Dermatology Specialists Of Coweta County, Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 20, 2022. The facility was found to be NOT in compliance with the Clinical Laboratory Improvement Amendments (CLIA) conditions: 42 CFR 493.801 Condition: Enrollment and Testing of Samples 42 CFR 493.803 Condition: Successful Participation 42 CFR 493.1230 Condition: General Laboratory Systems 42 CFR 493.1250 Condition: Analytic Systems 42 CFR 493.1441 Condition: General Laboratory ( High Complexity) A cease testing letter was submitted by the laboratory director at the summation discussion. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) logs, review of the procedure manual (SOP), and testing personnel interview, the laboratory failed to follow current SOP instructions for 1 of 1 waived testing performed by the laboratory. The findings include: 1. Review of the SOP revealed QC was required on each shipment/lot number received, and at least once per month. The laboratory failed to perform the required QC documentation since 09/01/2020 for the following waived test: Urine Human Chorionic Gonadotropin (HCG Combo Test cassette). 2. The lab failed to document the dates HCG Combo kits were received and opened. The SOP indicates, "each time a box of urine HCG test is received, an orange label should be placed on the top of the box before it is placed in the closet. If a box is opened, that has an orange sticker on it- check the log and see if the lot# has been tested. If it has, place a green sticker on it with your initials. If it has not been done, it must have external controls done on it. The control results are documented on the log (at each station) and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- a green sticker is placed over the orange sticker with 'OK TO USE' and your initials". 3. Interview with staff #11 (CMS 209), in nursing station B, at approximately 12:30 p. m., on 09/20/22, confirmed the lab failed to document dates the kits were received and opened and the lack of QC documentation since 09/01/2020 for the aforementioned waived test. 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 review of the CMS 116 form, lack of proficiency testing (PT) records, and confirmed in testing personnel interview, the laboratory failed to meet the requirements of participating in proficiency testing for the subspecialties of mycology (Dermatophyte Test Medium cultures) DTM or parasitology (presence or absence of parasites) as evidenced by: 1. The lab failed to enroll in PT for the subspecialty of parasitology (presence or absence of parasites) for the year 2021. Review of the CMS 116 form reveals the lab performs 10 parasitology exams per year. 2. The lab failed to enroll in PT for the subspecialty of mycology (DTM cultures) or parasitology (presence or absence of parasites) for the year 2022. 3. Interview with testing personnel # 11 (CMS 209), on 09/20/2022, at 12:29 pm, in nursing station B and phone interview with the CLIA Specialist (administrative office personnel of Epiphany Dermatology, who is based in another city/state, responsible for overseeing the CLIA documents and regulations), on 9/20/22, in the back office, at 2:15 P.M confirmed the laboratory had not enrolled in PT for the aforementioned subspecialties and dates. 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 -- 2 of 8 -- the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's Medical Laboratory Evaluation (MLE) proficiency testing (PT) reports and testing personnel interview, the laboratory failed to participate in 2021 PT events 2 and 3, for the subspecialty of Mycology (DTM culture). Refer to: D 2039 and D 2048 D2039 MYCOLOGY CFR(s): 493.827(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the laboratory's Medical Laboratory Evaluation (MLE) proficiency testing (PT) reports and testing personnel interview, the laboratory failed to participate in 2021 PT events 2 and 3, for the subspecialty of Mycology (DTM culture). The findings include: 1. Review of MLE PT reports of Mycology 2020 event 3 and 2021 events 1, 2, and 3, revealed the laboratory failed to participate in PT events 2 and 3 of 2021 for the subspecialty of mycology. 2. Interview with testing personnel # 11 (CMS 209), on 09/20/2022, at 12:29 pm, in nursing station B and phone interview with the CLIA specialist, on 9/20/22, at 2:15 P.M confirmed the laboratory failed to participate in the aforementioned PT. D2048 PARASITOLOGY CFR(s): 493.829(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the laboratory's Medical Laboratory Evaluation (MLE) proficiency testing (PT) reports and testing personnel interview, the laboratory failed to participate in 2021 and 2022 PT for the subspecialty of parasitology. The findings -- 3 of 8 -- include: 1. Review of MLE PT reports revealed the laboratory failed to participate in PT 2021 and 2022 for the subspecialty of parasitology. 2. Interview with testing personnel # 11 (CMS 209), on 09/20/2022, at 12:29 pm, in nursing station B and phone interview with the CLIA specialist, on 9/20/22, at 2:15 P.M confirmed the laboratory failed to participate in the aforementioned PT. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory personnel competency assessment policies, proficiency testing (PT) reports and policy, an interview with testing personnel and the CLIA Specialist, the laboratory failed to have an approved and signed Quality Assurance plan as evidenced by: refer to D 5209 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 review of the Center for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvements Amendments (CLIA) Application for Certification form (CMS 116), lack of laboratory records and testing personnel interview, the laboratory failed to verify the accuracy of qualitative mycology (detecting the presence or absence of fungi) in 2021 and 2022. The findings include: 1. Review of the CMS 116 revealed the laboratory performs approximately 308 qualitative mycology [potassium hydroxide (KOH)] analyses per year. 2. Lack of laboratory records revealed no documentation of peer review or proficiency testing results for qualitative mycology analysis. The lab failed to perform