Westwood Dermatology

Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Specimen Transports Log (STL) and interview with Testing Personnel (TP), the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems for Histopathology tests from 7/1/24 to 9/10/24. The finding includes: 1. The PM states "Specimens are picked up at the doctor's office and counted by the doctor's secretary and the driver before leaving the office. Initials of both parties are included on the master sheet. Driver brings back specimens to the lab and each separate doctor's specimens are again recounted by the in charge technician at the lab and the master sheet is again initialed by said person." 2. The STL did not have any initials or signatures in the designated column. 3. TP #1 as listed on the CMS 209 form confirmed on 9/10/24 that the laboratory failed to follow its procedure for specimen accessioning and specimen pickup. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). 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 2 -- Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to record discontinuance dates for procedures not in use in the laboratory from 5/2/23 to 9/10/24. The finding includes: 1. TP #1 as listed on the CMS 209 form stated that the procedure for "Water Testing" was no longer being performed. 2. The procedure did not have a written discontinuance date. 3. TP #1 as listed on the CMS-209 form confirmed on 9/10/24 at 12:15 pm that discontinuance dates were not documented. 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: Based on surveyor review of the room humidity records and interview with the Testing Personnel (TP), the laboratory failed to record the actual humidity percentage of the room on each day of patient testing from 1/1/24 to 9/10/24. The finding includes: 1. The room humidity records only had the testing personnel initials as evidence of being in acceptable range and did not have the actual humidity percentage. 2. The acceptable humidity range on the daily temperature record was indicated as 5%-80% 2. The TP #1 as stated on the CMS 209 form confirmed on 9/10 /24 at 1:35 PM, the laboratory did not record the actual room humidity percentage on each day of patient testing. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on surveyor review of th Procedure Manual and interview with the Testing Personnel (TP), the Laboratory Director (LD) did not establish a Quality Assurance (QA) procedure for verifying manually entered results into the Electronic Media Record (EMR) from 5/2/23 to 9/10/24. The finding includes: 1. The laboratory did not have a procedure for verifying manually entered results into the EMR. 2. The TP#1 as stated on CMS-209 form confirmed on 9/10/24 at 1:45 PM, the LD did not establish a procedure for verifying manually entered results into the EMR. -- 2 of 2 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation of the laboratory reagents, the lack of a flammable cabinet and interview with the Techincal Supervisor (TS), the laboratory failed to ensure protection from chemical and physical hazards at the time of survey. The finding include: 1. All flammable and inhalation risk reagents were not kept in a flammable cabinet. 2. All flammable and inhalation risk reagents were kept under the laboratory sink and ancillary cabinets. 3. The TS confirmed on 5/2/23 at 2:00 pm that the laboratory did not ensure protection from chemical and physical hazards. D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on surveyor review of Procedure Manual (PM) Staining station (SS) and interview with the Techincal Supervisor (TS), the laboratory failed to include the dates of initial use and discontinuance for staining procedures on the date of survey. The findings include: 1. The PM and the SS had five different histopatholoy staining procedures for Mohs testing in the PM. 2. Five out of five of the staining procedures 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 -- did not have dates of initial use and or discontinuance. 3. The TS confirmed on 5/2/23 at 2:00 pm the laboratory failed to include the dates of initial use and discontinuance for staining procedures. 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: a) Based on surveyor review of the Procedure Manual (PM), and interview with the Technical Supervisor (TS), the laboratory failed to have a complete procedure for "Slide Storage" 4/15/21 to the date of the survey. The findings include: 1. The procedure for "Slide Storage" did not define a retention time for histopathology slides. 2. The TS confirmed on 5/2/23 at 1:30 pm that the laboratory did not have a complete procedure for "Slide Storage" . b) Based on surveyor review of the Procedure Manual (PM), Cryostat Temperature Log (CTL) and interview with the Technical Supervisor (TS) the laboratory failed to follow their procedure for Cryostat Temperature Range (CTR) from 4/15/23 to the date of survey. The finding includes: 1) The PM stated the CTR was 20-25 C. 2) the CTL had the CTR as 20-30 C. 3) The TS confirmed on 5/2 /23 at 1:35 the laboratory failed to follow their procedure for CTR. 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: Based on the lack of Temperature Log (TL), review of the Operators Manual (OM) for the progress capture Pro 2.7 Jenoptick camera, AXICSKOP 40 microscope and interview with the Technical Supervisor (TS), the laboratory failed to monitor room temperature and humidity range where the Professional component (PC) for Histopathology tests are performed from 4/15/21 to the date of the survey. The finding include: 1. The OM defined the acceptable temperature and humidity range for the aforementioned equipment as 5%-80% humidity and 20-75 F. 2. There was no TL in the office where PC was being performed. 3. The TS confirmed on 5/2/23 at 1:35 pm that an acceptable range was not defined. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially -- 2 of 3 -- available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Techincal Superisor (TS), the laboratory did not establish a maintenance protocol for the microscope on the date of survey. The TS confirmed on 5/2/23 at 1:30 pm the laboratory did not have a maintenance procedure in the PM. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Technical Supervisor (TS), the Laboratory Director failed to establish a Competency Assessment (CA) procedure with the required elements at the time of the survey. The TS confirmed on 5/2/23 at 2:30 pm that a CA procedure was not established. -- 3 of 3 --

Summary Statement of Deficiencies 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 surveyor observation of Histology reagents and interview with the Technical Supervisor (TS), the laboratory failed to discard expired Histopathology reagents from 3/1/21 to the date of survey. The findings include: 1. On the date of the survey the laboratory used expired reagents as follows: a. 1% Acid Alcohol Lot 077924 expiration 3/1/21. b. Scott's tap water Bluing Solution Lot J080-01 expiration 3/22/21. 2. The TS confirmed on 4/15/21 at 1:30 pm that the laboratory used expired reagents. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Biannual Assessment (BA) records and interview with the Testing Personnel (TP), the laboratory failed to have a written procedure for BA for the Mohs laboratory and the main Histopathology laboratory from 7/11/18 to the date of the survey. The TP#1 of CMS form 209 confirmed on 7/11/18 at 10:30 am that the laboratories did have a written procedure for BA. 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 --