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Based on observations, staff interviews and record reviews throughout the survey, the Critical Access Hospital (CAH) Condition of Participation for Provision of Services was not met related to non-compliance with the following standards.

Based on review of CAH policies, and confirmed through staff interview, physician orders for 3 applicable patients included interventions/services for which there was no facility policy to define and direct those services. (Patients #26, #28 & #10). Findings include:

1. Per record review Patients #26 & #28, both of whom had exhibited aggressive and potentially unsafe behaviors, each had ED (Emergency Department) physician orders, dated 5/24/16 and 6/27/16 respectively, that directed staff to provide patient observation levels/status of 1:1. Despite these orders there was no policy that defined the scope of service or provided staff with training in how to conduct the observations including: parameters for; what constitutes 1:1 observation, (does it include constant eyes on the patient, inclusive of bathroom use); what distance from the patient should the observer be located; who should conduct the observations, (licensed or non-licensed staff), and what information should be relayed to nursing regarding concerns/issues; will the observer provide any direct care in the form of hands and what documentation is expected related to the observations.

2. Per record review for Patient #10, on 6/7/16 at 0:811 a physician's order read, "Constant observation for safety ". Per interview on 8/4/16 at 9:28 AM with the Nurse Manager (NM) of Medical Surgical Services and Special Care Unit, s/he stated that a one to one (constant observation) was instituted for Patient #10 on 6/7/16, due to increased agitation. Per the NM, the staff who performed the one to one observation were the housekeepers and/or security personnel; and that these personnel were to sit with the patient and were not to perform any hands on care. Per the NM, the security guard and/or housekeeper were to alert the nurse caring for the patient when, "something does not look right". S/he confirmed that there was no training for the personnel who performed the constant observation (one to one) and no hospital policy.

During interview, on the afternoon of 8/3/16, the Director of Quality acknowledged that there
was no facility policy related to services for 1:1 observation status.

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 were followed in accordance with accepted professional principles. Findings include:
1. Per observation in the Multidisciplinary clinic on 8/3/16 beginning at approximately 9:30 AM, the following drug storage issues were identified: In Exam room #7, a bottle of Betadine (a broad spectrum topical antiseptic) and a bottle of isopropyl alcohol 70% were not dated when opened. In the storage closet in Exam room #1, a bottle of Betadine was not dated when opened. In Exam room #6, a bottle of Lidocaine hydrochloride 2% (a local anesthetic) oral/topical solution was not dated when opened and put in use. A staff nurse confirmed the above observations at the time of the tour and stated that the above solutions are used for multiple patients and should have been dated when opened.
Additionally, the medication storage closet in the nurses office contained drugs provided by manufacturer representatives to be given to patients as samples. On the shelf above the sample medications, was a container of germicidal wipes (opened) and cloths; on a shelf below the medications, was an open bottle of urine test strips, pipettes, a test tube rack, nonsterile gauze pads and paper replacement rolls. The sample medication log book was positioned on top of the container holding the lab supplies. A staff nurse confirmed the above observations at the time of the observation. S/he also confirmed that the urine test strip bottle was currently in use and posed a potential infection control issue related to its storage in the same cabinet with the sample medications.
Per review, the facility policy: III-09.2 Unit Inspections states that "All drug storage areas within Copley Hospital will be inspected at least monthly by pharmacy technicians and/or pharmacists to ensure proper storage of medications" .... "Inspections shall address at least the following: ...Test agents, germicidals, disinfectants and other household substances shall be stored separately from drugs."
Per interview with the Pharmacy Director (PD) on 8/4/16 beginning at 9:32 AM, s/he confirmed that the pharmacy department is responsible for safe drug storage in all areas of the hospital. S/he stated that s/he was not aware of the storage issues in the multidisciplinary clinic until identified during the survey though the clinic had been inspected monthly by pharmacy technicians. Per review, the last inspection of the sample closet and procedure rooms occurred on 7/13/16 and no concerns were identified. The PD confirmed that drugs should be stored separately form cleaning and lab supplies.
Additionally, the PD stated that the current procedure for sample drugs includes that the PD review the completed Pharmaceutical Sample Log Forms monthly; however, s/he confirmed that s/he has not reviewed the forms from the multispecialty clinic for quite a while and could not remember the last time they were forwarded for review. S/he reported that she had just heard that the clinic's office manager (OM) had revised the log form but had not reported that there had been discrepancies related to a lack of consistent documentation on the forms. Per review of the current log form, the PD agreed that it would be difficult to track and account for medications due to the current entry and disposition procedure on the form and s/he identified a need for further revision.
2. Per observation on 8/1/16 at 3:15 PM of Operating Room #2, a bottle of Betadine (Povidone-iodine, a broad spectrum antiseptic for topical application, used as a skin preparation for surgery) was noted in the supply cabinet; the bottle had previously been opened and was without a date as to when it was opened. The Nurse Manager of Surgical Services confirmed that the bottle had been opened and was without an open date on the bottle. S/he stated that there was no way to know how long the bottle of Betadine had been in the cabinet. Per manufacturer's guideline's, Betadine was good for one year from the date opened. This was further confirmed by the CAH Pharmacy Director, who stated on 8/2/16 at 2:20 PM, that bottles of Betadine would be safe for use for 1 year after being opened, with the expectation staff would date the antiseptic solution when initially opened.

Based on observations, interviews 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. During a tour of the Peri-Operative department on the afternoon of 8/1/16 accompanied by the Director of Peri-Operative services the following observations were made:

a. Operating Room (OR) #2 and OR #3 each had anesthesia carts. Within each cart was a drawer which contained laryngoscopes and laryngoscope blades. Together both are used by Anesthesiologists and CRNAs (Certified Registered Nurse Anesthetists) when performing a endotracheal intubation for general anesthesia. After use and contact with a patient's mucus membranes the laryngoscope blades requires high-level disinfection (which eliminates all microorganisms in or on the instrument to prevent transmission of infection). After each use the laryngoscope blades are reprocessed (as above mentioned) by the Central Sterile department, packaged in a peel pack and returned and stored individually in a way to prevent recontamination. However, at 3:10 PM in OR #3 2 laryngoscope blades were not stored covered in the anesthesia cart. At 3:15 PM in OR #2 also noted 2 blades were also stored without a protective covering. It could not be verified by the Peri-Operative manager if the blades had been reprocessed, had been recently used and/or were safe for patient use. Per interview on the afternoon of 8/1/16 the Manager for Central Sterile confirmed all used laryngoscope blades after reprocessing always leave the Central Sterile department in a covered pack. Per CDC (Centers for Disease Control and Prevention) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 states: Semicritical items contact mucous membranes or nonintact skin. This category includes respiratory therapy and anesthesia equipment......laryngoscope blades. These medical devices should be free from all microorganisms.....Semicritical items minimally require high-level disinfection using chemical disinfectants..."

b. At 3:05 PM in OR #3 and at 3:15 PM in OR #2 a powder-like dust was observed on the ventilation faceplates covering each out take airvent located on the lower walls of each of the operating rooms. Per CAH policy Cleaning Surgical Suite last approved 03/18/15 states " 6. Scheduled Cleaning: Every 6 months damp wipe all wall vents, mop ceiling and damp mop ceiling vents ". It could not be confirmed when the last cleaning of the airvents was conducted.

2. Per tour of the Multispecialty clinic with the practice manager and a staff nurse on 8/3/16 beginning at 9:30 AM, the following observations were made and confirmed at the time of the observation:
a. In the medication closet, an open container of germicidal wipes and lab supplies that included an open bottle of urine test strips, pipettes, a test tube rack, nonsterile gauze pads and paper replacement rolls were stored in the same cupboard as sample medications. The sample medication log book was positioned on top of the container holding lab supplies. A staff nurse confirmed that the urine test strip bottle was being used by the clinic. S/he agreed that the storing used lab supplies in the same cupboard as medication samples posed a potential infection control issue. Per review, the facility's pharmacy policy: III-09.2 Unit Inspections states "...Test agents, germicidals, disinfectants and other household substances shall be stored separately from drugs." b. In Exam room #7, oxygen tubing was unpackaged and loosely coiled on the oxygen wall outlet. An office nurse stated that the plastic bag had come off the tubing and agreed that it looked used and should have been discarded and replaced. c. Also in Exam room #7, two open bottles of single use gauze packing tape were in a storage cupboard and had not been discarded after use. Per interview with the Infection Control Practitioner (IP) on the morning of 8/3/16, s/he confirmed that the above observations/practices in the multispecialty clinic did not follow infection control standards.

3. During a tour of the Outpatient Rehab Unit and therapy pool with the rehab supervisor on 8/1/16 beginning at 2:37 PM, the following infection control issues were identified and confirmed.
a. Open cell and soft foam positioning/exercise blocks and cylinders were ready for patient use in the clinic. The rehab supervisor confirmed that the equipment was used with multiple patients and that the foam surfaces could not be adequately sanitized between patients. b. Per review of the Therapy pool testing records and maintenance action logs from 1/1/16- 8/1/16, policies and procedures were not followed consistently to ensure that water quality fell within the prescribed ranges. [Bromine (3.0-5.0)]. Per review of the pool maintenance procedure, if the bromine level is above 8.0 suspend operations and/or add Chem Out per label to decrease concentration to acceptable levels, recheck in 2 hours. If Bromine is 0-2 ppm operate as normal, adjust bromine feeder up 10-15 points, recheck in 2 hours. Per review of the pool logs on days patients were scheduled to use the pool: on 1/29, 5/16, 5/24, 7/11 and 7/25/16 bromine levels tested out of range (high) and there is no documentation that the bromine level was retested in 2 hours after the addition of chemical treatments; on 6/6/16, there is no documentation that the pool water was tested at all; on 2/19 and 2/22/16, the Bromine levels were low ( 1 and 2.0) and not rechecked in 2 hours after treatment per policy. On multiple instances in this date range, "chem out" was added to the pool water to correct Bromine levels, but there was no evidence that the Bromine levels were retested in the 2 hour interval to assure that the level did not go below the accepted range and then need further adjustment (for example, on 7/18/16, the Bromine level tested high at 7:00 but was reportedly in range when retested at 7:02 after the addition of chem out).

On 8/2/16 at 12:00 noon, the Director of Rehab services (DR) confirmed that the policies and procedures for pool sanitization had not been followed consistently to ensure safe water quality. S/he further confirmed that the foam bolsters and cylinders in the outpatient rehab units could not be adequately sanitized and would be removed from service and replaced.

4. During tour of the Emergency Department (ED), on the morning of 8/1/16, the tops to both suction canisters, attached to wall outlets located at the heads of each of the two beds in room #8, were heavily coated with dust. In addition there was a yankauer tip (the component of suction equipment that is placed in the patient's oral cavity during suctioning) attached to the end of the suction tubing on one of the canisters that was uncovered and exposed to potential environmental contamination. The beds were cleanly made and ready for patient access. The ED Nurse Manager confirmed the observations at the time of tour and also agreed that the yankauer tips should be kept covered to prevent contamination.

Based on observation and staff interview the Director of Food Services failed to assure that dietary staff adhered to recognized safe food handling practices for 1 of 3 observations of the kitchen areas. The Food Service Director also failed to assure that all staff were educated and adhered to Manual and Automatic Dishwashing Policy/Procedures at all times.
Findings include:

1. Per observations in the hospital kitchen during the initial tour (11:04 AM, a package containing frozen pumpkin was observed defrosting on a tray at room temperatures. Additionally in another area of the kitchen, a tray on a baker's rack contained several bags of green beans removed from the freezer and defrosting at room temperature. Accepted safe food handling practice recommends that to minimize the growth of harmful bacteria, frozen foods should be defrosted in a manner that will assure that the food is not maintained in the temperature range between 41 degrees F. (Fahrenheit) and 135 degrees F. (This is known as the "temperature danger zone" and bacteria growth is limited when foods are held above or below the temperature danger zone*.)
2. During the initial tour, near a prep area in the kitchen (11:20 AM), 3 cases identified as containing 'pudding' were observed sitting on the counter next to a reach-in refrigerator. When the staff person working there was asked how long the delivered items had been on the counter, they said that they were delivered earlier and they wanted to finish what they were doing before putting the pudding away. Per interview with the Sous Chef, the delivery arrived at approximately 10:15 AM that morning, and the driver left at about 10:25 AM.

During interview, the Director of Food Services confirmed that staff should not be defrosting any frozen foods on trays at room temperature; s/he confirmed that this was not a safe way to defrost frozen foods. S/he also confirmed that deliveries of perishable cold foods should be prioritized and put away upon delivery.
(*Reference: ServSafe Manager, 6th edition book., Chapters 1 and 2.)

3. Per observation of the Manual Dishwashing Procedure, staff had not followed the hospital's P/P "Nutrition Services, Pots and Pans Washing Procedure", revised 7/27/15. The staff used a damaged test strip to measure the level of sanitizing solution in the 3rd sink, used for the sanitizing of manually washed items. The only color chart available to compare the test strip to was damaged and inaccurate. A new container of test strips was obtained per surveyor suggestion and the proper process was reviewed with the staff present. Additionally, the sink had been filled to top, beyond the marked "fill line" on the outside of the sink. Overfilling the sink would dilute the sanitizing solution, that automatically dispenses from a wall mounted unit above the sink. These issues were confirmed with the staff present.

4. Per observations of the automatic Dish Machine operation at 4 separate times on the first day of survey, The wash cycle failed to reach the recommended 160 degrees F., per the Nutritional Services Policy, "Proper Dish Machine Temperatures", revised 7/29/15. The temperatures for the washed cycles ranged from 149 degrees F. to 158 degrees F. Per interview with the staff present, s/he stated that the machine has not been reaching the required temperatures for washing on many recent days and s/he has to stop and restart the machine several times in order to get it to the proper temperatures. On the day of the observation, the Maintenance Director needed to adjust the temperatures prior to the booster motor and replace a part and the dish machine was fixed the next day.
During interview, the Food Service Director confirmed s/he had not been aware of the problems with the dish machine and some staff's lack of knowledge of the proper manual dishwashing procedures and test processes.

Based on record review and confirmed through staff interview the CAH failed to include all required components in the list of services provided under agreements or arrangements. Findings include:

Per review the list describing the nature and scope of services provided by the CAH through agreements or arrangements did not include whether or not the services being offered were offered on site or off; whether there is any limit on volume or frequency of services being offered or when the services are available.

The Director of Quality acknowledged, during interview on the afternoon of 8/4/16, that the CAH's list of services provided through arrangement or agreement did not include the required components listed above

Based on observation and interview the Condition of Participation for Surgical services was not met as evidenced by the failure of Perioperative Services to limit access to the operative and recovery areas to only authorized personnel; failure to assure staff providing housekeeping services were knowledgeable regarding the correct concentrations of disinfectant solutions used during the cleaning of operating rooms; and staff failed to adhere to maximum hair coverage when entering ORs and during surgical procedures. Findings include:

1. Throughout the days of survey, observations were made of the accessibility of unauthorized individuals to potentially enter the peri-opertive area which included the operating rooms (ORs), Post Anesthesia Recovery Unit (PACU) and Central Sterile Supply. During a tour on 8/1/16 at 1:50 PM with the Director of Peri-Operative Services, the entrance into the Peri-Operative area was observed located on the second floor of the CAH. The sliding door entrance to this restricted location is accessed from a public hallway. The sliding doors can be opened by unauthorized individuals by pressing a push pad or waving a hand over an automatic eye sensor. Although a sign is posted stating only authorized individuals allowed beyond the door entrance and a red line is also noted on the floor in front of the sliding doors to the restricted area, unauthorized access can be easily accomplished. The Director had indicated the doors are locked during the evening and night hours and can only be accessed by CAH personnel with ID badge authorization. S/he further stated during hours when surgical services are being provided there was always staff at the scheduling and charge nurse's desk located at the front entrance of the Peri-Operative suite. However, during frequent observations to include 8/3/16 at 10:10 AM, no staff were observed at the desk or hallway leading to the operating rooms or Central Sterile Supply. PACU nurses were observed often busy with patient care and unable to consistently monitor the entrance. The operating room scheduler assigned to the front desk, frequently sits with his/her back to the entrance and is often occupied on the phone with physician services. The Charge nurse is also frequently absent from the front desk, often participating in a supervisory role within the operating rooms or as an active participant in a surgical case.

2. Per interview on the afternoon of 8/1/16, housekeeping staff assigned to cleaning operating rooms in between surgical cases failed to demonstrate accurate knowledge for the correct concentration of disinfectant solution used when cleaning the operating room floors. Per CAH policy Cleaning Surgical Suite current version dated 03/18/15 states: "After Case Completed f.: The floor should be mopped with a freshly laundered mop head and EPA-registered hospital-grade germicidal agent". The housekeeper identified Virex II as the solution used for mopping the OR floors and stated s/he "...used 7-8 hand pumps...." (approximately 1 oz per pump) of the disinfectant cleaner into a mop bucket containing "..40 gallons of water". However, in accordance with the manufacturer Diversey recommendations, states Virex II ".... used as directed at 1:256 dilution (1/2 oz per gallon of water)...." is indicated. The correct size of the mop bucket was confirmed by the Peri-operative Manager to be approximately only 5 gallons. The Manager further acknowledged there has been no recent competency and/or supervision to ensure housekeeping staff were aware of correct use and dilution of this very concentrated disinfectant. In addition, the Infection Preventionist acknowledged on the afternoon of 8/2/16 that although the CAH had an automatic feed system for Virex II in other housekeepering closets throughout the facility, the Peri-operative area had not been provided with this convenience and provision for accurate water/solution ratio. Prior to completion of this survey, an automatic delivery system was installed in the Peri-Operative housekeeping closet, thus providing staff with the correct dilution of Virex II when cleaning OR floors. Per AORN 2015 Edition Guidelines for Perioperative Practice states: "Environmental Cleaning: II.c3. Cleaning chemicals must be prepared, handled, stored, and disposed of according to manufacturer's instructions for use.....microbial contamination of disinfectants has been reported with improper dilution of the disinfectant."

3. Per observations on 8/2/16 at 7:45 AM during the course of a surgical procedure in OR #2, the circulating nurse was observed wearing Personal Protective Equipment ( PPE) hair covering that failed to completely cover his/her hair which was protruding from under the protective hat at the nape of the nurse's neck while actively involved in the surgical procedure. Per AORN (Association of PeriOperative Registered Nurses) Journal, January 2012 Vol 95 No 1 "Implementing AORN Recommended Practices for Surgical Attire, states, "All personnel should cover their head and facial hair when in the semirestricted and restricted areas. Hair coverings should cover facial hair, sideburns, and the nape of the neck. Perioperative nurses can help minimize the risk of surgical site infections by covering head and facial hair...." AORN further states " Skull caps are not recommended because they do not completely cover the wearer's hair and skin; they fail to cover the side hair above and in front of the ears and the hair on the nape of the neck". In addition, per CAH policy Surgical Attire current version dated: 03/31/15 states: "Attire in Semi-restricted and Restricted Areas: All peri-operative personnel will cover head and facial hair, including sideburns and the nape of the neck."

Based on record review and staff interview, anesthesia services failed to conduct post anesthesia evaluations on both inpatient and outpatients who received the services of anesthesia for 3 applicable patients. ( Patients #5, 17, 24) Findings include:

1. Patient #17 was admitted to the CAH on 5/21/16 and required emergent surgery for acute appendicitis. The patient received general anesthesia and remained hospitalized until 5/23/16. A post anesthesia evaluation was not conducted. This omission was confirmed on 8/4/16 at 12:00 PM by the CAH Clinical Director of Anesthesia Services.
2. Patient # 24 was admitted to the CAH on 8/1/16 for a total right knee replacement. The patient received intrathecal analgesia by anesthesia. The patient was discharged on 8/3/16. A post anesthesia evaluation was not conducted.
3. Patient #5 had an outpatient surgical procedure on 8/1/16 for a Right bunion. The patient also has a history of Atrial fibrillation and asthma. Prior to the patient being discharged home, there was no documentation regarding a post anesthesia evaluation.

Per interview on 8/3/16 at 9:05 AM the Clinical Director for Anesthesia Services acknowledged all patients receiving general anesthesia, regional anesthesia or monitored anesthesia care should be receiving a post anesthesia evaluation. The anesthesiologist stated: "We could be doing a better job" regarding the required follow-up to evaluate each patient's condition for proper anesthesia recovery.

Based on review of facility policies, and confirmed through staff interview, the CAH failed to include all components in their patient visitation policy that would assure it is consistently implemented by staff in an appropriate manner that would not limit or restrict the visitation rights of patients. Findings include:

Per review, the CAH's policy titled Visitation Rights of Patients, dated 1/22/16, did not address how staff who are involved in controlling visitor access to patients will be trained to assure ongoing consistent implementation of the policy, and avoid unnecessary limitations or restrictions on visitation for patients.

The Director of Quality acknowledged, during interview on the afternoon of 8/4/16, that the policy did not address staff training regarding the visitation policy.