Summary:
Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the slide referral send out log and interview with the testing person, the laboratory did not ensure the integrity of slides that were referred for consultation or further testing. Findings: 1. The laboratory has a send out log for slides that are referred for second opinion or further testing. 2. On 4/5/18 patient "A" had frozen sections performed and the slides were sent out for second opinion. The patient had multiple slides B2018-70 and B2018-71. The "MOHS#" case number nor the return date of the slides were documented on the log. 3. The testing person was unsure which slides were sent for second opinion and did not know when the slides were returned. 4. On 1/15/18 patient "B" and on 1/16/18 "patient "C" slides were referred for further testing. The return date of the slides were not documented on the log and the testing person was unable to locate the slides. 5. During the year 2017 seven patients on the send out log had slides prepared six were sent for consultation. Patient "D" slides performed on 8/15/17 did not include the reason for send out. 6. The return dates of the slides were not documented on the log for any of the patients that were sent out for consult or further testing during the year 2017. 7. The testing person confirmed that the laboratory did not ensure the integrity of slides that were referred for consultation or further testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the cryostat temperature log and interview with the testing person, the laboratory director (LD) did not ensure that daily temperatures were within range for performing patient testing. Findings: 1. Review of the cryostat temperature log showed from May 2017-December 2017 the LD did not review and sign the documented temperature. 2. The signature section of the log was not signed monthly by the LD. 3. The testing person confirmed that the LD did not review and sign the cryostat temperature log at the end of each month. -- 2 of 2 --