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Based on observation, record review, and interview, the facility failed to ensure new equipment was inspected and tested before initial use as evidenced by:

-Two new machines used in an Aesthetic Clinic were not inspected and tested before being use on approximately 40 patients.


Findings include:


- Observation on 4/14/16 at 2:15 p.m. of the facility's new Aesthetic Clinic with DON (Director of Nursing) C, Director of Risk Management/Quality Assurance (Risk/QA) B and Aesthetic Therapist GG revealed two new machines used for laser hair removal, vein reduction, pigmentation reduction and toe nail fungus removal in the treatment room. There was no label on either machine to show they had been checked out by biometrics for patient safety.


Interview at this time with Therapist GG, she was asked if the machines had been checked out. She said she did not know. She said she had done about 40 procedures since the machines had arrived.


Interview at this time with Risk/QA Director B, she said she forgot to tell Therapist GG to get the machines checked out before using them. She said she would contact the Director of Maintenance and have the machines checked before any more procedures were done.


- Record review of the facility's Policy and Procedure for Inventory and Inspection of New Equipment dated 11/13 revealed the following:


"PROCEDURE: ... After receipt of any new equipment, but prior to its installation, equipment must be inspected. Electrical and mechanical tests shall be performed and the Engineering Department shall determine that it meets all appropriate safety standards. After passing inspection, the new equipment is assigned an identification number and is placed on a maintenance schedule ... "

Based on observation, record review, and interview the facility failed to ensure drugs were properly stored as evidenced by:

-Controlled medications in two emergency carts were not double locked.


Findings include:


- Observation on 4/13/16 at 9:30 a.m. with Director of Nursing (DON) C of the emergency cart on the acute patient unit revealed two syringes of Valium (a controlled medication) in the top drawer of the cart. The cart was not locked, but had a yellow plastic tie that could be easily broken to get into the drawers on the cart.


- Observation on 4/13/16 at 1:30 p.m. with DON C of the emergency cart in the Emergency Department (ED) revealed syringes of Valium and Versed (both controlled medications) in the top drawer. The cart was not locked, but had a yellow plastic tie that could be easily broken to get into the drawers on the cart.


Interview at this time with DON C, she was asked if the controlled medications were double locked. She said they were not double locked. She said she would take the medications out of both carts, return them to the Pharmacy until the facility could discuss how they could be secured under double locks.


- Record review of the facilities Policy and Procedure (P&P) for Controlled Substances - Pharmacy dated 6/16/09 revealed the following:

"Pharmacy Storage: All Schedule ...drugs are stored in a double locked narcotics cabinet. "

Based on observation, record review and interview the facility failed to ensure drugs and biologicals were checked for expirations dates in the Emergency Department (ED) medication cabinet, ED emergency cart and in the Operating room suite.


Findings include:


- Observation on 4/13/16 at 11:30 a.m. with DON C of the Emergency Department (ED) revealed the following 1000 ml (milliliter) bags of IV solutions were out of date:


5% Dextrose - 3 bags expired on 2/1/16
.45% Sodium Chloride - 2 bags expired on 1/1/16
5% Dextrose and .45% Sodium Chloride - 2 bags expired 1/1/16
10% Dextrose - 1 bag dated 3/1/15


- Continued observation at this time of the ED emergency cart revealed the following vials of medications were out of date:
20 ml of sterile water - 3 vials expired 5/1/15
20 ml of sterile sodium chloride - 1 vial expired 2/1/15
Single dose vials of atropine sulfate (a rescue drug used for resuscitation) 0.4 mg/cc - 5 vials expired 3/16


Interview at this time with DON C, she said the nurses should have been checking the dates on the IV bags and medications.


- Observation of the Operative Suite on 4/13/16 at 2:10 p.m. with RN S, Director of Surgical Services, revealed the Betadine scrub brushes in a box at the scrub sink outside the Operating Room expired 3/2016.


Interview at this time with RN S, she said she did not realize they had an expiration date.


- Record review of the facility's Policy and Procedure (P&P) for Unusable and Outdated Drugs dated 6/15/09 revealed the following:


"PROCEDURE: All drug storage areas of the hospital will be inspected, including: Surgery, night medication locker and other patient care unit stock areas if applicable, for outdated drugs ...The staff member conducting the inspection will remove all of these types of drugs from the area ... "


- Record review of the facility's P&P for IV Medication or Solution Preparation dated 11/16/06 and revised on 4/13 revealed the following:


" Procedure: ... 2. Check medication date for outdate.

Based on observation, record review and interview, the facility failed to ensure there was a system for identifying and investigating infections and providing a clean environment as evidenced by:

- Warmed IV and Irrigation Solutions were not removed from the warmer by the labeled expiration dates.

-Relative Humidity (RH) was not kept above 30% in the Operating Suite. The RH was changed to 20% without following CMS (Centers for Medicare/Medicaid Services) guideline for applying for a waiver.

-Single wrapped hinged instruments were not processed in the open position.

-The kitchen had dust and grime and the water in the steam table had not been changed for two weeks.

-The Physical Therapy Department had thick layers of dust.


Findings include:


Warmed IV and Irrigation Solutions


- Observation on 4/13/16 at 2:10 p.m. with RN S, Director of Surgical Services, revealed seven 1000ml (milliliter) bottles of irrigating sterile water in a warming cabinet. Six bottles had a sticker that noted the bottles were to be removed on 4/6/16 and one bottle to be removed on 4/4/16. There was one 1000 ml bottle of irrigating sodium chloride with a label to be removed on 4/4/16. There were two bags of 1000 ml IV fluids labeled to be removed on 4/4/16.


Interview at this time with RN S, she said they did surgery cases so seldom that she forgot to check on the fluids. She said she used the warmed irrigating water to rinse the cords for scopes when they did laparoscopic cases. She said the fluid needed to be warm to help with fogging of the lenses. RN S gave a copy of an information letter from the IV company stating what the manufacturer's recommendations were for heating IV solutions and bottles of irrigation in plastic containers.


Record review of the information letter dated 4/29/2010 about Company A's recommendations for heating IV and irrigation solutions in plastic contains was a follows:

"(Company A) recommends that these fluids be stored according to the criteria specified in the individual product labeling. The labeling for these products indicates storage at ...(68-77 [degrees F (Fahrenheit)]. The expiration date assigned to each product is based on stability data derived from samples stored at ...(77 [degrees] F). These data support the length of time a product may be stored under normal conditions while remaining pharmaceutically acceptable...Some clinical situations may however warrant the use of solutions for injection and irrigation at higher temperatures than specified on the product label. For this purpose, we provide the following guidance " : ...

Solutions for injection and irrigation ...may be warmed at a temperature not to exceed ...(104 [degrees] F) ...for a period no longer than two weeks (14 days). Once the product is removed from the warming cabinet, it should be clearly labeled with a revised expiration date".


- Record review of the facility's Surgical Log revealed the last surgery was done on 4/6/16.


Surgical Suite

- Record review of CMS (Centers for Medicare/Medicaid Services) S&C (Survey & Certification Group) letter dated 4/19/13 revealed the following:
"SUBJECT: Relative Humidity (RH). Waiver of Life Safety Code (LSC) Anesthetizing Location Requirements ...

B. Categorical Waiver for RH Levels in Anesthetizing Locations ...
CMS strongly recommends that facilities maintain RH in a range of (greater than or equal to) 20 - (Lesser than or equal to) 60 percent in all anesthetizing locations.
C. Waiver Does Not Apply If:
-More stringent RH levels are required under State or local laws and regulations; or
-The reduction of RH would negatively affect ventilation system performance.
D. Facilities Option to Elect to Use the Waiver
Facilities that elect to use the categorical waiver must document their decision to do so .... At the entrance conference for any survey assessing LSC compliance, a facility that has elected to use this waiver must notify the survey team of this fact, as well as the fact that it meets the minimum RH standard of (greater or equal) 20 percent. The facility must provide documentation of its prior election to apply the waiver option ...
E. Ongoing Requirements
Facilities must monitor RH levels in anesthetizing locations and be able to provide evidence that the RH levels are maintained at or above 20 percent .... In addition, facilities must provide evidence that timely corrective actions are performed successfully in instances when internal monitoring determines RH levels are below the permitted range. "


- Observation on 4/13/16 at 2:10 p.m. with RN S, Director of Surgical Services, revealed the facility had one Operating Room. There was a device on the wall that monitored the temperature and relative humidity RH. The temperature at that time was 70.8 degrees F. and the RH was at 44%. RN S provided the log she used to document the temperature and humidity. She said the RH had been below 20% several times and she informed the Director of Maintenance about it. She did not know what he had done about it. In the decontamination area there was a device on the wall that monitored the temperature. RN S said it did not monitor the RH. She said the temperature and RH was monitored by a computerized system that the Director of Maintenance monitored. When she was informed the temperature and RH needed to be monitored throughout the Operative Suite, which included he clean side of Sterile Processing and the instrument storage area, she said she did not know that.

- Record review of the SURGERY TEMPERATURE AND RELATIVE HUMIDITY LOG for 2016 revealed the following:
" CMS (Centers for Medicare/Medicaid Services) & AORN (Association of periOperative Registered Nurses) Standards for Relative Humidity: 20-60% "

January - 9 entries: 1 at 39%, 7 from 21 to 29%, and 1 at 17%
February - 12 entries: 8 from 23 to 26%, 4 from 15 to 18%
March - 9 entries: 1 at 48%, 6 from 33 to 39/%, 2 at 24%
April - 3 entries: 2 from 23 to 27% and 1 at 46%


Interview at this time with RN S, she said the humidity was changed to 20% based on AORN recommendations. When she was asked if the changed was approved by the Governing Body, she said she did not know.

The facility did not announce at the Entrance Conference that they were using the Waiver to decrease the RH to 20% as required.

- Record review of the facility's Governing Board meeting minutes from 4/2015 to 1/2016 revealed nothing about adopting the Waiver to decrease the relative humidity RH to 20%.

- Observation on 4/14/16 at 2:45 p.m. with Director of Maintenance R revealed he could monitor the temperature and RH on his computer in the Maintenance Department. He said the program had a set point at 35% RH, which was set by the company who installed the unit. If the RH dropped below that an alarm sounded. He said you would have to be at the computer to hear the alarm. He said he wanted the alarm to go to his cell phone and needed to get the company to do that for him. He said he knew the RH had been down, but did not know why.

- Observation and review on 4/15/16 at 11:30 a.m. with Director of Maintenance R of the computerized every 15-minute monitoring numbers for RH from 1/31/16 to 4/13/16 revealed the RH was sporadic and went below 20 % and 30 % regularly. There were only a few times the RH was above 30% for 2 to 7 hours in a 24-hour period.


- During an interview at this time with Director of Maintenance R, he said he was out on sick leave from January, February and half of March, 2016. He said to his knowledge no one had been to the facility to check out the system. He said he did not know if anything had been done to keep the humidity within range. He said he had no idea why the RH fluctuated so much in a 24-hour period. He said the probe that monitored the temperature and RH was located in the ceiling outside the Operating Room.

- Record review of the facility's P&P (Policy and Procedure) dated 6/5/07 revealed the following:

"Policy: To maintain code-compliant humidity and temperature levels in all critical areas ....

Procedure:

In order to ensure patient and employee safety and comfort in the operating (sic) the staff will:
1. Install and maintain devices that indicate room temperature and humidity readings in such rooms.
2. Take corrective actions when it is reported that the readings are not code compliant ...
Temperature and Humidity Table ...
Operating Room (only one listed) ... Relative Humidity - 50-60 (%)


- Record review of the AORN (Association of perioperative Registered Nurses) Journal dated June 2009 revealed the following:

A relative humidity level that is too low can result in excessive bacteria-carrying dust in the surgical environment or static electricity ...Log should be maintained on humidity, temperature and air exchanges. " The recommended settings were in a table and were as follows for the American Institute of Architects (AIA):
Humidity in all areas: 30 to 60%



Sterile Processing


- Observation on 4/13/16 at 11:30 a.m. in the Emergency Department with DON (Director of Nursing) C revealed multiple single wrap packages of sterilized hinged instruments, i.e. hemostats and nasal speculums, were not in the open position.


Interview at this time with DON C, she said she did not know about sterilizing instruments and called RN S, who processed instruments.


Interview at this time with RN S, she said she thought keeping the instrument unlocked was keeping it in the opened position. She said she would check all the packages and reprocess them.


- Observation on 4/13/16 at 2:10 p.m. in the Surgical Suite with RN S revealed multiple packages of sterilized hinged instruments not in the open position.


Record review of an on-line reference for Sterilization by AORN dated 2015 when asked if instruments with sharp points and edges be sterilized in the open or closed position revealed the following:

"All hinged instruments should be sterilized in the open position, unless the manufacturers instructions advise against this practice. If hinged instrument are on stringers, racks, or instrument pegs, the instruments should be kept open and unlocked. The rationale behind the practice is to expose all surfaces to the sterilant."


Kitchen


- Observation on 4/14/16 at 9:50 a.m. of the kitchen with Dietary Manager (DM) AA revealed the following:

1. The top ledges of the doors on 2 freezer units (3 doors each) had a thick build-up of greasy grime.
2. The top ledges of the doors on 2 refrigerator units (2 doors each) had a thick build-up of greasy grime.
3. The convection ovens had a thick accumulation of burnt on grease and grime.
4. The back splash of the stove had a thick accumulation of burnt on grease and grime.


Interview at this time with DM AA, she said the chemical company they used said they would provide something that would clean the oven and back splash. She was asked if she followed up with them to get the cleaning agent and she said had not.


5. There was a thick build-up of brown grime on the floor by the wall and the convection ovens. The ovens were on wheels and could be moved.
6. The metal seven shelved storage unit had two bottom shelves and the side that were rusted.
7. The steam table had three rectangular water wells and a domed well. The water in the wells was dirty and discolored from milky white to brown. There was an accumulation of grime and lime scale on the sides of the wells. The shelf under the water wells was greasy to touch.


Interview with DM AA, she said the water had not been changed for two weeks.


Interview on 4/15/16 at 12:00 p.m. with Dietitian Q, she said DM AA had cleaning schedules for the staff who documented cleaning on the daily sheet. She showed copies of the daily and weekly cleaning checklists for the cook and tray aide. There was a monthly cleaning schedule. The cook was responsible for cleaning the ovens daily. The steam table, refrigerators and freezers were not listed.


Record review of the facility's P&P for Cleaning of Steam Table (not dated) revealed the following: "DAILY CLEANING ...

2. Drain or remove water from the well.
3. Use a soft cloth or sponge with a mild detergent to clean the entire warmer assembly. Rinse completely with warm water and then dry ...

WEEKLY CLEANING...
1. Scale deposits due to the mineral content of the water may be removed using a plastic scouring pad and a de-scaling agent approved for use on stainless steel..."


Physical Therapy Department


- Observation on 4/13/16 at 3:50 p.m. of the Physical Therapy department with Director of Therapy Y revealed the following:


1. The bottom shelf of a three tiered cart had a thick layer of dust. There was tape residue on top of the E Stim machine on the top shelf of the cart.
2. A traction table had a layer of dust on the lower legs and ledge.
3. There was scale build-up on the hydroculator with water stains on the outside. The water inside the unit was discolored.


Interview at this time with Director of Therapy Y, he said he changed the water quarterly or more often if needed.


4. There was an E Stim unit on a three tiered cart in the storage room that had a thick layer of dust on the middle and lower shelves.
5. There were several storage units with open shelving in the storage room with multiple equipment and supplies that had a thick layer of dust.


Interview at this time with Director of Therapy Y, he was not able to say if Housekeeping was to clean the area or if it was therapy staffs' duties.


- The facility was asked for the P&P for cleaning therapy equipment and environment. By the time of exit on 4/15/16 at 3:00 p.m. the facility did not provide any P&Ps. A Quality Improvement Activity Report was provided dated 4/14/16 with a plan to schedule equipment and environment cleaning. There was also a Cleaning Log.

Based on observation, record review, and interview, the facility failed to ensure patients and staff were protected from exposure to radiation hazards as evidenced by:

-The facility did not routinely check their leaded aprons and shields to ensure they were safe to use.


Findings include:


- Observation on 4/13/16 at 3:00 p.m. of the Radiology Department with DON (Director of Nursing) C and Director of Risk Management /Quality Assurance (Risk/QA) B revealed multiple leaded aprons and thyroid shields.


Interview at this time with Radiology Director T, she was asked to see the Physicist's evaluation of the aprons and thyroid shields. She said they did not have the Physicist evaluate the shields. She said she did not think they had to have them checked out. She said they were fairly old and needed to be replaced.


- Record review of the facility's Policy and Procedure (P&P) for Radiation Safety (no date) revealed the following: "POLICY STATEMENT ...


5. Whenever possible, all reproductive organs are to be shielded by lead ...
7. Any individual whose presence is required in the scanning room during examination exposure is required to wear a lead apron. "


- Record review of the facility's P&P for Radiation Exposure (no date) revealed the following: "PATIENT SAFETY: ...Patient must be shielded as much as possible ...
EMPLOYEE SAFETY: ...Technologist or nursing personnel MUST NOT remain in the exposure area unless assisting the radiologist or technologist; then they must be adequately shielded. "


- The facility did not have a P&P stating how often lead aprons and thyroid shields were to be inspected for cracks and defects.


- The Quality Control Recommendations for Diagnostic Radiography dated July 2001 read in part:...Lead Apron, Glove, Gonadal, and Thyroid Shield Integrity Check...Objective: To assure that the lead aprons, golves, gonadal shields, and thyroid collars provide optimal protection when positioned appropriately...Frequency: Annually...

Based on observation, record review and interview the facility failed to ensure oxygen therapy equipment for 2 of 2 patients on oxygen therapy (Patients #1 and #3) was dated to ensure replacement of the equipment was done according to Policy and Procedure (P&P). There was no P&P for when to change nasal cannula tubing.


Findings include:


- Observation on 4/13/16 at 9:00 a.m. in Patient #1 ' s room revealed a nebulizer with tubing hanging from an oxygen outlet. There was no date on the nebulizer or tubing.


Interview with Patient #1 at this time, he said he was admitted with rectus sheath hematoma from coughing. He said he thought he got the cough from smoke inhalation from the wild fires several weeks ago. He said part of his treatment was getting nebulizer medications.


- Observation on 4/13/16 at 9:35 a.m. in Patient #3 ' s room revealed a nebulizer with tubing attached hanging from an oxygen outlet. There was no date on the nebulizer or tubing. The patient was on oxygen by nasal cannula. The tubing was not dated.


Interview with Patient #3 at this time, he said he got breathing treatments when he asked for them.


Interview on 4/13/16 at 8:30 a.m. with Director of Risk Management/Quality Assurance B, she was asked if the facility had Respiratory Therapists. She said the nurses provided respiratory therapy treatments.


Interview on 4/14/16 at 4:00 p.m. with DON (Director of Nursing) C, she was asked when nebulizing and nasal cannula (N/C) tubing were to be changed. She said the nebulizing tubing was to be changed every three days. She said she did not know when the N/C tubing was to be changed. DON #3 was asked for the Policy and Procedure (P&P) for nebulizer and N/C treatments. At 4:30 p.m. DON #3 had a P&P for nebulizer treatment, but said she could not find one for use of N/C.


- Record review of the facilities Policy and Procedure for Aerosol Therapy Guidelines for Medicines and dosages dated 8/14 revealed the following:
" Mark the nebulizer tubing with patient name and date. Change tubing every 3 days. "

Based on record review and interview, the facility failed to ensure the Medical Record was complete and accurate for 8 of 10 sampled patient records (#'s 10, 12, 13, 14, 15, 16, 17, and 18) reviewed for accuracy as evidenced by:

-Multiple entries were not dated or timed.
-Emergency Department Physician examination notes were not complete.
-Surgical History and Physicals were not updated prior to surgery.



Findings include:



- Record review with DON (Director of Nursing) C of three closed electronic medical records of patients who visited the ED (Emergency Department) revealed the Emergency Physician's Record was not completed as follows:


Patient #10 came to the ED on 3/19/16 with diagnosis of alcohol intoxication. The patient was documented as not willing to give any information. The top of the physician's sheet for Psychiatric Disorder was not dated or timed. The only thing documented was a circle around F for Female. Doctor DD signed the back sheet, but the line for Disposition Time was blank.


Patient #12 came to the ED on 1/4/16 for acute chest pains. None of the requested information on the top left portion of the Chest Pain Physician's Record was filled out. That included the date, time, room, age of the patient, sex, race, who gave the information, treatment prior to admission or where the patient came from. On the back right side of the report PA (Physician Assistant) EE signed the form but did not enter the disposition time.


Patient #13 came to the ED on 2/4/16 with head ache, blurred vision, and chest pain. None of the requested information on the top left portion of the Chest Pain Physician's Record was filled out. That included the date, time, room, age of the patient, sex, race, who gave the information, treatment prior to admission or where the patient came from. On the back right side of the report PA FF signed the form but did not enter the disposition time, where the patient went, or the condition at time of discharge.


Interview at this time with DON C, she said most of the Mid-level practitioners felt it was the nurse's job to fill in the top portion of the physician's record. She said the nurses already had enough paperwork they had to complete.


- Record review of the following records of patients who had surgical or endoscopy procedures revealed they were not complete and accurate:


Patient #14 was admitted on 11/18/15 for left inguinal hernia (soft tissue bulges through a weakness in the abdominal muscles) repair. The consent signatures were not dated or timed on both lines for physician, patient, legal guardian and witness. The patient's Anesthesia preoperative questionnaire was not dated or timed by anesthesia. The Post Anesthesia Evaluation was not timed by anesthesia. The Patient's History and Physical (H&P) was dated 11/13/16, five days before the surgery. There was nothing on the H&P or the electronic record to show the physician had reassessed the patient prior to surgery.


Patient #15 was admitted on 2/3/16 for laparoscopic bilateral tubal ligation. The consent witness signature was dated on the second line, but not timed. The top line with the physician and patient signature was not dated or timed. The patient's Anesthesia preoperative questionnaire was not dated or timed by anesthesia. The Post Anesthesia Evaluation was not timed by anesthesia. The Patient's H&P was dated 1/28/16, six days before the surgery. There was nothing on the H&P or the electronic record to show the physician had reassessed the patient prior to surgery.


Patient #16 was admitted on 3/23/16 for Laparoscopic Cholecystectomy (gallbladder removal). The consent witness signature was dated on the second line, but not timed. The top line with the physician and patient signature was not dated or timed. The patient's Anesthesia preoperative questionnaire was not dated or timed by anesthesia. The Post Anesthesia Evaluation was not timed by anesthesia. The Patient's H&P
was dated 3/11/16, 12 days before the surgery. There was nothing on the H&P or the electronic record to show the physician had reassessed the patient prior to surgery.


Patient # 17 was admitted on 4/15/16 for a colonoscopy. The consent witness, physician, and patient signatures were dated on the top and second line, but not timed on either. The patient's Anesthesia preoperative questionnaire was not dated or timed by anesthesia. The Post Anesthesia Evaluation was not timed by anesthesia.


Patient # 18 was admitted on 4/15/16 for a colonoscopy. The consent witness signature was dated on the second line, but not timed. The physician and patient signatures were dated on the top line, but not timed. The patient's Anesthesia preoperative questionnaire was not dated or timed by anesthesia. The Post Anesthesia Evaluation was not timed by anesthesia.


- Record review of the facility's Policy and Procedure (P&P) for Medical Records Entry Authentication (not dated) revealed the following:

"POLICY:

1. Doctors of Medicine, Osteopathy and all other Health Care Professionals will sign, date and time all entries in the Medical Record pursuant to CFR 485.638 (a)1. "

Record review of the facility's P&P for History and Physical - Treatment Room dated 11/13 and revised 11/13 revealed the following:

"POLICY:

History and physicals must be performed within 30 days ...prior to scheduled outpatient procedure date ...there must be an update of the patient ' s condition in the medical record within seven (7) days of admission, or 48 hours after admission, but before surgery. "