Rheumatology And Dermatology Associates Pc

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 a review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155), the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) evaluation reports, and interviews the laboratory failed to maintain satisfactory performance for two out of three PT events resulting in the first unsuccessful PT occurrence for the subspecialty of Mycology (Refer to D2046). D2046 MYCOLOGY CFR(s): 493.827(e) 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 -- 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 a desk review of the CMS 155, the laboratory's 2023 and 2024 WSLH PT evaluation reports, and interviews, the laboratory failed to maintain satisfactory performance for two out of three events for the Mycology subspecialty. The findings include: 1. A review of the CMS 155 report revealed the following unsatisfactory Mycology scores: 2023 Event Two 75% 2024 Event One 60% 2. A review of the WSLH PT evaluation report for 2023 Event Two revealed an overall score of 75% for the Mycology subspecialty. 3. A review of the WSLH PT evaluation report for 2024 Event One revealed an overall score of 60% for the Mycology subspecialty. 4. Electronic interviews with the laboratory director on 07/15/2024 at 3:35 pm and 07/16 /2024 at 3:05 pm and the WSLH PT agency coordinator on 07/17/2024 at 3:00 pm confirmed the survey findings. -- 2 of 2 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's Wisconsin State Laboratory of Hygeine (WSLH) proficiency testing records, the laboratory procedure manual, patient test reports and interview with the laboratory director, the laboratory failed to report their proficiency testing results to the proficiency testing program in the same manner as it reported patients in 2021, 2022, and 2023. The findings include: 1. Review of the laboratory's WSLH proficiency testing records from 2021, 2022 and 2023 revealed positive results for mycology cultures were reported to the proficiency testing program as 'present.' 2. Review of the laboratory's procedure manual revealed the following under section 9.1.3 "Fungus is reported to the" "Species level." 3. Review of patient test reports revealed the following: Laboratory records and letters issued to patients revealed reporting of cultures to the genus and species level as follows: Culture date= 03/02 /2021, Batch #1150928, left 1st toenail, read out on 03/31/2021 as "positive for T. rubrum." A letter was issued to the patient on 03/31/2021 with a comment of "The results show a fungus called Trichophyton rubrum." Culture date=01/27/2022, batch #1152747, scalp, read out on 02/09/2022 as "Positive for Trichophyton tonsurans." A letter was issued to the patient on 02/09/2022 with a comment of "The results show a fungus called Tricophyton tonsurans." Culture date=01/19/2023, batch #1153622, Lt. 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 -- 2nd toenail, read out as positive for multiple Candida. A letter was issued to the patient on 02/23/2023 with a comment of "The results show a fungus called Candida albicans." 4. Interview with the laboratory director on 10/09/23 at 11:30 am confirmed the laboratory failed to report fungal culture results to the WSLH proficiency testing program in the same manner as it reported patient results in 2021, 2022 and 2023. D2038 MYCOLOGY CFR(s): 493.827(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Centers for Medicare and Medicaid Casper Report 0155D (CMS 155), the laboratory's proficiency testing records and interview with the laboratory director, the laboratory failed to maintain satisfactory participation in mycology for 2023 event two. The findings include: 1. Observation of the laboratory on 10/09/23 at 8 am revealed multiple patient samples for fungal culture being incubated at ambient room temperature. 2. Review of the CMS 155 revealed an overall event score of 75% for 2023 event two for mycology. 3. Review of the laboratory's proficiency testing records revealed an overall event score of 75% for 2023 event two for mycology. 4. Interview with the lab director on 10/09 /23 at 11:30 am confirmed the laboratory failed to maintain satisfactory performance for mycology for 2023 event two. D2044 MYCOLOGY CFR(s): 493.827(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with the laboratory director, the laboratory failed to perform