Heidelberg Dermatology Pc

Summary Statement of Deficiencies D5006 MYCOLOGY CFR(s): 493.1203 If the laboratory provides services in the subspecialty of Mycology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interview with the Practice Administrator (PA), the laboratory failed to meet the subspecialty of mycology requirements as specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to perform and document the microscope maintenance. Refer to D5429. 2. The laboratory failed to perform and document the refrigerator temperature that houses the dermatophyte test media. Refer to D5431. 3. The laboratory failed to perform and document the quality control for the dermatophyte test media (DTM) with the appropriate organisms with each new lot number and/or shipment . Refer to 5519 4. The laboratory failed to monitor and evaluate the analytic system assessment activities. Refer to D5793 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on record review and interview with the Practice Administrator (PA), the laboratory failed to perform and document the microscope maintenance as required 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 -- for 1 (2020) of 2 years reviewed. Findings include: 1. A review of the "Laboratory Procedure Manual" under the "Quality Control" section, the laboratory is to have the microscope cleaned every 6 months. 2. A record review of the microscope maintenance revealed for 1 (2020) of 2 years reviewed a lack of documentation as follows: a. lack of documentation for June 2020 cleaning b. lack of documentation for December cleaning 3. An interview on 5/12/2021 at 9:52 am, the PA confirmed the microscope cleaning was not performed in 2020. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the Practice Administrator (PA), the laboratory failed to perform and document the refrigerator temperature that houses the dermatophyte test media each day of operation for 3 months (December 2020 and March and April 2021) of 2 years reviewed. Findings include: 1. Record review of the "Equipment Quality Control" log sheet revealed for 3 months (December 2020 and March and April of 2021) of 2 years reviewed a lack of documentation of the refrigerator temperature as follows: a. December 2020 - lack of documentation, 23 days b. March 2021 - lack of documentation, 23 days c. April 2021 - lack of documentation, 18 days 2. An interview on 5/12/2021 at 10:30 am, the PA confirmed the lack of documentation of the temperature for the refrigerator during the above listed months. D5519 MYCOLOGY CFR(s): 493.1263(b)(c) (b)For antifungal susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antifungal agent(s) before, or concurrent with, initial use, using an appropriate control organism(s). (b)(1) The laboratory must establish limits for acceptable control results. (b)(2) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(3) The results for the control organism(s) must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on record review and interview with the Practice Administrator (PA), the laboratory failed to perform and document the quality control for the dermatophyte test media (DTM) with the appropriate organisms with each new lot number and/or shipment for 11 months (July 2020 to May 2021) of 2 years reviewed. Findings include: 1. Review of the "Fungal Culture Logbook" revealed "Fungal Cultures" procedure, step #2, "All new lot numbers are to be tested with positive and negative controls. A copy of the test will be maintained in the Fungal Culture Logbook." 2. Record review of the "Fungal Culture Controls" log revealed for 11 months (July 2020 to May 2021) of 2 years reviewed the laboratory did not perform and document -- 2 of 3 -- quality control for the new lot number and/or shipment of media received as follows: a. 7/31/2020 lot #917802 - lack of documentation of the results for the positive and negative controls. b. 5/12/2021 lot #231583, the current lot in use - lack of documentation for performing controls on the shipment of media. 3. An interview on 5 /12/2021 at 11:04 am the PA confirmed there was no documentation on the log to show that quality control was performed on the new lot number and/or shipment of DTM. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with testing personnel #3 and #4 (TP3 and TP4), the laboratory failed to have an electronic request for patient testing from an authorized person for the routine mycology fungal culture testing for one (#20) of 20 patient charts audited. Findings include: 1. Record review revealed the laboratory did not have an electronic request for the fungal culture in the patient's electronic medical record (EMR) for patient chart audit #20. 2. During the interview on March 11, 2019 at approximately 11:00 AM, TP4 was unable to find the request for the fungal culture in the patient's EMR file. 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 manufacturer's instruction, record review, and interview with testing personnel #3 and #4 (TP3 and TP4), the laboratory failed to follow the "Troy DTM Media" section of the "CLIA Manual" for interpreting dermatophyte testing media (DTM) culture readings within "14 days of inoculation" or did not include a date of 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 -- interpretation for four (#11 -#12, #15, and #18) of 20 patient charts audited. Findings include: 1. Manufacturer's instructions for the Troy DTM media stated "Dermatophytes produce typical morphology and a pink to red color in the medium surrounding the colony within 10-14 days of incubation. Disregard any color changes in the medium after 14 days of incubation." 2. Record review of patient final results revealed 1) patient test results were reported greater than the 14 day incubation and 2) no date was recorded in the log book to compare against the 14 days following manufacturer's instructions as follows: a. read greater than 14 days 1. patient #11 - read at 29 days 2. patient #12 - read at 39 days 3. patient #18 - read at 31 days b. no result written in log book 1. patient #15 - result entered into EMR at 42 days 3. During the interview on March 11, 2019 at approximately 11:00 AM, TP4 acknowledged that results were not written in the log book and result reading was interpreted greater than the 14 days specified in the "CLIA Manual" and the manufacturer's instructions. D5785