Dermatology Associates Of Macomb - Oakland Pc

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY 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 observation, record review, and interview with the Office Manager, the laboratory failed to establish policies to ensure positive patient identification of specimens collected for 1 unlabeled Eswab specimen container observed. Findings include: 1. The surveyor observed a white Eswab specimen containter on the counter near the laboratory that did not have patient identifying information on 8/1/22 at 12:18 pm. 2. An interview on 8/1/22 at 12:18 pm with the Office Manager confirmed the specimen did not have patient identifying information on the specimen container. 3. An interview on 8/1/22 at 12:20 pm with the Laboratory Director revealed they collected the specimen and had left it on the counter without labeling it with patient identifying information before walking away. The specimen was to be sent out to a reference laboratory for bacterial culture. 4. A review of the laboratory's policies and procedures revealed a lack of policy regarding positive patient identification of patient specimens from the time of collection through the testing process or referral. 5. An interview on 8/1/22 at 1:45 pm with the Office Manager confirmed the laboratory had not established a policy for positive patient identification of patient specimens from the time of collection through the testing process or referral. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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 -- 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 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 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: . Based on lack of documentation and interview with the Office Manager (OM), the laboratory failed to document the onsite professional interpretation of the Hematoxylin & Eosin (H&E) differential stain quality for 10 (#1 to #10) of 10 dermatopathology cases reviewed from March 2019 to March 2021. Findings include: 1. Record review revealed for 10 (#1 to #10) of 10 dermatopathology cases reviewed, lack of documentation for the on-site H&E stain interpretation for the professional component on the final report or recorded elsewhere as follows. 2. A interview on 3/16 /2021 at 12:45 pm, the OM confirmed the on-site H&E stain interpretation was not performed and documented. ***Repeat Deficiency from 9/12/2018 survey*** Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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, the laboratory failed to ensure written competency policies were implemented for four (#5-#8) of eight testing personnel performing the moderately complex mycology and parasitology testing for two years. Findings include: 1. On September 12, 2018 at 12:30 PM, record review of the competency evaluations revealed for four (#5 - #8) of eight testing personnel the competency evaluations were not performed and documented for two (2017 and 2018) of two years as follows: a. testing personnel #5-#7 - no annual evaluation for 2017 and 2018 b. testing personnel #8 - no semi-annual evaluation for 2018 2. During the interview on September 12, 2018 at 12:30 PM, the office manager confirmed the competency evaluations were not performed and documented. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview, the laboratory failed to use the mycology potassium hydroxide 20% (KOH) reagent before the manufacturer's expiration date. 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 -- Findings include: 1. During a tour of the laboratory on September 12, 2018 at 10:14 AM, the surveyor observed four of four bottles of KOH reagent in use with an expiration date of April 19, 2018 recorded on the manufacturer's label. 2. During the interview on September 12, 2018 at 10:14 AM, the office manager confirmed the KOH reagent was in use past the manufacturer's stated expiration date. 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, the laboratory failed to perform and document the annual maintenance for 1) the mycology and parasitology microscope (Accu-Scope) and 2) the dermatopathology and Mohs' microscope (Olympus BH2) for one (2017) of three years of use. Findings include: 1. On September 12, 2018 at 10: 30 AM, record review of the preventive maintenance sticker on the two microscopes indicated the last preventive maintenance documented was October 17, 2016. When queried, the laboratory was unable to provide documentation to show the microscopes had been serviced in 2017. 2. During the interview on September 12, 2018 at 10:30 AM, the office manager confirmed the annual maintenance was not performed and documented in 2017. 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: . Based on document review and interview, the processing laboratory failed to 1) provide documentation for the quality of the Hematoxylin & Eosinophil (H&E) stain and the professional interpretation of the tissue slide reading failed to 2) acknowledge and document the quality of the H&E stain for nine (#1 to #9) of nine patient charts audited. Findings include: 1. On September 12, 2018 at 12:15 PM, document review for nine of nine patient charts audited revealed the laboratory did not have documentation for 1) H&E stain quality from the processing laboratory and 2) the professional interpretation on the slide reading for the H&E stain quality. 2. On September 12, 2018 at 12:15 PM when queried, the office manager was not able to provide the surveyor documentation to show the processing laboratory and the professional interpretation of the H&E stain quality was performed and documented. 3. During the interview on September 12, 2018 at 12:15 PM, the office manager confirmed the H&E stain quality was not available from the processing laboratory and there was no documentation of the the stain quality during the interpretation of the slide reading. -- 2 of 2 --