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Based on the manner and degree of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §485.627 ORGANIZATIONAL STRUCTURE was out of compliance.

C-0241 - Standard: Governing Body or Responsible Individual - The governing body did not maintain separate critical access hospital space and services in a manner that permitted the facility to comply with all applicable conditions of participation. The failure resulted in the commingling of patient services, physical space, and personnel with a separately certified Nursing Facility (NF).

Based on observations, interviews and document reviews, the governing body did not maintain separate critical access hospital space and services in a manner that permitted the facility to comply with all applicable conditions of participation.

The failure resulted in the commingling of patient services, physical space, and personnel with a separately certified Nursing Facility (NF).

FINDINGS

1. The facility commingled space and services with a separately certified Nursing Facility (NF).

a) Tours conducted throughout the survey revealed several areas of the facility that were shared with a separately certified NF.

i) On 04/10/17 at 4:32 p.m., a tour of the acute care unit was conducted with the Unit Manager of Acute Care (Registered Nurse, RN #19). While touring the hallway where rooms for patients of the CAH were located, RN #19 explained patient care room #102 was used by physicians to conduct evaluations on residents of the separate NF.

ii) On 04/11/17 at 11:45 a.m., a tour of the medical records department was conducted with the Director of Revenue Cycle (Director #14), who revealed s/he also provided oversight of the Medical Records Department. The department included a room with 2 walls containing cabinets filled with medical records. Director #14 stated one wall of cabinets stored medical records from the CAH and the other wall of cabinets stored medical records from the NF attached to the facility. There was no separate storage location for the medical records from the NF. Director #14 stated one full time and one part time staff member employed by the CAH were solely responsible for maintaining the separate NF medical records as well.

iii) On 04/12/17 at 8:45 a.m., a tour of the laboratory was conducted with the Laboratory Manager (Manager #20) who revealed laboratory services were offered to inpatients and outpatients of the facility. Manager #20 stated on rare occasions laboratory staff would walk over to the separate NF and collect blood samples from NF patients for tests run in the facility's laboratory while working for the CAH. Manager #20 stated all laboratory staff were employed by the facility.

iv) On 04/13/17 at 11:40 a.m., a tour of the main floor of the facility was conducted with Director #16. The tour included walking past the linens and housekeeping department. Director #16 stated the linens and housekeeping departments were areas and services shared by the CAH and the separately certified NF.

However, there was no contract between the two separate facilities which identified who was providing the services and how they were to be managed.

v) On 04/13/17 at 11:46 a.m., a tour of the central supplies storage department was conducted with Director #16 and the Director of Materials Management (Director #18). Observations of the department revealed a large room with several aisles of shelving which stored patient care supplies. There was no distinction or separation between supplies for the CAH and the separate NF.

During the tour of the central supplies storage department, an interview with Director #18 was conducted. Director #18 stated there was no separation between supplies used for the facility and the NF. Director #18 explained supplies for both facilities were ordered under the same asset account under the CAH. The cost would then be allocated to the correct department under either the facility or NF once it was determined where the supplies would be used.

b) On 04/13/17 at 3:17 p.m., an interview with the Medical Director (Director #3) was conducted. Director #3 confirmed patient care supplies from the CAH and the separately certified NF were stored in the same area. Director #3 stated when patient care supplies were ordered they were charged to the CAH, then allocated to the correct department or the NF once the specific supply items were distributed.

Director #3 confirmed patient room #102 was used by physicians to conduct examinations on NF patients because it offered more space and privacy than areas available in the NF. Director #3 verified there was no contract between the CAH and the NF for laboratory, kitchen, linens, housekeeping and patient care supplies services to be provided to the NF.

c) On 04/12/17 at 10:20 a.m. an interview with the Chief Executive Officer (CEO #17) was conducted. CEO #17 confirmed the CAH's materials management department and staff was considered a shared service between the facility and the NF. CEO #17 stated human resources, housekeeping, and laundry services were also considered shared services between the facility and the separately certified NF. CEO #17 stated the NF had a different Centers for Medicare and Medicaid Services Certification Number (CCN) than the CAH. CEO #17 stated a joint operating contract between the facility and the NF was established in 1993 which defined the shared relationship and services offered to both facilities.

However, review of the Joint Operating Contract, dated 11/30/93, revealed it was between the Hospital District and the State. There was no evidence a contract had been completed between the CAH and the separately certified NF for services which were currently shared between the two facilities..

Based on the manner and degree of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §485.635 PROVISION OF SERVICES was out of compliance.

C-0276 - Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. The facility failed to ensure all medications intended for patient use were stored in a secured manner to avoid diversion or tampering. This failure resulted in unauthorized access to medications.

C-0278 - A system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel. The facility failed to provide a sanitary environment in the areas of equipment reprocessing, hand hygiene, supplies usage and food storage. The failure created the potential for the transmission of bacteria or cross contamination, creating negative patient outcomes.

Based on observations and interviews, the facility failed to ensure all medications intended for patient use were stored in a secured manner to avoid diversion or tampering.

This failure resulted in unauthorized access to medications.

FINDINGS

POLICY

According to the policy Drug Storage Areas, drugs shall be stored in the appropriate drug storage areas and shall be secured with a security lock.

According to the policy Inspecting Drug Storage Areas, the Pharmacy Department is responsible for all drug and preparation areas throughout the hospital. Inspection of all drug storage areas will be made at least quarterly to ensure that meds are stored under proper conditions.

REFERENCE

1. The facility failed to store medications securely.

a) On 04/10/17 at 1:22 p.m., a tour of the facility was conducted. Observations in the Post Anesthesia Care Unit (PACU) revealed an unlocked refrigerator located in the patient care area. Inspection of the inside of the unlocked refrigerator revealed several medications, including 6 intravenous (IV) vials of Lorazepam (used to treat anxiety and seizures), 1 IV vial of Rocuronium (a muscle relaxant used during surgeries), approximately 13 IV vials of Famotidine 20 mg (used to treat stomach acid), 2 boxes of phenylephrine hydrochloride ophthalmic solution and 3 IV fluid bags of 3000 ml 0.9% Sodium Chloride. An unlocked drawer was also observed in the PACU with 12 IV Saline Flushes and approximately 15 syringes and needles. During the observation of the unlocked refrigerator, a patient was recovering in the area with a visitor at the bedside.

Registered Nurse (RN #10) and the PACU charge nurse (RN #11) were present during the observation in the PACU and both verified the refrigerator was unlocked. RN #11 stated the general practice was to unlock the refrigerator in the morning when the initial medication count was performed. RN #10 added the refrigerator was kept unlocked throughout the day and was locked at the end of the shift. RN #10 then stated maybe the refrigerator should have been locked in order to prevent possible diversion.

During the same tour, the Preoperative Unit Nurses Station was observed with no staff present at the station. An unlocked cabinet was inspected and revealed several unsecured medications, including 1 IV vial of Xylocaine 1% (a local numbing agent), 5 IV fluid bags of 0.9% Normal Saline, approximately 15 IV vials of Bacteriostatic 0.9% Sodium Chloride, and approximately 15 IV vials of Bacteriostatic Water. Also observed in the station was an unlocked drawer containing syringes, needles, 3 IV fluid bags of 5% Dextrose, approximately 20 IV fluid bags of Lactated Ringer's and approximately 10 Saline Flushes.

On 04/12/17 at 8:15 a.m., a tour of the outpatient family clinic was conducted. Observations revealed an unlocked medication room with several unsecured vials of 0.7 ml Sterile Diluent (Sterile Water). Inspection inside of an unlocked refrigerator in the unlocked medication room revealed several unsecured medications including vaccinations for polio, human papillomavirus virus (HPV), and meningococcal disease. A separate unlocked freezer located next to the refrigerator contained 4 boxes of varicella vaccines.

b) On 04/11/17 at 10:03 a.m., an interview with Pharmacist #12 was conducted. Pharmacist #12 stated there was never a problem resulting from the unlocked medication refrigerator in the PACU although s/he added there could have been potential for diversion of the medications by unauthorized personnel. Pharmacist #12 further stated s/he was unaware of the unlocked and unsupervised medications located in the Preoperative Unit Nurses Station.

An additional interview with Pharmacist #12 was conducted on 04/12/17 at 3:56 p.m. During the interview, the observation of unsecured medications and vaccines in the outpatient family clinic was reviewed with Pharmacist #12, who then stated s/he had no oversight or responsibility with the out patient clinic.

c) On 04/13/17 at 2:36 p.m., an interview with Pharmacy Tech (Tech #13) was conducted. Tech #13 stated the hospital's pharmacy department did not have anything to do with the outpatient family clinic. Tech #13 further stated the clinic staff were responsible for ordering and auditing their own medications.

d) On 04/13/17 at 3:17 p.m., an interview with the Medical Director (Director #3) was conducted. Director #3 stated s/he could not recall any issues arising from having unsecured medications; however, Director #3 stated s/he could see the importance of securing medications to avoid unauthorized personnel from potential tampering with or taking medications.

Director #3 explained s/he was a member of the Pharmacy and Therapeutics Committee and was responsible for providing oversight of the medications in the outpatient family clinic. Director #3 stated staff at the clinic ordered and tracked all of the medications used at the clinic.

Review of the Pharmacy and Therapeutics Meeting Minutes from July 14, 2016 to January 12, 2017 revealed no evidence that information from the outpatient family clinic was discussed or integrated into the facility's Pharmaceutical Department.

Based on observations, interviews, and document review, the facility failed to provide a sanitary environment in the areas of equipment reprocessing, hand hygiene, supplies usage and food storage.

The failure created the potential for the transmission of bacteria or cross contamination, creating negative patient outcomes.

FINDINGS

POLICY

According to the policy Hand Hygiene, decontaminate hands after removing gloves.

According to the policy Food Storage and Handling, food will only be purchased from dependable sources.

REFERENCE

According to the Operation Manual for the Endocavitary Transducer, clean the transducer before and after examination, and disinfect or sterilize it. Failure to do so may result in the transducer becoming a source of infection.

According to the Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, items which come into contact with mucous membranes or non-intact skin should be free from all microorganisms (p. 10). Because condoms/probe covers can fail, the vaginal probe should be high-level disinfected between each patient (p. 19).

According to the CDC Guideline for Hand Hygiene in Health Care Settings, October 25, 2002, indications for hand hygiene include after glove removal (p. 27). Failure to remove gloves after patient contact or between "dirty" and "clean" body-site care on the same patient must be regarded as non-adherence to hand hygiene recommendations (p. 24).

According to the Covidien Alcohol Prep pad wrapper, the alcohol prep pad is a single use item.

According to an email dated 04/11/17 from Baxter Healthcare Corporation to the facility, the purpose of the plastic overwrap used with VIAFLEX Plastic Containers is to act as a moisture barrier. If a product in a VIAFLEX container is removed from its overwrap and is not used immediately, the product should be used as soon as possible and the following data related to out of overwrap storage must be followed. Containers between 100 milliliters (ml) and 1000 ml must not be stored out of overwrap for longer than 30 days.

1. The facility failed to ensure the Endocavitary Transducer used for vaginal ultrasounds was cleaned and disinfected in accordance with manufacturer's instructions.

a) On 04/11/17 at 9:25 a.m., a tour of the Radiology Department was conducted with a Staff Technologist (Tech #1), who revealed s/he was the only staff member responsible for conducting vaginal ultrasounds and cleaning the transducer used for the ultrasounds. Tech #1 began demonstrating the cleaning process by removing the transducer from a pillowcase in an unlocked drawer with gloved hands. Tech #1 used one CaviWipe (disinfecting towelette) to wipe the cord, a second CaviWipe to wipe the handle, and a third CaviWipe to wipe the tip of the transducer. Tech #1 explained s/he would wipe the tip of the transducer 3 times and discard the CaviWipe. Tech #1 then placed the transducer in a clean pillowcase and returned it into the unlocked drawer.

During the observation, Tech #1 stated s/he was trained to clean the transducer by a representative (rep) from the manufacturer. Tech #1 further stated the rep told him/her that since the transducer was only used for diagnostic purposes and not to collect tissue biopsies, the transducer did not need to undergo the disinfection or sterilization step of the cleaning process.

Tech #1 provided a certification of completion for training from the manufacturer on 04/04/14; however, the facility was unable to provide written training materials used by the rep during the training process. In addition, the facility failed to provide written guidance from the manufacturer providing the guidance Tech #1 stated s/he received on not having to disinfect the transducer after cleaning it. The cleaning process conducted by Tech #1 was in contrast to the manufacturer's guidance which stated failure to disinfect or sterilize the transducer could result in it becoming a source of infection.

A review of the case log revealed the facility conducted vaginal ultrasounds on 81 patients between 04/04/14 to 04/11/17.

b) On 04/13/17 at 2:28 p.m., an interview with the Infection Control Manager (Manager #2) was conducted. Manager #2 explained his/her role in managing the infection control program included acting as a resource for departments when infection control guidance was needed. Manager #2 stated the facility used the CDC as guidance for managing the infection control program. Manager #2 stated staff was expected to follow manufacturer's guidelines when cleaning and processing equipment used for patient procedures. Manager #2 further stated s/he was unaware of how staff was cleaning the vaginal ultrasound until it was observed in the tour on 04/11/17.

c) On 04/13/17 at 3:17 p.m., an interview with the Medical Director (Director #3) was conducted who revealed s/he was concerned to find out the transducer was not being disinfected after being cleaned. Director #3 stated staff was expected to follow the manufacturer's guidelines when reprocessing the transducer in order to decrease the risk of patients' exposure to microorganisms.

2. Staff did not perform hand hygiene after removing gloves. In addition, staff used the same alcohol prep pad for multiple uses.

a) On 04/10/17 at 1:43 p.m., an observation of Patient #1's endoscopy procedure was conducted in Operating Room (OR) #2. During the observation, the Certified Registered Nurse Anesthetist (CRNA #4) was observed wearing gloves, wiping Patient #1's IV access port with an alcohol prep pad and administering intravenous (IV) medication to Patient #1. With the same gloves, CRNA #4 opened the medication drawer of the anesthesia cart, retrieved a syringe, returned to the patient, wiped Patient #1's IV access port with the same alcohol pad, administered IV medication, returned to the medication drawer to retrieve a medication, and touched the patient. CRNA #4 then changed gloves without performing hand hygiene before donning the new gloves.

Later in the observation, CRNA #4 was observed wearing gloves and writing on a clip board. With the same gloves, CRNA #4 wiped an IV medication vial with an alcohol prep pad, drew up IV medication into a syringe, wiped Patient #1's IV access port with the same alcohol prep pad, administered the IV medication and touched the patient. CRNA #4 then changed gloves without performing hand hygiene before donning the new gloves.

On 04/11/17 at 9:30 a.m., an observation was conducted of a Registered Nurse (RN #5) conducting a blood glucose test on a Patient #12 in room 121. RN #5 was observed wearing gloves and typing on the keyboard of a mobile computer next to Patient #12's bed. With the same gloves, RN #5 picked up the blood glucose machine, touched the patient's wrist, scanned the patient's wrist band, opened the test strips container, retrieved a testing strip and inserted it into the machine. Without changing gloves and performing hand hygiene, RN #5 then wiped Patient #12's finger with an alcohol prep pad, poked the patient's finger with a lancet and administered a drop of blood to the test strip in the glucose machine.

b) On 04/13/17 at 7:45 a.m., an interview with CRNA #4 was conducted. CRNA #4 stated hand hygiene was expected to be performed when entering and exiting a patient's room and after the removal of gloves. CRNA #4 stated s/he should have performed hand hygiene after removing gloves during the observed case on 04/10/17. CRNA #4 further stated during patient care s/he would hold an alcohol prep pad in his/her hand and use the same pad more than once because it was still moist.

c) On 04/13/17 at 12:17 p.m., an interview with the Chief Clinical Officer (CCO #8) was conducted. CCO #8 provided an alcohol prep pad wrapper which indicated the alcohol prep pad was intended for one use only. CCO #8 stated staff should have been using the alcohol prep pads once then discarding and using a new one.

d) On 04/13/17 at 2:28 p.m., an interview with the Infection Control Manager (Manager #2) was conducted. Manager #2 explained hand hygiene was expected to be performed before and after patient care as well as when removing gloves. After reviewing the observation of RN #5 conducting a blood glucose test, Manager #2 stated the expectation was for staff to perform hand hygiene and don gloves immediately before collecting the blood sample in order to avoid cross contamination.

3. The facility failed to ensure food served to patients, visitors and staff was safe for consumption.

a) On 04/11/17 at 11:02 a.m., a tour of the kitchen was conducted with the Food Service Director (Director #6) and the Kitchen Manager (Manager #7). Observations in the dry food storage room revealed a 1 gallon container labeled Pacific Jade Japanese Style Seasoned Vinegar approximately one third filled with a sticker dated 05/01/14. Manager #7 stated once opened, vinegar was usually good for one year; however, s/he verified the vinegar was out of date. Manager #7 then removed the container from the room. Also observed in the dry food storage room was a 33.8 fluid ounce bottle labeled Monin Raspberry Premium Gourmet Syrup approximately three fourths filled. The bottle contained a written open date of 04/27 with no year indicated.

Further observations in the dry food storage room revealed several packages of food with no expiration date indicating when the food was to be discarded if not used. Examples of the packaged food with no discard dates included Barilla Orzo, Sysco long grain rice, Uncle Bens Rice Pilaf, and 5 pound bags of pancake mix. In addition, the tops of the packages of rice and orzo were covered with a layer of white debris. Manager #7 verified the packages had no date of discard on them and stated the debris was most likely from the bags of pancake mix that was stored above the packages of rice.

Observations in the refrigerator used to store produce revealed a cardboard box filled with yellow peppers, one of which contained a brown colored patch and hole at the top of the pepper. Manager #7 verified the pepper appeared to have mold on it and s/he proceeded to discard the pepper. Manager #7 then stated there have been several instances where the kitchen had received moldy food from the food delivery service.

b) On 04/13/17 at 1:35 p.m., an interview with Manager #7 was conducted. Manager #7 provided a tracking sheet s/he had obtained from the food delivery service. Manager #7 explained the tracking sheet documented all of the correspondence between the facility and the delivery service regarding receiving outdated or moldy food. Review of the sheet revealed 7 entries between 01/09/17 to 04/10/17. Three entries documented receiving rotten bananas, 3 entries documented receiving expired milk or milk expiring the next day, and the final entry documented receiving watermelons that were going bad.

Manager #7 stated dry food was usually dated with an expiration date; however, s/he was unaware the packages observed from the tour on 04/11/17 had no expiration dates indicated on the packages. Manager #7 explained expiration dates sometimes appeared on the large cardboard boxes used to ship the packages of food. Once the packages of food were unpacked and stored on the shelf, staff discarded the large box. Manager #7 stated the expiration date located on the large shipping box should have been marked on each package so staff would know when the item expired. Manager #7 further stated there was no way to ensure stored food was within expiration date when there were no expiration dates indicated on the packages.

c) On 04/13/17 at 2:28 p.m., an interview with the Infection Control Manager (Manager #2) was conducted. Manager #2 explained his/her responsibilities with the facility's food service was to review any issues discovered from kitchen staff in the infection control meetings. Manager #2 stated s/he was not aware of food stored in the kitchen without a date indicating when it was expired. Manager #2 stated s/he was unaware of the facility receiving moldy or expired items from the food delivery service and that s/he would have wanted to be notified of that trend in the infection control meetings in order to help address the issue.

Review of the Infection Control Meeting Minutes from April of 2016 to January of 2017 revealed no discussion of receiving expired or moldy items from the food delivery service or of outdated or undated food items being stored in the kitchen.

4. The facility failed to ensure IV fluid bags stored outside of their outer wrapper were used within the discard date instructed by the manufacturer.

a) On 04/10/17 at 3:30 p.m., a tour of the Preoperative Nurses Station was conducted and revealed an unlocked cabinet with 5 IV bags of 0.9% Normal Saline 100 ml stored outside of its protective overwrap. There was no date on the IV bags indicating how long they had been out of their overwrap or when they were to be discarded.

On 04/11/17 at 9:15 a.m., a tour of the Radiology Department revealed 1 IV bag of 0.9 NS 100 ml stored outside of its protective overwrap. The Director of Diagnostic Services (Director #9) was present during the tour and stated s/he did not know how long IV fluid bags were safe for use once outside their packaging.

b) On 04/13/17 at 2:28 p.m., an interview with the Infection Control Manager (Manager #2) was conducted. Manager #2 stated s/he thought IV fluids stored outside of their overwrap would be safe for use until the manufacturer's printed expiration on the bag as long as the bag was still intact and the seal to the bag was not opened. Manager #2 further stated s/he was not aware of the manufacturer's instructions stating 100 ml IV bags must be discarded within 30 days once they were taken out of the overwrapping.

Based on the manner and degree of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §485.638 CLINICAL RECORDS was out of compliance.

C-0308 - Standard: Protection of Record Information - The facility failed to comply with Federal regulations through the commingling of medical records services with the separately certified Nursing Facility (NF). This failure allowed unauthorized personnel from a separately certified facility access to medical records and Protected Health Information (PHI).

Based on observations, interviews and document review, the facility failed to comply with Federal regulations through the commingling of medical records services with a separately certified Nursing Facility (NF).

This failure allowed unauthorized personnel from a separately certified facility access to medical records and Protected Health Information (PHI).

FINDINGS

POLICY

According to the policy Protection and Availability of Medical Records, access to medical records is restricted to authorized personnel and medical staff. The facility shall safeguard the information in the medical record against loss, defacement, tampering, or use by unauthorized persons.

1. The facility commingled the medical records department and services with a separately certified NF.

a) On 04/11/17 at 11:45 a.m., a tour of the medical records department was conducted with the Director of Revenue Cycle (Director #14), who revealed s/he also provided oversight of the Medical Records Department. The department included a room with 2 walls containing cabinets filled with medical records. Director #14 stated one wall of cabinets stored medical records from the CAH and the other wall of cabinets stored medical records from the NF attached to the facility. There was no separate storage location for the medical records from the NF. Director #14 stated one full time and one part time staff member employed by the CAH were solely responsible for maintaining the separate NF medical records as well.

b) On 04/13/17 at 11:34 a.m., an interview with a medical records technician (Tech #15) was conducted. Tech #15 confirmed s/he was solely responsible for maintaining medical records from the separately certified NF. Tech #15 stated s/he would store the NF medical records in the cabinets located in the CAH's medical records department for 2 years after which they would be stored at a storage facility.

The Director of Support Services (Director #16) was present during the interview with Tech #15. Director #16 stated there was a storage facility located on the facility's campus that only stored medical records.

A review of Tech #15's job description, dated 06/21/16, listed both the CAH and the NF on the top of the description.

c) On 04/12/17 at 10:20 a.m., an interview with the Chief Executive Officer (CEO #17) was conducted. CEO #17 confirmed the facility's medical records department and staff was considered a shared service between the CAH and the NF. CEO #17 stated the NF had a different Centers for Medicare and Medicaid Services Certification Number (CCN) than the CAH; however, both facilities operated under the same Tax Identification. CEO #17 further a joint operating contract between the facility and the NF was established in 1993 which defined the shared relationship and services offered to both facilities.

A review of the Joint Operating Contract, dated 11/30/93, revealed it was between the Hospital District and the State and not between the two separately certified facilities.