Tru-Skin Dermatology Lab

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, interview and query, the laboratory failed to ensure stains and supplies used to process tissue specimens for dermatopathology specimens had not exceeded their expiration date by 41 days. Findings follow. 1. During a tour of the facility on June 10, 2021 at 1505 hours, surveyor observed the following expired stain and supply located in the cabinet in the storage room: a. Fisher Brand Eosin-Y Solution, Lot 511186, expiration date of 04/2021 (expired by 41 days) b. Stat Lab Dissect Aid, Lot 065107, expiration date of 03/2021. 2. Interview with the testing personnel #1 on June 10, 2021 at 1505 hours confirmed the Eosin used in the Hematoxylin and Eosin stain was expired and in use by the laboratory. The Dissect Aid was used to help the ink attach to the specimen, so it doesn't blot up in the processor, was available to the laboratory, but not currently in use. 3. Query from the computer revealed from 05/01/2021 - 06/10/2021, the laboratory had processed 554 number of cases/patients, and 994 number of blocks/slides. 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. 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 laboratory's policies and procedures, review of quality control (QC) records, interview, and query, the laboratory failed to document the performance of the Hematoxylin and Eosin quality control, including the intended reactivity to ensure predictable staining characteristics, used to stain specimens for dermatopathology interpretations for 5 of 5 months reviewed. Findings follow. 1. Review of the laboratory's policy and procedure titled, Staining Policy, stated, "a QC control slide will be stained with the first rack of the day to ensure accurate staining." The laboratory did not have a Quality Control policy and procedure. 2. On June 10, 2021 at 1530 hours quality control records were requested from January 2021 to June 2021, but not provided. 3. Interview with testing personnel #1 on June 10, 2021 at 1530 hours in the office confirmed there was no documentation of the Hematoxylin and Eosin quality control. A control slide was prepared each day of staining and checked by the histotechnician, but the slide was sent to the reference laboratory that also interpreted dermatopathology slides. A control slide was not retained for the dermatopathology specimens interpreted at the laboratory, but the laboratory could include one moving forward. When asked what they would do if slides were unacceptable, testing personnel #1 stated they would recut and remake the slides. The laboratory began interpreting slides on-site in January 2021. Specimens were processed and stained Monday through Friday, and the dermatopathology interpretations performed at the laboratory were performed once per week. Interview with the Laboratory Director on June 10, 2021 at 1537 hours via phone confirmed he did not document the quality of the Hematoxylin and Eosin stain. 4. Query from the computer revealed from January 2021 - June 10, 2021 the laboratory had processed 2257 number of cases/patients, and 4197 number of blocks/slides. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 laboratory's policies and procedures, attempted review of quality control (QC) records, interview, and query, the laboratory director failed to establish a quality control program to ensure the quality of laboratory services provided for dermatopathology interpretations for 5 of 5 months reviewed (see D5473). D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory records and interview, the technical supervisor failed to perform annual competency evaluations for 2 of 2 testing personnel who performed grossing in 2019 and 2020. Findings follow. 1. Review of the Employee Training Competency Evaluation provided during the survey showed at the bottom of the page lines for: "Initial training: ____________ Semi-Annual training: ___________ Annual training: ____________" 2. Available Annual training forms showed: Testing personnel #1 was trained on 05/01/2018 (signed by the TS on 05/01 /2019) and 05/01/2020 (signed by the TS on 05/01/2020) and Testing personnel #2 was trained on 07/10/2018 (signed by the TS on 07/10/2019) and 07/10/2020 (signed by the TS on 07/10/2020). 3. Interview with testing personnel #1 on June 10, 2021 at 1500 in the office revealed the form was used to document initial, semi-annual, and annual training that was performed, the technical supervisor reviews the training document (as indicated by his signature on the form). Competency evaluations were not performed. -- 3 of 3 --

Summary Statement of Deficiencies D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) At least twice annually, the laboratory must verify the accuracy of any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory records for histopathology, and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessment for three of three testing personnel performing gross tissue examination in 2018 and 2019. Findings included: 1. Review of the laboratory's records for 2018 and 2019 found no documentation of twice annual accuracy assessment for histopathology. 2. Interview of testing person one listed on the CMS report 209 Laboratory Personnel Report conducted on July 10, 2019 at 10:51 AM confirmed that twice annual accuracy assessment for gross tissue examination had not been conducted by the laboratory in 2018 and 2019. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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: Observations, review of the instrument operator manuals and interview facility personnel found that the laboratory failed to monitor and document the temperature, humidity and atmospheric pressure of the room where the Tissue -Tek Film Automated Coverslipper and the Excelsior AS Tissue Processor were used to prepare patient specimens for microscopic examination. The findings included: 1. Observations made during the inspection found no means of measuring the temperature, humidity and atmospheric pressure of the room. 2. Review of the operators manuals found: a. Tissue -Tek Film Automated Coverslipper - on page 1-8 "Operating Conditions. Operating temperature: 10C to 40C (50F to 104F) Relative Humidity: 30 to 80% (non-condensing) Atmospheric Pressure: 70kPa to 106kPa" b. Excelsior AS Tissue Processor - on page 19 "Temperature (operating limits) +5C to +40C (+41F to +104F) Temperature (recommended operation) +15C to +30C (+59F to +86F) Performance may deteriorate when operated outside this temperature. Humidity - maximum 80% relative humidity at 31C (88F), decreasing linearly to 50% relative humidity at 40C (104F) 3. Interview of testing person one on the CMS report 209 Laboratory Personnel Report conducted on July 10, 2019 at 9:29 AM confirmed that the laboratory did not measure and record the temperature, humidity and atmospheric pressure of the room where instrumentation was used to prepare patient specimens for microscopic examination. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Review of policies and procedures and interview of facility personnel found that the laboratory had no written quality assurance program to monitor, assess and correct problems identified in the analytic systems. The findings included: 1. Review of policies and procedures found no written quality assurance program. 2. Interview of testing person one listed on the CMS report 209 Laboratory Personnel Report confirmed during interview conducted on July 10, 2019 at 10:52 AM that the laboratory did not have a written quality assurance program to monitor, assess and correct problems identified in the analytic systems. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of testing personnel files, and interview of facility personnel, the Technical Supervisor failed to evaluate and document personnel competency at least semiannually during the first year the individual tests patient specimens for three of three testing personnel. The findings included: 1. Review of personnel files found the -- 2 of 3 -- following three testing personnel had no record of semiannual competency evaluation during the first year of testing: Testing Person: 1 Date of Hire: February 2018 initial training completed May 11, 2018 one competency assessment completed May 1, 2019 labeled 12 months Testing Person: 2 Date of Hire: July 2018 initial training completed July 9, 2018 one competency assessments completed July 9, 2019 labeled 12 months Testing Person: 3 Date of Hire: July 2018. Initial training completed July 20, 2018. No additional competency assessments available for review 2. Interview of testing person one listed on the CMS report 209 Laboratory Personnel Report conducted on July 10, 2019 at 9 AM confirmed that competency assessments had not been performed and documented at least semiannually for the first year of testing for three of three testing personnel. -- 3 of 3 --