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Based on observation, interview and record review, the facility failed to ensure physician orders for dialysis treatment were followed for ten (10) of 11 sampled patients. Patients 1, 2, 3, 4, 5, 8, 9, 10 and 11 received hemodialysis treatment with the dialyzer (artificial kidney) the physician did not prescribe. For Patients 9 and 10, there was no documentation why the prescribed blood flow rate (BFR) was not met. Patient 6 had peritoneal dialysis (PD) which did not follow the physician's order.
This deficient practice had the potential for not meeting patient needs during hemodialysis treatment.

Findings:

1. The Admission Face Sheet indicated Patient 8 was admitted to the facility on December 5, 2016, due to swelling. The patient has a diagnosis of acute chronic renal failure.
On December 6, 2016, at 9:30 a.m., during observation of initiation of dialysis with central venous catheter, Patient 8 was observed lying in bed with central venous catheter (CVC) in place on his left chest. The patient was on a Revaclear dialyzer, with 3 potassium (K) and 2.5 calcium (Ca) bath.
Review of the Acute Hemodialysis Flow Sheet dated December 6, 2016 indicated the patient was using a Revaclear dialyzer. Hemodialysis is a procedure for removing metabolic waste products or toxic substances from the bloodstream by dialysis. Dialysis is an artificial process of eliminating waste and unwanted water from the blood.

A review of the physician order dated December 6, 2016 indicated to use F160 NR dialyzer type.

2(a). The Admission Face Sheet indicated Patient 9 was admitted to the facility on August 25, 2016, due to gangrene of the right foot.
Review of the Acute Hemodialysis Flow Sheet dated August 27, 2016 indicated the patient was using a Revaclear dialyzer.
A review of the physician order dated August 26, 2016 indicated to use F160 NR dialyzer type.
(b). Review of the Acute Hemodialysis Flow Sheet dated August 28, 2016 indicated the patient was using a Revaclear dialyzer and BFR of 350 ml/min.
A review of the physician order dated August 28, 2016 indicated to use F160 NR dialyzer type and BFR of 400 ml/min. BFR represents the speed that the patient's blood is moving through the dialysis tubing.
There was no documentation to indicate why the physician order for F160 NR dialyzer type was not provided during treatment and the rationale why the ordered BFR was not met.
(c). Review of the Acute Hemodialysis Flow Sheet dated August 30, 2016 indicated the patient was using a Revaclear dialyzer and BFR of 350 ml/min.
A review of the physician order dated August 30, 2016 indicated to use F160 NR dialyzer type and BFR of 400 ml/min.
There was no documentation to indicate why the physician order for F160 NR dialyzer type was not provided during treatment and the rationale why the ordered BFR was not met.
(d). Review of the Acute Hemodialysis Flow Sheet dated September 1, 2016 indicated the patient was using a Revaclear dialyzer.
A review of the physician order dated September 1, 2016 indicated to use F160 NR dialyzer type.
(e). Review of the Acute Hemodialysis Flow Sheet dated September 3, 2016 indicated the patient was using a Revaclear dialyzer and BFR was 300 ml/min.
A review of the physician order dated September 3, 2016 indicated to use F160 NR dialyzer type and BFR of 400 ml/min.
There was no documentation to indicate why the physician order for F160 NR dialyzer type was not provided during treatment and the rationale why the ordered BFR was not met.
(f). Review of the Acute Hemodialysis Flow Sheet dated September 6, 2016 indicated the patient was using a Revaclear dialyzer and BFR was 350 ml/min.
A review of the physician order dated September 6, 2016 indicated to use F160 NR dialyzer type and BFR of 400 ml/min.
There was no documentation to indicate why the physician order for F160 NR dialyzer type was not provided during treatment and the rationale why the ordered BFR was not met.

3(a). The Admission Face Sheet indicated Patient 10 was admitted to the facility on May 28, 2016, due to severe anemia, renal failure and bradycardia.
Review of the Acute Hemodilaysis Flow Sheet dated May 28, 2016 indicated the patient used Revaclear type dialyzer and blood flow rate (BFR) of 300 ml/min.
A review of the physician order dated May 28, 2016 indicated to use F160 NR type of dialyzer and BFR was 400 ml/min.
There was no documentation to indicate why the physician order for F160 NR dialyzer type was not provided during treatment and the rationale why the ordered BFR was not met
(b). Review of the Acute Hemodilaysis Flow Sheet dated May 31, 2016 indicated the patient used a Revaclear type dialyzer.
A review of the physician order dated May 31, 2016 indicated to use F160 NR dialyzer type during treatment.
(c). Review of the Acute Hemodialysis Flow Sheet dated June 2, 2016 indicated the patient used a Revaclear type dialyzer and blood flow rate (BFR) was 380 ml/min.
A review of the physician order dated June 2, 2016 indicated to use F160 NR dialyzer type during treatment and BFR of 400 ml/min.
There was no documentation to indicate why the physician order for F160 NR dialyzer type was not provided during treatment and the rationale why the ordered BFR was not met.

4(a). The Admission Face Sheet indicated Patient 11 was admitted to the facility on July 23, 2016, with diagnoses of weakness and status post fall.
Review of the Acute Hemodialysis Flow Sheet dated July 25, 2016 indicated the patient used a Revaclear dialyzer during treatment.
A review of the physician order dated July 24, 2016 indicated to use F160 NR dialyzer type.




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5. During a medical record review on 12/6/16 at 3:40 p.m. Patient #1 Hemodialysis order dated 9/15/16 at 6:40 p.m. indicated to use Dialyzer F160NR and on the acute hemodialysis flow sheet dated 09/16/16 the dialyzer used is documented as Revaclear. There was no documentation of communication with the physician to change the dialyzer.

6. During a medical record review on 12/6/16 at 3:15 p.m. Patient #2 Hemodialysis order dated 7/27/16 at11:23 a.m. indicated to use Dialyzer F160NR and on the acute hemodialysis flow sheet dated 07/27/16 the dialyzer used was documented as Revaclear. There was no documentation of communication with the physician to change the dialyzer.

7. During a medical record review on 12/6/16 at 3:30 p.m. Patient #3 Hemodialysis order dated 11/11/16 at 12:21 p.m. indicated to use Dialyzer F160NR and on the acute hemodialysis flow sheet dated 11/11/16 the dialyzer used was documented as Revaclear. There was no documentation of communication with the physician to change the dialyzer.

8. During a medical record review on 12/6/16 at 4:15 p.m. Patient #6 Peritoneal Dialysis order dated 2/6/16 indicated "P.D. order DaVita cycles fill 2000 cc 1.5% P.D. fluid 9 hours/Day Total 8000 cc/Day 4 exchanges. The Peritoneal Dialysis Order dated 2/14/16 indicated "same orders" and recapped the Peritoneal Dialysis orders from 2/6/16... On 2/16/16 Peritoneal Dialysis Order indicated "Daily Peritoneal Dialysis DaVita No change in orders". No recap orders were included.

A review of Patient #6 medical record dated 2/17/16 titled, "Acute Peritoneal Dialysis Treatment Record" did not document exchanges. On 2/19/16 "Acute Peritoneal Dialysis Treatment Record" did not document exchanges. On 2/23/16 "Acute Peritoneal Dialysis Treatment Record " indicated the Dianeal was 2.5% dextrose, did not document exchanges. On 2/24/16 "Acute Peritoneal Dialysis Treatment Record" indicated the Dianeal was 2.5% dextrose. There was no documentation of communication with the physician to change the number of cycles on 2/17/16 or 2/19/16. There was no documentation of the physician changing the Dextrose from 1.5% to 2.5% on 2/23/26 and 2/24/26.

(Peritoneal dialysis (PD) (a treatment for patients with severe chronic kidney disease - the process uses the patient's peritoneum [a continuous thin sheet of tissue, or membrane, which lines the cavities of the abdomen and pelvis, and covers the surfaces of the organs found within] in the abdomen as a membrane across which fluids and dissolved substances are exchanged from the blood).

During an interview with RN#1 at 4:30 p.m. she indicated the computer did not have Revaclear in the computer as an option to pick when placing the order. RN#1 was asked to show if there were any new orders or communications changing the peritoneal dialysis orders for Patient #6 on 2/17; 2/19; 2/23 or 2/24. She indicated there were no Peritoneal order changes. When asked if a physician order stating "same order" is acceptable RN#1 indicated it was not acceptable and is no longer an acceptable practice with physician orders.

The facility policy and procedure titled, "General Verbal and Telephone Orders" dated 5/2016 indicated "when a verbal or telephone order is accepted the recipient will write down and read back the order to confirm the accuracy of the communication "



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9. A record review of the "Facesheet" for Patient 4 indicated that for the service date of September 2, 2016 he was diagnosed with severe anemia, acute renal failure, and leg edema. There was a subsequent order to dialyze the patient on September 4, 2016. The orders included the use of the F160NR dialyzer.

A record review of the "Acute Hemodialysis Flow Sheet" for the service performed on September 4, 2016 for Patient 4 indicated that the procedure had to be rescheduled for the following day due to malfunction of the fistula for hemodialysis. The procedure was restarted on September 5, 2016. A record review of the "Acute Hemodialysis Flow Sheet" for this day indicated that the Revaclear dialyzer was used during dialysis.

10. A record review of the "Facesheet" for Patient 5 indicated that for the service date of July 1, 2016 she was diagnosed with intractable leg pain. History and physical of the patient revealed a history of shortness of breath, kidney disease, hypertension, and ESRD (End Stage Renal Disease - medical condition in which the kidneys cease to function properly). There was a subsequent order to dialyze the patient on July 1, 2016. The orders included the use of F160NR dialyzer.

A record review of the "Acute Hemodialysis Flow Sheet" for the service performed on July 1, 2016 for Patient 5 indicated that the Revaclear dialyzer was used during dialysis.

During an interview with the Dialysis RN on December 6, 2016, she stated that she just uses the dialyzer that is available in the store room and checks for the expiration date on it before use.

Based on observation, interview and record review, the facility failed to monitor the temperature and humidity of the dialysis storage room to ensure that dialysis medication and reagents were stored under proper conditions in a sanitary environment to maintain the medications integrity, stability and effectiveness.

Findings:

a. During tour of the Facility dialysis storage room on 12/1/16 at 10:20 a.m. the following were observed:
1. Revaclear Dialysate;
2. Dianeal Low calcium Peritoneal Dialysis solution with Dextrose (4.25%)
3. Dianeal Low calcium Peritoneal Dialysis solution with Dextrose (2.5%)
4. Dianeal Low calcium Peritoneal Dialysis solution with Dextrose (1.5%);
5. Naturalyte acid concentrate (2K+/2.5CA++);
6. Naturalyte acid concentrates (2K+/0CA++)
7. CentisolLiquid bicarbonate concentrate
8. Potassium Chloride 11.5 gms (additives)
9. Calcium Chloride 5.7 gms (additives)
10. Conductivity Standard solution
11. RCP E-2 check PH strips
12. RCP E -2check residual Chloride test strips
13. RCP E-2 Ultra low total Chloride test strips
14. Pure Bright germicidal Bleach
15. Vinegar
16. Lunch Pail
17. Jacket
b. At 10:30 a.m., during tour of the dialysis room a lunch pail with food including; soup, banana, mandarin and a jacket were observed on a shelf with the sterile supplies in the Dialysis storage room.
c. At 10:45 am, on 12/1/16, when asked for the temperature and humidity daily log for the Dialysis storage room, Supervisor#1 indicated he did not have a daily temperature and humidity log of the dialysis storage room. There was no documentation available for the temperature and humidity the above mentioned dialysis medication and reagents were stored and maintained in a safe and sanitary manner.
A review of the facility policy and procedure dated 5/2016 titled, "Pacific Alliance Medical Center Storage: General Pharmacy" indicated "Drugs and devices shall be stored to ensure their integrity, stability and effectiveness" and "Drugs shall be stored under the proper conditions of sanitation, temperature, light, moisture, ventilation ... " and " Storage temperatures shall be maintained based on US Pharmacopeia (USP)requirements: Controlled room temperature 15 degrees Centigrade (C) to 30 degrees C, 59 degrees Fahrenheit (F) to 86 degrees F.

Based on observation, interview and record review, the facility failed to:
1. Disinfect the exit site prior to initiating hemodialysis treatment and to use single alcohol swab stick on each ports (arterial and venous) when disinfecting access ports prior to initiating hemodialysis treatment. This deficient practice placed patients at risk for infection.
2. Store properly the bottles of Pure Bright Germicide Ultra Bleach in order not to loose its potency.
3. Develop measure for Hepatitis B status evaluation of the medical staff treating patients undergoing hemodialysis treatment.
4. Provide supplies whose expiration date had not passed since the date of inspection. This practice had the potential to increase the risk for patient infection.

Findings:

1. The Admission Face Sheet indicated Patient 8 was admitted to the facility on December 5, 2016, due to swelling. The patient has a diagnosis of acute chronic renal failure.
On December 6, 2016, at 9:30 a.m., during observation of initiation of dialysis with central venous catheter, Patient 8 was observed lying in bed with central venous catheter (CVC) in place on his left chest.
Dialysis RN gathered her supplies and equipment to start disinfection/ cleaning of the access site. With glove hands, she removed the soiled dressing on the catheter ports and discarded the soiled dressing. Dialysis RN changed to a new pair of glove, picked up the packet of alcohol swab that contained 3 individual swab sticks; cleaned the cap of the arterial port, proceeded to clean the venous port using the same swab stick. The process was repeated twice and then she hooked up the patient to the hemodialysis machine and started the dialysis.
During an interview with Dialysis RN, at the time of observation, she stated the exit site was not cleaned prior to hemodialysis treatment because the dressing on the exit site was a Biopatch dressing (a transparent dressing) which is changed every 7 days thereafter or PRN (as needed). She also stated that she should have not re-used the same alcohol swab for one port to the other.
A review of the contracted dialysis agency policy #7-04-02B titled, "Central Venous Catheter (CVC ) Care with Use of An Antimicrobial Patch Procedure" indicated for the exit site, holding catheter with the non-dominant hand and using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/ 70% Isopropyl Alcohol swab for a minimum of 30 second apply to the CVC exit site in a "back and forth" pattern, using gentle friction using both sides of the swab. Then wait 60 seconds for air dry. For the CVC limbs and caps (ports) with alcohol prep pads large enough to cover the circumference of the catheter, per limb for 60 seconds (15 seconds per pad(s).

2. During the tour of the Dialysis storage area on December 1, 2016, at 11 a.m., there were five (5) bottles of Pure Bright Germicide Ultra Beach which was opened on November 23, 2016. Upon closer observation, the bottle caps were not tightly closed which leave room for the vapors to be released.
According the Safety Data Sheet for the said product indicated under Handling and Storage Conditions to keep containers tightly closed in a dry, cool and well-ventilated place.


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3. During a review of the medical staff credentialing files Six out of six reviewed medical staff did not have Hepatitis B status or waiver on file.
Medical staff#1;Medical staff#2; Medical Staff#3; Medical Staff #4; Medical Staff#5; Medical Staff #6 did not have Hepatitis B status or waiver on file.
During an interview with the Medical Staff credential supervisor, she indicated MD#4 was in charge of reviewing the Medical staff health file. When asked for medical staff evaluation for Hepatitis B status evaluation she indicated, the facility currently did not have a policy for Hepatitis B status screening and evaluation for the medical staff.


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4. During an inspection of the storage room at the facility on December 1, 2016 at 10:03 a.m., there was a cart with several drawers containing supplies for routine use during hemodialysis (medical procedure to mechanically remove fluid and waste products from the blood and to correct electrolyte imbalance, i.e., salts such as with potassium and sodium). The top drawer which was marked "15 Gauge Fistula Needles" contained 8 fistula needles (used to connect blood lines to the blood vessel through a needle when hemodialysis is carried out through a fistula. A fistula is an internal bridge between a vein and artery usually surgically created in the lower arm). All of the needles were marked with an expiration date of November 2016.

During an interview with the Quality Professional Services Executive Director at this time, she stated that the fistula needles were probably left there because the facility never used that particular one. She stated she would have them removed from the store room at once. She stated that the store room was maintained and stocked wholly by an outside service.