Satya P Kastuar Md

Summary Statement of Deficiencies 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 confirmed on 8/2/21 at 10:00 am that the laboratory did not perform BA for Histopathology testing twice in 2019 and 2020. 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 surveyor review of the Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to establish a written procedure for Biannual Assessment (BA) from 1/23/19 to the date of survey. The LD confirmed on 8/2/21 at 10:00 am that a BA procedure was not established. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) 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 -- (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 surveyor review of Quality Control (QC) records and interview with the Laboratory Director (LD), the laboratory failed to document Hematoxylin and Eosin (H&E) control slide reaction from January 2019 to the date of survey. The findings include: 1. The laboratory did not document H&E stain QC reaction for reading of biopsy slides. 2. The laboratory read and reported approximately 2500 patient slides. 3. The LD confirmed on 8/2/21 at 10:15 am that the laboratory did not document H&E QC stain reaction. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Laboratory Director (LD), the laboratory failed to follow the Turn Around Time (TAT) sign out procedure from 3/15/17 to the date of the survey. The finding includes: 1. The PM stated "The Specimen Accession Log (SAL) will keep track of specimen collected date and slide receipt date" but a review of the SAL revealed the slide receipt date was not recorded in the log. 2. The LD confirmed on 1/23/19 at 10: 30 am that the laboratory did not follow the PM. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --