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Based on information obtained at the time of survey, the Critical Access Hospital was determined not to be in compliance with the Condition of Participation: Provision of Services. The following regulatory violations included:

C- 0271: Failure to ensure that care and services were provided in accordance with currently established written policies and procedures in all areas of the hospital and outpatient clinics.

C-0272: Failure to ensure that existing policies were reviewed annually and/or developed directing the care and services for patients.

C-0273: Failure to establish policies and procedures that describe the services that the facility provides including those furnished through agreement or arrangement.

C-0276: Failure of Pharmacy Service to ensure that policies and procedures for the safe storage, handling, labeling, dispensation and monitoring of drugs throughout the hospital and out patient clinics were followed in accordance with accepted professional principles.

C-0278: Failure of the Infection Control Program to ensure that staff consistently maintained infection control standards of practice throughout all areas and departments of the hospital.

Refer to citations: C-0271, C-0272, C-0273, C-0276, C-0278

Based on record review and staff interview, the Critical Access Hospital (CAH) failed to ensure that care and services were provided in accordance with currently established written policies and procedures in all areas of the hospital and outpatient clinics. The findings include:

1. Per observation in the Perioperative department/Operating Room (OR) #1, accompanied by the Director of Surgical Services on 12/19/16 at 3:45 PM, the housekeeper assigned to perform the daily terminal cleaning of the 3 ORs stated s/he utilized a concentrated glass cleaner to clean the computer keyboards (including computer keyboards utilized consistently during surgical procedures by nursing and anesthesia staff), noting "..not sure what anyone else uses.....". Per review of the CAH policy OR Terminal Cleaning last reviewed : 5/2016, (which lacks approval), states "Mechanical friction and use of an EPA-registered agent are used to clean equipment and areas that should include, but are not limited to: All horizontal surfaces e.g., tops of counters, fixed shelving, computers and keyboards." Although the Windex glass cleaning product is listed as 1 of the supplies needed for terminal cleaning, it is not established as a proven EPA-registered agent effective for surface disinfection. Per interview on the morning of 12/21/16, the Infection Preventionist confirmed other products were identified and available which can provide the appropriate surface disinfection of computer keyboards within the Preoperative area.

2. Per observation and interview, the Quality Manager and Director of Plant Operations confirmed on 12/19/16 at 4:20 PM that 3/5 Oxygen (O2) E Cylinder tanks were empty and 1/6 Nitrous Oxide E Cylinder tanks were empty located in the Birth Center medical gas storage room. Per staff interview, the Quality Manager confirmed on 12/19/16 at 4:20 PM that staff did not follow the Birth Center Policy to exchange empty medical gas tanks for full tanks. Per " Birth Center Policy Nitrous Oxide Use in Obstetrics " policy effective July 17, 2015, "the Birth Center RN will turn both the O2 tank and nitrous tank "on" and check the regulator pressure. If in the red zone, change for a full tank". In addition, the Birth Center staff competency check sheet for " Administration of Nitrous Oxide " states, "Changing the Tanks: Recommendation is to change Nitrous Cylinders between patients if pressure is at or below 500 pounds/square inch .... Place work order in Meditech (computer system) or call Maintenance for more tanks when empty."

3. During the tour of the Ear, Nose, Throat and Audiology Clinic, at 8:34 AM on 12/20/16, in Exam Room #2, a cabinet containing sample medications was found unlocked. The Practice Manager confirmed at this time that the cabinet was not locked and should be locked at all times. During an interview on 12/20/16 at approximately 9:20 AM with the Practice Manager, s/he stated that the Clinic Nurse checks and logs the sample medications. Upon review of the Drug Sample Dispensing Log at this time, there was no clear reconciliation of the sample medications, and this was also confirmed by the Practice Manager.

Per review of the facility Drug Sample Policy, it stated, " All drug samples received must be recorded in the Drug Record. This record will list: Drug Name, Dosage, Manufacturer, Lot Number, Expiration Date, Who received the sample, Date received, and Quantity received. Storage of drugs in the clinical areas should not be located in waiting areas and public areas. The storage area will be secure and locked, and located in an area where it can be in full view of the staff and have limited access by patients. The count will be checked by the Physician office monthly and the Pharmacy department will inspect the storage area quarterly. The inspection record will be kept in the Drug Record book. " Per interview on 12/20/16 at 1:40 PM with the Vice President of Marketing and Community Health Improvement, Director of Physician Practices, Director of Pharmacy, and the Vice President of Quality, they confirmed that the clinic should be following the Drug Sample Policy and that they were not aware that the clinic had sample medications. The Director of Pharmacy further confirmed that there was no Pharmacy oversight of the clinic sample medications.

Based on observation, record and policy review and staff interview, the CAH failed to ensure that existing policies were reviewed annually and/or developed directing the care and services for patients. Findings include:

1. Per review of Surgical Services policies and procedures it was noted multiple policies are outdated and had not been reviewed as required on a annual basis to include: Surgical Consent & Surgical Checklist (last reviewed 3/14/11); Admission and discharge of conscious sedation (last reviewed 12/31/14); Ambulatory Services (last reviewed 8/28/12); VBAC (last reviewed 11/21/13) and Malignant Hyperthermia (8/14/15. In addition, the policy OR Terminal Cleaning was reviewed on 5/2016, however there is no indication it has been approved. Per on interview on 12/21/16 at 8:50 AM, the Vice President of Quality Management confirmed patient care policies and procedure had not been developed and/or reviewed in multiple areas throughout the CAH. The Vice President of Quality Management further stated the deficent practice was partially associated with the present software system used to assist staff in the entire review and development process.


2. Per observation of the Birth Center medication room and confirmed per staff interview with the Birth Center Manager on 12/19/16 at 12:27 PM, the hospital wide policy titled Destruction of Controlled Substances and Non Hazardous Medication Waste was posted in the medication room with no effective or revision date. Per staff interview and policy review, the Quality Manager confirmed on 12/20/16 at 1:28 PM the hospital wide policy for Destruction of Controlled Substances and Non Hazardous Medication Waste was posted in Share Point (hospital wide policy management system) with no effective or revision date approximately 2 weeks prior to 12/20/16.

3. a. Per review of medical record policies for the hospital, the majority of the policies reviewed on 12/19/16 had not been updated since 2011 and/or 2014. Per interview on 12/19/16 at 3:12 PM, the Vice President of Quality confirmed that the policies listed on the computer share-point site for medical records had not been updated since 2011 and/or 2014.

b. Per interview on 12/20/16 at 9:20 AM with the Practice Manager of Ear, Nose, Throat, and Audiology, s/he stated that s/he had been working on updating the clinic policies for the last three years that s/he had been in the role; and that the policies were not completely updated and some were still in draft form, some of the unrevised policies include the following: Allergy Clinic Policy (last reviewed 10/19/15), Instrument and Scopes Policy, (last revised 10/19/15).

4. During a tour of the Diagnostic Imaging Department with the PAC administrator on 12/19/16 beginning at 2:34 PM, a box of 20 ml syringes and (5) 60 ml syringes along with a box of hypodermic needles were observed on an open shelf of x-ray room #1 where fluoroscopy studies were done. The PACs administrator confirmed that the syringes and needles were not locked and the open door to the room was accessible by a common corridor used by patients and hospital staff who were not authorized to access the supplies. On 12/21/16 at 10:30 AM, the Infection Control Practitioner (ICP) confirmed that there was no evidence that a policy related to safe storage of syringes/needles had been developed and that the supplies should have been in a locked space.

5. Per staff interview and policy review, the Quality Manager confirmed on 12/19/16 at 3:48 PM, there was not a hospital wide policy that addressed the use of Nitrous Oxide and Oxygen (02) within the Critical Access Hospital. Per observation and confirmed with Director of Plant Operations and the Quality Manager on 12/19/16 at 3:48 PM, the Birth Center medical gas storage room contained 6 E-cylinders of Nitrous Oxide and 5 E Cylinder size Oxygen cylinders (medical gasses). It was further confirmed a sign was not posted on the gas storage room door alerting staff of the precautions for the safe handling of the medical gases. The Director of Plant Operations confirmed on 12/19/16 at 3:40 PM, Nitrous Oxide is only used in the Birth Center and Surgery, stating medical gases should be secured, behind a locked door, well vented, in a clean room, and signs should be posted. Per review of the Hospital Safety Data Sheets for Nitrous Oxide and Oxygen, received by the Director of Plant Operations on 12/20/16 at 8:32 AM, these materials are considered hazardous. Per review of the National Fire Protection Agency facilities code (NFPA) 99-2012 Edition, Chapter 11 received by the Director of Operations on 12/21/16 at 12:01, section 11.3.4.1 states a precautionary sign, readable from a distance of 1.5 meters (5 feet) shall be displayed on each door or gate of the storage room or enclosure and section 11.3.4.2 states the sign shall include at a minimum: Caution, oxidizing gas(es) stored within, no smoking.
6 . Per policy review and staff interview on 12/19/16 at 11:45 AM, the Birth Center Manager confirmed on 12/19/16 at 11:45 AM that Birth Center Policies are not included in the hospital wide policy review and revision process. Per staff interview and record review, the Birth Center Manager confirmed on 12/19/16 at 11:57 AM, that the policy for Oxygen Administration to Newborns in the Birth Center had an effective date of 7/10/88 and was last reviewed " 6/2001 " . Per record review and interview, the Birth Center Nurse Manager confirmed on 12/19/16 at 11:47 AM, the policy for Nitrous Oxide Use in Obstetrics has an effective date of July 17, 2015 and had not been revised or reviewed since the effective date. Per record review and interview, the Birth Center Nurse Manager confirmed on 12/19/16 at 11:50 AM, the policy for "Guidelines for Electronic Documentation and Fetal Heart Strips Storage and Archive in the GE Centricity System did not have an effective date. The effective date was labeled "XXX" and was last revised 5/30/16. Per staff interview and policy review, the Quality manager confirmed on 12/19/16 at 1:36 PM that the policy for Guidelines for Electronic Documentation and Fetal Heart Strips Storage and Archive in the GE Centricity System policy was not written in the required Hospital format for Hospital Policies and Procedures. Per record review and interview, the Quality Manager confirmed on 12/19/16 at 1:36 PM the policy for Labor Epidural and or Intrathecal: Nursing Management was not written in the required Hospital format for Hospital Policies and Procedures. Per staff interview and policy review, the Quality Manager confirmed on 12/20/16 at 4:28 PM, that the policy Birth Center Policy Nitrous Oxide Use in Obstetrics effective July 17, 2015 had not been revised since the effective date.

7. Per review of the Medical/Surgical Nursing policies on 12/21/16, there was no evidence of a policy/procedure for Intravenous (IV) Medication Administration. During interview, the Nurse Manager of the unit confirmed that there was no policy/procedure to address administration of intravenous (IV) medication(s).

Based on interview and policy review, the CAH failed to establish policies and procedures that describe the services that the facility provides including those furnished through agreement or arrangement. Findings include:

Based on interview on 12/21/16 at 8:50 AM, the Vice President of Quality Management confirmed patient care policies and procedure had not been developed that described CAH health care services furnished through agreements or contracts for both on-site and off-site locations where services are provided.

Based on observation, record review and interview, the pharmacy service failed to ensure that policies and procedures for the safe storage, handling, labeling, dispensation and monitoring of drugs throughout the hospital and out patient clinics were followed in accordance with accepted professional principles. Findings include:

1. During an observation on the Medical Surgical Unit on 12/20/16 at 11:16 AM of the Crash Cart (used to store emergency drugs and equipment) located across from the nurse's station, the top drawer of the Crash Cart was open approximately 3 inches, was not secured, and not under direct observation of nursing staff. Per observation, the drawer remained open and unsecured from 11:16 AM until 11:28 AM until it was closed by a Pharmacy Technician. During this time, multiple staff and a visitor were observed walking by the Crash Cart while the top drawer was open and unsecured. Per interview, the Clinical Manger confirmed on 12/20/16 at 11:28 AM that the Crash Cart top drawer was open and unsecured until it was closed by the pharmacy technician, and the top drawer contained injectable medications used in cases of emergencies.
Per interview on 12/21/16 8:53 AM, the Director of the Medical Surgical Unit confirmed that the video surveillance of the Crash Cart revealed that the Crash Cart top drawer had been unlocked with the safety seal removed and the top drawer was open about 3 inches for approximately 1 hour and 10 minutes before the Director was made aware that the the crash cart drawer was open and unsecured on 12/20/16 at 11:28 AM. The video surveillance revealed that a Pharmacy Technician opened the Crash Cart top drawer and left it open/ unsecured, Medical Surgical Staff walked by the open/unsecured Cash Cart and did not take action, and a visitor walked by the unsecured Crash Cart during this time.
Per review of the policy "Crash Cart Security, Checking" (no effective date listed) received by the Quality Manager on 12/20/15 at 1:31 PM, the policy states "Crash carts shall be furnished for each nursing station to satisfy the need for emergency drug and equipment storage ...The medication drawers of crash carts and will be sealed and dated by the Pharmacy Department to assure the cart integrity .... If the seal has been broken or the expiration date has passed, the pharmacy will be contacted to inspect, restock and reseal cart."
2. During a tour of the Ear, Nose, Throat and Audiology Clinic on 12/20/16 at 8:09 AM, a 16 Oz bottle of Hydrogen Peroxide (A colorless, viscous, unstable liquid commonly used in diluted form in disinfectants and bleaches.) was located on a shelf in the Audiologist ' s hearing aid fitting room. The bottle was opened and had an expiration date of 1/2013. Per interview with Practice Manager at this time, s/he confirmed that the bottle of Hydrogen Peroxide was outdated and should be thrown away.

3. While continuing on the tour of the Ear, Nose, Throat and Audiology Clinic, at 8:34 AM, in Exam Room #2, a cabinet containing sample medications was found unlocked. The Practice Manager confirmed at this time that the cabinet was not locked and should be locked at all times. During an interview on 12/20/16 at approximately 9:20 AM with the Practice Manager, s/he stated that the Clinic Nurse checks and logs the sample medications. Upon review of the Drug Sample Dispensing Log at this time, there was no clear reconciliation of the sample medications, and this was also confirmed by the Practice Manager.
Per review of the facility Drug Sample Policy, it stated, " Storage of drugs in the clinical areas should not be located in waiting areas and public areas. The storage area will be secure and locked, and located in an area where it can be in full view of the staff and have limited access by patients. The count will be checked by the Physician office monthly and the Pharmacy department will inspect the storage area quarterly. The inspection record will be kept in the Drug Record book. " Per interview on 12/20/16 at 1:40 PM with the Vice President of Marketing and Community Health Improvement, Director of Physician Practices, Director of Pharmacy, and the Vice President of Quality, they confirmed that the clinic should be following the Drug Sample Policy and that they were not aware that the clinic had sample medications. The Director of Pharmacy further confirmed that there was no Pharmacy oversight of the clinic sample medications.

4. During a tour of the Perioperative area on 12/19/16 accompanied by the Director of Surgical Services, in OR #3 open and undated 16 oz bottles of Povidone/Iodine 10 % Topical solution and Povidone/Iodine Scrub/Antiseptic were observed stored on a window sill within the OR. Two additional 16 oz biological solution bottles were found in OR # 2, which were also opened and undated. The Director confirmed the bottles of Povidone/Iodine topical solutions and scrub should have been dated when opened and stored appropriately. It was confirmed both solutions are often used during urology and gynecology surgical procedures.

5. During a tour of the Diagnostic Imaging Department with the PACs administrator on 2/19/16 beginning at 2:34 PM, an open bottle of 100 Barium sulfate 700 mg tablets and 1 open box and 1 full box of 50 packets of EZ-Gas II effervescent granules were observed unsecured on an open shelf of x-ray room #1 where fluoroscopy studies were done. The PACs administrator confirmed that the medications were not locked and the open door to the room was accessible by a common corridor used by patients and hospital staff who are not authorized to access the drugs. The Pharmacy policy titled, Designated Drug Storage Areas, states under Procedure, that "other medications... may be located in a locked cabinet in a room ...where specific procedures are performed."

Based on observation, interview and record review, the Infection Control Program failed to ensure that staff consistently maintained infection control standards of practice throughout all areas and departments of the hospital. Findings include:

1. Per observation in the Perioperative department/Operating Room (OR) #1, accompanied by the Director of Surgical Services on 12/19/16 at 3:45 PM, the housekeeper assigned to perform the daily terminal cleaning of the 3 ORs stated s/he utilized a concentrated spray glass cleaner to clean the computer keyboards (utilized by nursing and anesthesia staff during surgical cases), noting "..not sure what anyone else uses.....". Per review of the CAH policy OR Terminal Cleaning last reviewed : 5/2016, (which lacks approval), states "Mechanical friction and use of an EPA-registered agent are used to clean equipment and areas that should include, but are not limited to: All horizontal surfaces e.g., tops of counteres, fixed shelving, computers and keyboards." Although the Windex glass cleaning product is listed as 1 of the supplies needed for terminal cleaning, it is not established as a proven EPA-registered agent effective for surface disinfection. Per interview on the morning of 12/21/16, the Infection Control Practitioner confirmed other products were identified and available which can provide the appropriate surface disinfection of computer keyboards within the Preoperative area.

Per the AORN (Association of periOperative Registered Nurses) evidenced-based 2016 Guidelines for Perioperative Practice states: "1. IV.c. Terminal cleaning of operating and procedure rooms should include cleaning and disinfecting of all exposed surfaces, including wheels and casters, of all items, including: computer accessories (eg, keyboard, mouse, touch screen). In addition, the housekeeper was utilizing a spray bottle which is contraindicated as per AORN: "Spray and misting methods (eg, a spray bottle) should not be used to apply cleaning chemicals in the perioperative practice setting."
2. During a tour of the Perioperative department on the afternoon of 12/19/16 accompanied by the Director of Surgical Services while inspecting OR #3 a fracture table attachment was observed to have 7 small tears in the vinyl covering running down the side of the positioning device and a shoulder table also used during surgical procedures was observed to have worn exposed edges. On 12/20/16 the operating table in OR #2 was also noted to have tears in the vinyl covering. Per AORN: " II.f.2. If a protective barrier covering is used, the cover should be removed or cleaned and disinfected per the manufacturer ' s instructions after each patient use.....II.h. Mattresses and padded positioning device surfaces (eg, OR beds, arm boards, patient transport carts) should be moisture-resistant and intact". II.h.1. Damaged or worn coverings should be replaced." However, due to the torn and worn vinyl coverings of the positioning boards and OR table, it could not be confirmed infection control prevention was being met due to the lack of integrity of the vinyl coverings. The Director of Surgical Services confirmed the observations.
3. During a tour of the supply room within the Perioperative department accompanied by the Infection Control Practitioner and Legal Compliance Officer on the afternoon of 12/20/16 a cabinet used specifically for safe and clean storage of processed endoscopes, miscellaneous supplies/boxes were observed laying precariously on the bottom of the cabinet in direct exposure of the endoscopes which had been deemed clean and available for patient use. The cabinet was equiped with a rolled door and when closed would prevent exposure of the scopes from the daily traffic of Perioperative staff entering and exiting the large supply room and decrease exposure of environmental contaminates. However, the cabinet door was observed not to be used and 10 scopes were suspended within the cabinet. A second cabinet within the Perioperative area was also noted on the afternoon of 12/19/16 to be consistently left open, providing additional opportunity of environmental contaminates. Per AORN recommendation: "Guidelines for Processing Flexible "IX: The collective evidence supports effective storage of flexible endoscopes and endoscope accessories as a means of helping to ensure devices are safe for patient use...flexible endoscopes and endoscope accessories should be stored in a manner that minimizes contamination and protects the device or item from damage..."
4. During a tour of the Perioperative department on the afternoon of 12/19/16 accompanied by the Director of Surgical Services a tour was conducted of the Central Sterile Processing (CSR) area where equipment and surgical instruments are reprocessed and sterilized. In the decontamination room where endoscopes are processed after being used in a diagnostic procedure a container of "3 in 1 Residual Soil Test" strips was noted to be opened. The manufacturer's instructions on the container label of the test strips stated: "Best if used within 90 days". There was no date indicating when the test strips were opened. At the time of the observation, a technician responsible for cleaning of the endoscopes, acknowledged the test strips are used to detect any residual contaminates in the endoscopes to include hemoglobin, protein and/or carbohydrates prior to proceeding to a high level disinfection of the endoscopes. Staff was unable to ensure the efficacy of the "3 in 1 Residual Soil Test" strips since no date was documented when the container was opened. Utilizing the test strips within the 90 day period, also ensures the potential to detect residual soil and verifying the adequacy of manual cleaning is effective and helps detect if a endoscope has not been sufficiently cleaned prior to the final process of high level disinfection, thus requiring the endoscope to be put through the wash process one more time.

5. During observation of the Administration of an Intravenous (IV-in the vein) Medication on the Medical Surgical Unit on 12/20/16 at 4:00 PM, a Registered Nurse donned gloves once s/he entered the Patient's room and then proceeded to touch the patient, multiple objects in the room (computer, ID bracelet scanner, IV pump, bedside table), himself/herself and then administered the IV Medication. The Registered Nurse failed to change his/her gloves and sanitize his/her hands prior to administering the IV medication. Per interview on 12/20/16 at 4:14 PM with the Registered Nurse, s/he confirmed that s/he donned gloves when s/he entered the Patient's room and did not change and/or remove the gloves and/or sanitize his/her hands until prior to leaving the room.
Upon review of the facility Hand Hygiene policy it stated, "Hand Hygiene must take place: 2. Before and after direct patient contact; 5. After contact with a source of microorganisms (inanimate objects); 7. After contact with body fluids, excretion, mucous membranes, non-intact skin and wound dressings; 8. After contact with a patient's intact skin; 11. Whenever indicated to avoid transfer of microorganisms to patients, staff or the environment." Per interview with the Infection Control Practitioner 12/21/16 at 10:40 AM, s/he stated that all hospital employees receive education about hand hygiene during intial hospital orientation.

6. During the tour of the Ear, Nose, Throat, and Audiology Clinic on 12/20/16 at approximately 9:15 AM, there was an area designated for emergency equipment located diagonally from exam room #3. A portable oxygen tank was located in this area. On top of the portable oxygen tank there was a bag containing single use oxygen tubing. The bag of single use oxygen tubing was opened with part of the oxygen tubing exposed. Per interview with the Practice Manager at this time, s/he stated that s/he did not know how long the tubing had been exposed. S/he stated that the oxygen tubing was single use and was to be thrown out after each use.

7. During a tour of the Diagnostic Imaging Department with the PACs administrator on 12/19/16 beginning at 2:34 PM, in x-ray rooms #1 and #3, open cell foam positioning blocks used during diagnostic imaging procedures were observed on the shelves. In room #3, one positioner had a vinyl cover with an approximate 5" tear along the seam and holes in vinyl in the corner seams and the top. The facility Standard and Isolation Precautions policy (last reviewed 12/20/16), stated in section e. that "Noncritical equipment (i.e. equipment that touches only intact skin) must be cleaned and disinfected after use." At the time of the tour, the PACs administrator confirmed that a thorough disinfection of the positioner surfaces could not be ensured. In the nuclear medicine room, oxygen extension tubing was observed loose and unpackaged in a drawer and reported by the tech to be used for multiple patients who required aerosolized lung scans. On 12/21/16 at 10:30 AM, the Infection Control Practitioner (ICP) confirmed that oxygen extension tubing was labeled for single use, should not be used for multiple patients and posed a potential infection control issue.

Based on interview and medical record review, the CAH failed to ensure that medical records were complete and accurately documented for 1 of 20 records reviewed. Findings include:

1.Per medical record review on 12/21/16, Patient #9 was admitted on 10/27/16 and discharged on 10/29/16. Upon further review, there was no evidence of a discharge summary in the medical record for Patient #9. Per interview on 12/21/16 at 9:55 AM with a Medical Records Staff member, s/he confirmed that there was no discharge summary in the medical record for Patient #9.

Based on observation, interview and policy review, the Quality Assurance program failed to ensure that the CAH's health care policies were reviewed and revised yearly as part of the annual program evaluation. Findings include:

During an interview on 12/21/16 at 8:07 AM and at a presentation later in the early afternoon, the Vice President of Quality Management (VPQM), reported that the annual review of facility policies was challenging and that there was a need to develop a more effective management system so that the review requirement could be met. The VPMQ reported that though the facility had tried to gather policies in an electronic policy management system, both the meditech and current sharepoint systems did not deliver the functionality needed. In addition, the VPMQ confirmed that the current systems were not being effectively used by all managers to keep their department specific policies reviewed and revised. The VPQM reported that the annual review was still a work in progress and the quality department was working to improve hospital wide compliance and was in the process of exploring other management system options. (Refer 272).