Pinski Dermatology & Cosmetic Surgery

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory records, patient reports, product operation manual, direct observation, lack of documentation, and interviews with the laboratory representatives; the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283. Findings include: 1. The laboratory failed to outline all components of the test procedure for the subspecialty of histopathology. See D5403. 2. The laboratory failed to define and document preventative maintenance (PM) for one of one microscope. See D5433. 3. The laboratory failed to exam and document the quality (intended reactivity) of Hematoxylin and Eosin staining material used for histopathology interpretations. See D5473. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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 review of laboratory policies and procedures manuals; patient testing logs; patients' test reports; and interview with the laboratory director, the laboratory failed to ensure that it referred patients' specimens to CLIA-certified laboratories. Findings: 1. The laboratory policies and procedures manual reads as follows: "All tissue removed during a biopsy or surgical procedure is sent out to a pathology laboratory." The name. and address location of the reference laboratory is documented in the procedure manual. Direct Immunofluorescent (DIF) biopsies are sent to a 2nd reference laboratory. However, the name and address location was not documented. 2. Review of patient testing logs revealed that specimens were sent to a referral laboratory for processing and /or interpretation. 3. Review of 10 patients' biopsy reports revealed 2 of 10 biopsy results were reported by the referral laboratory for the following dates: a. 09/18/18 b. 03/27/19 4. There was no documentation to show that either of the 2 laboratories the laboratory referred its specimens to are CLIA - certified. 5. On November 12, 2020 at 12:00 PM, the laboratory director confirmed the surveyor's findings. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on review of the Clinical Laboratory Improvement Amendments Application for Certification (CMS 116); Laboratory Personnel Report (FORM CMS-209); laboratory policies and procedures manuals; and interview with the laboratory director, procedures and changes in procedures were not approved, signed, and dated by the current laboratory director. Findings: 1. There was a new laboratory director listed on the CMS 116 collected during the survey of November 12, 2020. 2. The new laboratory director was also listed as "Laboratory Director" on FORM CMS-209. 3. Documentation in the laboratory's policy and procedures manual shows that the procedures were revised November 10, 2020. 4. The new laboratory director did not sign and date the revised policies and procedures manual. 5. On November 12, 2020 at 12:00 PM, the laboratory director confirmed the surveyor's findings. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manuals and interview with the laboratory director, the laboratory failed to maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). Findings: 1. The laboratory had 2 procedures manuals. One for Biopsies. The other for Mohs. 2. On November 12, 2020 at 10:00 AM the laboratory director told the surveyor that the Mohs Surgeon quit in June 2020. He stated, "As of June 2020, we are no longer performing Mohs." 3. There was no documentation to show when the laboratory discontinued its Mohs procedures. 4. On November 12, 2020 at 12:00 PM, the laboratory director confirmed the surveyor's findings. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures manuals; laboratory's quality control (QC) records; patients biopsy reports; patients' biopsy slides; and interview with the laboratory director, the laboratory failed to perform and document the quality of staining material it used to stain its biopsy specimens. Findings: 1. The laboratory's policies and procedures read as follows: "All tissue removed during biopsy or surgical procedure is sent out to a pathology laboratory." 2. There were no procedures or programs and services manuals provided to the surveyor for each reference laboratory the laboratory uses. 3. During survey date November 12, 2020 at 11:30 AM, the surveyor selected 10 patients' biopsy test results along with their corresponding slide (s) for the following dates: a. 08/24/18 b. 09/18/18 c. 11/27/18 d. 03/27/19 e. 06/13/19 f. 12/26/19 g. 02/12/20 h. 03/19/20 i. 05/27/20 j. 08/15/20 4. There was no -- 2 of 3 -- documentation to show that QC of the stain was performed when each patients' specimens were stained for 10 of 10 patients' specimens (slides) reviewed for the following dates: a. 08/24/18 b. 09/18/18 c. 11/27/18 d. 03/27/19 e. 06/13/19 f. 12/26 /19 g. 02/12/20 h. 03/19/20 i. 05/27/20 j. 08/15/20 5. On November 12, 2020 at 12:00 PM, the laboratory director confirmed the surveyor's findings. -- 3 of 3 --