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Based on review of documents, observational tour, and interview, it was determined, for 6 of 6 patients (Pts. #11, 17, 18, 19, 20, and 21) receiving hemodialysis on 1/27/14, 1/28/14 and 1/29/14, the hospital failed to ensure the pH of the dialysate was safe for dialysis treatment. Thus the potential for all 6 patients to be harmed.

Findings include:

1. On 1/28/14 at 3:30 PM, policy #2-201, titled, "Prescription Verification and Safety Check", revised 3/31/13, was reviewed. The policy required, "Procedure... B. Safety Check... 2. [dialysate] pH parameters between 6.9 - 7.6." This policy follows AAMI (Association for the Advancement of Medical Instrumentation) recommendations for the safe dialysate pH range.

2. On 1/28/14 at 1:20 PM, an observational tour of the Clinical Coordinators Dialysis Work Room (room 231), was conducted. The work room included a container of pH strips for measuring dialysate acidity (pH). The container of pH strips was labeled EMD "colorphast" pH 5.0 - 10.0. The level of measurement on the container was 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0... 10.0. The strips were not sensitive for reading the safe level of pH (6.9 - 7.6).

3. On 1/28/14 at 12:30 PM, an interview was conducted with the Manager of Acute Dialysis (E #2). E #2 stated the safe range of dialysis pH was between 6.5 and 7.5. Later that afternoon, at 3:30 PM, E #2 returned with the policy and stated the safe dialysate pH range was between 6.9 and 7.6 and the pH strips being used do not provide readings of 6.9 or 7.6.

4. The patients receiving dialysis treatments on 1/28/14 and 1/29/14 included: Pt #11, a 73 year old male admitted on 1/20/14 with a diagnosis of deconditioning. Pt #11 received dialysis on 1/21, 1/23, 1/25, and 1/28/14; Pt #17 was a 77 year old male admitted on 1/27/14 with a diagnosis of left hip dislocation. Pt #17 received dialysis on 1/28/14; Pt #18 was a 79 year old female admitted on 1/27/14 with a diagnosis of acute chest pain. Pt #18 received dialysis on 1/28/14; Pt #19 was 34 year old female admitted on 1/27/14 with a diagnosis of acute hyperkalemia. Pt #19 received dialysis on 1/28/14; Pt #20 was a 65 year old male admitted on 1/15/14 with a diagnosis of vascular disease. Pt #20 received dialysis on 1/21/14, 1/23/14, and 1/27/14; and Pt #21 a 66 year old female admitted on 1/28/14. Pt #21 received dialysis on 1//28/14.

6. The Vice President of Patient Care acknowledged that the pH test strips were not sensitive enough to accurately read the dialysis pH, during an interview on 1/30/14 at approximately 2:45 PM.

Based on document review and interview, it was determined for 1 of 3 (Pt. #25) clinical records reviewed of patients in restraints, the hospital failed to ensure the discontinuation the restraint at the earliest possible time.
Findings include:
1. Hospital policy titled, "Restraint and Seclusion" revised 11/25/13, was reviewed on 1/29/14 at 1:00 PM. The policy required, "G. Reassessment, Monitoring and Documentation... 6. The RN will assess the patient's behavior and remove restraints on a trial basis when the criteria for removal have been met. If the patient's behavior remains under control then the restraint or seclusion is discontinued..."
2. The clinical record of Pt. #25 was reviewed on 1/29/14 at 1:45 PM. Pt. #25 was a 22 year old male, treated in the ED on 1/26/14 with the diagnosis of suicidal ideation. A physician's order dated 1/26/14 at 3:15 PM, for 5 point restraints for "aggressive/hostile behavior representing danger to others" for up to 4 hours with "early release [if] patient no longer exhibiting behavior requiring restraint."
3. Pt. #25's closed observation flow sheet included, 5 point restraints were applied on 1/29/14 at 3:16 PM. Close observation was recorded every 15 minutes - Pt. #25 was agitated at 3:30 PM, restless at 3:45 PM, sleeping from 4:00 PM through 5:00 PM, awake and calm at 5:15 PM, sleeping at 5:30 PM, awake and calm at 5:45 PM, sleeping at 6:00 PM and 6:15 PM. Pt. #1's restraints were removed at 6:15 PM. Nursing notes written at 5:15 PM, 5:20 PM, 5:21 PM, and 5:49 PM indicated Pt. #1 was drinking water and attempting to urinate, with no documentation of agitated or aggressive behavior. Reassessment for restraint removal did not occur when Pt. #25 was awake and calm at 5:15 PM, one hour before the restraints were removed.
4. On 1/30/14 at approximately 1:00 PM, an interview was conducted with the Documentation Liaison for the ED (E #11). E #11 reviewed Pt. #25's clinical record and stated she did not find documentation that the restraints should have remained when Pt. #1 was awake and calm.

Based on document review and interview, it was determined that for one of one medical records department, the hospital failed to ensure that medical records were completed within 30 days after discharge.

Findings include:

1. On 1/30/14 at approximately 10:30 AM the hospital's procedure entitled "Medical Record Delinquency," (reviewed 5/15/13) was reviewed and required, "This procedure outlines steps to facilitate compliance with Bylaws and regulatory guidelines requiring a complete medical record within 30 days of discharge from the hospital."

2. On 1/30/14 approximately 10:50 AM the Hospital presented an attestation letter that included, "As of today's date, January 30, 2014, there are 114 delinquent medical records, greater than 30 days post discharge..."

3. The Director of Health Information Management stated during an interview on 1/20/14 at approximately 9:30 AM that clinical records become delinquent after 30 days.

Based on observation, interview and document review the facility failed to maintain the hospital food service area (1 of 1), equipment and supplies in a safe and sanitary manner. This has the potential to affect all 204 patients in the hospital on 1/29/14.

Findings include:

1. On 1/29/14 at 10:20 AM an observational tour of the hospital's kitchen was conducted with E #10 (Dietary Manager). The following observations were made during the tour:

- Disposable ware (dishes, bowls, flatware, serving containers and covers) were observed throughout the kitchen to be stored outside of their ordinal containers. They were stored in such a manner that the plating surfaces was exposed to possible contamination of food splatters and dust.

2. The dry storage area was toured with E #10 at 9:45 AM. E #10 stated in part, the department practices FIFO system (first in first out). The following observations were made during the tour:
- Two of 2 bags of nuts were observed without receiving dates;
- 3 of 3 bags of nuts had no content labeling as to what the bags contained; - 5 of 5 bags of pasta were not labeled for content or dated and;
- one opened bag of rice was also not labeled for content or dated.

3. Opened plastic utensils were observed to be stored in a cardboard box marked as ground beef patties. Also in the dry storage area a used hair covering and a soiled back brace were on the same shelf as food product.

4. E #10 (Dietary Manager) stated in part that these things belonged to the employee who was responsible for maintaining the dry storage area. A personal beverage was on a shelf containing food product posing the potential for cross contamination.

5. The walk-in freezer was observed, at 10:05 AM to contain an uncovered 5 gallon food bucket, on the floor, which was filled with used grease. E #10 stated in part they had just cleaned the fryers and always brought the grease into the freezer to cool down. She confirmed that this process should not have been completed inside a freezer with food product.

6. The walk-in freezer also contained an open package of four meat patties that were not dated and/or labeled. In this unit it was observed to have an unlabeled or dated fish product which was freezer burned. The unit also had five pie crusts and eleven frozen cream and fruit pies which were dated. E #10 confirmed that without dating staff could not practice FIFO (first in first out).

7. At 10:10 AM the walk-in cooler (produce) was observed to have a very heavy build up of food debris and a black substance on the floor between the shelving units. The lower area of the walls near the floor also had a black substance on the surface.

8. At 10:25 AM the walk-in dairy cooler was observed to have a soiled condenser with black substances on the fan cover and back air fins.

9. Five of 5 garbage cans observed at 10:30 AM and during the entire tour of the kitchen were observed to be uncovered exposing the contents. E #10 was asked were the lids to these cans were and she stated in part they don't use them.

10. Hospital policy: Number FN 513, "Garbage Holding and Covers" Review date 3/10 required, "Policy: the Food Service department will follow the protocol regarding proper covering and storage of garbage containers. Procedure: 1. Check all trash containers daily to ensure the lid is on the can."

11. In the main kitchen area at 10:35 AM the the baking oven was observed to have a dusty fan cover located over a food preparation table.

12. Two of 2 sanitation buckets were checked for sanitizer and found not to meet the minimum of 150 ppm (parts per million).

13. Four small steam table pans of soup and a pan of mashed potatoes were on the line for service. E#10 was asked to have temperature taken as no temperature log for these food items had been taken. E#10 instructed temperatures to be taken by staff. It was observed that staff took the thermometer from her apron and submerged the stem in a sanitation bucket for less than 15 seconds. She did not wash, rinse or immerse the thermometer for the required 60 seconds.

14. Hospital policy, "HACCP/Food Safety Program Food Safety Standards & Requirements" (issue date 1/27/12) documents "B. Receiving/Storage Thermometer stems must be washed, rinsed and sanitized...correct immersion time one minute minimum".

15. At 10:50 AM, in the dish machine area it was observed that staff was drying black trays with a blue towel. When E #10 was asked about this procedure, E #10 indicated when it was busy staff hand dry the dishware because they are short of time. E #10 confirmed that all dishware should be air dried.

Based on random observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Medicare Sample Validation Survey conducted on January 28 - 30, 2014, the surveyors find that the facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see A710.

Based on random observation during the survey walk-through, staff interview, and document review during the Life Safety portion of a Medicare Sample Validation Survey conducted on January 28 - 30, 2014, the surveyors find that the facility does not comply with the applicable provisions of the 2000 Edition of the NFPA 101 Life Safety Code.
See the Life Safety Code deficiencies identified with K-Tags on the CMS Form 2567, dated January 30, 2014.

A. Based on observation, document review and interview, it was determined for 2 of 2 (E# 3 & 4) staff observed in operating room #5, the hospital failed to ensure sterile supplies were not left unattended.

Findings include:

1. An observation of operating room #5 was conducted on 1/29/14 from 7:00 AM to 7:45 AM and the following was observed:
- 7:15 AM, E#4 (surgical technician) had opened sterile packs and placed them on the sterile field, E#4 left the room to retrieve another pair of gloves. E#3 (circulating nurse) having also left the room, returned to the room 30 seconds later, thus leaving the sterile opened supplies unattended.
- 7:18 AM - E#3 and #4 left the room again for 20 seconds, leaving the sterile opened supplies unattended.

2. The AORN (Association of periOperative Registered Nurses) 2013 guidelines required, "Once created, a sterile field should not be left unattended until the operative or other invasive procedure is completed. Observation increases the likelihood of detecting a breach in sterility."

3. The Manager of Surgical Services, stated during an interview on 1/29/14 at approximately 8:00 AM, that he was surprised "that the room was left unattended".


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B. Based on document review, observation and interview, it was determined for 3 of 4 (E #5, 6 and MD #1) , the hospital failed to ensure compliance with the surgical attire policy.

Findings include:

1. The hospital's policy entitled "Surgical Attire - Restricted and Semi-restricted Procedural Areas," (revised 5/29/13) required, "...All head/facial hair and scalp must be covered by a lint free hat or hood while in the procedural areas..."

2. During the observational tour of operating room 4 on 1/29/14 between approximately 7:00 am and 8:15 am, the following was observed:
- At 7:10 AM, E #5 (circulator) entered OR 4 with exposed hair from the sides and back of the surgical cap.
- At 7:12 AM, E #6 (Certified Registered Nurse Anesthetist) entered OR 4 with exposed facial hair between his mask and surgical cap.
- At 8:06 am, MD #1 (surgeon) entered OR 4 with exposed hair from the sides and back of the surgical cap.

3. The Manager of Surgical Services, did not respond to the allegation of hair exposure, during an interview on 1/29/14 at approximately 8:00 AM.



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C. Based on document review, observational tour, and interview, it was determined, for 2 of 2 Operating Rooms (OR #4 & 5) and 1 of 2 Labor and Delivery (L&D) Surgical Suites (LD #1), the hospital failed to ensure surgical equipment was free from tears, tape residue, and rust to enable thorough disinfection, potentially affecting patients scheduled for OR & L&D procedures on 1/29/14 (OR #4 - 6 patients, OR #5 - 4 patients, and L&D #1 - unscheduled Caesarian sections).

Findings include:

1. Hospital policy entitled "Equipment Cleaning" (revised 7/11/13) required, "...All equipment must be cleaned between patients using the appropriate disinfectant..."

2. On 1/28/14 at 12:50 PM, an observational tour was conducted in L&D surgical suite 1. Both arm board's cushion material was torn and tape was affixed to the material, eliminating thorough arm board disinfection.

3. On 1/28/14 at 12:50 PM, an interview was conducted with the L&D Clinical Manger (E #1). E #1 was present during the tour and stated that she had ordered new arm boards which take 5 to 6 weeks for delivery.

4. On 1/29/14 at approximately 7:55 AM, the covering on the armboard cushion was observed to be torn, exposing the foam insides, rendering it unable to be disinfected per policy.

5. On 1/29/14 at approximately 7:10 AM in OR 4, 3 of 8 metal carts contained rusty wheel bases, rendering them unable to be disinfected per policy.

6. The Manager of Surgical Services, stated during an interview on 1/29/14 at approximately 8:00 AM, that the carts are in the process of being replaced with plastic carts and the arm boards could not be cleaned properly.