resources dedicated to continually improving patient care and quality from medical laboratories, including a quality management system focused on path of workflow.

A thorough understanding of the path of workflow in a clinical laboratory, also called the testing process, is essential to understanding the importance of proper tissue specimen documentation, record keeping, and storage. The path of workflow allows clinical laboratories to provide quality results and reduce medical errors. Regardless of the specimen, whether a blood sample or a Mohs layer, a defined sequential process is followed to transform a physician’s order into a usable result. This process is called the path of workflow, and it is often subdivided into three separate processes: preexamination, examination, and postexamination. All of the specific policies and procedures for a given laboratory should stem from this simple path of workflow. Development of an organized, thorough, and well-understood path of workflow is the foundation of quality laboratory results. An overview of the path of workflow, also known as the total testing process, is shown in Fig. 14.1 [12]. During inspections, demonstration of appropriate documentation, understanding, training, and execution of a well-organized path of workflow is important to obtaining and maintaining accreditation.

Consider the path of workflow for an MMS practice. All the processes from the time of patient checkin through the preparation of tissue slides make up the preexamination process. The microscopic evaluation of Mohs frozen tissue sections on glass slides is the examination step. The recording, documentation, and notification of results, as well as the storage of slides and tissue, are part of the postexamination process. The American Academy of Dermatology (AAD) has prepared a sample policy and procedure manual that details the individual steps in the path of workflow for an MMS practice. This document is available for AAD members on the AAD Web site (www.aad.org/pm/ compliance/clia). Pertinent features for each of these processes in the path of workflow specific to an MMS surgical practice are discussed next.

Summary: Preexamination Process

•Preexamination process involves collection, transport, receipt, and initial processing of tissue specimens.

•Rate of medical errors is higher in the preexamination process.

•Medical errors occurring in the preexamination process are often preventable.

Clinical laboratory examination key processes

Examination ordering sample collection sample transport sample receipt/processing

Fig. 14.2 Overview of the preexamination process with permission from NCCLS [10]

Steps in the preexamination process for a mohs surgery patient

Examination ordering

1.Patient check-in and identity verification

2.Review and confirm pathology diagnosis and biopsy location and other pertinent clinical data

3.Verify patient identity on printed patient labels and orders

Sample collection

1. Preparation of patient and surgical site

2 Verify patient identification

3.Removal of Mohs tissue layer with correct orientation

4.Preparation of tissue and Mohs map

5.Proper labeling of tissue container and Mohs map

14.4Preexamination Process

The preexamination process includes all of the processes from ordering of the examination to collection, transport, receipt, and processing of the specimen (Fig. 14.2). Each step in this process requires appropriate documentation. A example of the preexamination process for a Mohs surgery patient is shown in Fig. 14.3.

The rate of medical errors for the preexamination process is higher than that for the rest of examination process [13, 14]. Decreasing errors in the preexamination process has become the focus of system-based improvement initiatives and quality measures. The focus on the preexamination process is partly because these errors are more common and can potentially lead to serious negative outcomes and partly because many errors are preventable by modifying the system of specimen collection. Preexamination errors include those related to failure to verify patient identity and incorrect labeling of specimens. Medical errors related to mislabeling of specimens represents a common, serious, and often preventable error. Specimen labeling errors are estimated to occur at rates of 0.1–5% [13–16]. A recent prospective trial found a rate of 4.3 per 1,000 for mislabeling of surgical specimens over a 6-month period. Skin specimens were the second most common tissue involved with labeling errors. Compared with specimens obtained in an operating room, specimens obtained in the outpatient setting were more likely to be mislabeled with the incorrect patient, site, or laterality or to involve an empty container [14]. The potential for patient harm related to mislabeled specimens may result from treatment delay, repeat biopsy procedures, unnecessary treatment, or procedures to the wrong site or wrong patient.

In an effort to reduce these types of errors, the Joint Commission requires the use of two patient identifiers in specimen labels and a preoperative Universal

Sample transport

1.Ensure proper and safe packaging of specimen

2.Safe delivery of properly labeled specimen and Mohs map from surgical suite to laboratory

Sample receipt and processing

1.Surgeon or nurse delivers properly labeled specimen and Mohs map to lab

2.Lab technician confirms proper labeling of specimen and documents patient identity, tissue identity and Mohs map identity and enters data in Mohs log

3.Specimens prepared frozen sectioning in the proper order

4.Frozen sections are cut and stained on properly labeled slides showing patient name, number, date and source

5.Coverslips applied and labeled slides and Mohs map brought to surgeon for examination

6.Excess tissue maintained in freezer until examination process complete

Fig. 14.3 Steps in the preexamination process for a Mohs surgery patient

Protocol consisting of a preprocedure verification process, marking of the procedure site, and performing a time-out before any procedure [17]. In addition to creation of standardized processes for specimen collection and labeling, procedures such as use of radiofrequency identification of specimens, introduction of a paperless pathology requisition process, and confirmation of correct site and correct patient by two health care providers have been shown in other studies to decrease errors [11, 18]. CLSI guidelines and standards with sample documents are available to assist with development of standardized labeling and identification systems for both patients and specimens [19–21]. These documents set standards for labels including exact specifications on the content, size, and arrangement of clinical data on the label. A sample label adhering to these recommendations is shown in Fig. 14.4.

Fig. 14.4 Sample Mayo Clinic patient label. This sample patient label illustrates key features of a well-designed patient label highlighted by standardized arrangement of important patient data. Standardized labeling is a key component of the preexamination process [19–21] (Figure used by permission of Mayo Foundation for Medical Education and Research. All rights reserved)

Some aspects of the preexamination process deserve special attention in relation to MMS, including identification of a previous biopsy site. The time between initial biopsy and MMS treatment is often several weeks. Identification of biopsy sites that are well healed is often difficult. Documentation of the exact anatomic location of the biopsy site is often lacking. To prevent or minimize this problem, we recommend photographic documentation of biopsy sites and modifying the documentation of the biopsy site to include a measurement from a fixed anatomic point (e.g., “biopsy site is located 6 cm in the 9 o’clock position from the tragus”). The use of photography to document biopsy sites has been shown to decrease errors in biopsy site identification [22]. After drawing the proposed surgical plan with a surgical marker at the MMS appointment, it is recommended to verbally and visually verify the biopsy site with the patient using a handheld mirror.

Summary: Examination Process

•Examination process involves the evaluation of a tissue specimen and recording of results.

•Special emphasis on MMS examination phase given the unique importance of tissue orientation in recording results and because a single provider is obtaining, evaluating tissue, recording results, and then providing treatment based upon those results.

Clinical laboratory examination key processes

Examination Results review and follow-upInterpretation

Fig. 14.5 Overview of the examination process with permission from NCCLS [10]

14.5Examination Process

The examination process must provide accurate and reliable results in order to be successful. The examination process in MMS involves the surgeon evaluating the frozen sections and recording the results of the evaluation on the Mohs map. The process itself is straightforward and involves two steps: evaluation and recording (Fig. 14.5). As has been emphasized previously, special attention should be given to continuing to verify the identity of the specimen and ensure that it matches the identity on the Mohs map with each handoff. The most important and complex step in the examination process is the accurate evaluation of Mohs frozen section histopathologic samples for the presence or absence of tumor. This examination process is somewhat unique in MMS for several reasons. First, correct orientation of the tissue is absolutely vital to treatment. Second, the surgeon is often the only person evaluating the slides, marking results on the Mohs map, and providing treatment for a patient with skin cancer on the basis of the results. This places much responsibility on the surgeon to carefully examine each slide for the presence or absence of tumor, to determine the accurate location and orientation within the tissue block, and to properly record and orient the results on the Mohs map.

A successful Mohs surgeon must recognize the importance of these steps in the examination process for MMS (Fig. 14.6).

The process of converting the histopathologic evidence of tumor on a Mohs section both to a diagnosis and to proper recording of the tumor on the Mohs map is difficult to standardize. This complex and poorly understood process is valueless if the results are recorded on the wrong Mohs map. Thus, it is important for the Mohs surgeon to constantly verify that the

Steps in the examination process for a mohs surgery patient

1.Mohs surgeon reviews stained slides and Mohs map confirmed for patient identity and adequacy of specimen preparation

2.Notifies laboratory if specimen inadequate

*Documented process for reqular and routine assessment of slides and stains and correlation of results (quality assessment)

Interpretation

1.Slides reviewed at microscope by Mohs surgeon

2.Presence or absence of residual tumor and other pertinent data on tumor location, histologic features recorded on Mohs map

3.Mohs surgeon reviews finalized Mohns map

Fig. 14.6 Steps in the examination process for a Mohs surgery patient

orientation, specimen, and Mohs map are correct. Implementation of a well-documented standardized process for regular quality control to ensure that the preparation, staining, tracking, and evaluation of specimens are consistent will limit preventable errors in the examination process. This will allow the Mohs surgeon to devote his or her full attention to the often challenging task of interpreting slides rather than wondering if the examined sections belong to the correct patient.

In our practice, quality checks are regularly performed by randomly selecting both positive and negative slides for blinded peer review by fellow MMS colleagues. Results of the quality assurance measures are recorded, and discrepancies in results undergo careful root cause analysis. Ultimately, the goal of the examination process is to produce a usable result that will guide further patient care. Once all slides have been evaluated and results have been properly recorded, the postexamination process begins.

Summary: Postexamination Process

•Postexamination process involves reporting of results and archiving of records and specimens.

•Postexamination process is streamlined in a MMS practice where results are obtained and acted upon in the same day.

Clinical postexamination key process

Results reporting and archive Sample management

Fig. 14.7 Overview of the postexamination process with permission from NCCLS [10]

Steps in the postexamination process for a mohs surgery patient

Results reporting and archiving

1.Patient brought back to surgical suite

2.Nurse verifies patient identity

3.Notifies patient of results

4.Mohs surgeon reviews result of Mohs map

5.Prepares patient for repair or next Mohs layer

6.Mohs map and surgical note with all pertinent detail on patient identity, tumor type, location, size, number of Mohs layers, blocks, and other pertinent details is prepared, finalized, signed by surgeon and stored in medical record

Specimen management and storage

1.Final count and verification of all prepared Mohs sections and slides recorded in Mohs log

2.Properly labeled Mohs slides are stored in defined and standardized method to meet governmental, accreditation, and laboratory requirements

*See sample table on sample and record retention schedule

Fig. 14.8 Steps in the postexamination process for a Mohs surgery patient

14.6Postexamination Process

The postexamination process involves reporting of results and archiving of records and specimens (Fig. 14.7). This process is simplified and streamlined by the nature of MMS practice, which usually involves same-day specimen collection, processing, and notification of results overseen by one Mohs surgeon (Fig. 14.8). This same-day processing inherently simplifies the postexamination process compared with that in a large clinical laboratory that must record and interpret clinical results for critical values and have a standardized system for relaying results to a multitude of ordering providers. Thus, the most salient feature of the postexamination process for the MMS practice is

having a system for proper retention and storage of records and specimens. Regulations regarding proper storage and retention of various tissue specimens and associated records vary by state law, accrediting organization, and institution. Examples of tissue sample and document retention schedules are shown in Figs. 14.9 and 14.10.

In our practice, photographs of the treated area(s) are obtained before and after treatment and after repair. The patient photographs and the finalized Mohs map are double-checked for correct labeling and then scanned and loaded into each patient’s electronic medical record for permanent storage. An MMS surgical note also is entered, which contains all pertinent