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Based on observation, interview, and record review, the facility failed to ensure that contracted Registered Nurses who provided care and services to hemodialysis patients labeled gallon containers of concentrate that were spiked with additives on 2 of 6 (#45 & #46) sampled hemodialysis patients. Failure to label spiked containers with patient's names place hemodialysis patients at risk for receiving incorrect dialysis concentrates and possible harm.

The facility failed to ensure that the contracted dialysis Company #AA followed their policy and procedure and maintained an Acid Concentrate Adjustment Control Record. This failure resulted in preventing the Medical Director to demonstrate oversight and adverse finding would not be able to be summarized and monitored which could result in possible harm to patients.


Findings:


Observation of the Renal Unit at 9:30 AM on 02/21/2018 along with employee ID #86 and contract staff employee ID #87 identified 2 patients (ID #45 and #46) out of 6 dialysis patient reviewed. The acid concentrate containers for both patients (#45, #46) had been spike with additional potassium additive and no patient identification labels were seen attached to containers. No Concentrate Adjustment Control Record was observed in the renal unit and no staff members was observed documenting spiked acid concentrates on an additives log.


Patient #45

Observation on 02/21/2018 at 9:30 AM in the acute hemodialysis unit of the facility Patient ID #45 was seen to be receiving hemodialysis on a Fresenius T machine. The machine was observed with the following settings: blood flow rate of 350, dialysate flow rate of 800 milliliters per minute, dialyzer F160, treatment time 3.5 hours, bicarbonate at 35 mEq per liter, Sodium 140 mEq per liter, Calcium 2.5 mEq per liter, UF rate set at 3500 ml. It was observed that the acid container had a black and white label applied to the top portion of the jug. The label was identified as a concentrate adjustment label. Label had been dated, timed, initialed, amount of potassium chloride added was listed as 1 gram, initial potassium of bath was listed as a 2.0 gram and final potassium 3.0 grams by staff ID #88. No patient identifier was observed to be attached to the jug.


Record review on 02/21/2018 at 10:00 AM in the hemodialysis unit patient's #45 hemodialysis order sheet dated 02/21/2018 was reviewed. Treatment orders were noted 06:35 AM on 02/21/2018 per telephone orders from employee ID #69. Order sheet documented hemodialysis treatment orders as follows: Dialyzer F-160, time 3.5 hours, Dialyzer flow rate: 800 milliliters per minute, Bicarbonate 35 mEq per liter, K (Potassium) 3.0 grams mEq per liter, Calcium 2.5 mEq equivalent per liter and UF as tolerated.



Patient # 46

Observation on 02/21/2018 at 9:40 AM in the acute hemodialysis unit of the facility Patient ID #46 was seen to be receiving hemodialysis on a Fresenius T machine. The machine was observed with the following settings: blood flow rate of 350, dialysate flow rate of 800 ml per minute, dialyzer F160, treatment time 3.5 hours, bicarbonate at 35 ml mEq per liter, Sodium 140 (mEq) per liter, Calcium 2.5 (mEq) per liter, with UF rate set at 3500 ml. It was observed that the acid container had a black and white label applied to the top portion of the jug. The label was identified as a concentrate adjustment label. Label had been dated, timed, initialed, amount of potassium added was listed as 1 gram, initial potassium of bath was listed as a 2.0 gram and final potassium 3.0 grams by staff ID #88. No patient identifier was observed to be attached to the jug.


Record review on 02/21/2018 at 10:10 AM in the hemodialysis unit patient's #46 hemodialysis order sheet dated 02/19/2018 was reviewed. Treatment orders were noted 8:30 AM on 02/19/2018 per telephone orders from employee ID #90. Order sheet documented hemodialysis treatment orders for one week every Monday, Wednesday, and Friday as follows: Dialyzer F-160, time 3.5 hours, Dialyzer flow rate: 800 ml per minute, Bicarbonate 35 mEq per lt, K (Potassium) 3.0 grams mEq per lt, Calcium 2.5 mEq per lt and UF as 3 to 4 liters as tolerated.


During an interview on 02/21/2018 at 9:45 AM in the renal unit with dialysis contract program manager RN, employee #87, was asked if the spiked jugs of acid concentrates were labeled with patient identifier information. Employee # 87 stated, "No, we never have done that, we do not do that."


During an interview on 02/21/2018 at 9:45 AM in the renal unit with dialysis contract RN, employee #88, was asked if he had spiked the concentrate and filled out the label for the additives for patients #45 and #46. Employee # 88 confirmed he had completed the label, added the potassium and placed the label on the acid jug. Employee #88 was asked if the jug was identified by patient labels for use on patient's ID #45 and #46. Employee ID #88 stated, "No, we are not required to put patient names on the jugs."


During an interview along with Employee #54 at 9:30 AM on 02/21/2018 dialysis Nurse Manger, employee #88, was asked for the Acid Concentrate Adjustment Control Log for the month of January 2018 to date. Employee #88 stated she did not know what log I was speaking of. Employee #88 was shown their procedure and form that was attached to the Dialysis Company Procedure FMS-CS-IS-I-525-070C. Employee #88 stated they do not fill out the form for concentrate additives and have no list from January 2018 till today with additives added to concentrates for patients.


During an interview in the administration offices at 10:00 AM on 02/26/2018 with Director of Services for Company AA, Employee ID #73, and contracted program manager, Employee ID #87, were asked to review their company's policy and procedure for labeling of concentrate containers with additives and additive log records. Both employee (ID #73 and #8) confirmed the company's policy and procedure did not require staff to label jugs of concentrate. The state licensing rules for Tag X0629 (133.41(t)(2)(C)(v) was showed to Employee ID #73 and she was asked to read the regulation. Employee ID #73 was asked if the jugs of concentrates that had been spike with additives were required to have patient labels on them per the state regulation. Employee ID #73 stated, "Yes, the jugs should be labeled and the policy and procedure needs to be changed." Employee ID #73 was asked for the Acid Concentrate Adjustment Control Record and she stated they did not have one, that was something they do not use. Employee ID #73 was shown dialysis Company AA's policy and procedure and acknowledge they should have been completing an additive log per the company policy.


Review of contracted dialysis service's Company ID #AA current policy titled "Use of concentrate Additives for FMS Inpatient Services", Document Number FMS-CS-IS-I-525-070C, Reviewed 07/06/2011 reads in part:

"Purpose: The purpose of this procedure is to instruct the trained FMS inpatient nurse to safely mix individual concentrate additives for use in hemodialysis ...

6. Label the container with the dialysis concentrate of the targeted electrolyte, the quantity and the part number of the additive used, date, time, initials of the preparer and date of the expiration (30) days from mixing. Note: Care must be taken to ensure the container with the additive is used for the appropriate patient. Distinguished marking on the container will help to ensure appropriate labeling of contents."

8. "The Clinical Manager will review the compliance with the Acid Concentrate Adjustment Control Record CS-IS-I-525-070D with the Medical Director. The Medical Director will sign the mixing log to demonstrate oversite. Any adverse finding will be summarized along with potential interventions in the routine quality assessment and process improvement meetings."


Documentation: A record will be maintained and all mixed jugs labeled to show the following on mixed dialysis concentrate:

1. The name of the individual preparing the acid concentrate

2. The date prepared

3. Intended electrolyte and MEq/L value

4. Base Product Number used

5. Additive product Number used

6. Number of packets used to achieve the intended value

7. A routine method of Physician oversite - by way of monthly "Quality Assessment and Improvement" activities.

Based on observation, interview, and record review, the dietary Director ID #57 failed to ensure the overall operational components of daily management of the dietary services for the department as evidenced by 2 of 2 ovens not cleaned, and the failure of staff on the food preparation line to sanitize or wash hands with glove changes.


Findings include:

Two (2) of 2 ovens not cleaned, #1 contained rust, #2 Contained dark brown debri and grease.

Six of (6) Kitchen staff preparing the food trays for delivery did not sanitize their hands after removing contaminatesd gloves.


Observed on 2/21/18 at 10:00 am, it was observed on the facility tour of the Dietary Service area 2 ovens not safe or clean for usage. The first oven had large amounts of rust on the door, on the inside of the bottom shelf and on the sides of the oven. The second oven was dirty with grease on glass window, the oven door and the racks were covered with dark brown grime and grease.


Observed on 2/21/18 at 11:15 am, the food preparation line consisted of six (6) of (6) dietary staff did not sanitize hands between glove changes, nor was there sanitizer visibly seen for accesss in the area.


Interview on 2/22/18 with Director of Dietary ID # 57 at time of kitchen tour stated, I see the rust on the door and oven. It will be taking out today and replaced. ... "Yes, the grease on the door and racks in the oven are not acceptable". The staff are to change their gloves every 15 minutes.


Record Review of the Department of Food and Nutrition Services Orientation reads:

A violation of the following departmental policies and procedures could result in a 3-day suspension without pay and or termination:

DRESS CODE & GROOMING
...Y. Hand washing procedure
...EE___ Demonstrates the Proper Use and Cleaning of Equipment:
... 3. Ovens.


CDC policy on Hand Hygiene revealed:

"Guideline for Hand Hygiene in Health -Care Settings recommendation:

1. Indications for handwashing and hand antisepsis

a. When hands are visibly dirty or contaminated with proteinaceous material or are visibly soiled with blood or other body fluids, wash hands with either a nonantimicrobial soap and water or an antimicrobal soap.

b. If hands are not visibly soiled, use an alcohol-based hand rub for routinely decontaminating hands in all other clinic situations described in items 1 C-J (1A) ( 74, 93, 166, 169, 283, 294, 312, 398).

c & d. Decontaminate hands before donning sterile gloves and before having direct contact with patients.

i. Decontaminate hands afer contact with inanimate objects ( including medical equipment).

j. Decontaminate hands after remooving gloves ( 1B) (50,58,321)."

Based on observation, interview, and record review, the facility failed to maintain a sanitary environment in that staff failed to follow infection control policies when providing direct patient care, failed to remove contaminated suction equipment, and failed to remove a non cleanable device in 2 of 6 operating rooms (ORs) (OR# 3 and OR #6).


Findings include:


Observation on 2/20/2018 at 10:30 A.M. in operating room #3 revealed a patient positioning device that is not cleanable (sponge material) covering an electrical outlet hanging from the operating room ceiling and visible debris in the anesthesia suction tubing and yankauer suction tip.


Interview with interim director of surgical services (ID#64) at the time of observation stated that the electrical outlet has the positioning device wrapped around it to protect staff because they could easily hit their heads. The protective covering is changed each day. She then acknowledged that the item was a sponge material and could not be wiped clean and could be contaminated during a surgical procedure.


Interview with Chief Certified Registered Anesthetist (CRNA) (ID# 67) at the time of observation stated that the room had been cleaned and was ready for use.
Record review of facility policy titled Surgical Area Cleaning Procedures dated 9/2013 revealed the following:


Between Case and Concurrent Cleaning:

3. Solid waste should be bagged or containerized, securely closed, and removed to an appropriate storage area. Regulated (infectious) waste contaminated with blood or body fluids should be placed in color coded or properly labeled bags or containers, securely closed, and handled or disposed of in accordance with hospital policies and procedures and applicable regulations.


Record review of facility checklist for Anesthesia Tech Turnover (End of Case) Checklist revealed suction Tubing is to be removed.


Observation on 2/20/2018 at 11:30 A.M. in Operating Room # 14 Plastic Surgery resident (ID#77) clipping "shaving" patient (ID#1) in preparation for surgery. Wearing non sterile gloves he was observed wiping excess hair form the patient. He then proceeded to put on and adjust his headlight, check his cellular phone and then folded his arms placing hands in axilla area wearing the same gloves used providing direct patient care.


Interview with interim director of surgical services (ID#64) on 2/20/2018 at 11:35 revealed that it is expected that staff remove gloves and perform hand hygiene after direct patient contact.


Record review of facility policy titled Hand Hygiene Procedure & Guidelines dated 5/6/2008 revealed the following information:

Guidelines:

A. Indications for Handwashing

2. Before and after each patient contract

8. After removing gloves and other PPEs.