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Based on documentation in 9 of 21 medical records reviewed (Patients 1, 4, 6, 7, 8, 10, 11, 12, and 21), and review of policies and procedures and other documents, it was determined that the CAH failed to fully comply with the requirements of 42 CFR 489.102 regarding advance directives as the CAH failed to provide and document information in accordance with the federal requirements which include:
* That the CAH provide written information, including notice of its policies, regarding the implementation of patients' rights to make decisions concerning medical care, such as the right to formulate advance directives;
* That the written information and notice of the CAH's advance directive policy be provided at the time an individual is admitted as an inpatient;
* That the CAH also provide the advance directive notice to outpatients;
* That issuance of the written notice of the CAH's advance directive policies to the patient or the patient's representative must be documented in the patient's medical record; and
* That the CAH staff document in a prominent part of the patient's medical record whether or not the patient has executed an advance directive.
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Findings include:

1. The policy and procedure titled "Advance Directive" with a revision date of "11/09" was reviewed. It required that "To comply with the Patient Self-Determination Act of 1990, every patient who is admitted to Coquille Valley Hospital for an acute hospital stay or in observation status will be asked if they have an Advance Directive and if not, information regarding Advance Directives will be offered...Record appropriately in the hospital information system if a patient brings in a completed Advance Directive..."

Although the forms used for recording and filing an advance directive were observed in the patient admission packet provided, there was no evidence that the CAH's policy regarding advance directives was included and provided to patients.

2. In the record of Patient 4, the "Conditions of Care" consent form signed and dated by the patient on 04/28/2015 included checkboxes for "Yes" and for "No" next to items that read "An Advance Directive has been given to me", "I have previously received the Advanced (sic) Directive Information", and "I have executed an Advanced (sic) Directive". Neither the yes of no box was checked for any of those items. In addition, the "Advance Directive" space on the "Patient Information" and demographics sheet was blank.

3. In the record of Patient 21, the "Conditions of Care" consent form signed and dated by the patient's representative on 02/19/2015 included checkboxes "Yes" and for "No" next to items that read "An Advance Directive has been given to me". That item was checked as "yes". However, for the following two items "I have previously received the Advanced (sic)Directive Information" and "I have executed an Advanced (sic) Directive" neither the yes of no boxes were checked. In addition, the "Advance Directive" space on the "Patient Information" and demographics sheet was blank.

4. There was no documentation provided for Patient 6 related to advance directives.

5. Similar findings were identified in the records of Patients 1, 7, 8, 10, 11, and 12.

Based on observation, interview and review of documentation it was determined that the CAH failed to ensure that all operations were approved as required by the State of Oregon hospital licensing requirements, and consistent with the State license issued.
* OAR 333-515-0050, OAR 333-535-0000, and OAR 333-675-0000 require that a hospital submit building construction plans to the SA for review and approval prior to building construction/alterations for the addition of new services to the CAH's operations and relocation of existing services. Those areas may not operate until approval to commence services is received from the SA, the Oregon hospital licensing authority. The CAH began providing Nuclear Medicine services in March 2015 without the required SA review and approval; and construction/alterations were in process for relocation of the Stress Test Lab without the required SA review and approval; and
* OAR 333-500-0036 stipulates that no hospital licensed...shall in any manner or by any means assert, represent, offer, provide or imply that such...hospital...may render care or services other than that which is permitted by or which is within the scope of the license issued to the hospital by the Division..." Although the CAH discontinued OB services in 2013 and OB services were removed from the CAH's State license, the CAH currently represented in signage and marketing materials that it provided OB services.

Findings include:

1. During interview on 06/09/2015 at 1100 the CEO stated that the CAH began providing Nuclear Medicine services in March 2015 in the CAH's East Wing, formerly the "old hospital". The CEO confirmed that was a new service the CAH had not provided previously.

The Nuclear Medicine department was observed during tour on 06/10/2015 at 1030. The Nuclear Medicine technologist was interviewed at that time. He/she indicated having been employed by the CAH since September 2014 to help set up the service. During the tour the technologist confirmed that physical alterations were made to the physical structures of the department that included: Installation of a new Gamma Camera; removing doors; moving walls; building a "hot lab" for storage and management of radioactive materials; and adding air conditioning. He/she stated that operations began on 03/23/2015. The technologist stated that 21 patient procedures had been performed since that time and provided a list of those 21 procedures titled "Nuclear Medicine 2015 Patients".

The review of Oregon hospital licensing records maintained by the SA revealed no evidence that the CAH had initiated the licensing plans review process prior to building construction/alterations for the addition of Nuclear Medicine services.

The review of CMS certification records reflected that the most recent CAH Medicare Database Worksheet completed by the CAH was dated 06/30/2011. In the section for the description of services it denoted that the CAH did not provide Nuclear Medicine services. There was no evidence that the CAH had initiated the process of notification to CMS of the addition of the new service.

2. During tour of the "East Wing" on 06/10/2015 at 1125 a room identified by the DQPI as the "new stress test lab location" was observed. Observations at that time revealed the space was actively under construction. A ladder, paint, and tools were evident and there were electrical outlet cutouts in walls. One of the walls in the room separated that space from the "old hospital kitchen." A few minutes later at 1135 the backside of that wall was observed while in the "old kitchen." The wall was completely unfinished and the studs were fully exposed. Layers of uninstalled sheetrock were observed in the "old kitchen" space.

During interview with the DQPI at the time of the tour he/she stated that the door to the "new stress test lab" was new and the door had been moved about 18 inches from it's original position. He/she also confirmed that alterations had been made to walls. During the interview it was confirmed that an air conditioning unit had been installed and that the electrical had been altered to "220" voltage to accommodate an electric treadmill.

The review of Oregon hospital licensing records maintained by the SA revealed no evidence that the CAH had initiated the licensing plans review process prior to building construction/alterations for relocation of an existing service.

3. SA records reflected that the State license application submitted for 2014 annual renewal denoted that the CAH no longer provided OB services. The CEO confirmed that in an email to the SA dated 12/03/2013 and wrote that the CAH "...discontinued providing elective Obstetrical services about mid-year (2013)." As a result, the State licenses issued to the CAH for 2014 and for annual renewal 2015 lacked the written designation for OB services. However, observations and records reviewed reflected that CAH was representing that it provided OB services.

The current CAH brochure titled "Locations and Services" contained a section titled "Services". The list of services included "Obstetrics/Labor & Delivery; Birthing Suite; Rooming in; Cesarean Sections; and Prenatal Education Classes". The brochure contained a map of the CAH that denoted room or space "322" as "Obstetrics/Labor & Delivery".

The current admission packet provided to patients was reviewed. It contained the brochure identified above and a second brochure titled "Coquille Valley Hospital". It also contained a list of services that included "Obstetrics/Labor & Delivery; Birthing Suite; Rooming in; Cesarean Sections; and Prenatal Education Classes".

During tour of the CAH on 06/09/2015 at 1445, and on all days of the survey, the signage next to the central public elevators was observed to identify "Obstetrics/Labor & Delivery".

On 06/11/2015 at 1545 in the Pharmacy Drug Room a replacement code cart tray was labeled as OB.

The current policy and procedure from the "Materials Management" department titled "Outdates" included checking the OB utility room and the nursery.

A "...equipment inventory 1/28/2015" included the following items: Birthing bed and 2 fetal monitors located in "LDRP", and an infant warmer located in "Nursery/LDRP". A UHS "Inventory and Service History" dated 06/10/2015 also included a section for OB services and identified 3 fetal monitors and an infant warmer as equipment for that department with PM completion dates of 04/20/2015.

The CMS CAH Medicare Database Worksheet was completed with the CEO on 06/17/2015 at 1530. The CEO denoted on the form that the CAH did not provide OB services.

Based on observation, interview, and review of licensure documentation for 1 of 5 RTs (#5), and other records it was determined that the CAH failed to ensure that all personnel for whom licensure was required were currently licensed.

Findings include:

Review of a list of current CAH personnel reflected a total of 5 RTs who worked in the RT department.

During tour of the RT department on 06/11/2015 at approximately 1500 the licenses of the five RTs were observed posted on a filing cabinet. The license of RT 5 was observed with an expiration date of 04/30/2015. A review of RT 5's license on the Oregon RT Health Licensing Board website at that time confirmed that RT 5's license had expired on 04/30/2015 and his/her license status was denoted as "inactive".

During interview on 06/12/2015 at approximately 1115 the DQPI confirmed that RT 5 worked full-time and had been scheduled to work that day.

Based on observations, interviews, and review of policies, procedures, and other documents and records it was determined that the CAH failed to fully develop and implement policies and procedures to ensure that drugs necessary for use in emergencies throughout the CAH, including those in emergency code carts, were controlled and secured, and outdated and otherwise unusable drugs were not available for patient use.

Findings include:

Refer to Tag C276, CFR 485.635(a)(3)(iv), regarding drug management, which reflects the CAH's failure to ensure drugs necessary for use in emergencies throughout the CAH were controlled and secured, and outdated and otherwise unusable drugs were not available for patient use.

Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure that the physical environment was constructed and maintained in a safe, clean, and orderly manner for patients and staff:
* Numerous areas in the CAH were in disrepair, cluttered and dirty;
* Construction alterations to the physical plant had been made for the provision of Nuclear Medicine Services, and were in process for the provision of a Stress Test Lab, without approval of the Oregon hospital licensing authority;
* CAH space at a provider-based clinic was arranged and maintained for the sharing of space and operations with non-CAH providers;
* There was lack of an organized CAH-wide patient-care equipment preventive maintenance program;
* Drugs and biologicals were not controlled and secured, and outdated and otherwise unusable drugs were available for patient use;
* There was lack of proper temperature control and monitoring in drug and food storage areas;
* There was lack of oversight of laundry services provided by an outside vendor without a contract or formal arrangement;
* There was lack of proper temperature and humidity control and monitoring in surgery;
* There was lack of staff training in handling fire emergencies; and
* There was lack of compliance with the Life Safety From Fire requirements as indicated on the report of the Oregon State Fire Marshal.

The findings identified during the survey by both the health survey team and the fire safety survey team reflect the CAH's limited capacity to provide care in a safe, clean and orderly environment, and represents a Condition-level deficiency of CFR 485.623, Condition of Participation: Physical Plant and Environment.

Findings include:

1. Refer to the findings identified at Tag C221, CFR 485.623(a), Construction.

2. Refer to the findings identified at Tag C222, CFR 485.623(b)(1), Maintenance - Housekeeping and preventive maintenance.

3. Refer to the findings identified at Tag C224, CFR 485.623(b)(3), Maintenance - Drugs and biologicals.

4. Refer to the findings identified at Tag C225, CFR 485.623(b)(4), Maintenance - Clean and orderly.

5. Refer to the findings identified at Tag C226, CFR 485.623(b)(5), Maintenance - Ventilation, lighting, temperature control.

6. Refer to the findings identified at Tag C227, CFR 485.623(c)(1), Emergency Procedures - Staff training.

7. Refer to the findings identified on the report of the Oregon State Fire Marshal at Tags C231 through C237, CFR 485.623(d), Life Safety From Fire.

Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure that the physical environment was constructed, arranged, and maintained in a safe, clean, and orderly manner for patients and staff:
* Numerous areas in the CAH, including where patient services were provided, were in disrepair, cluttered and dirty;
* Building construction/alterations had been made for the addition of Nuclear Medicine services to the CAH's operations, and were in process for relocation of a Stress Test Lab, without the required approval of the SA, the Oregon hospital licensing authority; and
* CAH space at a provider-based clinic was arranged and maintained for the sharing of space and operations with non-CAH providers.
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Findings include:

1. The East Wing of the CAH was formerly the "old hospital." During observations on 06/09/2015, 06/10/2015, 06/11/2015, and 06/12/2015 the provision of patient care and other CAH operations was observed on the East Wing. Patient care services provided on the East Wing included nuclear medicine, stress testing, provider-based outpatient and injection services. Many of the spaces in the East Wing were cluttered, disorganized, and dirty, including those where patient services, drug storage, and medical records storage occurred.

On the days of the survey identified above, the open and unlocked East Wing "injection room" was observed in the "old ED", across the hall from the East Wing provider-based clinic. The "injection room" space was in the entrance to the "old ED" and was separated from the main "old ED" space with a curtain that partially blocked the view of the main "old ED" space. Behind the curtain shelves, cabinets, countertops and floor surfaces were extremely dirty, stained, and in disrepair; and were cluttered and crowded with supplies, old equipment, tools, housekeeping supplies, and numerous boxes.

During interview with an "East Wing" clinic staff person on 06/12/2015 at 1100, he/she confirmed that the "injection room" is used for the administration of injections to patients and that patients are seated in the "injection room" to wait for and receive their injections in that space.

2. The following observation was made during tour of SP with the ST 06/12/2015 beginning at 1130:

* In the decontamination area the countertop next to the sink had white staining that had the appearance of spilled liquid. During an interview conducted with the ST at the time of the observation, he/she stated that the stain was probably caused by something that had spilled on the countertop.

3. Refer to Tag C225, CFR 485.623(b)(4) which reflects that the CAH was not arranged and maintained in a clean and orderly manner.

4. Refer to Tag C153, CFR 485.608(c), Licensure of CAH, which reflects that building construction/alterations had been made for the addition of Nuclear Medicine services to the CAH's operations, and were in process for relocation of a Stress Test Lab, without the required approval of the SA.

5. The following observations were conducted during tour of the NBMC provider-based clinic with the clinic manager on 06/11/2015 beginning at 1115:

* A laundry room/utility room was observed and contained a side by side washing machine and dryer set, a stackable washing machine and dryer unit, and laundry supplies. During an interview with the clinic manager at the time of the observation, he/she stated that linens used for patient injections and patient gowns were laundered in the room. He/she further stated that the laundry room and laundry equipment was shared between the NBMC provider-based clinic and non-CAH providers who also occupied the building. This area was accessible and used by non-CAH personnel. Therefore, the CAH did not maintain control of the space in order to ensure appropriate CAH processes were in place related to laundering of linens used for CAH patients.

* A janitorial closet was observed with the clinic manager. Equipment and supplies for maintenance and cleaning floors, cleaning solutions, paper towels, red biohazard bags, crutches, a box of children's toys and various other supplies were observed stored in the room. During an interview with the clinic manager at the time of the observation, he/she stated that the janitorial closet was shared between the NBMC provider-based clinic and non-CAHl providers who also occupied the building. This area was accessible and used by non-CAH personnel and was therefore not under the control of CAH personnel at all times.

* A patient treatment room #20 was observed with the clinic manager. A patient examination table, examination light equipment, a wall mounted sharps container, examination gloves, and other equipment and supplies for patient care were observed. During an interview with the clinic manager at the time of the observation, he/she stated that the patient room was shared between the NBMC provider-based clinic and non-CAH providers who also occupied the building. This area was accessible and used by non-CAH personnel and patients. This area was accessible and used by non-CAH personnel and was therefore not under the control of CAH personnel at all times.

* Additional observations conducted with the clinic manager included but were not limited to the following: The clinic entrance and lobby area, reception desk, open common area behind the reception desk, employee break/lunch room, attic storage area, and nurse station. During an interview with the clinic manager on 06/11/2015 at 1245 he/she confirmed that all of those areas were shared between the NBMC provider based clinic and non CAH providers. The clinic manager stated that almost all of the clinic was "shared."

6. Refer to Tag C276, CFR 485.635(a)(3)(iv), regarding drug management, which includes findings that NBMC provider-based clinic drug storage was combined with non-CAH provider drug storage and was not controlled and secured to prevent theft, misuse, and tampering; and to ensure outdated and otherwise unusable drugs were not available for CAH patient use.






29708

Based on observation, interview, review of PM documentation and policies and procedures, it was determined that the CAH failed to fully develop and implement systems to ensure that all electrical and bio-medical patient care equipment had been maintained to ensure an acceptable level of safety and quality:
* All patient care equipment throughout the CAH had not been incorporated into a clear and complete inventory;
* Documentation did not reflect that timely PM's had been conducted for patient care equipment that was in use or was available for use.

Findings include:

1. The policy and procedure titled "Maintenance Management Policy" with an effective date of 05/2012 was reviewed. It stipulated that "It is the policy of Coquille Valley Hospital and its clinics to identify the activities in writing for maintaining, inspecting and testing for all medical equipment on the inventory...All medical equipment used for treatment, diagnosis, monitoring and care of patients, operated within or by the Coquille Valley Hospital and the Coquille Valley Hospital's clinics, must pass an inspection for safety, performance and compliance with the manufacturer's specifications prior to use with patients. The engineering department normally performs these inspections. All medical equipment must meet or exceed applicable codes for local and national jurisdiction to be accepted. ..The Director of Plan Operations is responsible for determining preventive maintenance strategies associated with the medical equipment maintenance program. The Director also assures that medical equipment is scheduled according to its strategy for maintenance and for evaluation of the rate of compliance with schedule inspection activity.."

The policy further stipulated that "When new equipment is received, as part of the initial check-in equipment is assessed using Criteria for Inclusion. The results of the assessment are noted in the documentation and are used to select the strategy for maintenance...An equipment history file must be maintained for each ID number in the Medical Equipment Maintenance Inventory. An additional file for equipment not owned by the hospital (short term inventory) will also be established and maintained.

2. Two lists of patient care equipment were reviewed. One titled "Biomed inventory 1/27/2015" and the other titled "...equipment inventory 1/28/2015". The 01/28/2015 list contained several more items than the 01/27/2015 list. The 01/28/2015 list contained 42 types of equipment, with 103 total pieces of equipment, and had columns for the type of equipment, the manufacturer, the model, the serial number, the "Location/Notes", "Inst. Date", and "Total Count.":
* There was no indication of whether there were inventory or ID numbers associated with each piece of equipment;
* The list was incomplete with numerous omissions in various columns including serial numbers, location, and "Inst. Date";
* It was not clear what "Inst. Date" was intended to be, however, there were 12 items on the list that had dates and those dates ranged from 01/01/1978 to 03/12/2012;
* Multiple numbers of the same type of equipment were identified, such as the defibrillators (3), the AEDs (4), Vital sign monitors (5), infusion pumps (24), and bedside monitors (10). Each of those items were not individually listed and each piece's serial number was not identified.

3. A UHS Biomedical report for the reporting period of 07/01/2014 through 06/10/2015 was titled "Medical Equipment Management Program Safety Committee Report".

The "Inventory and Service History" section of the 51 page document contained a list of equipment for each CAH department. The "Total Equipment Count" was 154, not consistent with the 103 items identified on the "...equipment inventory 1/28/2015". Although some equipment listed on the UHS inventory was also on the 01/28/2015 inventory, most of the two lists contained different equipment.

The "Preventive Maintenance Performance" section of the report reflected that 78 pieces of equipment scheduled for PM, with PM due dates ranging from 07/24/2014 to 04/22/2015 had not been done.

4. During tours conducted throughout the CAH observations of patient care equipment were made. The equipment lists and PM records identified under findings #s 2 and 3 above were reviewed for the equipment observed. Discrepancies identified include, but are not limited to the following:

On 06/09/2015 at 1440 in the OR, equipment observed included:
A Steris Amsco warming cabinet with SN 0403412054; and a Hobart washer LX 30. Neither of those were found on either the "...equipment inventory 1/28/2015" or the UHS "Inventory and Service History."

On 06/09/2015 beginning at 1530 in the East Wing, equipment observed included:
A standing weight scale; a Befour wheelchair scale; a hydraulic Hoyer lift with a sticker that identified #000523. Those items were not found on either the "...equipment inventory 1/28/2015" or the UHS "Inventory and Service History."

On 06/09/2015 at 1545 in the East Wing "Stress Test Room", equipment observed include:
A GE Treadmill with a Jaken Medical sticker that indicated inspection was done in 06/2014 and was due in 06/2014; and a Precision suction machine with a sticker that indicated "Tested For Electrical Safety Date 11/6/2012". None of those were found on either the "...equipment inventory 1/28/2015" or the UHS "Inventory and Service History."
In addition, a Zoll defibrillator had a UHS Biomed sticker with #495097. There was no PM sticker evident. This was not found on the "...equipment inventory 1/28/2015" list, and the UHS "Inventory and Service History" reflected that the next PM was "Due 2/17/2015."

On 06/10/2015 at 1030 in the Nuclear Medicine department, equipment observed included:
A Gamma Camera; a Ludlum Survey Meter 14c; and a Precision suction machine with no PM no sticker visible. None of those were found on either the "...equipment inventory 1/28/2015" or the UHS "Inventory and Service History."

On 06/10/2015 at 1150 in "old Room 119", equipment observed included:
A Castle exam lamp identified with a sticker as #2766 and with a Biomed date of 07/17/2013; and an Aaron 940 Bovie with a sticker dated 08/09/2013. Neither of those were found on either the "...equipment inventory 1/28/2015" or the UHS "Inventory and Service History."

On 6/10/2015 at 1200 in East Wing provider-based clinic exam room #1, equipment observed included:
A Welch Allyn Sure Temp Plus and wall charger unit with no PM sticker evident. The only Welch Allyn "Vitals Monitors" reported on the "...equipment inventory 1/28/2015" list were five identified as "SPOT" models in "Various" locations, and this item was not on the UHS "Inventory and Service History."

On 6/10/2015 at 1215 in East Wing provider-based clinic exam room #3, equipment observed included:
A Welch Allyn wall charger unit with no PM sticker evident; and a goose neck exam lamp identified with a Biomed 8689 label and an inspection sticker that indicated it had been inspected in 06/2009 and was due for next inspection in 06/2010. Neither of those were found on either the "...equipment inventory 1/28/2015" or the UHS "Inventory and Service History."
A Ritter 104 electric exam table was also observed. Four "Midmark 104" exam tables were reported on the "...equipment inventory 1/28/2015" list identified only as "CV Med Clinic/East Unit", and this item was not on the UHS "Inventory and Service History."

On 06/10/2015 at 1445 in the corridor outside CAH administration, an AED was observed in a wall unit with a label that indicated "Preventive Maintenance Next Check Date 12/27/13." Four AEDs were reported on the "...equipment inventory 1/28/2015" list identified only as "RT/1st FL/2nd FL/Clinic", and it was not found on the UHS "Inventory and Service History."

On 06/10/2015 at 1500 in the corridor outside the East Wing provider-based clinic, an AED was observed in a wall unit with a label that indicated "Tested for Electrical Safety Date 11/6/12." That was not found on either the "...equipment inventory 1/28/2015" or the UHS "Inventory and Service History."

On 06/10/2015 at 1630 in the ED, equipment observed included:
A Zoll defibrillator had a label that indicated "Biomedical Equipment Control 2913". No inspection sticker was evident. Three defibrillators were reported on the "...equipment inventory 1/28/2015" list identified only as "ER/Med Surg/OR".

On 06/11/2015 at 1200 in the NBMC provider-based clinic, equipment observed included:
A Welch Allyn wall unit with a sticker identified with #180111; and a goose neck lamp on wheels. Neither of those were found on either the "...equipment inventory 1/28/2015" or the UHS "Inventory and Service History."

On 06/11/2015 at 1520 in the laboratory, equipment observed included:
A blood refrigerator with a Biomed sticker that identified #160164. The UHS "Inventory and Service History" reflected that the next PM on that item was "Due 10/11/2014."
A GE Mac 5500 EKG with a PM label was not found on the "...equipment inventory 1/28/2015".

5. Interview with the three plant operations staff was conducted on 06/12/2015 at 1135. The staff initially reported that they were unaware of whether there was an inventory list that contained each piece of patient care equipment used in the CAH. They indicated that plant operations did not have such a list. However, during the interview an extensive search of electronic files in the department was conducted by the staff and two lists of equipment were found. One with a filename of "Biomed inventory 1/27/2015 and the other with a filename of "...equipment inventory 1/28/2015", as described under finding #2 above..

The staff reported a lack of understanding and knowledge about how department specific patient care equipment was maintained for safety and calibration, and that departments were responsible for their own specialized equipment.

They indicated that all patient care equipment is supposed to come to plant operations from purchasing and have an "inspection...to be looked at...visual at a minimum." They reported that the most recent manager of the department had been the individual responsible to do equipment "safety checks" and now that he/she was recently retired one of the three of them would be responsible for that. That staff person stated that they would like to have an electrical safety inspection for every piece of equipment. During the interview an electrical safety inspection sticker was provided for observation. Staff indicated that all equipment should have either the electrical safety inspection sticker or the UHS sticker.

The staff reported that patient care equipment that requires calibration is supposed to have a biomedical inspection, but that the equipment is put into service in the CAH for use prior to that inspection.

Staff stated that there was no documentation of initial inspections of new equipment. They reported they were unaware of any records kept for ongoing inspections and repairs for each piece of equipment, except for the UHS report. Staff also reported that work order forms used to generate work on equipment needing repair or reservicing were "kept for awhile then purged."

Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure appropriate storage of drugs and biologicals:
* Drugs and biologicals were not controlled and secured, and outdated and otherwise unusable drugs were available for patient use; and
* There was lack of proper temperature control and monitoring in drug storage areas.

Findings include:

Refer to Tag C276, CFR 485.635(a)(3)(iv), regarding drug management, which reflects the CAH's failure to appropriately store, control and secure drugs throughout the CAH to ensure drug integrity and efficacy; to prevent theft, misuse, and tampering; and to ensure outdated and otherwise unusable drugs were not available for patient use.

Refer to Tag C278, CFR 485.635(a)(3)(vi), regarding infection control, which reflects outdated or otherwise unusable biologicals were available for patient use. The adequacy, efficacy, and reliability of those items for their intended purpose is not ensured when used beyond the expiration date.

Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure that the physical environment was maintained in a safe, clean, and orderly manner for patients and staff. Numerous areas in the CAH, including where patient services were provided, were in disrepair, cluttered and dirty.

Findings include, but are not limited to:

1. On 06/09/2015 beginning at 1515 during tour of the East Wing, formerly the "old hospital", the following observations were made:
* The medication room counter behind the nurses station was covered with a large amount of a thick pink and beige colored matter;
* Boxes of patient care infusion supplies were stored on the counter immediately next to the sink and the pink and beige colored matter in the medication room;
* A glass jar of home-canned "salmon" was stored in the medication room on a counter above the infusion supplies;
* In patient room 103 there were peeling tiles in the patient bathroom;
* In the linen closet in the patient room corridor, shelving was in disrepair and covered with a white powder-like substance;
* A single patient use washbasin was stored on the floor of the linen closet with an uncovered toothbrush inside of it;
* In the utility room the hopper was stained with a dark brown matter or residue;
* In the Stress Test Room the fabric on a chair was significantly torn and tattered; and
* The closet floor and shelves where patient supplies were stored in the Stress Test Room was covered with dirt and debris.

2. On 06/10/2015 at 1030 in the East Wing Nuclear Medicine department the following observations were made:
* Multiple square cutouts of flooring had been reset in the floor along two walls in the Gamma Camera room, some of which had unsealed gaps resulting in openings in the floor;
* A large fly was flying in the Gamma Camera room and CAH staff stated "That's a big fly"; and* Several boxes were stored on the floor in the "hot lab", rendering the floor not readily cleanable.

3. On 06/10/2015 at 1115 in the East Wing plant operations and maintenance area the following observations were made:
* A large Oxygen tank was observed standing upright and not secured to anything; and
* Shelves, cabinets, countertops and floor surfaces were extremely dirty, stained, and in disrepair; and were cluttered and crowded with supplies, carts overflowing with items, old equipment, tools, paints, housekeeping supplies, handtrucks, numerous boxes, patient medical records, and radiology films and lab reports.

4. On 06/10/2015 at 1135 in the East Wing "old kitchen" the following observations were made:
* The entire length on one wall was observed to be studded only without sheetrock;
* Dozens of popsicle boxes were piled on a long countertop; and
* Shelves, cabinets, countertops and floor surfaces were extremely dirty, stained, and in disrepair; and were cluttered and crowded with supplies, carts, old equipment, an uninstalled old cabinet, new equipment, pieces of sheetrock, five-gallon buckets, tools, wooden "sawhorses", housekeeping supplies, and numerous boxes.

5. On 06/10/2015 at 1140 in the East Wing "old laboratory" the following observations were made:
* Multiple uninstalled porcelain sinks were stored on the countertops;
* The base of an old uninstalled and stained toilet was stored on the floor next to an uninstalled diaper changing wall-unit;
* Bottled of lab reagents and diluents were stored on cabinet shelves; and
* Shelves, cabinets, countertops and floor surfaces were extremely dirty, stained, and in disrepair; and were cluttered and crowded with supplies, carts, old lab equipment, office equipment, computer equipment, piles of cabinet shelves, wires and cords, tools, lampshades, housekeeping supplies, and numerous boxes of miscellaneous items.

6. On 06/10/2015 at 1145 in the East Wing "old community relations and IT space" the following observations were made:
* Numerous pieces of computer equipment and numerous wires and cords were inundating the spaces on all surfaces including attached to the walls;
* Countless pieces of paper and records and documents were covering the walls, desktops and shelves; and
* Shelves, cabinets, countertops and floor surfaces were extremely dirty, stained, and in disrepair; and were cluttered and crowded with lab and patient care supplies, old equipment, new equipment, tools, a handtruck, housekeeping supplies, and numerous boxes.

7. 06/10/2015 at 1155 in the East Wing "old central storage and surgical services area" the following observations were made:
* Shelves, cabinets, countertops and floor surfaces were extremely dirty, stained, and in disrepair; and were cluttered and crowded with surgical and patient care supplies, carts, old equipment, old cabinets, a couch, chairs, other furniture, numerous gallons of paint, maintenance supplies, tools, housekeeping supplies, patient care equipment such as a treadmill, and numerous boxes of miscellaneous supplies and items; and
* In a room connected to the surgical services area, a household type bed covered with bed linens was observed, as were slippers on the floor. The toilet in an adjoining bathroom was stained with a brown residue. During interview with the QM during the observation, he/she acknowledged that someone might be sleeping there.

8. 06/10/2015 at 1230 in the East Wing "old ED" the following observations were made:
* Boxes of drugs were stored on the floor and in unlocked cabinets and shelves;
* Cabinet doors were off their hinges;
* Multiple gurneys were covered with boxes and other items;
* A mattress what propped up on its side on a countertop;
* Boxes of patient care supplies were stored in the cabinets;
* Large cutout holes in the walls with exposed wires;
* A hopper and the sink were stained with brown residue; and
* Shelves, cabinets, countertops and floor surfaces were extremely dirty, stained, and in disrepair; and were cluttered and crowded with supplies, old equipment, tools, housekeeping supplies, and numerous boxes.

Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure proper temperatures and other environmental conditions throughout the facility:
* There was lack of proper temperature control and monitoring in drug storage areas;
* There was lack of proper temperature control and monitoring in food storage areas;
* There was lack of assurance that appropriate temperatures were used for processing soiled linens; and
* There was lack of proper temperature and humidity control and monitoring in surgery.

Findings include:

Refer to Tag C276, CFR 485.635(a)(3)(iv), regarding drug management, which reflects the CAH's failure to monitor temperatures of refrigerated drug storage to ensure temperatures were maintained within manufacturer's recommendations.

Refer to Tag C278, CFR 485.635(a)(3)(vi), regarding infection control, which reflects the CAH's failure to ensure appropriate food temperatures and storage; failure to ensure appropriate soiled linen processing temperatures; and failure to monitor temperatures and humidity in the ORs to ensure those critical measurements were maintained within required parameters.

Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure the safety of patients in non-medical emergencies:
* There was lack of staff training in handling fire emergencies; and
* There was lack of compliance with the Life Safety From Fire requirements as indicated on the report of the Oregon State Fire Marshal.

Findings include:

Refer to the findings identified on the report of the Oregon State Fire Marshal at Tags C231 through C237, CFR 485.623(d), Life Safety From Fire, which reflects the CAHs failure to comply with fire safety requirements.

Based on documentation in 21 of 21 medical records reviewed (Patients 1 through 21), and review of policies and procedures and other documents, it was determined that the CAH failed to fully develop and implement the patient's rights policies and procedures it had adopted to ensure that patients received complete and accurate notification of all their rights as CAH patients, in writing, in advance of furnishing care whenever possible.

Findings include:

1. The policy and procedure titled "Patient Rights and Responsibilities" with revision date of 08/16/2011 was reviewed. It required that "Each patient, or the patient's family and/or responsible guardian, will be fully informed of the patient's rights and responsibilities prior to or at the time of admission to the hospital...On admission the patient will be asked by admitting personnel to read and acknowledge that he/she has received a copy of the patient rights."

The undated "Patient Rights" form identified in the patient admission packet as the one provided to patients was reviewed.

The list of patient rights identified in the policy did not coincide with the list of rights identified on the patient rights form.

2. In the record of Patient 4, the "Conditions of Care" consent form signed and dated by the patient on 04/28/2015 included a checkbox for "Yes" and one for "No" next to an item that read "I have received a Patient Bill of Rights." Neither the yes of no box was checked.

3. In the record of Patient 5, the "Conditions of Care" consent form signed and dated by the patient on 01/08/2015 included a checkbox for "Yes" and one for "No" next to an item that read "I have received a Patient Bill of Rights." Neither the yes of no box was checked and a large handwritten "X" was marked on the form over the entire section of the form that contained the patient rights and other acknowledgements, such as advance directives.

4. There was no documentation in the record of Patient 6 related to receipt or notification of patient rights information.

5. Similar findings were identified in the records of Patients 7, 8, 10, and 12.

6. Refer to Tag C1001, CFR 485.635(f), Patient Visitation Rights, which reflects the CAH's failure to develop and implement the required policies and procedures related to patient visitation. The required rights were not incorporated into the patient's rights policy and procedure, and form provided to patients. There was no documentation in the medical records of Patients 1 through 21 to reflect that patient's had been informed, prior to the furnishing of care, of their visitation rights.

Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure that the physical environment was constructed and maintained in a safe, clean, and orderly manner for patients and staff:
* Drugs and biologicals, including narcotics, were not controlled and secured to prevent theft, misuse, and tampering;
* Outdated and otherwise unusable drugs were available for patient use, including expired drugs, manufacturer's samples, filled patient prescriptions, opened and used MDVs of injectable drugs; and opened and used topical drugs; and
* There was lack of proper temperature control and monitoring in drug storage areas.

Findings include:

1. On 06/09/2015 at 1515 in the East Wing vacated and unoccupied nurses station medication room the following observations were made:
* The door to the room was unlocked and open;
* The medication refrigerator was filled with drugs and it was unlocked;
* Numerous drugs in the refrigerator had outdated such as: Four MDVs of Humulin Insulin were outdated 10/2014; 12 MDVs of Humalog Insulin were outdated 04/2014 and 05/2015; and eight pre-filled insulin "FlexPens" were outdated with dates of 11/2012, 12/2012, 01/2014, 03/2014, and 05/2014; and
* Six MDVs of insulin were labeled with prescription labels for two different patients and were also outdated 01/2014 and 01/2015;
* MDVs of TB PPD, Influenza Vaccine, Pneumococcal Vaccine, and Tetanus/Diptheria/Pertussis were stored in the refrigerator;
* The freezer was covered with a layer of ice two to three inches thick; and
* There was no thermometer in the refrigerator and no other method of temperature monitoring was evident to ensure the integrity and efficacy of the drugs and vaccines.

2. On 06/09/2015 at 1545 in the East Wing Stress Test Room the following observations were made:
* The door to the room was unlocked.
* An emergency code cart was in the room and a plastic "lock" with a number on it was attached to a rod that was positioned in front of all the doors of the cart. A "Crash Cart Lock" form was noted on a clipboard on the cart. The form reflected that the numbered cart "locks" were changed 7 times since 08/2013 on 08/16/2013, 09/30/2013, 04/04/2014, 08/22/2014, 09/02/2014, 01/09/2015, and 04/03/2015. A "lock" number was recorded next to each of those dates. A stock of numbered locks was observed unsecured in a pile next to the code cart. There was no evidence that the integrity of the cart was monitored on a more frequent basis than eight times in almost two years.
* The cart was opened and in the bottom drawer of the cart were observed 6 large clear Ziplock type bags for "critical drip" infusion kits. Each kit contained drugs and supplies specific to the drip. The contents of each kit was recorded on a form which included the expiration dates of the applicable items, and was observed through the clear bag as follows:
The Lidocaine kit contained Lidocaine outdated 03/2015 and NACL IV solution outdated 06/01/2015;
The Dopamine kit contained Dopamine outdated 02/2015 and NACL IV solution outdated 06/01/2015;
The Amiodarone kit contained Amiodarone outdated 04/2015 and NACL IV solution outdated 06/01/2015;
The Dobutamine kit contained NACL and D5W IV solutions outdated 06/01/2015;
The Heparin/TNK kit contained NACL IV solution outdated 06/01/2015;
The Nitroglycerin kit contained NACL IV solution outdated 06/01/2015.
* The top drawer of the cart contained in excess of 76 boxes, ampules, and various sizes of MDVs of drugs that were loose in the drawer, not readily identifiable in the event of an emergency, and not easily inventoried for control and security purposes.

3. During a tour of the outpatient services department on 06/10/2015 beginning at 1055 the following observations were made:
* In a patient treatment room an unlocked cabinet was observed and contained IV, injectable and oral medications. An interview was conducted with the RN at the time of the observation. The RN stated he/she locked the door to the treatment room when he/she went on a lunch break. However, he/she acknowledged that the cabinet was not locked and stated he/she did not have a key to the cabinet in order to ensure the security and integrity of the medications at all times.

4. On 06/10/2015 at 1200 in the East Wing provider-based outpatient clinic the following observations were made:
* In exam room 1 a large opened and used container of Silver Sulfadiazine Cream was outdated 06/2010; and a MDV of NACL Injection was outdated 06/2013; and
* In exam room 3 a box of Triple Antibiotic Ointment single use dose packets was outdated 11/2013.

5. On 06/10/2015 at 1230 in the East Wing "Injection Room" in the "old ED" the following observations were made:
* The door to the room was unlocked and open;
* An unlocked blue metal wall cabinet contained numerous MDVs of injectable medications including: 7 MDVs of Ceftriaxone; 4 MDVs of Methotrexate; 7 MDVs of Cyanocobalamin; and multiple other MDVs of drugs; and a MDV of 1% Xylocaine was outdated 01/2014; and
* An unlocked "Rubbermaid" type double door standing cabinet contained in excess of 150 different packages and containers of oral and injectable medications, including manufacturer's samples, filled patient-specific prescription bottles, and outdated drugs. The cabinet was disorganized and contained boxes and bins full of drugs. Drugs included, but were not limited to: Celebrex; Lyrica; Chantix; Viagra; Spiriva; NACL Injection flushes outdated 12/01/2014; packages of Advil outdated 07/2013; packages of Senokot-S outdated 06/2014 and 02/2015; Narcotic Fentanyl Patch outdated 11/2013; Narcotic Morphine Sulfate, 55 tabs; and multiple others.

6. On 06/10/2015 at 1450 in the East Wing "Injection Room" in the "old ED" the following additional observations were made:
* The door to the room was unlocked and open; and
* Three boxes of drugs stored on the floor under a table contained numerous outdated drugs, manufacturer's samples, and filled patient-specific prescription bottles including: 4 Accucheck kits outdated 12/31/2013; Diltiazem; Amitriptyline; Amox-Clav; Spironolact; Flagyl; Pepcid outdated 01/2015; Nexium; Premarin; Bystolic; Cialis outdated 02/2015; Detrol LA outdated 11/2014; and multiple others.

7. On 06/10/2015 at 1600 in the supply storage room in the public corridor outside the Radiology Department the following observations were made:
* The door to the room was unlocked;
* The room contained approximately 30 MDVs of Sodium Bicarbonate and Lidocaine for Injection; and
* Two MDVs of 8.4% Sodium Bicarbonate for injection were outdated 03/01/2015.

8. On 06/10/2015 at 1630 in the ED the following observations were made:
* An emergency code cart was in the ED and a plastic "lock" with a number on it was attached to a handle mechanism that would allow the opening of the cart doors when it was turned. The "Crash Cart Lock Log" (different from the one observed on the Stress Test Room code cart) contained three columns, one for "Lock #", one for "Date", and one for "Initial". The form did not specify on what unit the code cart was located; entries were not routinely recorded; since 02/2015 there were 23 entries recorded; there were no times recorded; and no reasons documented. There was no evidence that the integrity of the cart was monitored on a regular and routine basis to ensure the security and integrity of the drugs inside.
* Observation of the drugs in the cart revealed numerous drugs lying loose in the top drawer of the cart similar to the Stress Test Room cart described under finding #2 above. There was no systematic or efficient way to determine when each of those drugs were to expire. A pre-filled syringe of Lidocaine was outdated 04/01/2015.
* Red tool box type kits were observed in the bottom drawer of the cart and were labeled as "Dopamine", "Dobutamine", and "Amiodarone." During interview with the pharmacy tech at that time he/she stated that those were the "critical drip" kits and that in order to see the contents of the kit, including expiration dates, one would need to break the numbered "lock" on each kit and open the kit to see the form with the list of the contents and the corresponding expiration dates.

9. On 06/10/2015 at 1645 in the Med/Surg Unit the following observations were made:
* An emergency code cart was in the Med/Surg Unit and there were 3 records associated with the monitoring of the cart. The "Defibrillator Check List" contained 8 items pertaining only to the defibrillator and related supplies. It did not contain any system for monitoring of the numbered "lock" on the cart or the drugs in the cart. The "Crash Cart Lock Log" (different from the one observed on the Stress Test Room code cart) contained three columns, one for "Lock #", one for "Date", and one for "Initial". The form did not specify on what unit the code cart was located; entries were not routinely recorded; since 08/2014 there were 42 entries recorded; and there were no times documented.
* In addition, two different versions of the form were observed and discrepancies were noted between the two. For example on each of the two versions of the form "lock" number 453345 was recorded on 05/06/2015 by two different authors and "lock" number 453352 was recorded on 05/08/2015 by two different authors. One version of the form had two "lock" number entries on 05/23/2015 and the other version did not contain those entries. One version also had a few sporadic reasons the cart was opened while the other had no reasons recorded. For example, one of the entries dated 05/08/2015 for "lock" # 453352 reflected "Lock was not on night (sic?)". It was not clear whether that was "night" or "right". However, there was no further explanation for what that meant and what numbered "lock" was being referred to. As that "lock" number was recorded on both versions of the form, the "lock number" prior on one form was 963967 which had been recorded on 05/06/2015, and on the other version the "lock" number prior was 453345 recorded on 05/06/2015.
* During interview with an RN at the time of the observation he/she stated that a stock of the numbered "locks" are kept in the code cart.

The discrepancies in the documentation in conjunction with a lack of routine monitoring of the "lock" numbers reflect lack of a system that ensures the security and integrity of the medications in the cart.

10. On 06/11/2015 at 1140 in the NBMC provider-based clinic the CAH shared with non-CAH providers the following observations were made:
* Eight drug storage cabinets on both sides of a corridor (4 on each side), leading to a portion of the building used for CAH services, were observed.
* During interview at that time clinic staff stated that the 8 drug storage cabinets on both sides of the corridor were shared by the NBMC provider-based CAH providers and the non-CAH providers. However, other clinic staff stated at that time that only specific cabinets were used by the CAH providers. None of the cabinets were labeled or marked to indicate CAH versus non-CAH operations. All of those cabinets were in an unsecured corridor, were unlocked, and contained in excess of 200 packages and containers of drugs, including manufacturer's samples. Drugs included: Ulovic outdated 05/22/2015; Pulmicort outdated 04/2015; Flovent outdated 04/2015; Symbicort; MDVs of Bystolic; Pristiq; Savella; and Namenda.
* In the clinic exam room 11 MDVs of Depo-Medrol, Lidocaine, and Marcaine had been opened and used and did not reflect the open dates. During interview with the QM at that time he/she stated that when a MDV is opened the date and time is to be recorded on the label and the drug should be used within 30 days.
* In the clinic exam room 12 an opened and used MDV of Lidocaine was outdated 04/01/2015. In addition, that MDV, and MDVs of Depo-Medrol and Marcaine had been opened and used and did not reflect the open dates.
* In the clinic exam rooms 13 and 14 MDVs of Lidocaine had been opened and used and did not reflect the open dates.

11. On 06/11/2015 at 1500 in the Respiratory Therapy department the following observation was made:
* Brovanna Inhalation Solution stored in the refrigerator was outdated 02/2015.

12. On 06/11/2015 at 1545 in the Pharmacy Drug Room the following observations were made:
* A back room of the Drug Room contained countless containers of drugs that were disorganized and piled on countertops and on top of code cart replacement trays;
* One of the replacement code cart trays was labeled as OB and contained a list of drugs that reflected that Droperidol was outdated on "2-1-14." Observation of the medications through the clear tray confirmed 4 vials of the injectable medication, each with an expiration date of 02/2014.

13. A tour of the ED was conducted on 06/11/2015 at 1720. An unlocked box of medications was observed at the nurse's station in an unlocked cabinet. The box contained 14 bins of various IV, injectable and oral medications including but not limited to the following:
Chloropromazine 25 mg PO;
Chloropromazine 50 mg/2 ml;
Clindamycin 150 mg PO;
Cyclobenzaprine 10 mg PO;
Hydralazine 20 mg/ml;
Hydroxyzine Pamoate 25 mg PO;
Vancomycin 1 gm IV;
Propofol 1%; and
Meclizine 25 mg PO.
* During an interview conducted with the ED RN at the time of the observation, he/she stated that the bin was an "emergency go to box" and that the cabinet containing the box of medications was never locked.

14. During a tour of the surgical services department on 06/12/2015 beginning at 1045 the following observations were made:
* In the "Prep/Recovery C" room an unlocked emergency supply cart was observed with a surgical RN and contained various anesthesia supplies and medications. The cart had a tackle box on top of it that was also unlocked and contained anesthesia medications and supplies including vials of Propofol and Anectine. * During an interview conducted with the surgical RN at the time of the observation, he/she stated that the cart and tackle box were used for emergency airway procedures throughout the hospital. The RN acknowledged that the cart and tackle box were unlocked and that there was no system in place for monitoring the security and integrity of the contents within the cart and tackle box.
* In an area of the open nurse's station referred to by staff as the "med work area," multiple unlocked stacking bins of injectable and oral medications were observed stocked on the counter top. The medications were not locked or secured in any way. This observation was conducted with the surgical RN.
* In the preop/postop area an emergency cart was observed with the surgical RN. The cart was unlocked and the top drawer of the cart contained a plexiglass container with various emergency medications. The plexiglass container had two red plastic breakaway "locks" in place. Each of the "locks" had an identification number. On one lock the identification number was 453371, and on the other lock the identification number was 453319. Inside the plexiglass container was a form titled "For Emergency Use Only Code Tray." The form contained a list of 25 medications and associated expiration dates. The bottom of the form reflected "Checked By" followed by a pharmacist signature. The bottom of the form also reflected: "Exp 7.31.2015" and "Tag # 529705, 529707, 453371, 453319". There was no documentation to reflect what those numbers represented or when they were last checked.
* In addition, the drawers of the cart were labeled indicating it contained multiple other emergency supplies and medications including malignant hyperthermia medications, malignant hyperthermia kits, irrigation kits, endotracheal tubes, nasogastric tubes, urine dip sticks, and anesthesia supplies.
* A one page checklist form with the heading "Department: Surgery" located with the cart was reviewed. It was dated June 2015 and contained numerous emergency equipment items and supplies to be checked. Those included a defibrillator, suction unit and an oxygen tank, all of which were observed stored outside the cart. The form did not include provisions for checking supplies or any of the medications contained within the cart, including checking the numbered "locks" on the medication container in the top drawer.
* During an interview conducted with the a surgical RN on 06/12/2015 at 1120, he/she was unaware of a system for checking the medications and supplies inside the emergency cart. He/she stated the cart was "always unlocked" and he/she did not know who had a key to the cart.
* In OR 2 an anesthesia supply cart was observed with a surgical RN and ST. The cart was unlocked and contained numerous emergency, anesthetizing and other medications including but not limited to the following: Labetalol Hydrochloride, Ephedrine, Bupivacaine, Heparin, Lasix, Benadryl, Robinul, Tetracaine, Pitocin and Naropin. In addition, unopened containers of Epinephrine, Calcium Chloride and Lidocaine medications were observed unsecured and stored on top of the cart. Nobody was observed monitoring or supervising the cart at the time of the observation.
* In OR 1 an anesthesia supply cart was observed with the surgical RN and ST. The cart was unlocked and contained numerous emergency, anesthetizing and other medications including but not limited to the following: Caldolor, Cafcit, Ondansetron, Amidate, Tranexamic Acid, Cefazolin, and Bumetanide. Nobody was observed monitoring or supervising the cart at the time of the observation.

15. On 06/12/2015 at 1130 in the Pharmacy Drug Room the following observations were made:
* The replacement code cart tray labeled as OB observed on 06/11/2015 was again observed with the consulting pharmacist. During interview at that time he/she stated that there had been a drug shortage of the Droperidol and so he/she had kept the outdated drugs as "an outdated drug was better than not having the drug at all." He/she also confirmed that the CAH does not provide OB services and that in regards to both the OB tray and the Droperidol he/she "thought both of those were gone."

16. A policy and procedure titled "Drug Room Department Overview" dated as revised "04/04" reflected that "Any and all drugs and medications used in the hospital will be of a quality that conforms with all standards set forth...All medications used at the hospital for the benefit of any patients will be supplied by the hospital pharmacy, except where noted...Personal prescriptions, brought to the hospital by patients, will not be administered by any hospital personnel nor allowed to remain in possession of the patient, except where noted. All such medications will be separately stored in the drug room until they can be returned to the patient at the time of discharge...No sample medications will be administered to in-patients of the hospital. Manufacturer's representatives will not distribute such samples with the institution. All drugs must be under the control of the drug room at all times. Samples may be distributed to outpatients through ER and outpatient clinics, but must not be dispensed by the prescribing physician...All samples must be distributed by the Pharmacy Department."

17. The policy and procedure titled "Code Blue: Medical emergency", with a last revision date 12/08/2014 and approval date 04/08/2015, stipulated that "Code carts are located in PACU, ER, Med-surg and East Wing...Code cart contents will be verified and documented Q shift by RN in charge of area. Medications will be verified and documented by pharmacy staff every other month...Code carts and intubation kits are locked, lock # will be documented by RN during Q shift checks..."

18. An undated policy and procedure titled "Multi-Dose Medication Vials" reflected that "All multi-dose vials of medication shall be dated when first opened fourteen days(14) from the date of opening. The vials shall be discarded on that date. Once opened, vials shall be stored in an enclosed clean area. Storage is to be at the manufacturer's recommended storage temperature for that drug."

19. Policies and procedures requested related to CAH-wide drug storage, temperatures, control, security, and management of outdated or unusable drugs were not provided.

20. A "Letter of Understanding Pharmacy Services" dated and signed by the CAH CEO and the Consulting Pharmacist on 01/05/2015 required that the services to be provided by the pharmacist included "meeting both the practical, routine functional requirements of operating a hospital pharmacy...designing systems and processes to effectively provide same, tracking and accounting for the distribution of all medications - including controlled substances...meeting the Hospital's legal and regulatory requirements regarding its Pharmacy Service(s). The latter includes, at a minimum, satisfying all Oregon State statutes as well as Federal laws and regulations, including Medicare and Medicaid participation requirements..."

21. On 06/10/2015 at 1310 the Consulting Pharmacist was interviewed regarding the unsecured storage of drugs including narcotics and the outdates observed on the East Wing. The pharmacist stated that he/she hadn't managed the drugs in the clinics and those were taken care of by the physicians in those clinics.

22. On 06/12/2015 at 1120 interview with consulting pharmacist stated that the Oregon Board of Pharmacy had not conducted an onsite inspection of the drug room since 2005. He/she provided annual "Hospital Drug Room Inspection Forms" completed by CAH staff. The only date on the most current form was the "Controlled Substance Inventory Date" and was recorded as 05/01/2014. The author of the entries on the form and the date it was completed were not recorded. The same observations were made on the 3 previous forms where the dates recorded as above were 04/30/2013, 04/30/2012, and 05/02/2011. On all four annual inspections the 10 items on the inspection were all checked as "compliant".


29708

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:
* Hand hygiene supplies and practices;
* Management of multi-dose medication vials and other medications;
* Humidity and temperature levels in ORs;
* Sterile processing and disinfection supplies and processes;
* Management of patient care supplies;
* Management of housekeeping supplies;
* Processing of linens; and
* Storage and labeling of food in the dietary department.

Findings included:

1. The following observations were made related to hand hygiene practices and supplies for hand hygiene:

* On the M/S unit an LPN was observed to provide patient care on 06/09/2015 at 1450. The LPN handled/touched the patient with gloved hands while assisting the patient to the bathroom. He/she removed the gloves and donned another pair of gloves and then handled/touched the patient while assisting the patient walk from the bathroom. He/she then removed an IV line and a dressing from the patient's hand/lower arm, and applied another dressing to the patient's hand/lower arm. He/she then removed the gloves, donned another pair of gloves and then took the patient's oral temperature and blood pressure. He/she did not perform hand hygiene during this observation.

* During a tour of the outpatient services department with the WCN/RN and RN on 06/10/2015 beginning at 1055 wall mounted Purell hand hygiene dispensers were observed and contained expired solution.
* At the door entrance inside treatment rooms 2, 3 and 4, solution containers within the dispensers had an expiration date of 12/2013; and
* At the door entrance inside treatment room 1 the solution container within the dispenser had an expiration date of 06/2015.

* During a tour of the surgical services department with a surgical RN and a ST on 06/12/2015 beginning at 1045 wall mounted Purell hand hygiene dispensers were observed empty or contained expired solution:
* Near the door entrance inside OR 1, the dispenser was empty and contained no hand hygiene solution; and
* Near the door entrance inside OR 2, the solution container within the dispenser had an expiration date of 12/2013.

* Review of the policy titled "Hand Hygiene" dated as approved "06-01-09" stipulated the following: "...associates may use an alcohol-based hand rub...for routinely decontaminating hands in clinical situations where hand hygiene is...required such as...After removing gloves...The World Health Organization describes the process of deciding when to wash hands during patient care as...Before an aseptic task: Clean your hands immediately before any aseptic technique..."

2. During a tour of the surgical services department on 06/12/2015 beginning at 1045 the following observations were conducted:

* In OR 2 at 1215, two sterile packs of patient care supplies were observed with a surgical RN and a ST inside the anesthesia supply cart. Both packs had a label affixed that reflected "Expires Load No 06.02.15..."

* During tour of the sterile processing area of the surgical services department, log records for Sterilizer 1 and Sterilizer 2 were reviewed. The logs were designed to reflect documentation of daily monitoring of specified criteria, including BIs, to ensure the sterilizers functioned appropriately. The log records were blank, incomplete and/or unclear. Examples included but were not limited to the following:

Documentation on the "3M Attest Biological Indicator" log was reviewed. The "Load Information" section dated 04/13/2015 for Sterilizer 1 reflected a BI control incubation "Time in" of 0800. The incubation "Date" was recorded as "4-1 10/15." The following areas were not completed and were blank: Facility/Dept. name, Sterilizer Process type, BI 24 hour readout, BI 48 hour readout, Chemical Indicator/Integrator Lot No, Load, RH percent, Load contents/Patient/Reference, and date/time the BI control was removed from the incubator.

Documentation on another "3M Attest Biological Indicator" log for Sterilizer 1 was reviewed. The "Load Information" section was dated 04/13/2015 and the "Load Contents/Patient/Reference" section reflected "ortho trays/." The incubation "Time in" was 0800. The following areas were not completed, blank and/or unclear: Facility/Dept. name, Sterilizer Process Type, BI 24 hour readout, BI 48 hour readout, Chemical Indicator/Integrator Lot No, Load, RH percent, incubation "Date" in, incubation "Date" out, and Action Taken. A "+" result for the 48 hour BI test result was circled but had been written over and scratched out. There was no documentation describing why the positive result was altered, the author and date of the entry, or any follow up actions taken.

Documentation on the "Coquille Valley Hospital" BI log for 05/07/2015 was reviewed. There was no documentation reflecting which sterilizer the log referred to. The following areas were not completed, blank and/or unclear: Pass, Fail, Time In:, Time/Date Out:, Read By, Well Location #, Test and Control. The "Load Sticker(s) section for load "2 Biological" contained a hand written "Failed!!" entry. There was no documentation to explain the reason for the failed entry, the date and author of the individual who wrote the entry, or any follow up actions taken as a result of the failure.

Documentation on the "Coquille Valley Hospital" BI log for 06/04/2015 reflected that the following entries were not completed, blank and/or were unclear: Pass, Fail, Time/Date Out:, and Read By. The "Load Sticker(s) section for load 2, reflected "2 Biological" and contained a hand written entry that reflected "stn trays Towels ER single Failed dry time". There was no documentation to explain the reason for the failed entry, the date and author of the individual who wrote the entry, or any follow up actions taken as a result of the failure. Another entry in the "Load Sticker(s)" section load 4 reflected "biological yes" and included no other information related to the "biological". The "Other" section on the bottom of the log reflected "Towels X 15 [arrow up] Load 2" and "Towels X 15 (Load 4) fill a form/followers (Biological)?" and did not reflect any other actions taken as a result of the "failed" entry.

Documentation for Sterilizer "Puff", referred to by staff as Sterilizer 2 on the "3M Attest Biological Indicator" log for load 2 on 05/24/2015 reflected that the following entries were not completed, blank and/or unclear: The RH percent, the initials of the individual who documented the incubator "Time out/Date". The log reflected that the 24 and 48 hour BI test results were positive. There was no documentation reflecting actions taken to address the positive results.

Documentation for Sterilizer "Puff", referred to by staff as Sterilizer 2 on the "3M Attest Biological Indicator" log for load 1 on 05/26/2015 reflected that the following entries were not completed and were blank: RH percent, the initials of the individual who documented the incubation time out and date, and Actions Taken. The date recorded for the incubator "Time in/Date" was written over and obliterated. The 24 hour indicator test result was positive and the 48 hour test result was not recorded. There was no documentation reflecting actions taken to address the positive result.

Documentation for "Puff", referred to by staff as Sterilizer 2 on the "3M Attest Biological Indicator" log for load 3 on 05/26/2015 reflected that the following entries were not completed and were blank: RH percent, the initials of the individual who documented the incubation time out and date, and Actions Taken. The log reflected that the 24 and 48 hour test results were positive and there was no documentation reflecting actions taken to address the positive results.

These findings were confirmed with the ST on 06/12/2015 at 1135.

* Undated Manufacturer instructions provided titled "3M Attest Biological Indicator" reflected the following: "Log sheet instructions...Record the facility/department name...Check sterilizer process type, if applicable...Check the Attest BI product used...Record the BI manufacturing lot number...Record the date of sterilization, the load and sterilizer number...Record if load contains an implant...Record the %RH (relative humidity) in the room...Record the well number the BI was placed into...Record the time the BI indicator was placed in the incubator and your initials...Record the time the BI was removed from the incubator and your initials...Record the BI test results by circling the + (positive) or - (negative) results...Record the BI control results by circling the + (positive) or - (negative) results...Record any action taken as a result of a sterilization process failure or incorrect incubation in the Action Taken section."

* A fax received 06/16/2015 at 1308 from the ST was reviewed and reflected "There are no policies on [Biological] Indicators."

3. The following observation was made during tour of SP with the ST on 06/12/2015 beginning at 1130:

* An unmarked open one gallon bottle of Endozyme AW Plus was observed in the decontamination area. There was no date on the container to reflect when it was opened. During an interview conducted at the time of the observation, the ST stated that the Endozyme AW Plus was used for pre-cleaning surgical instruments, and that he/she did not know how long the detergent could be used after the container was opened.

* A scope reprocessor was observed in the decontamination area. Two water filters were attached to the back of the reprocessor. One of the filters was dated "[change] by 12/14" and the other was dated "[change] by 3/15." During an interview conducted at the time of the observation, the ST indicated that the dates on the filters reflected when the filters should be changed. The ST stated he/she did not know when the filters were last changed, how often the filters should be changed or who was responsible for changing them.

* An unmarked one gallon container of Cidex OPA was observed with the ST in the decontamination area on 06/12/2015 at 1135. The container was open and was in use. There was no indication as to when it had been opened. Review of manufacturer instructions on the container at the time of the observation reflected the following: "Do not reuse beyond 14 days or sooner as indicated...Once opened, the unused portion of the solution may be stored in the original container for up to 75 days until used." During an interview conducted with the ST at the time of the observation, he/she acknowledged having no way of identifying when the Cidex was opened. He/she further stated that the Cidex in the scope reprocessor should be changed every month which was contradictory to the manufacturer instructions.

* Log records for the Cidex were reviewed and reflected the following:

Documentation on the Cidex log was reviewed with the ST on 06/12/2015. A 05/08/2015 log entry reflected "Cleaned tank complete refill." The next documentation on the log reflecting the Cidex was changed was not until 06/12/2015, more than a month later and reflected "Cleaned [and] changed." This was confirmed with the ST at the time of the review.

4. Review of the policy titled "Maintaining a Safe, Functional Environment" dated effective "5/2012" reflected the following: "Coquille Valley Hospital consistently strives to reduce the potential for hospital-acquired illnesses by monitoring and maintaining ventilation, temperature, and humidity levels in appropriate areas...Monitoring and recording of temperature and humidity conditions shall be the responsibility of Plant Operations dept. utilizing the automated building environmental control(s)...Temperature and humidity conditions shall be monitored and recorded daily in anesthetizing locations...Individual room conditions shall be documented and records shall be maintained readily available for a period of at least 3 years...Weekend and holiday readings shall be made prior to the start of the procedures...Temperature and humidity conditions observed outside the permissible ranges shall be reported to Plant Operations immediately. Plant Operations will take corrective actions and document their response...Patient safety, staff safety and infection control standards shall be considered at all times and appropriate actions will be taken based on the individual circumstances. The Surgical Services Director and Infection Control Practitioner shall be informed and consulted on an as needed basis." The policy required that humidity in the ORs be maintained at 35-60 percent and temperature maintained at 68-73 degrees.

On 06/09/2015 at 1700, an interview was conducted with an individual who identified him/herself as the recently "retired" Director of Facilities. He/she stated that humidity levels for the ORs were monitored by surgical services staff every morning. The director stated that the hospital's automated system was not able to monitor humidity levels in the OR and therefore he/she was not able to provide documentation of monitoring records from the system. The director stated that the acceptable humidity level in the ORs was 30-60 percent which was contradictory to hospital policy which required 35-60 percent. The director stated he/she was not aware of any time when the humidity had been outside the acceptable range.

In relation to OR temperatures, the director stated he/she was not sure what the acceptable temperature range was but thought it may be 62-68 degrees. He/she also stated that "it was up to the physician."

* Handwritten "OR Temperature/Humidity Check" logs for ORs 1 and 2 were reviewed:

Review of OR 1 logs reflected no temperature or humidity readings were recorded 02/02/2015 through 05/11/2015; 05/12/2015 through 05/14/2015; 05/23/2015 through 05/25/2015; and 06/06/2015 and 06/07/2015. Review of the log records reflected the humidity was not maintained within the acceptable range of 35-60 percent. Examples included but were not limited to the following: On 12/09/2014 the humidity was recorded 67 percent; on 12/22/2014 the humidity was recorded 71 percent; on 12/23/2014 the humidity was recorded 70 percent; and on 02/02/2015 the humidity was recorded 69 percent.

In addition, log records for OR 1 reflected the temperature was not maintained within the acceptable range of 68-73 degrees. Examples include but were not limited to the following: On 05/22/2015 the temperature was recorded 57 degrees; on 06/01/2015 the temperature was recorded 58 degrees; on 06/02/2015 the temperature was recorded 57 degrees; and on 06/03/2015 the temperature was recorded 56 degrees.

Review of OR 2 logs reflected no temperature or humidity readings were recorded 02/28/2015 through 05/10/2015. There were no readings recorded 05/12/2015 through 05/14/2015; 05/23/2015 through 05/25/2015. Review of the logs reflected the humidity was not maintained within the acceptable range of 35-60 percent. Examples included but were not limited to the following: On 12/09/2014 the humidity was recorded 72 percent; on 12/10/2014 the humidity was recorded 82 percent; and on 12/23/2014 the humidity was recorded 67 percent.

In addition, log records for OR 2 reflected the temperature was not maintained within the acceptable range. Examples include but were not limited to the following: On 12/10/2014 the temperature was recorded 61 degrees; on 02/27/2015 the temperature was recorded 51 degrees; on 05/15/2015 the temperature was recorded 64 degrees; and on 06/02/2015 the temperature was recorded 62 degrees.

There was no documentation on the logs reflecting the reason the humidity and temperature readings were not documented daily. In addition, there was no documentation to reflect actions taken when humidity and temperature levels were outside the acceptable range.

5. Outdated or unclearly marked patient care, laboratory testing, housekeeping, and hand hygiene supplies were available for patient use. The adequacy, efficacy, and reliability of the supplies for their intended purpose is not ensured when used beyond the expiration date.

The following observations of were made during tour with CAH staff on 06/09/2015 beginning at 1515 in the East Wing:
* In the Nurses Station Medication Room there were 2 Boxes, 10 per box, of Medtronic Quickset Infusion Sets outdated 04/2015 and 09/2013.
* In Patient Room 106 the Purell hand sanitizer in the wall mount was outdated 01/2012.
* In the Stress Test Room the Red Dot Electrodes were outdated 09/2014 and code cart pads attached to the code cart defibrillator were outdated 09/15/2014.

The following observations were made during tour with CAH staff on 06/10/2015 beginning at 1115 in the East Wing:
* In the Plant Operations area Purell hand sanitizer refills for wall mounts were outdated in 2012, 2013, and 2014.
* In the Outpatient Clinic exam room 1 Surgilube was outdated 05/2014, a bottle of Sodium Chloride for irrigation was outdated 06/2013, Hemocult Blood Developer was outdated 01/2015, Chemstrips were outdated 12/2013, 7 SurePath Gyn Pap specimen containers with preservative were outdated 12/2013, 4 specimen tubes with liquid medium were outdated 02/20/2014 and 07/15/2014, a sterilized package which contained a speculum was not dated, another sterilized instrument package contained two unclear sets of handwritten numbers that were possibly incomplete dates "11-1" and "6-2", and Sani-cloth Germicidal Disposable Wipes were outdated 10/2014.
* In the Injection Room Sani-Cloth Wipes were outdated 10/2014 and 2 containers of CaviWipes Disinfecting Towelettes were outdated 04/2013 and 01/2014.

The following observation were made during tour on 06/10/2015 beginning at 1445:
* Outside Rehabilitation Services the exam gloves in the AED wall unit were outdated 08/2013.
* In the Radiology Department Ultrasound Room a sterilized package of scissors had the date 05/01/2015 written on it, however the meaning of the date was not specified.

The following observations were made during tour with CAH staff on 06/11/2015 beginning at 1155 in the NBMC provider-based clinic:
* In exam room 11 a bottle of Hydrogen Peroxide was outdated 06/2012, and opened and used without an open date evident.
* In exam room 13 a bottle of Hydrogen Peroxide was outdated 10/2013. Bottles of Hydrogen Peroxide, Betadine, and sterile water were all opened and no open dates were evident.
* In exam room 14 bottles of Hydrogen Peroxide were outdated 08/2012 and 12/2013 and opened with no open dates evident, Surgilube was outdated 05/2015, and sterile water was opened with no open date evident.

On 06/11/2015 at 1500 in the Respiratory Therapy department Normal Saline was observed to be outdated 02/2015.

A policy and procedure from the "Materials Management" department titled "Outdates", with a revised date 05/16/2007, reflected "It is the policy...to check supplies for outdates and restock supplies in a consistent and timely manner."

6. Food products were not packaged and stored under appropriate conditions. During tour of the food service area and kitchen on 06/11/2015 at 1620 the following observations were made:

* The outsides of containers of dry goods, spices, and condiments in dry and refrigerated storage were not clean and were covered with drips, grime, and other residue.
* Containers and bags of food items, condiments, and spices were observed to be open in dry and refrigerated storage. For example: biscuits and spices.
* Numerous food items were stored in plastic bags in the walk-in freezer that were not labeled or dated, not identifiable, and in some cases the food items inside the bag were covered with ice.
* Numerous food items stored in plastic bags in the walk-in freezer were labeled with the name of the item but not the date the food was prepared or placed in the freezer. For example: "Beef Broth" and "Past". Staff present at that time stated that the "Past" was pastrami.
* The shelves in the walk-in freezer were full and crowded with packages of frozen food items in a disorganized fashion. A large rolling cart was stored in the middle of the freezer, consuming most of the "walk-in" space and that cart was full and crowded with packages of frozen food in a disorganized fashion. The ceiling of the walk-in freezer was covered with layers of ice which was melting and dripping during the observation.

A "Food Service Inspection Report" completed by a county sanitarian and dated 11/07/2014 reflected that the dietary department was cited for five violations which included food temperature, food storage, and sanitation. Three of those were identified as "Priority" violations. One of those was specifically the lack of labeling and dating food items in plastic bags.

A "Food Service Inspection Report" completed by a county sanitarian and dated 03/24/2015 reflected that the dietary department was cited for three "Priority" violations which included repeat citations related to food temperature.

"Dietary Consultation Reports" signed by a RD were reviewed and reflected monthly consultation visits since May 2014, except there was no visit in February, 2015. The dietician reports contained sections that included "Food Handling", "Food Storage", and "General Sanitation" that had checkmarks next to them to indicate those subjects had been reviewed. However, the reports dated 11/25/2014 (identified as the "December" report) and 01/27/2015 contained no follow-up to the 11/07/2014 sanitarian inspection. The next consult report dated 03/17/2015 only indicated "Discussed food storage improvements planned." The next reports dated 04/28/2015 and 05/19/2015 contained no follow-up to the 03/24/2015 sanitarian inspection.

7. During interview on 06/12/2015 at 1300 the Nurse Executive confirmed that the CAH's laundry services were conducted by an offsite vendor located in Eugene, Oregon. He/she stated that the CAH did not have a contract with the current vendor. He/she stated that the CAH had used the vendor since 2007 and had never entered into a contractual or written arrangement. He/she stated that there had never been an evaluation of the linen processing services provided by the vendor and that no one from the CAH had conducted an onsite visit to evaluate the vendor's processes. During interview on 06/12/2015 at 1305 the CEO confirmed there was no contract or formal arrangement or agreement.

There was no evidence to reflect that the soiled linens removed from the CAH and returned for patient care were processed in accordance with infection control standards, including temperatures and chemical disinfection processes.

8. Refer to Tag C 276, CFR 485.635(a)(3)(iv), regarding drug management, which reflects the hospital's failure to ensure multi-dose medication vials and other medications available for patient use were managed and stored appropriately and in accordance with hospital policies and procedures.

Based on interview and review of the list of the services furnished under arrangement or agreement by the CAH it was determined that the list was not fully complete as it did not include descriptions of the nature and scope of the services provided.

Findings include:

1. A document titled "Coquille Valley Hospital Offers the Following Services", dated as "updated" on 04/28/2015, was reviewed. It contained two sections, one with the "Services Provided Directly", and the other "Indirect (Contracted) Services." The "Indirect (Contracted) Services" list identified 19 services.

The specific nature of all of the listed services was not delineated. For example, one entry on the list was recorded only as "Lifeline." It was not clear what that service was.

There was no description of the scope of services for any of the services listed.

2. During interview on 06/12/2015 at 1345 the CEO stated that the CAH had a contract with a qualified medical records practitioner consultant until December of 2014 and did not have a replacement for that consultant contract as of the survey. However, the services of a qualified medical records practitioner was not identified under either of the sections on the list.

Refer to Tag 9999, that reflects the State licensing requirement at OAR 333-505-0050(19), Medical Records, and requires that a qualified medical records practitioner provide direction and oversight of the medical records services.

Based on observation, interview, review of contracts, and review of policies and procedures and quality documentation it was determined that the CAH failed to fully develop and implement policies and procedures to ensure that services provided under contract, arrangement or agreement were furnished in a manner that enabled the CAH to comply with all applicable CFRs. There was a lack of an organized and methodical system for the evaluation of services provided under contract, arrangement or agreement; services had not been evaluated; and services provided under those arrangements were identified to be deficient during this survey.

Findings include:

1. A document titled "Coquille Valley Hospital Offers the Following Services", dated as "updated" on 04/28/2015, was reviewed. It contained two sections, one with the "Services Provided Directly", and the other "Indirect (Contracted) Services." Although the CAH had a Pharmacy Drug Room, pharmacy services were not identified on the "Services Provided Directly" list. The "Indirect (Contracted) Services" list did reflect that the CAH had a contract or agreement with a pharmacist.

A "Letter of Understanding Pharmacy Services" dated and signed by the CAH CEO and the Consulting Pharmacist on 01/05/2015 required that the services to be provided by the pharmacist included "meeting the Hospital's legal and regulatory requirements regarding its Pharmacy Service(s). The latter includes, at a minimum, satisfying all Oregon State statutes as well as Federal laws and regulations, including Medicare and Medicaid participation requirements..."

Refer to Tag C276, CFR 485.635(a)(3)(iv), regarding drug management, which reflects the CAH's failure to appropriately store, control and secure drugs throughout the CAH to ensure drug integrity and efficacy; to prevent theft, misuse, and tampering; and to ensure outdated and otherwise unusable drugs and biologicals were not available for patient use.

2. A document titled "Coquille Valley Hospital Offers the Following Services", dated as "updated" on 04/28/2015, was reviewed. The "Indirect (Contracted) Services" list reflected that the CAH had a contract or agreement with a clinical dietician consultant.

During interview on 06/12/2015 at 1345 the CEO stated that the CAH had a contract with another hospital for qualified clinical dietician services and that the contract could not be located. However, "Dietary Consultation Reports" signed by a RD were reviewed and reflected monthly consultation visits since May 2014, except there was no visit in February, 2015.

Refer to Tag C278, CFR 485.635(a)(3)(vi), regarding infection control, which reflects the CAH's failure to ensure appropriate food storage and sanitation practices in the dietary department.

3. A document titled "Coquille Valley Hospital Offers the Following Services", dated as "updated" on 04/28/2015, was reviewed. The "Indirect (Contracted) Services" list reflected that the CAH had a contract or agreement for "Laundry" services.

During interview on 06/12/2015 at 1300 the Nurse Executive stated that the CAH did not have a contract with the laundry vendor located in Eugene, Oregon. He/she stated that the CAH had used the current vendor since 2007 and had never had a contract or written arrangement. He/she stated that there had never been an evaluation of the linen processing services provided by the vendor and that no one from the CAH had conducted an onsite visit to evaluate the vendor's processes. During interview on 06/12/2015 at 1305 the CEO confirmed there was no contract or formal arrangement or agreement.

Refer to Tag C278, CFR 485.635(a)(3)(vi), regarding infection control, which reflects
the lack of oversight of the contracted laundry services.

4. A document titled "Coquille Valley Hospital Offers the Following Services", dated as "updated" on 04/28/2015, was reviewed. It contained a section for "Indirect (Contracted) Services."

During interview on 06/12/2015 at 1345 the CEO stated that the CAH had a contract with a qualified medical records practitioner consultant until December of 2014 and did not have a replacement for that consultant contract as of the survey. The services of a qualified medical records practitioner was not identified on the list.

Refer to Tag C302, CFR 485.638(a)(2), regarding medical records, which reflects the CAH's failure to ensure that medical records were complete and accurately documented.

Refer to Tag C308, CFR 485.638(b), regarding medical records, which reflects the CAH's failure to ensure that medical records were protected against loss, destruction, and unauthorized access and use.

5. An undated policy and procedure titled "Annual Program Review and Quality Assurance Review" was reviewed. It indicated that at least annually a review of CAH contracted services would be conducted. It stipulated that "A review of the list of all services furnished under formal agreements (contracts) or informal arrangements to determine if the services are actually being provided to patients, whether the nature and scope of services is appropriate, and whether the services meet the hospital's standards of quality." The policy and procedure did not specify the methodology that would be used conduct an evaluation which included determining whether the services met the CAH's standards of quality.

6. The Joint Professional and Policy Advisory Council Meeting minutes were reviewed for 2013, 2014, and 2015. Those minutes each contained a section for review of "all services furnished under formal agreements (contract) or informal arrangements to determine if the services are actually being provided to patients, whether the nature and scope of services are appropriate and whether the services meet the hospital's standards of quality."

The minutes dated 02/28/2013 reflected that the evaluation of the contracted services was "The council agreed that the services reported are being provided and that the scope of services are appropriate and meeting the needs of the community." There was no other evaluation information .

The minutes dated 04/10/2014 reflected that the evaluation of the contracted services was "List provided and previously reviewed in this annual appraisal and found to be adequate and of appropriate quality." In another section of the minutes the question was asked "Whether the services rendered met quality standard(s)." The written response was "Most assuredly."
The minutes dated 02/26/2015 reflected that the evaluation of the contracted services was "Services reviewed and discussed to be not only adequate but laudable in scope, particularly in consideration of size, location and financial capacity." In another section of the minutes the question was asked "Whether the services rendered met quality standard(s)." The written response was "...changes are given a lot of consideration and taken to committee for consideration and review. In practice, we both demonstrate and document the model to follow for all employees."

7. There was no evidence provided during the survey to reflect that the CAH had methodically or systematically evaluated the pharmacy, dietary, laundry, and medical records services, and other services provided under contract, arrangement, or agreement, to ensure that the services complied with all regulatory requirements.

Based on interview, review of documentation in 5 of 5 medical records of patients who had blood transfusions (Patients 7, 8, 18, 19, and 20), and review of policies and procedures, it was determined that the hospital failed to ensure that 10 of 10 blood units dispensed from the laboratory blood bank were managed and transfused in accordance with clearly developed policies and procedures. Transfusion documentation recorded on electronic narrative notes, electronic transfusion flow sheets, electronic vital sign flow sheets, and handwritten transfusion forms contained omissions and discrepancies related to:
* The times blood left the lab;
* Transfusion start times;
* Transfusion end times and length of transfusions;
* Blood type;
* Blood unit #s;
* Volume of blood transfused;
* Whether reactions occurred;
* Times and completeness of vital signs; and
* Authentication by authors of the entries.

Findings include:

1. The policy and procedure titled "Administration of Blood and Blood Products", revised "8/022/11 (sic)", was reviewed. It stipulated the following "Blood Transfusions will be documented by the nurse(s) administering the blood...Blood shall not be removed from refrigerator unit it is ready to be infused. No more than thirty (30) minutes shall elapse between removal and the beginning of the infusion. Blood should be administered over a period of time not to exceed two (2) hours...Obtain baseline vital signs and pre-transfusion H&H and document...Under any circumstance, blood must be administered within 4 hours of leaving refrigeration...Check patient at least every 15 minutes. VS every 15 minutes times 4, then every hour, and 1 hour after transfusion ends...Observe for reactions..."

The policy contained contradictory requirements in relation to "No more than thirty (30) minutes shall elapse between removal and the beginning of the infusion. Blood should be administered over a period of time not to exceed two (2) hours", which is a total of 2 hours and 30 minutes of leaving refrigeration, and "Under any circumstance, blood must be administered within 4 hours of leaving refrigeration."

2. The medical record of Patient 7 reflected he/she was admitted on 01/31/21015 and had physician's orders for blood transfusions.
* An electronic "Patient-Product Inquiry" form generated by the laboratory blood bank reflected that blood unit W202114297160 was signed out to nursing staff from the blood bank on 02/02/2015 at 1030.
* The electronic "Blood Product Transfusion" flow sheet reflected that the blood consent was obtained and the blood unit verified by nursing staff on 02/02/2015 at 1002, 28 minutes prior to the blood being signed out of the blood bank. The volume of blood hung and the transfusion start time was not evident on that record.
* An electronic progress note dated 02/02/2015 at 1024 reflected "1st unit PRBC's (sic) started...RN with pt for first 15 mins of transfusion start time."
* The transfusion end time was not recorded.
* As transfusion start and stop times were not clear, it was not clear whether the transfusion was started within 30 minutes of leaving the blood bank refrigeration and completed within 2 hours after that.
* VS were recorded at 1039, 1053, 1124, 1138, 1149, 1224, and 1253. As transfusion start and stop times were not clear it was not clear whether VS were taken as required by the policy.

* Also for Patient 7 an electronic "Patient-Product Inquiry" form generated by the laboratory blood bank reflected that blood unit W202114317324 was signed out from the blood bank on 02/02/2015 at 1338.
* The electronic "Blood Product Transfusion" flow sheet reflected that the blood consent was obtained and the blood unit verified by nursing staff on 02/02/2015 at 1312, 26 minutes prior to the blood being signed out of the blood bank. The volume of blood hung and the transfusion start time was not evident on that record.
* An electronic progress note dated 02/02/2015 at 1320 reflected "2nd unit PRBC's (sic) started."
* The transfusion end time was not recorded.
* As transfusion start and stop times were not clear, it was not clear whether the transfusion was started within 30 minutes of leaving the blood bank refrigeration and completed within 2 hours after that.
* VS were recorded at 1334 with no temp, 1348 with no temp, 1404 with no temp, 1411 with no temp, 1441 with temp taken at 1443, and 1509 with temp taken at 1510. The next vital signs were recorded at 1913. VS were not complete and as transfusion start and stop times were not clear, it was not clear whether VS were taken as required by the policy.

3. The medical record of Patient 18 reflected he/she was admitted on 04/03/2015 and had physician's orders for blood transfusions.
* An electronic "Patient-Product Inquiry" form generated by the laboratory blood bank reflected that blood unit W202115432574 was signed out to nursing staff from the blood bank on 04/05/2015 at 1440.
* The electronic "Blood Product Transfusion" flow sheet reflected that the blood consent was obtained and the blood unit verified by nursing staff on 04/04/2015 at 1429, nearly a full day prior to the blood being signed out of the blood bank. The volume of blood hung and the transfusion start time was not evident on that record.
* An electronic progress note dated 04/05/2015 at 1500 reflected "transfusion initiated."
* A "Transfusion Record" form completed manually had a date of 04/05/2015 and a time of 1400 recorded at the top of the form. Under that were spaces for "signed out by" and "checked by". The time recorded and what those spaces were meant to indicate was not clear.
* The "Transfusion Record" form reflected the Transfusion Begins" time was 1515, 35 minutes after being signed out of the lab, in excess of the policy, and contradictory to the time of 1500 recorded on the electronic progress note.
* The blood unit number was not recorded on the "Transfusion Record" form, including in the space provided.
* The "Transfusion Record" form reflected that the amount of blood the patient received was 325 mls, however, the volume of blood hung was not recorded on the electronic "Blood Product Transfusion" flow sheet.

* Also for Patient 18 an electronic "Patient-Product Inquiry" form generated by the laboratory blood bank reflected that blood unit W202115429668 was signed out from the blood bank on 04/05/2015 at 2308.
* The electronic "Blood Product Transfusion" flow sheet reflected that the blood consent was obtained and the blood unit verified by nursing staff on 04/05/2015 at 2200, 68 minutes prior to the blood being signed out of the blood bank. The volume of blood hung was recorded as 350 ml. The transfusion start time was not evident on that record.
* A "Transfusion Record" form completed manually had a date of 04/05/2015 and a time of 2240 recorded at the top of the form. Under that were spaces for "signed out by" and "checked by". The time recorded and what those spaces were meant to indicate was not clear.
* The "Transfusion Record" form reflected the "Transfusion Begins" time was 2300, 8 minutes prior to being signed out of the lab, and 60 minutes after the electronic record reflected the blood was hung.
* The "Transfusion Record" form reflected that the amount of blood the patient received was 300 mls, contradictory to the 350 ml recorded on the electronic "Blood Product Transfusion" flow sheet.
* As transfusion start and stop times were not clear, it was not clear whether the transfusion was started within 30 minutes of leaving the blood bank refrigeration and completed within 2 hours after that.

4. The medical record of Patient 19 reflected he/she was admitted on 04/16/2015 and had physician's orders for blood transfusions.
* An electronic "Patient-Product Inquiry" form generated by the laboratory blood bank reflected that blood unit W202115408186 was signed out from the blood bank on 04/19/2015 at 1053.
* The electronic "Blood Product Transfusion" flow sheet reflected that the blood consent was obtained and the blood unit verified by nursing staff on 04/19/2015 at 1025, 28 minutes prior to the blood being signed out of the blood bank. The volume of blood hung and the volume of blood infused was recorded in the same entry at 1025. The transfusion start and end times were not evident.
* An electronic progress note dated 04/19/2015 at 1030 reflected "Initiated first unit of blood."
* A "Transfusion Record" form completed manually had a date of 04/19/2015 and a time of 1035 recorded at the top of the form. Under that were spaces for "signed out by" and "checked by". The time recorded and what those spaces were meant to indicate was not clear.
* The "Transfusion Record" form reflected the "Transfusion Begins" time was 1040, 13 minutes prior to being signed out of the lab, and contradictory to the time of 1030 recorded on the electronic progress note.
* The blood unit number was not recorded on the "Transfusion Record" form, including in the space provided. In addition, the form was blank in the spaces for the patient's blood type, the expiration date of the blood unit, the transfusion end time, the amount of blood patient received, and whether or not the patient had a reaction.
* As transfusion start and stop times were not clear, it was not clear whether the transfusion was started within 30 minutes of leaving the blood bank refrigeration and completed within 2 hours after that, and whether VS were taken as required by the policy.
* VS recorded on the "Transfusion Record" form at 1040, 1100, 1115, 1130, 1145, 1200, 1215, and 1230 did not include the temp. VS were not complete and as transfusion start and stop times were not clear, it was not clear whether VS were taken as required by the policy.

* Also for Patient 19 an electronic "Patient-Product Inquiry" form generated by the laboratory blood bank reflected that blood unit W202115436538 was signed out to nursing staff from the blood bank on 04/19/2015 at 1347.
* The electronic "Blood Product Transfusion" flow sheet reflected that the blood consent was obtained and the blood unit verified by nursing staff on 04/19/2015 at 1332, 15 minutes prior to the blood being signed out of the blood bank. The volume of blood hung and the volume of blood infused was recorded in the same entry at 1332. The transfusion start and end times were not evident.
* An electronic progress note dated 04/19/2015 at 1430 reflected "Second unit of blood started."
* A "Transfusion Record" form completed manually had a date of 04/19/2015 and a time of 1320 recorded at the top of the form. Under that were spaces for "signed out by" and "checked by". The time recorded and what those spaces were meant to indicate was not clear.
* The "Transfusion Record" form reflected the Transfusion Begins" time was 1422, 35 minutes after being signed out of the lab, in excess of the policy, and contradictory to the time of 1430 recorded on the electronic progress note.
* The blood unit number was not recorded on the "Transfusion Record" form, including in the space provided. In addition, the form was blank in the spaces for the patient's blood type, the expiration date of the blood unit, the transfusion end time, the amount of blood patient received, whether or not the patient had a reaction, and the "Nurse(s) Administering Transfusion". The form was not authenticated and dated by the individual who completed the entries.
* As transfusion start and stop times were not clear, it was not clear whether the transfusion was started within 30 minutes of leaving the blood bank refrigeration and completed within 2 hours after that.
* VS recorded on the "Transfusion Record" form at 1450, 1505, and 1521 did not include the temp. VS were not complete and as transfusion start and stop times were not clear, it was not clear whether VS were taken as required by the policy.

5. Similar findings were identified for 4 other blood transfusions documented in the records of Patients 8 and 20.

Based on review of documentation in 21 of 21 medical records reviewed, it was determined that the CAH failed to ensure that medical records were complete and accurately documented. Patient care documentation related to blood transfusions, post anesthesia evaluations, patient rights, and advance directives was not complete, clear, and accurate.

Findings include:

1. Refer to Tag C297, CFR 485.635(d)(3), Nursing Services, regarding the lack of clear, complete, and accurate blood transfusion documentation.

2. Refer to Tag C322, CFR 485.639(b), Anesthetic Risk and Evaluation, regarding the lack of clear and complete pre and post anesthesia evaluations.

3. Refer to Tag C271, CFR 485.635(a)(1), Patient Care Policies, regarding the lack of clear and complete patient's rights documentation.

4. Refer to Tag C151, CFR 485.608(a), Compliance with Federal Laws and Regulations, regarding the lack of clear and complete advance directives documentation.

Based on observation and interview it was determined that the CAH failed to ensure the confidentiality of patient medical record information. The CAH failed to provide safeguards against loss, destruction, and unauthorized access and use as patient medical records and information was stored in areas throughout the CAH that were not locked or secured and were accessible to unauthorized staff, patients, and visitors.

Findings include:

1. During tours of the CAH conducted with CAH staff the following observations were made:

* On 06/09/2015 at 1515, 06/10/2015 at 1145 and 1445, and 06/12/2015 at 1100 in the East Wing, formerly the "old hospital", behind the vacated and unoccupied nurses station, a large room, formerly the "newborn nursery", was observed to contain two walls of shelves of patient medical records. There were two entrances into the room and both doors were fully open. There was no one in the room attending to the records, except on one of those occasions. Patients of the East Wing provider-based clinic across the hall, visitors, and staff that would be unauthorized to have access to medical records, were observed in the area.

* On 06/10/2015 at 1115 in an open room in the the unlocked and open East Wing plant operations and maintenance area, a wall with six shelves of patient radiology films and written reports, and another wall with three shelves of numerous notebooks full of patient laboratory testing records, were observed. Some of the patient laboratory testing records were dated in 2014. Although a sign on the door indicated "Keep Door Closed", the door to the room was tied or secured in the open position. The room was cluttered and disorganized with boxes and various types of equipment and supplies used by non-patient care departments and staff on shelves and on the floor.

* On 06/10/2015 at 1230 in an open and unlocked East Wing "injection room" in the "old ED" across the hall from the East Wing provider-based clinic, patient injection records for 13 patient injections were observed lying on the table top next to the door. Those records had patient names and drugs administered. The records were dated between 05/26/2015 and 06/05/2015.

* On 06/10/2015 at 1230 and 1450 in an open and unlocked East Wing "injection room" in the "old ED" numerous filled patient prescription bottles were observed in unlocked cabinets and in boxes placed under the table. Those bottles had prescription labels with patient names, dates, and the names of drugs.

* During interview with a clinic staff person on 06/12/2015 at 1100, he/she stated that the "injection room" is used for the administration of injections to patients. He/she stated that patients are seated in the "injection room" to wait for and receive their injections to "keep flow going" in the clinic exam rooms. He/she stated that after a patient's East Wing provider-based clinic visit, staff "put the patient in the [injection room], put the next patient in the [clinic exam room], and come back and give the injection."

* During a tour of the NBMC provider-based clinic on 06/11/2015 beginning at 1215 with the clinic manager the following observations were made:
Two unlocked open shelving units containing patient medical records were observed in an open common area behind the reception desk. During an interview conducted at the time of the observation, the clinic manager stated that the reception desk and the common area were used by both CAH provider-based clinic staff and non-CAH employees of two non-CAH providers. The clinic manager acknowledged that the medical records were not secured and were accessible to the non-CAH employees. Approximately 500 boxes, and multiple additional files and records were observed stored on open shelves in a locked attic space accessible from the reception desk and the common area behind the reception desk. During an interview conducted at the time of the observation, the clinic manager stated that the boxes contained medical records, and the shelves contained additional medical records, radiology films and billing records of CAH patients. The manager stated that the attic also contained medical records of non-CAH clinic patients and therefore two employees of the non-CAH provider also had a key to the attic. The clinic manager acknowledged that the CAH patient records were accessible at any time to those non-CAH employees.








29708

Based on documentation in 6 of 6 medical records reviewed for anesthesia services (3, 12, 13, 14, 15 and 16) and review of policies and procedures, it was determined that the hospital failed to implement its policies and procedures to ensure that a post-anesthesia evaluation was completed and documented by a qualified practitioner before discharge to evaluate for proper anesthesia recovery.

Findings included:

1. Review of the record for Patient 12 reflected that the patient underwent a shoulder arthroscopy procedure on 02/03/2015. The surgery start time was 1008 and the surgery stop time was 1131. The "CVH Anesthesia" report reflected the anesthesia type was a "Regional Block" and the anesthesia was started at 0943 and stopped at 1140. The PACU nursing notes reflected that the patient was discharged from the PACU on 02/03/2015 at 1605. The patient was discharged from the CAH on 02/03/2015 at 2300. The record lacked documentation reflecting that an evaluation for anesthesia recovery was completed and documented prior to discharge.

Review of the record for Patient 14 reflected that the patient underwent a right knee surgery on 02/26/2015. The surgery start time was 0906 and the surgery stop time was 1145. The "CVH Anesthesia" report reflected the anesthesia type was "Spinal" and the anesthesia was started at 0835 and stopped at 1150. The PACU nursing notes reflected that the patient was discharged from the PACU on 02/26/2015 at 1318. The patient was discharged from the CAH on 03/01/2015 at 1707. The record lacked documentation reflecting that an evaluation for anesthesia recovery was completed and documented prior to discharge.

Review of the record for Patient 15 reflected that the patient underwent a left hip surgery on 03/05/2015. The surgery start time was 1104 and the surgery stop time was 1411. The "CVH Anesthesia" report reflected the anesthesia type was "Spinal" and the anesthesia was started at 1013 and stopped at 1420. The PACU nursing notes reflected that the patient was discharged from the PACU on 03/05/2015 at 1515. The patient was discharged from the CAH on 03/08/2015 at 1658. The record lacked documentation reflecting that an evaluation for anesthesia recovery was completed and documented prior to discharge.

Similar findings were identified during review of the medical records for Patients 3, 13 and 16.

2. Review of the undated policy titled "Postoperative Anesthesia Care" reflected the following: "At least one (1) postanesthetic visit will be recorded, describing the presence or absence of anesthesia related complications...The number of visits will be determined by the nature of the procedure, the anesthesia and the patient's condition. A visit shall be made early in the postoperative period and again after complete recovery from anesthesia...Each postanesthesia visit will be documented on the postanesthesia evaluation form or the progress notes. The date and time of each visit will be specified...The attending anesthetist is responsible for post anesthesia care of all patients who have received anesthesia (general, spinal, regional, local anesthesia with standby). This includes documentation of all post anesthesia visits."

Based on review of policies and procedures, and other documents it was determined that the CAH failed to fully develop and implement policies and procedures to ensure that prior to providing patient care services, patients were fully informed of their visitation rights in writing in a language or manner that the patient (or the patient's support person) can understand. Information about visitation did not include the language specified in (f)(1) and (f)(2) in this regulation.

Findings include:

1. The following policies, procedures and documents were reviewed:
* A new patient admission packet which was reviewed. It contained no documents which addressed patient visitation.
* An undated document titled "Patient Rights" was reviewed. It contained no information which addressed patient visitation rights.
* A policy titled "Patient Rights and Responsibilities" dated last approved 08/16/2011 was reviewed. It contained no information which addressed patient visitation rights.
* An undated policy titled "Visitors to Patients" was reviewed and reflected "Visiting hours and Visiting Privileges Because of physician's orders and personal or family requests, individual patients may at times have restrictions allowing no visitors or limited visitors. Nursing Service shall post such restrictions at the entrance to the patient's room and shall note them at the Nursing Station so that prospective visitors may be informed. Changes in these restrictions shall be kept current." The policy contained no information related to ensuring patients were informed of their visitation rights, and no information related to a patient's right, subject to his or her consent, to receive the visitors whom he or she designates, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, and his or her right to withdraw or deny such consent at any time.

2. These findings were reviewed at the exit conference conducted on 06/12/2015 at 1530. No additional documents or information was provided.