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Based on observation, interview, and review of policies and procedures and PM documentation, it was determined that the CAH failed to implement its policies and procedures to ensure that patient care equipment available for patient use was identified and maintained to ensure an acceptable level of safety and quality. All patient care equipment had not been incorporated into the PM system; had not been maintained in accordance with the PM policies; and PM documentation was incomplete and unclear. In addition, patient care supplies available for use were outdated.

Findings include:

1. Equipment.

a. The policy and procedure titled "Equipment Management," with an effective date 07/01/2007, was reviewed. It reflected "All equipment which is used by or for patients falls into a risk category. This policy defines the risk categories and describes care and training...The Engineering Department will keep an overall inventory on all equipment within the scope of this policy as submitted by all affected departments...All equipment must have an electrical and performance test performed by a qualified person. A record of the evaluation, or a copy of it, shall be centrally maintained by the Engineering Department...All newly acquired equipment must be evaluated for inclusion into the proper risk category...Each piece of equipment categorized as Risk II or III must be electrically safety checked annually...All Risk II and III devises will be assigned a biomedical equipment control number by the Engineering department...The Engineering Department will keep an overall inventory on all equipment within the scope of this policy. This inventory will include:
* Biomedical Equipment Control Number;
* Equipment nomenclature;
* Serial numbers;
* Original Manufacturer;
* Owner Department;
* Location of Equipment;
* Place in Service Date;
* Patient Risk Class...
Equipment will be reviewed annually for possible additions or deletions into the different risk categories..All Risk II and III equipment will have periodic maintenance as recommended by the equipment manufacturer. This is in addition to the annual equipment inspections. If maintenance schedule differs from the manufacturer's recommendation, justification must be documented in the department procedure manual. The department will keep records of all scheduled and unscheduled maintenance..."

b. The following observations were made during tour of the medical/surgical patient care unit with the DNS and the ADNS on 09/10/2014 beginning at 1005:

* A Healthmeter wheelchair scale in Room 128, had a label on it with CAH property number 913. It had a PM label affixed to it that reflected PM was last done 10/31/2012 and was due 10/20/2013. Review of the "Bio-Med PM Schedule" reflected the PM was due 10/20/2013 as reflected on the label.

* An Invacare Reliant 450 in the bathroom of Room 128, had a label on it with property number 150, PM label last done 10/13/2012 and due 11/13/2013. Review of the "Bio-Med PM Schedule" provided reflected the PM was due 11/13/2013 as reflected on the label.

* A Gomco Model 270 GI Drainage machine in a "storage room" had no property number label or PM label.

* A Level 1 Hotline Fluid Warmer in a "storage room" had a label on it with property number 569. It had a PM label affixed to it that reflected PM was done 04/01/2014 and was due 05/01/2014. It was on a shelf which was covered with thick residue of unidentified dark substance. The rubber feet/pads on the bottom of the machine were observed to be melted and disfigured.

c. The following observations were made during tour of the radiology department with the Director of Radiology on 09/10/2014 beginning at 1145:

* An iStyle ultrasound machine in the ultrasound room had no CAH property number label and no PM label on it.

* A Sonosite portable ultrasound machine placed outside the door of ultrasound room had no property number label and no PM label on it. Radiology staff interviewed at that time stated that the Sonosite machine was "bought from [a doctor] who owned it and sold it to the hospital when [doctor] left."

* A small refrigerator was observed in the ultrasound room. The inside of the refrigerator contained a few food items and was dirty with debris and spills. The freezer compartment door could not be opened as the build-up of ice was observed to be protruding from the freezer and encasing the door. The Director of Radiology stated that the refrigerator was for staff use.

During interview with the Director of Radiology on 09/10/2014 during the tour he/she stated that the CAH facilities department does not do work on or have records for any radiology equipment as "its our equipment."

d. The following observations were made during tour of the respiratory therapy department with the Director of Respiratory Therapy on 09/10/2014 beginning at 1635:

* A Viasys Ventilator, CAH property number 1004, had no PM label;
* A Respironics NICO 2 machine, property number 824, had no PM label;
* A Respironics Conchatherm machine, property number 864, had a PM label affixed to it that reflected a last inspection dated of "7/05";
* A Pulmoaide, property number 620, had one type of PM label affixed to it that reflected an inspection date of 11/03/2004 and another type of PM label also affixed to it that reflected an inspection date of 02/06/2007 and a due date of 02/06/2008;
* A second Pulmoaide, property number 1049, had a PM label affixed to it that reflected an inspection date of 05/23/2013 with a due date of 05/23/2014; and
* A BIPAP machine, property number 862, had a PM label affixed to it that reflected an inspection date of "5/2009" with a due date of "5/2010."

During interview with the Director of Respiratory Therapy at the time he/she stated being unaware of the discrepant equipment PM information.

e. During tour of the surgical services department on 09/09/2014 at 1315 an ERBE Electrosurgical Unit Cauterizer was observed in sterile processing. The cauterizer unit was not identified on the facilities surgical "Equipment List," the "Surgical Services Equipment List," or the "Bio-Med PM Schedule."

f. During tour of the ED on 09/11/2014 at 1200 a Welch Allyn vital sign machine (01036) was observed. That machine was not listed on the "Bio-Med PM Schedule" on which three other Welch Allyn vital sign machines were listed.

g. During interview with the DPO & ES on 09/11/2014 at 1510 he/she stated that although the CAH facilities department maintains a list of all equipment in each department, the facilities department does not do work or maintain records on the radiology and respiratory therapy equipment. He/she provided those departmental lists and stated that the directors of those departments should have the PM records.

The DPO & ES further stated that the facilities department maintained a "Bio-Med PM Schedule" and provided that list for review. In relation to the PM schedule he/she stated "I would guess it includes everything."

Equipment used in the radiology department was listed on three different forms: A radiology "Equipment List" with numerous omissions and last dated 04/13/2005; a second radiology "Equipment List" last dated 07/07/2010; and an "Equipment Control" list last dated 06/26/2014. No radiology equipment was identified on the "Bio-Med PM Schedule." Neither of the ultrasound machines were listed on any of the lists.

Equipment used in the respiratory therapy department was listed on two different forms: A respiratory therapy "Equipment List" last dated 08/11/2009; and a second respiratory therapy "Equipment List" last dated 05/23/2013. No respiratory therapy equipment was identified on the "Bio-Med PM Schedule." The Pulmoaide machine with property number 1049 was not on any list.

Equipment used in the surgical services department was listed on four different forms and lists and all of them contained different information: A surgery "Equipment List" last dated 06/29/2010; an "Equipment Control" list last dated 12/27/2013; a "Surgical Services Equipment List" with no dates; and the "Bio-Med PM Schedule."

None of the lists reviewed included the risk category of each piece of equipment. There was no one list that included all of the elements required by the CAH policy. Nor had the facilities department maintained records for all equipment in accordance with the policy. There were omissions and discrepancies on the lists and between the lists.

2. Supplies.

a. A tour of the medical/surgical patient care unit was conducted with the DNS and the ADNS on 09/10/2014 beginning at 1005.

Observations in the Room 129 anteroom reflected:
* Nine sterile gauze sponge packages with expiration dates "06/2012" and "01/2013;" and
* Six plus antimicrobial drain sponge packages with expiration dates of 01/10/2011.

Observations in the "Storage Room" reflected:
* Multiple 500ml InfoV.A.C. Canister with Gel units with expiration dates "12/2013," "8/2014" and "9/2011;"
* Two packages of GranuFoam Dressing with expiration dates of 03/26/2011;
* V.A.C. Drape package with expiration date of "6/2010;" and
* Three packages of V.A.C. Y-Connectors with expiration date of "7/2014."

b. During tour of the radiology department with the Director of Radiology on 09/10/2014 beginning at 1145 it was observed that MedChoice ultrasound Gel was packaged in large bulk containers in the ultrasound room. The expiration date on those containers was "5/2017." Three smaller squeeze bottles of ultrasound gel were observed with labels reflecting expirations dates of "9/2015." During interview at that time a radiology technician explained that the small squeeze bottles were re-used and re-filled from the large bulk container. The technician indicated he/she was unaware that it was a problem to pour solution with one lot number and expiration date into a container that was labeled with another lot number and expiration date.

c. During tour of the respiratory therapy department with the Director of Respiratory Therapy on 09/10/2014 beginning at 1635 an observation that Opticheck liquid control for a blood gas machine had an expiration date of "04/14."

Based on documentation in 3 of 6 medical staff files reviewed (Staff 9, 12, and 13), and review of medical staff bylaws and other documentation, it was determined that the governing body failed to ensure that medical staff bylaws were clear, fully implemented and monitored. Medical staff appointments and reappointments were not timely, were unclear, and not consistent with their individual applications or the CAH's medical staff bylaws.

Findings include:

1. The Medical Staff Bylaws, dated as amended "July 2011," were reviewed. The bylaws contained the following provisions:

* In regards to "Conditions and Duration of Appointment" - "Initial appointments shall be for a period extending to the end of the current medical staff year. Reappointment shall be for a full Medical Staff year."

However, the term for reappointment was not clear as a section in the bylaws titled "Reappointment Process" reflected that "Reappointments to any category of the Medical Staff will be for a period of not more than two years unless stated otherwise in these bylaws."

* In regards to "Categories of Appointment" - "The categories of the Medical Staff shall include the following: Active Staff, provisional, and Courtesy."

* In regards to "Term of Provisional Staff Status" - "A staff member shall remain on the provisional staff for a period of six(6) months, unless that status is extended for an additional period of up to one year upon determination of good cause."

* In regards to "Temporary Privileges" - "Temporary privileges...will be valid for up to sixty (60) days...."

2. The file of Medical Staff 9 reflected an application for reappointment dated 06/05/2013. The application submitted by Medical Staff 9 requested "Courtesy" medical staff with voting privileges. However, a letter dated 07/02/2013 and signed by the CEO reflected that "At its regular meeting on June 27, 2013, the Southern Coos Health District Board of Directors accepted the recommendation of the Medical Staff for reappointment as an Active Staff member in Radiology for the July 1, 2013 - June 30, 2015 term."

The "2013 - 2015 Appointments Medical Staff", dated 04/01/2014 was reviewed. It identified Medical Staff 9 as both "Active Staff" and "Courtesy Staff".

3. The file of Medical Staff 12 reflected that temporary privileges were initially granted on 05/08/2013 for 60 days. The file reflected that the appointment periods subsequent to that were unclear and inconsistent with the bylaws as follows:

* A "Provision for Granting Temporary Privileges" form in the file reflected that "These privileges will be effective for 60 days following the signing of this form. Effective dates: 07/08/2013 to 09/08/2013." The form was dated 06/25/2013 by the CEO.

* A "Provision for Granting Provisional Privileges" form in the file reflected that "These privileges will be effective for 6 months following the signing of this form. Effective dates: (7/9/2013 to 1/9/2014)." The form was dated after the effective date on 08/13/2013 by the CEO and was for an effective period which overlapped with the previously granted temporary privileges.

* A "Provision for Granting Temporary Privileges" form in the file reflected that "These privileges will be effective for 6 months following the signing of this form. (Effective 01/14/14 to 07/14/14)." The form was dated 01/14/2014 by the CEO, five days after the previous privileges had expired. Further, temporary privileges were granted for six months, approximately four months longer than the 60 days allowed by the bylaws.

* A "Provision for Granting Temporary Privileges" form in the file reflected that "These privileges will be effective for 6 months following the signing of this form. (Effective 06/10/14 thru 12/10/14)." The form was dated 06/16/2014 by the CEO and reflected that temporary privileges were granted for six months, approximately four months longer than the 60 days allowed by the bylaws.

The "2013 - 2015 Appointments Medical Staff" roster, dated 04/01/2014, did not include or identify Medical Staff 12 as a member of the medical staff.

4. The file of Medical Staff 13 reflected that temporary privileges were initially granted for two 60 day periods beginning on 04/26/2013 and again on 06/26/2013. The file reflected that the appointment periods subsequent to that were unclear and inconsistent with the bylaws as follows:

* A "Provision for Granting Provisional Privileges" form in the file reflected that "These privileges will be effective for 6 months following the signing of this form. (Effective dates: 08/13/13 to 02/13/14." The form was dated on 08/13/2013 by the CEO.

* A letter dated 02/22/2014 and signed by the CEO reflected that "At its regular meeting on February 27, 2014, the Southern Coos Health District Board of Directors accepted the recommendation of the Medical Staff for reappointment as a Courtesy Staff member in Emergency Medicine. This term of appointment will run until December 31, 2014." The letter was dated five days before the referenced Board of Directors meeting. Further, the appointment was accepted by the Board 14 days after the previous appointment had expired.

Review of Board of Director meeting minutes confirmed that a Board meeting was conducted on 02/27/2014.

The "2013 - 2015 Appointments Medical Staff" roster, dated 04/01/2014, did not include or identify Medical Staff 13 as a member of the medical staff.

5. The "2013 - 2015 Appointments Medical Staff" roster, dated 04/01/2014, identified Medical Staff 14 and 15 as both "Active Staff" and "Courtesy Staff".

Based on interviews, it was determined that the CAH failed to ensure that patient care policies were developed, and reviewed at least annually, by a group of professional personnel comprised of healthcare staff described in this regulation.

Findings include:

1. On 09/09/2014 at 1000 during interview with the CEO and DNS, documentation of annual review of CAH policies was requested. No evidence was provided during the survey to reflect that a group of professional personnel had developed the policies or annually reviewed them as required.

2. The CAH CEO and DNS were interviewed on 09/11/2014 at 1615. The CEO stated that a group of professional personnel was not in place and confirmed that an annual review of patient care policies had not occurred in recent years.

29708



Based on observation, interview, and review of policies and procedures and other documentation, it was determined that the CAH failed to develop and implement policies and procedures to ensure that outdated/expired or otherwise unusable drugs were not available for patient use throughout the CAH. Outdated/expired drugs were available; vials and bottles of drugs for multi-dose use were not managed in accordance with CAH policies and manufacturer's instructions; and the code carts were not managed consistently to provide assurance that outdated/expired drugs would not be used.

Findings include:

1. Review of a CAH policy and procedure titled "Muli Dose Medication Vials" dated as last revised "2/09" reflected "When a multi dose vial is opened, the date must be written on the vial...The expiration date of a multi dose vial is one month from the time it was opened...If a multidose vial date is over one month, the vial should be discarded."

2. The following observations were made during tour of the radiology department with the Director of Radiology on 09/10/2014 beginning at 1145:

* A MDV of Lidocaine 1% 50ml for injection with an expiration date of 08/01/2014. The MDV was open and there was no open date on the bottle.

* MDV of xylocaine 1% 2ml for injection with an expiration date of "09/14." The open date recorded on the bottle was "3/29/12." During interview with a radiology technician at that time he/she stated that the policy for using MDVs was to record the date on the vial when the vial is opened and use the vial until the medication expiration date.

* Betadine solution in the CT room expired "12/13."

* Gastrografin 37% Iodide solution, used for oral or rectal administration, 120 ml bottle was observed opened and partially full. There was no date which identified when the bottle was opened. During interview with Director of Radiology at the time of the observation, he/she stated that the Gastrografin was used for multiple patients until the bottle is empty.

Written manufacturer's instructions and FDA Prescribing Information for Gastrografin published on Drugs.com require "Single Use Bottles - Discard unused portion" and "Discard any unused portion after procedure."

3. The following observation was made during tour of the OR in the surgical services department with the surgical technician beginning on 09/09/2014 at 1400:

* An open MDV of injectable Serapin 50 ml. The outside of the vial had hand written date "7/15/14." There was no other date on the vial to reflect when the vial had been opened.

4. The following observation was made during tour of the Respiratory Therapy department with the Director of Respiratory Therapy on 09/10/2014 beginning at 1635:

* Xopenex .63mg/3ml inhalation solution for treatment of asthma had an expiration date of "03/14."

5. a. The surgical services policy and procedure titled "Crash Carts" revised "07/03/13" was reviewed and reflected "It is the policy of Southern Coos Hospital & Health Center to provide a uniform method of maintaining all Emergency Crash Carts in a constant state of readiness. Emergency Crash Carts are kept in the following departments:
* Emergency Department
* Surgery/Recovery Room
* Nursing...The Crash Carts are to be checked for completeness (including outdated medications) by nursing personnel. Completeness will be documented on a checklist which will be kept on top of the Crash Cart. The Crash Cart check is assigned on the Monthly Assignment Schedule. After a Crash Cart has been used, nursing personnel are responsible for replacing all medications used...The top drawer containing the drug tray will be checked and replaced as necessary by the Pharmacy Nurse."

An undated policy and procedure titled "Crash Cart, Care of" was reviewed and reflected "It is the policy of Southern Coos Hospital to provide a uniform method of maintaining all Emergency Crash Carts in a constant state of readiness. Emergency Crash Carts are kept in the following departments:
a. Emergency Room
b. Surgery/Recovery Department
c. Medical/Surgical Department...Each drawer of each crash cart is set up in a modular fashion in order to facilitate restocking and use familiarity." The policy reflected that drawer 2 of the cart contained the following items: "angio caths, IV supplies, alcohol wipes, tape, assorted syringes, assorted needles and spinal needles." The policy further reflected "A [log] sheet will be signed after completion of the checklist. This checklist is to be done on a shift to shift (7a-7p and 7p-7a) rotational basis...It is the responsibility of the pharmacy RN to make weekly checks for outdates of medications, IV solutions, tubing and other supplies."

A nursing services policy and procedure titled "Crash Cart, Care of" dated as last revised "01/06" was reviewed and reflected "It is the policy of Southern Coos Hospital to provide a uniform method of maintaining all Emergency Crash Carts in a constant state of readiness. Emergency Crash Carts are kept in the following departments:
* Emergency Department
* Surgery/Recovery Department
* Medical/Surgical Nursing Department...Each drawer of each Crash Cart is set up in a modular fashion in order to facilitate restocking and use familiarity. The policy reflected that drawer 2 of the cart contained medications which was different than the items identified in the policy above: "This drawer contains commonly used medications. These drugs are contained in a sealed tray."

The policies and procedures contained inconsistent information related to the arrangement of medications in the carts, and the frequency in which medications were to be checked and documented.

b. The following observation of a code cart was made during tour of the medical/surgical patient care unit with the DNS, the ADNS, the Nurse Manager, and the Drug Room RN on 09/10/2014 at 1120:

* The "Medical Surgical Daily Code Cart Check List" included an attachment of "Code Cart Expiration Dates." That attachment identified the contents and next expiration date for medications and supplies in drawers 2, 3, and 4 of the code cart. Observed in drawer 5 were multiple pre-packaged "kits" in large ziploc type bags which included multiple medications for injection and other supplies to be used in emergency situations. The code cart checklist and expiration date attachment did not identify the contents and expirations dates of the medications and supplies in those kits. It was observed that the only way to visually examine the contents to assess expiration dates was to empty the contents of each "kit."

Interview with the DNS, the ADNS, the Nurse Manager, and the Drug Room RN at the time of the tour confirmed that the code cart checklist system did not include a method to alert staff responsible for checking the code cart contents to pending outdates for those medications and supplies in drawer 5.

During further interview with the ADNS and the Drug Room RN on 09/11/2014 at 1500 the ADNS stated that a previous version of the code cart checklist had included the contents of drawer 5. The ADNS stated that she/he had not previously seen the version of the checklist observed on the cart on 09/10/2014.

c. Review of the "Surgical Services Crash Cart Check List" reflected that no monthly checks were documented for January 2014 and May 2014. The contents identified on the check list included but were not limited to the following items: A list of 17 emergency medications, syringes, assorted needles, oxygen connector tubing, and intravenous solutions.

During interview on 09/09/2014 at 1350 the surgical technician stated that the crash cart check list for the surgical services department should be checked and documented every month. During the interview he/she confirmed that the crash cart checks were not documented every month as they should have been.

29708


Based on observation, interview, documentation in 6 of 6 files reviewed of staff and medical staff hired or granted privileges in the last 18 months (Staff 2, 5, 7, 8, 12, and 13), review of policies and procedures and other documentation, it was determined that the CAH failed to fully develop and implement its policies and procedures for infection prevention in the following areas: Management and testing of solutions used for cleaning/disinfection; cleanliness of the physical environment; storage of surgical supplies; surgical instrument sterilization processes; hand hygiene; blood glucose meter cleaning and disinfection; and TB testing for staff.

Findings include:

1. a. During tour of the decontamination area of the surgical services department with the surgical technician beginning 09/09/2014 at 1200 the following observations were made:

* An open one gallon bottle of Endozyme AW Plus observed in the decontamination area had an illegible expiration date. During an interview conducted at the time of the observation, the surgical technician stated that the Endozyme AW Plus was used for pre-cleaning surgical instruments, and that he/she had no way of identifying when the detergent expired.

* During observation of the scope processing area conducted on 09/09/2014 at 1250 the surgical technician was interviewed and stated that testing of the solution used in the scope reprocessor for disinfection of scopes was conducted, but the testing was not documented.

* Dust and lint on the countertop between two instrument pass through doors separating the decontamination and sterile processing areas. This was verified during observation of the decontamination area with the surgical technician on 09/09/2014 at 1230.

2. During tour of the OR in the surgical services department on 09/09/2014 beginning at 1400 the following observation was made:

Four packages of LMAs in the anesthesia supply cart were opened and had with "sterilized" dates 05/01/2007, 08/11/2011, and 02/07/2014. One package had no date.

b. During an interview conducted on 09/09/2014 at 1425 the surgical technician stated that LMAs should be sterilized if the integrity of the LMA package was broken.
During an interview conducted on 09/10/2014 at 1130 the CRNA acknowledged he/she had no policy or procedure for ensuring the opened packages of LMAs were appropriately cleaned and/or sterilized prior to patient use.

3. a. During tour of the sterile processing area of the surgical services department beginning on 09/09/2014 at 1300 log records for the steam sterilizers were reviewed. Documentation on the log for 08/01/2014 reflected that the "Sterilizer ID/Process Type" section was not completed and was blank. The load number was documented "1/2." The load time in was documented 0630 and the load time out was 0700. The description of the load contents was documented "Dart Warm," "Dart Test," "ER Instruments,, and "Biological." There was no documentation of biological indicator results.

Documentation on the log for 08/04/2014 reflected the "Sterilizer ID/Process Type" was "large." The load number was documented "1/2." The load time in was documented 0630 and the load time out was 0700. The description of the load contents was documented "D-Warm," "D-Test," "ER minor," and "Bio." There was no documentation of biological indicator results.

b. During an interview conducted on 09/09/2014 at 1300 the surgical technician stated that a biological indicator should be included and resulted in the first load of surgical instruments every day for both sterilizers. He/she verified that the log records lacked documentation of biological indicator results.

4. The following observations were made during tour of the radiology department with the Director of Radiology on 09/10/2014 beginning at 1145:

* Two bottles of Cidex OPA Test Strips used for testing the ultrasound probe disinfection solution had expired "11/2013." During interview at that time a radiology technician explained that he/she uses the test strips from the bottles "daily" to check the solution. However, he/she stated that the testing was not documented.

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

a. A urinary catheterization procedure was observed in the ED on 09/11/2014 at 1115. While assisting an RN with the procedure, a CNA was observed to handle/touch patient care supplies and the patient with gloved hands. The CNA then removed the gloves and left the room. The CNA did not perform hand hygiene during this observation.

b. During a tour of the surgical services department on 09/09/2014 beginning at 1200, wall mounted Purell hand hygiene dispensers were observed and did not work:
* At the door entrance inside the decontamination area;
* In the hallway outside the OR between the supply room and the entrance to the surgical services department; and
* In the employee break room of the surgical services department.

c. During tour of the medical/surgical patient care unit with the DNS and the ADNS on 09/10/2014 beginning at 1005, wall mounted Purell hand hygiene dispensers were observed and did not work:
* At the north end of patient care unit next to exit door;
* In the Room 129 anteroom; and
* In Room 128.

d. The online CDC "Guidelines for Hand Hygiene in Health-Care Settings" page dated last reviewed and updated 05/19/2011 reflected the following recommended indications for handwashing and hand antisepsis: "...Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient...Decontaminate hands after removing gloves..."

6. a. During an interview conducted on 09/10/2014 at 0950 the Director of Surgical Services stated that the CAH used its glucose meters for multiple patients, and "manufacturer's instructions were followed" for cleaning the meters.

b. During an interview conducted on 09/11/2014 the Director of Nursing Services confirmed that the CAH used OneTouch Ultra 2 Blood Glucose Monitoring System meters for multiple patients. The "OneTouch Ultra 2 Blood Glucose Monitoring System User Guide," revision date "07/2009", was provided by the DNS as the directions for the meter. It reflected the following cleaning instructions: "To clean your meter, wipe the outside with a soft cloth dampened with water and mild detergent. Do Not use alcohol or another solvent to clean your meter." That direction reflected a disinifection solution should not be used on the meter. The guide contained no provisions for use between patients nor the frequency and process of disinfection.

c. Review of a CAH surgical services policy and procedure titled "Blood Glucose Testing" revised 06/27/2013 reflected "...the same glucometer meter (sic)will be used on Pre-Op holding, PACU, Emergency Room and Med/Surg patients...Replace equipment in proper drawer of PACU after cleaning the unit with manufacturer recommended cleaning solution." The policy and procedure did not include provisions for the frequency and process of disinfection between patients, including the disinfection solution to be used.

d. The online CDC website page titled "Infection Prevention during Blood Glucose Monitoring and Insulin Administration" web page last updated 05/02/2012 reflected the following: "...Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer's instructions. If the manufacturer does not specify how the device should be cleaned and disinfected then it should not be shared."

7. a. The policy and procedure titled "Employee Health Program", last revised "3/11," was reviewed. It required that "...any employee who does not have a documented history of a positive tuberculin test shall have a Mantoux two step method tuberculin test. The first tuberculin test shall be done upon employment and the second three weeks from the first one...Any employee with an existing positive Mantoux will have a chest xray every two years or more often to be determined..."

The policy and procedure titled "Administering and Reading a New Employee 2-Step PPD," last revised "4/12," was reviewed. It reflected "It is the policy of Southern Coos Hospital to perform a two step PPD test on new employees as a diagnostic tool to aid in the detection of infection with Mycobacterium Tuberculosis." The procedure described the steps for administration of the test and required that "A new employee shall have a second PPD three weeks after the first PPD is complete. The procedure for administration and reading is the same as described."

b. The TB records of CAH staff and medical staff were reviewed:

* The file of Staff 2 reflected a hire date of 10/08/2013. A PPD test was administered on 10/14/2013 and was read on 10/16/2013. There was no documentation to reflect that a second PPD was conducted three weeks later.

* The file of Staff 5 reflected a hire date of 04/07/2014. The only documentation of TB testing in the file was on an a untitled document which included an unsigned entry that reflected "PPD 0 mm induration 4-5-13 neg." There was no evidence to reflect where the document was from, when the PPD was administered and by whom, when the PPD was read and by whom, and there was no evidence of a second PPD test. Contrary to CAH policy the incomplete PPD test was dated a year prior to the hire date.

* The file of Staff 7 reflected a hire date of 05/30/2014. A PPD test was administered on 06/04/2014 and was read on 06/16/2014. There was no documentation to reflect that a second PPD was conducted three weeks later.

* The file of Staff 8 reflected privileges were initially granted in November 2013. There was no documentation of the required TB testing. The only TB related documentation was on a Washington State hospital's form and was titled "TB Screen For Employees." It was dated "April 2013" and indicated it was an "Annual Requirement for employees who can not take the regular TB skin test." It required that "If you have had a documented positive TB skin test and have a chest x-ray report in your Employee Health File, please answer the following questions..."

* The file of Staff 12 reflected privileges were initially granted effective 05/08/2013. There was no documentation of the required two step PPD testing.

* The file of Staff 13 reflected privileges were initially granted effective 04/26/2013. There was no documentation of the required two step PPD testing.

c. The staff files were reviewed with the Employee Health RN on 09/11/2014 at 1300. During the review the RN was interviewed and stated that some of the PPD testing was not done as there had been a shortage of PPD in 2013. She/he stated that the State TB program issued a shortage alert and that some of the testing was deferred. However, the only documentation provided was a copy of an email from the State TB program dated 04/16/2013 which provided notice of the alert and the following: "We are requesting notification by you if TB screening must be deferred due to the shortage." The RN stated she/he had no other documentation related to the shortage and that she/he didn't know when the shortage was resolved. The RN stated there was no documentation to reflect that the CAH had provided notification to the State TB program as directed. There was no documentation in staff files to reflect that testing had been deferred due to the shortage.

d. A copy of a written communication sent to hospitals from the Oregon Health Authority TB Program was received and reviewed on 09/23/2014. The memo was dated 07/09/2013 and was titled "TB Alert: Resolved Isoniazid (INH) Shortage." It reflected "The nationwide shortage of INH has resolved. We have experienced no difficulties ordering INH and the FDA Drug Shortages website is no longer listing an INH shortage."

Based on observation, interview and review of documentation, it was determined that the CAH failed to maintain a complete list of all services furnished under contract, arrangement or agreement, that also described the nature and scope of the services provided.

Findings include:

1. A document titled "Service Index" was provided on 09/10/2014 at 1130 and was reviewed. The index contained a list of approximately 94 contracts, arrangements or agreements with various agencies, organizations, and companies, organized under broad category headings.

The index lacked the specific nature and scope of the services provided under each contract, arrangement or agreement. Examples include:
* Under the heading of "Equipment Service Agreements" was an entry for "Expire 2015 April 30 Stago Start 4." There was no indication as to what the nature and scope of the contract, arrangement or agreement was for.
* Under the heading of "Medical Purchased Services" was an entry for "Expire 2014 September-30 Sightpath." There was no indication as to what the nature and scope of the contract, arrangement or agreement was for. In addition, it did not include all contracted services such as "Contract for Pacific Northwest Transplant Bank Organ Procurement Services" signed by the CAH on 03/28/2013.

2. An interview was conducted on 09/11/2014 1220 with the Director of Laboratory Services. The director indicated that the CAH had a verbal agreement with four hospitals for obtaining and providing blood. The Director stated that when the CAH experienced a blood shortage or needed a blood type they didn't normally carry, they would send a courier to pick up the blood from one of the four hospitals participating in the verbal agreement. During the interview, the Director stated there was no written agreement between the CAH and the other four hospitals for these services. The agreement described was not included or identified on the "Service Index."

3. The CAH CEO, DNS, and DOO were interviewed on 09/11/2014 at 1615. The DOO stated that some of the services the CAH provided under contract, agreement or arrangement included linen laundering services provided by an outside company, consulting RD services provided by another hospital, and laboratory tests not conducted at the CAH were provided by another health system's laboratory. The nature and scope of those services were not identified on the "Service Index."


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Based on interview and review of quality assurance and other documentation, it was determined that the CAH failed to evaluate the provision of services rendered under contract, arrangement or agreement to ensure the services were furnished in a manner that enabled the CAH to comply with all applicable conditions of participation and standards for those services.

Findings include:

1. A document titled "Service Index" was provided on 09/10/2014 at 1130 and was reviewed. The index contained a list of approximately 94 contracts, arrangements and agreements with various agencies, organizations, and companies, organized under broad category headings. Refer to the deficiency cited at CFR 485.635(c)(3), at Tag C291, which reflects that the list of services provided under contract, arrangement or agreement was not complete. There was no documentation to reflect that those services provided under contract, arrangement or agreement had been evaluated.

2. The ADNS, who was also responsible for quality assurance, was interviewed on 09/10/2014. At 1610 she/he stated that the services provided under contract or agreement had not been evaluated as part of the CAH's quality assurance program.

3. The CAH CEO, DNS, and DOO were interviewed on 09/11/2014 at 1615. The DOO stated that for equipment contracts there was a service agreement committee that met annually when contracts were up for review and they would "talk about it." She/he also stated that they were "building a program" for evaluation of all services provided under contract, arrangement or agreement but that there was not a set schedule for review of those yet. The DOO stated that there was a "draft" policy and procedure for those services that was under review.

Based on documentation in 2 of 2 medical records reviewed of discharged patients (Patients 1 and 2), and review of policies and procedures it was determined that the CAH failed to implement its policies and procedures related to care planning, including planning for discharge. A plan of care was not developed for each patient, and patient needs related to discharge planning were not evaluated and identified on the plan of care in accordance with hospital policies and procedures.

Findings included:

1. The record for Patient 2 was reviewed. The record reflected the patient was admitted to the hospital on 06/28/2014 at 1057 and discharged on 06/29/2014 at 1121. The physician discharge summary dated 06/29/2014 reflected that the patient was experiencing abdominal pain and had discharge diagnoses including possible diverticulitis/urinary tract infection, cerebrovascular accident and atrial fibrillation. The record lacked documentation of a nursing plan of care. In addition the record lacked documentation of whether or not the patient had any specific discharge planning needs.

2. The record for Patient 1 was reviewed. The record reflected the patient was admitted to the hospital on 06/12/2014 and discharged on 06/17/2014. The physician discharge summary dated 06/17/2014 reflected that the patient was "generally bedbound" and had discharge diagnoses including reactive airway disease and "presumed aspiration pneumonia." The record lacked documentation reflecting whether or not the patient had any specific discharge planning needs.

3. The CAH Nursing department policy and procedure titled "Discharge Planning" dated as last revised "9/1/04" was reviewed. It contained the requirement that: "Southern Coos Hospital staff will identify patient needs and plan for patients who require post hospital care. A discharge plan, which includes special services and/or equipment, and follow up medical care, will begin upon admission...The discharge planning process will...Promote a continual system of communication through documentation and re-evaluation of the patient considering the anticipated post discharge needs..."

The CAH Nursing department policy and procedure titled "Discharge Planning - Acute" dated as last revised "06-07-01" was reviewed. It contained the requirement that: All Acute Care patient care plans will contain a note from the Discharge Planner indicating whether specific discharge planning needs are present. When there is a need for planning the Discharge Planner will document in the patients' medical record..."

Based on interviews, it was determined that the CAH failed to carry out or arrange for a periodic evaluation of its total program to include review of:
* The utilization of services as required by CFR 485.641(a)(1)(i);
* A representative sample of both active and closed clinical records as required by CFR 485.641(a)(1)(ii); and
* The CAH's health care policies as required by CFR 485.641(a)(1)(iii).
The CAH failed to ensure such review was done at least annually to determine whether the utilization of services was appropriate, the established policies were followed, and any changes were needed as required by CFR 485.641(a)(2).

Findings include:

1. On 09/09/2014 at 1000 during interview with the CEO and DNS, documentation of periodic evaluation and quality assurance review was requested. No evidence was provided during the survey to reflect that an annual evaluation of the CAH's total program had been conducted as required.

2. The ADNS was interviewed on 09/10/2014 at 1430. She/he stated that an annual evaluation of the CAH's total program had not been conducted in the last year and that it may have last been done four years ago.

3. The CAH CEO and DNS were interviewed on 09/11/2014 at 1615. The CEO confirmed that a periodic evaluation of the CAH's total program had not occurred in recent years.

Based on interview and review of quality assurance and other documentation, it was determined that the CAH failed to ensure that the quality assurance program evaluated the quality and appropriateness of all patient care services and other services affecting patient health and safety in accordance with its policies. The quality assurance program did not include those patient care and other services provided under contract, arrangement or agreement.

Findings include:

1. The undated document titled "Performance Improvement Plan" was reviewed. It reflected that "The Board of Directors is ultimately responsible for ensuring the program reflects the complexity of the health districts organization and services; involves all hospital departments and services...The CEO is responsible to delegate quality management efforts for the entire facility to all staff through the quality management committee...Every department within Southern Coos Hospital and Health Center is responsible for implementing quality improvement activities..."

2. Refer to CFR 485.635(c)(4) at Tag C 292 which reflects that services provided under contract, arrangement or agreement had not been evaluated.

Based on interview, documentation in 1 of 2 medical records reviewed of a patient who expired at the CAH (Patient 3), and review of OPO documentation, it was determined that the CAH failed to notify the OPO of the patient's death in accordance with the CAH's documented OPO process.

Findings included:

1. An undated document titled "Identifying potential organ donors after cardiac death" was reviewed. The document reflected the CAH's process for OPO notification and included the following: "...All deaths or pending deaths are to be called to the Pacific Northwest Transplant Bank..."

2. Review of the medical record for Patient 3 reflected that the patient expired at the CAH on 06/15/2014. There was no documentation in the record that the OPO was notified of the patient's death or pending death in accordance with the CAH's documented OPO process.

This was verified during an interview with the ADON on 09/11/2014 at 1500.

Based on interview, review of CAH Swing-bed policies and procedures, and review of Swing-bed admission documents, it was determined the CAH failed to develop and implement its policies and procedures to ensure Swing-bed patients were fully informed of their rights as required by 483.10(b)(1) which includes the requirement that the CAH must inform Swing-bed patients both orally and in writing in a language that the patient understands of his or her rights. Swing-bed patient rights policies and procedures, and admission documents were inconsistent, inaccurate and incomplete.

Findings included:

1. Review of a policy titled "Swing Beds-Patient Rights" Index 1-4, dated as last reviewed "7/2010" reflected "The patient, next of kin, and/or responsible party shall be informed of the following rights and presented with a copy of these rights upon admission to the Swing Bed Program." The policy lacked numerous Swing-bed patient rights required by this regulation including but not limited to the following:

*The right to personal privacy and confidentiality of his or her personal and clinical records.
*The right to refuse to perform services for the facility.
*The right to privacy in written communications, including the right to send and promptly receive mail that is unopened; and have access to stationery, postage, and writing implements at the resident's own expense.
*The right to retain and use personal possessions, including some furnishings, and appropriate clothing.

Review of a CAH policy titled "Patient Rights" Index 1-3, dated as last reviewed "7/2010" reflected that the policy lacked a complete list of Swing-bed patient rights including the following:

* The right to choose a personal attending physician.

2. A CAH Swing-bed admissions document titled "Swing Bed Patient Rights" dated "11/07/2013 3:17 PM" was reviewed. The document lacked a complete list of Swing-bed patient rights. In addition, language on the document reflected "Should you have a grievance with the hospital during your stay - you may call or write to...Oregon Health Division Department of Human Resources 800 NE Oregon Street #21 Suite 640 Portland, Oregon 97293 (503) 731-4013. The name and address for this agency was inaccurate, and a phone call to (503) 731-4013 on 09/23/2014 revealed that the phone number was invalid.

During an interview conducted on 09/10/2014 at 1440 an admissions staff stated the document above was part of an admission packet that was provided to all Swing-bed patients.

During an interview conducted on 09/10/2014 at 1600 the Director of Nursing and Swing-bed Coordinator acknowledged that the Swing-bed patient rights policies, procedures and admission documents were incomplete and inconsistent.

Based on interview, documentation in 3 of 3 medical records reviewed of Swing-bed patients (Patients 5, 6 and 7), and review of CAH Swing-bed policies and procedures, it was determined the hospital failed to provide an on-going program of activities for its Swing-bed patients. In addition, activities assessments and care plans for Swing-bed patients were not completed in accordance with CAH Swing-bed policies and procedures.

Findings include:

1. The medical record for Swing-bed Patient 5 was reviewed. The record reflected the patient was admitted to a Swing-bed on 08/29/2014. The record lacked documentation of an activities assessment and plan of care in accordance with CAH Swing-bed policies and procedures.

2. The medical record for Swing-bed Patient 7 was reviewed. The record reflected the patient was admitted to a Swing-bed on 09/08/2014. The record lacked documentation of an activities assessment and individualized plan of care.

3. The medical record for Swing-bed Patient 6 was reviewed. The record reflected the patient was admitted to a Swing-bed on 09/10/2014. The record lacked documentation of an activities assessment and individualized plan of care.

4. A hospital Swing-bed policy titled "Activity Program Purpose & Objectives" dated last reviewed "7/2010" was reviewed and reflected "The purpose of the Activity Program is to create an environment that encourages their abilities and to develop a broad spectrum of coping methods that will help them function at the highest level possible. The Activity Program provides a selection of social, emotional, spiritual, and intellectual opportunities. These are individually selected and planned...the needs of each patient are assessed and realistic, achievable goals for each patient based on their interests and abilities are developed."

A hospital Swing-bed policy titled "Activity Program Purpose & Objectives" dated last reviewed "7/2010" was reviewed and reflected "An Activity Program is provided which is suited to the intellectual, social, spiritual, creative, and physical needs and capabilities of patients...It is incorporated with the over-all plan of care...An Activity Plan is developed for each patient based on total patient assessment, including but not limited to past and current interests, activities, skills, medical limitations, cognitive, and emotional functioning. This plan is initiated as soon as possible after admission of a patient to the Swing Bed Program. It is completed within four (4) days. Goals and plans are entered on an overall plan of care."

5. An interview was conducted with the Swing-bed Coordinator on 09/10/2014 at 1420. During the interview, he/she stated that the hospital did not have a formal activities program for Swing-bed patients. He/she additionally stated that the CAH had no formal process for assessing Swing-bed patients for their activities needs relative to their physical, mental and psychosocial well-being.

Based on interview and review of CAH Swing-bed documents, it was determined that the hospital failed to fully develop its Swing-bed policies and procedures to ensure a comprehensive assessment was completed for each Swing-bed patient as required by this regulation.

Findings included:

1. Review of a CAH Swing-bed document titled "Charting Index," dated as last reviewed "7/2010" reflected the following daily and weekly charting requirements: "DAILY...Chart to skilled needs...Activities of Daily Living Flow Sheet...Medication and response to PRN Medications...Procedures/Therapies done and patient's response...Activities patient involved with and Patient's response...Significant patient changes...WEEKLY...Summary of patient's condition and progress toward short and long term goals...Update of multidisciplinary care plan (with patient care conference)...Physician Progress Note..."

The document did not include a clear process for ensuring all elements of a comprehensive patient assessment were conducted as required. Examples included the following assessment areas which were unclear and/or were not addressed: Customary routine, cognitive pattern, communication, vision, mood and behavior patterns, psychosocial well-being, physical functioning and structural problems, continence, and documentation of patient participation in the assessment.

2. An interview was conducted with the Swing-bed Coordinator on 09/10/2014 at 1420. The coordinator stated that a document within the CAH's Swing-bed manual titled "Charting Index," reflected the CAH's assessment requirements for Swing-bed patients. During the interview the coordinator acknowledged that the CAH's Swing-bed policies and procedures were not fully developed to include provisions for ensuring the completion of a comprehensive patient assessment as required by this regulation.

Based on interview, and review of patient's rights 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. A new patient admission packet was reviewed. It contained two documents which addressed patient visitation:

* An undated document titled "Southern Coos Hospital - Patient Information Orientation to Hospital" included a section for "Visiting Hours" which reflected "Visiting hours are 10:00 a.m. to 8:00 p.m., although your family may visit at anytime."

* An undated, untitled document on CAH letterhead reflected that "The patient rights ensure that, at least, the patient, next of kin and/or responsible person, admitted to the facility:...May associate and communicate privately with persons of his choice...If married, is assured privacy for visits by his/her spouse; if both are residents in the facility, they are permitted to share a room..."

2. During an interview on 09/09/2014 at 1450 the Health Information Manager provided several additional documents. She/he stated that those documents were provided to new patients by CAH registration staff during the registration process and that the new patient admission packet referred to in 1 above was provided to new patients by nursing staff during the inpatient CAH and swing-bed admission process. The documents provided included information about health information privacy rights, Medicare patient rights and information, Medicaid patient information, swing-bed patient rights, and the form titled "Terms and Conditions of Services" for "Consent to Hospital Services." Those documents were reviewed and none contained the required information about patient visitation rights.