HospitalInspections.org

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22705

Based on observation, interview, and record review, the hospital failed to ensure patient care services were provided in accordance with State laws and regulations evidenced by:

1. Failure to have a Committee on Interdisciplinary Practice; and

2. Failure to provide nurse staffing at 1:5 ratio.

These failures had the potential for unsafe patient care.

Findings:

1. California Code of Regulations (CCR) Title 22 Section 70706 stipulates in part: "(a) In any (licensed hospital) ... in which licensed or certified healing arts professionals who are not members of the medical staff will be granted privileges pursuant to Section 70706.1 there shall be a Committee on Interdisciplinary Practice established by and accountable to the Governing Body, for establishing policies and procedures for interdisciplinary medical practice. (b) The Committee on Interdisciplinary Practice shall include, as a minimum, the director of nursing, the administrator or designee and an equal number of physicians appointed by the Executive Committee of the medical staff, and registered nurses appointed by the director of nursing. Licensed or certified health professionals other than registered nurses who are performing or will perform functions as in (a) above shall be included in the Committee."

During the initial recertification survey on 3/19/13 at 10:15 a.m., the Quality Director verified that the hospital did not have an Interdisciplinary Practice Committee (IDPC) and there had been no committees or other meetings of medical staff and Allied Health Practitioners (AHP) members to write or reviewed any hospital policies.

During a subsequent interview on 5/1/13 at 12 pm, the Chief Executive Officer stated that although an IDPC committee had been formed, the first meeting would take place on 5/18/13.

During a subsequent interview on 6/11/13 at 4 pm, the Chief Executive Officer stated that the IDPC would review the agenda material for the first time in a meeting scheduled for 6/18/13.


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2. California Code of Regulations Title 22 70217(a)(11) stipulates, "The licensed nurse-to-patient ratio in medical/surgical care units shall be 1:5 or fewer at all times."

The hospital's Nursing Assignment Reports were reviewed for two weeks, from 5/31/13 - 6/11/13. Two shifts had one nurse caring for more than five patients for at least part of her 12 hour shift. On these two days, 5/31 and 6/2, there were five patients on the medical surgical floor. In addition to these five patients, there were two outpatient admissions on 5/31/13 and one outpatient admission on 6/1/13. On these two days the nurse cared for six or seven patients instead of five patients.

During an interview on 6/12/13 at 11:30 am, Nurse Manager G confirmed the above information.

Based on observation, interview, and record review, the facility failed to ensure that equipment and supplies were stored and maintained to maintain a level of safety and quality as evidenced by:

1. Preventative maintenance was not performed annually on patient care equipment;

2. Hazardous cleaning supplies were accessible to children;

3. Unlabeled liquid was present in the surgery department;

4. Clamps and scissors were not sterilized in an open position;

5. A clamp was not cleaned and stored properly in the operating room (OR) suite; and

6. A box of sterile syringes was stored on the floor in the CT (Computer Tomography, xray) scan room.

These failures had the potential for equipment failures, inaccurate patient testing, accidental ingestion, infections, and errors in use which could negatively impact a patient's health status.

Findings:

1. On 6/11/13 during the initial tour, starting at 10:45 am, the following items were observed to have outdated or a lack of preventative maintenance stickers:
- A patient scale in the Dexa (a type of xray) Room of the radiology department had a sticker dated 7/08;
- A patient monitor for blood pressure and vitals signs in the CT room of the radiology department had no preventative maintenance sticker;
- An arthroscopy pump (equipment for knee surgery) in the operating suite (OR) had a sticker dated 3/23/12; and
- A Cabot Medical Niagara 2 liter fluid pumper (irrigation equipment) of in the clean storage room for endoscopy (visual scope) equipment had no preventative maintenance sticker

In a concurrent interviews, the above findings were acknowledged by Radiology Manager F and OR Nurse I for their respective departments. OR Nurse I stated the fluid pumper in the OR was no longer in use.

On 6/12/13, the hospital policy, titled, "Medical Equipment Management," dated 9/11, indicated that all mechanical and/or electronic devices used inpatient care or diagnosis, including new and used incoming equipment would be evaluated a least annually for safety and risk.

On 6/12/13 at 9 am, Biomedical Technician (BT) V acknowledged the above findings. BT V stated the fluid pumper should be removed from the OR suite if it was not longer in use. BT V provided evidence that the arthroscopy pump had been tested on 5/20/13 but did not have an accurate sticker.

2. On 6/11/13 at 11 am, the public bathroom in the CT room contained an unlocked under-sink cabinet that contained six bottles of five different cleaning supplies. Each bottle contained a warning to keep out of the reach of children and gave instruction to call the poison control center if the product was accidently ingested. The cabinet had a key lock that was not used.

On 6/12/13, the hospital policy, titled, "Hazardous Chemical Program," last reviewed 2/13, indicated that the labels of hazardous chemicals will be followed."

In a concurrent interview, Radiology Manager F acknowledged that children do enter the area and the cleaning supplies should be locked.

3. On 6/11/13 at 11:30 am, the surgery department handwashing sink was observed to have an unlabeled bottle with white liquid. In a concurrent interview, Licensed Nurse (LN) I, who supervises the surgeries, stated the bottle contained soap and should be labeled when it was filled.

The hospital policy, titled, "Hazardous Chemical Program," last reviewed 2/13, indicated that all containers should be labeled with the contents.

4. On 6/11/13 at 11:40 am, the supply of sterile clamps and scissors was observed. A small sampling revealed nine packages of sterile scissors and three packages of sterile clamps were processed in the closed position.

In a concurrent interview, LN I stated the hospital followed AORN standards (Association of periOperative Registered Nurses). LN I acknowledged the the packages should have been processed in the open position.

On 6/12/13, the AORN recommended practice for cleaning surgical instruments, recommendation XXII, read, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces...Instruments should be open and unlocked position..."

5. On 6/11/13 at 11:30 am, the anesthesia (artifically induced loss of ability to feel discomfort and/or sensation) cart in the OR suite was observed to have a clamp on top of the cart and several clamps in the drawer. LN I stated they had endoscopies the previous day and had cleaned the room following the last procedure. LN I stated the clamps do not have to be sterile because they are used to hold towels in place during the surgery to protect the patient's face during surgery. LN 1 stated the clamps are cleaned after use and stored in the cart. LN I acknowledged that the clamp on top of the anesthesia cart should have been cleaned and placed in the cart at the end of the procedure.

6. On 6/11/13 at 11:20 am, a box of sterile syringes was observed on the floor in the CT scan room of the radiology department.

In a concurrent interview, Radiology Manager F acknowledged that patient care supplies were not to be stored on the floor.

On 6/12/13, the hospital policy, titled, "Storage of Clean Supplies and Equipment," revised on 2/12, read, "Clean supplies are to be placed in proper storage areas...in cabinets and drawers."

Based on observation, interview and record review, the hospital failed to ensure that the operating suite (OR) was free of dust accumulation. This failure has the potential for post operative infections to occur.

Findings:

On 6/11/13 at 11:30 am, the operating room was observed with Licensed Nurse (LN) I. The OR circulator cabinet was observed to have a layer of dust on the shelves.

On 6/12/13, the hospital policy, titled, "Housekeeping Procedures in the Operating Room, " last reviewed 1/13, read, "Damp dust all flat surfaces prior to the first surgical procedure."

During a concurrent interview, LN I stated they had endoscopy procedures the day before and the OR should have been cleaned at the end of the day. LN I acknowledged that the OR circulator cabinet had a layer of dust, but should have no dust accumulation.

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Based on observation, interview, and record review, the hospital failed to ensure that the operating room (OR) blanket warmer temperature was properly maintained to prevent patient burns.

Findings:

On 6/11/13 at 11:30 am, the operating room was observed with Licensed Nurse (LN) I. Temperature gauges were observed in the blanket warmer. LN I was asked about the proper temperature levels and she was unable to recall but stated she would refer to the policy. LN 1 provided OR temperature and humidity logs for 5/13 which included a column for daily blanket warmer temperatures which was blank. LN I acknowledged that the blanket warmer temperature should have been monitored.


On 6/12/13, the hospital policy, titled, "Equipment Logs and Guidelines," reviewed on 1/13, read, "Temperatures are monitored and recorded daily." The policy did not address the temperature range for the blanket warmer.

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Based on interview and record review, the facility failed to have a governing body that assumes full legal responsibility for determining, implementing, and monitoring policies governing the hospitals total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment as evidenced by:

1. Failure to have a quality plan that addresses high-risk, high-volume, and problem prone indicators and provide analysis, performance thresholds, and action plans to assure and improve the quality of patient services. (Refer to C 241)

2. Failure to ensure that the hospital's Allied Health Practitioners (AHPs) participated in the development, execution, or review of written policies governing the services furnished in the hospital. (Refer to C 265)

3. Failure to ensure the provision of services standards are met. (Refer to C 270)

4. Failure to provide periodic evaluation and quality assurance review of all services provided directly and by contracted services. (Refer to C 330)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Participation: Organizational Structure.

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Based on document review and staff interview, the governing body (Board of Directors: BOD) failed to ensure that a quality program was developed, implemented, and monitored high-risk, high-volume, and problem prone indicators and provide analysis, performance thresholds, and action plans to ensure health care was provided in a safe manner and safe environment. This failure permitted the hospital to operate without functional safeguards designed to ensure quality health care in a safe environment, and could contribute to patient or staff harm.

Findings:

On 6/12/13, the Quality and Performance Annual Improvement Plan, last revised 3/13, read under Duties, "The Quality Committee evaluates the quality of both clinical care and services across all settings and for the full spectrum of services provided. Ensures systems are in place to identify potential problems in patient care. Refers priority problems for assessment and corrective action to the appropriate departments or committees. Prioritizes, sponsors, approves, and supervises quality and performance improvement activities." The plan further read under Duties, "the Standing Quality Committee of the Board reviews and evaluates reports on quality of care and services and reports of such results to the Board of Directors. Ensures that an effective and ongoing quality program is in place." Under Prioritizing Opportunities, the plan read, "The decision making model used by EPHC (Facility's Name Health Care) is based on PI (Performance Improvement) activities that are high-risk, high-volume, and problem-prone areas or affect health outcomes, patient safety, and quality of care."

On 6/12/13, the Quality Assurance Committee minutes were reviewed. The minutes failed to show any indicators approved to address issues identified in the recertification survey on 3/21/13, and again during the revisit survey on 5/1/13. (Refer to C 337, item 3 a-f) Evidence was provided during the survey that monitoring was occurring in some departments but not necessarily representing all of the patient services. High-risk, high-volume, and problem-prone indicators had not been developed. Thresholds for performance, analysis, and actions plans had not been developed or reported through the Quality Assurance Committee to the Board of Directors.

On 6/11/13, a report was provided that was represented as a QIO (Quality Improvement Organization) report. The report was dated 5/20/13 and included a review and recommendations for the hospital's quality and credentialing program.

As of 6/12/13, Board of Directors had not acted on the recommendations in the report. On 6/12/13 at 3:30 pm, the Chief Executive Officer acknowledged the above findings and confirmed that there had not been enough time for the Board to act as it was first shared with the Quality Assurance on 5/21/13.

22705

Based on interview and document review, the hospital failed to ensure a committee meeting that included Allied Health Practitioners (AHP) in order to develop, execute or periodically review written policies governing the services furnished in the hospital. This failure may result in AHPs not colaborating with physicians in developing and implementing the facility's policies.

Findings:

California Code of Regulations (CCR) Title 22 Section 70706 stipulates in part: "(a) In any (licensed hospital) ... in which licensed or certified healing arts professionals who are not members of the medical staff will be granted privileges pursuant to Section 70706.1 there shall be a Committee on Interdisciplinary Practice established by and accountable to the Governing Body, for establishing policies and procedures for interdisciplinary medical practice. (b) The Committee on Interdisciplinary Practice shall include, as a minimum, the director of nursing, the administrator or designee and an equal number of physicians appointed by the Executive Committee of the medical staff, and registered nurses appointed by the director of nursing. Licensed or certified health professionals other than registered nurses who are performing or will perform functions as in (a) above shall be included in the Committee."

During the initial recertification survey on 3/19/13 at 10:15 a.m., the Quality Director verified that the hospital did not have an Interdisciplinary Practice Committee (IDPC) and there had been no committees or other meetings of medical staff and AHP members to write or review any hospital policies.

During a subsequent interview on 5/1/13 at 12 pm, the Chief Executive Officer stated that although an IDPC had been formed, the first meeting would take place on 5/18/13.

During a subsequent interview on 6/11/13 at 4 pm, the Chief Executive Officer stated that the IDPC would review the agenda material for the first time in a meeting scheduled for 6/18/13.

Based on observation, interview, and record review, the hospital failed to ensure that the provision of services was done in a safe manner, as evidenced by:

1. Failure to ensure that one of one patients who had a Fentanyl (pain medicine) patch, was prescribed that medication in accordance with product labeling and with pharmacist oversight as per hospital policy. (Refer to C 276, item 1)

2. Failure to have a current CLIA (Clinical Laboratory Improvement Amendments - regulates all laboratory testing) certificate. (Refer to C 282)

3. Failure to obtain physicians orders prior to administering medication and intravenous (in the vein)fluids. (Refer to C 294, items 1 and 2)

4. Failure to evaluate the competence of two surgical nursing staff. (Refer to C 295)

5. Failure to develop care plans that met the needs of the patients. (Refer to C 298)

6. Failure to ensure that expired medications were not available for use. (Refer to C 276, item 2)

7. Failure to ensure physicians' orders for biologicals (normal saline - intravenous fluids) were administered. (Refer to C 297, item 1)

8. Failure to ensure policies and/or physician's orders were present for intravenous fluids and post procedure nursing care. (Refer to C 279, item 2-4)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Participation: Provision of Services.




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22705

Based on observation, interview, and document and record review:

1. The hospital did not ensure that Physician Y verified that one of one patients who received a Fentanyl patch, met conditions of opioid tolerance (ability to take narcotics without significant side effects) as documented on the "Fentanyl Patch Order Form" (which matched the Food and Drug Administration (FDA) approved product labeling for the Fentanyl patch) prior to the placement of a Fentanyl patch. This had the potential to result in respiratory depression (decrease in the rate and depth of breathing) up to and including death. (Patient 50)

2. The facility failed to ensure that all medications available for patient use had not expired.

This had the potential to put patients at risk for poor clinical outcomes and an ineffective responsive to those medications.

Findings:

1. A review of Patient 50's record disclosed that she was admitted on 5/31/13 with diagnoses that included dehydration, kidney infection, and had a history of metastatic cancer (spread to more than one organ). There was a physician's admission order, written by Physician Y, for a topical Fentanyl patch 50 micrograms (mcg) every 72 hours.

The Fentanyl transdermal system also called a Fentanyl patch contains Fentanyl, a potent synthetic opiate medication used to treat pain. This medication has a boxed warning (also called a "black box" warning) which is the most serious warning required by the FDA to be placed in the product labeling (also called the package insert) for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for the Fentanyl patch documents that "Respiratory depression and death may occur with the use of the (Fentanyl patch), even when (it) has been used as recommended and not misused or abused." It documents that use of this patch "is contraindicated for use in conditions in which the risk of life-threatening respiratory depression is significantly increased, including ... use in non-opioid tolerant patients ...." Under "Indications and Usage" the product labeling documents opioid-tolerant patients as those who have taken at least 60 mg (milligrams) of oral morphine, 30 mg of oral oxycodone, or 8 mg of oral hydromorphone (opioid medications used to treat pain) or an equianalgesic dose of another opioid medication daily for a week or longer.

The facility's policy titled, "Fentanyl Patch Order Form," revised 4/13, read as follows, "When a Fentanyl Patch is ordered, the nurse shall initiate the Fentanyl Patch Order form. Before the Fentanyl Patch is to be administered, the Fentanyl Patch Order form must be completed in its entirety." The Fentanyl Patch Order Form provided check boxes that a prescriber could use to document that a patient was opioid tolerant, as documented in the FDA approved product labeling for this medication.

The Fentanyl Patch Order form had been used by Physician Y to order the Fentanyl Patch for Patient 50 and the box that indicated that Patient 50 had used at least 30 mg of oxycodone daily for seven days had been checked. However, the medication reconciliation sheet (lists names and dosages of medication used at home), that was completed by the nurse and Patient 50 upon admission and signed by Physician Y, did not indicate that Patient 50 received enough medication to be opioid tolerant. On 6/3/13, another physician, Physician Z, discontinued the Fentanyl Patch order because Patient 50 did not meet the criteria necessary to be opioid tolerant.

During an interview on 6/12/13 at 10:20 am, Nurse Manager G confirmed that according to the medication reconciliation sheet, Patient 50 was not opioid tolerant. She also confirmed that Physician Z, who discontinued the Fentanyl Patch on 6/3/13, did so because Patient 50 was not opioid tolerant at that time.

On 6/9/13, the Fentanyl Patch was reordered and administered. The Fentanyl Patch Order form was not completed until 24 hours later, on 6/10/13.

During an interview on 6/12/13 at 10:20 am, Nurse Manager G confirmed that Physician Y had not completed the Fentanyl Patch Order Form at the time she/he ordered the medication, as required by their policy. Nurse Manager G stated that the Fentanyl Patch Form could not be located at the time Physician Y wrote the order so it was not completed until the next day.

During an interview conducted during a prior survey, on 4/30/13 at 3:30 pm, Administrative (Admin) Nurse F stated that the nursing staff had been educated on the use of the Fentanyl Patch Order Form during their annual skills training from 4/29-4/30/13.

During the initial recertification survey on 3/21/13 at 2:02 pm, Admin Nurse A, stated the hospital had developed the FENTANYL PATCH ORDER FORM on 3/15/12 which was a year ago. She stated from that time forward, physicians had been expected to use that form to prescribe Fentanyl patches for hospital patients.

2.a. During the initial tour of the Emergency Department on 6/11/13 at 10:35 am, four tablets of Bisacodyl (used to treat constipation), with expiration dates of 4/1/13, were found in the stock medication area.

During a concurrent interview, the Pharmacy Tech confirmed the expiration dates and stated that it was everybody's responsibility to check the expiration dates on medications.

b. During the tour of the medication room on the medical unit on 6/11/13 at 11:05 am, the refrigerator contained two Infuvite (vitamins to be given intravenous) vials, both with expiration dates of 1/13. There was a 100 milliliter (ml) vial that was opened with no open date. There was a 50 ml vial with an open date of 7/31/12.

During a concurrent interview, the Pharmacy Tech confirmed the dates as listed above, then disposed of the medications.

A hospital policy titled, "Multidose Vials and Single Dose Vials", last revised in 2/13, read as follows, "Multi-dose vials must be dated when opened. Multi-dose vials will expire after 28 days of being punctured. Single dose vials are for one time dose only as clearly indicated on the vial. Medication that is not used in a single dose vial may not be saved for another dose even if it is for the same patient. Any medication left in a single dose vial must be immediately disposed of in an appropriate waste pharmaceutical container. Any opened vial must be removed from stock at the expiration date."

Based on observation, interview, and record review, the hospital failed to have a current CLIA (Clinical Laboratory Improvement Amendments - regulates all laboratory testing) certificate. This failure may result in inaccurate test results.

Findings:

On 6/11/13 at 10:45 am, the laboratory posting board was observed to have the hospital's CLIA certificate posted. The expiration date on the license was 4/9/13.

On 6/12/13 at 2 pm, Laboratory Manager (LM) U stated there was confusion regarding the the CLIA certificate and the license which were previously timed to expire at the same time. LM U stated the hospital passed its inspection but the fee for certification had not yet been paid.

On 6/12/13 at 2:20 pm, a representative from the California Laboratory Field Services confirmed that the hospital was in compliance but needed to send a check prior to the certification being issued.

The regulation above references part 493 of this chapter which reads, "Laboratories performing only waived tests, PPM (Provider Performed Microscopy) procedures, or any combination of these tests, are not required to obtain a registration certificate.
(a) A registration certificate is required-- (1) Initially for all laboratories performing test procedures of moderate complexity (other than the subcategory of PPM procedures) or high complexity, or both; and
(2) For all laboratories that have been issued a certificate of waiver or certificate for PPM procedures that intend to perform tests of moderate or high complexity, or both, in addition to those tests listed in ?493.15(c) or specified as PPM procedures.
Interpretive Guidelines ?493.45(a)
All facilities performing laboratory testing must have a registration certificate or certificate of waiver prior to performing patient testing.
See ??6006 and 6030 of the SOM for instructions on handling a laboratory operating without an appropriate CLIA certificate.
(b) HHS (Health and Human Services Department) will issue a registration certificate if the laboratory--
(1) Complies with the requirements of ?493.43;
(2) Agrees to notify HHS or its designee (CDPH Lab Field Services) within 30 days of any changes in ownership, name, location, director or technical supervisor (laboratories performing high complexity testing only);
(3) Agrees to treat proficiency testing samples in the same manner as it treats patient specimens; and
(4) Remits the fee for the registration certificate, as specified in subpart F of this part.
(c) Prior to the expiration of the registration certificate, a laboratory must--
(1) Remit the certificate fee specified in subpart F of this part;
(2) Be inspected by HHS as specified in subpart Q of this part; and
(3) Demonstrate compliance with the applicable requirements of this subpart and subparts H, J, K, M, and Q of this part.
(d) In accordance with subpart R of this part, HHS will initiate suspension or revocation of a laboratory's registration certificate and will deny the laboratory's application for a certificate of compliance for failure to comply with the requirements set forth in this subpart. HHS may also impose certain alternative sanctions. In addition, failure to meet the requirements of this subpart will result in suspension of payments under Medicare and Medicaid as specified in subpart R of this part."

22705

Based on interview and record review, the facility failed to ensure that physicians' orders were followed and interventions were completed to meet the needs for 2 of 18 sampled patients. (Patients 48 and 49)

1. Patient 48 had an Intravenous (IV) line started without a physician's order and medication effectiveness was charted prior to the time the medication order was written and given.

2. Patient 49 had a physician's order for IV fluids that was not followed and documentation of nursing care was not completed as required.

These failures had the potential for patients' needs to go unattended and suffer adverse health consequences.

Findings:

1. A concurrent record review of Patient 48's record and interview was conducted on 6/12/13 at 10:35 am, with Nurse Manager G. Patient 48 arrived to the Emergency Department (ED) on 6/1/13 at 3:20 pm, with a complaint of severe shortness of breath and chest pain. The ED nurse charted she started an IV at 3:28 pm, but there was no order from the physician. There was an order for Lasix (medication that increases urination) 40 milligrams at 4:36 pm. However, the nurse had charted at 4 pm, "patient states he felt better after lasix and urinating."

Nurse Manager G confirmed that according to the notes, it looked liked the Lasix was given before the order was written. She also confirmed that she was unable to determine what time the physician examined Patient 48. Nurse Manager G confirmed there was no order for the IV and stated that the ED physicians do not always write an order to start an IV for certain complaints.

During a subsequent interview on 6/12/13 at 1:25 pm, Nurse Manager G confirmed that the facility does not have a standing order, standardized procedure, or policy and procedure that allowed nurses to start an IV or administer Lasix to patients without an order from the physician.

2. A concurrent record review of Patient 49's record and interview was conducted on 6/12/13 at 10:35 am, with Manager Nurse G. Patient 49 arrived to the Emergency Department (ED) on 5/8/13 at 10:10 am, with a complaint of abdominal pain. An order for an IV at 500 milliliters (ml) per hours was written at 10:32 am. The nurse charted she started the IV at 100 ml per hour at 10:32 am, and at 11:30 am, the patient was discharged. The intake and output was left blank, as was the time the IV was discontinued.

Nurse Manager G stated she did not know why the nurse charted she started the IV at 100 ml per hour when the order was for 500 ml per hour. She also stated that the nurse should have charted the total amount of IV fluids that Patient 49 received as well as what time the IV was discontinued.

Based on interview and record review, the facility failed to evaluate the competence of two of two surgical nursing staff. (Registered Nurses (RN) I and X) This failure had the potential for patients to suffer adverse consequences such wrong site surgery, infection, and injury.

Findings:

On 6/11/13 at 11:30 am, RNs I and X stated they worked in the surgical suite on the days that surgery/procedures were performed, generally one to two times per month.

On 6/12/13, personnel files for RN I and X were reviewed. RN I and X's personnel files contained two competence assessment tests procedural sedation (the sedating of patients so ther will not experience pain or discomfort during a procedure) dated 8/12 but did not contain an evaluation of their competence related to their perioperative (before, during, and after surgery) skills. The 8/12 tests for the procedural sedation were not scored so it is unknown whether they were deemed competent.

On 6/12/13 at 10:45, Administrative Staff D reviewed the above personnel files and confirmed that RN I and X did not have evidence that their perioperative competence had been evaluated.

Based upon document, record review and staff interview, the facility failed to obtain a physician's order for biologicals (normal saline) that were administered to seven outpatients (42, 53, 54, 56, 57, 58, and 60) and no notification to the physician that an ordered medication was unavailable for one of 18 patients. (Patient 42) This had the potential to result in adverse health consequences.

Findings:

1. Patient 42 was admitted for an outpatient visit on 5/15, 6/1, and 6/2/13. The patient had a physician order for "PICC (Peripheral Intravenous Central Catheter, a slender tube inserted into the arm for the purpose of administering medications, blood, and other drugs) dressing change". Normal saline (an intravenous fluid) was administered into the PICC without a physician's order on 5/16 and 6/2/13.

On 6/1/2013 there was a physician's order for IV fluids and Kytril (anti-nausea medication). There was a handwritten note next to the Kytril order that read "not available". They was no nursing documentation regarding whether the MD was notified that Kytril was "unavailable".

During a record review and interview on 6/12/13 at 11:30 am, Nurse Manager G confirmed there was no order for normal saline for the above patient. Nurse Manager G was unable to clarify if the physician was notified that Kytril was unavailable.

2. Patient 58 was admitted for an outpatient visit on 5/31/13 for a blood transfusion. Normal saline was administered into the Intravenous (IV) line without a physician's order.

During a record review and interview on 6/12/13 at 11:30 am, Nurse Manager G confirmed there was no order for normal saline for the above patient.

3. Patient 60 was admitted on 5/12/13 for antibiotic therapy. After the antibiotic had been given, normal saline (flush) was given without a physician's order.

During a record review and interview on 6/12/13 at 11:30 am, Nurse Manager G confirmed there was no order for normal saline for the above patients. Nurse Manager G acknowledged the facility failed to have specific policies that directed the nurse regarding PICC dressing changes and line flushes, and antibiotic and other intravenous fluid administration.


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4. On 6/12/13, Patients 53, 54, 56, and 57's records were reviewed. Patients 53, 54, 56, and 57 records indicated they had endoscopic procedures (tube inserted into a body cavity to view the internal gut) performed. These records did not contain evidence of physician's orders for the care of the patient after the procedure (recovery) or for the patients discharge. The above records indicated that the patients had received IV fluids without physician's orders during their recovery period.

On 6/18/13 at 8:10 am, the Health Information Management Director reviewed the above patient records and confirmed that there were no orders for nursing care following the endoscopic procedure or discharge orders.

Based on interview and record review, the facility failed to ensure that a comprehensive nursing care plan had been developed for one of 18 sampled patients. (Patient 61) This had the potential to result in the patient's needs not being met and a decline in her overall health condition.

Findings:

A review of Patient 61's record disclosed that she was admitted on 6/7/13 with a diagnosis of chest pain. A review of the care plans disclosed there was not one that dealt with the problem of pain.

During an interview on 6/12/13 at 1:25 pm, Nurse Manager G confirmed there was not a care plan for pain although there should have been since Patient 61 had been admitted for chest pain.

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Based on interview and record review, the facility failed to ensure that patient records were complete and accurately documented for eight of 18 sampled patients as evidence by:

1. Patients 52, 54, 55, 56, and 57 had pre-surgical forms which were incomplete and/or not timed; and

2. Patient 42, 43, and 58 had no documented assessments of Intravenous (IV) sites and incomplete blood transfusion consent forms.

These failures could result in miscommunication which could negatively impact the patients' health status, such as incorrect surgical site, incorrect procedure, and incorrect blood type for transfusion.

Findings:

1. On 6/12/13, Patients 52, 54, 55, 56, and 57 records contained short form history and physicals which were completed on the day of surgery. None of these forms included the time of the examination on the form.

a. On 6/12/13, Patient 55's record contained a anesthesia (artificially induced loss of ability to feel discomfort and/or sensation) questionnaire, not dated, which contained blanks on several questions.

b. On 6/12/13, Patient 56's record contained a pre-procedure checklist, dated 5/29/13, in which the verification of patient identity, procedure, and code status were blank. Patient 56's record also contained a pre-procedural data collection form which was blank for all medical history elements and the whether the history and physical was present and current, consent was current , and pre-procedure labs were done.

c. On 6/12/13, Patient 57's record contained a pre-procedure checklist, dated 6/10/13, in which the patient's height and denture status were blank.

On 6/12/13 at 2:45 pm, Nurse Manager G reviewed the above records and confirmed the above forms should not contain blanks.


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2.a. A review of Patient 42's record disclosed that he had two outpatient visits on 5/15 and 6/1/13. Documentation for both visits did not include the intravenous (IV) site where medication was given, assessment including patency (being open) of the site prior to the administration of ordered therapy. The "Agreement for Blood Transfusion" consent form was incomplete for physician name, witness date & time and no title after the nurse's signature.

b. A review of Patient 43's record disclosed there was one outpatient admission on 6/1/13, for a blood transfusion and Normal Saline (intravenous (IV) fluids). Documentation did not include the IV site where the blood was given, assessment including patency (being open) of the site prior to the administration of the blood, amount, date or time of IV fluids. The "Agreement for Blood Transfusion" consent form was incomplete for the physician name, and no title after the nurse's signature.

c. A review of Patient 58's record disclosed there was one outpatient visit on 5/31/13, for a blood transfusion. Documentation did not include the intravenous (IV) site where the blood was given, assessment including patency (being open) of the site prior to the administration of the blood. The "Agreement for Blood Transfusion" consent form was incomplete for physician name, no title after nurse signature on the consent. Benadryl and Tylenol were ordered as "pre-medications" to be given prior to the blood transfusion. There was no documentation that the patient received these medications.

During a record review and interview on 6/12/2013 at 11:30 am, Nurse Manager G confirmed the above missing documentation including the incomplete "Agreement for Blood Transfusion" consent forms. Nurse Manager G stated that the nurse assigned to care for the patient was responsible for the above missing documentation.

26611

Based on staff interview and document review, the hospital failed to ensure that requirements were met for the condition of participation: Periodic Evaluation and Quality Assurance Review as evidenced by:

1. Failure to have quality assurance programs to evaluate the effectiveness and safety of the radiology services for patients and staff; (Refer to C 222, items 1, 2, and 6, and C 337, item 1)

2. Failure to evaluate the maintenance of a proper environment in the Operating Room; (Refer to C 222, items 3, 4, and 5, C 225, C 226, and C 337, item 2)

3. Failure to evaluate the effectiveness of its nursing and pharmaceutical services; (Refer to C 276, C 294, C 295, and C 337, item 3)

4. Failure to adequately evaluate the completeness and accuracy of patient care documentation; (Refer to C 302, and C 337, item 4) and

5. Failure to maintain evidence of the evaluation of the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy (disease of a bone) at the hospital. (Refer to C 340)

The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Condition of Participation: Periodic Evaluation and Quality Assurance Review.

Based on interview and record review, the hospital failed to have an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished, and of treatment outcomes for all patient care services and other services affecting patient health and safety as evidence by:

1. Failure to have quality assurance programs to evaluate the effectiveness and safety of the radiology services for patients and staff; (Refer to C 222, items 1, 2, and 6)

2. Failure to evaluate the maintenance of a proper environment in the Operating Room (Refer to C 222, items 1, 3, 4, and 5, C 225, and C 226) and develop a quality plan to ensure the patient safety and quality surgical care;

3. Failure to evaluate the effectiveness of its nursing and pharmaceutical services; (Refer to C 276, C 294, and C 295)

4. Failure to adequately evaluate the completeness and accuracy of patient care documentation; (Refer to C 302) and

5. Failure to maintain evidence of the evaluation of the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy at the hospital as well as Allied Health Professionals. (Refer to C 340)

The failure to evaluate patient care services resulted not only in the lack of identification of problems that may harm patients or negatively impact their health status but also resulted in a delay in the monitoring and evaluation of processes to correct problems once they were identified.

Findings:

1. During the initial recertification survey on 3/19/13 at 11:40 pm, Radiology Manager F was interviewed regarding the quality program for the services provided in Radiology. Radiology Manager F stated mammography (xray of breast tissue) indicators were reported regularly to the Quality Committee but none of the other imaging services had data that was reported to the Quality Committee. When asked if data regarding the radiation exposure to patients and staff was evaluated as part of the quality program, he stated it had not been.

During the revisit survey, at an interview on 5/1/13 at 10:15 am, Administrative (Admin) Nurse F confirmed that the facility had a meeting scheduled for later that morning to discuss specific quality indicators for each area in which the hospital had been found to be deficient in during the initial recertification survey. Administrative (Admin) Nurse F confirmed that no data had been collected and no monitoring or evaluation had occurred yet.

On 6/12/13 at 2 pm, Radiology Manager F stated that data had been collected for badge safety (staff radiation exposure) and mammogram but had not developed criteria to measure other patients services such as CT (Computerized Tomography) scan (a type of xray).

A review of the Quality Assurance Committee minutes demonstrates that badge safety indicator had not been presented at the 4/29 and 5/21/13 meetings.

On 6/12/13 at 1:30 pm, Quality Nurse W confirmed the badge safety data had not been presented at the Quality Assurance Committee.

2.a. On 4/30/13 at 10:15 am, the operating room (OR) temperature and humidity log was observed with Registered Nurse (RN) I who confirmed they were not in compliance with their policy regarding the temperature on two of five days in 4/13.

A problem with the OR temperature and humidity had been identified in the initial recertification survey on 3/21/13 but no specific quality indicators had been developed to monitor and evaluate this issue.

During the first revisit survey, in an interview on 5/1/13 at 10:15 am, Admin Nurse F confirmed that the facility had a meeting scheduled for later that morning to discuss specific quality indicators for each area in which the hospital had been found to be deficient in during the initial recertification survey. Admin Nurse F confirmed that no data had been collected and no monitoring or evaluation had occurred yet.

On 6/11/13, when asked to see documents regarding the quality improvement program in the operating room, the logs of temperature and humidity were provided (which were blank for blanket warmer temperatures) and examples of missing pre-surgical documentation. There was no evidence of quality indicators, analysis, or actions taken in these documents.

On 6/12/13 at 2:30 pm, when asked if there was any analysis or actions taken, RN G, who supervises the surgery/procedure nurses, stated they talk with the staff but was unable to provide documentation.

b. The OR environment and supplies were not kept cleanly and sterilized per nationally recognized standards. (Refer to C 222, items 3, 4, and 5, C 225, and C 226) This area is supervised by two RNs, RN I and Quality Nurse W who performed duties as circulating and scrub nurses, respectively, for surgeries and procedures that were performed one to two times per month. There was no evidence that their competence had been assessed for surgical procedures. (Refer to C 295)

A review of the Quality Assurance Committee minutes demonstrates that none of these topics have had indicators presented at the 4/29 and 5/21/13 meetings.

On 6/12/13 at 1:30 pm, Quality Nurse W stated that no quality assurance plan had been developed for the surgical services.

3. The following nursing and pharmaceutical problems were found in the initial recertification, the first revisit survey, and again on the second revisit survey:

a. The hospital did not ensure that its physicians verified that a patient met conditions of opioid (narcotic) tolerance as documented on the hospital's "Fentanyl Patch Order" form. (Refer to C 276, item 1)

b. A patient in the Emergency Department (ED) received a medication prior to being examined by the ED physician. (Refer C 294, item 1)

c. Medications in the ED were expired or outdated. (Refer to C 276, item 2)

d. Five patients did not have all pre-procedure forms completed by nursing personnel. (Refer to C 302, items 1-5)

e. A patient did not have a physician's order for IV (intravenous) fluids before the nurse started the IV. (Refer to C 294)

f. Changes in the patient condition and/or treatment plan were not reported to the physician. (Refer to C 294 and C 297)

Non-compliance with Fentanyl patch policy, storage of medications, expired medications, assessment of ED and medical-surgical patients, reporting changes to the physician, and incomplete forms for patients who had procedures performed were all identified during the initial recertification survey on 3/21/13, the first revisit survey on 5/1/13, and again on the revisit survey on 6/12/13. No specific quality indicators had been developed to monitor and evaluate these issues.

A review of the Quality Assurance Committee minutes demonstrates that none of the above deficient practices had monitoring indicators presented at the 4/29 and 5/21/13 meetings.

In an interview with Quality Nurse W on 6/12/13 at 1:30 pm, she stated that they had started with data collection but had not yet done any analysis or reports. Quality Nurse W acknowledged that these problems had persisted and compliant performance had not been achieved.

4. The facility failed to ensure that records were complete and accurately documented. (Refer to C 302) Similar problems were found during the initial recertification survey on 3/21/13.

During the first revisit, in an interview on 5/1/13 at 10:15, Admin Nurse F confirmed that the facility had a meeting scheduled for later that morning to discuss specific quality indicators for each area in which the hospital had been found to be deficient in during the initial recertification survey. Quality Nurse W confirmed that no data had been collected and no monitoring or evaluation had occurred yet.

On 6/12/13 at 1:30 pm, Quality Nurse W confirmed that data had been collected and the staff were shown the errors but an analysis had not yet occurred.

5. During the initial recertification, there was no Quality Improvement Organization (QIO) that provided an evaluation of the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy at the hospital.

During the first revisit, in an interview on 5/1/13 at 12 pm, the Chief Executive Officer (CEO) stated he had contacted a QIO to complete the required service but the QIO would not start the evaluation until 5/15/13.

On 6/11/13, a report was provided that was represented as a QIO report. The report was dated 5/20/13 and included a review and recommendations for the hospital's quality and credentialing program. This report was done by a registered nurse and did not include the required elements of "an evaluation of the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy at the hospital." Appropriateness of medical care was customarily reviewed by physicians due to their expertise. The report did include recommendations that included the process to meet this requirement by participating in the Medicare Beneficiary Quality Improvement Project (MB-QIP).

As of 6/12/13, the Quality Assurance Committee and Board of Directors had not acted on the recommendations in the report. On 6/12/13 at 3:30 pm, the CEO stated that there had not been enough time for the Committee to act as it was first shared with the Committee on 5/21/13.


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26611

Based on interview and document review, the hospital failed to maintain evidence that it had utilized an agreement with a hospital, QIO (Quality Improvement Organization) or other equivalent/qualified outside entity to evaluate the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy at the hospital. This failure had the potential for substandard medical care to persist and negatively impact patients' health status.

Findings:

A review of the provided list of services by contract or agreement did not list a hospital, QIO or other entity that was listed as providing an evaluation of the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy at the hospital. The list did contain one QIO, however the "Contracted Services" list, did not describe the services provided other than to read "Medicare Quality Assurance." The hospital provided no documentation to show that this QIO had been utilized to conduct an evaluation of the quality and appropriateness of the diagnoses and treatments furnished by practitioners at the hospital.

The Administrative Policy #AD 066, titled "Quality and Performance Improvement" (Q/PI), last reviewed 4/25/13, did not specify a plan to have an outside entity evaluate the diagnoses and treatments furnished by practitioners at the hospital.

During the first revisit survey, in an interview on 5/1/13 at 12 pm, the Chief Executive Officer stated he had contacted a QIO to complete the required service but the QIO would not start the evaluation until 5/15/13.

On 6/11/13, a report was provided that was represented as a "QIO report". The report was dated 5/20/13 and included a review and recommendations for the hospital's quality and credentialing program. This report was done by a registered nurse who was contracted by the critical access hospital network. The report did cover the elements of the annual review but did not include the required elements of "an evaluation of the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy at the hospital." Appropriateness of medical care was customarily reviewed by physicians due to their expertise.

On 6/24/13 at 1:15 pm, the hospital Chief Executive Officer acknowledged that the report did not include the required elements for this regulation.