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Based on document review, interview, and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

CFR 482.12 Governing Body

CFR 482.25 Pharmaceutical Services

CFR 482.30 Utilization Review

CFR 482.42 Infection Control

A. Based on observation, it was determined that the facility failed to ensure that all patients are provided care in a safe setting, with a means to call for assistance, if needed.

On 9/19/12 at 11:05 AM, Unit 4 West was toured in the presence of Staff #18 and Staff #42. The patient in Room 455 was observed to be sitting out of bed in a chair that was located at the end of his/her bed against the wall. The patient did not have the call bell within reach, was on falls precautions per a yellow falling star posted outside the door, and stated that he/she needed assistance to go to the bathroom.

B. Based on observation, it was determined that the facility failed to ensure that a safe environment for the psychiatric patient population in the Behavioral Health Unit was provided.

Findings include:

1. On 9/19/12 at 11:45 AM, the Behavioral Health Unit on the second floor of the hospital was toured in the presence of Staff #18 and Staff #43. The following environmental hazards were observed that are not suicide proof and could support a patient's weight in a suicide attempt:

a. Patient Room 206:

i. The two ceiling sprinkler heads were exposed and not covered

ii. The sink's water control knobs

iii. The air vent was not covered

b. The air vent in Patient Room 205

c. The Men's Bathroom on the East Side of the Unit:

i. Shower water control knobs

ii. The sink water control handles

d. The Ladies Bathroom on the East side of the Unit:

i. Shower water control knobs

ii. The sink water control handles

iii. The ceiling air vent

e. The water control knob of the sink in Patient Room 204

f. Patient Room 219:

i. Shower water control knobs

ii. The sink water control handles

iii. The wall air vent

iv. The two hospital beds within the room each have side-rails, hand cranks at the bottom of the bed to raise the beds, and the bed frame. Staff #43 stated at 12:15 PM that this room is an involuntary patient room.

A. Based on review of facility policy and procedure, it was determined that the facility failed to ensure that the time limits for children and adolescents being restrained for violent or self destructive behavior was not limited to patients only in the crisis unit.

Findings include:

1. Review of the policy titled "Restraints" states under section "XV Restraints: Violent or Self Destructive Behavior: 7. Physician Orders are time limited and will be written based on age specific requirements as follows:
A. Four (4) hours for adults
B. Two (2) hours for ages 9-17-Crisis Unit Only
C. One (1) hour for under age 9- Crisis Unit Only"

2. The policy states that the time limits of one (1) or two (2) hours for children and adolescents is for the crisis unit only and does not include other areas of the hospital, for example, children and adolescents being restrained in the Emergency Department for violent/self destructive behaviors.

B. Based on review of facility policy and procedure and review of the medical records of three patients (Medical Record #9, #11, #12) who were physically restrained for the management of violent or self-destructive behavior, that jeopardized the immediate physical safety of the patient, a staff member, or others, it was determined that each order for restraint was not time-limited to 4 hours for adults 18 years of age or older, or 2 hours for children and adolescents 9 to 17 years of age.

Findings include:

Reference: Facility policy titled, "Restraints" states under section "XV Restraints: Violent or Self Destructive Behavior: 6. Each written restraint order for Violent or Self Destructive reasons will be time limited based on age specific requirements and will not exceed 4 hours. (See # 7 below) At the end of the limited time period, if a reassessment by the RN determines the need for the continuation of the use of the restraint, the LIP [Licensed Independent Practitioner] will grant the RN authorization for renewal. This will be done for a maximum of 4 hours. At that time, the LIP must conduct a face to face interview with the patient to determine the need for continuance... 7. Physician Orders are time limited and will be written based on age specific requirements as follows:
A. Four (4) hours for adults
B. Two (2) hours for ages 9-17-Crisis Unit Only
C. One (1) hour for under age 9- Crisis Unit Only"

1. Review of Medical Record #9 revealed the following:

a. A 29 year old patient was seen in the Emergency Department on 3/24/12 with the chief complaint of "Drug Abuse-Estacy [sp] and Alcohol Abuse."

b. An order for restraints for violent or self destructive behavior was written on 3/24/12 at 23:19. According to the "Seclusion/Restraint 24 Hour Flow Sheet," the patient was in restraints from 11:15 PM until they were removed at 4:30 AM (on 3/25/12).

c. There was no evidence of an order to continue with the restraints after 4 hours.

2. Review of Medical Record #11 revealed the following:

a. A 15 year old patient was brought to the Emergency Department by police on 6/12/12 for violent behavior and attempting to elope.

b. An order for seclusion and locked leather (4) point restraints for violent/self destructive behavior was ordered at 4:30 AM on 6/12/12. According to the "Seclusion/Restraint 24 Hour Flow Sheet," the patient was in restraints from 4:30 AM until at least 8:30 AM.

c. There was no evidence of an order to continue with the restraints after 2 hours.

3. Review of Medical Record #12 revealed the following:

a. A 28 year old patient was brought to the Emergency Department by police on 3/6/12 for violent behavior.

b. An order for locked leather (4) point restraints for violent/self destructive behavior was ordered at 21:59 (9:59 PM) on 3/6/12. According to the "Seclusion/Restraint 24 Hour Flow Sheet," the patient was in restraints from 9:59 PM on 3/6/12 until they were removed at 3:00 AM on 3/7/12.

c. There was no evidence of an order to continue with the restraints after 4 hours.

Based on observation, document review and staff interview conducted on 9/18/12, it was determined that the facility failed to ensure that medications are administered in accordance with physician's orders and facility policies and procedures.

Findings include:

Reference #1: Facility policy titled "Pharmacy-Administration of Medications" states, "Standard Medication Administration Times - Unless the prescriber directs otherwise, all medications prescribed by authorized practitioners shall be administered according to the recognized and approved drug administration schedule as defined below...daily - 10am."

Reference #2: Facility policy titled "Pharmacy-Administration of Medications" states, "Medication Administration Procedure - Keep unit-dose packages intact until just prior to administration...Read the medication label at least three times:...Just after administration...Correctly identify the patient as the one for when the medication was ordered using at least the two hospital identifiers."

Reference #3: Facility policy titled "Pharmacy-Administration of Medications" states, Medication Administration Record All personnel authorized to administer medication must record all drugs administration (activity) on the Medication Administration Record (MAR) immediately after the drug is given."

1 On 9/18/12 at 10:45 AM, Staff #27 was observed administering medication to Patient #25 and Patient #44. The following deficient practices were observed:

a. Staff #27 did not record the medications as given on the MAR immediately after the administration. This was done after medication was administered to other patients.

b. Patient #25 had a medication order for Folic Acid 1mg daily (10AM). The medication was not administered during the medication pass. Folic Acid 1mg was observed in the patient's medication cassette after the medication pass. Upon later review of the MAR at 11:30AM, it was observed that Folic Acid 1mg was initialed as administered by the nurse.

c. Prior to the medication pass, 2 white tablets were found in a medication cup in Patient #25's medication cassette drawer. Upon interview, Staff #27 stated that the 2 tablets were "Tylenol." Staff #27 was observed administering the 2 tablets to Patient #25.

d. Staff #27 was observed administering Hydrochlorothiazide 25mg, a diuretic that can lower blood pressure, to Patient #25. He/she stated that the patient's blood pressure was 122/76. He/she recorded this blood pressure on the MAR. During the medication reconciliation, it was noted that Lisinoprel, an antihypertensive, was not administered. Staff #27 stated that he/she did not administer the medication because the blood pressure was 111/56. Two conflicting blood pressures were recorded on the MAR; 111/56 for Lisinoprel and 122/76 for Hydrochlorothiazide.

e. Staff #27 failed to use two identifiers prior to administration of medications to Patient #44. He/she only checked the patient's ID band for the pateint's name.

Based on observation and staff interview conducted on 9/18/12 and 9/19/12, it was determined that the facility failed to ensure that pharmaceutical services are provided in a safe manner.

Findings include:

1. The facility failed to ensure implementation of policies and procedures addressing the use of drug dispensing devices. Refer to Tag A-0500.

2. The facility failed to ensure that medications were compounded in a safe manner in accordance with acceptable standards of practice. Refer to Tag A-0501.

A. Based on observation and staff interview conducted on 9/18/12, it was determined that the facility failed to ensure implementation of policies and procedures addressing the management of medications dispensed via the medication dispensing device.

Findings include:

Reference: Facility policy titled, "Automated Dispensing Systems - Pyxis System Setup/Procedures" states, "RETURN/WASTE MEDICATIONS All medications that are intact, and in its original contain (sic), will be returned to the stock using the return function."

1. During a review of medication cassette drawers on 3 Main at 11:30 AM, the following discrepancies were noted:

a. A medication cassette drawer labeled for Patient #24 contained Calcium Acetate, Ramipril, Lasix, Sensipar, Quetiapine, Mirtazapine and Protonix. Upon further review, it was determined that this patient had 2 medication cassette drawers on two different carts. The medications from this cart had not been used and had not been returned to the Pyxis as required by policy.

b. A medication cassette drawer labeled for Patient #27 contained Bacid, Metoprolol and Onglyza. Upon further review, it was determined that this patient had 2 medication cassette drawers on two different carts. The medications from this cart had not been used and had not been returned to the Pyxis as required by policy.

c. A medication cassette drawer labeled for Patient #28 contained Bacid, Haldol, Atorvastatin, Metoclopramide, Phenytoin oral suspension, and Furosemide. Upon further review, it was determined that this patient had 2 medication cassette drawers on two different carts. The medications from this cart had not been used and had not been returned to the Pyxis as required by policy.

d. A medication cassette drawer labeled for Patient #32 contained 2 tablets of Norvasc 10mg. The patient's last scheduled dose of Norvasc 10mg was at 10:00 AM. Upon interview, Staff #26 could not explain why there were 2 tablets of Norvasc in the cassette drawer. The medication was not returned to the Pyxis as required by policy.

e. A medication cassette drawer bearing no patient identification contained Milk of Magnesia 30ml (milliliter), Clopidogrel 75mg, Cyclobenzaprine 10mg, Prednisone 20mg, Prednisone 5mg and Pantoprazole 40mg.

(i) Upon interview, Staff #26 stated the medication cassette drawer was assigned to Patient #31. A review of the medical record for Patient #31 revealed that he/she did not have active medication orders for Prednisone 5mg and Pantoprazole 40mg. Staff #26 could not explain why Prednisone 5mg and Pantoprazole 40mg were in the medication cassette drawer assigned to Patient #31.

f. A medication cassette drawer bearing no patient identification contained a Risperidone 2mg tablet.

(i) Upon interview, Staff #26 could not identify which patient the medication cassette drawer was assigned to.

B. Based on document review and staff interview conducted on 9/18/12, it was determined that the facility failed to ensure that the pharmacist reviewed medication orders for appropriateness of use.

Findings include:

1. Medical Record #25 contained an order for "Lidoderm patch to right knee daily." Review of the Medication Administration Record (MAR) indicated that the patch was removed and a new one applied at 10:00 PM daily. This was confirmed by Staff #27. The manufacturer's package insert states, "Apply up to three patches, only once for up to 12 hours within a 24-hour period."

a. There was no evidence that the pharmacist obtained a clarification of the directions from the physician. Upon interview, Staff #8 stated that the special instructions are sent with the initial dose of the medication and that nursing personnel have the responsibility of writing these instructions onto the MAR. This was not done.

2. During a medication pass observation on unit 3 Main with Staff #26 at 11:30 AM, the following discrepancies were noted in the medical record for Patient #24:

a. Two active orders for "Ramipril 2.5mg (milligram) PO (by mouth) daily, Hold if SBP (systolic blood pressure) less than 100" ordered on 9/11/12 at 3:00 PM and "Lisinopril 5mg PO daily, Hold if SBP less than 110" ordered on 9/12/12 at 8:00 AM, were noted on the Routine Medication Administration Record. Both Ramipril and Lisinopril belong to the angiotensin converting enzyme (ACE) inhibitor class of medications used for the treatment of hypertension.

(i) Upon interview, Staff #8 stated that a pharmacist failed to clarify the duplicate therapy orders with the physician. At 11:45 AM, a call was placed to the physician to clarify the orders and Lisinopril was discontinued.

b. An active order for "Carvedilol 6.25mg PO Q12H (every 12 hours), Hold for SBP less than 110" ordered on 9/11/12 at 8:14 PM was noted. A review of the Routine Medication Administration Record revealed that Patient #24 also received "Metoprolol 50mg PO Q12H, Hold for SBP less than 100 or HR (heart rate) less than 60" ordered on 9/11/12 at 3:00 PM. Both Metoprolol and Carvedilol belong to the beta-adrenergic blocker class of medications used to treat myocardial infarction and hypertension.

(i) The order for Metoprolol was discontinued on 9/14/12, however, documentation shows Metoprolol was administered from 9/12/12 to 9/14/12, in addition to Carvedilol.

(ii) Upon interview, Staff #8 stated that a pharmacist failed to clarify the duplicate therapy orders with the physician prior to the first dose of medication being dispensed.

C. Based on observation and staff interview conducted on 9/18/12, it was determined that the facility failed to ensure that pharmacy labels are permanently affixed to containers and that they are not transferred to other containers by non-pharmacy personnel.

Findings include:

1. During a review of the medication room on Unit 3 Main, it was noted that pharmacy labels were partially affixed to the overwrap of Ciprofloxacin 400mg/200ml and Zyvox 600mg/300ml. Upon interview, Staff #8 stated that the labels would be transferred to the medication bag by the nurse prior to administration of the medication.

2. Upon interview Staff #8 confirmed that some intravenous medications are dispensed in this manner.

3. Pharmacy labels must be permanently affixed to the medication container and cannot be altered in any way by non-pharmacy personnel. At the time the medication is dispensed, the dispensing pharmacist initials the label to indicate that the medication was checked against the physician's order and is correct. This label cannot be transferred by someone else to another medication container prior to drug administration.

4. These findings were confirmed by Staff #8.

Based on observation, document review and staff interview conducted on 9/19/12, it was determined that the facility failed to ensure that medications were prepared and administered in accordance with acceptable standards of practice.

Findings include:

Reference: United States Pharmacopeia (USP), Chapter 797 when addressing single-dose containers states, "Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSP's [Compounded Sterile Products] shall be used within 1 hour if opened in worse that ISO [International Standards Organization] Class 5 air quality, and any remaining contents must be discarded."

1. During a tour of the Operating Room Suite, a 100 ml partial fill intravenous bag of 0.9% Sodium Chloride with a label stating "phenylephrine, 9/19/12" and the initials of Staff #55 was found in the drawer of the anesthesia machine in Operating Room #2 at 11:30 AM. Upon interview, Staff #55 stated that he/she had prepared the compound at about 7:30 that morning and he/she would discard it at noon. Staff #55 stated that he/she would prepare syringes for more than one patient from the bag.

a. Upon interview, Staff #8 confirmed that this practice was not in compliance with facility policy. He/she stated that the compounded product must be used for just one patient and discarded within one hour of preparation.

2. These findings resulted in an Immediate Jeopardy which immediately curtailed this practice. The Immediate Jeopardy was abated on 9/19/12, upon receipt of an acceptable plan of correction.

Based on observation and staff interview conducted on 9/19/12, it was determined that the facility failed to ensure that opened single dose vials of medication and expired medications were not available for use.

Findings include:

1. At 2:30 PM during a tour of the Pharmacy IV (intravenous) Room, the following items were noted in the pharmacy active stock available for use:

a. One opened single dose vial of potassium phosphates injection 50ml (milliliter) labeled "open 9/16/12".

b. Three Pentam 300mg (milligram) and 5% dextrose injection 250ml IV bags labeled "use by 8/30/12" and "use by 9/13/12".

2. The findings with the opened single dose vial of potassium phosphates injection resulted in an Immediate Jeopardy on 9/19/12. The Immediate Jeopardy was abated on the afternoon of 9/19/12, after receiving an acceptable plan of correction.

Based on review of facility documents and staff interview, it was determined that the facility failed to have a utilization review plan (URP) in effect for 2011 and part of 2012.

Findings include:

1. On 9/17/12, the Utilization Committee meeting minutes were reviewed, and indicated the following:

a. The minutes for 2/16/12 indicated on page 3 under the heading 'Agenda /Topic and New Business,' "2011 Utilization Review Plan- Review and Recommendations." The third column of page 3, 'RECOMMENDATIONS/ACTIONS Decision/Outcomes/Next Steps' indicates that the Committee "Recommended to the Medical Executive Committee that the 2011 Utilization Review Plan be approved. 2012 Utilization review Plan to be presented at the next meeting."

b. The minutes for 4/19/12 indicated on page 3 under the heading 'Agenda /Topic and New Business,' "2011 Utilization Review Plan- Review and Recommendations." The third column of page 3, 'RECOMMENDATIONS/ACTIONS Decision/Outcomes/Next Steps' indicates that the Committee "Recommended to the Medical Executive Committee that the 2012 Utilization Review Plan be approved."

c. The minutes for 5/17/12 lacked evidence that the 2011 and 2012 URPs were approved by the Medical Executive Committee.

2. According to Staff #1 on 9/17/12, the URPs are approved first at the Performance Improvement Committee, then they are submitted to the Executive Team.

3. Review of the Performance Improvement Committee meeting minutes indicated the following:

a. The minutes for 2/29/12 indicated in Topic #8 Open Forum: under the 'Discussion/ Recommendations' section that "The 2011 Utilization Management Plan was presented for review and approval. No corrections or additions were offered. It was moved, seconded and approved to accept the plan as written."

b. The minutes for 4/25/12 indicated in Topic #6 2012 Utilization Management Plan under the 'Discussion/ Recommendations' section that "--[Staff #5]-- called for a vote to approve the 2012 Utilization Management Plan given the absence of any corrections being offered by this membership and the approval of the plan as written by the Utilization Review Committee at their April meeting. It was moved and seconded to approve this plan as written."

4. Review of a letter from the the President of the Medical Staff to the Chief Executive Officer, dated 5/18/12, indicated that "At the Medical Executive Committee meeting held on Wednesday, May 16, 2012 , the following recommendations were referred to the Board of Trustees for approval, without controversy: ... 10. That the 2012 Utilization Review Plan be approved for implementation."

a. Review of the Medical Executive Committee Meeting minutes for 5/16/12 indicate under the 'Agenda Topic Utilization Review Committee, 2/16/12 & 4/19/12' that the minutes of both meetings were reviewed and [under 'Discussions/Conclusions']" MEC members reviewed the 2012 Utilization Review Plan, after a summary of the changes from the 2011 Plan." The 'Recommendations/Actions' indicated the 2012 URP was "Accepted for information."

5. There was no evidence that the facility had an URP plan that was approved by the Medical Executive Committee for the year 2011.

a. Staff #5 confirmed in interview, on 9/17/12, that the 2011 URP was not approved in 2011.

b. Staff #1 confirmed in interview, on 9/18/12 at 10:10 AM, that there was no evidence of approval by the Medical Executive Committee of the 2011 URP.

6. The 2012 URP was not approved by the Medical Executive Committee until their meeting of 5/16/12. The Utilization Review Committee/ Team members were functioning without an approved URP for the first five months of 2012.

A. Based on observation, it was determined that the facility failed to ensure that a sanitary and safe environment was maintained.

Findings include:

1. The ceiling tiles in the substerile room (between Operating Room #2 and Operating Room #3), above the sterilizer, had loosely peeling layers and the drop ceiling framework was discolored with rust.

2. The cabinet in the substerile room (between Operating Room #2 and Operating Room #3), across from the sterilizer had an accumulation of dust and contained a variety of miscellaneous storage such as; bolsters, a soiled suction canister and tubing, cassette tapes and a CD case.

3. The top of the sterilizer and the floor in the substerile room (between Operating Room #2 and Operating Room #3) contained an accumulation of dust.

4. The sink inside of the anesthesia workroom (workroom is used for sterile supply storage) in the Operating Room, was continuously dripping water at the faucet and the interior of the sink was laden with slime and was spotted with a dark coloration. On 9/17/12 at 12:00 Noon, Staff # 11 stated that the sink is never used.

5. The wall behind the decontamination sink in the Endoscopy processing room was covered with dried splash and the caulking behind the sink was yellowed and encrusted with residue.


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B. Based on observation and staff interview, it was determined that the facility failed to ensure that walls, floors and equipment are maintained clean and sanitary in the central sterile processing department.

Findings include:

1. On 9/17/12, the corridor located between the Decontamination Room and the Operating Room Suites had coved floor baseboards that were detached from the wall perimeters.

2. On 9/17/12, several water stained ceiling tiles were noted in the Decontamination Room. Staff #34 stated that he/she had noticed the water leak after a heavy rainfall.

3. On 9/17/12, the wall perimeters next to the manual reprocessing sinks were covered with sticky brown fluid.


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C. Based on observation, it was determined that the facility failed to keep all windows and screens clean to sight and touch and in good repair.

Findings include:

1. On 9/18/12 at 10:30 AM, Unit 2 West was toured in the presence of Staff #18. The window in patient Room #268 was opened and did not have a window screen in place. Without a window screen insects from outside could enter the hospital. There was a patient in the bed next to the window.

2. On 9/18/12 at 1:50 PM, the ICU was toured in the presence of Staff #4, Staff #18, and Staff #37. The window in ICU Bay #5003 did not have a window screen. According to Staff #37, the window can be opened.

3. On 9/19/12 at 10:35 AM, Unit 4 West was toured in the presence of Staff #18 and Staff #42. The window in the Soiled Utility Room was opened without a window screen in place.

D. Based on observation, it was determined that the facility failed to ensure that the safety and well-being of patients was maintained.

Findings include:

1. On 9/19/12 at 11:45 AM, the Behavioral Health Unit on the second floor, was toured in the presence of Staff #18 and Staff #43. The following was observed:

a. The water faucet at the sink in the Activity Room was running and could not be turned off.

b. The patient sink in Room #204 was missing the hot water control knob.

Based on observation, staff interview, and review of documentation, it was determined that the facility failed to maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases.

Findings include:

1. The facility failed to provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases. Refer to Tag A-0701.

2. The facility failed to implement nationally recognized infection control guidelines. Refer to Tag A-0749.

A. Based on observation, staff interview and review of facility documents, it was determined that the facility failed to ensure that the manufacturer's instructions and industry standards were followed for the hi-level disinfection of endoscopes in the Endoscopy Department.

Findings include:

Reference #1: Facility Policy and Procedure titled, "Care and Handling of Endoscopes and accessories" states, "Immediately after scope is used on patient flush all channels with water to remove any refluxed material. If scope was exposed to blood, flush all channels with hydrogen peroxide to avoid a clogged channel."

1. The facility policy and procedure that describes the method of cleaning endoscopes (flush all channels with hydrogen peroxide) is not supported by recognized guidelines or manufacturer's instructions for use as stated in the Pentax Video GI scopes reprocessing/maintenance manual.

Reference #2: Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes, Society of Gastroenterology Nurses and Associates (SGNA) states, "Precleaning step 1.b. Immediately after removing the endoscope from the patient, wipe the insertion tube with the wet cloth or sponge soaked in the freshly prepared detergent solution. 2. Place the distal end of the endoscope into the appropriate detergent solution and suction a large volume of detergent solution through the endoscope until clear."

1. On 9/18/12 at 11:00 AM, Staff #2 stated that the Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes, Society of Gastroenterology Nurses and Associates (SGNA) guidelines are implemented in the Endoscopy processing area.

2. During an interview on 9/18/12, Staff #57 stated that potable water is used to pre-clean the scope prior to removal from the OR suite into the processing room. Appropriate detergent is not in use during pre-cleaning.

Reference #3: SGNA, Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes states, "Each individual who reprocesses instruments should complete the initial infection control orientation and reprocessing competency. Competency review and infection control updates should be validated and documented annually. Training with documented competency must be completed for new models endoscopes, accessories, valves, and automatic endoscope reprocessors as they are introduced in the facility."

1. The Steris System 1E (a liquid chemical sterilant processing system) was installed in April 2012. Staff competencies for the Steris System 1E were requested but could not be provided.

2. Review of competencies for Staff #57 and Staff #58 did not include the new Steris System 1E. The last competencies for Staff #57 and Staff #58 were dated 10/28/11, which is prior to the installation of the Steris System 1E.

Reference #4: AAMI ST 58, section 9.2.2 states, "For each chemical sterilization or hi-level disinfection cycle the following information should be recorded and maintained: the results of (CI) chemical indicator testing."

1. On 9/18/12 at 11:20 AM, Staff #58 stated that Verify chemical indicator test strips are used to test the S40 liquid sterilant in every cycle of the Steris System 1E. The chemical indicator verifies that the minimum recommended concentration of S40 Sterilant Concentrate use dilution has been met. Documented results (pass/fail) of the chemical indicator test strip findings were not available upon request. Staff #58 stated that results of the chemical indicator test were not recorded.

Reference #5: SGNA, Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes states in section Reprocessing Room: "Considerations include adequate space for reprocessing activities, proper airflow and ventilation requirements, work flow patterns, work surfaces, lighting, adequate utilities such as electrical support and water, hand washing and eye washing facilities, air drying capability, and storage."

1. A hand washing sink was not provided in the endoscope decontamination/processing area. The only sink available was an endoscope washing sink equipped with an eye wash station.

Reference #6: AAMI ST 58: Chemical sterilization and hi-level disinfection in health care facilities, 3.3 "Traffic control" states, "Criteria for authorized entry, movement within processing areas and attire should be specified in written policies and procedures."

1. Facility policy and procedure does not address traffic control in the endoscope processing area. The policy provided for the endoscopy area "Care and Handling of Endoscopes and Accessories" did not include the separation of soiled and clean processes and movement of instruments and personnel within the processing room.

2. All endoscope processing activities; cleaning/decontamination, chemical disinfection and hi-level disinfection are conducted in a common room. One entrance into the processing room is off the main corridor and opens into the clean side of the processing area. The second entrance is from inside of one of two Endoscopy Operating Room Suites, requiring the transport of soiled endoscopes from Operating Room #2 into the processing area by first entering Operating Room #1 or access through the main corridor directly into the clean side of the processing room.

B. Based on observation, it was determined that the facility failed to ensure that sterilized materials are monitored and stored in the Operating Room in accordance with industry standards, "The Association for the Advancement of Medical Instrumentation, AAMI ST 79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities."

Findings include:

Reference #1: AAMI ST79:2010 -8.4.3 states, "Instruments should be carefully inspected for cleanliness and flaws or damage and dried before packaging."

1. On 09/17/12 at 11:45 AM, a sterile Cataract tray (without a processing label), in Operating Room #3, was opened and contained a soiled fingermat, which holds instruments in place. The mat contained a dark residue that was easily removed with a swab.

Reference #2: AAMI ST79:2010-10.5.3.1 states, All BIs [Biological Indicators] should be used in accordance with the BI manufacturer's instructions.

1. The Operating Room 3M Steam Sterilizer Record for biological indicator test results were reviewed for the month of July through September 2012.
100% of the records failed to provide the date or time when the BI test and control vials were placed into and taken out of the incubator for the final read or the operators initials as requested by the 3M manufacturer's steam sterilizer record.

Reference #3: AAMI ST79:2010-10.3.2 states, "For each sterilization cycle, the following information should be recorded and maintained: g) the response of the CI placed in the PCD (BI challenge test pack, BI challenge test tray, or CI challenge test pack).

1. Results (+ or -) of the chemical indicator (integrator) (CI) used for flash steam sterilization (270 degrees Fahrenheit for 3 minutes/1 minute dry) in the Operating Room sterilizer reviewed for the month of July through September 2012, were not reported on the steam sterilizer record on: 9/14/12 (eye instrument R3/C5), 8/15/12 (burr), 8/14/12 Load 2 (blue chopper), 8/16/12 load 3 (Acufex), 07/13/12 (phaco R3/C4), and 07/20/12 (Dr Scott-R3/C/3).

Reference #4: AAMI ST 79:11.2.5 states, "Procedures for flash sterilization should be based on a documented quality process that measures objective performance criteria. This quality process should be developed in conjunction with the appropriate using departments and should be integrated into the overall quality process in the health care facility. Monitoring frequency will vary, depending on the quality improvement goals, on facility policy and procedures for the handling of untoward events, and on the type of performance measure."

1. A documented quality process to measure flash sterilization cycles in the Operating Room failed to provide necessary information adequate to determine the reasons for the flash sterilization being used. Ongoing auditing does not provide data to assess the effectiveness of the process and make ongoing improvements in performance. Objective performance criteria to enable performance improvement, such as insufficient time for complete sterilization processing, identification of sufficient instrument inventory, and dropped instruments were not reported with flash sterilization.

2. On 9/18/12 at 10:40 AM, Staff #2 provided the Operating Room report for June 2012 QA which identified 20 flash sterilization cycles in the Getinge sterilizer and 22 flash sterilization cycles in the Castle sterilizer, all having a negative Biological indicator test. Items identified as flash sterilized included; Phaco handpiece, cataract instruments, vascular forceps, retractor and speculums. No reasons for immediate use sterilization were reported. Sufficient instrument inventories were not established.

3. On 09/18/12 at 1:20 PM, Staff #59 stated no other information regarding flash sterilization in the Operating Room was collected other than the number of biological indicator tests.




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C. Based on observation, staff interview, and document review, it was determined that the facility failed to ensure that a sanitary environment, to avoid sources and transmission of infections and communicable diseases, was provided.

Findings include:

Reference #1: AAMI ST 79 section 3.3.6.8 on "Handwashing facilities" states,
"Handwashing facilities should be located in or near all areas in which instruments and other devices are decontaminated and prepared for sterilization."

1. A designated handwashing sink is not available in the Central Processing Department Decontamination Room. Staff #32 stated that he/she routinely utilizes wall mounted hand sanitizer and washes his/her hands at the double bay compartment sinks, which are used as reprocessing sinks to preclean soiled instruments.

Reference #2: AAMI ST 79 section 7.2.2 on "Manufacturer's instructions" states, "The written recommendations of the device manufacturer should always be followed."

Reference #3: Facility policy and procedure titled "Reprocess of Laryngoscope Blades" states, "1. The blades will be manually cleaned with enzymatic cleaner. 2. The scope will be inspected for cracks or damage and the lights turned on. 3. The blades will be wrapped and processed in ETO sterilizer or steam sterilized."

1. On 9/17/12 at 11:00 AM, over five (5) conventional and convertible laryngoscope blades and handles were observed being stored in unprocessed peel packages labeled as "cleaned" in the sterile storage of the Central Processing Department. The care and maintenance instructions for standard "Welch Allyn" laryngoscope blades states, "All Welch Allyn blades are compatible with enzymatic cleaners. ULTRASONIC CLEANING IS NOT RECOMMENDED. Disinfection/Sterilization (Minimum high level disinfection required). Steam autoclave is appropriate."

a. Upon interview, Staff #17 stated that after manual cleaning, the laryngoscope blades are placed in the ultrasonic cleaner, rinsed, dried and packaged in peel packages. When Staff #17 was questioned about use of high level disinfectant or sterilization as the final step, he/she stated that the blades do not undergo high level disinfection and/or sterilization.

2. On 9/17/12, a newly installed "Getinge Washer Disinfector" was observed in the Decontamination Room of the Central Processing Department. Staff #17 stated that the operations manual for this specific piece of equipment was not provided upon installation, in January 2012.

Reference #4: The manufacturer of "Pilling Maloney and Hurst Tungsten-Filled Silicone Bougies" state, "US Medical Device Amendments of 1976 and review by the FDA has prompted Pilling to stamp bougies with an expiration date. This expiration date has been established by taking into account the material, normal use, care and cleaning of the product."

1. On 9/17/12, a total of 9 expired (7 expired 2012-07, 2 expired 6/30/12) bougies were being stored in the sterile storage room of the Central Processing Department. Although the facility did not have policies and procedures on checking expiration dates, Staff #17 stated he/she routinely checks for outdates. However, documentation and facility's policy and procedures on checking for outdates was not available upon request.

Reference #5: AAMI ST 41 section 4.3.1 on "Sterile processing personnel" states, "Personnel engaged in sterile processing must receive both an initial orientation and on-the-job training designed to lead to competency-based knowledge and skills in all tasks performed in the sterile processing department. Training should also include orientation in facility and department policies and procedures regarding infection prevention and control, safety, attire, personal hygiene, and compliance with state and federal regulations. For EO sterilizer and aerator operators, this training should specifically include instruction on EO sterilizer operation, loading and unloading procedures, aerator operation, parameters of EO sterilization, safety precautions, and potential hazards. Ethylene oxide evacuation drills should be conducted at least annually. All orientation, on-the-job, and in-service training should be documented. A training manual should document all aspects of training related to the on-site approved protocols. This manual should include checklists to document that training was performed and when competency was achieved. This training manual should be based on the facility's policies and procedures, accepted standards of practice and manufacturer's recommendations."

1. On 9/18/12, Staff #17 stated that the facility does not have any policies and procedures on staff education of the Ethylene oxide (EO) sterilization. Staff #17 stated that each staff involved in EO sterilization attends continuing education classes to maintain their own pesticide licenses. Facility specific policies and procedures on conducting EO sterilization staff competencies, education and training have not been developed, therefore, were not available for review.

Reference #6: AAMI ST41 section 4.3.1.2 on "In service training" states, "In-service programs on EO sterilization processing must be scheduled at least annually by the health care facility and must be held frequently enough to ensure that all operators, maintenance personnel, and other potentially exposed workers are kept abreast of current technical knowledge and regulatory requirements."

Reference #7: AAMI ST41 section 4.3.2 on "Other personnel" states, "Personnel who are not assigned to sterilization but who have responsibility for maintaining EO sterilizers, aerators, ventilation systems, or emission control systems or for changing EO supply sources should be trained in safe work practices and engineering controls and should demonstrate competence. Personnel training and continuing education must be documented."

1. On 9/18/12, Staff #33, who is routinely involved in semiannual alarm testing of the EO sterilizer, stated that he/she has not received any training on ethylene oxide exposure. Staff #17 confirmed that an in-service program has not been developed for staff exposed to ethylene oxide.

Reference #8: AAMI ST41 section 11 on "Environmental and employee monitoring" states, "To ensure a safe work environment and to establish compliance with federally mandated limits and voluntary guidelines on occupational exposure to EO, actual EO concentrations must be measured in the workplace during and after the use of sterilization equipment."

Reference #9: Facility policy and procedure titled "Preventative Measure for Ethylene oxide Gas Hazards" states, "Ethylene oxide trak monitors will be worn four times a year by an employee who is at the highest potential for exposure ethylene oxide. Two 8 hour badges and two 15 minute badges. "

1. The badge air monitoring records provided by Staff #17 from 2009 to present was reviewed. In 2011, only one air monitoring badge testing result was available for one out of three staff currently involved in EO sterilization and no other air monitoring test records were available from 2009 to 2010.


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D. Based on observation, it was determined that the facility failed to control the prevention of infection among patients and personnel.

Findings include:

Reference: Facility policy and procedure Code No.: A:SR:012, titled "Standard and Transmission-Based Precautions" states, "... Contact Precautions... Purpose: To prevent the transmission of microorganisms that can be transmitted by direct contact or contact with patient care items in the patient's environment. Procedure: ... 3. Gloves: a. Will be worn when entering the room. ... 5. Gown: a. When entering the room if anticipating that clothing will be in contact with patient's environmental surfaces, items in the patient's room, if the patient is incontinent or has diarrhea, or patient has drainage not contained by a dressing."

1. On 9/18/12 at 10:30 AM, Unit 2 West was toured in the presence of Staff #18. The patient in Room #268 had a Contact Isolation sign posted outside the door that indicated staff and visitors were to wear Personal Protective Equipment (PPE) of gowns and gloves when in the patient's room. There was a visitor of the patient in the room and was not wearing the appropriate PPE.

2. On 9/19/12 at 11:05 AM, Unit 4 West was toured in the presence of Staff #18 and Staff #42. Room #455 had a sign on the door indicating that the patient was on isolation. According to Staff #42, the patient was on enteric precautions. There was a volunteer in the room that had a gown over his/her head, hanging around his/her neck, but it was not tied or fastened around him/her. The volunteer was not wearing gloves. The sign on the door indicated gowns and gloves should be worn when entering this patient's room.

3. During a medication pass observation at 10:45 AM on 3 Main, Staff #56 was observed entering the room of a patient who was on Contact Precaution without wearing gloves and washing his/her hands before leaving the room.

Based on medical record review, staff interview, and review of facility policy and procedure, it was determined that the facility failed to implement its policies and procedures for respiratory care.

Findings include:

Reference #1: Facility policy and procedure Code No:D:RCS titled "Treatment Schedules" states, "I. POLICY: 1. Treatments will be administered "while awake" between the hours of 8 am-11p [sic] unless specifically written as "around the clock" ... 3. Treatments that are missed will be noted in CE [computer charting] with a reason ... II. PURPOSE: 1. To ensure that all respiratory treatments are effectively administered in accordance with physicians' orders. 2. To standardize respiratory treatment schedules."

Reference #2: Facility policy and procedure Code No:10-03 titled "Orders: Verbal and Telephone" states, "I. POLICY [3rd bullet] Telephone orders may also be taken by a licensed, ... respiratory therapist for respiratory medications."

Reference #3: Facility policy and procedure Code No:D:RCS titled "Patient Assessment / Re-assessment" states, "I. POLICY: ... 2. Respiratory Therapists will perform a limited patient evaluation when initiating therapy and document the patient's response to therapy. 3. Respiratory Therapists will perform and document a limited evaluation of objective and subjective response prior to and following therapy at each subsequent bedside visit. 4. Documentation of limited patient assessment should include medication dose and/or therapy type, time of therapy/assessment, measured responses: vital signs, breath sounds, lung function (if applicable), and patient's progress. ... VI. PROCEDURE: ... 4. Perform pre therapy assessment: i. Auscultate chest ii. Obtain pulse rate iii. Obtain respiratory rate iv. Perform pulse oximetry v. Lung function (if applicable) ... 6. Document pre therapy assessment on progress note or flowsheet 7. Perform post therapy assessment: i. Auscultate chest ii. Obtain pulse rate iii. Obtain respiratory rate iv. Perform pulse oximetry v. Lung function (if applicable) vi. Observe for adverse reactions to therapy 8. Document post therapy assessment on progress note or flowsheet."

Reference #4: Facility policy and procedure Code No:D:RCS, titled "Chest Physiotherapy" states, "I. POLICY: 1. Chest physiotherapy shall be provided upon a physicians order or an order from a licensed medical professional with ordering privileges."

1. On 9/18/12 at 1:50 PM, the ICU was toured in the presence of Staff #4 and Staff #18. Medical Record #36 was reviewed that indicated a physician order dated and timed, 9/17/12 at 7:30 AM, to insert a nasal airway and suction every two hours. Also, a respiratory treatment of Duoneb unit dose with 20% Mucomyst .3 milliliters every 4 hours with chest physiotherapy and suctioning was to be provided to the patient. Respiratory treatments and assessments for Patient #36 were reviewed in the computerized medical record in the presence of Staff #10. On 9/17/12 respiratory treatments and assessments were completed at 08:26, 12:24, 16:19, and 20:05.

a. There was no evidence that the respiratory therapist suctioned the patient or performed chest physiotherapy at 08:26, 12:24, and 16:19. The therapists did not implement the facility policy in Reference #4.

b. There was no evidence during the 20:05 treatment that chest physiotherapy was provided to the patient.

c. The respiratory therapist did not implement the facility policy in Reference #4.

d. There was no evidence in the medical record that a nasal airway was inserted.

2. There were no documented assessments or notes from the respiratory therapist in the medical record at this time for treatments given on 9/18/12. According to Staff #35 on 9/18/12 at 2:30 PM, he/she gave Patient #36 treatments at 9:00 AM and 1:45 PM, but had not charted the treatments and assessments. Staff #36 failed to document treatments and assessments as per facility policy in Reference #3.

3. Medical Record #37 was reviewed in the presence of Staff #10 on 9/18/12 at 3:00 PM during a tour of the ICU. A telephone physician order dated and timed 9/16/12 at 12 Noon, indicated a respiratory treatment order for Duoneb one unit dose nebulizer around the clock. The Respiratory Medication Administration Record (MAR) was reviewed and revealed that the medication was given on 9/16/12 at 4:00 PM and at 8:00 PM. The order was transcribed to be given as ordered around the clock at 12 AM, 4 AM, 8 AM, 12 Noon, 4 PM, and 8 PM.

a. The initial transcribed order on the MAR was re-written on the back of the MAR as " Duoneb unit dose via nebulizer Q 4 h [every 4 hours] around the clock", but the administration times were changed from every 4 hours, as above, to every 4 hours while awake at 8 AM, 12 PM, 4 PM, and 8 PM.

b. There was no evidence of a new physician order changing the administration times from every four hours around the clock to every four hours while awake.

i. According to Staff #35 and Staff #36, the respiratory therapists can take physician orders over the phone.

ii. There was no evidence that the Respiratory Therapist had re-transcribed the respiratory treatment on the MAR clarifying the order with the physician as per Reference #2.

c. The patient was not given the ordered doses of the Duoneb nebulizer treatments on 9/17/12 at 12:00 AM and 4:00 AM, and on 9/18/12 at 12:00 AM and 4:00 AM.

4. On 9/19/12 at 11:30 AM, Medical Record #38 was reviewed in the presence of Staff #10 on Unit 4 West. A physician order, dated and timed 9/16/12 at 6:30 AM, for Duoneb unit dose via nebulizer every 4 hours was evident. There was no evidence in the medical record of a documented pulse oximetry assessment, per policy in Reference #3, on 9/17/12 at 12:00 PM and 4:00 PM, and on 9/18/12 at 12:00 PM and 4:00 PM.