HospitalInspections.org

Based on interviews, record review and policy review the facility:

-failed to follow its internal policy regarding administration of blood and blood products;
-failed to ensure only registered nursing staff administered blood products;
-failed to document the date, time and correct amount of blood product patients received; and
-failed to ensure staff administering blood completed competencies related to blood administration (A-0-409).

These failures have the potential to affect any patient admitted to the facility who receives blood or blood components. The hospital census was 27 at the St. Anthony's location and 36 at the Lindell location.

The severity and cumulative effect of these systemic practices resulted in the facility being out of compliance with 42 CFR 482.23 - Condition of Participation: Nursing Services.



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Based on observation, facility policy review, and interviews the facility:

- failed to implement infection control policies and procedures to prevent the risk of transmission of infections for patients;
- failed to prevent the potential for transmission of infections and communicable diseases from patients to facility staff and, then, potentially to others at the St. Anthony's campus; and
- failed to implement infection control policies in regard to visitors to patients at the Lindell campus.

See the deficiency at A-0749.

The result of failures to consistently implement infection control practices on both campuses is that any infectious microorganism could potentially be transmitted throughout the campus to all patients, staff, and visitors.

The potential severity and cumulative effect of these systemic practices resulted in the facility being out of compliance with 42 CFR 482.42 - Condition of Participation: Infection Control.

Based on observation, medical record review, facility policy review and interviews, the facility staff failed to follow hospital policy regarding:

- consistent documentation of pressure sores;
- notification of the wound care nurse of patient skin breakdown;
- implementation of physician orders for one current patient (Patient #L-25) at the Lindell campus, a standard of practice; and
- failed to obtain a physician order for treatment of a pressure sore on admission for one current patient at the Lindell campus (Patient #L-15) of three patients reviewed with pressure sores at both the Lindell and St. Anthony campuses.

The census at the Lindell campus was 36 patients and 27 patients at the St. Anthony's campus.

Findings included:

1. Facility policy titled "Wound Assessment and Classification", policy number H-WC 09-001, revision date 11/2009, states in part the following:
- "All wounds will be assessed upon admission or occurrence. A wound Care Status Report form H-WC-900-009, modeled after the Bates-Jenson Wound Assessment Tool, will be completed on all patients admitted with wounds, weekly, change in wound status, new wounds and at discharge.
- Initial goals should be set by the admitting nurse or Wound Care Coordinator/designee within 48 hours of admission.
- The Wound Care Coordinator/designee [will] assess every new admission with wounds within 72 hours of admission.
- Wounds will be reassessed weekly (at some point during each week, but not to imply every seventh day i.e. before or on the seventh day but not after), with each dressing change and with any significant change.
- Weekly assessments will be conducted by the Wound Care Coordinator/designee. Assessments will include the following: etiology, location of the wound, centimeter measurements of wound length, width, depth, tunneling and undermining, depth/stage, edges, necrotic tissue type/amount, surrounding skin, peripheral tissue edema/induration, granulation tissue.
- Wound assessment and documentation with each dressing change will include: wound etiology, location, exudates type/amount, odor, periwound skin appearance, wound bed tissue type documented in percentages of each type to equal 100%".

2. Facility policy titled "Initial Wound Treatment", policy number H-WC 03-002, revision date 11/2009, states in part the following:
- To provide the staff with a protocol for initial wound care on newly admitted patients and those developing new wounds and the Wound Care Coordinator is unavailable to see the patient. All newly admitted patients will be referred to the Wound Care Coordinator for further evaluation and treatment orders.
- Remove all dressings from wound(s), cleanse with normal saline, photograph and measure per photographing wound(s) guidelines.
- Notify Wound Care Coordinator of all new admissions and newly discovered wounds".

3. Observation of Patient #L-15 on 01/28/10 at 10:10 a.m. showed the patient with a small open area, a pressure sore, on the left buttock and a pink area on the left upper thigh.

Review of Patient #L-15's medical record on 01/28/10 at 2:00 p.m. showed the following:
- Patient L #15 was admitted to the facility on 12/24/09.
- The physician history and physical dated 12/24/09 stated the reason for admission for this patient included ventilator management, medical management, and wound management.
- The nursing admission assessment dated 12/24/09 stated the patient has a Stage II pressure ulcer (partial thickness skin loss involving epidermis) on the left buttock measuring 2 centimeters (cm.) X 3cm.
- There are no photographs of the wound in the medical record.

The Flowsheet Wound Daily Assessments for the left buttock show the following:
- 12/25/09 at 8:00 p.m. stated the dressing is intact.
- 12/26/09 there is no documentation regarding the wound.
- 12/27/09 there is no documentation regarding the wound.
- 12/28/09 at 9:00 a.m. stated the dressing is intact.
- 12/29/09 at 8:00 a.m. stated there is no dressing and described the area as pale red/pink.
- 12/29/09 at 11:37 p.m. stated the dressing is intact.
- 12/30/09 there is no documentation regarding the wound.
- 12/31/09 there is no documentation regarding the wound.
- 01/04/10 at 10:28 p.m. stated there is no cover dressing.
- 01/05/10 at 9:10 a.m. stated no cover dressing and described the area as pale red/pink.
- 01/06/10 at 8:29 a.m. stated no cover dressing and described the area as pale red/pink.
- 01/09/10 at 11:00 p.m. stated the dressing is intact.
- 01/10/10 there is no documentation regarding the wound.
- 01/11/10 there is no documentation regarding the wound.
- 01/12/10 there is no documentation regarding the wound.
- 01/13/10 there is no documentation regarding the wound.
- 01/14/10 there is no documentation regarding the wound.
- 01/15/10 there is no documentation regarding the wound.
- 01/16/10 there is no documentation regarding the wound.
- 01/17/10 at 8:00 a.m. stated no cover dressing with wound bed red/granulating 90%.
- 01/18/10 at 10:14 a.m. stated dressing is intact.
- 01/18/10 at 8:00 p.m. stated mepilex dressing was applied to prevent further breakdown and stoma powder was used in the folds for protection; will continue to monitor.
- 01/19/10 stated the dressing is intact.
- 01/20/10 there is no documentation regarding the wound.
- 01/21/10 there is no documentation regarding the wound.
- 01/22/10 there is no documentation regarding the wound.
- 01/23/10 stated the dressing is intact.
- 01/24/10 there is no documentation regarding the wound.
- 01/25/10 at 8:00 p.m. stated the dressing is intact.
- 01/26/10 at 12:00 p.m. stated dressing changed, wound bed pink 100%.
- 01/26/10 at 9:00 p.m. stated the dressing is intact.

Although the patient was admitted on 12/24/09 with a wound/pressure sore, there was no physician order for wound care until 01/14/10 at 6:00 p.m.for Xenaderm to entire buttock and left hip area three times daily until healed. This was 21 days after the patient's admission.

There is a physician telephone order dated 01/15/10 for a wound care consult. However, there was no wound care consult found in the medical record.

Staff I, Quality Assurance, on 01/28/10 at 2:00 p.m. verified the above findings.

Staff F, Registered Nurse, Day Shift Nursing Supervisor said on 01/28/10 at 2:00 p.m.during a telephone interview that he/she noticed on or around 01/15/10 that Patient #L-15's buttocks were excoriated and had redness under the breasts and in abdominal folds. He/she thought the wound care nurse had seen the patient, but could not find the consult or an order for treatments. He/she got an order at that time for these areas and an order for a wound care consult.

4. The facility policy titled "Overdue Orders and Active Unscheduled Orders Reports", policy number H-PC 06-015, last revised 01/2007 states in part the following:
- "Purpose. To collect data to monitor the compliance of patient documentation.
- To provide a tool to facilitate clinical managers in assuring compliance with patient documentation requirements.
- Definitions. Overdue order report: A report that includes all overdue scheduled tasks that have not been charted against in Pro Touch (Electronic Medical Record). This report includes a summary and then detailed information. Lab orders will only display on this report of they have not been charted as collected.
- Use of Reports. Each clinical shift leader (Nursing Supervisor) will print the Overdue Orders and Active, Unscheduled Orders reports prior to shift change and distribute to staff as necessary to communicate orders that need to be documented".

5. On 01/28/10 at 1:50 p.m. at the St. Louis campus, staff U, physician, asked nursing staff why current Patient #L-25's laboratory orders had not been completed. He/she said the patient had been admitted the evening before at 8:00 p.m. and the test results were not available.

Review of current Patient #L-25's medical record on 01/28/10 at 2:00 p.m. showed physician orders dated 01/27/10 at 8:00 p.m. which the following admission laboratory tests had been ordered:
- CBC (complete blood count), CMP (comprehensive metabolic panel), TSH (thyroid stimulating hormone), PT/PTT (Prothrombin time and partial thromboplastin time), UA (urinalysis), ABGs (arterial blood gases), and Pre-Albumin.

On 01/28/10 at 3:30 p.m. during an interview with staff FF, Registered Nurse (RN), nursing supervisor 3rd Floor, said that the tests had not been done last night, and should have been done. Blood is drawn by nursing staff and sent to the laboratory when ordered.

During an interview on 01/29/10 at 2:00 p.m. staff I, Quality Director, said it is set practice for nursing to check the charts for orders. At the end of each shift, nursing staff are to run a report which would show overdue orders. This is done to catch these orders so the next shift can implement them.

Based on observation, facility policy review, record review, and interviews, the facility:

- failed to ensure medications were administered as ordered by the physician for one (Patient #SA-5) of 9 patients observed during medication administration; and
- failed to follow hospital policy with regard to administering medication per gastric tube (G-Tube, also referred to as PEG tube), a percutaneous endoscopic gastrostomy tube surgically placed into a patient's stomach via the abdomen used for feeding and administration of fluids and medications) for one (Patient #SA-5) of two patients observed receiving medications via PEG.

The census at the Lindell campus was 36 patients and 27 patients at the St. Anthony's campus.

Findings included:
1. Review of the facility policy titled, "Review of Medication Orders," effective date 01/07, last revised 11/09, showed the following (in part):

- All medication orders will be reviewed by a licensed pharmacist prior to dispensing and administering the medication:
o Appropriateness of the drug, dose, frequency, and route of administration
o Real or potential interactions between the prescription and other medications, food, and laboratory values

- When a medication order is received in the Pharmacy and clarification or verification is needed, the pharmacist is responsible for:
o Contacting the prescribing practitioner
o Informing the nurse that a clarification is needed and that the medication will not be dispensed until the prescriber is contacted
o Resolving the problem relating to the medication order

2. Review of the facility policy titled, "Administration of Medications," effective date 01/07, last revised 11/09, showed the following (in part):

Cited from page 1 "Administration"

- All medications must be properly stored/secured at all times prior to administration. Prepared medications must never be left unattended

Cited from page 3 "General Guidelines for Administration of Medication"

- The Pharmacist will check all new medication orders for possible drug allergy drug/drug and food/drug interactions

- The healthcare professional administering the medication, in collaboration with the pharmacist, second nurse (if after-hours) and review of the medical record will verify that there are no contraindications for administering the medication

Cited from page 7 "Medications via Feeding Tube"

- Discontinue feeding product by turning off pump, clamping tube and if necessary disconnecting from feeding

- Check placement and patency of feeding tube. Follow MD [medical doctor - a physician] and/or facility guidelines specific to residuals

- Unclamp tubing or restart feeding

3. Observation during medication administration to Patient #SA-5 on 01/29/10 at approximately 9:10 a.m showed:

- Staff EE temporarily disconnected the patient's gastric tube feeding and administered all crushed medications through the tube without checking for correct tube placement or flushing the tube prior to administration of the medications

Review of the medical record for current Patient #SA-5 showed:

- Physician order dated 1/25/10 at 10:30 a.m. for Seroquel (antipsychotic) 50 mg (milligrams) PO (by mouth) at bedtime

- Physician order written 01/24/10 at 5:50 p.m. to decrease Dilantin (phenytoin, a seizure medication) to 300 mg (milligrams) per GT (gastric tube) BID (twice daily)

- Patient was NPO (nothing per mouth) since admission to the facility on 01/20/10

However, review of the Medication Administration Records (MARs) for current Patient #SA-5 dated 1/25/10 through 01/28/10 showed:

- The Seroquel was listed to be given PO at bedtime each night and documented as given

- Dilantin was transcribed onto the MAR with instructions to give PO (by mouth)

During interview on 01/29/10 at approximately 8:45 a.m., staff EE stated, "The meds are always crushed and given through the G-tube. I don't know why the orders weren't changed."

During interview with staff D, Infection Control Officer and staff DD, Nursing Unit Manager, on 01/29/10 at approximately 10:00 a.m., both agreed that:

- Nursing should have communicated with pharmacy and/or could have notified the physician regarding the discrepancy with the physician orders and the MAR

- A gastric tube the tube should be flushed with water prior to administering medications

Based on policy review, record review, and interviews, the facility:

- failed to follow its internal policy regarding administration of blood and blood products;
- failed to ensure only registered nursing staff administered blood products;
- failed to document the date, time and correct amount of blood product patients received;
and
- failed to ensure one staff (staff K) administering blood completed competencies related to blood administration for fifteen patients (#L-12, #L-13, #L-14, #L-16, #L-17, #L-19,# L-20, #L-21, #L-22, #L-23, #L-24, #SA-8, #SA-9, #SA-13, and #SA-14) out of twenty-five current records and one discharged record (#L-18) sampled (L=Lindell and SA-St. Anthony's campus locations). The hospital census was 36 at the Lindell location and 27 at the St. Anthony's location.

Findings included:

Practice Guidelines for Blood Transfusion, published by the American Red Cross, Second Addition, dated April 2007 states in the APPENDIX: SIDE EFFECTS AND HAZARDS OF BLOOD TRANSFUSION on page 47:

-Circulatory overload, leading to pulmonary edema, can occur after transfusion of excessive volumes or at excessively rapid rates. This is a particular risk in the elderly and in patients with chronic severe anemia in whom low red cell mass is associated with high plasma volume. Small transfusion volumes can precipitate symptoms in at-risk patients who already have a positive fluid balance.
-Bacterial contamination occurs rarely but can cause acute, severe, sometimes life-threatening effects. Onset of high fever (?2 C or ?3.5 F rise in temperature), severe chills, hypotension, or circulatory collapse during or immediately after transfusion should suggest the possibility of bacterial contamination and/or endotoxin (toxins associated with certain bacteria) reaction. Platelet components stored at room temperature ... ... .... have been implicated.

Review of the report published by the College of American Pathologist, dated as published June 1, 2006, states the following in part:
.....Approximately 10-12 patients are thought to die annually in the US from bacterially contaminated red cell units. Annual deaths from bacterially contaminated platelets is likely even higher. The room temperature storage of platelets provides ideal growth opportunities for bacteria; refrigerated red cell unit storage supports bacterial growth less well .....
Lindell Location:

1. The Kindred-Lindell location provides renal dialysis services by the hospital-employed staff and the Kindred-St. Anthony's location provides dialysis services through a provider contracted for that service.

Renal dialysis is the process by which a patient's blood is removed, processed through a machine where unwanted blood components are removed, then returned to the patient.

2. Review of the Lindell facility policy titled "Blood Administration", Policy Code # 4.005-N-STA, undated, showed the policy directed staff to do the following:

The purpose of the policy indicated it is...To provide for safe, therapeutic administration of blood and blood components, including leuko-filtered cells, washed red blood cells, fresh frozen plasma, platelets, cryoprecipate [a frozen blood product prepared from blood plasma], Plasmanate [a product has been prepared from large pools of human plasma], and albumin [which is the most abundant plasma protein in humans and other mammals] at KH [Kindred Hospital] St. Louis (Lindell).
The policy states in part that it is "Performed by RN [registered nurse] or LPN [licensed practical nurse] unless designated as RN only."
The procedure states in part, "Administration...After obtaining blood products from lab, Transfusion must begin within 30 minutes or products returned to blood bank. Blood may hang no longer than four (4) hours. Any blood remaining after four hours must be discarded.
The policy direct staff to document in part the following items...Amount infused, and Time and date....

The facility's internal blood administration policy does not include instructions to staff, including employed dialysis staff, related to any time constraints for rapid infusion of blood.

The facility's internal blood administration policy does not include instructions to staff, including employed dialysis staff, related to diluting and/or adding any additional solution(s) to the blood products delivered by the blood bank for infusion.

2. Medical record review for current patient #L-12, with an unknown admission date and diagnosis, showed:
? Blood product identified as unit #W33350900079-2, administered on 01/19/10. There is no signature of the nursing staff designated as the transfusionist.
? Blood product identified as unit #W333509001244-1, administered on 01/19/10. There is no signature of the nursing staff designated as the transfusionist.

3. Medical record review for current patient #L-13, admitted on 12/17/09 with a diagnosis of Acute Respiratory Failure, showed:
? Blood product identified as unit #W333609002246-O administered on 01/16/10 beginning at 10:00 A.M. The completion time is documented as 01/16/10 at 1:00 P.M. The blood bank documentation showed the volume to be 250 released from the blood bank. However, the nursing documentation showed the total volume transfused as 300 milli-liters (ml).
? Blood product identified as unit #W38309119927-Y administered on 01/16/10 beginning at 3:10 P.M. The completion time is documented as 01/16/10 at 6:00 P.M. Although the blood bank documentation showed the volume to be 250 released from the blood bank, the nursing documentation showed the total volume transfused as 304 ml.

4. Medical record review for current patient #L-14, admitted on 12/29/09, with a diagnosis of Acute Respiratory Failure, showed:
? Blood product identified as unit #W333609005005-A administered on 01/19/10 beginning at an unknown time. The completion time is documented as 01/20/10 at 00:50 A.M. Without a beginning and completion time, it is not possible to determine the length of time taken to infuse the blood product. Additionally the blood bank documentation showed the volume to be 250 released from the blood bank, but the nursing documentation showed the total volume transfused as 380 ml.
? Blood product identified as unit #W333609000656-K administered on 01/20/10 beginning at 06:25 A.M. The completion time is documented as 01/20/10 at 12:30 P.M. This showed the blood to be left hanging six hours and five minutes. Also, the amount transfused is blank.

When interviewed on 01/19/10, Staff K said when patient #14's blood product unit #W333609000656-K was hung by the night shift, patient #14's intravenous access (small needle access into the vein) was not working properly and need to be restarted. Staff K said the night shift nurse restarted the intravenous access. Staff K did not know how long the blood hung until it was started on the patient. Staff K said that he/she is newly hired, but has completed orientation. Staff K does not think orientation included blood administration.

Registered nurse educator (at both locations), staff R, provided a copy of the document titled "Initiating Blood Transfusion, Competency/Demonstration Record" and said staff K has not completed this competency. Staff R said staff K has ninety days to complete. Review of the personnel file for registered nurse staff K showed he/she has been at the facility since 12/07/09.

During an interview on 1/27/10 at 1:30 P.M. registered nurse (Lindell) staff K confirmed he/she was the transfusionist for patient #L-14. Staff K review a copy of the blood transfusion policy and said he/she was not really familiar with the content. Staff K said he/she thinks the blood administration was completed at 11:15 A.M. and not at 12:30 P.M. as documented on the Blood Transfusion Administration form.

5. Medical record review for current patient #L-16, admitted on 12/23/09 with a diagnosis of Large Abdominal Wound, showed:
? Blood product identified as unit #W333409002907-7 administered on 01/10/10 beginning at 06:20 A.M. The completion time is documented as 01/10/10 at 10:20 A.M. There is no signature of the nursing staff designated as the transfusionist.
? Blood product identified as unit #W333409002906-9 administered beginning on an unknown date and time. The completion time is documented as 01/10/10 at 06:00 A.M. The blood bank documentation showed the volume to be 250 released from the blood bank. However, the nursing documentation showed the total volume transfused as 373 ml.

6. Medical record review for current patient #L-17, admitted on 01/20/10 with a diagnosis of Respiratory Failure and Acute Renal Failure, showed:
? Blood product identified as unit #W38309084975-C, administered on 01/9/10. There is no signature of the nursing staff designated as the transfusionist.

7. Medical record review for current patient #L-19, admitted on 12/29/09, with a diagnosis of Decubitus Ulcer, showed:
? Blood product identified as unit #W333509000105-2, administered on 01/05/10. The blood bank documentation showed the volume to be 250 released from the blood bank. However, the nursing documentation showed the total volume transfused as 448 ml. There is no signature of the nursing staff designated as the transfusionist.
? Blood product identified as unit #W333509000073-N, administered on 01/05/10 beginning at an unknown time. The completion time is documented as 01/06/10 at 01:50 A.M. There is no way to determine how long the blood product was left to hang after release from the Blood Bank. The blood bank documentation showed the volume to be 250 released from the blood bank, but the nursing documentation showed the total volume transfused as 329 ml. The signature of the transfusionist showed the blood administered by a licensed practical nurse.

8. Medical record review for current patient #L-20, admitted on 12/24/09, with a diagnosis of Acute Respiratory Failure, showed:
? Blood product identified as unit #W333409000990-H, administered on 01/10/10 beginning at 02:25 A.M. The completion time is documented as 01/10/10 at 06:00 A.M. The blood bank documentation showed the volume to be 250 released from the blood ban, but the nursing documentation showed the total volume transfused as 332 ml. The signature of the transfusionist showed the blood administered by a licensed practical nurse.
? Blood product identified as unit #W333409005960-Z, administered on 01/10/10 beginning at an unknown time. The completion time is documented as 01/10/10 at 21:00 P.M. There is no way to determine how long the blood product was left to hang after release from the Blood Bank.

9. Medical record review for current patient #L-21, admitted on 12/04/09, with a diagnosis of Acute Respiratory Failure, showed:
? Blood product identified as unit #W038309134638-V administered on 01/03/10 beginning at 11:30 A.M. The completion time is documented as 01/03/10 at 03:40 A.M. The blood bank documentation showed the volume to be 250 released from the blood ban, but the nursing documentation showed the total volume transfused as 337 ml.
? Blood product identified as unit #W333509000099-3, administered on 01/09/10 beginning at 11:00 P.M. The completion time is documented as 01/10/10 at an unknown time. There is no way to determine how long the blood product was left to hang after release from the Blood Bank. The blood bank documentation showed the volume to be 250 released from the blood bank. However, the nursing documentation showed the total volume transfused as 359 milli-liters (ml).

10. Medical record review for current patient #L-22, admitted on 11/13/09, with an admitting diagnosis of Acute Respiratory Failure, showed:
? Blood product identified as unit #W333409000625-M administered on 01/11/10 beginning at 12:53 P.M during a dialysis treatment. The blood bank documentation showed the volume to be 250 released from the blood bank, but the nursing documentation showed the total volume transfused as 330 ml.
? Blood product identified as unit #W38309136587-Q administered on 01/11/10 beginning at 1:15 P.M during a dialysis treatment. The completion time is documented as 01/20/10 at 1:30 P.M, a 15-minute period. The blood bank documentation showed the volume to be 250 released from the blood bank, but the nursing documentation showed the total volume transfused as 336 ml.

11. Medical record review for current patient #L-23 showed:
? Blood product identified as unit #W038309108703-3, administered on 01/03/10 beginning at 3:55 P.M. The completion time is documented as 01/03/10 at 6:55 P.M. The blood bank documentation showed the volume to be 250 released from the blood bank, but the nursing documentation showed the total volume transfused as 280 ml.

12. Medical record review for current patient #L-24, admitted on 12/04/09, with a diagnosis of Decubitus Ulcer, showed:
? Blood product identified as unit #W333609008523-T, administered on 01/20/10 beginning at 12:41 P.M during a dialysis treatment. The completion time is documented as 01/20/10 at 12:49 P.M. with a total infusion time of 8 minutes. The blood bank documentation showed the volume to be 250 released from the blood bank. However, the nursing documentation showed the total volume transfused as 430 ml.
? Blood product identified as unit #W333609000796-X, administered on 01/20/10 beginning at 12:58 P.M during a dialysis treatment. The completion time is documented as 01/20/10 at 1:08 P.M. This is a total infusion time of ten minutes. The blood bank documentation showed the volume to be 250 released from the blood ban while the nursing documentation showed the total volume transfused as 430 ml.
This means documents showed patient #L-24 received a total of two units of packed red blood cells in a matter of 18 minutes.

During an interview on 1/29/10 at 08:45 A.M. registered staff dialysis nurse Lindell staff M reviewed patient #L-24's blood Administration Record and confirmed he/she was the transfusionist. Staff M said the facility policy is to infuse blood products in fifteen to thirty minutes. Staff M could not remember any reason why the blood products would have been given so fast. Staff M said he/she received their dialysis training when employed at a prior dialysis company. Staff M reviewed the facility policy manual, but was unable to locate any policy specifying dialysis nursing staff can infuse blood products at a faster time rate. Staff M also reviewed the dialysis contract service policy manual and was unable to locate any policy specifying that dialysis nursing staff can infuse blood products at a faster time rate. Staff M later said the facility is planning on adopting the dialysis contract service policy manual, but had not done so at that time.

13. Medical record review for discharged patient #L-18, admitted with a diagnosis of Acute Respiratory Failure, showed:
? Blood product identified as unit #W333609000319-H administered on 01/08/10. There is no signature of the nursing staff designated as the transfusionist.
? Blood product identified as unit #W333609000286-3 administered on 01/09/10 beginning at 01:20 A.M. The completion time is documented as 01/09/10 at an unknown time. There is no way to determine how long the blood product was left to hang after release from the Blood Bank. While the blood bank documentation showed the volume to be 250 released from the blood bank, the nursing documentation showed the total volume transfused as 300 ml.

14. During a phone interview on 01/29/10 at 10:00 A.M. (Lindell) Medical Doctor (MD) staff DD said he/she is the attending physician for patient #L-24. Staff DD said he/she prefers blood products to be given in a short amount of time during the time patients are receiving their dialysis treatments. However, staff DD did not know just how short that time should be.

However, during a phone interview with 01/29/10 at 10:10 A.M. (Lindell) Nephrologist (a specialist for diseases of the kidneys) Medical Doctor (MD) staff AA said he/she was patient #L-24's specialist. Staff AA said he/she was not aware of the speed the blood was infused to patient #L-24 on 01/20/10 and prefers for patients to receive blood over a one to two-hour period. Staff AA said he/she plans on speaking with the dialysis staff.


St. Anthony's Locations:

15. Review of the St. Anthony's facility policy titled "Blood Administration", Policy Code # 4.005-N-STA, undated, showed the policy directed staff to do the following:

The purpose of the policy indicated it is...To Provide for safe, therapeutic administration of blood and blood components, including leuko-filtered cells, washed red blood cells, fresh frozen plasma, platelets, and cryoprecipate at KH (Kindred Hospital) St. Anthony's.
The policy states in part...Performed by RN [registered nurse]. LPN [licensed practical nurse] may monitor blood/blood products.
The procedure states in part, Administration...All blood products must be infused within 4 hours of issue...[and also] All blood products must be completely infused within 4 hours of being issued.
The policy direct staff to document in part the following items, Amount infused, and Time and date....

The facility's internal blood administration policy does not include instructions to staff, including employed dialysis staff, related to any time constraints for rapid infusion of blood.

The facility's internal blood administration policy does not include instructions to staff, including employed dialysis staff, related to diluting and/or adding any additional solution(s) to the blood products delivered by the blood bank for infusion.

16. Review of the contracted dialysis company policy titled "Administration of Blood and Blood Products", dated as revised September 2009, states in part the following direction to staff: ...Blood is administered during dialysis at a rate of no less that fifteen minutes per unit and not to exceed three hours per unit unless otherwise ordered by the nephrologist.
The facility was unable to provide any evidence of adopting the dialysis contract service's policy and procedure manual as the recognized facility policy.

17. Medical record review for current patient #SA-8, admitted 12/31/09 with a diagnosis of Acute Respiratory Failure showed:
? Blood product identified as unit #11FV61277 administered on 01/13/10 beginning at 4:10 P.M. The completion time is unknown. The signature of the transfusionist showed the blood administered by a licensed practical nurse.

18. Medical record review for current patient #SA-9, admitted 01/08/10 with a diagnosis of Acute Respiratory Failure showed:
? Blood product identified as unit #11KT18479 administered on an unknown date at 01:45 A.M. The completion time is documented as an unknown date at 05:15 A.M.
? Blood product identified as unit #11GC98155 administered on 01/27/10 beginning at 5:33 P.M. The completion time is documented as 5:51 P.M. which means the unit was infused in eighteen minutes, however, there is no documentation the blood was given during a dialysis treatment.

19. Medical record review for current patient #SA-13 admitted 01/08/10 with a diagnosis of Intestinal Obstruction showed:
? Blood product identified as unit #24FV06424 administered on 01/13/10 beginning at 09:00 A.M. The completion time is documented as 09:15 A.M. The unit was infused in fifteen minutes, however, there is no documentation the blood was given during a dialysis treatment.
? Blood product identified as unit #11FT37144 administered on 01/13/10 beginning at 09:17 A.M. The completion time is documented as 09:32 A.M. The unit was infused in fifteen minutes, however, there is no documentation the blood was given during a dialysis treatment.

20. Medical record review for current patient #SA-14, admitted on 12/31/09, with a diagnosis of Acute Respiratory Failure, showed:
? Blood product identified as unit #11KV38517 administered on 01/1/10 beginning at 3:00 P.M.. The completion time is documented as 01/20/10 at 20:45 P.M. This showed the blood to be left hanging six hours and forty-five minutes.

21. During an interview on 01/29/10 at 1:40 P.M. registered dialysis contract nurse, (St. Anthony's) staff DD, said he/she usually always gives blood products in about a fifteen to thirty minute timeframe. The dialysis nurse makes the decision on how fast the blood can be given based on how stable the patient is and what the blood pressure and other vital signs are at the time of dialysis.
During a phone interview on 01/29/10 at 2:10 P.M. (St. Anthony's location) Nephrologist (diseases of the kidneys specialist) Medical Doctor (MD) staff GG said he/she was patient #L-13's specialist. Staff GG said the speed of the infusion of the blood depends on the patient. Staff GG said it could be given fairly quickly in about thirty minutes, but fifteen minutes might be a little too quick. Staff GG said that during his/her training and fellowship, thirty minutes was understood to be a reasonable transfusion administration time.

Based on record review and interview, the facility failed to have consistently and accurately collected data related to blood product usage. The absence of such data prevents hospital staff from analyzing and making improvements regarding blood transfusion reactions, a patient safety issue. The hospital census was 36 at the Lindell location and 27 at the St. Anthony's location.

Findings included:
1. The following is, in part, the recommendation for blood transfusion monitoring from the Practice Guidelines for Blood Transfusion, published by the American Red Cross, Second Addition, dated April 2007 states:
The Transfusion Committee or its equivalent, should document activities by minutes and generate reports of its work for submission to other entities of the hospital (e.g., clinical departments of the Medical Staff, the Medical Staff Executive Committee, the Clinical Practices
Committee, the Credentials Committee). The intent of this reporting is to provide other peer review committees with the results of reviews of transfusion related patient care.

Hospitals are required to review blood transfusion practices and adverse outcomes. Accrediting and regulatory agencies do not specify how this peer review function is accomplished, as long as it is being performed.

2. Review of the Lindell location quality data collected showed the following:
- 11/09-of the five total medical record audits performed, only two audits documented the patient identification information needed to collaborate the accuracy of the data collected.
- 1/10- of the six total medical record audits performed, only five audits documented the patient identification information needed to collaborate the accuracy of the data collected.
During an interview on 01/28/10 at 1:30 P.M. Lindell Quality Nurse Manager, staff I said that the expectation for the staff gathering the data is to identify the patients in order to improve the quality of patient care, and confirmed it would not be possible to correct the problematic areas without confirmation of the specific patient.

3. Review of the St. Anthony's location quality data collected showed the following:
- 10/09-of the eleven total medical record audits performed, only nine audits documented the patient identification information needed to collaborate the accuracy of the data collected.
- 11/09-of the seven total medical record audits performed, only six audits documented the patient identification information needed to collaborate the accuracy of the data collected.
- 12/09-of the ten total medical record audits performed, only seven audits documented the patient identification information needed to collaborate the accuracy of the data collected.

During an interview on 01/29/10 at 12:50 P.M. St. Anthony's Quality Nurse Manager, staff C, said that the Quality Department is not owner of blood product transfusion data. The Quality Department only stores the gathered data. Staff C said the nursing unit managers are responsible for the blood product transfusion data.

During an interview on 01/29/10 at 1:10 P.M. St. Anthony's Registered Nurse Manager staff DD agreed there is a breakdown on the blood audit record review when the patient identifiers are not included, and confirmed it would not be possible to correct the problematic areas without confirmation of the specific patient.

Based on observation, facility policy review and record review, facility staff failed to provide patient safety and reduce risk of a drug reaction with regard to administering medication via percutaneous endoscopic gastrostomy (PEG) tube for one (Patient #SA-5) of two patients observed receiving medications via PEG. The census at the Lindell campus was 36 patients and 27 patients at the St. Anthony's campus.

A PEG tube is a tube surgically placed into a patient's stomach via the abdomen that is used for feeding and administration of fluids and medications.

Findings included:
1. Review of the facility policy titled, "Review of Medication Orders", effective date 01/07, last revised 11/09, showed the following (in part):

- All medication orders will be reviewed by a licensed pharmacist prior to dispensing and administering the medication:
o Appropriateness of the drug, dose, frequency, and route of administration
o Real or potential interactions between the prescription and other medications, food, and laboratory values

- When a medication order is received in the Pharmacy and clarification or verification is needed, the pharmacist is responsible for:
o Contacting the prescribing practitioner
o Informing the nurse that a clarification is needed and that the medication will not be dispensed until the prescriber is contacted
o Resolving the problem relating to the medication order

2. Review of the facility policy titled, "Administration of Medications", effective date 01/07, last revised 11/09, showed the following (in part):

Cited from page 3 "General Guidelines for Administration of Medication"

- The Pharmacist will check all new medication orders for possible drug allergy drug/drug and food/drug interactions

- The healthcare professional administering the medication, in collaboration with the pharmacist, second nurse (if after-hours) and review of the medical record will verify that there are no contraindications for administering the medication

Cited from page 7 "Medications via Feeding Tube"

- Discontinue feeding product by turning off pump, clamping tube and if necessary disconnecting from feeding

- Check placement and patency of feeding tube. Follow MD and/or facility guidelines specific to residuals

- Unclamp tubing or restart feeding

3. Observation 01/29/10 at approximately 8:45 a.m. showed staff EE crushed oral medications to administer simultaneously to Patient #SA-5 per gastric tube. These medications included: Dilantin, Lasix (furosemide, a diuretic which increases urination), and Coumadin (warfarin, an anticoagulant used to prevent blood clots). Patient #SA-5 was receiving Two Cal HN (a tube feeding) continuously at that time.

At approximately 9:10 a.m., staff EE temporarily disconnected the patient's tube feeding and administered medications without checking for tube placement or flushing the tube prior to administration of the medications.

4. Review of the medical record of Patient #SA-5 on 01/29/10 at approximately 9:45 a.m. showed the following (in part):

- A physician order written 01/24/10 at 5:50 p.m. for Dilantin (a seizure medication) 300 mg (milligrams) per gastric tube BID (twice daily).

- An order written 01/21/10 at 8:00 a.m. by the dietitian and co-signed by the physician: "Due to Dilantin, change TF [tube feeding] to Two Cal HN 60 ml [milliliters] per hour. Hold one hour before and after Dilantin given to minimize food and drug interaction."

5. Review of the Physician's Drug Reference showed that when Dilantin is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Among the list of drugs identified for potential interaction are Furosemide and Warfarin. Both medications are received by Patient #SA-5.

6. Review of the Medication Administration Records (MARs) dated 01/24/10 through 01/29/10 for current Patient #SA-5 showed no warning that there was a potential for drug interaction. Nor was there notation for nursing staff to hold tube feeding before and after Dilantin administration.

Based on observation, facility policy review, and interviews the facility:

- failed to implement infection control policies and procedures to prevent the risk of transmission of infections for six patients (Patient St. A-#18, St. A- #16, L- #25, L- #16, L- #5, and L-# 21);
- failed to prevent the potential for transmission of infections and communicable diseases from patients to facility staff and, then, potentially to others at the St. Anthony's campus; and
- failed to implement infection control policies in regard to visitors to patients L-#8, L-#32, L-#10, L-#17, L-#31, and L-#24 at the Lindell campus.
.
The census at the Lindell campus was 36 patients and 27 patients at the St. Anthony's campus. The result of the failure to consistently implement infection control practices on both campuses is that any infectious microorganism could potentially be transmitted throughout the campus to all patients, staff, and visitors.

Findings included:

1. The facility policy titled "Contact Precautions", policy number H-IC02-002, revised 11/2009 states in part under Procedure:
- Don gloves and gown prior to entering a Contact Precautions room.
- Contact precautions are implemented for each individual patient, therefore, change gloves, gowns and perform hand hygiene between patients.
- Remove and dispose of gown and gloves before leaving the patient's room and perform the appropriate form of hand hygiene immediately.
- If use of common equipment is unavoidable, then adequate cleaning and disinfecting is necessary upon removal from the room, before use with other patients".

2. Review of the policy titled "Infection Prevention and Control Practices-Standard Precautions", dated as revised 8/2007, states in part in the procedure: PPE or personal protective equipment will be used for patient care as noted. PPE will be available to all staff in the clinical areas and specialty areas.

The Contact Precautions signage outside the doors of isolated patients instructs the following:
1. Stop
2. Contact Precautions
3. Everyone entering room must:
- Wash Hands with Soap and Water or Alcohol Foam on the Way In and Out of the Room
- Wear Gown and Gloves While you are in the Room
- Remove Gown and Gloves before Leaving the Room

3. Review of the facility policy and procedure titled "Hand Hygiene", effective date of 09/1997, and last revision date 01/2007, showed the following (in part):

- Hand hygiene will be performed "after situations during which microbial contamination of the hands is likely to occur (i.e. contact with potentially contaminated environmental surfaces)."

4. Observation of wound care to Patient St-.A-#18 at the St. Anthony's campus on 01/29/10 at 10:30 a.m. showed a sign stating Contact precautions on the patient's door. However, Staff JJ, pharmacy technician, entered the room without gloves or gown and went to the medication box. The medication box was open with a ledge to place items. Staff JJ placed a plastic bag which contained medications and a set of keys on the ledge and leaned against the ledge, contaminating both his/her clothing, the plastic bag and the keys. Staff JJ then took medications out of the plastic bag and placed in the medication drawer, went through the medications to find Vasolex ointment and placed a new label on the ointment. He/she then picked up the plastic bag and keys and left the room without performing hand hygiene.

Review of the St. Anthony's Infection Control Log on 1/29/10 showed Patient St. A-#18 in contact isolation for Vancomycin Resistant Enterococcus (VRE), a multi-drug resistant organism (MDR).

Staff D, Infection Control Practitioner (ICP), said during an interview on 01/29/10 at 1:14 p.m. that the pharmacy technicians and all staff must follow isolation precautions when entering contact isolation rooms.

5. Observation of medication administration to Patient L- #25 and Patient L-#16 at the Lindell campus on 01/28/10 at 10:55 a.m. showed a sign on the patient's door for Contact isolation precautions.

However, Staff EE, Registered Nurse (RN), entered the room, placed Medication Administration Sheets (MARs) on the sink behind the faucet, washed hands and then applied gown and gloves. Staff EE than took the MARs and placed them on Patient L #25's bedside table, then on the shelf of the medication container and proceeded to administer medications.

Staff FF, RN, entered the room with the narcotic accountability sheet from the medication room and placed it on the shelf of the medication container belonging to Patient #16.
After administration of medications, staff EE removed gown and gloves, performed hand hygiene, and took the MARS and narcotic accountability sheet to the medication room.

When interviewed at this time, Staff FF said that he/she keeps all the MARs "with me for all the patients I am assigned to."

Review of the St. Louis Infection Control Log on 1/29/10 showed Patient L- #16 was positive for Methicillin Resistant Staphylococcus Aureus (MRSA) and VRE and Patient L-#25 was positive for MRSA all are MDR Organisms.

6. Observation of medication administration to Patient St. A- #16 at the St. Anthony's campus on 01/29/10 at 9:15 a.m. showed a Contact isolation precautions sign on the patient's door.

Staff II, RN, gowned and gloved entered the room and placed the MAR on the shelf of the medication container. Following administration of medications staff II removed gown and gloves, performed hand hygiene and took the MAR out of the room and placed it on the Computer on Wheels in the hallway.

Review of the St. Anthony's Infection Control Log on 01/29/10 showed Patient St. A-#16 was positive for MRSA.

7. Staff D, ICP, said during an interview on 01/29/10 at 1:14 p.m. that taking the MARs in and out of the contact isolation rooms is an infection control problem.

In regard to the narcotic sheet taken into a patient room, Staff D said that staff are not to take narcotic sheets into the rooms. The narcotics should be counted and prepared in the medication room prior to administration.




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8. Observation on 01/28/10 at 10:16 a.m. showed RN staff K preparing medications for Patient #L-21 who was in contact isolation. Staff K wore a gown into the room, but no gloves. Staff K placed the medications on the overbed table of Patient #L-5, who was also in contact isolation. Staff K did not perform hand hygiene or put on gloves before picking up the medications previously placed on the overbed table of Patient #L-5 and proceeding to administer the medication to Patient #L-21.

RN staff K then picked up a bottle used earlier that day for catheter irrigation for Patient #L-5, in contact isolation. Staff K wore a gown, but not gloves while handling the potentially contaminated irrigation set. Staff K did not perform hand hygiene after handling the irrigation equipment.


9. Review of the Lindell Infection Control Log dated 01/27/10 showed the following (in part):

- Patient #L-5 in contact isolation for VRE, MRSA and Acinetobacter baumannii - which are bacteria which are resistant and/or susceptible to few antibiotics.
- Patient #L-21 in contact isolation for MRSA and Multi-Drug Resistant Acinetobacter baumannii.

10. Observation of staff EE on 01/29/10 at 8:50 a.m. showed disposal of a used insulin syringe into a sharps container filled past the fill line (indicating need for replacement) and into the neck of the container.

Review of guidelines for "Selecting, Evaluating, and Using Sharps Disposal Containers " date January, 1998 from the National Institute for Occupational Safety and Health (NIOSH) showed the following (in part):
- As many as one-third of all sharps injuries have been estimated to be related to the disposal
process. These injuries have most often been related to a number of factors, including overfilling of sharps disposal containers.



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11. Review of the policy titled "Infection Prevention and Control Practices-Contact Precautions" dated revised 11/2009, states in part, Procedure as follows: Don gloves and gown prior to entering a Contact Precautions room. Visitors: Educational information on Contact Precautions is available and will be included in Patient/Family teaching. Evidence of consistent non-compliance should be documented in the patient's chart along with any follow-up activity.

12. During an observation on 01/27/10 at 1:50 p.m. two visitors are observed to be in patient L #10's room designated outside the door as contact isolation. Neither visitor is wearing a gown or gloves as the contact isolation signage instructs outside the door. Review of the document provided by the facility titled "St. Louis Infection Control Log", dated 01/27/10, documents patient L #10's infection as MRSA.

During an interview on 01/27/10 at 2:00 p.m. Chief Nursing officer, RN, staff B, said that everyone should wear a gown and gloves when entering isolation rooms.

During an interview on 01/27/10 at 2:10 p.m. staff D RN ICP said that the policy for protective outerwear is for everyone to wear a gown and gloves when entering isolation rooms.

13. During an observation on 01/27/10 at 2:10 p.m. two female visitors and one small child (age 2) are observed to be in Patient L #8's room designated outside the door as contact isolation. None of the visitors are wearing a gown or gloves as the contact isolation signage instructs outside the door. Later, during an interview with staff D RN ICP, Staff D said that the sign should have been taken down. The patient on contact isolation was removed from the room earlier.

14. During an observation on 01/27/10 at 2:15 p.m. two female and two male visitors are observed to be in patient L #32's room designated outside the door as contact isolation. None of the visitors are wearing a gown or gloves as the contact isolation signage instructs outside the door. Review of the document provided by the facility titled "St. Louis Infection Control Log", dated 01/27/10, documents the patient's infection as MRSA, VRE and C-Diff (Clostridium difficile).

15. During an observation on 01/29/10 at 10:45 a.m. a physician (staff HH) and RN staff unknown, are observed to be in patient L #10's room designated outside the door as contact isolation at the bedside. Neither are wearing a gown or gloves, as the contact isolation signage instructs outside the door. The nurse identified the physician staff as the infectious disease doctor. After the physician staff HH left patient L #10's room, he/she was observed to enter another patient's room across the hallway. The physician did not wash his/her hands, or use alcohol gel prior to entering the next patient's room. The next patient was not on isolation precautions.
16. During an observation on 01/29/10 at 10:48 a.m. a visitor is observed to be in L #17's room, sitting in a chair at the bedside, designated outside the door as contact isolation. The visitor is not wearing a gown or gloves, as the contact isolation signage instructs outside the door. Review of the document provided by the facility titled "St. Louis Infection Control Log", dated 01/27/10, documents the patient's infection as MRSA, VRE and C-Diff.


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17. During an observation on 01/27/10 at 3:00 p.m. a visitor is observed moving a patient chair into the hallway from patient L #31's room. The visitor does not have on a gown or gloves as the contact isolation signage on the patient's door instructs. Review of the facility Infection Control Log reveals patient L#31 is on contact precautions for MRSA, C-diff and acinobactor.

18. During an observation on 01/28/10 at 2:35 p.m., two visitors are observed sitting in patient L#24's room; neither visitor has on a gown or gloves as the contact precautions sign on the patient's bedroom door instructs. Review of the facility Infection Control Log reveals patient L#24 is on contact precautions for VRE. Staff CC at the time of the observation instructed the visitors of the need to follow the contact precaution signage. The visitors stated "no one told us to do this before".