Skin Pathology Services Inc

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on record review and an interview with the Office Manager, the laboratory failed to successfully participate in a PT (proficiency testing) program for the non- waived Gram stain testing, performed under the subspecialty of Bacteriology. All patients who had Gram stain testing in this laboratory from the third WSLH (Wisconsin State Laboratory of Hygiene) PT event of 2020 to the first WSLH PT event of 2021 had the potential to be affected by this deficient practice. Findings Include: 1. The laboratory failed to achieve satisfactory PT performance for the analyte of Gram Stain in two out of three consecutive PT testing events, which resulted in subsequent unsuccessful analyte performance. All patient Gram stain 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 -- specimens tested from the third WSLH PT event of 2020 to the first WSLH PT event of 2021 had the potential to be affected by this deficient practice. (Refer to D2028) D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and an interview with the Office Manager, the laboratory failed to achieve satisfactory (Proficiency Testing) PT performance for the analyte of Gram Stain in two out of three consecutive PT testing events, which resulted in subsequent unsuccessful analyte performance. All patient Gram stain specimens tested from the third WSLH (Wisconsin State Laboratory of Hygiene) PT event of 2020 to the first WSLH PT event of 2021 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the WSLH PT documentation for the third testing event of 2020 found the laboratory received an overall score of 60%. The laboratory received a result of "Fail" on the Gram stain specimens GS-11 and GS-13. 2. Review of the WSLH PT documentation for the first testing event of 2021 found the laboratory received an overall score of 60%. The laboratory received a result of "Fail" on the Gram stain specimen GS-3 and GS-5. 3. The Office Manager confirmed, via a telephone interview on 05/04/2021, that the laboratory routinely used Gram stain on histological specimens to visualize bacteria that may be present. Patient results are routinely reported as 'positive' (bacteria present), and 'negative' (bacteria absent). The PT results were reported as such; however, the PT provider stated the specific Gram stain reaction should be reported for each specimen. For PT results, 'positive' should be reported when Gram positive organisms were present, and 'negative' should be reported when Gram negative organisms were present. Thus, due to this miscommunication of reporting structure,the Office Manager confirmed, via a telephone interview on 05/04/2021, that the laboratory failed to achieve satisfactory PT performance for the analyte of Gram stain on the third WSLH PT event of 2020 and the first WSLH PT event of 2021. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and an interview with the Laboratory Manager (LM), the laboratory failed to enroll in a proficiency testing (PT) program for gram stain testing. Findings Include: 1. The laboratory failed to enroll in a gram stain proficiency testing (PT) program. (Refer to D2001) D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Manager (LM), the 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 -- laboratory failed to enroll in a gram stain proficiency testing (PT) program. Findings Include: 1. Review of the laboratory's test menu, provided on the date of the inspection, revealed the laboratory performed and reported an annual average of 24 gram stain testing procedures on patient tissue biopsy specimens. 2. Review of the laboratory's "Gram Stain, Lillies's" policy and procedure, provided on the date of the inspection, found instructions for the histologic/cytologic tissue gram stain procedure and the following expected results: "Gram negative - red Nuclei, etc. - red Gram positive - intense blue-black" 3. The Surveyor requested the laboratory's 2016, 2017 and 2018 gram stain PT documentation from the LM. The LM confirmed the laboratory was not enrolled in a gram stain PT program and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 10 /02/2018 at 10:35 AM. 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. This STANDARD is not met as evidenced by: Based on record review and interviews with the Laboratory Manager (LM) and tissue processor, the laboratory failed to define criteria consistent with the manufacturer's instructions and document humidity conditions for reliable tissue biopsy procedures and test result reporting. Findings Include: 1. Review of the laboratory's policies and procedures did not find any instructions to monitor and document humidity conditions consistent with manufacturer's operating specifications. 2. Review of the Tissue-Tek VIP Vacuum Infiltration Processor E150/E300 Series manufacturer's operating humidity conditions revealed the following: "The ambient operating humidity range is 0% to 85% relative humidity." %; percent 3. The Surveyor requested the laboratory's policy and procedure of the humidity criteria consistent with the manufacturer's instructions and the 2016, 2017 and 2018 humidity documentation from the LM and tissue processor. The LM and tissue processor confirmed the laboratory had not established humidity criteria consistent with the manufacturer's instructions, did not monitor and document humidity in 2016, 2017, and 2018, and were unable to provide the requested documentation on the date of the inspection. The interviews occurred on 10/02/2018 at 10:35 AM. 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 record review and an interview with the Laboratory Manager (LM), the Technical Supervisor (TS) failed to evaluate and document the competency of Testing Personnel (TP) #2 responsible for high complexity tissue biopsy gross testing procedures at least annually after the first year. Findings Include: 1. Review of the laboratory's "Histology Laboratory Competency Performance" policy and procedure, provided on the date of the inspection, revealed "Once a year, the Laboratory Director observes each employee from the beginning to the end of their duties..." 2. Review of the laboratory's Form CMS-209, approved, signed, and dated by the Laboratory Director on 09/12/2018, revealed two individuals listed as TP who had tested patient specimens for at least one year and responsible for highly complex Histopathology testing procedures. 3. Review of the laboratory's 2016, 2017 and 2018 annual competency assessment documentation, provided on the date of the inspection, revealed TP#2 did not have a tissue biopsy grossing competency assessment conducted in 2017 and 2018. 4. The Surveyor requested the laboratory's 2017 and 2018 competency assessment documentation for TP#2 from the LM. The LM confirmed the laboratory did not assess the competency of TP#2 in 2017 and 2018, and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 10/02/2018 at 10:40 AM. -- 3 of 3 --