Panhandle Dermatology Of Summitmd

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: I. Based on review of the laboratory's records, presurvey paperwork, and interview, the laboratory failed to retain the chemical name and concentration (if applicable), manufacturer, lot number, expiration date, received date, and open date of the chemicals and stains used in the laboratory for Mohs testing for two of two years reviewed. Findings follow. A. The reagent log was requested on August 20, 2024 at 1000 in the laboratory but not provided. B. Review of the CMS Form 116 showed an estimated annual volume of 470 Mohs stages. C. Interview with the Medical Assistant on August 20, 2024 at 1030 hours in the laboratory confirmed the laboratory did not have a reagent log available for review. II. Based on review of the Mohs log and interview, the laboratory failed to retain the number of slides and blocks per case for Mohs testing for 21 of 21 months reviewed. Findings follow. A. Review of the Mohs log from 09/22/2022 to 07/18/2024 (elapsed time 21 months) showed the number of slides and blocks per case was not recorded. B. Review of the CMS Form 116 showed an estimated annual volume of 470 Mohs stages. C. Interview with the Medical Assistant on August 20, 2024 at 1015 hours in the laboratory confirmed the number of slides and blocks was not recorded. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, slide review, test reports, Mohs logs, and interview, the laboratory failed to ensure positive identification and optimum integrity of patient specimens from the time of collection and receipt of the specimen through completion of testing and reporting of results for two of 10 cases reviewed. Finding follow. I. A. Review of the laboratory's policies and procedures did not have a procedure for the labeling of slides. B. Review of the slide for case 01-18- 23-33 showed an identifier of 1-18-19 on the slide label. Laboratory practice was the date of service was documented on the slide. C. Review of the test report and map showed the date of service was 1-18-23 for case number 33 that day. D. Interview with the Medical Assistant on August 20, 2024 at 1210 hours in the laboratory confirmed the slide was mislabeled. II. A. Review of the laboratory's policies and procedures did not have a procedure for the documentation of Mohs logs. B. Review of the Mohs log showed the wrong date of birth (03/10/1948) for the fourth name on the case list on 07-19-23. C. Review of the test report showed the date of birth was 03 /30/1966. D. Interview with the Medical Assistant on August 20, 2024 at 1200 hours in the laboratory confirmed the date of birth on the Mohs log was incorrect. 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 laboratory's policies and procedures, accuracy assessments, pre-survey paperwork, and interview, the laboratory failed to provide documentation of twice a year accuracy assessments of Mohs testing for two of two years reviewed. Findings follow. A. Review of the laboratory's policies and procedures did not have a procedure for accuracy assessments. B. Review of the accuracy assessments from 2022 and 2023 and to date in 2024, showed cases were sent out for review, but the laboratory never received the results of the peer review. C. Review of the CMS Form 116 showed an estimated annual volume of 470 Mohs stages. D. Interview with the Medical Assistant on August 20, 2024 at 1100 hours in the laboratory confirmed the findings. *This is a repeat deficiency from the 09/28/2022 survey. 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 -- 2 of 4 -- 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 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: Review of the laboratory's policies and procedures, test records and staff interview of facility personnel found the laboratory failed to have documentation of performing twice annual accuracy assessment for histopathology in 2022. Findings included: 1. A review of the laboratory's policy and procedure manual found no written policy for performing twice annual accuracy assessment of histopathology. 2. Review of patient test records found the laboratory had tested 202 patient specimens on 10 days between March 13, 2022 and September 23, 2022 without twice annual accuracy assessment. 3. The PA confirmed that the twice annual accuracy assessment had not been performed during the interview conducted on September 28, 2022 at 9:48 AM. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of policies and procedures and interview of facility personnel, the laboratory failed to have a written policy for the step by step procedure for performing Mohs micrographic surgical procedures and interpretations to include specimen 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 -- collection, preparation, interpretation and reporting of results. The Findings included: 1. Review of procedures found no written procedure for performing Mohs micrographic surgery to include step by step instructions for specimen collection , preparation interpretation and reporting of results. 2. During interview conducted on September 28, 2022 at 11:00 AM, the medical assistant confirmed there were no written policies available for review. The PA stated they just bought the CLIA Manual for Dermatology, but it had not been approved as the procedure by the laboratory director. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observations and interview of facility personnel, the laboratory failed to label four of four secondary containers (used for Hematoxylin and Eosin ) to identify the contents, storage, preparation and expiration dates and other pertinent information. The findings included: 1. Observations made in the laboratory found four unlabeled screw top containers with Orange lids (containing small amounts of dark liquids) in a tray below the sink with the Hematoxylin and Eosin stains and reagent grade alcohol 100%. 2. During the interview of the medical assistant and Pa conducted September 28, 2022 at 9:54 AM, the medical assistant stated they were stains used to stain specimens. The PA went on to say they had ordered a flammables cabinet but it had not yet arrived. -- 2 of 2 --