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Tag No.: C0241
Based on interview and record review the facility failed to ensure that a Doctor of Podiatry Medicine (DPM) and Physician Assistant (PA) were listed as members of the active medical and courtesy staff within the facility's Medical Staff By-laws. This failure had the potential for all patients admitted to the facility to receive substandard care from providers that were not approved by the governing body. The facility census was six.
Findings included:
1. Record review of the facility document titled, "Medical Staff By-laws," revised 04/18/11 Article III, Section 1, stated that membership on the medical staff was a privilege that was to be extended only to professionally competent physicians and dentists who continuously meet the qualifications, standards and requirements set forth in these By-laws. The applicant for membership on the Medical Staff shall be required to be a graduate of an accredited school of medicine or dentistry, conferring the degree of Doctor of Medicine, Doctor of Osteopathy, or Doctor of Dentistry.
Record review of the facility document titled, "Medical Staff By-laws," revised 04/18/11 Article IV, Section 2 Categories of Medical Staff showed (c) Courtesy Staff consisted of physicians, nurse practitioners and dentists and (e) Active Staff consisted of physicians and dentists who regularly admitted patients to the facility.
During an interview on 03/01/17 at 3:25 PM, Staff A, Chief Executive Officer, stated that the facility had one DPM (Staff DD) and one PA (Staff CC) on staff and verified that these positions were not listed within the By-laws and that the DPM should have been listed as active staff and the PA should have been listed as courtesy staff.
2. Record review of an untitled and undated facility document showed a listing of active staff that included advanced practice nurses and Staff DD, DPM and Staff CC, PA.
Tag No.: C0276
Based on observation, interview, record review, and policy review, the facility failed to ensure that the pharmacy staff followed their policies and the infection prevention standards for The United States Pharmacopeia (USP) for compound sterile preparations (CSP) when they failed to:
- Provide a segregated compounding area (SCA, a separate area that is designated for hazardous drug compounding), where the doors did not open into a high-flow traffic area;
- Decrease the chance of contamination by placing the Compounding Aseptic Isolator (CAI, a positive pressure unit used to compound nonhazardous medications), which is the Primary Engineering Control (PEC, a device or room that provides an environment for compounding medications) for this room, next to a sink;
- Remove all paper products from the SCA;
- Remove jewelry before entering the SCA;
- Put on a gown, gloves and mask (PPE, personal protective equipment) before entering the SCA; and
- Clean the SCA daily and perform a terminal clean (a thorough, deep-cleaning of a room to include the ceiling, walls and floors) of the SCA monthly.
- Label medications, when they were opened, so an expiration date could be determined, for two of two medications reviewed.
- Have an accurate accounting system for two of four sample medications reviewed in their Medical Clinic.
These failures had the potential to increase the risk of cross contamination with infection, increase the risk of harm to any patients who received expired/unstable medications, and increase the risk of medications being diverted which placed all of the patients and/or staff at risk. Over 70 medications were compounded in the last three months. The facility census was six.
Findings included:
1. Record review of the USP, Chapter 797, dated 2013, showed that:
- The SCA cannot be located with doors opening to a high-flow traffic area;
- The PEC cannot be located near a water source;
- Particle shedding objects (pencils, corrugated cardboard, paper towels, and cotton items) are prohibited in the SCA;
- Wearing jewelry in the SCA is prohibited;
- All personnel must put on PPEs prior to entering the SCA; and
- The SCA floors should be cleaned daily and the walls, ceilings and storage shelving are to be cleaned monthly and documented on a cleaning log.
2. Record review of the facility's Compound Sterile Log, for the last three months, showed that the following medications were compounded:
- 47 Antibiotics
- 8 Proton-Pump inhibitors (Protonix, used to treat acid reflux)
- 5 Potassium
- 3 Calcium gluconate
- 3 Iron
- 3 Lasix (diuretic) and
- 2 Anti-nausea
3. Observation on 02/28/17 at 10:12 AM, in the SCA for the CSP's, showed:
- The entrance into the SCA was a high-flow traffic area;
- Staff H, Pharmacy Technician, wore a necklace, earrings and rings into the SCA;
- Staff H, did not put on gown, glove or mask before entering the SCA;
- The PEC (CAI) was located to the back of the room with paper cleaning logs hanging on the left wall and paper compounding recipes hanging on the right wall; and
- Staff H, washed hands in a sink to the right of the PEC.
During an interview on 02/28/17 at 10:20 AM, Staff G, Director of Pharmacy, stated that she was aware Staff H wore jewelry and they didn't realize that they had to put on PPEs before they entered the SCA since they have a CAI. She stated that she was aware of Chapter 797, but they did not interpret it correctly and that she thought the sink was grandfathered in (which meant that it was still functioning under an old rule).
During an interview on 03/02/17 at 9:17 AM, Staff C, Infection Control Specialist, stated that she understood the compound sterile room to be a closed class 5 (a cleanroom, since the CAI was there) and didn't realize that the entire room was included. She was familiar with Chapter 797, and the sink being next to the isolator (CAI) was discussed, but interpreted wrong.
4. Observation on 02/28/17 at 3:52 PM, showed Staff H, Pharmacy Technician, did not put on PPEs before she entered the compound sterile room to perform a terminal clean. Staff H cleaned the CAI but did not clean the SCA that contained the CAI.
During an interview on 02/28/17 at 3:55 PM, Staff H stated that she only cleaned the CAI and that housekeeping came in to clean the counters, floors and the sink and they didn't put on PPEs before they entered.
During an interview on 03/01/17 at 9:20 AM, Staff K, Director of Operations (housekeeping), stated that housekeeping wasn't allowed access to the compound sterile room unless the pharmacy personnel let them in. When they did clean they cleaned the floors, sink and took out the trash.
During an interview on 03/01/17 at 9:25 AM, Staff C, Infection Control Specialist, stated that housekeeping did not perform terminal cleans on the compound sterile room and she was unaware that it was necessary.
5. Record review of the facility's Pharmacy policy titled, "Expiration Dating," revised 10/14/14, showed the following:
- The expiration date is the date after which a product should no longer be used by or for a patient.
- Multi-dose vials and/or containers may be accessed repeatedly for 28 days.
- Sterile topical irrigation solutions expire 24 hours after initial entry.
6. Observation and concurrent interview in the Medical/Surgical unit medication room, on 02/28/17 at 2:05 PM, showed a pre-filled insulin pen of Lantus 100 units/milliliter (ml), (a medication used to treat diabetes-a disease characterized by high blood sugar levels), had been opened and used, but did not have an expiration date on it. Staff F, Registered Nurse (RN), stated that the insulin should have been labeled with the open date and an expiration date, or 28 days after opening.
7. Observation and concurrent interview in the Medical Clinic, on 03/01/17 at 1:33 PM, showed a two ounce bottle of Benzoin Tincture (a skin preparation solution), 3/4 full, had no expiration date on it. Staff Q, RN, stated that the bottle should have been dated as to when opened, or with at least an expiration date.
8. Observation on 02/27/17 at 3:55 PM, in the ER medication room, showed a multi-use Humalog insulin vial with no label or expiration date.
During an interview on 02/27/17 at 4:30 PM, Staff I, ER Registered Nurse, stated that the Humalog insulin vial should have had an expiration date.
9. Observation, concurrent interview, and sample medication log review, in the Medical Clinic, on 03/01/17 at 1:45 PM, showed the following:
- The sample medication log, dated 03/01/17, showed 56 Eliquis (a blood thinner) 2.5 milligrams (mg) tablets/capsules, when they actually had 66.
- The sample medication log, dated 03/01/17, showed zero Farxiga (for diabetes) 5 mg tablets/capsules, when they actually had 14.
- Staff R, Clinic Manager, stated that the log definitely did not accurately reflect the actual inventory. Staff R stated that the nurses of the clinic were responsible for the log and that she did not specifically oversee the accuracy of it.
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Tag No.: C0278
Based on observation, and interview, the facility failed to:
- Ensure the sterile processing room was free of paper and books, which create dust.
- Clean the sterilizer according to manufacturers/infection control guidelines.
- Ensure that expired/opened supplies were removed and not available for use.
These failures had the potential to increase the risk for infection and the risk of harm to any patient who received care utilizing these items/processes, placing all patients at risk. The facility census was six.
Findings included:
1. Observation and concurrent interview on 03/01/17 at 4:15 PM, in the sterile processing room, showed three pieces of paper hung on the left wall and books (these items create dust) on the counter next to sterilized items. Staff O, Sterile Processing Technician, stated that she was unaware that the paper was an issue.
2. Observation and concurrent interview on 03/01/17 at 4:20 PM, in the sterile processing room, showed the sterilizer (Eagle series 3000) had a large amount of residue and lime in the inside around the front and the drain. Staff O stated that she cleaned the drain sometimes, but had no cleaning logs. She stated that Steris (a company that services the sterilizers) maintained the sterilizer.
During an interview on 03/02/17 at 9:17 AM, Staff C, Infection Control Specialist, stated that Staff O was in charge of cleaning the sterilizer and that she was unaware there was lime and residue in the sterilizer.
3. Observation on 03/01/17 at 4:00 PM in the PACU (post anesthesia care unit), showed a pair of Magill forceps (used to guide a tube placed through the mouth and down the airway to maintain an open airway) in the bottom drawer of the crash cart that were unpackaged and unwrapped.
During an interview on 03/01/17 at 4:05 PM, Staff Z, Registered Nurse (RN) Operating Room Manager, stated that he knew the forceps were in the drawer, but was unaware that it was an issue.
4. Observation on 02/27/17 at 4:30 PM in the Emergency Room, showed:
- In the Pediatric crash cart, a pack of pediatric resuscitation electrodes for ages 0-8 year olds
had expired on 01/03/17;
- In the wound care cart, an Iodoform packing ½ inch (used for packing wounds), had expired 01/2014;
- In the wound care cart, a Kerlix gauze roll (used for dressing wounds) had no expiration date;
- In trauma room #1, a CaviWipes (a cleaner and disinfectant) container had expired on 09/2015 and in trauma room #4, a CaviWipes container that had expired on 12/23/16;
- In trauma room #1, #2, #3 and # 4, linens, gowns and towels were stored under the sinks around the water pipes.
During an interview on 02/27/17 at 4:30 PM in the Emergency Room (ER), Staff I, RN, stated that the ER technician checks all outdates one time per week and the crash cart and wound care cart were checked one time per month unless they had been opened.
During an interview on 03/01/17 at 9:35 AM, in the ER, Staff J, ER Technician, stated that she checked the outdates at the end of the month and that some of the items don't have dates. She also stated that she hadn't realized the CaviWipes and the linen under the sink were an issue.
During an interview on 03/02/17 at 9:25 AM, Staff B, Director of Nursing and Director of the ER, stated that she expected her employees to check the expiration dates monthly and was aware of the linens under the sink.
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Tag No.: C0279
Based on observation, interview and record review the facility failed to ensure that:
- Foods used for patient consumption were dated when opened and/or thawed;
- Trash cans were covered with lids when not in use;
- Hand held can openers were free from rust;
- The table mounted can opener was free from debris and food residue; and
- The approved diet manual was available for nursing staff as reference information.
These deficient practices placed all patients at risk for unsanitary food service, cross contamination of food and had the potential to affect the therapeutic accuracy of diets. The facility census was six.
Findings included:
1. Record review of the facility's policy titled, "Food Storage," revised 03/01/13 showed that the Nutritional Services Director or designee was responsible for receiving and storing all food and supplies in a proper area. The policy did not show direction for labeling of food.
2. Observation and concurrent interview on 03/01/17 at 1:30 PM, in the dietary department, showed:
- Two packages of ham in the walk-in cooler dated 12/27/16;
- Two packages of turkey in the walk-in cooler dated 02/13/17;
- Two hand held can openers with rust on the ends that was used to puncture cans that contained liquid;
- One table mounted can opener with visible debris and dried food; and
- Three uncovered trash cans partially filled with trash and garbage.
Staff T, Registered Dietician, stated that their "process" was to date all foods with the date of receipt. She stated she was not able to verify the date in which the ham and turkey were thawed. She stated the dietary staff was responsible for cleaning of the department. Staff T also stated that the lids were placed on the trash cans at night.
3. Observation and concurrent interview on 03/01/17 at 3:15 PM, at the Medical/Surgical nursing unit, showed Staff U, Registered Nurse (RN) and Staff L, RN seated at the nursing desk. When asked to see the Diet Manual neither Staff U nor Staff L was aware of what the Diet Manuel was or where it was located. Staff U stated that if she had a question about a patient's diet or what they were allowed to eat she would just call down to the kitchen and ask one of the dietary staff. Staff T, Registered Dietician stated that the Diet Manual could be obtained on the facility's intraweb (internal internet site).
During an interview on 03/02/17 at 9:15 AM, Staff C, Infection Control Specialist stated that she made quarterly environmental rounds in the dietary department with her last one being approximately three months ago. She stated she was aware of the process for dating of foods upon receipt and stated that if she observed a date of 12/27/16 on the packages of ham and the date of 02/13/17 on the turkey she would be concerned that they were outdated and not safe for use.
Tag No.: C0308
Based on observation, interview and policy review, the facility failed to ensure patient paper medical records were protected against unauthorized access (by individuals who were not providing care for those patients) in two areas (the physician dictation room and the record storage room of the Medical Clinic), of four areas observed in the hospital. This deficient practice had the potential to permit unauthorized individuals access, review, and/or possibly alteration of the documented health information in patients' paper medical records located in those areas. The facility census was six.
Findings included:
1. Record review of the facility's policy titled, "Medical Records Department Policy and Procedure," dated 08/31/16, showed that:
- All Medical Records Department staff will have access to the department;
- Emergency Room Technicians and the Charge Nurse will have access to enter the department during off hours;
- Housekeeping will enter the Medical Records Department during normal business hours; and
- No other staff had access to the medical records storage areas.
2. During an interview on 03/02/17 at approximately 9:30 AM, Staff V, Medical Records Director, stated that the facility's policy was outdated and required revision. Staff V stated that Emergency Room staff did not have access to the medical records department.
3. Observation and concurrent interview on 03/01/17 at approximately 1:40 PM. showed a physicians' dictation room with paper medical records in three of four physician dictation cubicles. Staff V stated that physicians, medical records staff, clinic managers and the hospital receptionist had access to the dictation room. Staff V stated that the receptionist would deliver physician mail to the room, and clinic managers would pick the mail up for the physicians.
During an interview on 03/01/17 at 3:15 PM, Staff X, Hospital Receptionist, stated that she had access to the physicians' dictation room to deliver the physicians' mail and to post updated phone lists. Staff X stated that housekeeping would also ask her for the code to access the physicians' dictation room for cleaning purposes.
During an interview on 03/02/17 at approximately 9:30 AM, Staff V stated that she believed that any hospital staff member could have access to the medical records storage, as long as they had signed the hospital's confidentiality waiver.
4. Observation and concurrent interview in the record storage room of the Medical Clinic, on 03/01/17 at 1:48 PM, showed multiple (too numerous to count) paper medical records in unlocked file cabinets and stacked on top of the file cabinets, along one entire wall (approximately ten feet by five feet). Staff R, Clinic Manager, stated that the housekeeper, Staff S, was considered a caregiver who had signed the confidentiality waiver, and had a key which allowed her full, unsupervised, access to the medical records. Staff R stated that Staff S typically cleaned the medical record storage room early, before other staff arrived.
Staff failed to ensure a staff member that did not need to have access to patients' medical records was supervised and/or prevented access to them.
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