Singer Dermatology

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager, the laboratory failed to assess employee and consultant competency for 2 (Testing Personnel #1 (TP1) and Testing Personnel #2 (TP2)) of 6 personnel listed on the CMS 209 form. Findings include: 1. A review of the laboratory's competency records revealed a lack of competency records in 2019 for the following employees: a. TP1, also functioning as Clinical Consultant #1, the Technical Consultant, Technical Supervisor #1, and General Supervisor #1. b. TP2, also functioning as Clinical Consultant #2, Technical Supervisor #2, and General Supervisor #2. 2. An interview on 2/26/2020 at 9:26 am with the office manager confirmed competency assessments were not performed on the two laboratory employees listed above. 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 record review and interview with the office manager, the laboratory failed to verify the accuracy of fungal culture testing for 2 (February 2018 to February 2020) 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 -- of 2 years reviewed. Findings include: 1. The surveyor requested twice annual verification of accuracy documentation for fungal culture testing on 2/26/2020 at 10: 32 am and it was not made available. 2. An interview on 2/26/2020 at 10:32 am with the office manager confirmed the laboratory did not perform verification of accuracy on fungal culture testing. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager, the laboratory failed to check each shipment of fungal culture media for positive and negative reactivity for 2 (February 2018 to February 2020) of 2 years reviewed. Findings include: 1. A record review of the laboratory's "Mycosel Received Log" and "Mycosel Controls" log revealed shipments of mycobiotic agar received on the following dates were not checked for positive and negative reactivity: a. Lot number 1805210 received on 3/21 /18 b. Lot number 1805210 received on 6/13/18 c. Lot number 1805210 received on 7 /11/18 d. Lot number 1805210 received on 7/25/18 e. Lot number 1805210 received on 8/15/18 f. Lot number 1805210 received on 9/5/18 g. Lot number 1805210 received on 9/19/18 h. Lot number 1805210 received on 10/3/18 i. Lot number 1805210 received on 11/14/18 j. Lot number 1805210 received on 11/28/18 k. Lot number 1834608 received on 1/29/19 l. Lot number 1834608 received on 2/7/19 m. Lot number 1834608 received on 2/20/19 n. Lot number 1834608 received on 3/6/19 o. Lot number 1904506 received on 5/17/19 p. Lot number 1904506 received on 6/17 /19 q. Lot number 1904506 received on 6/29/19 r. Lot number 1904506 received on 7 /12/19 s. Lot number 1904506 received on 7/25/19 t. Lot number 1904506 received on 8/14/19 u. Lot number 1904506 received on 8/21/19 v. Lot number 1904506 received on 8/23/19 w. Lot number 1904506 received on 9/10/19 x. Lot number 1904506 received on 9/19/19 y. Lot number 448215 received on 1/22/2020 2. An interview on 2/26/2020 at 11:00 am with the office manager confirmed each shipment of fungal culture media was not tested for positive and negative reactivity. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: . Based on procedure manual review, record review, and interview, the laboratory failed to ensure written competency policies were established, contained the requirements from subpart M, and implemented for three (#4-#6) of five testing personnel performing the parasitology and mycology testing in 2017 and 2018. Findings include: 1. On March 26, 2018 at 11:30 a.m., procedure manual review revealed the laboratory did not establish a written competency policy that included the competency requirements from subpart M and for the mycology and parasitology testing that included the following: a. Direct observations of routine patient test performance, patient preparation, specimen handling, processing, and testing. b. Monitoring the recording and reporting of patient test results. c. Review of test results, worksheets, quality control records, proficiency testing results, and preventive maintenance. d. Direct observation of performance of instrument maintenance and function checks. e. Assessment of problem solving skills. 2. On March 26, 2018 at 11: 30 a.m., record review revealed the laboratory did not have any documentation to show that for three of five testing personnel the competency assessments were performed and documented for the mycology and parasitology testing. 3. On March 26, 2018 at 11:30 a.m. when queried, the office personnel was not able to provide the surveyor with a competency policy that contained the six minimal requirements and the documentation of those requirements for three of five testing personnel performing the mycology and parasitology testing from July 6, 2017 to March 26, 2018. 4. During the interview on March 26, 2018 at 11:30 a.m., the office personnel 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 -- confirmed the laboratory did not establish a competency policy that contained the requirements from Subpart M and did not implement the policy. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview, the laboratory failed to perform and document media checks for the mycobiotic agar with each new batch, lot, or shipment of media for sterility, the ability to support growth, and selectivity/inhibition or biochemical responses for 12 (lot # 1706616, 1709414, 1709414, 1709414, 1718804, 1718804, 1718804, 1718804, 1731807, 1718804, 1805210, and 1805210) of 12 lots received in 2017 and 2018. Findings include: 1. On March 26, 2018 at 10:40 a.m., record review of the "Mycosel Received Log" for 12 of 12 mycobiotic agar "Certificate of Analysis" sheets revealed there was no documentation to show the sterility, the ability to support growth, and selectivity/inhibition or biochemical responses of the media for each new batch, lot or shipment was performed in 2017 and 2018. 2. During the interview on March 26, 2018 at 10:40 a.m., the office personnel confirmed the media checks were not performed and documented. D5781