Ozark Dermatology Clinic

Summary Statement of Deficiencies 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: Observation, review of temperature records, lack of documentation and interview demonstrated that the laboratory failed to monitor the temperature on each day of operation in one of two rooms in which supplies with storage temperature requirements were stored. . Findings follow: A) During a tour of the laboratory on 8/23 /24 at 08:45 a.m., the surveyor observed two separate rooms (Histology Laboratory, Mohs Surgery Laboratory ) containing laboratory items with a temperature storage requirement. B) During a review of the laboratory's temperature records it was noted that no temperature records were presented for the Histology Laboratory. C) During a tour of the laboratory on 8/23/24 at 10:40 a.m. the surveyor observed 4 bottles of Harris Hematoxylin stain (lot # 2308335) expiration date 2025-03-30 with a storage temperature requirement of 15 degrees Centigrade (C.) to 30 degrees C., and 1 bottle of CAT Hematoxylin Stain (lot # 32924 A) expiration date 2025-09-30 with a storage temperature requirement of 20 degrees Centigrade (C.) to 25 degrees C., in the Histology laboratory.. D) Upon request, the laboratory could not present the temperature records for the Histology Laboratory room in which the supplies identified above were stored. E) In an interview on 8/23/24 at 10:57 a.m., the laboratory staff member (# 3 on form CMS 209) confirmed that temperature records for the Histology Laboratory were not kept. 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 -- D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Review of personnel records of five testing personnel performing highly complex laboratory procedures (tissue gross descriptions), lack of documentation and interviews with laboratory staff, determined the laboratory director failed to give written authorization for one of five testing personnel reviewed to perform highly complex procedures without direct supervision. Survey findings follow: A) A review of personnel records of five testing personnel, who perform highly complex procedures, revealed that one (#13 as listed on the form CMS-209) failed to have the laboratory director's written authorization to perform highly complex procedures without supervision. B) Upon request, the laboratory was unable to provide documentation of the authorization to perform highly complex procedures for the personnel identified above. C) In an interview, at 10:57 a.m. on 8/23/24, laboratory staff member (#3 as listed on form CMS 209) confirmed the lack of written authorizations for the personnel identified above and that they performed highly complex procedures. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Through a review of the "Lab Procedures SOPs Personnel", lack of documentation, and interviews with laboratory staff, it was determined the laboratory director failed to approve, sign, and date the procedures for the permanent sections histopathology lab (Pinnacle Dermatology). Survey findings include: A. During a review of the "Lab Procedures SOPs Personnel" it was determined the manual was not signed and dated by the laboratory director to indicate approval of procedures and that individual procedures within the manual lacked approval signatures and dates of approval. B. In an interview at 9:19 on 3/11/2021, laboratory employee #14 (as listed on the form CMS-209) confirmed the laboratory director had not approved, signed, and dated the "Lab Procedures SOPs Personnel" or any of the procedures contained in the manual. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: 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 -- Through a review of the "Lab Procedures SOPs Personnel"and "Pinnacle Dermpath Specials / IHC" log, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to document immunohistochemical stain quality control each time of use. Survey findings include: A. A review of the "Lab Procedures SOPs Personnel" manual revealed procedures for Immunohistochemical staining of tissue samples in the laboratory. B. Through a review of the "Pinnacle Dermpath Specials / IHC" log it was determined 85 IHC stains were performed in February 2021. C. The surveyor requested documentation of positive and negative quality control documentation for immunohistochemical stains but none was provided for review. D. In an interview at 9:19 on 3/11/2021, laboratory employee #14 (as listed on the form CMS-209) confirmed the laboratory did not document positive and negative control results for IHC stains. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Through a review of personnel records contained in the "Lab Procedures SOPs Personnel" manual, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to document initial training in two out of two testing personnel listed on the CMS-209 from the permanent histopathology lab (Pinnacle Dermatology). A. A review of the personnel files in the "Lab Procedures SOPs Personnel" manual, revealed that two of two (personnel #14 and #15 as listed on the form CMS-209) testing personnel working in the permanent histopathology (Pinnacle Dermatology) laboratory failed to have documentation of training for the permanent section procedures listed in the manual. B. In an interview at 9:19 on 3/11/2021, laboratory employee #14 (as listed on the form CMS-209) confirmed employees #14 and #15 failed to have documented training for the laboratory procedures performed in the permanent section histopathology laboratory. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Through a review of personnel records contained in the "Lab Procedures SOPs Personnel" manual, lack of documentation, and interviews with laboratory staff, it was determined the laboratory director failed to authorize two out of two testing personnel -- 2 of 3 -- listed on the CMS-209 from the permanent histopathology lab (Pinnacle Dermatology) to perform grossing of tissue specimens without direct supervision. Survey findings include: A. A review of the personnel files in the "Lab Procedures SOPs Personnel" manual, revealed that two (personnel #14 and #15 as listed on the form CMS-209) testing personnel working in the permanent histopathology (Pinnacle Dermatology) laboratory performed grossing of tissue specimens. The personnel files for two out of two testing personnel did not include a written authorization, from the current laboratory director, stating the test processes each was allowed to perform without direct supervision. B. In an interview at 9:19 on 3/11/2021, laboratory employee #14 (as listed on the form CMS-209) confirmed employees #14 and #15 failed to have documented authorizations from the current laboratory director to perform permanent section laboratory procedures without direct supervision. 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: Through a review of personnel records contained in the "Lab Procedures SOPs Personnel" manual, lack of documentation, and interviews with laboratory staff, it was determined the technical supervisor failed to document semiannual competency assessments for two out of two testing personnel listed on the CMS-209 from the permanent histopathology lab (Pinnacle Dermatology). Survey findings include: A. A review of the personnel files in the "Lab Procedures SOPs Personnel" manual, revealed that two of two (personnel #14 and #15 as listed on the form CMS-209) testing personnel working in the permanent histopathology (Pinnacle Dermatology) had initial competency assessments dated 2/5/2020. No other competency assessments were documented in the first year of performing gross exams and all other test procedures in the permanent histopathology laboratory. B. In an interview at 9:19 on 3 /11/2021, laboratory employee #14 (as listed on the form CMS-209) stated that he and employee #15 began working at the end of 2019. He further confirmed employees #14 and #15 had not had competency assessed other than the initial competency dated 2/5 /2020. -- 3 of 3 --