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 provide nurse staffing at 1:5 ratio.
2. Failure to have an annual meeting with the nursing staff to review and revise, if needed, the patient classification system.
3. Failure to have a Committee on Interdisciplinary Practice.

These failures had the potential for unsafe patient care.

Findings:

1. 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 4/16 - 4/30/13. Three shifts had one nurse caring for more than five patients for at least part of her 12 hour shift. On these three days, 4/19, 4/23 and 4/26/13, there were five patients on the medical surgical floor. In addition to these five patients, there were two outpatient admissions on 4/19/13 and 4/23/13 and one outpatient admission on 4/26/13. On these three days the nurse cared for six or seven patients instead of five patients.

During an interview on 5/1/13 at 7:40 am, Licensed Nurse G confirmed the above information.

2. California Code of Regulations Title 22 70217(e) stipulates, "The reliability of the patient classification system for validating staffing requirements shall be reviewed at least annually by a committee appointed by the nursing administrator to determine whether or not the system accurately measures patient care needs."

On 5/1/13 at 9:30 am, Admin Nurse F confirmed that a nursing committee had not been established for staffing requirements.

3. 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 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 an interview on 5/1/13 at 12 pm, the Chief Executive Officer stated that although an Interdisciplinary Practice committee had been formed, the first meeting would not take place until 5/18/13.

Based on observation and interview, the facility failed to ensure that all emergency drugs in the Emergency Department (ED) crash cart (contains supplies and drugs to be used in case of an emergency) as well as other medication storage areas had not expired. This had the potential to put patients at risk for poor clinical outcomes including infection and an ineffective response to medication/treatment in the case of a patient emergency.

Findings:

1. During the initial tour of the ED on 4/30/13 at 10:05 am, the crash cart contained the following emergency intravenous medication, available for patient use, that had expired dates: Dextrose (medication used when a patient's blood sugar is low) 50% that had expired on 3/1/13. The following was written on the box that contained this medication, "Can use in ER only."

During an interview on 4/30/13 at 10:05 am, Registered Nurse (RN) M confirmed the above expiration date.

During a subsequent interview on 4/30/13 at 2:45 pm, the Pharmacy Tech explained that the hospital had difficulty obtaining two emergency drugs that had expired, Dextrose 50% and Magnesium Sulfate. She was asked if the problem with drug shortages and possible solutions had been discussed at the Pharmacy & Therapeutics committee meeting. She stated that it would be discussed in their next meeting scheduled for 5/6/13.

2. During the initial tour of the ED on 4/30/13 at 10:05 am, the following opened vials of medication were observed in a medication cart: A single dose vial of Sodium Bicarbonate 4% opened, with no date; Xylocaine 2% 10 milliliter (ml) multi-dose vial, opened with no date; Xylocaine 2% 20 ml multi-dose vial with an opened date of 2/17/13. During a concurrent interview, RN M confirmed this and stated that multi-dose vials should be dated when opened.

During a subsequent interview on 4/30/13 at 11:30 am, Licensed Nurse G also confirmed the above dates and stated that the bottle dated 2/17/13 had expired and should have been discarded. She also stated that the single dose vial should have been discarded.

A hospital policy titled, "Multidose Vials and Single Dose Vials", last revised in 2/2013, 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 ensure that the operating room (OR) temperature levels were maintained according to facility policy and standard of care. This had the potential to result in the spread of infections.

Findings:

On 4/30/13 at 10:15 am, the operating room temperature and humidity log was observed with Licensed Nurse (LN) I. The humidity and temperature had been recorded on the following days during the month of 4/2013: 4/8, 4/15, 4/22, 4/23, and 4/29. The word "closed" was written on the other days. The humidity ranged from 22-27% and temperatures ranged from 59-63 degrees. The temperature was below 62 on two of these days.

During an interview on 4/30/13 at 11:40 am, LN I stated on days when there was no surgery she would write "closed" on the log and not document the temperature or humidity on that day. She confirmed that there were two days during 4/2013, where the temperature was lower than 62 degrees and confirmed they were not in compliance with their policy on those days.

On 3/19/13, the hospital policy, titled, "Equipment Logs and Guidelines," reviewed on 1/2013, read, "Temperature and humidity logs are monitored and recorded daily. The days when the operating room is closed the recording on the log for that day will read closed. Temperature for the operating room is to be maintained at 68-72 degrees Fahrenheit. The temperature may be lowered if requested by a surgeon for comfort. If such a request is made the range for the temperature will not be lower than 62 degrees Fahrenheit."



26611

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 Medical Records Committee as outlined in the Medical Staff Bylaws. (Refer to C 241)

2. Failure to have a credible review by the governing body of the the hospital's quality plan. (Refer to C 241)

3. Failure to ensure that its physicians and allied health practitioners (AHP) participated together in periodically reviewing patients' health records. (Refer to C 266)

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.



26611

22705

Based on document review and staff interview, the governing body (Board of Directors: BOD) failed to ensure that the medical staff Bylaws, Rules and Regulations and Administrative Policies were carefully developed, implemented, administered, and monitored so as to ensure that quality 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:

1. The Medical Staff Bylaws, revised 12/8/12, Section 9.6 (pages 64 & 65) describe the Medical Records Committee, listing their duties and stating that they shall meet at least quarterly, and maintain a permanent record of its proceedings.

During an interview on 5/1/13 at 12 pm, the Chief Executive Officer (CEO) confirmed that the Medical Records Committee had been formed but no meetings had occurred.

2. Administrative Policy #AD066, titled "Quality and Performance Improvement" (Q/PI), was reviewed and it was noted to have been reviewed and approved by the BOD in 3/2013.

During an interview on 5/1/13 at 12 pm, the CEO stated that the above new Quality Improvement Plan had been approved by the Board on closed session.

Even though the plan had been approved by the BOD, it had not yet been implemented, administered, and monitored as required.

During 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.

22705

Based on interview and document review, the hospital's Allied Health Practitioners (AHPs) had not participated in the development, execution, or reviewed written policies governing the services furnished in the hospital.

Findings:

California Code of Regulations (CCR) Title 22 Section 70706 stipulated 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 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 an interview on 5/1/13 at 12 pm, the Chief Executive Officer stated that although an Interdisciplinary Practice Committee that included AHPs had been formed, the first meeting would not take place until 5/18/13.

22705

Based on interview and document review, the hospital did not ensure that its physicians and allied health practitioners (AHP) participated together in periodically reviewing patients' health records, and did not ensure that its Medical Staff (MS) Bylaws, Rules and Regulations regarding this practice were developed and implemented. This resulted in inadequate supervision of the nurse practitioners and physician assistants that could have negative patient care outcomes.

Findings:

Appendix III - Rules and Regulations for Allied Health Practitioners is appended to the MS Bylaws. This document was reviewed on 3/19/13 and it reads, in part, (beginning at page 97), section III - C: "All allied health professionals may generate progress notes. They may not generate orders themselves, and may not transcribe orders except on verbal order of the physician with the exceptions of Physician Assistants & Nurse Practitioners.. Physician Assistants & Nurse Practitioners may generate orders, subject to protocols approved by the Medical Executive Committee." ... V. - A: "Allied health professionals shall be subject to a continuing audit by the attending supervision. A probationary review after 90 days will be formalized by and through the Credentials Committee. Protocols and operating procedures will be reviewed annually."

A document titled, "Standardized Procedures for the Nurse Practitioner", dated 8/2009 was reviewed. It reads as follows, "Annual review, between the nurse practitioner and an associate physician or nurse practitioner, of 20 randomly selected charts written by the nurse practitioner. A written record of the review will be kept."

During an interview on 5/1/13 at 9:30 am, Admin Nurse F confirmed that the protocols for review of Physician Assistant and Nurse Practitioners' records were to be approved by the Medical Executive Committee later that morning. However, no review of any of the Physician Assistants or Nurse Practitioners' records had been started as of 5/1/13.

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 the medication in accordance with product labeling and hospital policy. (Refer to C 276, item 1)

2. Failure to ensure that medications met requirements for potency and were stored under proper temperatures. (Refer to 276, item 2)

3. Failure to ensure that the emergency medications were listed on the outside of all the facility's crash carts (emergency supplies and medications). (Refer to C 276, item 3)

4. Failure to ensure that all emergency drugs in the Emergency Department (ED) crash cart as well as other medication storage areas had not expired. (Refer to C 202)

4. Failure to have qualified supervision of the radiology services to ensure competency of staff performing imaging procedures. (Refer to C 283)

4. Failure to adequately assess and meet the needs of patients. (Refer to C 294)

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.






26611

22705

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

1. The hospital did not ensure that its physicians verified that a patient met conditions of opioid tolerance as documented on the hospital's Fentanyl Patch Order form prior to the placement of a Fentanyl patch on Patient 26 and potentially for any patient with an order for 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.

2. The hospital did not ensure medications met requirements for potency and were stored under temperatures stipulated by the manufacturers. This had the potential to result in reduced effectiveness of the medication.

3. The hospital failed to list the contents of its crash carts on the outside of the crash cart, in accordance with state law. This had the potential to result in emergency medications not being available in the event of an emergency.

Findings:

1. 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," last revised 4/2013 (original date of policy 3/2012), read as follows, "When a Fentanyl Patch is ordered, the nurse shall initiate the Fentanyl Patch Order from. 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.

A review of Patient 26's record disclosed that he was admitted on 4/20/13 with diagnoses that included acute chest pain and heart failure. There was a physician's admission order for a topical Fentanyl patch every 48 hours.
The Fentanyl Patch Order form had not been used by the physician to order the Fentanyl Patch for Patient 26.

During an interview on 5/1/13 at 2:10 pm, Admin Nurse F confirmed the physician had not used the Fentanyl Patch Order Form as required by their policy.

During an interview on 4/30/13 at 3:30 pm, Licensed Nurse (LN) G stated that the nurses had been educated on the use of the Fentanyl Patch Order Form during their annual skills training from 4/29-4/30/13. She stated their physicians had not yet been educated in the use of this form.

2 a. On 4/30/13 at 11:35 am, twenty-three 50 ml vials of mannitol 25% (used to decrease pressure inside of the skull secondary to brain swelling after a traumatic injury to the head and to increase urine flow), were observed in the blanket warmer in the Operating Room (OR). During a concurrent interview, Licensed Nurse (LN) G confirmed that there was no temperature log that documented the temperature for the warmer on a daily basis. According to LN G, the current temperature inside the warmer measured 135 degrees F.

According to the manufacturer's instructions, this medication should be stored at temperatures of 68 to 77 degrees F.

A review of Policy and Procedure #PH010 titled, "Drug Procurement Inventory Control," read as follows, "All medications must meet USP, NF, or FDA requirements for potency and labeling. All medications shall be stored under appropriate conditions of temperature." The FDA is the Food and Drug Administration which is the federal agency charged with approving medications and regulating the safe manufacture, distribution, storage, and proper use of medications in the United States. It enforces standards published by the United States Pharmacopoeia Convention in the United States Pharmacopoeia/National Formulary (USP/NF).


b. On 4/30/13 at 11:30 am, it was also observed that all 23 mannitol vials contained mannitol crystals that had precipitated out of solution. Mannitol for injection 25% is a highly concentrated solution and can precipitate out of solution. For this reason, the manufacturer provides direction that the vials can be heated to 60 to 80 degrees centigrade (140 to 176 degrees F) to dissolve the crystals. Then the solution would need to be cooled down to controlled room temperature before it was administered to the patient which could potentially delay therapy. Vials of mannitol that have crystals in them would not be at the labeled 25% concentration and therefore, would be unusable for patients in the hospital.

During a concurrent interview LN G stated that they had put the mannitol vials in the blanket warmer to try to keep them warm enough that the crystals would not form but someone had turned off the blanket warmer the prior day so the temperature had dropped and the crystals had formed.

During a subsequent interview on 4/30/13 at 2:45 pm, the Pharmacy Tech stated she would move the mannitol to the medication room on the medical-surgical unit to comply with the manufacturer's recommended storage temperatures .


3. California Code of Regulations, Title 22 Section 70236(f)(2) stipulates: "The emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. The contents of the container shall be listed on the outside cover and shall include the earliest expiration date of any drugs within."

During the initial tour of the Emergency Department (ED) on 4/30/13 at 10:05 am, the crash cart was inspected and no list of the emergency drugs contained inside was seen. During a concurrent interview, Registered Nurse (RN) M stated they no longer had a list of the emergency medications contained inside the crash cart.

During a subsequent interview on 4/30/13 at 2:45 pm, the Pharmacy Tech stated that the lists that contained the medications for all the crash carts in the hospital were kept in a binder in her office in the Administration area of the hospital.

Based on interview and document review, the facility failed to have a qualified Radiology Manager supervise the functions of the department as well as properly supervise radiology technicians according to its policy. This had the potential to result in substandard patient care in this department as well as pose a safety risk to both staff and patients.

Findings:

A review of Radiology Tech 1 and 2's personnel files disclosed that there were no competency checklists. During an interview on 3/20/13 at 3:40 pm, Admin Staff F stated that he was trained as a clinical lab scientist and not trained in Radiology. Admin Staff F confirmed he was unable to perform competency checks for the radiology technicians.

During a subsequent interview on 5/1/13 at 9 am, Admin Staff F stated that their radiologist would perform the evaluations and competency checks that involved actual technique for radiology, CT (computerized tomagraphy - imaging), and mammography but this had not been done and was scheduled for 5/6/13.

A facility policy, titled "Supervisor Responsibilities," last reviewed 2/2013, read as follows, "the Radiologist/supervisor shall be responsible for ascertaining compliance with the stated of California Radiation Control Regulations and with the Rules of Good Practice for Mammography. The Imaging Services Supervisor, by law, has responsibility for and control of the quality, radiation safety and technical aspects of all x-ray examinations and procedures."

22705

Based on interview and record review, the facility failed to ensure that accurate assessments were completed and interventions done to meet the needs for eight of 15 sampled patients. (Patients 32, 33, 34, 35, 36, 38, 43, and 45)

1. Patient 32 received a medication in the Emergency Department (ED) prior to being examined by the ED physician.

2. Patients 32, 33, and 34 did not have an assessment regarding how acutely ill they were upon presentation to the ED.

3. Patients 36, 37, and 38 did not have all pre-procedure forms completed by nursing personnel.

4. Patient 38 did not have a physician's order for IV (intravenous) fluids before the nurse started the IV.

5. Patient 43 did not have critical lab results (those that are much higher or lower than normal) reported to his physician.

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

Findings:

1. A concurrent record review of Patient 32's record and interview was conducted, on 5/1/13 at 9:15 am, with Admin Nurse F. Patient 32 arrived to the ED on 4/20/13 at 4:45 am with a complaint of severe shortness of breath and wheezing. The ED nurse charted a telephone order from the ED physician at 4:55 am for a breathing treatment. The physician did not examine the patient until 5:15 am.

Admin Nurse F confirmed that the nurse had started the medication ordered by the physician before the patient had been seen by the physician.

2. A concurrent record review of Patients 32, 33, and 34 and interview was conducted, on 5/1/13 at 9:15 am, with Admin Nurse F. Admin Nurse F confirmed that Patients 32, 33 and 34 had no documented triage acuity level (Level 1 - patients require immediate resuscitation, Level 2 patients are High Risk/Emergent, Level 3 patients are Urgent, Levels 4 and 5 patients could be seen in the clinic annex). He confirmed Patients 32 and 33's record did not contain the time the triage assessment was completed. Admin Nurse F stated this was not in compliance with their policy and standard of care.

A hospital policy titled, "Triage Guidelines," revised in 4/2011, read as follows: "Each patient presenting to the hospital requesting or in need of medical care will be triaged into Level 1-5, based upon assessment by the Registered Nurse."

3.a A review of Patient 36's record disclosed she was admitted for surgery on 4/22/13. The record contained a form titled "Pre-Procedure Verification," that had been only partially completed. The section for height was blank, last narcotic taken was blank, and the documentation that the patient had loose or capped teeth was blank.
b. A review of Patient 37's record disclosed that she was admitted for surgery on 4/23/13. The record contained a form titled "Pre-Procedure Verification," that had been only partially completed. The section for height was blank.
c. A review of Patient 38's record disclosed that he was admitted for surgery on 4/22/13. Patient 38's record contained a form titled, "Pre-Procedure Verification," that had been only partially completed. The section for pain level was blank.
Patient 38's record contained a form titled, "Pre-Procedure Data Collection," the section for pertinent medical history was blank and the RN who collected the data signed with the initials "PH" instead of a signature as required.
A hospital policy, titled, "Documentation Standards," last reviewed in 2/2013, read as follows, "medical record entries must be signed with the first initial, last name and category (e.g. RN. . .) on all entries."

On 4/30/13 at 4:14, LN G and R reviewed the records of Patients 36, 37, and 38 and acknowledged that all sections of the nursing assessment forms should have been completed and documented.
4. Patient 38's record also contained a form titled, "Preoperative Orders" dated 4/23/13, with a section for the MD to order, "On Admission" IV orders for the patient. This form had not been completed by the MD. LN J noted on form "Pre-procedure Verification" that an IV was started with Normal Saline, and a 20 gauge catheter in Patient 38's right arm at 7:45 am.
On 4/30/13 at 4:14, LN G and R reviewed Patient 38's record and acknowledged that all IVs needed an order prior to the nurse starting the IV to ensure the patient's safety during surgery.
5. Patient 43 was admitted on 4/24/13, for a blood transfusion on an outpatient basis. A Complete Blood Count (CBC) had been completed with results that showed the hemoglobin (oxygen carrying part of the blood) to be critically low. No documentation could be found in the record that showed that Patient 43's physician had been notified of this result.
During an interview on 5/1/13 at 10:20 am, Admin Nurse B confirmed the lack of documentation.

22705

Based on document and medical record review and staff interview, the facility failed to ensure that records were complete and accurately documented with dates and times, for seven of 15 records reviewed. This failure had the potential for miscommunication regarding patient care. (Patients 36, 37, 38, 41, 42, 44, and 45)

Findings:

1 a. A review of Patient 36's record disclosed that she was admitted for an endoscopy (tube inserted through the mouth to view the stomach) procedure on 4/22/13. Patient 36's record contained a form titled "Intra-Procedure Documentation" section for MD signature and the MD did not sign the form. The form titled "Pre-Operative Orders" dated 4/22/13 did not document if there would be an assisting physician, did not estimate the length of the surgery, date of surgery was blank, and the type of anesthesia was not completed. The form was not timed when the MD signed.
1 b. A review of Patient 37's record disclosed that she was admitted for endoscopy procedure on 4/23/13. Patient's record contained a form titled "Pre-operative Orders" dated 4/23/13. It was not documented on this form if there would be an assisting physician, did not estimate the length of the surgery, date of surgery was blank, diagnosis was blank, no IV order was noted, yet Zofran 4 mg IV was noted to have been given by the nurse, and the type of anesthesia was not completed. The form was signed by the MD on 4/25/13 with no time. The record also contained a progress note by the MD with no time documented.
1 c. A review of Patient 38's record disclosed that he was admitted for an endoscopy procedure on 4/23/13. The record contained a form titled "Pre-operative Orders" dated 4/23/13. It was not documented on this form if there would be an assisting physician, no estimate the length of the surgery, no notation regarding patient allergies, date the surgery was scheduled was blank, diagnosis was blank, no IV order was noted, and the type of anesthesia was not completed. The form was signed by the MD on 3/26/13 with no time.
The Medical Staff Bylaws, Rules and Regulations (revised 1/1/12) were reviewed on 3/18/13. Appendix 1, Section 34 states: "All progress notes and orders are to be timed and dated for all patients."

On 4/30/13 at 4:14 pm, LN G reviewed the records of Patients 36, 37, and 38 and acknowledged that all sections of the "Preoperative Order" form should have been completed and documented by the physician to ensure the patients' safety during surgery.
2 a. A review of Patient 41's record disclosed that she was admitted for a colonoscopy (tube inserted through the rectum to view the colon) and endoscopy on 4/23/13. The record contained a form titled "Pre-operative Orders" dated 4/23/13. It was not documented on this form the estimated length of surgery, the date the surgery was scheduled, and the diagnosis. The history and physical form was completed but not dated. The patient was given IV fluids but there was no physician's order.
2 b. A review Patient 42's record disclosed that he was admitted on 4/22/13 to receive a medication. He was given the medication subcutaneous (in the subcutaneous tissue) but the location of the injection was not documented.
2 c. A review of Patient 44's record disclosed that she was admitted on 4/19/13 for a dressing change of a central catheter. There were no vital signs taken upon admission and no documentation regarding how the site looked.
During an interview on 5/1/13 at 12:10 pm, Admin Nurse B confirmed the above findings.
3. A review of Patient 45's record disclosed he was admitted on 4/26/13 to have a blood transfusion.
During an interview on 5/1/13, at 12:10 pm, Licensed Nurse G stated that it was their protocol to have patients sign a blood transfusion consent every 30 days.
During a concurrent record review and interview on 5/1/13 at 12:10 pm, Admin Nurse B confirmed that the last blood transfusion consent was signed on 3/7/13, 50 days before the transfusion was given.









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 337, item 1)

3. Failure to evaluate the maintenance of a proper environment in the Operating Room. (Refer to 226)

4. Failure to evaluate the effectiveness of its nursing and pharmaceutical services. (Refer to C 202, C 276, and C 294)

5. Failure to adequately evaluate the documentation of its medical providers. (Refer to C 302)

6. Failure to maintain evidence of the evaluation of the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy and its Allied Health Professionals at the hospital. (Refer to 266 and 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.





26611

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22705

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.

1. Failure to have quality assurance programs to evaluate the effectiveness and safety of the radiology services for patients and staff.

2. Failure to evaluate the maintenance of a proper environment in the Operating Room (Refer to 226)

3. Failure to evaluate the effectiveness of its nursing and pharmaceutical services (Refer to C 202, C 276, and C 294)

4. Failure to adequately evaluate the documentation of its medical providers (Refer to C 302)

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 266 and 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 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 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. Admin Nurse F confirmed that no data had been collected and no monitoring or evaluation had occurred yet.

2. On 4/30/13 at 10:15 am, the operating room (OR) temperature and humidity log was observed with Licensed Nurse (LN) I who confirmed they were not in compliance with their policy regarding the temperature on two of five days in 4/2013.

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 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.

3. The following nursing and pharmaceutical problems were found.

a. The hospital did not ensure that its physicians verified that a patient met conditions of opioid tolerance as documented on the hospital's Fentanyl Patch Order form.

b. The hospital did not ensure medications met requirements for potency and were stored under temperatures stipulated by the manufacturers.

c. The hospital failed to list the contents of its crash carts on the outside of the crash cart, in accordance with state law.

d. A patient in the Emergency Department (ED) received a medication prior to being examined by the ED physician.

e. Three ED patients did not have an adequate assessment upon presentation to the ED.

f. Medications in the ED were expired or outdated.

g. Seven patients did not have all pre-procedure forms completed by nursing personnel and one patient received a blood transfusion without a current consent.

h. A patient did not have a physician's order for IV (intravenous) fluids before the nurse started the IV.

i. One patient did not have critical lab results (those that are much higher or lower than normal) reported to his physician.

A problem with Fentanyl patches, storage of medications, expired medications, crash cart contents, assessment of ED and medical-surgical patients, and partially completed forms for patients who had procedures performed were all identified during the initial recertification survey on 3/21/13. Following that survey no specific quality indicators had been developed to monitor and evaluate these issues.

During 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. Admin Nurse F confirmed that no data had been collected and no monitoring or evaluation had occurred yet.

4. The facility failed to ensure that records were complete and accurately documented with dates and times. Similar problems were found during the initial recertification survey on 3/21/13.

During 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. Admin Nurse F confirmed that no data had been collected and no monitoring or evaluation had occurred yet.

5a. 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 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.

5b. The hospital did not ensure that its physicians and allied health practitioners (AHP) participated together in periodically reviewing patients' health records.

During an interview on 5/1/13 at 9:30 am, Admin Nurse F confirmed that the protocols for review of Physician Assistant and Nurse Practitioners' records were to be approved by the Medical Executive Committee later that morning. However, no review of any of the Physician Assistants or Nurse Practitioners' records had been started as of 5/1/13. Admin Nurse F confirmed that no data had been collected and no monitoring or evaluation had occurred yet.

22705

Based on interview and document review, the hospital failed to maintained 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 and failed to maintain documentation that any such evaluation had been conducted within the hospital.

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 #AD066, titled "Quality and Performance Improvement" (Q/PI), last reviewed 3/2013, did not specify a plan to evaluate or detail any means of evaluating the diagnoses and treatments furnished by practitioners at the hospital.

During 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.