Summary:
Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of the Biannual Assessment (BA) records, lack of Procedure Manual (PM) and Quality Control (QC) records, instrument maintenance and interview with the Laboratory Director (LD) via telephone the laboratory failed to ensure that quality systems for the preanalytic and analytic phase of Histopathology testing was monitored from 4/27/18 to the date of survey. 1. The laboratory referred the technical component of Histopathology to a non- CLIA certified laboratory. Cross Refer to D5315 2. The laboratory failed to perform maintenance on the microscope used for Histopathology. Cross Refer to D5433 3. The laboratory failed to document all control procedures performed. Cross Refer D5601 4. The laboratory failed to retain Histopathology slides Cross Refer to D5603 D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Biannual Assessment (BA) records and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of Histopathology testing twice annually in the calendar years 2019 and 2020. The LD Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- via telephone confirmed on 3/16/21 at 10:30 am that the laboratory did not verify the accuracy of the Histopathology testing twice annually. * Note- this is a repeat deficiency. This was cited at the last survey (4/27/18) D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of a Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to establish a written procedure for Biannual Assessment (BA) from 4/27/18 to the date of survey. The LD via telephone confirmed on 3/16/21 at 10:35 am that a BA procedure was not established. * Note- this is a repeat deficiency. This was cited at the last survey ( 4/27/2018) D5315 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(c) The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS. This STANDARD is not met as evidenced by: Based on lack of Histopathology records and interview with the Laboratory Director (LD), the laboratory referred the technical portion of Histopathology testing to a non- CLIA-certified laboratory from 4/27/18 to the date of survey. The LD via telephone confirmed on 3/16/21 at 10:42 am that testing was referred to a non-CLIA-certified laboratory. . D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: a) Based on lack of a Procedure Manual (PM), observation of the maintenance sticker on the microscope, lack of a maintenance log, and interview with the Laboratory Director (LD), the laboratory did not perform and document maintenance on the microscope, from October 2020 to the date of the survey. The LD via telephone confirmed on 3/16/21 at 11:15 am the laboratory did not perform and document maintenance on the microscope. b) Based on lack of a PM and interview with the LD, -- 2 of 5 -- the laboratory did not establish a maintenance protocol for the microscope from 4/27 /18 to the date of the survey. The LD via telephone confirmed on 3/26/21 at 10:16 am the laboratory did not have a maintenance protocol. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the surveyor review of the lack of Quality Control (QC) record and interview with the Laboratory director (LD), the laboratory failed to prepare and record the QC procedures on each day of Histopathology testing from 4/27/18 to the date of survey. The LD via telephone confirmed on 3/16/21 at 10:30 am that QC was not recorded on each day of patient testing. D5603 HISTOPATHOLOGY CFR(s): 493.1273(b)(f) (b) The laboratory must retain stained slides, specimen blocks, and tissue remnants as specified in 493.1105. The remnants of tissue specimens must be maintained in a manner that ensures proper preservation of the tissue specimens until the portions submitted for microscopic examination have been examined and a diagnosis made by an individual qualified under 493.1449(b), (l), or (m). (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review of Histopathology and interview with the Laboratory Director (LD), the laboratory failed to retain Histology Slides (HS) from April 2018 to the date of the survey The LD confirmed on 3/16/21 at 10:15 am that HS were not retained. D5779