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Based on review of staffing records and staff interview, it was determined the CAH failed to verify staff were properly licensed and trained for 3 of 20 facility staff and 3 of 3 contracted providers reviewed. Failure of the CAH to ensure staff were trained, licensed, certified, or registered had the potential to result in unqualified personnel working within the CAH. Findings include:

1. The facility's policies and procedures were reviewed. Policies related to ensuring contracted staff were appropriately trained, licensed, certified, or registered could not be found. The Director of Human Resources verified during an interview on 5/05/10 at 9:50 AM, that the facility did not have such a policy.

Failure of the facility to develop, approve and implement policies resulted in inadequate staff training as follows:

a. The CAH's Central Service Policy #6, not dated or signed, stated, "All equipment used at [CAH's name] will be cleaned/sterilized as appropriate to its manufacture and use."

During a tour of the GI Clinic on 5/05/10 starting 12:53 PM, it was noted that the CAH used Cidex Plus to do high-level disinfection of its endoscopes. High-level disinfection is the process that kills all microbial organisms.

According to Johnson & Johnson, the manufacturer of Cidex Plus, "High-level disinfection is acceptable for GI endoscopes..." A review of the package insert on the bottle of Cidex Plus showed the following recommendations:

"The use period for activated CIDEX PLUS solution is up to a maximum of 28 days following activation or sooner, as indicated by the CIDEX PLUS Solution Test Strips...Solution can be reused for a period not to exceed 28 days provided the required conditions of glutaraldehyde concentration, pH, and temperature exist based upon monitoring described in directions for use...Test the solution prior to each use to assure that the glutaraldehyde concentration is above its MEC (minimum effective concentration)."

In an interview 5/05/10 at 12:45 PM, with the CNA, ER/Endoscopy Technician, who did all of the endoscopy cleaning, he stated the person who trained him told him as long as test strip comes out positive there is no need to change the solution. No documentation of this training was found.

The facility failed to ensure staff were trained on appropriate use of high-level disinfection chemicals necessary to ensure infection control.

b. The CAH's Central Service Policy #3, Resterilization of Supplies, and Policy #12, Resterilization of Packs and Trays, last reviewed on 1/17/08, stated an Attest was to be used with every load autoclaved.

The American National Standard dated 2006, stated "Biological indicators should be used...for routine sterilizer efficacy monitoring at least weekly, but preferably every day that the sterilizer is in use." A biological indicator (spore test) is a device used to monitor the sterilization process of the autoclave. It consists of a standardized population of bacterial spores. A biological indicator monitors the autoclaving cycle and ensures that all the parameters necessary for sterilization were present during the autoclaving process.

During a tour of the CAH's Sterile Processing unit on 5/4/10 starting at 2:43 PM, it was noted that instruments used for patient care were autoclaved.

The CAH's "ATTEST Biological Monitoring System for Steam Sterilization" log sheets, documented the last time an Attest was run was 12/21/07. The CAH did use a chemical indicator with each load that was autoclaved. However, without the use of weekly biological indicators, in conjunction with the chemical indicators, the facility could not ensure that the parameters necessary for sterilization were present.

The DON was present during the tour. She did not know what an Attest was.

On 5/05/10 starting at 9:25 AM, the CS Technician was interviewed. She stated that she was trained 18 years ago on how to autoclave instruments. However, she stated that she had not performed autoclaving for many years and stated she started her current CS job on 1/04/10. She stated she did not know what an Attest was or how to run one.

On 5/05/10 starting at 9:30 AM, the CS Director was interviewed. She stated she did not know what an Attest was for.

The facility failed to ensure staff were trained regarding Attest biological monitoring necessary to ensure infection control.

2. The Director of Human Resources, in an interview on 5/05/10 at 9:50 AM, stated the CAH worked with numerous contract agencies and not all contracted personnel had a personnel file with the CAH. Three contracts were reviewed. Missing from the contracted personnel files were documentation of licensure, CPR, orientation, TB screening, in-service attendance, and job description.

She confirmed that the CAH had no individual files for any contracted personnel who had worked at the facility.

The CAH failed to ensure policies and procedures were developed, approved by the Governing Body and implemented to ensure the appropriate licensing, certification, and training of all facility and contract staff.

Based on review of policies, patient records, and staff interview, it was determined the Governing Body failed to ensure it had developed and maintained an effective organizational structure. This resulted in the CAH's inability to ensure quality health care was provided and had the potential to impact all patients seeking medical services at the CAH. Findings include:

1. Refer to C-241 as it relates to the failure of the Governing Body to ensure it had implemented and/or enforced policies governing the CAH's operations.

2. Refer to C-270, Condition of Participation: Provision of Services and related standard level deficiencies as they relate to the failure of the Governing Body to ensure patients received appropriate care and services.

3. Refer to C-330, Condition of Participation: Periodic Evaluation and Quality Assurance Review and related standard level deficiencies as they relate to failure of the Governing Body to ensure a data driven QA program was developed and implemented.

The cumulative effect of these systemic practices compromised the Governing Body's ability to ensure staff provided quality health care.

5. A review of the CAH's policies & procedure titled, "Emergency Crash Carts," was not dated and not signed by the governing body. "Nursing personnel is responsible to check the crash cart two times monthly for outdates and appropriate stock levels." The policy did not provide direction to personnel when outdated medication was found. The facility failed to ensure the policy was sufficiently developed and implemented to ensure outdated drugs were removed from the crash cart as follows:

On 5/03/10 at 2:30 PM, a tour of the ED was conducted. The ED unit was located off a main hallway in a high traffic area for patients, visitors, and staff. The doors of the two ED rooms were open, and the rooms were unattended.

The crash cart was against the wall in clear vision to the open door. The crash cart was unlocked. Medications were in the drawer such as, Sodium Bicarbonate, Epinephrine, Atropine and IV solutions of Dextrose and Normal Saline. These medications were accessible to unauthorized personnel, patients, and visitors. In a carrier on the crash cart was an oxygen tank, with the indicator on empty, indicating the tank needed to be replaced.

Additionally, in the Emergency Room, on the storage shelves was an IV solution, (1) liter bag of Lactated Ringers that expired 3/10 and Silver Nitrate sticks, one container, open, that expired 5/07.

On 5/03/10 starting at 4:00 PM, an ED nurse was interviewed. She verified the findings of open and accessible crash cart, expired drugs, empty oxygen tank. The ED nurse stated when the ED is unattended the rooms are under camera surveillance which are monitored at the main nursing station.

Additionally, the "Emergency Crash Carts," policy did not include information regarding the locking of crash cart medications and no additional policy was found documenting that crash carts should be locked. The lack of policy was confirmed during a phone interview on 5/12/10 at 10:45 AM, with the pharmacy technician

The CAH failed to follow established standards of practice and policies in management of medications.

6. The facility's policy for VERBAL AND WRITTEN ORDERS, for the Emergency Department, undated, stated: "Verbal orders for medication shall be received and recorded by the pharmacist or licensed nurse. The order will be written on the physician order sheet by the person receiving the order and noting the date and time received, the name of the licensed independent practitioner issuing the order and the receiver's name and title."

However, the patients' medical records did not include physician orders for all drugs which were administered, as well as, occasions where drugs were ordered and not given. Examples include:

a. Patient #2 was a 53-year-old male who was seen in the ED on 4/30/10 for lower back pain. On the Provider Order and Documentation Record, dated 4/30/10, but untimed, Flomax 0.4 mg (a medication that relaxed smooth muscle and improved flow of urine), was ordered. There was no documented evidence that Patient #2 received Flomax as ordered. The ER Record contained a nursing note entry that Patient #2 was given Zofran 4 mg (medication to suppress nausea). However no order for the medication was found in Patient #2's record.

On 5/05/10 starting at 9:20 AM, the DON was interviewed. She was unable to determine if Patient #2 had received the dose of Flomax. The DON could not explain why Patient #2 received the dose of Zofran without an order.

b. Patient #4 was a 27-year-old female, who had inadvertently taken the wrong medication, and was seen in the ED on 7/20/09. Review of Patient #4's medical record documented a nicotine patch was administered at 4:08 PM. There was no evidence of a written order for the nicotine Patch.

On 5/05/10 starting at 9:20 AM the DON was interviewed. She reviewed the record for Patient #4 and verified the absence of an order for the nicotine patch.

c. Patient #10 was a 26-year-old female who was seen in the ED on 1/19/10 for pregnancy complications and cramping. The Emergency Record, dated 1/19/10 at 7:15 PM, documented Patient #10 received Ampicillin 1 gram IV (an antibiotic used as a precaution if pre-term labor was the result of an infection), and approximately 600 ml of IV fluid. There was no written orders for the IV fluid and antibiotic given.

On 5/05/10 starting at 9:20 AM the DON was interviewed. She reviewed the record for Patient #10, and was unable to find an order for the Ampicillin and IV fluid that was administered.

d. Patient #22 was a 52-year-old male who was seen in the ED on 12/01/09 for hypoglycemia. Review of Patient #22's Emergency Room Record documented that on 12/01/09, between 12:25 and 12:40, Patient #22 received Dextrose 50% (1) ampule, Glucose Gel (1) tube (medications used for the rapid treatment of low blood sugar), and Normal Saline (IV) 400 ml. There were no written orders for the medications provided.

On 5/05/10 starting at 9:20 AM the DON was interviewed. She verified the medications had been administered without a written order.

The CAH failed to ensure that the policy for administration of medications was followed.

7. The facility's Medication Administration policy, that was not dated and not documented as being approved by the governing body, did not identify that PRN medications needed to be assessed for effectiveness and to document the assessment. Without consistent documentation, the facility would not be able to assess and report to the physician the effectiveness of the medications and treatments, which directly impacted patients as follows:

a. Patient #15 was an 83-year-old male admitted on 4/21/10 for generalized ataxia (a neurological sign and symptom consisting of gross lack of coordination of muscle movements) and probable stroke. His MAR dated 4/24 - 5/03/10, were reviewed and documented he received Ativan (a medication for anxiety) for agitation no less than 10 times. However, his record did not contain documentation of the effectiveness of the medications and treatments.

Additionally, Patient #15's record included a nursing note dated 4/24/10 at 2:10 AM stated "Ativan given x 2 this shift." Patient #15's MAR only documented that Ativan was given once on 4/24/10 at 10:00 PM. A second nursing note dated 4/25/10 from 6:00 PM to 4/26/10 at 6:00 AM, stated Ativan was given twice during the shift. However, Patient #15's MAR only documented that Ativan was given once on 4/25/10 at 10:00 PM.

When asked during an interview on 5/03/10 at 2:30 PM, the DON confirmed the lack of documentation and stated the effectiveness of the medications and treatments should be documented.

b. Patient #14 was a 95-year-old female admitted on 4/29/10 for continued care following a hip fracture. Her MAR dated 4/29 - 5/03/10, was reviewed and documented she received prn Vicodin 14 times, prn Ativan twice, and prn Tylenol once. However, her record did not contain documentation of the effectiveness of the medications.

The DON confirmed on 5/03/10 at 2:30 PM, the record did not contain information regarding the effectiveness of PRN medications.

c. Patient #13 was a 66-year-old female who was admitted to the CAH on 4/05/10 for generalized ataxia. Her MAR, dated 4/05 - 4/20/10, was reviewed and documented she received prn Avitan 6 times and prn Hydrocodone 8 times. However, her record did not contain documentation of the effectiveness of the medications.

The DON confirmed on 5/03/10 at 2:30 PM, the record did not contain information regarding the effectiveness of PRN medications.

d. Patient #12 was a 71-year-old female who was admitted to the CAH on 2/26/10 for post care after a total knee surgery. Her MAR dated 2/26 - 3/09/10, was reviewed and documented she had received prn Percocet 29 times. However, her record did not contain documentation of the effectiveness of the medications.

The DON confirmed on 5/03/10 at 2:32 PM, the record did not contain information regarding the effectiveness of PRN medications.

The CAH failed to ensure records contained accurate comprehensive information including all medications administered, medication doses and information regarding the effectiveness of PRN medications.

8. The CAH's Restraint policy that was not documented as being approved by the Governing Body, defined a physical restraint as any device that restricts the freedom of movement.

Patient #14 was a 95-year-old female admitted on 4/29/10 for continued care following a hip fracture. Patient #14 was observed to be confused and often tried to get out of bed. A Quality Management Memo, dated 5/01/10, stated Patient #14 had fallen out of the bed at 4:45 AM. On 5/03/10 at 3:00 PM, Patient #14 was observed in bed with all four bed rails up.

On 5/03/10 at 3:05 PM, Patient #14's LPN was asked why all four bed rails were up. She stated that Patient #14 had Alzheimers and the side rails helped keep her in bed. She acknowledged this was a restraint and put 2 of the four bed rails down.

However the facility's Restraint policy failed to identify 4 bed rails as a restraint. The facility failed to ensure the Restraint policy was sufficiently developed.

9. The CAH's Central Service Policy #3, Resterilization of Supplies, and Policy #12, Resterilization of Packs and Trays, last reviewed on 1/17/08, stated an Attest was to be used with every load autoclaved. This policy was not followed. Examples include:

The CAH's "ATTEST Biological Monitoring System for Steam Sterilization" log sheets, documented the last time an Attest was run was 12/21/07. The CAH did use a chemical indicator with each load that was autoclaved. However, without the use of weekly biological indicators, in conjunction with the chemical indicators, the facility could not ensure that the parameters necessary for sterilization were present.

The DON was present during the tour. She did not know what an Attest was.

On 5/05/10 starting at 9:25 AM, the CS Technician was interviewed. She stated that she was trained 18 years ago on how to autoclave instruments. However, she stated that she had not preformed autoclaving for many years and stated she started her current CS job on 1/04/10. She stated she did not know what an Attest was nor how to run one.

On 5/05/10 starting at 9:30 AM, the CS Director was interviewed. She stated she did not know what an Attest was for.

The facility failed to ensure the Central Service Policy #3, Resterilization of Supplies, and Policy #12, Resterilization of Packs and Trays, was implemented.

10. The CAH's Central Service Policy #1, Objectives of Central Services, last reviewed on 1/17/08, stated, "Central Services will maintain an accurate record of the various processes of cleaning, disinfecting, and sterilization."

During a tour of the CAH's Sterile Processing unit on 5/04/10 starting at 2:43 PM, and the ED on 5/04/10 starting at 3:00 PM, it was noted that more than 100 instruments, such as clamps, scissors and tweezers, that were autoclaved did not have a sterilizer load number, or a date written on the package as to when they were autoclaved. Additionally, the Sterile Processing unit did not have a log book that contained sterilizer load number, dates or contents of autoclaved instruments. This was confirmed by the DON during the observations. This had the potential to effect the CAH's ability to recall suspected contaminated equipment and pull outdated stock.

The CAH's Central Service Policy #9, Expiration Dates, last reviewed on 1/17/08 stated, "Dates will be marked in indelible ink and placed on package side which will face the person opening the package." Additionally, The CAH's Central Service Policy #8, Shelf life of packaged materials, last reviewed on 1/17/08, stated the following:

"Autoclave tape, marked with the expiration date is to be placed on autoclaved packages."
" Single wrapped items will have a shelf life of no greater than one month."
" Double wrapped packs, basins and linens will have a shelf life of no greater than three months."
" Items wrapped in plastic will have a shelf life of no greater than six months."
" All outdated items will be removed from service area on day of expiration and returned to CS."

The facility failed to ensure policies were followed.

11. The CAH's Rules and Regulations of the Medical Staff (Bi-Laws), dated 09/06 stated, a discharge summary should contain brief notations concerning medical complaint, history, physical findings, pertinent lab and radiology findings, treatments including complications, hospital course, condition on discharge and follow-up instructions and treatment. The Bi-Laws were not implemented as follows:

- Patient #12 was a 71-year-old female who was admitted to the CAH on 2/26/10 for post care after a total knee surgery. She was discharged on 3/10/10.

Patient #12's discharge summary was hand written on the record's inpatient face sheet that had the address and the billing information for Patient #12. The discharge summary did not include history, physical findings, pertinent lab and radiology findings, treatments including complications, hospital course, or condition on discharge.

On 5/04/10 at 2:45 PM, the CAH's HIS manager was interviewed. She reviewed Patient #12's discharge summary and stated that the lack of documentation was typical for Patient #12's physician.

The facility failed to ensure discharge procedures were implemented.

12. The HIS director was interviewed on 5/04/10 starting at 1:30 PM. She stated that the CAH did not have a policy in place to direct staff as to when their evaluations and progress notes were to be recorded in the patient's record. This resulted in patient's medical records being incomplete as follows:

- Patient #14 was a 95-year-old female admitted on 4/29/10 for continued care following a hip fracture. Patient #14's physician had ordered PT five times a week and an OT evaluation on 4/29/10. Patient #14's record was reviewed on 5/03/10. The record contained no documented evidence that PT had evaluated Patient #14 or had been providing PT five times a week. Additionally, the record contained no documented evidence that OT had evaluated Patient #14.

On 5/03/10 at 2:17 PM, an RN called the OT/PT clinic to see if they had evaluated and were treating Patient #14. She stated that PT had evaluated Patient #14 and was treating her. However, she stated it was often that the Physical Therapist did not "turn in his evaluations and notes." She further stated that OT had not received the order to evaluate Patient #14 and that was why it was not done.

- Patient #15 was an 83-year-old male admitted on 4/21/10 for generalized ataxia (a neurological sign and symptom consisting of gross lack of coordination of muscle movements) and probable stroke. Patient #15's physician had ordered PT seven times a week. Patient #15's record was reviewed on 5/03/10. The record contained no documented evidence that PT had evaluated Patient #14 or had been providing PT seven times a week.

On 5/03/10 starting at 2:10 PM, a PTA was interviewed. She stated that PT had evaluated Patient #15 and was treating him. However, she stated that the Physical Therapy department did not "turn in their evaluations and notes for an extended period of time." She further stated that she had worked with Patient #15 two times a week but could not provide documented evidence that anyone had provided PT services the other 5 days a week.

The CAH failed to ensure policies were developed, approved by the Governing Body, implemented and monitored to ensure PT and OT services had provided and/or documented specialized rehabilitative services per physician's orders.


21595

Based on review of policies, patient records, and staff interview, it was determined the Governing Body failed to ensure it had sufficiently developed, implemented and/or enforced policies governing the CAH's operations. This failure directly impacted 18 of 39 patients (#1, #2, #4, #5, #7, #10, #13, #12, #14, #15, #20, #22, #26, #27, #30, #31 and #33 - #39) reviewed and had the potential to impact all patients seeking medical services at the CAH. This resulted in the CAH's inability to direct staff on how to provide quality health care in a safe environment. Findings include:

1. The facility's policy "COMPLAINT/GRIEVANCE REPORTING AND INVESTIGATION," dated 3/22/05, documented, "The Complaint/Grievance Log will indicate the date and nature of final resolution."

Patient #26 was a 64-year-old female who received a colonoscopy (examination of the colon through a sigmoidoscope or a colonoscope) on 5/21/08. During a phone interview, conducted on 5/04/10 at 8:30 AM, Patient #26 stated that she had written a letter of grievance to the CAH, dated 2/05/10 and received a written response from the CEO/Administrator, dated 3/05/10.

The Complaint/Grievance log was reviewed on 5/04/10 at 3:00 PM. Review of grievances dated 1/08 to 5/03/10 documented no evidence of Patient #26's grievance.

In an interview conducted with the Quality Improvement Coordinator on 5/04/10 at 3:15 PM, she stated she had no information on Patient #26's grievance.

The CEO/Administrator confirmed in an interview conducted 5/04/10 at 3:25 PM, that Patient #26's information was missing from the Complaint/Grievance Log but he was aware of her concern.

The Governing Body failed to ensure the CAH followed its established Complaint/Grievance policy.

2. The facility's policies and procedures were reviewed. Policies related to ensuring contracted staff were appropriately trained, licensed, certified, or registered could not be found. The Director of Human Resources verified during an interview on 5/05/10 at 9:50 AM, that the facility did not have such a policy. She stated the CAH worked with numerous contract agencies and not all contracted personnel had a personnel file with the CAH. Three contracts were reviewed. Missing from the contracted personnel files were documentation of licensure, CPR, orientation, TB screening, in-service attendance, and job description.

The CAH failed to ensure policies and procedures were developed, approved by the Governing Body and implemented to ensure the appropriate licensing, certification, and training of all facility and contract staff.

3. Review of the CAH's policy and procedures, "TRANSFER POLICY," dated 4/01/05, detailed the process for the transfer of patients. The policy stated the "Consent for Transfer" form was to be completed. However, review of patient records documented Patients #1, #2, #7, #10, #30, and #31 were transferred without complete documentation of transfer orders.

On 5/05/10 starting at 9:20 AM, the CAH DON was interviewed. She confirmed the patients' "Consent for Transfer" forms were either incomplete or not present in the patients' records.

The CAH failed to ensure that all patients who were transferred to other facilities had appropriate documentation as defined in the written policy.

4. The facility's Emergency Department Log from 10/01/09 to 4/01/10 was reviewed and documented the CAH had 289 non-ED outpatients visits.

On 5/03/10 starting at 2:30 PM, the CAH DON was interviewed. She stated the CAH had a large volume of non-emergency patients that she considered as outpatients. However, she stated that policies and procedures had not been developed for an outpatient department within the CAH. The failure to ensure appropriate policies were developed, implemented and monitored resulted in the potential to compromise patient care as follows:

a. The CAH did not have an established policy for antibiotic infusion rates for outpatients receiving medications.

- Patient #20's 12/23/09 nursing note documented he received Cubicin (an antibiotic) at 12:05 PM, and completed at 12:30 PM. This was 25 minutes. (Nursing 2010 Drug Handbook recommended the antibiotic be infused over 30 minutes). Additionally, a nursing note on 12/29/09, Patient #20's Cubicin administration started at 8:30 AM and was completed at 8:55 AM, after an infusion of 25 minutes.

On 5/05/10 starting at 9:20 AM, the DON was interviewed. She stated she was unaware the staff did not follow the 30 minute infusion recommendation.

The facility failed to ensure policies to guide the staff in antibiotic infusion rates were developed, implemented and monitored.

b. "Percutaneous Inserted Central Catheter" is an intravenous catheter inserted in a small vein, usually in the arm, and then advanced to a point just outside of the heart for drug administration into a much larger vessel. PICC lines are often used for long term antibiotic usage. The failure to follow specific guidelines for the management of those special IV access devices could result in a PICC becoming blocked, dislodged, or damaged.

The CAH did not have a written policy for the use of infusion devices to be used with PICC lines and other vascular access devices.

- Patient #20 was an 81-year-old male who had a MRSA infection. Patient #20 was seen as an outpatient on a daily basis for IV antibiotic therapy from 11/06/09 to 12/30/09. Patient #20 had a right forearm PICC. On 11/09/09, timed at 7:28 AM, a nursing note documented the antibiotic was infused by "gravity" flow.

According to Lippincott Manual of Nursing Practice Eighth Edition, "Positive pressure (pump) flushing will keep the PICC from clotting."

On 5/05/10 starting at 9:20 AM, the DON was interviewed, she stated she was unaware of how the staff infused medications through PICCs. She was unable to produce a policy regarding PICC infusion management and patient care.

The CAH failed to establish written policy and procedures for outpatient care of patients with vascular acces devices such as a PICC.

c. The CAH did not have an established policy for the monitoring of outpatients for complications after receiving IV antibiotics. This had the potential of patients being discharged without a thorough assessment of the patients' response to the medications given.

- Patient #27 was a 46-year-old male, who required IV antibiotic treatment for a throat abscess. He was seen as an outpatient on 4/12/10 and 4/13/10 for the antibiotic administration. Patient #27 was discharged on both days immediately after the antibiotic infusion had completed. Review of the records for Patient #27 did not indicate discharge vital signs were done, or a delay in his discharge to allow evaluation of tolerance to the medication given.

- Patient #20 was an 81-year-old male who had a MRSA infection. Patient #20 required many outpatient visits for IV antibiotic therapy. Patient #20's nursing notes from 11/06/09 - 12/30/09 were reviewed. No less than 14 nursing notes documented his discharge (all within 5 minutes) after the completion of the antibiotic and no time provided for the evaluation of his response to the medication.

On 5/04/10 at 11:45 AM, the CAH's Medical Director was interviewed. He stated it was a standard of practice for any patient that received antibiotics, to be held for 15 minutes after completion of the antibiotics to assess for complications. That assessment included vital signs. The CAH's outpatient department did not have a policy to direct staff in this standard of practice.

The CAH failed to establish a policy for the monitoring of outpatients that had received antibiotic therapy.

d. The CAH did not have an established policy for PICC dressing changes, or management of PICC complications. The failure of staff to follow a consistent and detailed process for changing the PICC dressing had the potential for increased patient infection rates, dislodgement of the catheter, and variations in staff technique. The absence of the policy for PICC complications had the potential of staff caring for patients with PICCs to not recognize when the catheter was not functioning properly. Examples include:

Lippincott Manual of Nursing Practice Eighth Edition states, "Dressing change should be performed 24 hours after insertion and then weekly." Lippincott further advises, "An X-ray to determine placement of central catheter [PICC] is necessary for all devices that deliver fluid into the subclavian vein or superior vena cava."

- Patient #20 was an 81-year-old male who had a right forearm PICC. In an outpatient nursing note dated 11/08/09, (untimed), noted Patient #20's PICC dressing was changed. The note stated the PICC had pulled out to approximately 20 cm, which is approximately 8 inches. The PICC insertion site was in the right forearm, and 8 inches would not ensure that the PICC was in proper placement as a central line. There was no indication that an x-ray was done to confirm placement, or if the physician was notified regarding the PICC position change. Patient #20's record did not indicate where the placement of the PICC was initially.

In a nursing note dated 11/09/09, (untimed), Patient #20 required lab work drawn, and the nurse was unable to draw blood from the PICC line, but was able to flush the line and administer the antibiotic. Inability to draw back blood from a PICC can indicate improper placement.

On 5/05/10 starting at 9:20 AM, the DON was interviewed, she was unable to produce a policy or guidelines for the outpatient department staff to follow relating to PICC treatments. The DON re-confirmed there were no outpatient policies that included IV therapy and PICC line management.

The CAH failed to establish written policies and procedures for the management of outpatients with PICC line complications.

e. The CAH did not have an outpatient policy related to patient teaching. The lack of a policy for patient education had the potential to result in the patient not recognizing complications or side effects from therapy administered by the CAH outpatient department. Examples include:

- Patient #27 was a 46-year-old male, who required IV antibiotic treatment for a throat abscess. He was seen as an outpatient on 4/12/10 and 4/13/10 for the antibiotic administration. There was no indication of patient education regarding the medication and potential serious side effects which included fatal ulcerative colitis (in which the large intestine becomes inflamed and ulcerated, leading to episodes of bloody diarrhea, abdominal cramps, and fever).

- Patient #20 was an 81-year-old male who had a MRSA infection. Patient #20 required many outpatient visits for IV antibiotic therapy. Review of Patient #20's nursing notes did not indicate patient education was provided regarding areas such as PICC precautions, side effects of medication, or MRSA precautions.

On 5/05/10 starting at 9:20 AM, the DON was interviewed, she was unable to say if patient education was provided routinely to outpatients. She confirmed that outpatient policies to direct staff regarding patient educational needs were not developed.

f. The CAH did not have an outpatient policy that detailed how and when outpatient vital signs were to be taken and recorded. This had the potential to result in the failure to monitor and assess patient response to the therapy provided by the CAH. Examples include:

- Patient #20 was an 81-year-old male who had a MRSA infection. Patient #20 required many outpatient visits for IV antibiotic therapy. Review of Patient #20's outpatient visits from 12/09/09 - 12/30/09 showed failure to record discharge vital signs on no less than 9 occasions.

On 5/05/10 starting at 9:20 AM, the DON was interviewed, and verbalized concern that the staff providing outpatient care had not been consistent with taking and recording of vital signs as well as completing other documentation.

The CAH failed to develop a policy for taking of outpatient vital signs and the documentation of such.

g. The CAH did not have a written policy for caring for outpatients with isolation precautions. The lack of a policy for the management of outpatients with highly contagious communicable diseases had the potential to expose staff, patients, and visitors to otherwise preventable illness. Examples include:

- Patient # 20 was an 81-year-old male with MRSA, requiring IV therapy as an outpatient from 11/06/09 to 12/30/09. The nursing notes for Patient #20 did not indicate isolation precautions were taken.

On 5/05/10 starting at 9:20 AM, the DON was interviewed. She verified that Patient #20 was being treated for MRSA. When asked about precautions the staff took in caring for Patient #20, she stated the staff had an isolation cart placed by the room. The DON was not able to verify if the staff utilized contact isolation precautions and stated she did not think the staff had used any extra measures after Patient #20 was discharged when cleaning the room that he had been in.

The CAH failed to develop a policy for the management of outpatients and isolation requirements.

h. The CAH did not have written policies and procedures to define and guide the staff in the management of outpatient care. This lack of ability to separate outpatient from emergency patient status had the potential for confusion in the staff and ancillary services providing care. Further, it prevented the CAH from identification of quality indicators for improving patient outcome. Examples include:

- Patient #5 was a 28-year-old male who was seen in the ED on 7/26/09. He was entered into the ED log with a notation of "OP" indicating he was an outpatient. Review of Patient #5's medical record documented two dictated notes by the FNP, each dated 7/26/09. The dictated reports were both titled "Emergency Room Report" and the face sheet described the patient type as "ER". The Emergency Room Record as well as the ER Provider Order and Documentation Record were present in the record. The "Admission Agreement" was signed by Patient #5 on 7/25/09.

On 5/05/10 starting at 9:20 AM, the DON was interviewed. She stated Patient #5 was seen as an outpatient on 7/26/09 to follow up with lab work done the previous day. The DON confirmed there was no consent for services signed by Patient #5, or face sheet for the 7/26/09 visit in the medical record. The DON stated the facility practice was to put each patient being seen in to the Emergency Room Record. She stated there is no separate Outpatient Department where patients are seen, and there are no guidelines, or policies for the management of outpatients. She reviewed the "Admission Agreement" signed by Patient #5, and was not able to clarify if the form included treatment for outpatient services.

The CAH failed to ensure that written policies and procedures for outpatient services were developed and utilized.

Based on staff interview, review of medical records and hospital policies, it was determined the hospital failed to ensure staff followed established policies related to the transfer of patients for additional medical care. This failure directly impacted 6 of 10 patients (#1, #2, #7, #10, #30, and #31) requiring transfer to other facilities whose ED records were reviewed and had the potential to impact all patients requiring a transfer to another facility. The failure of staff to follow policy had the potential to contribute to miscommunication between healthcare workers from each facility and potential negative impacts to the patients' health. Findings include:

1. Review of the CAH's policy and procedures, "TRANSFER POLICY," dated 4/01/05, detailed the process for the transfer of patients. The policy stated the "Consent for Transfer" form was to be completed. However, review of patient records documented the following:

a. Patient #1 was a 16-year-old male who was brought to the ED on 4/29/10 by the police. Patient #1 complained of hearing voices telling him to harm his peers at school. A nursing note, dated 4/29/10 and timed 2:05 PM, stated the referral facility was contacted regarding a transfer. However, the nursing note did not include information that Patient #1 was accepted or the name of an accepting physician. The FNP dictated note, dated 4/29/10, stated Patient #1 must be admitted to a behavioral health unit for evaluation. On the EMERGENCY ROOM RECORD, under "Discharge" the box "other" was checked, with the name of the referral facility. The last nursing entry, timed 4:45 PM, stated: "Father, Mother, patient agree to admission, instructed to go quickly to (the referral facility), not delay." The record did not contain the "Consent for Transfer" form.

On 5/05/10 starting at 9:20 AM, the CAH DON was interviewed. She confirmed the "Consent for Transfer" form was not present in Patient #1's record, and there was no evidence of a notice of acceptance by the facility or of an accepting physician.

b. Patient #2 was a 53-year-old male, who presented to the ED on 4/30/10 with lower back pain. The physician who provided care for Patient #2 arranged for transfer to a receiving facility. The "Consent for Transfer form," section III, "Transfer Consent" was signed by Patient #2, but the areas to be filled in with the accepting physician, as well as the name of the facility, were left empty. On the reverse side of the form, titled "Physician Assessment and Certification" the referring physician listed the accepting physician, but not the facility.

On 5/05/10 starting at 9:20 AM, the CAH DON was interviewed. She confirmed the "Consent for Transfer" form for Patient #2 included areas that were not complete. The DON stated the ED nurse was responsible for completing the paperwork.

c. Patient #7 was a 22-year-old female who arrived via ambulance in active labor on 9/13/09. The physician found Patient #7 to be completely dilated, with the baby's head presenting. The physician and nurse then got into the ambulance and traveled with Patient #7 to the referral facility. The medical record of Patient #7 did not contain a "Consent for Transfer."

On 5/05/10 starting at 9:20 AM, the CAH DON was interviewed. She confirmed the "Consent for Transfer" form was not completed, as Patient #7 never left the ambulance.

d. Patient #10 was a 26-year-old female who was 19 weeks pregnant and presented to the ED with cramping, abdominal pain and vaginal bleeding. The dictated note by the physician who provided care for Patient #10 stated the name of the accepting physician and facility she would be transferred to. The "Consent for Transfer" form was signed by Patient #10, but the areas to be filled in with the accepting physician as well as the name of the facility were left empty.

On 5/05/10 starting at 9:20 AM, the CAH DON was interviewed. She confirmed the "Consent for Transfer" form for Patient #10 had areas that were not complete.

e. Patient #30 was a 40-year-old female who quickly, and without assistance delivered her baby (Patient #31) in the CAH parking lot in a wheelchair on the way to the ED on 9/19/09. Patient #30 and #31 were transported to a referral facility for newborn and postpartum care. The "Consent for Transfer" was not signed by Patient #30 and the "Consent for Transfer" form was not in the record of Patient #31.

On 5/05/10 starting at 9:20 AM, the CAH DON was interviewed. She confirmed the Consent for Transfer form for Patient #31 was not in the record. The DON stated the ED nurse was responsible for completing the paperwork.

The CAH failed to ensure that all patients who were transferred to other facilities had appropriate documentation as defined in the written policy.

Based on review of policies, medical patient records, and staff interview, it was determined the CAH failed to ensure systemic practices were developed, implemented, and monitored for all patients receiving care at the facility. This failure resulted in departments which were not defined and organized and impeded the ability of the CAH to effectively provide safe, quality care. Findings include:

1. Refer to C-271 as it relates to the failure of the CAH to establish written policies and procedures related to OP services.

2. Refer to C-281 as it relates the failure of the CAH to define outpatient services and demonstrate integration of policies and procedures, oversight of infection control, and quality management.

3. Refer to C-276 as it relates to the failure of the CAH to follow established standards of practice in management of medications.

The cumulative effect of these systemic practices compromised the CAH's ability to effectively provide safe and quality care.

Based on staff interview, and review of medical records and CAH policies, it was determined the CAH failed to establish written policies and procedures related to OP services. The lack of policies for outpatient services directly impacted 3 of 5 patients (#5, #20 and #27) whose outpatient records were reviewed and had the potential to impact all patients receiving outpatient services. This had the potential to compromise the quality of patient care. Findings include:

1. The facility's Emergency Department Log from 10/01/09 to 4/01/10 was reviewed and documented the CAH had 289 non-ED outpatients visits.

On 5/03/10 starting at 2:30 PM, the CAH DON was interviewed. She stated the CAH had a large volume of non-emergency patients that she considered as outpatients. However, she stated that policies and procedures had not been developed for an outpatient department within the CAH. The failure to ensure appropriate policies were developed, implemented and monitored resulted in the potential to compromise patient care as follows:

a. The CAH did not have an established policy for antibiotic infusion rates for outpatients receiving medications. This had the potential for the delivery of antibiotics over varying times, resulting in the potential for untoward side effects.

- Patient #20 was an 81-year-old male who had an MRSA infection (Methicillin-resistant Staphylococcus aureus is a bacterial infection that is highly resistant to some antibiotics). In a nursing note on 12/23/09, it was documented Cubicin (an antibiotic) was given to Patient #20 at 12:05 PM, and completed at 12:30 PM. This was 25 minutes. (Nursing 2010 Drug Handbook recommended the antibiotic be infused over 30 minutes).

- In a nursing note on 12/29/09, Patient #20's Cubicin administration started at 8:30 AM and was completed at 8:55 AM, after an infusion of 25 minutes.

On 5/05/10 starting at 9:20 AM, the DON was interviewed. She stated she was unaware the staff did not follow the 30 minute infusion recommendation.

The facility failed to ensure policies to guide the staff in antibiotic infusion rates were developed, implemented and monitored.

b. "Percutaneous Inserted Central Catheter" is an intravenous catheter inserted in a small vein, usually in the arm, and then advanced to a point just outside of the heart for drug administration into a much larger vessel. PICC lines are often used for long term antibiotic usage. The failure to follow specific guidelines for the management of those special IV access devices could result in a PICC becoming blocked, dislodged, or damaged.

The CAH did not have a written policy for the use of infusion devices to be used with PICC lines and other vascular access devices.

- Patient #20 was an 81-year-old male who had a MRSA infection. Patient #20 was seen as an outpatient on a daily basis for IV antibiotic therapy from 11/06/09 to 12/30/09. Patient #20 had a right forearm PICC. On 11/09/09, timed at 7:28 AM, a nursing note documented the antibiotic was infused by "gravity" flow.

According to Lippincott Manual of Nursing Practice Eighth Edition, "Positive pressure (pump) flushing will keep the PICC from clotting."

On 5/05/10 starting at 9:20 AM, the DON was interviewed, she stated she was unaware of how the staff infused medications through PICCs. She was unable to produce a policy regarding PICC infusion management and patient care.

The CAH failed to establish written policy and procedures for outpatient care of patients with vascular acces devices such as a PICC.

c. The CAH did not have an established policy for the monitoring of outpatients for complications after receiving IV antibiotics. This had the potential of patients being discharged without a thorough assessment of the patients' response to the medications given.

- Patient #27 was a 46-year-old male, who required IV antibiotic treatment for a throat abscess. He was seen as an outpatient on 4/12/10 and 4/13/10 for the antibiotic administration. Patient #27 was discharged on both days immediately after the antibiotic infusion had completed. Review of the records for Patient #27 did not indicate discharge vital signs were done, or a delay in his discharge to allow evaluation of tolerance to the medication given.

- Patient #20 was an 81-year-old male who had a MRSA infection. Patient #20 required many outpatient visits for IV antibiotic therapy. Patient #20's nursing notes from the following dates reflect his immediate discharge after the completion of the antibiotic and no time provided for the evaluation of his response to the medication as follows:

11/06/09: Patient #20's antibiotics was completed at 7:55 AM. Patient #20 was discharged at 8:00 AM, 5 minutes after completion.

11/07/09: antibiotic completed at 7:45 AM, Patient #20 was discharged at 7:45 AM.

11/08/09: antibiotic completed at 7:50 AM, Patient #20 was discharged at 7:50 AM.

On 11/10/09: antibiotic completed at 2:00 PM, Patient #20 was discharged at 2:00 PM.

On 11/11/09: antibiotic completed at 1:20 PM, Patient #20 was discharged at 1:20 PM.

On 12/17/09: antibiotic completed at 6:00 PM, Patient #20 was discharged at 6:00 PM.

On 12/17/09: antibiotic completed at 4:10 PM, Patient #20 was discharged at 4:10 PM.

On 12/20/10: antibiotic completed at 2:50 PM, Patient #20 was discharged at 2:50 PM.

On 12/24/09: antibiotic completed at 12:30 PM, Patient #20 was discharged at 12:30 PM.

On 12/25/09: antibiotic completed at 11:35 AM, Patient #20 was discharged at 11:40 AM, 5 minutes after completion of the medication.

On 12/26/09: antibiotic completed at 10:05 AM, Patient #20 was discharged at 10:10 AM, 5 minutes after completion of the medication.

On 12/27/09: antibiotic completed at 9:20 AM, Patient #20 was discharged at 9:25 AM, 5 minutes after completion of the medication.

On 12/28/09: antibiotic completed at 10:32 AM, Patient #20 was documented as discharged at 10:30 AM, which was before the antibiotic was completed.

On 12/30/09: antibiotic completed at 9:40 AM, Patient #20 was discharged at 9:40 AM.

On 5/04/10 at 11:45 AM, the CAH's Medical Director was interviewed. He stated it was a standard of practice for any patient that received antibiotics, to be held for 15 minutes after completion of the antibiotics to assess for complications. That assessment included vital signs. The CAH's outpatient department did not have a policy to direct staff in this standard of practice.

The CAH failed to establish a policy for the monitoring of outpatients that had received antibiotic therapy.

d. The CAH did not have an established policy for PICC dressing changes, or management of PICC complications. The failure of staff to follow a consistent and detailed process for changing the PICC dressing had the potential for increased patient infection rates, dislodgement of the catheter, and variations in staff technique. The absence of the policy for PICC complications had the potential of staff caring for patients with PICCs to not recognize when the catheter was not functioning properly. Examples include:

Lippincott Manual of Nursing Practice Eighth Edition states, "Dressing change should be performed 24 hours after insertion and then weekly." Lippincott further advises, "An X-ray to determine placement of central catheter [PICC] is necessary for all devices that deliver fluid into the subclavian vein or superior vena cava."

- Patient #20 was an 81-year-old male who had a right forearm PICC. In an outpatient nursing note dated 11/08/09, (untimed), noted Patient #20's PICC dressing was changed. The note stated the PICC had pulled out to approximately 20 cm, which is approximately 8 inches. The PICC insertion site was in the right forearm, and 8 inches would not ensure that the PICC was in proper placement as a central line. There was no indication that an x-ray was done to confirm placement, or if the physician was notified regarding the PICC position change. Patient #20's record did not indicate where the placement of the PICC was initially.

In a nursing note dated 11/09/09, (untimed), Patient #20 required lab work drawn, and the nurse was unable to draw blood from the PICC line, but was able to flush the line and administer the antibiotic. Inability to draw back blood from a PICC can indicate improper placement.

On 5/05/10 starting at 9:20 AM, the DON was interviewed, she was unable to produce a policy or guidelines for the outpatient department staff to follow relating to PICC treatments. The DON re-confirmed there were no outpatient policies that included IV therapy and PICC line management.

The CAH failed to establish written policies and procedures for the management of outpatients with PICC line complications.

e The CAH did not have an outpatient policy related to patient teaching. The lack of a policy for patient education had the potential to result in patient not recognizing complications or side effects from therapy administered by the CAH outpatient department. Examples include:

- Patient #27 was a 46-year-old male, who required IV antibiotic treatment for a throat abscess. He was seen as an outpatient on 4/12/10 and 4/13/10 for the antibiotic administration. There was no indication of patient education regarding the medication and potential serious side effects which included fatal ulcerative colitis (in which the large intestine becomes inflamed and ulcerated, leading to episodes of bloody diarrhea, abdominal cramps, and fever).

- Patient #20 was an 81-year-old male who had a MRSA infection. Patient #20 required many outpatient visits for IV antibiotic therapy. Review of Patient #20's nursing notes did not indicate patient education was provided regarding areas such as PICC precautions, side effects of medication, or MRSA precautions.

On 5/05/10 starting at 9:20 AM, the DON was interviewed, she was unable to say if patient education was provided routinely to outpatients. She confirmed that outpatient policies to direct staff regarding patient educational needs were not developed.

f. The CAH did not have an outpatient policy that detailed how and when outpatient vital signs were to be taken and recorded. This had the potential to result in the failure to monitor and assess patient response to the therapy provided by the CAH. Examples include:

- Patient #20 was an 81-year-old male who had a MRSA infection. Patient #20 required many outpatient visits for IV antibiotic therapy. Review of Patient #20's outpatient visits showed failure to record discharge vital signs as follows:

12/09/09, no discharge vital signs were noted.
12/19/09, no discharge vital signs were noted.
12/21/09, no discharge vital signs were noted.
12/24/09, no discharge vital signs were noted.
12/25/09, no discharge vital signs were noted.
12/26/09, no discharge vital signs were noted.
12/27/09, Vital signs listed on outpatient chart, but were not timed. The discharge vital signs area was blank.
12/28/09, no discharge vital signs were noted.
12/30/09, no discharge vital signs were noted.

On 5/05/10 starting at 9:20 AM, the DON was interviewed, and verbalized concern that the staff providing outpatient care had not been consistent with taking and recording of vital signs as well as completing other documentation.

The CAH failed to develop a policy for taking of outpatient vital signs and the documentation of such.

g. The CAH did not have a written policy for caring for outpatients with isolation precautions. The lack of a policy for the management of outpatients with highly contagious communicable diseases had the potential to expose staff, patients, and visitors to otherwise preventable illness. Examples include:

- Patient # 20 was an 81-year-old male with MRSA, requiring IV therapy as an outpatient from 11/06/09 to 12/30/09. The nursing notes for Patient #20 did not indicate isolation precautions were taken.

On 5/05/10 starting at 9:20 AM, the DON was interviewed. She verified that Patient #20 was being treated for MRSA. When asked about precautions the staff took in caring for Patient #20, she stated the staff had an isolation cart placed by the room. The DON was not able to verify if the staff utilized contact isolation precautions and stated she did not think the staff had used any extra measures after Patient #20 was discharged when cleaning the room that he had been in.

The CAH failed to develop a policy for the management of outpatients and isolation requirements.

h. The CAH did not have written policies and procedures to define and guide the staff in the management of outpatient care. This lack of ability to separate outpatient from emergency patient status had the potential for confusion in the staff and ancillary services providing care. Further, it prevented the CAH from identification of quality indicators for improving patient outcome. Examples include:

- Patient #5 was a 28-year-old male who was seen in the ED on 7/26/09. He was entered into the ED log with a notation of "OP" indicating he was an outpatient. Review of Patient #5's medical record documented two dictated notes by the FNP, each dated 7/26/09. The dictated reports were both titled "Emergency Room Report" and the face sheet described the patient type as "ER". The Emergency Room Record as well as the ER Provider Order and Documentation Record were present in the record. The "Admission Agreement" was signed by Patient #5 on 7/25/09.

On 5/05/10 starting at 9:20 AM, the DON was interviewed. She stated Patient #5 was seen as an outpatient on 7/26/09 to follow up with lab work done the previous day. The DON confirmed there was no consent for services signed by Patient #5, or face sheet for the 7/26/09 visit in the medical record. The DON stated the facility practice was to put each patient being seen in to the Emergency Room Record. She stated there is no separate Outpatient Department where patients are seen, and there are no guidelines, or policies for the management of outpatients. She reviewed the "Admission Agreement" signed by Patient #5, and was not able to clarify if the form included treatment for outpatient services.

The CAH failed to ensure that written policies and procedures for outpatient services were developed and utilized.

Based of patient record review, staff interview and review of facility policy and procedures, it was determined that the CAH failed to follow established standards of practice and policies in management of medications. The failure to follow established standards of practice and policies had the potential for unauthorized accessibility to medications and possible administration of outdated drugs. Findings include:

1. Idaho Board of Pharmacy IDAPA 27.01.01.254.01.03 Storage of Drugs states, "All drugs shall be stored within the institutional pharmacy in designated areas equipped to ensure proper sanitation, temperature, light, ventilation, moisture control, segregation, and security. (7-1-93)"

The CAH failed to secure medications and remove expired medications from the floor stock. Findings include:

a. On 5/03/10 starting at 1:16 PM, a tour of the ICU was conducted. The ICU was located off a main hallway and directly in view of the nursing station. The door to the ICU was open and the crash cart was in clear view of the open door.

The medication cart was located in the nurses station. In the top drawer was a plastic packet containing six Darvocet N 100 tablets that expired 2/10.

The crash cart, located to the right of an occupied bed, was unlocked. The cart contained one 1000 ml 5% Dextrose intravenous solution that had expired on 5/01/10 and a box of Epinephrine 1:10000 that expired on 5/01/10.



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b. On 5/03/10 at 2:30 PM, a tour of the ED was conducted. The ED unit was located off a main hallway in a high traffic area for patients, visitors, and staff. The doors of the two ED rooms were open, and the rooms were unattended.

The crash cart was against the wall in clear vision to the open door. The crash cart was unlocked. Medications were in the drawer such as, Sodium Bicarbonate, Epinephrine, Atropine and IV solutions of Dextrose and Normal Saline. These medications were accessible to unauthorized personnel, patients, and visitors. In a carrier on the crash cart was an oxygen tank, with the indicator on empty, indicating the tank needed to be replaced.

Additionally, in the Emergency Room, on the storage shelves was an IV solution, (1) liter bag of Lactated Ringers that expired 3/10 and Silver Nitrate sticks, one container, open, that expired 5/07.

On 5/03/10 starting at 4:00 PM, an ED nurse was interviewed. She verified the findings of open and accessible crash cart, expired drugs, empty oxygen tank. The ED nurse stated when the ED is unattended the rooms are under camera surveillance which are monitored at the main nursing station.

A review of the CAH's policies & procedure titled, "Emergency Crash Carts," was not dated and not signed by the governing body. "Nursing personnel is responsible to check the crash cart two times monthly for outdates and appropriate stock levels." The policy did not provide direction to personnel when outdated medication was found. The facility failed to ensure the policy was sufficiently developed and implemented to ensure outdated drugs were removed from the crash cart.

Additionally, the "Emergency Crash Carts," policy did not include information regarding the locking of crash cart medications and no additional policy was found documenting that crash carts should be locked. The lack of policy was confirmed during a phone on 5/12/10 at 10:45 AM, with the pharmacy technician

The CAH failed to follow established standards of practice and policies in management of medications.

Based on staff interview, it was determined the CAH failed to define their outpatient department, develop policies and procedures, and include infection control and quality management over site. Failure of the development of a separate differentiated department providing non-emergency care to patients had the potential to affect patient safety and outcome. Findings include:

1. On 5/03/10 at 3:30 PM, the DON was interviewed. She provided a large black book, titled "Emergency Room Log." The log contained names and details of patients seen in the ED. She explained that all patients seen in the ED were listed in the log provided, and it was noted on the page if the patient was an outpatient or emergency patient.

The DON was not able to provide outpatient policies, procedures, meeting minutes or other information defining the outpatient department as a separate department. She stated there were no quality indicators, process improvements, PIPS, or record audits for the outpatient department.

2. The facility's Emergency Department Log from 10/01/09 to 4/01/10 was reviewed and documented the CAH had 289 non-ED outpatients visits.

On 5/03/10 starting at 2:30 PM, the CAH DON was interviewed. She stated the CAH had a large volume of non-emergency patients that she considered as outpatients. However, she stated that policies and procedures had not been developed for an outpatient department within the CAH. The failure to ensure appropriate policies were developed, implemented and monitored resulted in the potential to compromise patient care as follows:

a. The CAH did not have an established policy for antibiotic infusion rates for outpatients receiving medications.

- Patient #20's 12/23/09 nursing note documented he received Cubicin (an antibiotic) at 12:05 PM, and completed at 12:30 PM. This was 25 minutes. (Nursing 2010 Drug Handbook recommended the antibiotic be infused over 30 minutes). Additionally, a nursing note on 12/29/09, Patient #20's Cubicin administration started at 8:30 AM and was completed at 8:55 AM, after an infusion of 25 minutes.

On 5/05/10 starting at 9:20 AM, the DON was interviewed. She stated she was unaware the staff did not follow the 30 minute infusion recommendation.

The facility failed to ensure policies to guide the staff in antibiotic infusion rates were developed, implemented and monitored.

b. "Percutaneous Inserted Central Catheter" is an intravenous catheter inserted in a small vein, usually in the arm, and then advanced to a point just outside of the heart for drug administration into a much larger vessel. PICC lines are often used for long term antibiotic usage. The failure to follow specific guidelines for the management of those special IV access devices could result in a PICC becoming blocked, dislodged, or damaged.

The CAH did not have a written policy for the use of infusion devices to be used with PICC lines and other vascular access devices.

- Patient #20 was an 81-year-old male who had a MRSA infection. Patient #20 was seen as an outpatient on a daily basis for IV antibiotic therapy from 11/06/09 to 12/30/09. Patient #20 had a right forearm PICC. On 11/09/09, timed at 7:28 AM, a nursing note documented the antibiotic was infused by "gravity" flow.

According to Lippincott Manual of Nursing Practice Eighth Edition, "Positive pressure (pump) flushing will keep the PICC from clotting."

On 5/05/10 starting at 9:20 AM, the DON was interviewed, she stated she was unaware of how the staff infused medications through PICCs. She was unable to produce a policy regarding PICC infusion management and patient care.

The CAH failed to establish written policy and procedures for outpatient care of patients with vascular acces devices such as a PICC.

c. The CAH did not have an established policy for the monitoring of outpatients for complications after receiving IV antibiotics. This had the potential of patients being discharged without a thorough assessment of the patients' response to the medications given.

- Patient #27 was a 46-year-old male, who required IV antibiotic treatment for a throat abscess. He was seen as an outpatient on 4/12/10 and 4/13/10 for the antibiotic administration. Patient #27 was discharged on both days immediately after the antibiotic infusion had completed. Review of the records for Patient #27 did not indicate discharge vital signs were done, or a delay in his discharge to allow evaluation of tolerance to the medication given.

- Patient #20 was an 81-year-old male who had a MRSA infection. Patient #20 required many outpatient visits for IV antibiotic therapy. Patient #20's nursing notes from 11/06/09 - 12/30/09 were reviewed. No less than 14 nursing notes documented his discharge (all within 5 minutes) after the completion of the antibiotic and no time provided for the evaluation of his response to the medication.

On 5/04/10 at 11:45 AM, the CAH's Medical Director was interviewed. He stated it was a standard of practice for any patient that received antibiotics, to be held for 15 minutes after completion of the antibiotics to assess for complications. That assessment included vital signs. The CAH's outpatient department did not have a policy to direct staff in this standard of practice.

The CAH failed to establish a policy for the monitoring of outpatients that had received antibiotic therapy.

d. The CAH did not have an established policy for PICC dressing changes, or management of PICC complications. The failure of staff to follow a consistent and detailed process for changing the PICC dressing had the potential for increased patient infection rates, dislodgement of the catheter, and variations in staff technique. The absence of the policy for PICC complications had the potential of staff caring for patients with PICCs to not recognize when the catheter was not functioning properly. Examples include:

Lippincott Manual of Nursing Practice Eighth Edition states, "Dressing change should be performed 24 hours after insertion and then weekly." Lippincott further advises, "An X-ray to determine placement of central catheter [PICC] is necessary for all devices that deliver fluid into the subclavian vein or superior vena cava."

- Patient #20 was an 81-year-old male who had a right forearm PICC. In an outpatient nursing note dated 11/08/09, (untimed), noted Patient #20's PICC dressing was changed. The note stated the PICC had pulled out to approximately 20 cm, which is approximately 8 inches. The PICC insertion site was in the right forearm, and 8 inches would not ensure that the PICC was in proper placement as a central line. There was no indication that an x-ray was done to confirm placement, or if the physician was notified regarding the PICC position change. Patient #20's record did not indicate where the placement of the PICC was initially.

In a nursing note dated 11/09/09, (untimed), Patient #20 required lab work drawn, and the nurse was unable to draw blood from the PICC line, but was able to flush the line and administer the antibiotic. Inability to draw back blood from a PICC can indicate improper placement.

On 5/05/10 starting at 9:20 AM, the DON was interviewed, she was unable to produce a policy or guidelines for the outpatient department staff to follow relating to PICC treatments. The DON re-confirmed there were no outpatient policies that included IV therapy and PICC line management.

The CAH failed to establish written policies and procedures for the management of outpatients with PICC line complications.

e The CAH did not have an outpatient policy related to patient teaching. The lack of a policy for patient education had the potential to result in patients not recognizing complications or side effects from therapy administered by the CAH outpatient department. Examples include:

- Patient #27 was a 46-year-old male, who required IV antibiotic treatment for a throat abscess. He was seen as an outpatient on 4/12/10 and 4/13/10 for the antibiotic administration. There was no indication of patient education regarding the medication and potential serious side effects which included fatal ulcerative colitis (in which the large intestine becomes inflamed and ulcerated, leading to episodes of bloody diarrhea, abdominal cramps, and fever).

- Patient #20 was an 81-year-old male who had a MRSA infection. Patient #20 required many outpatient visits for IV antibiotic therapy. Review of Patient #20's nursing notes do not indicate patient education was provided regarding areas such as PICC precautions, side effects of medication, or MRSA precautions.

On 5/05/10 starting at 9:20 AM, the DON was interviewed, she was unable to say if patient education was provided routinely to outpatients. She confirmed that outpatient policies to direct staff regarding patient educational needs were not developed.

f. The CAH did not have an outpatient policy that detailed how and when outpatient vital signs were to be taken and recorded. This had the potential to result in the failure to monitor and assess patient response to the therapy provided by the CAH. Examples include:

- Patient #20 was an 81-year-old male who had a MRSA infection. Patient #20 required many outpatient visits for IV antibiotic therapy. Review of Patient #20's outpatient visits from 12/09/09 - 12/30/09 showed failure to record discharge vital signs on no less than 9 occasions.

On 5/05/10 starting at 9:20 AM, the DON was interviewed, and verbalized concern that the staff providing outpatient care had not been consistent with taking and recording of vital signs as well as completing other documentation.

The CAH failed to develop a policy for taking of outpatient vital signs and the documentation of such.

g. The CAH did not have a written policy for caring for outpatients with isolation precautions. The lack of a policy for the management of outpatients with highly contagious communicable diseases had the potential to expose staff, patients, and visitors to otherwise preventable illness. Examples include:

- Patient # 20 was an 81-year-old male with MRSA, requiring IV therapy as an outpatient from 11/06/09 to 12/30/09. The nursing notes for Patient #20 did not indicate isolation precautions were taken.

On 5/05/10 starting at 9:20 AM, the DON was interviewed. She verified that Patient #20 was being treated for MRSA. When asked about precautions the staff took in caring for Patient #20, she stated the staff had an isolation cart placed by the room. The DON was not able to verify if the staff utilized contact isolation precautions and stated she did not think the staff had used any extra measures after Patient #20 was discharged when cleaning the room that he had been in.

The CAH failed to develop a policy for the management of outpatients and isolation requirements.

h. The CAH did not have written policies and procedures to define and guide the staff in the management of outpatient care. This lack of ability to separate outpatient from emergency patient status had the potential for confusion in the staff and ancillary services providing care. Further, it prevented the CAH from identification of quality indicators for improving patient outcome. Examples include:

- Patient #5 was a 28-year-old male who was seen in the ED on 7/26/09. He was entered into the ED log with a notation of "OP" indicating he was an outpatient. Review of Patient #5's medical record documented two dictated notes by the FNP, each dated 7/26/09. The dictated reports were both titled "Emergency Room Report" and the face sheet described the patient type as "ER". The Emergency Room Record as well as the ER Provider Order and Documentation Record were present in the record. The "Admission Agreement" was signed by Patient #5 on 7/25/09.

On 5/05/10 starting at 9:20 AM, the DON was interviewed. She stated Patient #5 was seen as an outpatient on 7/26/09 to follow up with lab work done the previous day. The DON confirmed there was no consent for services signed by Patient #5, or face sheet for the 7/26/09 visit in the medical record. The DON stated the facility practice was to put each patient being seen in to the Emergency Room Record. She stated there is no separate Outpatient Department where patients are seen, and there are no guidelines, or policies for the management of outpatients. She reviewed the "Admission Agreement" signed by Patient #5, and was not able to clarify if the form included treatment for outpatient services.

The CAH failed to ensure that written policies and procedures for outpatient services were developed and utilized.

3. The facility's policy for VERBAL AND WRITTEN ORDERS, for the Emergency Department, undated, stated: "Verbal orders for medication shall be received and recorded by the pharmacist or licensed nurse. The order will be written on the physician order sheet by the person receiving the order and noting the date and time received, the name of the licensed independent practitioner issuing the order and the receiver's name and title."

However, the patients' medical records did not include physician orders for all drugs which were administered, as well as, occasions where drugs were ordered and not given. Examples include:

a. Patient #2 was a 53-year-old male who was seen in the ED on 4/30/10 for lower back pain. On the Provider Order and Documentation Record, dated 4/30/10, but untimed, Flomax 0.4 mg (a medication that relaxed smooth muscle and improved flow of urine), was ordered. There was no documented evidence that Patient #2 received Flomax as ordered. The ER Record contained a nursing note entry that Patient #2 was given Zofran 4 mg (medication to suppress nausea). However no order for the medication was found in Patient #2's record.

On 5/05/10 starting at 9:20 AM, the DON was interviewed. She was unable to determine if Patient #2 had received the dose of Flomax. The DON could not explain why Patient #2 received the dose of Zofran without an order.

b. Patient #4 was a 27-year-old female, who had inadvertently taken the wrong medication, and was seen in the ED on 7/20/09. Review of Patient #4's medical record documented a nicotine patch was administered at 4:08 PM. There was no evidence of a written order for the nicotine patch.

On 5/05/10 starting at 9:20 AM the DON was interviewed. She reviewed the record for Patient #4 and verified the absence of an order for the nicotine patch.

c. Patient #10 was a 26-year-old female who was seen in the ED on 1/19/10 for pregnancy complications and cramping. The Emergency Record, dated 1/19/10 at 7:15 PM, documented Patient #10 received Ampicillin 1 gram IV (an antibiotic used as a precaution if pre-term labor was the result of an infection), and approximately 600 ml of IV fluid. There was no written orders for the IV fluid and antibiotic given.

On 5/05/10 starting at 9:20 AM the DON was interviewed. She reviewed the record for Patient #10, and was unable to find an order for the Ampicillin and IV fluid that was administered.

d. Patient #22 was a 52-year-old male who was seen in the ED on 12/01/09 for hypoglycemia. Review of Patient #22's Emergency Room Record documented that on 12/01/09, between 12:25 and 12:40, Patient #22 received Dextrose 50% (1) ampule, Glucose Gel (1) tube (medications used for the rapid treatment of low blood sugar), and Normal Saline (IV) 400 ml. There were no written orders for the medications provided.

On 5/05/10 starting at 9:20 AM the DON was interviewed. She verified the medications had been administered without a written order.

The CAH failed to ensure that the policy for administration of medications was followed.

4. The facility's Medication Administration policy, that was not dated, and not documented as being approved by the governing body, did not identify that PRN medications needed to be assessed for effectiveness and to document the assessment. Without consistent documentation, the facility would not be able to assess and report to the physician the effectiveness of the medications and treatments, which directly impacted patients as follows:

a. Patient #15 was an 83-year-old male admitted on 4/21/10 for generalized ataxia (a neurological sign and symptom consisting of gross lack of coordination of muscle movements) and probable stroke. His MAR dated 4/24 - 5/03/10, were reviewed and documented he received Ativan (a medication for anxiety) for agitation no less than 10 times. However, his record did not contain documentation of the effectiveness of the medications and treatments.

Additionally, Patient #15's record included a nursing note dated 4/24/10 at 2:10 AM stated "Ativan given x 2 this shift." Patient #15's MAR only documented that Ativan was given once on 4/24/10 at 10:00 PM. A second nursing note dated 4/25/10 from 6:00 PM to 4/26/10 at 6:00 AM, stated Ativan was given twice during the shift. However, Patient #15's MAR only documented that Ativan was given once on 4/25/10 at 10:00 PM.

When asked during an interview on 5/03/10 at 2:30 PM, the DON confirmed the lack of documentation and stated the effectiveness of the medications and treatments should be documented.

b. Patient #14 was a 95-year-old female admitted on 4/29/10 for continued care following a hip fracture. Her MAR dated 4/29 - 5/03/10, was reviewed and documented she received prn Vicodin 14 times, prn Ativan twice, and prn Tylenol once. However, her record did not contain documentation of the effectiveness of the medications.

The DON confirmed on 5/03/10 at 2:30 PM, the record did not contain information regarding the effectiveness of PRN medications.

c. Patient #13 was a 66-year-old female who was admitted to the CAH on 4/05/10 for generalized ataxia. Her MAR, dated 4/05 - 4/20/10, was reviewed and documented she received prn Avitan 6 times and prn Hydrocodone 8 times. However, her record did not contain documentation of the effectiveness of the medications.

The DON confirmed on 5/03/10 at 2:30 PM, the record did not contain information regarding the effectiveness of PRN medications.

d. Patient #12 was a 71-year-old female who was admitted to the CAH on 2/26/10 for post care after a total knee surgery. Her MAR dated 2/26 - 3/09/10, was reviewed and documented she had received prn Percocet 29 times. However, her record did not contain documentation of the effectiveness of the medications.

The DON confirmed on 5/03/10 at 2:32 PM, the record did not contain information regarding the effectiveness of PRN medications.

The CAH failed to ensure records contained accurate comprehensive information including all medications administered, medication doses and information regarding the effectiveness of PRN medications.

The CAH failed to ensure that the outpatient department was established as a separate department from the ED with facility oversight and policies and procedures.

Based on record review, review of facility policies and interview, it was determined the CAH failed to ensure staff administered medications to patients in accordance with pharmacy medication administration policies. Failure to follow policy and standards directly impacted 4 of 9 ED patients (#2, #4, #10 and #22), and 3 of 4 Swing Bed patients (#13, #14, and #15), whose records were reviewed. The failure to follow pharmacy medication administration policies and standards of practice had the potential to result in adverse patient outcome. Findings include:

1. The Idaho Board of Pharmacy IDAPA 27.01.01.256.01, ADMINISTRATION OF DRUGS states,"Drugs shall be administered at an institutional facility, only upon the orders, including chart orders, of those members of the medical staff who have been granted clinical privileges, or who are authorized members of the house staff, by authorized licensed facility personnel in accordance with policies and procedures specified by the appropriate committee of the facility, under applicable law and rules, and in accordance with usual and customary standards of good medical practice."

The facility's policy for VERBAL AND WRITTEN ORDERS, for the Emergency Department, undated, stated: "Verbal orders for medication shall be received and recorded by the pharmacist or licensed nurse. The order will be written on the physician order sheet by the person receiving the order and noting the date and time received, the name of the licensed independent practitioner issuing the order and the receiver's name and title."

However, the patients' medical records did not include physician orders for all drugs which were administered, as well as, occasions where drugs were ordered and not given. Examples include:

a. Patient #2 was a 53-year-old male who was seen in the ED on 4/30/10 for lower back pain. On the Provider Order and Documentation Record, dated 4/30/10, but untimed, Flomax 0.4 mg (a medication that relaxed smooth muscle and improved flow of urine), was ordered. There was no documented evidence that Patient #2 received Flomax as ordered. The ER Record contained a nursing note entry that Patient #2 was given Zofran 4 mg (medication to suppress nausea). However no order for the medication was found in Patient #2's record.

On 5/05/10 starting at 9:20 AM, the DON was interviewed. She was unable to determine if Patient #2 had received the dose of Flomax. The DON could not explain why Patient #2 received the dose of Zofran without an order.

b. Patient #4 was a 27-year-old female, who had inadvertently taken the wrong medication, and was seen in the ED on 7/20/09. Review of Patient #4's medical record documented a nicotine patch was administered at 4:08 PM. There was no evidence of a written order for the nicotine patch.

On 5/05/10 starting at 9:20 AM the DON was interviewed. She reviewed the record for Patient #4 and verified the absence of an order for the nicotine patch.

c. Patient #10 was a 26-year-old female who was seen in the ED on 1/19/10 for pregnancy complications and cramping. The Emergency Record, dated 1/19/10 at 7:15 PM, documented Patient #10 received Ampicillin 1 gram IV (an antibiotic used as a precaution if pre-term labor was the result of an infection), and approximately 600 ml of IV fluid. There was no written orders for the IV fluid and antibiotic given.

On 5/05/10 starting at 9:20 AM the DON was interviewed. She reviewed the record for Patient #10, and was unable to find an order for the Ampicillin and IV fluid that was administered.

d. Patient #22 was a 52-year-old male who was seen in the ED on 12/01/09 for hypoglycemia. Review of Patient #22's Emergency Room Record documented that on 12/01/09, between 12:25 and 12:40, Patient #22 received Dextrose 50% (1) ampule, Glucose Gel (1) tube (medications used for the rapid treatment of low blood sugar), and Normal Saline (IV) 400 ml. There were no written orders for the medications provided.

On 5/05/10 starting at 9:20 AM the DON was interviewed. She verified the medications had been administered without a written order.

The CAH failed to ensure that the policy for administration of medications was followed.



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2. The facility's Medication Administration policy, that was not dated and not documented as being approved by the governing body, did not identify that PRN medications needed to be assessed for effectiveness and to document the assessment. Without consistent documentation, the facility would not be able to assess and report to the physician the effectiveness of the medications and treatments, which directly impacted patients as follows:

a. Patient #15 was an 83-year-old male admitted on 4/21/10 for generalized ataxia (a neurological sign and symptom consisting of gross lack of coordination of muscle movements) and probable stroke. His MAR dated 4/24 - 5/03/10, were reviewed and documented he received Ativan (a medication for anxiety) for agitation as follows:

- 4/26/10 at 3:50 PM.
- 4/26/10 at 10:50 PM.
- 4/27/10 at 11:53 PM.
- 4/28/10 at 5:00 PM.
- 4/28/10 at 11:00 PM.
- 5/01/10 at 7:05 AM.
- 5/02/10 at 3:30 PM.
- 5/02/10 at 9:30 PM.
- 5/03/10 at 7:30 AM.
- 5/03/10 at 2:10 PM.

However, his record did not contain documentation of the effectiveness of the medications and treatments.

Additionally, Patient #15's record included a nursing note dated 4/24/10 at 2:10 AM stated "Ativan given x 2 this shift." Patient #15's MAR only documented that Ativan was given once on 4/24/10 at 10:00 PM.

A second nursing note dated 4/25/10 from 6:00 PM to 4/26/10 at 6:00 AM, stated Ativan was given twice during the shift. However, Patient #15's MAR only documented that Ativan was given once on 4/25/10 at 10:00 PM.

When asked during an interview on 5/03/10 at 2:30 PM, the DON confirmed the lack of documentation and stated the effectiveness of the medications and treatments should be documented.

b. Patient #14 was a 95-year-old female admitted on 4/29/10 for continued care following a hip fracture. Her MAR dated 4/29 - 5/03/10, was reviewed and documented she received the following:

- 4/29/10 at 5:45 PM. Vicodin (a medication for pain), 2 tablets were given for pain.
- 4/29/10 at 6:00 PM. Ativan was given for agitation.
- 4/30/10 at 3:00 AM. Vicodin 2 tablets, were given for pain.
- 4/30/10 at 10:50 AM. Vicodin 1 tablet, was given for pain.
- 4/30/10 at 4:15 PM. Vicodin 1 tablet, was given for pain.
- 4/30/10 at 7:25 PM. Vicodin 1 tablet, was given for pain.
- 5/01/10 at 8:30 AM. Vicodin 1 tablet, was given for pain.
- 5/01/10 at 9:55 AM. Vicodin 1 tablet, was given for pain.
- 5/01/10 at 4:10 PM. Vicodin 2 tablets, were given for pain.
- 5/01/10 at 10:30 PM. Vicodin 2 tablets, were given for pain.
- 5/02/10 at 8:00 AM. Vicodin, no dose listed, was given for pain.
- 5/02/10 at 3:00 PM. Vicodin, no dose listed, was given for pain.
- 5/02/10 at 9:00 PM. Vicodin, no dose listed, was given for pain and Ambien no dose listed, was documented as being given for restlessness.
- 5/03/10 at 7:15 AM. Vicodin 1 tablet, was given for pain.
- 5/03/10 at 7:15 AM. Tylenol 650 mg, was given for pain.
- 5/03/10 at 12:30 PM. Vicodin 2 tablets, were given for pain.
- 5/03/10 at 7:45 PM. Ativan was given for anxiety.

However, her record did not contain documentation of the effectiveness of the medications. The DON confirmed on 5/03/10 at 2:30 PM, the record did not contain information regarding the effectiveness of PRN medications.

c. Patient #13 was a 66-year-old female who was admitted to the CAH on 4/05/10 for generalized ataxia. Her MAR, dated 4/05 - 4/20/10, was reviewed and documented she received the following:

- 4/05/10 at 9:00 PM. Ativan was given for anxiety.
- 4/06/10 at 9:00 PM. Ativan was given for anxiety.
- 4/07/10 at 9:00 PM. Ativan was given for anxiety.
- 4/08/10 at 9:00 PM. Ativan was given for anxiety.
- 4/10/10 at 9:00 PM. Ativan was given for "sleeplessness."
- 4/10/10 at 9:00 PM. Hydrocodone (a medication for pain), no dose was listed.
- 4/11/10 at 9:00 PM. Ativan was given for "sleeplessness."
- 4/13/10 at 10:31 PM. Hydrocodone 1 tablet, was given for pain.
- 4/17/10 at 1:30 AM. Hydrocodone, no dose listed, was given for pain.
- 4/17/10 at 11:30 PM. Hydrocodone 1 tablet, was given for pain.
- 4/18/10 at 9:00 PM. Hydrocodone 1 tablet, was given for pain.
- 4/19/10 at 4:11 AM. Hydrocodone 1 tablet, was given for pain.
- 4/19/10 at 10:30 PM. Hydrocodone 1 tablet, was given for pain.
- 4/20/10 at 5:05 AM. Hydrocodone 1 tablet, was given for pain.

However, her record did not contain documentation of the effectiveness of the medications. The DON confirmed on 5/03/10 at 2:30 PM, the record did not contain information regarding the effectiveness of PRN medications.

d. Patient #12 was a 71-year-old female who was admitted to the CAH on 2/26/10 for post care after a total knee surgery. Her MAR dated 2/26 - 3/09/10, was reviewed and documented she had received the following:

- 2/26/10 at 8:00 AM. Percocet (a medication for pain), 2 tablets were given.
- 2/26/10 at 8:00 PM. Percocet 2 tablets, were given for pain.
- 2/27/10 at 8:00 PM. Percocet 1 tablet, was given for pain.
- 2/28/10 at 6:50 AM. Percocet 1 tablet, was given for pain.
- 2/28/10 at 12:30 PM. Percocet 1 tablet, was given for pain.
- 2/28/10 at 5:00 PM. Percocet 1 tablet, was given for pain.
- 2/28/10 at 9:00 PM. Percocet 1 tablet, was given for pain.
- 3/01/10 at 8:00 AM. Percocet 1 tablet, was given for pain.
- 3/01/10 at 1:00 PM. Percocet 1 tablet, was given for pain.
- 3/01/10 at 8:00 PM. Percocet 1 tablet, was given for pain.
- 3/02/10 at 6:30 AM. Percocet 1 tablet, was given for pain.
- 3/02/10 at 12:30 PM. Percocet 1 tablet, was given for pain.
- 3/02/10 at 6:30 PM. Percocet 1 tablet, was given for pain.
- 3/03/10 at 8:00 PM. Percocet, no dose listed, was given for pain.
- 3/04/10 at 1:30 PM. Percocet, no dose listed, was given for pain.
- 3/04/10 at 9:00 PM. Percocet, no dose listed, was given for pain.
- 3/05/10 at 8:00 AM. Percocet, no dose listed, was given for pain.
- 3/05/10 at 1:30 PM. Percocet, no dose listed, was given for pain.
- 3/06/10 at 8:00 AM. Percocet, no dose listed, was given for pain.
- 3/06/10 at 2:45 PM. Percocet, no dose listed, was given for pain.
- 3/06/10 at 8:45 PM. Percocet, no dose listed, was given for pain.
- 3/07/10 at 7:30 AM. Percocet 1 tablet, was given for pain.
- 3/07/10 at 2:00 PM. Percocet 1 tablet, was given for pain.
- 3/07/10 at 8:00 PM. Percocet 1 tablet, was given for pain.
- 3/08/10 at 7:30 AM. Percocet 1 tablet, was given for pain.
- 3/08/10 at 1:45 PM. Percocet 1 tablet, was given for pain.
- 3/08/10 at 8:30 PM. Percocet 1 tablet, was given for pain.
- 3/09/10 at 7:30 AM. Percocet 1 tablet, was given for pain.
- 3/09/10 at 1:15 PM. Percocet 1 tablet, was given for pain.

However, her record did not contain documentation of the effectiveness of the medications. The DON confirmed on 5/03/10 at 2:32 PM, the record did not contain information regarding the effectiveness of PRN medications.

The CAH failed to ensure records contained accurate comprehensive information including all medications administered, medication doses and information regarding the effectiveness of PRN medications.

Based on observation, staff interview, and review of medical records, facility policies, and QA/QI documents, it was determined the CAH failed to ensure a comprehensive data driven QA program was developed and implemented. This resulted in missed opportunities for improved patient care. Findings include:

1. Refer to C-336 as it relates to the facility's failure to ensure the QA program had analyzed all patient adverse events.

2. Refer to C-337 as it relates to the facility's failure to ensure the QA program had evaluated the quality and appropriateness of all patient care services offered.

3. Refer to C-281 as it relates to the facility's failure to define outpatient services and demonstrate integration of quality management.

The cumulative effect of these systemic practices compromised the QA program's ability to effectively evaluate the quality and appropriateness of all patient care services offered.

Based on staff interview and review of patient records and Quality Management Memos, it was determined the CAH failed to ensure the QA program had analyzed all patient adverse events for 2 of 39 patients (#13 and #20) whose records were reviewed. This resulted in the inability of the CAH to develop and implement processes to improve care. Findings include:

1. Patient #13 was a 66-year-old female who was admitted to the CAH on 4/05/10 for generalized ataxia (a neurological sign and symptom consisting of gross lack of coordination of muscle movements). A nursing note dated 4/09/10, that was timed 6:00 AM - 6:00 PM, stated the nurse had found a Norco (a narcotic medication used for pain management), on Patient #13's bedside table that Patient #13's husband brought in.

Review of the CAH's Quality Management Memos on 5/04/10 did not document the nurse had notified the QA department of the incident.

On 5/04/10 starting at 11:18 AM, the QA Manager was interviewed. She confirmed a Quality Management Memo had not been completed out for the incident and stated one should have been.



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2. Patient #20 was an 81-year-old male who had a right forearm PICC. An outpatient nursing note, dated 11/08/09, that was untimed, stated Patient #20's PICC dressing was changed, and the note stated the PICC had pulled out to 20 cm, which is approximately 8 inches. Patient #20's PICC insertion site was in the right forearm, and 8 inches would not ensure that the PICC was in proper placement as a central line.

On 5/05/10 starting at 9:20 AM, the DON was interviewed. She stated no incident report had been completed regarding Patient #20's PICC line dislodgement.

The CAH failed to ensure that all events were reported to the quality improvement program so they could be analyzed and steps could be taken to prevent further incidents.

Based on observation, staff interview, and review of medical records, facility policies, PIP and QI documents, it was determined the CAH failed to ensure its QA program had evaluate the quality and appropriateness of all patient care services and departments within the CAH. This directly impacted 7 of 7 patients (Patients #33 thru #39), who received endoscopy services and had the potential to impact all patients seeking medical care. The lack of quality oversight had the potential to affect patient safety. Findings include:

1. Review of the CAH's QI log and PIPs for 2009, and the first quarter of 2010 documented that the GI Laboratory, Sterile Processing, PT services, OT services, and Out Patient services, did not have QIs being collected and PIPs. On 5/05/10 at 9:15 AM, the Director of Quality Improvement confirmed that the GI Laboratory, Sterile Processing, PT services, OT services, and Out Patient services, did not have QIs being collected and PIPs. The lack of an organized QA program resulted in the inability of the CAH to evaluate and improve its processes. Because of the absence of Quality Improvement oversight the following resulted:

a. During a tour of the GI Clinic on 5/05/10 starting 12:53 PM,it was noted that the CAH used Cidex Plus to do high-level disinfection of its endoscopes. High-level disinfection is the process that killed all microbial organisms. According to Johnson & Johnson, the manufacturer of Cidex Plus, "High-level disinfection is acceptable for GI endoscopes..."

Review of the package insert on the bottle of Cidex Plus showed the following recommendations:

"The use period for activated CIDEX PLUS solution is up to a maximum of 28 days following activation or sooner, as indicated by the CIDEX PLUS Solution Test Strips."

"Solution can be reused for a period not to exceed 28 days provided the required conditions of glutaraldehyde concentration, pH, and temperature exist based upon monitoring described in directions for use..." According to the Cidex log kept at the cleaning station this was not done.

"Test the solution prior to each use to assure that the glutaraldehyde concentration is above its MEC (minimum effective concentration)." According to the Cidex log kept at the cleaning station this was not done.

According to The Association for the Advancement of Medical Instrumentation (ANSI/AAMI) ST58:2005 ... "It must be realized that the actual reuse life can be shorter, as it depends upon factors such as the cleanliness of the item being disinfected, bioburden left on the device, residual detergents, temperature and pH of the solution, and the environmental temperature in the area."

Further the ANSI/AAMI stated,"Best practices monitor the disinfectant solution with an appropriate test strip prior to each time it is used during the expected reuse life." This was not done as follows:

In a review of the Cidex log on 5/05/10 at 12:53 PM, Cidex was activated on 2/24/09. Twenty-eight days from 2/24/09 would have been 3/24/09. Following manufacturer's recommendations, the Cidex should have been discarded on 3/24/09. It was documented the Cidex was discarded on 5/18/09.

Patient #33 had a colonoscopy on 3/31/09. There was no documentation of testing of the Cidex solution before the disinfection process began.

The Cidex was then activated on 5/19/09 and should have been discarded on 6/16/09. Instead the Cidex was discarded on 6/29/09.

Patient #34 had a colonoscopy on 6/16/09. There was no documentation of testing of the Cidex solution before the disinfection process began.

Patient #35 had a colonoscopy on 6/23/09. There was no documentation of testing of the Cidex solution before the disinfection process began.

The Cidex was then activated on 7/21/09 and should have been discarded on 8/18/09. Instead the Cidex was discarded on 9/06/09. However, a notation of "tested with pass on 9/01/09," was documented on the log.

The next documented activation of Cidex was 9/06/09 with another notation of "test with pass on 10/14/09." The next discarded date recorded was 12/07/09. The Cidex should have been discarded on 10/04/09.

Patient #36 had a colonoscopy on 11/03/09. There was no documentation of testing of the Cidex solution before the disinfection process began.

Documentation on the Cidex log shows activation 2/23/10 with discard recorded as 4/27/10. Twenty-eight days from 2/23/10 would have been 3/23/10.

Patient #37 had an EGD on 4/05/10. An EGD is a visualization of the esophagus, stomach, and duodenum with a scope. There was no documentation of testing of the Cidex solution before the disinfection process began prior.

Patient #38 had an EGD on 4/20/10. There was no documentation of testing of the Cidex solution before the disinfection process began.

Patient #39 had a colonoscopy on 4/27/10. There was no documentation of testing of the Cidex solution before the disinfection process began.

In an interview 5/05/10 at 12:45 PM, with the CNA, ER/Endoscopy Technician, who does all of the endoscopy cleaning, stated the person who trained him told him as long as test strip comes out positive there is no need to change the solution. No documentation of this training was found.

Further, he confirmed all dates documented on the Cidex log were correct as recorded.

The CAH's Central Service Policy #6, not dated or signed, states,"All equipment used at [CAH's name] will be cleaned/sterilized as appropriate to its manufacture and use." According to the CNA/ER/Endoscopy technician's statement and the observed Cidex log this was not done.

The QA failed to ensure the sterilization procedures was included in its QA program. The QA's failure to ensure that sterilization procedures had QI and PIPs resulted in poor sterilization practices.



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2. The American National Standard dated 2006, stated "Biological indicators should be used...for routine sterilizer efficacy monitoring at least weekly, but preferably every day that the sterilizer is in use." A biological indicator (spore test) is a device used to monitor the sterilization process of the autoclave. It consists of a standardized population of bacterial spores. A biological indicator monitors the autoclaving cycle and ensures that all the parameters necessary for sterilization were present during the autoclaving process.

During a tour of the CAH's Sterile Processing unit on 5/4/10 starting at 2:43 PM, it was noted that instruments used for patient care were autoclaved.

The CAH's Central Service Policy #3, Resterilization of Supplies, and Policy #12, Resterilization of Packs and Trays, last reviewed on 1/17/08, stated an Attest was to be used with every load autoclaved. This policy was not followed. Examples include:

The CAH's "ATTEST Biological Monitoring System for Steam Sterilization" log sheets, documented the last time an Attest was run was 12/21/07. The CAH did use a chemical indicator with each load that was autoclaved. However, without the use of weekly biological indicators, in conjunction with the chemical indicators, the facility could not ensure that the parameters necessary for sterilization were present.

The DON was present during the tour. She did not know what an Attest was.

On 5/05/10 starting at 9:25 AM, the CS Technician was interviewed. She stated that she was trained 18 years ago on how to autoclave instruments. However, she stated that she had not preformed autoclaving for many years and stated she started her current CS job on 1/04/10. She stated she did not know what an Attest was nor how to run one.

On 5/05/10 starting at 9:30 AM, the CS Director was interviewed. She confirmed the CS/SP units did not have any QI projects, QI indicators or PIPs. She stated she did not know what an Attest was for.

The QI program failed to evaluate the quality and appropriateness of the Sterile Processing unit and develop quality indicators and PIPs.

3. During a tour of the CAH's Sterile Processing unit on 5/04/10 starting at 2:43 PM, and the ED on 5/04/10 starting at 3:00 PM, it was noted that more than 100 instruments, such as clamps, scissors and tweezers, that were autoclaved did not have a sterilizer load number, or a date written on the package as to when they were autoclaved. Additionally, the Sterile Processing unit did not have a log book that contained sterilizer load number, dates or contents of autoclaved instruments. This was confirmed by the DON during the observations. This had the potential to effect the CAH's ability to recall suspected contaminated equipment and pull outdated stock.

The CAH's Central Service Policy #1, Objectives of Central Services, last reviewed on 1/17/08, stated, "Central Services will maintain an accurate record of the various processes of cleaning, disinfecting, and sterilization."

The CAH's Central Service Policy #9, Expiration Dates, last reviewed on 1/17/08 stated, "Dates will be marked in indelible ink and placed on package side which will face the person opening the package."

The CAH's Central Service Policy #8, Shelf life of packaged materials, last reviewed on 1/17/08, stated the following:

"Autoclave tape, marked with the expiration date is to be placed on autoclaved packages."

" Single wrapped items will have a shelf life of no greater than one month."

" Double wrapped packs, basins and linens will have a shelf life of no greater than three months."

" Items wrapped in plastic will have a shelf life of no greater than six months."

" All outdated items will be removed from service area on day of expiration and returned to CS."

These policies were not followed.

The QI program failed to evaluate the quality and appropriateness of the Sterile Processing unit. This resulted in the inability of the QI program to develop quality indicators and PIPs.

4. The CAH's Post Procedure Follow-Up Evaluation for the GI Laboratory, that was not documented as being approved by the Governing Body stated, "A Post Procedure Follow-up Evaluation by phone will be made by the GI Laboratory staff between 24 and 72 hours following a procedure." The telephone call was to be documented on a GI LABORATORY PATIENT PHONE QUESTIONNAIRE. The questions staff were to inquire about included if the patient had experienced any nausea, vomiting, dizziness, diarrhea, IV site inflammation and other quality indicators.

During an interview with the Director of Quality Assurance on 5/05/10 starting at 9:15 AM, she stated she could not remember the last time that the GI Laboratory had collected quality indicators or had a PIP. Additionally, the GI Laboratory had a PATIENT SATISFACTION SURVEY that was to be sent to all GI Laboratory patients that contained quality indicators.

During an interview with the Director of Quality Assurance on 5/05/10 starting at 9:15 AM, she stated that she was unaware when the patient satisfaction survey had been developed or the last time it was implemented.

The QI program failed to gather the GI Laboratory's quality indicators and develop PIPs.

5. Quality Improvement Committee Meeting Minutes were reviewed for 2009 through the first Quarter of 2010. The Meeting Minutes did not document that OT had attended the meetings or that quality indicators and PIPs had been developed for OT services. Additionally, in 04/14/09, the Quality Improvement Committee Meeting Minutes stated that Physical Therapy was to "work on ensuring they have orders documented for all treatments." This project was started in 5/07. Refer to C402 for the failure of the QA department to ensure PT and OT staff had documented evidence they had provided specialized rehabilitative services per physician's orders.

The QI program failed to gather PT quality indicators and develop PIPs. The QI program failed to evaluate the quality and appropriateness of OT services. This resulted in the inability of the QI program to develop quality indicators and PIPs.

Based on staff interview, review of hospital policies and observations, it was determined the CAH failed to ensure restraint measures were only used to ensure patient safety for 1 of 2 patients (#14), who were observed. This resulted in the patient being restrained as a convenience, rather than to treat the patient's medical symptoms. The findings include:

Patient #14 was a 95-year-old female admitted on 4/29/10 for continued care following a hip fracture. Patient #14 was observed to be confused and often tried to get out of bed. A Quality Management Memo, dated 5/01/10, stated Patient #14 had fallen out of the bed at 4:45 AM. On 5/03/10 at 3:00 PM, Patient #14 was observed in bed with all four bed rails up.

The CAH's Restraint policy that was not documented as being approved by the Governing Body, defined a physical restraint as any device that restricts the freedom of movement. However the policy failed to identify 4 bed rails as a restraint.

On 5/03/10 at 3:05 PM, Patient #14's LPN was asked why all four bed rails were up. She stated that Patient #14 had Alzheimers and the side rails helped keep her in bed. She acknowledged this was a restraint and put 2 of the four bed rails down.

The CAH failed to ensure staff did not use restraints as a substitute for supervision for Patient #14.

Based on staff interview and review of patient records and policies, it was determined the CAH failed to ensure 1 of 2 discharged Swing Bed patients (#12), whose records were reviewed, contained a comprehensive discharge summary. This had the potential to negatively impact coordination and quality of patients post care. The findings include:

The CAH's Rules and Regulations of the Medical Staff (Bi-Laws), dated 09/06 stated, a discharge summary should contain brief notations concerning medical complaint, history, physical findings, pertinent lab and radiology findings, treatments including complications, hospital course, condition on discharge and follow-up instructions and treatment.

Patient #12 was a 71-year-old female who was admitted to the CAH on 2/26/10 for post care after a total knee surgery. She was discharged on 3/10/10.

Patient #12's discharge summary was hand written on the record's inpatient face sheet that had the address and the billing information for Patient #12. The discharge summary did not include history, physical findings, pertinent lab and radiology findings, treatments including complications, hospital course, or condition on discharge.

On 5/04/10 at 2:45 PM, the CAH's HIS manager was interviewed. She reviewed Patient #12's discharge summary and stated that the lack of documentation was typical for Patient #12's physician.

On 5/06/10 at 3:35 PM, the CAH's CEO was interviewed. He stated the physician who took care of Patient #12 would not dictate his work. He stated that documentation had been an ongoing issue with the physician and he was unsure how to enforce compliance.

The CAH failed to ensure discharged Swing Bed patients contained a comprehensive discharge summary.

Based on staff interview and review of patient records and policies, it was determined the CAH failed to ensure 2 of 2 current Swing Bed patients (#14 and #15), had documented evidence they had received specialized rehabilitative services per physician's orders. The failure to document or provide specialized rehabilitative services had the potential to inhibit coordination of patient care between disciplines. The findings include:

The HIS director was interviewed on 5/04/10 starting at 1:30 PM. She stated that the CAH did not have a policy in place to direct staff as to when their evaluations and progress notes were to be recorded in the patient's record.

1. Patient #14 was a 95-year-old female admitted on 4/29/10 for continued care following a hip fracture. Patient #14's physician had ordered PT five times a week and an OT evaluation on 4/29/10. Patient #14's record was reviewed on 5/03/10. The record contained no documented evidence that PT had evaluated Patient #14 or had been providing PT five times a week. Additionally, the record contained no documented evidence that OT had evaluated Patient #14.

On 5/03/10 at 2:17 PM, an RN called the OT/PT clinic to see if they had evaluated and were treating Patient #14. She stated that PT had evaluated Patient #14 and was treating her. However, she stated it was often that the Physical Therapist did not "turn in his evaluations and notes." She further stated that OT had not received the order to evaluate Patient #14 and that was why it was not done.

The facility failed to ensure specialized rehabilitative services were provided and documented.

2. Patient #15 was an 83-year-old male admitted on 4/21/10 for generalized ataxia (a neurological sign and symptom consisting of gross lack of coordination of muscle movements) and probable stroke. Patient #15's physician had ordered PT seven times a week. Patient #15's record was reviewed on 5/03/10. The record contained no documented evidence that PT had evaluated Patient #14 or had been providing PT seven times a week.

On 5/03/10 starting at 2:10 PM, a PTA was interviewed. She stated that PT had evaluated Patient #15 and was treating him. However, she stated that the Physical Therapy department did not "turn in their evaluations and notes for an extended period of time." She further stated that she had worked with Patient #15 two times a week but could not provide documented evidence that anyone had provided PT services the other 5 days a week.

The CAH failed to ensure PT and OT services had provided and/or documented specialized rehabilitative services per physician's orders.