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5/25/2010 Survey Tag 0001 Detail for:
PRINTERS PLACE DIALYSIS CENTER
Wednesday, October 23, 2019 12:17 AM

Survey Date: 5/25/2010

Regulation Number:0001

Regulation Title: Survey Details

Regulation Description:

Surveyor Findings:


Section 1 - Statutory Authority and Applicability
1.2 A dialysis treatment clinic, as defined herein, shall comply with all applicable federal and state statutes and regulations, including but not limited to, the following:
(B) 6 CCR 1011-1, Chapter II, General Licensure Standards, including Part 7, Single Used Disposable Medical Devices.

This REGULATION was not met as evidenced by:
Based on review of medical records and staff interviews the facility failed to comply with Chapter II General Licensure Reporting requirements in one sample patient. The facility failed to report an incident of patient neglect to the Colorado Department of Public Health and Environment as required by statutes. This failure created the potential for a negative patient outcome.

The facility failed to comply with the following licensure requirements for Chapter II:

3.2 OCCURRENCE REPORTING Notwithstanding any other reporting required by state law or regulation, each health care entity licensed pursuant to 25-1.5-103 shall report to the Department the occurrences specified at 25-1-124 (2) C.R.S.
3.2.1 The following occurrences shall be reported to the department in the format required by the Department by the next business day after the occurrence or the health care entity becomes aware of the occurrence:
3.2.1 (5) Any occurrence involving neglect of a patient or resident, as described in section 26-3.1-101 (4)(b) C.R.S.;

Review of medical records on 5/19/2010 revealed that sample patient #2 received sample patient #1's dialyzer during a routine dialysis treatment. In addition, sample patient #2 had the incorrect type of dialyzer used for his treatment. Sample patient #1 was positive for Hepatitis C and, because of the dialyzer error, sample patient #2 then had the risk of being exposed to Hepatitis C.

Interview with the facility's Regional Operations Director (ROD) on 5/18/2010 at 12:25 p.m., revealed that the dialyzer incident with sample patient #2 was not reported by the facility as an occurrence to the Colorado Department of Public Health and Environment as required by statutes. The ROD stated that, after consulting with the corporation's lawyers, it was determined that the incident did not meet the reporting standards. This failure did not ensure that quality management and assurance was maintained by the facility.




Facility Plan of Correction:

S001
The Dialysis Company and facility
Governing Body strive to maintain a
safe, functional and comfortable
environment and focus on indicators
related to improving patient outcomes
and the prevention and reduction of
medical errors. We take the cited
incidents very seriously and consider
the variances from policy to be
unacceptable practice. The facility requested informal
reconsideration of this citation. The
Colorado Department of Public Health
and Environment (CDPHE) responded
and sustained the citation by letter dated
September 21, 2010. The facility
continues to believe that there was no
Reportable Occurrence of Neglect
because there was no actual patient harm,
history of neglect, or intentional
misconduct. Nonetheless, in light of
CDPHE's letter of September 21, 2010,
the facility has revised its policies as set
forth in the plan of correction.

The facility will comply with the
reporting requirements as listed and
defined in Colorado Department of Public
Health and Environment Occurrence
Reporting Manual.
The facility's Governing Body has
developed and plans to implement a
policy entitled “Occurence
Reporting” (Policy) (attached) regarding
this process. FA and the Governing Body
are responsible for ongoing compliance
with POC. Training of relevant staff on
the Policy will be conducted on or before
the completion date.



Adverse Occurrence Reporting Manual
DaVita Inc.
Facility Specific Policy Facility # 546
Property of DaVita Inc. Confidential and Copyrighted © 2010
Title: Occurrence Reporting Policy
_____________________________________________________________
Purpose: To establish the process for occurrence reporting to the State of Colorado as required by Colorado licensure law and regulations.
Policy:
1.
Any “Unexpected Event” that is inconsistent with the routine operation of a dialysis facility may be a “Reportable Occurrence,” as defined by this policy.
2.
All Unexpected Events will be promptly reported to the Facility Administrator (FA)/Manager or designee. The teammate involved in the Unexpected Event or who witnessed the Unexpected Event will document the details of the Unexpected Event as the teammate observed and not report opinions or details reported to him/her by third parties.
3.
The FA/Manager or designee is responsible for complying with any state-specific requirements for reporting of all adverse occurrences.
4.
Dialysis facilities licensed in Colorado are required to report certain Reportable Occurrences (identified below) to the Colorado Department of Public Health and Environment (“CDPHE”). C.R.S. § 25-1-125(2)(e).
5.
The FA/Manager or designee will review the details of the Unexpected Event to determine if it constitutes a Reportable Occurrence. Only events that constitute a Reportable Occurrence are to be reported to the CDPHE.
6.
The FA/Manager or designee may consult the Colorado Occurrence Reporting Manual to determine if the Unexpected Event meets the elements set forth in the Reporting Manual and therefore is a Reportable Occurrence. The FA/Manager or designee may also consult Colorado regulations at 6 C.C.R. 1011-1, Ch. II, § 3.2 to assist in determining whether an Unexpected Event must be reported as a Reportable Occurrence.
7.
If it is determined that a Reportable Occurrence has occurred, the FA/Manager or designee will report to CDPHE as per the current processes described in the online Colorado Occurrence Reporting Manual.
Definitions:
“Unexpected Event” is an event or an occurrence that is inconsistent with the routine operation of a dialysis facility.
Origination Date: October 2010
Revision Date:
Page 1 of 3
Adverse Occurrence Reporting Manual
DaVita Inc.
Facility Specific Policy Facility # 546
Property of DaVita Inc. Confidential and Copyrighted © 2010
“Reportable Occurrence” is an Unexpected Event that must be reported to the CDPHE pursuant to C.R.S. 25-1-124(2). Reportable Occurrences include the following:
1.
Any occurrence that results in the death of a patient and is required to be reported to the coroner per section 30-10-606, C.R.S, as arising from an unexplained cause or under suspicious circumstances.
2.
Any occurrence that results in any of the following serious injuries to a patient:
a.
Brain or spinal cord injuries;
b.
Life-threatening complications of anesthesia or life-threatening transfusion errors or reactions; or
c.
Second- or third degree burns involving twenty percent or more of the body surface area of an adult patient or fifteen percent or more of the body surface area a child patient.
3.
Any time a patient of the facility cannot be located following a search of the facility, the facility grounds, and the area surrounding the facility and there are circumstances that place the patient’s health, safety, or welfare at risk or, regardless of whether such circumstances exist, the patient has been missing for eight hours.
4.
Any occurrence involving physical, sexual, or verbal abuse of a patient as described in section 18-3-202, 18-3-203, 18-3-204, 18-3-206, 18-3-402, 18-3-403, as it existed prior to July 1, 2000, 18-3-404, or 18-3-405, C.R.S., by another patient, an employee of the facility or a visitor to the facility.
5.
An occurrence involving neglect of a patient by a caretaker (“Caretaker Neglect”) as described in C.R.S. § 26-3.1-101 (4) (b). Caretaker Neglect occurs when adequate food, clothing, shelter, psychological care, physical care, medical care, or supervision is not secured for an at-risk adult or is not provided by a caretaker in a timely manner and with the degree of care that a reasonable person in the same situation would exercise. An “at-risk adult” is an individual eighteen years of age or older who is susceptible to mistreatment or self-neglect because the individual is unable to perform or obtain services necessary for the individual's health, safety, or welfare or lacks sufficient understanding or capacity to make or communicate responsible decisions concerning the individual's person or affairs. There was an incident of Caretaker Neglect if one of the following three elements occurred with respect to a patient who qualified as an at-risk adult:
a.
Failure to provide any care or services as provided above resulting in actual harm;
b.
Staff member has a history in the past 12 months of similar neglect and had been counseled and/or re-educated; or
c.
Staff member intentionally failed to follow standard of practice and/or facility policy with significant potential for harm.
6.
Any occurrence involving misappropriation of a patient’s property.
Origination Date: October 2010
Revision Date:
Page 2 of 3
Adverse Occurrence Reporting Manual
DaVita Inc.
Facility Specific Policy Facility # 546
Property of DaVita Inc. Confidential and Copyrighted © 2010
Origination Date: October 2010
Revision Date:
Page 3 of 3
7.
Any occurrence in which drugs intended for use by patients are diverted to use by other persons.
8.
Any occurrence (i) involving the malfunction or intentional or accidental misuse of patient equipment that occurs during treatment or diagnosis of a patient, and (ii) that significantly adversely affects or if not averted would have significantly adversely affected a patient of the facility.

Back to Survey Tag Summary for:PRINTERS PLACE DIALYSIS CENTER

Colorado Department of Public Health and Environment
Health Facilities and Emergency Medical Services Division
4300 Cherry Creek Drive South
Denver CO 80246-1530
Email us or phone 303.692.2800 main

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