HospitalInspections.org

Based on interview, credentialing file review, and medical staff bylaw review, the provider failed to ensure:
*The credentialing reappointment form indicated if there was a change or no change in requested privileges for two of two reviewed physicians (K and L) reappointment forms.
*The credentialing committee documented recommendations to the governing board for two of two sampled physicians (K and L) reappointment forms.
*The physician assistant's performance was evaluated by their supervising physician and documented prior to recredentialing for three of three reviewed physician assistants (H, I, and J) credentialing files.
Findings include:

1. Review of the reappointment forms for physicians K and L revealed:
*The applicants had not identified if they were requesting or were not requesting additional privileges.
*A section to check if the applicants were recommended for reappointment, not recommended for reappointment, or the reappointment had been deferred had not been checked by the chief medical staff or the governing board.

Review of the Reappointment Administrative Questionnaire for physician assistants H, I, and J revealed:
*The following questions:
-"Is the above individual a member in good standing of your medical staff?
-To your knowledge has this applicant been involved in any malpractice claim or action while an appointee on your staff?
-To your knowledge has the applicant had his/her license to practice medicine in any state, medical staff membership at any facility, privileges to admit or treat patients at any facility, DEA registration or controlled substance registration limited, suspended, terminated, relinquished or reduced voluntarily or involuntarily?
-Have this individuals privileges ever been modified, restricted, or voluntarily relinquished in order to avoid disciplinary action?
-To the best of your knowledge, is there any reason why this individual should not be reappointed?"
*A request to provide a summary of the quality assurance findings regarding the applicant.

Interview on 7/19/17 at 2:20 p.m. with the medical staff secretary revealed:
*She was responsible for assembling information for medical staff initial appointments and reappointments.
*She knew the answers to the questions on the reappointment administrative questionnaire form, because she had gathered that information.
*She had signed off on the reappointment administrative questionnaire, because she knew the answers to those questions.
*The physicians should have indicated if there were or were not changes to their current privilege list.
*She had noticed the physicians were not answering the question regarding privilege change and started highlighting that question for them to notice. She might have forgotten a few.
*The chief of medical staff and governing body had approved the above listed physicians reappointments with the missing data on privileges.
*The chief of medical staff and governing body had approved the physician assistant appointments with her signature on the reappointment administrative questionnaire forms.

Review of the medical staff bylaws reappointment process revealed:
*Biennial a reappointment form should have been forwarded to each staff member at least ninety days prior to the expiration date of the present staff appointment.
*Sixty days prior to the expiration date the applicant should have sent his or her completed reappointment form to the medical staff secretary.
*The medical secretary collected and verified additional information made available on the reappointment form.
*When the collection and verification was completed the reappointment forms were transmitted with supporting material to the credentials committee.
*The credentials committee should have reviewed the information form, all relevant information, and on the prescribed form made recommendations regarding the appointment.
*The bylaws had not indicated reappointment administrative questionnaire should have been answered and signed by the medical staff secretary.
*The bylaws were not clear regarding who was authorized to sign the reappointment administrative questionnaire form.

A. Based on observation, record review, interview, and policy review, the provider failed to:
*Create proper traffic flow and construct separate clean and dirty areas for the processing, disinfection, and/or sterilization of endoscopes and surgical instruments.
*Ensure to prevent potential contamination for five of five sterilized packages after removal from the autoclave the packages were not stacked on top of each other for cooldown.
*Ensure five of five sterilized packages had been secured with sterilizer indicator tape to secure package folds and indicate processed status.
*List all surgical instruments and packets individually, so a recall could be conducted should a biological test fail.
*Store two of five endoscopes appropriately so as to prevent possible contamination.
Findings include:

1. Observation on 7/18/17 from 11:30 a.m. to 12:15 p.m. revealed:
*A small room approximately five foot by eight foot with the following:
-A handwashing sink in a countertop.
-An autoclave with the door ajar on a cart.
-Five wrapped sets of surgical kits for emergency room use on the cart with the autoclave were stacked on top of each other and the package folds had not been secured with indicator tape.
*An endoscope cabinet by the bed of the second bay of emergency room (ER) 2. That cabinet held 2 esophagogastroduodenoscopy (EGD) scopes and 3 colonoscopes. Two of the EGD scope ends were touching a towel that had been laid in the bottom of the cabinet.

Interview with certified nurse assistant (CNA) A at the time of the above observations revealed:
*They had done endoscopy procedures for a number of years.
*She had been shown how to do the disinfection and the sterilization from another CNA about a year ago.
*The five wrapped surgical kits had been sterilized and stacked on top of each other because they had been too hot to put away.
*She had attended training and completed a skills test this year for the endoscopes by the endoscope manufacturer.
*There was no clear traffic flow for semi-restricted and restricted areas.
*There was no separation of dirty and clean instruments or scopes in the small room with the autoclave.
*The handsink was used for handwashing as well as washing and rinsing of the instruments used in the two ER rooms.
*The countertop was used to process dirty, clean, sterile instruments, and package surgical kits.
-She did disinfect the countertop and all other surfaces between terminal disinfection of the endoscopes and each sterilization step.
*She kept a log of the instruments, surgical kits, and biological for sterilization. She initialed the peel packs to show she had done the sterilization.
-The log contained only the following words for each load "ER" or "clinic."
-It did not state what instruments nor how many had been sterilized.
-The peel packs did not indicate what sterilizer load it was for that day.
*CNA A was not aware she must record the individual instruments, number of instruments, and surgical kits and contents for each load. Nor was she aware she must identify the processed load on the peel packs.
*After terminal disinfection of the endoscopes she would hang them in the scope cabinet in ER 2.
-She was not aware the endoscope ends could not touch the bottom of the cabinet.

Review of the 11/6/15 provider's Equipment Sterilization policies and procedures revealed:
*No standards or practices from any association or government guidelines were given.
*Nothing was stated to adhere to the correct traffic from clean to dirty or semi-restricted to restricted.
*Nothing was stated to correctly describe the wrapping of surgical instrument kits/packs.
*No guidelines were given for the labeling of instruments and records of autoclaved instruments.
*No guidelines were given for the storage of EGD and colonoscopy scopes in the endoscope cabinet.

Review of the Association of periOperative Registered Nurses, Guidelines for Perioperative Practice, 2016 Edition, revealed:
*Page 825: The movement of clean and sterile supplies and equipment should have been separated from contaminated supplies, equipment, and waste by space, time, or traffic patterns. The functional workflow patterns should have been established to create and maintain physical separation between the decontamination and sterilization areas.
*Pages 677-678: Flexible endoscopes should have been decontaminated in an area physically separated from locations where clean items were handled. The endoscopy suite consists of a minimum of three functional areas: procedure room, processing room, and patient care areas. Having separate decontamination and clean rooms may avoid the risk of cross contamination from multiple individuals performing both clean and contamination processing activities in a single area.
*Page 842: Information should have been recorded from each sterilization cycle and should include the:
-Identification of the sterilizer.
-Type of sterilizer and cycle used.
-Load control number.
-Load contents (e.g.. suture set, clamps, scissors).
-Critical parameters for the specific sterilization methodology.
-Operator's name and date.
-Results of sterilization process monitoring.
-Package label information and proper record keeping allowed items to be identified or retrieved in the event of a sterilization processing error or equipment malfunction.
*Page 724: Flexible endoscopes should have been stored in a closed cabinet with adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet.

Review of Central Service Technical Manual, Seventh Edition, revealed:
*Page 247:
-"Tapes designated as "indicator tapes" are considered best practice because they are made specifically to withstand sterilization, and they will change color after being exposed to the sterilization process."
-"Indicator tapes or indicator stickers which change color after exposure should be used on every package."
*Page 258: "The right side of the wrapper is folded over the pack, overlapping the previous fold and folded back to form a cuff or tucked under and secured with indicator tape."
*Page 260: Conditions that can adversely affect the ability of a sterile package to maintain its sterilization until it is opened by the user at the point of use included:
-"Physical damage to the package including abrasions, cuts, tears, punctures, broken seals, and breakdown of packaging material." Items should have been wrapped securely to prevent gapping, billowing or formation of air pockets. All wrapper edges should have been secured when supplies were presented to the sterile field in surgery. Securing the loose wrapper edges would prevent them from contaminating the sterile field.
-"Moisture and liquid/fluid contamination."



15036

B. Based on observation, interview, and policy review, the provider failed to ensure:
*The enzymatic cleaner was prepared in accordance with the manufacturer's directions.
*The high-level disinfection process for colonoscopy endoscopes and accessories were performed to ensure the disinfection of two of two observed colonoscopy endoscopes cleaning and disinfection by one of one certified nursing assistant (CNA) (A).
*The endoscopy policy and procedure had been updated to reflect the hospital's current high-level disinfection process and the high-level disinfectant in use.
Findings include:

1. Observation and interview on 7/20/17 at 8:00 a.m. in the decontamination room of CNA A for the process for high-level disinfection of colonoscopes revealed:
*She had general instructions from the manufacturer for disinfecting endoscopic scopes used for colonoscopy procedures.
*Those written instructions did not match her process for cleaning endoscopes.
*She mixed the enzymatic cleaners by filling the sink half-way then added 30 milliliters of the enzymatic cleaner to the water. That was what the company representative had instructed her to do.
*She did not know how much water was in the sink or if that amount matched the manufacturer's recommendation for mixing the solution.
*A review of the instructions on the enzymatic cleaner bottle revealed the dilution ratio was 1/8 to 1/2 fluid ounce per one gallon of water.

Observation on 7/20/17 at 8:32 a.m. of the cleaning and high-level disinfection process for colonoscopy scopes by CNA A revealed:
*After internal cleaning of each colonoscope the colonoscope was placed in a tub of high-level disinfectant.
*After a colonoscopy procedure the first colonoscope was placed in the high-level disinfectant solution.
*The colonoscope had semi-opaque tubing with a syringe attached.
-That tubing and syringe were not completely immersed in the high-level disinfectant solution.
*Prior to putting the second colonoscope in the high-level disinfectant CNA B entered the decontamination area and:
-Rinsed out the water bottle used for irrigating during colonoscopy procedures in the high-level disinfectant.
-That process did not disinfect the water bottle.
-The water bottle required total immersion for eight minutes for disinfection to have occurred.
-Rinsed out the water bottle in the tub of clean water used to rinse the colonoscopes in after high-level disinfection.
-Rinsing the contaminated water bottle in the rinse water contaminated that water and should not have been used again.
*After the second colonoscopy procedure a second colonoscope was placed in the high-level disinfectant solution.
-The colonsocope had semi-opaque tubing with a syringe attached.
-The tubing, the syringe, and one knob on the colonoscope were not completely immersed in the high-level disinfectant solution.
*After the eight minute soak in the high-level disinfectant solution and removal of the top on the solution bin the disinfection process was halted by the surveyor.

Interview with CNA A immediately after stopping the disinfection process revealed:
*She was not aware the tubing and syringe should have been totally immersed for disinfection to occur.
-The endoscope representative that trained her had not mentioned that fact.
*After looking at the second colonscope in the disinfection solution she was not able to identify one of the colonscope knobs was not immersed in the high-disinfection solution.

Review of the provider's 6/27/17 Endoscopy policies and procedures revealed:
*The high-level disinfectant was listed as Cidex OPA that had a twelve minute soak time. The provider currently used Revital that had an eight minute soak time.
*The directions for disinfection were for Cidex OPA.
*There were no disinfection directions for the use of Revital.

Review of Revital manufacturer's instructions for use revealed:
*The high-level disinfection immersion time for disinfection was eight minutes.
*"Once the instrument has been immersed and all surfaces in contact with the disinfectant solution, soak the instruments for 8 minutes at 20 degree C [Celsius]."

Review of the Association of periOperative Registered Nurses, Guidelines for Perioperative Practice, 2016 Edition, revealed:
*Page 696: The cleaning solution manufacturer's instructions for use should have been followed for concentration and dilution.
*Page 703:
-"Water and irrigation bottles should be high-level disinfected or sterilized at least daily. There should be no residual water or moisture remaining in the water-bottle assembly."
-Water bottles consist of the water container, cap, and lens washing. Irrigation bottles consist of the water container, tubing, and accessories used to flush water through the endoscopes."
*Page 713: Chemicals and solutions used for cleaning and processing flexible endoscopes and endoscope accessories must be handled in accordance with the manufacturer's instructions for use.



35237

C. Based on interview, record review, and policy review, the provider failed to ensure:
*Trending of patient infections had been completed for all of 2016 though June 2017.
*Tracking and trending of employee illnesses had been completed for all of 2016 through June 2017.
*Documentation to confirm patient infections had been hospital or community associated for reports reviewed from all of 2016 through June 2017.
*The infection control preventionist had been provided with further training and education related to that role.
Findings include:

1. Review of the provider's quarterly Infection Control Report meeting notes from January 2016 though June 2017 revealed:
*Numbers of patients' cultures were tracked.
*Organisms for each type of culture were tracked.
*Antibiotic use was tracked.
*There was no analysis of what that tracking had indicated.
*There was no trending identified or mentioned for the above.

Review of the provider's quarterly Infection Data Collection Records revealed:
*A record was completed for each patient identified with an infection or using an antibiotic.
*On the record there was a place to fill out that indicated if the infection was hospital or community associated.
*Those records were separated into quarters.
*Of those records most did not indicate if the infection was hospital or community associated including the following:
-Twenty of twenty-two records for the first quarter of 2016.
-Two of thirteen records for the second quarter of 2016.
-Eight of nine records for the third quarter of 2016.
-Twenty of twenty-one records for the fourth quarter of 2016.
-Twenty-six of thirty-two records for the first quarter of 2017.
-Thirteen of fifteen records for the second quarter of 2017.
*Those above records had not indicated who had completed them.

Interview on 7/19/17 at 3:55 p.m. with the director of nursing (DON) regarding infection control revealed:
*She had been the DON since 2014 and was the person responsible for overall infection control.
*She completed the Infection Data Collection Records for each patient infection and collected the data for the quarterly infection control meetings.
*She had been trained by the previous DON and had not received other specific infection control training.
*The forms and processes she used had been implemented by the previous DONs, and she had continued what they had been doing.
*If she had specific questions related to infection control she had resources through other hospitals she could have contacted.
*She stated she tracked infections but had not trended them.
*She agreed trending infections was an important process for them to be able to identify areas of potential concerns related to infection control.
*There was no tracking of employee illnesses.
*She confirmed employee illnesses could have an effect on the patients.
*The Infection Data Collection Records had a section to fill out to indicate if the infection was hospital or community associated.
-She had not been filling that area out and agreed she should have done so.
*She stated most patient infections were present on admission and not hospital associated, but that had not been documented clearly.

Review of the provider's revised August 2006 Med Pass Infection Control Policy and Procedure Manual revealed:
*Page 5, for employee training on Infection Control:
-"The facility shall provide staff with appropriate information and instruction about infection control through various means."
-"3. The Infection Control Coordinator and Administrator will identify pertinent infection control topics and those disciplines or individuals who need to be informed in detail beyond that provided by policies and procedures. Some educational or informational sessions will be for all staff, while others will be targeted for individual staff persons or disciplines."
*Page 6, the infection control committee:
-"1. The Infection Control Committee shall oversee the surveillance, investigation, reporting, control and prevention of infections;..."
*Page 7, the infection control coordinator:
-"3. The Infection Control Coordinator shall keep abreast of changes in infection control guidelines and regulations to ensure our facility's protocols remain current and aid in preventing and controlling the spread of infections."
-"5. The Infection Control Coordinator shall collect and report statistics related to the facility's infections trends, patterns, and issues."
*Page 9, identifying nosocomial (healthcare associated) infections:
-"The facility shall identify and distinguish nosocomial infections from those acquired elsewhere."
-"The Infection Control Coordinator will divide statistics for infections into nosocomial and non-nosocomial, and will report this information to The Infection Control Committee or Quality Committee performing infection control oversight functions. The committee will review the reports and identify trends, patterns, or problems that might reflect outbreaks, nosocomial spread, or the need for additional investigation or infection control measures."

Surveyor: 20031
D. Based on random observation, record review, document review, and interview, the provider failed to ensure:
*Two of two disinfectants were used according to manufacturers' directions throughout the hospital.
*Clean patient supplies (tubing) were kept in the original packaging until ready for use.
*Walls were maintained without holes or cracks in central supply and the clean supply room on the north hall.
*One of one floor sink was maintained without cracked and missing tiles in the soiled utility room.
*One of one housekeeping cart stored paper hygiene products protected from possible contamination.
*All wooden shelves in the housekeeping supply room were kept cleanable with a sealant.
*The wooden chart shelf in ER 1 was sealed for cleanability.
*Laryngoscopes were stored to prevent possible contamination.
*The countertop in the sterile processing room was not chipped or broken.
*Surgical attire was correctly worn by one of one certified nursing assistant (CNA) (B) during a procedure.
*The entire two bay ER was terminally cleaned after surgical procedures.
Findings include:

Surveyor: 35237
1. Observation on 7/18/17 at 9:40 a.m. in ER 1 revealed:*Two spray bottles sitting on the edge of the sink.
-One bottle was labeled "Vesphene Nov 13" on a sticky note and was about one-third full of a brownish liquid.
-The other bottle was labeled Quat 25 disinfectant and had a clear liquid in it.

2. Observation on 7/18/17 at 10:05 a.m. in ER 2 revealed:*Two spray bottles on the edge of the sink.
-One bottled labeled "Vesphene use to clean counters & ER carts."
-One bottle labeled Quat 25 disinfectant.

Observation and interview on 7/18/17 at 10:40 a.m. with the DON in ER 2 revealed:*She thought the staff used Vesphene on the ER carts after patient use.
-They would have sprayed it on the surfaces and wiped it down.
-She thought it was a disinfectant.
*The staff used the Quat disinfectant if a patient had a potentially infectious disease, because it "covers more bugs."

Interview on 7/18/17 at 3:00 p.m. with CNA C, and RNs D and E regarding the cleaning chemicals revealed:*CNA C had never heard of Vesphene.
-She used the Quat disinfectant on patient beds and Sani Cloth wipes for other patient items.
*RN D thought the Vesphene was used for the patient carts and bed rails.
*RN E stated they used either the Quat or Vesphene for cleaning patient items since she thought both of them were disinfectants.

Surveyor: 20031
Interview on 7/18/17 at 3:45 p.m. with housekeeper/CNA M revealed she had been told RN F had brought the Vesphene product into the facility for a better disinfectant. She had been told it had an immediate contact time. She and the other housekeeper would mix it up for the spray bottles used throughout the hospital. She stated they used an ounce or two of the product mixed with water.

Review of the one gallon container of Vesphene the housekeepers used to mix the solution for the spray bottles revealed it had a contact time of ten minutes. It required two ounces of product to be mixed in a one quart container. It also had an expiration date of 5/1/16. Housekeeper/CNA M revealed she was not aware of the ten minute contact time or that the one gallon container had expired over a year ago.

Surveyor: 35237
Interview and label review on 7/19/17 at 11:30 a.m. with RN F during cleaning of ER 1 following patient use revealed:*Nursing staff cleaned the patient rooms after the patient left.
*Housekeeping staff did the daily cleaning of patient rooms.
*She sprayed Quat disinfectant on the counter tops, ER cart, and other surfaces and then started wiping the disinfectant off the surfaces approximately one to two minutes later.
*When asked how long the disinfectant needed to remain wet on the surface she replied she was "unsure."
*After checking the bottles label and instruction she stated the disinfectant should have remained wet on the surfaces for ten minutes.
*There was now a full bottle of Vesphene liquid with a date of July 19, 2017 on it by the sink.
*She stated she did not know what the Vesphene was used for, and she always used the Quat disinfectant.

Review of the 5/1/09 Vesphene IIse Germicidal Detergent Technical Data sheet revealed:*"Vesphene IIse Germicidal Detergent is a research developed one-step disinfectant, cleaner and deodorizer..."
*"The germicidal detergent is intended for use in institutions such as industrial plants, veterinary clinics, pharmaceutical plants and other indoor areas where disinfection, cleaning and deodorizing are a necessity."*Directions for use included:
-"...Apply solution with a cloth, sponge, mop or brush using normal cleaning methods. Thoroughly wet all surfaces to be cleaned, then remove excess solution with a wrung-out applicator. Treated surfaces should remain wet for 10 minutes..."
-"...Discard solution daily, or when it becomes dirty, and replace with fresh solution. A properly prepared solution of Vesphene IIse Germicidal Detergent intended for use as a hard surface disinfectant has a shelf life of 14 days (use life) in a closed container such as a spray bottle..."

Review of the April 2015 3M HB Quat Disinfectant Cleaner Concentrate 25A, 25L, and 25H Technical Data sheet revealed:*"...These products are broad spectrum hospital disinfectant cleaners for use on hard, nonporous surfaces such as floors, walls, desks or countertops, tables and chairs, telephones, bed frames and cabinets to clean, disinfect and deodorize..."
*Disinfection instructions included:-"...Treated surfaces must remain wet for 10 minutes..."

2. Observation on 7/18/17 at 9:40 a.m. in ER 1 revealed a suction machine on the crash cart. The tubing package had been opened, and the tubing was connected to the machine.

Observation on 7/18/17 at 10:05 a.m. in ER 2 revealed two suction machines had been ready for use. One was on the counter top, and one was on the crash cart. Both had the packages opened, the tubing hooked up, and it was connected to the machine.

Interview and label review on 7/18/17 at 10:40 a.m. with the DON in ER 2 regarding the suction machines revealed:*The suction tubing was always opened with the tubing hooked up and ready for use in an emergency.
*She confirmed there was a potential for contamination of those opened suction tubing packages.
*The packages stated "Do not use if package is opened or damaged."

There was no specific policy regarding one-time use supplies according to the DON.

Surveyor: 20031
3. Random observation on 7/18/17 from 10:30 a.m. to 3:30 p.m and again on 7/19/17 from 1:00 p.m. to 3:30 p.m. revealed:
*The wooden charting shelf in ER 1 needed to be sealed to be cleanable.
*Laryngoscope blades were stored intermingled in a plastic Tupperware container in ER 1.
*The east wall of central supply had two abandoned water faucets. Those water faucets protruded from the wall and had gaping holes the size of saucer plates around the piping.
*The west wall of the clean supply room on the north hall had two large cracks approximately 1/4 to 1/2 inch wide that extended from the ceiling to the floor.
*The floor sink in the soiled utility room had cracked, chipped, and missing tile.
-The cracked, chipped, and missing tiles allowed soil and grime to adhere to the unsealed cement surface.
*The housekeeping cart had paper hygiene products of toilet paper and paper towels stored with cleaners and chemicals on the bottom tier of the cart.
*All wooden shelves in the housekeeping supply room either had no sealant or needed to have sealant reapplied to make the shelves cleanable.
*The countertop in the sterile processing area room had a missing piece of laminate on the west edge about a foot long that left the area uncleanable.

Interview on 7/19/17 at 4:20 p.m. with the DON revealed she was not aware of all the above listed items. She stated they had a preventive maintenance program and work orders to do work as needed. She was not aware of the Centers for Disease Control guidelines that facilities must store laryngoscope blades individually to eliminate the risk of contaminating multiple devices. She also stated she had no idea what guidelines were used throughout the hospital. She had been told they used the guidelines of another hospital but was unsure what those guidelines were.

4. Observation and interview on 7/20/17 from 8:50 a.m. through 9:45 a.m. prior to, during, and following patient 1's colonoscopy procedure in ER 2 with CNA B revealed:*During her set-up and the patient's procedure she wore personal protective equipment that included a gown, gloves, glasses, and a mask.
*She wore the mask covering her mouth and chin area only.
-She had it placed so her nose was out in the open.
*Following the procedure she moved the mask down under her chin and assisted the patient back to her room.
*Upon her return to the ER room the mask remained in the same position under her chin.
*The above had been her usual practice.

5. Observation and interview on 7/20/17 from 8:50 a.m. though 9:45 a.m. prior to, during, and following patient 1's colonoscopy procedure with CNA B and RN F revealed:
*The endoscope procedures took place in ER 2 every month.
*They had been performing colonoscopies and EGDs in the ER room for years.*They cleaned the surfaces of the scope machine, carts used during the procedure, and bed prior to and following the procedure with Quat disinfectant.
*There were several other patient care items in the ER that were left in there during the endoscope procedures. Some of those included:
-IV pump and pole.
-Crash cart.
-Suction devices.
-Pediatric crash cart.
-Bair hugger machine.
-Endoscope storage cabinet was left open during the procedures and held the unused scopes.
*Following the endoscope procedure which was the last one of the day CNA B and RN F sprayed the bed, scope machine, and carts used during the procedure with the disinfectant.
*The additional items above and other surfaces in the room such as cabinets, countertops, and floor had not been included in that cleaning process.
*After the scopes were done for the day the room would be available for ER patients again.
*They confirmed that was their usual process.

Based on interview and policy manual review, the provider failed to ensure the policies and procedures that were annually reviewed for three of six departments (acute care, swing bed, and pharmacy) were updated to reflect current processes. Findings include:

1. Review of the acute care and swing bed policy and procedure manual revealed it had been last "reviewed and approved" and signed by the medical director, director of nurses (DON), chief executive officer (CEO), and board of directors representative on 10/16/16.

Interview on 7/19/17 at 2:40 p.m. with the DON revealed:
*The policy and procedure manual annual review had been signed and dated on 10/16/16 by the above persons at a medical staff meeting.
-She stated: "You know how they are, They just sign it and don't pay attention."
*The current policy and procedure manual had not reflected their current practices.
*She had been unable to state which policies and procedures had been updated and which had not.
*She stated, "I have been updating them when I have time. The policy and procedures being used aren't up to date."

A policy for policy and procedure revision and review had been requested on 7/20/17. The CEO stated if it was not returned with the other requested policies then there had not been one.

2. Review of the pharmacy policy and procedure manual revealed it had been last reviewed, approved, and signed by the medical director, DON, CEO, and board of directors representative on 10/3/16. Some of the policies and procedures that had not been current and did not reflect their current practices were:
*Pharmacy Policy and Procedure revised 1/10/80.
*5.0 Floor Stock of medications last revised 1/10/80.
*5.2 Restocking at the nurses station last revised 1/10/80.
*Controlled Substances last revised 9/20/07.
*Medication Security last revised 12/15/10.
*Medication Policy last revised 6/8/05.

Interview on 7/19/17 at 8:30 a.m. with the contracted pharmacist revealed:
*He had been aware the pharmacy policies had not been updated "for quite sometime."
*He hoped any needed policies were in the policy manual.
*He stated "I just know" of the changes in pharmacy policy and procedure.
-He had been aware the manual did not reflect current practices.
*He stated "The DON helps with a lot of the policy updates."
*He had not been certain if the DON had updated any of them.

Review of the provider's last revised 1/10/80 Pharmacy Policy and Procedure revealed: "It is the policy of [name] to provide the best possible pharmacy service to it's patients and to abide by all applicable state and federal regulations."

29162

Based on observation, record review, interview, and policy review, the provider failed to ensure:
*Expired medications were removed from patient use in one of two emergency rooms (ER) (ER 2).
*Medications were secured in two of two ERs.
*The medication cart located at the nurses station was locked when not in-use or in direct view.
*Personnel only areas including the x-ray room, the computed tomography (CT) scan room, and two of two ER rooms had access secured.
Findings include:

1. Observation on 7/18/17 at 9:30 a.m. with the administrator during the initial tour revealed:
*The main ER entrance from the outside led to a hallway containing the ER rooms, CT room, and x-ray room.
*That door was unlocked during the daytime hours of 6:00 a.m. through 8:00 p.m., and there was no patient reception area close by.
*She stated normally the ER patients walked to the end of the hallway to the nurses station to find the staff.
*There was also a doorbell for patients to push prior to entering the hallway, and a camera that showed who was at the door at the nurses station.
*She confirmed there might have been times when no staff were at the nurses station to hear the door bell or see the camera.
*Outside the entrance to the hallway there were signs stating:
-"Push button for emergency then enter."
-"Please push red button for assistance and staff will unlock the door (May need to push button more than once)."

2. Observation on 7/18/17 at 9:40 a.m. of ER 1 revealed:
*In a drawer there was a key that opened the locked cupboard above it that contained medications.
*Using that key provided access to the following medications:
-Albuterol.
-Aspirin.
-Benadryl.
-Decadron.
-Depo Medrol.
-Dermabond.
-Dextrose injection.
-Duonebs.
-Epinephrine.
-Heparin.
-Lasix.
-Lipitor.
-Metoprolol.
-Nitroglycerin.
-Phenergan.
-Pulmicort.
-Reglan.
-Singulair.
-Sodium bicarb.
-Kenalog.
-Solumedrol.
-Toradol.
-Zofran.

3. Observation on 7/18/17 at 10:05 a.m. of ER 2 revealed:*There were several cupboards that had key locks on them but had been left unlocked.
*Some of those cupboards had contained the following medications:
-Lactated ringers intravenous (IV) solution that had expired in June 2017.
-A top cupboard containing the same medications as ER room 1:
-Tenecteplase IV.
-Ancef IV.
-Gentamicin IV.
-Nexium.
-Rocephin IV/injectable.
-Zantac IV.
-A small locked box containing controlled substances including Demerol, Dilaudid, Fentanyl, morphine sulfate, Valium, and Versed.
--That box had not been secured to the cupboard and could have been removed easily.
-An adult respiratory emergency kit contained several medications including Albuterol, Epinephrine, Solumedrol, Singluair, Magnesium Sulfate drip, Benadryl, Zantac, and Aminophylline.
--The Solumedrol had expired in June 2017.
--The Xopenex nebulizer had expired in May 2017.

4. Observation and interview on 7/18/17 at 10:40 a.m. with the director of nursing in ER 2 revealed:*She confirmed the above medications had not been secured from unauthorized individuals.
*The cupboards should have been locked, and the key to them should not have been readily available.
*She confirmed the above medications had been outdated and should not have been kept available for patient use.
*The ER rooms should have been checked by the nurses for security and potentially outdated medications according to their checklist.
*The pharmacist checked medications for outdates monthly.

Interview on 7/18/17 at 11:30 a.m. with registered nurse (RN) F regarding the above revealed:*All medications should have been secured from unauthorized individuals.
*The keys for the cupboards in both ER rooms had always been stored in the room for easier access in case of emergency.
*All the nurses, the pharmacist, and practitioners knew where those keys were stored.
*Any outdated medications should have been disposed of and should not have been kept available for patient use.
*She confirmed the entrance to the ER rooms, x-ray room, and CT rooms had not been monitored closely.
-There was a camera at the nurses station and a door bell that rang to the nurses station if the patient pushed the button.
*She agreed those rooms had not been locked and unauthorized individuals would have had access to them if no one had known they were in that area.

Surveyor: 29162
5. Observation on 7/18/17 at 9:30 a.m. through 10:30 a.m. of the nurses station and unlocked treatment cart revealed:
*Two bottles of milk of magnesia sitting on top of the cart.
*One bottle of Tylenol ES in a drawer of the cart.
*Three bottles of a patient's medications from home in a drawer of the cart.
*The top drawer of the unlocked cart contained:
-Prescription pads from two different providers.
-Keys to the following areas:
--Pharmacy.
--Laboratory.
--Emergency room medications.
--Pyxis medication dispension station had two sets of keys in the drawer.
*Intravenous solutions in the bottom unlocked drawer:
-Six of 0.9% NaCl 50 mL.
-Seven of 0.9% NaCl 100 mL.
-Two of 0.9% NaCl 250 mL.
-Three 0.9% NaCl 500 mL.
-Two of Dextrose 5% 1000 mL.

Interview on 7/18/17 at 10:00 a.m. with RN E confirmed the treatment cart had been unlocked. She stated she was not sure why because it had always been kept locked.

Interview on 7/19/17 at 8:30 a.m. with the pharmacist revealed he had noticed the treatment cart at the nurses' station was unlocked sometimes. He stated he had been aware it should have been locked at all times unless it had been in-use by an authorized person.

Interview on 7/19/17 at 2:40 p.m. with the DON confirmed the treatment cart at the nurse's station was to have been kept locked. She was unsure why it had not been locked.

6. Observation and interview on 7/20/17 at 10:00 a.m. with RN F following one of two colonoscopy procedures revealed:*She had been trained and completed the conscious sedation for the patients' colonoscopy procedures.
*Colonoscopies were done monthly in the emergency room.
*The pharmacist would get the medications she used for the scope procedures ready the evening before the procedures.
-He then put those medications into the narcotic drawer in the medication cart at the nurses station.
*The medication stayed in that drawer until she got them out the next morning.
-Nursing staff did not ensure the count remained correct until she checked them the next morning.
*Prior to the procedures she would get those medications and bring them to the ER room for use.
*During the procedures she kept the medications in an unlocked metal cart drawer since she did not have a good locked area to keep them in.
*After the procedures were done for the day she signed out on the log sheet each medication she had used.
*She would then return the log and the remaining medications to the narcotic drawer in the medication cart.
*For the two scope procedures that day the pharmacist had left her:
-Eleven Demerol 25 milligrams (mg) doses.
-Twelve Demerol 50 mg doses.
-Fifteen Versed doses.
*For days when they had up to ten scope procedures scheduled there were a lot more of those medications available since the pharmacist was not available in the facility all day.
*After she was done signing her log sheet she brought the medications out to the medication cart at the nurses station.
*She unlocked the medication cart using a code that she typed into the keypad.
-Inside the top drawer of the medication cart was the key for the narcotic drawer.
*She used that key and placed the medications into the drawer and left the log sheet on the top of the medication cart.
*She stated all the nurses and the pharmacist knew the code to the medication cart.
*She was unsure when or if the code to the medication cart ever got changed.
*The narcotic key was always kept in the cart for easier access.
*She confirmed anyone who knew the code also would have had access to those high risk narcotic medications.
*She agreed the medications she used during the scope procedures were high risk narcotics, and access to them should have been limited.

Interview on 7/20/17 at 10:20 a.m. with the DON regarding the above process for the medications during the colonoscopy procedures revealed:*She confirmed those medications were high risk medications, and they should have been secured properly.
*The key code on the medication cart was not changed routinely.
*She agreed all nurses including nurses who were no longer employed would have known the code to the medication cart.
*The key to the narcotics drawer should not have been so easily accessible.
*She confirmed all nurses and the pharmacist had access to the medications in the medication cart, pharmacy, narcotic keys, and the ER rooms medications cupboards any time they needed.
*She agreed it would have been difficult to track and figure out what had happened when or if there was a missing medication.
-There would have been a large amount of staff and potentially unauthorized individuals that had access to those medications.

7. Observation and interview on 7/20/17 at 1:10 p.m. in the hallway by the ER rooms, x-ray room, and CT scan room with the radiology director, RN F and G revealed:*The radiology director's office was also in that hallway and sometimes she had to direct ER patients to the nurses station when they did not know where to go.
*They confirmed the rooms in that hallway were not locked, and anyone would have had access to them.
-Those areas should have been limited to authorized individuals or that staff was aware someone was near them.
*The nurses station had a camera that showed that ER entrance, but staff was not always at the nurses station to see that.

8. Review of the provider's July 2017 Hospital Day Shift and Night Shift checklists revealed:*All cabinets should have been locked in ER rooms.
*Outdated medications and supplies should have been checked twice a month.
-That had been initialed as completed on the seventh of July 2017.

Review of the provider's revised 12/15/10 Medication Security policy revealed:*"All drugs in this hospital shall be accessible only to authorized personnel."*"All drugs, except those intended for crash cart use, will be stored in lockable containers or areas."*"Controlled drugs will be double locked at all times prior to use (see Controlled Substances Policy)."*"All medications at nursing stations shall be in lockable storage at all times. Medications are stored either in lockable medication carts or the medication room. Floor stock in the medication room. Authorized personnel include registered nurses (RN), licensed practical nurses (LPN), pharmacist and pharmacist interns. When unattended the medication carts and medication rooms are to be locked."*"Medication security in ancillary departments is in locked cabinets or drawers. Responsibility for security rests with the pharmacist and director of nursing services."
Review of the provider's revised 9/20/07 Controlled Substances policy revealed:
*For pharmacy storage:
-"All Schedule II drugs are stored in a double locked narcotics cabinet."-"Keys are to the cabinets are kept in a secure location within the pharmacy"
*For medications at the patient care unit:-"All doses of controlled substances at the nurses' station are tracked on a perpetual inventory control record kept in the medication storage room...All doses removed from the inventory in the medication room by the nursing staff for patient administration are signed off the control sheet by the nurse. At each change of shift, the actual physical count of all controlled substances in the medication room is verified with the count on the sheet and signed by two nurses (the nurse from the shift that is ending and the nurse from the shift that is beginning) as verified on the sheet including date and time..."
*There was no specific mention of the security of the keys or medication cart code entry system at the patient care units.

Review of the provider's revised 6/18/09 Emergency Medications policy revealed "...Controlled substances are stored only in the crash cart..." which did not match with the observation above.

Based on record review and interview, the provider failed to ensure:
*There was a quality assurance improvement policy in place for the facility.
*All hospital services participated in quality improvement
Findings include:

1. Interview and review on 7/19/17 at 2:45 p.m. of the provider's quality improvement data with the director of nursing revealed:
*She was not able to locate the quality assurance and improvement policy. Therefore it was not available for review.
*She thought the policy was in a box in storage, and it was not on her computer.
*The services of laundry and maintenance had not been part of the facility's quality assurance and improvement program.