their rights in accordance with CAH policy.

Findings Included:

1. The policy and procedure titled "Rights and Responsibilities of Patients" with a revision date of "01/16" was reviewed. It reflected that "These rights and responsibilities will be provided to patients on admission and will also be displayed in all Admission areas and on hospital websites...will also be available in kiosks and information desks throughout our facilities."

The rights described included, but were not limited to:
* Know the name and role of each person who assists in your care.
* Receive care in a safe setting, free from abuse and harassment.
* Be told of reasonable alternatives for your care when acute inpatient care is no longer appropriate.
* Know if the hospital has outside relationships that may influence your treatment and care. Such relationships may be with educational institutions, health care providers or insurers.
* Be informed about hospital rules that affect you and your treatment.
* Know about hospital resources (such as care team-patient conferences) that can answer your questions and help you solve problems regarding your illness, treatment choice or hospital stay.
* Have an interpreter or telephone interpreter if you are not comfortable communicating in English, or if you are hearing-impaired, or require access to special needs equipment.
* Visitors of choice, free from discrimination based on age, race, color, creed, ethnicity, religion, national origin, marital status, sex, sexual orientation, gender identity, or expression...
* Designate a support person who has your authority to exercise all of the patient rights concerning your visitors.* Refuse to consent to a person visiting, or withdraw consent to see a visitor.

2. Brochures with the title "Patient Rights and Responsibilities" with four different version dates were observed in various departments throughout the hospital during the survey:
* In the MOB outpatient clinic the brochure was dated "09/13."
* In the ED the brochure was dated "07/14."
* In the off-campus outpatient rehab clinic the brochure was dated "05/15."
* In the admission packet the brochure was dated "11/15."

All four versions lacked the following rights described in the policy and procedure:
* Be free from abuse or harassment.
* Know the name and role of each person who assists in your care.
* Be told of reasonable alternatives for your care when acute inpatient care is no longer appropriate.
* Know if the hospital has outside relationships that may influence your treatment and care. Such relationships may be with educational institutions, health care providers or insurers.
* Be informed about hospital rules that affect you and your treatment.
* Know about hospital resources (such as care team-patient conferences) that can answer your questions and help you solve problems regarding your illness, treatment choice or hospital stay.
* Designate a support person who has your authority to exercise all of the patient rights concerning your visitors.* Refuse to consent to a person visiting, or withdraw consent to see a visitor.

The brochure dated "11/15" included expanded rights information about interpreter services that was not provided in the other three brochures.

The CAH website was reviewed on 05/16/2016 and revealed it also lacked rights described in policy. For example:
* Know if the hospital has outside relationships that may influence your treatment and care. Such relationships may be with educational institutions, health care providers or insurers.
* Visitors of choice, free from discrimination based on age, race, color, creed, ethnicity, religion, national origin, marital status, sex, sexual orientation, gender identity, or expression...
* Designate a support person who has your authority to exercise all of the patient rights concerning your visitors.* Refuse to consent to a person visiting, or withdraw consent to see a visitor.

In addition, the "09/13" version of the brochure lacked accurate and complete contact information for patients to file complaints or grievances with the SA, the Medicare QIO, and the AO, consistent with the contact information that was provided on the other three brochure versions.

Based on observation and interview it was determined that the CAH failed to ensure that narcotic and anesthetic IV drugs were stored, handled, and labeled appropriately.

Findings include:

The surgical services department was toured with the Manager of Surgical Services and the Manager of Patient Safety & Quality on 05/05/2016 beginning at 1000. In OR 3 a CRNA was observed to place two syringes into his/her pocket and then leave the OR. During interview at that time the CRNA stated that the syringes in his/her pocket were from a previous surgical case. The CRNA removed the two syringes from his/her pocket and they were both observed to contain a clear liquid. One of the syringes had a sticker affixed to it that identified the medication inside as Fentanyl, a narcotic analgesic/anesthetic, and the other had a sticker affixed to it that identified the medication inside as Versed, an anesthetic. Neither one of the syringes were dated, timed, or authenticated.

29708

Based on observation, interview, and review of policies and procedures, and other documents it was determined the CAH failed to fully develop and implement policies and procedures for infection prevention in the following areas:
* Surgical site infections were not thoroughly investigated in accordance with appropriate IC policies and procedures;
* Refrigerated food was improperly stored and was outdated;
* Disinfection and cleaning supplies were not dated when poured into secondary containers, expiration dates were illegible, cleaning supplies were stored with patient care supplies, and disinfection solutions were not managed in accordance with manufacturer instructions;
* Endoscopes were not stored in accordance with manufacturer recommendations;
* Hand hygiene was not appropriately performed;
* IV medications and tubing, imaging contrast solutions, and other biologicals and medical supplies were not managed or stored appropriately; and
* Environmental surfaces and areas were cluttered, in disrepair and were not cleanable.

Findings included:

1. During an interview on 05/05/2016 at 1000 the Manager of Surgical Services stated the CAH had an increase in the number of SSIs in 2015. He/she stated the CAH had five SSIs in 2015, and had no SSIs for two and half years prior to 2015. He/she stated an investigation was conducted for each of the SSIs.

The following documents were provided in response to a request for investigations of the SSIs identified by the CAH for 2015:
* An "OR Region: Surgical Site Infection (SSI) Surveillance & Response Process Overview" dated "July, 2014" which contained primarily information about a SSI SharePoint site and a surveillance and response process.
* An Oregon Region SSI Quarterly Dashboard document titled "PSH - Surgical Site Infection Report Ending Q1 of 2016" dated "Updated for Q1, 2014" that contained graphs pertaining to SSIs.
* A "Providence Health & Services Oregon Region: Pre-operative Decolonization Program" document dated "January, 2016" that was primarily information related to pre-operative protocols.
* An untitled undated document that contained primarily patient medical record information for five patients who had surgical procedures at the CAH in 2015 and who had SSIs.
There was no documentation in those records that reflected an investigation of the SSIs.

There were no IC p/ps related to investigation of SSIs.

An interview was conducted with the IP on 05/06/2016 at 1045. The IP confirmed that the CAH had an increase in SSIs in 2015. He/she stated that an investigation should be conducted for every SSI identified by the CAH. The IP stated he/she did not know of any IC p/p that described the CAH's process for investigating a SSI. He/she reviewed the documents above and acknowledged that although there had been patient data collected related to the increase in SSIs, it did not contain documentation of a complete and thorough investigation of each SSI as there should have been.

2. During a tour of the ED with the ED Manager and the Manager of Patient Safety & Quality on 05/04/2016 beginning at 1615 the following observations were made:
* The refrigerator used to store patient food contained numerous food items with illegible, outdated and unclear dates. For example, a Yoplait yogurt container was dated "Use by May 1, 2016;" an applesauce container had an illegible "best by" date; a tuna sandwich was observed and had only "4" hand-written on it and no information reflecting when it was prepared and/or when it was outdated; a turkey sandwich had only "5" written on it; an egg salad sandwich had only "5" written on it; a chicken salad sandwich had only "5" written on it; and two containers of Jello had only "13" written on them. These observations were verified with staff present at the time of the observation.
* The soiled utility room was cluttered with equipment and supplies. The handwashing sink and the containers for contaminated instrument storage were not readily accessible as there was a large bin and other equipment/supplies that blocked access. Numerous wall surfaces had gouges and areas of chipped paint. The counter top around the sink and the entry door both had laminate surfaces that were peeling and in disrepair. Those surfaces were not cleanable.
* Two containers of Prepzyme enzymatic solution used for pre-cleaning surgical instruments had illegible expiration dates.
* A bottle of 3M Quat disinfectant solution was observed in a secondary container with a manufacturer label affixed to it. There was no date on the bottle or other evidence reflecting when the disinfectant was transferred to the secondary container.

3. During a tour of the scope reprocessing area with the SPT, the Manager of Surgical Services, and the Manager of Patient Safety & Quality on 05/05/2016 beginning at 1150 the following observations were made:
* The counter top around the sink had a laminate surface that was peeling and in disrepair. That surface was not cleanable.
* An automated endoscope reprocessor was observed. The reprocessor had a container of Cidex OPA concentrate connected to it. The container was not dated and there was no evidence of when it was opened. Manufacturer instructions for the Cidex OPA 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." During an interview with the Manager of Surgical Services on 05/05/2016 at 1240, he/she acknowledged there was no evidence to reflect how long the container of Cidex OPA concentrate had been connected to the endoscope reprocessor.
* An endoscope storage cabinet was observed. The cabinet contained four endoscopes that were hanging vertically inside it. The cabinet also contained a rack that was positioned approximately in the bottom third of the cabinet on which eight pink denture cups were placed. The inside surfaces of the denture cups had a white film on them that had the appearance of dried liquid. An endoscope cap was observed in each of four of the denture cups, and the end of one of the endoscopes was dangling inside of another denture cup. An undated document titled "Starsys Scope Storage System" that contained manufacturer instructions for the endoscope storage cabinet reflected there were no recommendations or instructions for the use of denture cups inside the cabinet. This was confirmed with the Manager of Surgical Services. An interview was conducted with the IP on 05/06/2016 at 1115. In regards to the use of denture cups in the endoscope storage cabinet, he/she stated "This is not a practice I would expect to see or want to see."

4. The surgical services department was toured with the Manager of Surgical Services and the Manager of Patient Safety & Quality on 05/05/2016 beginning at 1000. In OR 3 the following observations were made in relation to hand hygiene and injection practices:
* With ungloved hands the RN touched the patient's skin, gown, blood pressure cuff and pulse oximeter. The RN then touched the computer mouse, placed his/her hands into his/her pockets, donned gloves, picked up a glove from the floor and discarded it, labeled a lab specimen container, picked up another glove from the floor and discarded it, and then removed his/her gloves. The RN then touched the computer mouse, put his/her hands into his/her pockets, and donned another pair of gloves. No hand hygiene was observed during these activities.
* With ungloved hands the CRNA touched the patient's skin and gown numerous times, donned gloves, administered two doses of IV medications, suctioned the patient's oral airway, removed the gloves, wiped the patient's gurney rails with a disposable wipe, donned another pair of gloves, touched the computer, and then assisted with transporting the patient out of the OR. No hand hygiene was observed during these observations
* In addition, the CRNA did not disinfect the IV port prior to administering the two doses of IV medications identified above.
* The CRNA returned to OR 3 a few minutes later and was observed to place two syringes into his/her pocket and then leave the OR. During interview at that time the CRNA stated that the syringes in his/her pocket were from a previous surgical case. The CRNA removed the two syringes from his/her pocket and they were both observed to contain a clear liquid. One of the syringes had a sticker affixed to it that identified the medication inside as Fentanyl, a narcotic analgesic/anesthetic, and the other had a sticker affixed to it that identified the medication inside as Versed, an anesthetic. Neither one of the syringes were dated, timed, or authenticated.
* A p/p titled "Hand Hygiene" dated "Effective: 03/2013" was reviewed and reflected the following: "Indications for Hand Hygiene...Before having direct contact with patients...After contact with patient or patient's environment...After contact with blood or body fluids...After removing gloves..."

5. During a tour of the ICU with the ICU Manager on 05/03/2016 at 1145, a spray bottle of 3M Quat disinfectant solution was observed in the medication room. The disinfectant was in a secondary container with a manufacturer label affixed to it. There was no date on the bottle or other evidence reflecting when the disinfectant was transferred from its original container to the secondary container. In addition, the disinfectant was observed in a cupboard with lab collection supplies, IV start supplies, and other patient care items. During an interview with the ICU Manager at the time of the observation, he/she stated the disinfectant should not be kept in a cupboard with patient care supplies.

6. During a tour of the M/S unit with the Manager of M/S and the Manager of Patient Safety & Quality on 05/03/2016 beginning at 1015 the following observations were made:
* In room 208, a one liter bag of IV fluids with tubing attached to it was observed hanging at the patient's bedside. A blue sticker was attached to the tubing. The sticker read "Change Thursday." The "Date," "Time" and "#" spaces on the sticker were not completed and were blank. There was no date or other evidence on the IV tubing to reflect how long it had been hanging or when it was last changed.
* In the soiled utility room, a spray bottle of 3M Quat disinfectant was observed. The disinfectant was in a secondary container with a manufacturer label affixed to it. There was no date on the bottle or other evidence reflecting when the disinfectant was transferred from its original container to the secondary container. During an interview with the IP on 05/04/2016 at 1510, he/she stated that disinfectants should be dated when they were transferred from their original container to a secondary container.

7. The off campus outpatient rehab department was toured with the Manager of Rehab Services on 05/05/2016 beginning at 1350. Treatment room 4 was observed and the wall surfaces at the entry of the room were gouged, in disrepair and were uncleanable.

8. During tour of the CT control room on 05/04/2016 at approximately 1630 the following observations were made:
* The small room was cluttered with supplies and equipment, including three foam mattresses and pads stored on the floor.
* Biological solutions and medical and lab supplies were stored in the room on top of the hot GE Medical Systems metal control cabinet. Numerous single-dose, 150 ml. bottles of Omnipaque Injection 300 mg/ml were stored in the room. Manufacturer's instructions on the bottle label stipulated that the bottles were to be stored between 20 to 25 degrees Celsius, to 68 to 77 degrees Fahrenheit. The room was significantly warmer than the adjacent CT workroom and the CT machine room and after a few minutes in the small enclosed room it felt hot. During interview with the Imaging Manager at that time he/she stated that Imaging staff didn't monitor the room temperature and there was not a thermometer in the room. On 05/06/2016 a temperature log from the hospital's HVAC system was provided that reflected that control room temperature had spiked in excess of 76 degrees on 05/04/2016, however, that temperature would not account for additional heat applied to solutions and supplies sitting directly on a hot metal surface.

Based on review of the contracted services list and review of contracts it was determined that the CAH failed to maintain a list of all CAH services that were furnished under contract or agreement.

Findings include:

Refer to the findings at Tag C292, CFR 485,635(c)(4), Services Provided Thru Agreement or Arrangement, which reflects that the CAH had a contract for Mobile Cataract Services and Oregon Janitorial Services, and those services were not on the CAH's list of services that were furnished under contract or agreement.

Based on interview, review of policies and procedures, review of the contracted services list and review of contracts it was determined that the CAH failed to develop and implement its policies and procedures to ensure that all services furnished in the CAH under contract, were provided in a manner that permitted the CAH to comply with all applicable CoPs. Written contracts for services did not contain language that ensured the contractor would comply with applicable CoPs and standards; and the CAH had not evaluated all contracted services to ensure they were provided in a manner to allow the CAH to comply with all applicable CoPs and standards. Those services were:
* Cardiac monitoring and devices;
* Blood products;
* Janitorial and cleaning; and
* Equipment and supplies for opthalmic procedures.

Findings include:

1. The p/p titled "Providence Seaside Hospital New Contract/Service Agreement Development Process" last updated "July, 2012" reflected the following: "If the contract or service agreement provides for the provision of direct patient care, the Manager will work through the Patient Care Contract Renewal process...Once all signatures are obtained, the completed contract...should be returned to the the Administration Executive Assistant...The Administration Executive Assistant will scan the completed Contract/Service Agreement and the Contract Review Checklist and save it as an attached file in the PSH Contracts SharePoint site..." The "Patient Care Contract Renewal Process" section of the policy reflected "The Manager of the Responsible Department must ensure that the contract...Establishes clear performance expectations for the services being provided...That these expectations are clearly communicated to the contracting service providers...The Manager of the Responsible Department will complete and return to Quality Management a Direct Patient Care Contract Service Evaluation Form within fifteen (15) days of being notified that the contract is due for review...Quality Management will provide additional input/information to the Direct Patient Care Contract Evaluation Form within (15) days of receipt of completed form...Quality Management will take completed form to the next scheduled Medical Executive Committee for input, review, and approval...The Administration Executive Assistant will scan the completed Direct Patient Care Contract Service Evaluation Form and save it as an e-file on the MGR folder in the Direct Pt Care Eval Folder..." The p/p included no language that required an evaluation of whether the contractor furnished services in a manner that permitted the CAH to comply with all applicable CoPs and standards for the contracted services.

2. The contract for "iRhythm Technologies, Inc." was dated 04/17/2014. The document reflected an agreement for cardiac monitoring and devices at the CAH. There was no language in the document that required the contractor to provide services in a manner that ensured compliance with all applicable CoPs and standards for the provision of safe and appropriate patient care. There was no evidence that the CAH had monitored and evaluated those services.

During interview with the Quality & Risk Management Coordinator on 05/06/2016 at 1230, he/she stated that the CAH had not evaluated the iRhythm cardiac monitoring services provided under contract.

3. The contract for "Puget Sound Blood Center" was dated effective 09/25/2014. The document reflected an agreement for blood product services at the CAH. There was no language in the document that required the contractor to provide services in a manner that ensured compliance with all applicable CoPs and standards for the provision of safe and appropriate patient care. There was no evidence that the CAH had monitored and evaluated those services to ensure it was in compliance with all applicable CoPs and standards for the contracted service.

4. The contract for "Oregon Janitorial Service" was dated effective 07/01/2015. The document reflected an agreement for janitorial and cleaning services at the CAH. There was no language in the document that required the contractor to provide services in a manner that ensured compliance with all applicable CoPs and standards for the provision of safe and appropriate patient care. There was no evidence that the CAH had monitored and evaluated those services.

An evaluation of the janitorial services provided under contract was requested from the Quality & Risk Management Coordinator on 05/06/2016 at 1230. No evaluation was received.

5. The contract for "Mobile Cataract Service, SLT and YAG Laser Service" was dated effective as of 02/03/2016. The document reflected an agreement for providing the CAH with equipment and supplies for opthalmic procedures. There was no language in the document that required the contractor to provide services in a manner that ensured compliance with all applicable CoPs and standards for the provision of safe and appropriate patient care.

6. A list of services furnished at the CAH under contract was provided and reviewed. It did not include Mobile Cataract Service or Oregon Janitorial Service.

29708

Based on interview, review of documentation in 6 of 18 medical records of CAH patients (Patients 6, 8, 13, 18, and 20) who received nursing services, and review of policies and procedures it was determined that the CAH failed to ensure that the RN supervised and evaluated the patient's care in accordance with CAH policies, procedures and physician orders in the following areas:
* Cardiac monitoring;
* Newborn identification; and
* Blood transfusion initiation times and vital signs.

Findings include:

1. The p/p titled "Regional Nursing Minimum Documentation Reference" dated last revised "08/2014" was reviewed and reflected the following: "This minimum documentation...applies to nursing units..." The "Emergency Department" section reflected "If placed on Telemetry: Initial rate and rhythm should be documented in Epic. Any change in rhythm is documented."

* The ED record for Patient 6 was reviewed. The record reflected the patient arrived at the ED on 05/02/2016 at 0630. The physician H&P dated 05/02/2016 at 0635 reflected "[patient] presents to the ED for evaluation of sudden onset of shortness of breath. Patient with fever. Working to breathe. Unable to speak...admitted to the ICU." Physician orders at 0640 reflected an order for cardiac monitoring.

The RN notes at 0632 reflected "Patient placed on cardiac monitoring..." The RN notes at 0642 reflected the the patient's pulse rate was 165. The patient was admitted to ICU on 05/02/2016 at 0838. There was no documentation in the record reflecting the RN evaluated and documented the patient's cardiac rhythm in accordance with the CAH's policy and procedure.

* An interview was conducted with the ED RN on 05/03/2016 at 1220. He/she acknowledged there was not documentation reflecting the RN evaluated the patient's cardiac rhythm. He/she stated the CAH policy and procedure was not followed because it required that the RN document the patient's cardiac rhythm when cardiac monitoring was initiated.

2. The p/p titled "Newborn/Mother Identification" dated last revised "February 2015" was reviewed. The "Objective" of the policy was "To ensure proper proper maternal/newborn identification." The policy required that "Completed identification bands must be applied within 30 minutes after delivery...Initial application of bands...Complete all required information on insert cards at time of delivery including newborn's sex, mother's full name, date and time of delivery and mother's care provider...Apply the two small bands to newborn's extremities, usually a wrist and ankle...All identification bands are applied within 30 minutes of age...Document all pertinent information on 'Newborn Identification' form."

* The medical record of newborn Patient 8 was reviewed. The record reflected the newborn patient's date and time of birth was 04/27/2016 at 0548. The first RN documentation reflecting an ID band was on the patient was not until 04/27/2016 at 0630, 42 minutes after the newborn patient's birth, and it reflected "...ID band/electronic transponder on..." In addition, there was no "Newborn Identification" form in the medical record as required by the CAH's policy and procedure.

3. The policy and procedure titled "Blood and Blood Products: Consent, Administration, and Transfusion Reaction," dated as last revised "02/2015," was reviewed. It stipulated that "Initiate the transfusion slowly...for the first 15 minutes...remain with, or be in a position to closely observe, the patient for at least the first 15 minutes...After the initial 15 minutes, obtain another set of vital signs." It further required that "All blood products must be initiated within 30 minutes from the time of release from Blood Bank/Transfusion Services."

* During interview with the Med/Surg & OB RN during the medical record review on 05/05/2016 at 1510, he/she stated that the hospital's policy was that vital signs are to be taken at 15 mins after a transfusion is initiated, at the end of the transfusion, and more often if indicated. He/she also confirmed that the transfusion must be started within 30 minutes after the blood leaves the lab.

* The record of Patient 20 reflected he/she had two blood transfusions on 12/12/2015. The transfusion record reflected the first one was started at 0115, however, the first vital signs taken after the transfusion start were at 0045, in excess of the 15 minutes required by policy. The transfusion record reflected a second transfusion was started at 0302, and the first vital signs taken were at 0335, in excess of the required 15 minutes.

* The record of Patient 18 reflected that he/she had a blood transfusion on 04/08/2016. The transfusion documentation reflected the blood for the transfusion was signed out of the lab at 1107. The transfusion record for the transfusion reflected it was initiated at 1320, in excess of the required 30 minutes.

* The record of Patient 13 reflected that he/she had a blood transfusion on 04/18/2016. The transfusion documentation reflected the blood for the transfusion was signed out of the lab at 1136. The transfusion record for the transfusion reflected it was initiated at 1420, in excess of the required 30 minutes.




37081

Based on interview and review of CAH evaluation documentation and other records it was determined that the CAH had not conducted timely, complete and accurate evaluations of its total program at least annually.

Findings include:

1. The "2014 Critical Access Hospital Annual Review" was reviewed. It reflected that it had been reviewed and signed by the CEO, the COO/CNO, and the CFO on 05/06/2016, the last day of this survey. The annual evaluation was not timely or complete. Examples include, but are not limited to:
* The "Clinical Record Review" section included the following statement: "Review of active and closed clinical records is conducted in a number of ways including but not limited to the following..." There was no description of actual record reviews conducted or a summary of record review findings in 2014.
* The "Quality Assurance" section consisted of a description summary of a quality program but did not include a description of actual quality activities conducted or a summary of quality findings in 2014.
* The "Infection Prevention Performance Indicators" for 2014 "Surgical Site Infections" was blank.

2. The "2015 Critical Access Hospital Annual Review" was reviewed. It reflected that it had been reviewed and signed by the CEO, the COO/CNO, and the CFO on 05/06/2016, the last day of this survey. The annual evaluation was not complete. Examples include, but are not limited to:
* The "Clinical Record Review" section included the following statement: "Review of active and closed clinical records is conducted in a number of ways including but not limited to the following..." There was no description of actual record reviews conducted or a summary of record review findings in 2015.
* The "Quality Assurance" section consisted of a description summary of a quality program but did not include a description of actual quality activities conducted or a summary of quality findings in 2015.
* The "Infection Prevention Performance Indicators" for 2015 "Surgical Site Infections" reflected that there were zero, or no such infections. However, during an interview on 05/05/2016 at 1000 the Manager of Surgical Services stated the hospital had five SSIs in 2015.
* The "Mid-level Evaluation" section included the following statement: "Nurse Practitioners and Clinical Nurse Specialists are not utilized in the hospital setting. There is one Physician Assistant utilized within surgical services who is evaluated annually..." However, review of the medical staff roster and credentialing records reflected that at the end of 2015 the hospital's medical staff included 11 CRNAs, 17 Nurse Practitioners, and 3 PAs.

3. In neither the 2014 or 2015 documents was there evidence that the information and data had been analyzed to evaluate the performance of the CAHs total programs and services in order to identify areas of improvement or change.

4. This information was reviewed with the COO/CNO and the CFO on 05/06/2016 at approximately 1200 and no additional information was provided.