Us Dermatology Partners Georgetown

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiency was cited. 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 review of accuracy assessments, patient testing logs, and interview, the laboratory failed to perform twice a year accuracy assessments of its Frozen sections for the diagnostic interpretations (diagnosis) for 19 of 19 months reviewed. Findings follow. A. Accuracy assessments for the diagnostic interpretations of Frozen sections were requested on July 10, 2025 at 1050 hours but not provided. B. Review of the frozen section patient log showed from 10/10/2023 - 05/19/2025 (elapsed time 19 months) there were 10 cases/patients reported. C. Interview with the histotech on July 10, 2025 at 1050 hours in the laboratory confirmed accuracy assessments for Frozens were not performed. 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 D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, patient testing logs, pre-survey paperwork, and interview, the laboratory failed to document the internal controls for the hCG (Human Chorionic Gonadotropin) Pregnancy Test Cassette for two of two years reviewed. Findings follow. A. Review of the Medline hCG Pregnancy Test Cassette (urine) package insert (effective 03/20/2015) under Quality Control stated, "Internal procedural controls are included in the test. A red line appearing in the control region (C) is the internal [positive] procedural control. It confirms sufficient specimen volume and correct procedural technique. A clear background is an internal negative background control. If the test is working properly, the background in the result area should be white to light pink and not interfere with the ability to read the test result." B. The Urine Pregnancy Test Log was requested on June 22, 2023 at 1400 hours but not provided. C. Interview with the Office Manager on June 22, 2023 at 1400 hours confirmed they did not have a pregnancy testing log. Interview with the Mohs histotechnologist on June 22, 2023 at 1405 hours confirmed they did not document the internal procedural controls. D. Review of the CMS Form 116 showed approximately 250 pregnancy tests were performed annually. 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 -- D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, and interview, the laboratory failed to retain the attestation statements for three of five events reviewed for KOH (potassium hydroxide) for fungal elements, and Scabies. Findings follow. A. Review of the AAB (American Association of Bioanalysts) PT records from the 1st and 2nd events of 2023, and the 1st, 2nd, and 3rd events of 2022 showed the 1st and 2nd events of 2023 and the 3rd event of 2022 were missing the signed attestation statements. The attestation statement attests that samples were tested in the same manner as patient samples. B. Interview with the Office Manager on June 22, 2023 at 1145 hours acknowledged she submitted the attestation statements with the results, but did not print a copy for her records. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, quality control (QC) records, testing logs, and interview, the laboratory failed to document the reactivity of the Hematoxylin and Eosin (H&E) stain to ensure predictable staining characteristics for their quality control used in Mohs testing for 7 out of 7 months reviewed. Findings follow. A. Review of the Instructions for Use for the Epredia Hematoxylin 7212 under Intended Use stated "Hematoxylin is intended be used as a nuclear stain for the diagnosis of general pathology specimens." And under Introduction stated the Hematoxylin will form "a distinct blue-purple color characteristic of hematoxylin stains." And under Hematoxylin 7211 & 7212 stated it "provides consistent well- delineated nuclear staining results". Review of the Instructions for Use for the Epredia Eosin-Y w/Phloxine under Intended Use stated "Eosin is intended to be used as a cytoplasmic stain for the diagnosis of general pathology specimens." And under Eosin- Y w/Phloxine stated "Eosin-Y w/Phloxine is a ready to use alcoholic, acidified counterstain to which phloxine B has been added." And under Eosin w/Alcoholic stated, "stains the cytoplasm of muscle, red blood cells, and connection tissue three distinct color hues of pink to red...[and] provides clear cytoplasmic and nuclear contrast". B. Review of the Mohs Control Slide Quality Assurance Log from 11/1/22 to 6/21/23 for 79 QC events showed Satisfactory or Unsatisfactory for the stain, but did not define what was considered satisfactory. C. Random review of the Mohs testing log showed the following cases were tested as listed by date of service and case number: Date of service Mohs Case # 1. 05/16/23 GTD23349 2. 04/04/23 GTD23236 3. 02/22/23 GTD23126 4. 01/09/23 GTD23011 5. 11/14/22 GTD22673 D. Interview with the Office Manager on June 22, 2023 at 1350 hours confirmed the QC form does not define what satisfactory is for the H&E stain. -- 2 of 3 -- D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of patient testing logs, pre-survey paperwork, and interview, the laboratory failed to document all their testing records on a log for KOH for fungal elements and Scabies performed in the laboratory for 17 of 17 months reviewed. Findings follow. A. Review of the KOH and Scabies logs showed from 01/01/2022 - 06/22/2023, there were 18 KOH and 1 scabies tests recorded. B. Interview with the Office Manager on June 22, 2023 at 1210 hours acknowledged they don't have a complete log for KOH and Scabies performed, the log was only for the ones they do peer reviews on. They were also unable to provide a complete list of who performed the KOH and Scabies and when the tests were performed. C. Review of the CMS Form 116 showed approximately 30 KOH and Scabies tests were performed annually. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the Mohs maps and interview, the laboratory failed to include the key on the Mohs map for the symbols indicating the marking dyes on the sections used on six of ten Mohs maps reviewed. Findings follow. A. Random review of ten Mohs maps from 05/16/2023 - 11/01/2021 showed six were missing the symbols for the marking dyes used, but there was no key on the map to show what colors the symbols were, as listed by date of service and Mohs case #: Date of Service Mohs Case # 1. 01/09/23 GTD23-011 2. 11/14/22 GTD22-673 3. 10/07/22 GTD22-560 4. 08 /15/22 GTD22-448 5. 01/31/22 GTD22-064 6. 11/01/21 GTD21-637 B. Interview with the Office Manager on June 21, 2023 at 1330 hours acknowledged Technical Supervisor #3 travels and likes using his own map, and that's why it is different from the one in the office. -- 3 of 3 --

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: I. Based on review of manufacturer's instructions, temperature logs, patient logs, and interview, the laboratory failed to ensure the Mohs laboratory was within the operating specifications for the Leica CM1510S cryostat for three of three months reviewed. Findings follow. A. Review of the Leica CM1510S Instruction Manual on chapter 4. Setup under 4.1 Installation site requirements stated, "The place of installation must meet the following requirements: ... room temperature maximum 22 degrees Celsius" (72 degrees Fahrenheit). B. Review of the temperature logs from 3/30 /21 - 9/07/21 showed the room temperature acceptable range was 41 - 95 degrees Fahrenheit. Review of the documented room temperature on the logs from 3/30/21 - 9 /07/21 showed the room temperature was between 73 - 78 degrees every day of patient testing. C. Interview with the Mohs histotech on October 13, 2021 at 1600 hours in the Mohs laboratory confirmed the room temperature was above 72 degrees in the Mohs lab. D. Review of the patient logs showed 623 Mohs cases were performed in 2020, and approximately 550 cases were performed in 2021 to survey date. I. Based on surveyor observation, temperature logs, patient logs, interview and email, the laboratory failed to document the room temperature of the grossing laboratory for nine of 21 months reviewed. Findings follow. A. Surveyor observed 6 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 -- bottles of Epredia Hematoxylin 7211 reagent stored in the cabinet of the grossing laboratory showed a room temperature requirement of 15-30 degrees Celsius on the bottle. Surveyor observed 9 bottles of Leica Surgipath Hematoxylin 560 MX reagent stored in the cabinet of the grossing laboratory showed a room temperature requirement of 15 - 30 degrees Celsius on the bottle. B. Review of the temperature logs showed temperatures were recorded for 2020, but none were available for review for 2021. C. Interview with testing personnel #6 on October 13, 2021 at 1500 hours in the grossing laboratory acknowledged the laboratory stopped recording room temperatures at the end of 2020 because inspections at other sites had not asked for that. The Epredia Hematoxylin reagent was used for the Hematoxylin and Eosin (H&E) stain for Mohs, and the Leica Hematoxylin was used in the grossing laboratory [to prepare H&E slides for dermatopathology review]. D. Review of the patient logs showed approximately 550 Mohs cases (with H&E staining) were performed to survey date in 2021. E. 6,237 cases have been processed for grossing and H&E staining to date in 2021 via email from the Office Manager on 10/14/2021. 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 review of reagent logs, laboratory policies and procedures, patient logs, and interview, the grossing laboratory failed to ensure the Carbol-Fuschin Solution used for the FITE Acid Fast-Stain was not available and in use beyond its expiration for three of 24 months reviewed. Findings follow. A. Review of the Carbol-Fuschin Lot Number Quality Control Log from 10/13/2019 - 10/13/2021 showed Lot 075563 expired on 05/01/2020 (in the Finish Date column on log), but Lot 084558 was not placed into use until 08/19/2020. B. Review of the FITE Acid Fast-Stain procedure, policy GTD-8.1, effective 09/01/2011, under Reagents included the Carbol-Fuschin Solution. Under Procedure stated, "the FITE stain is used for histologic visualization of acid-fast bacteria, Tubercle Bacilli, and Mycobacterium leprae (causative agent of leprosy) in tissue sections." C. Review of a query of the LIS from 05/02/2020 - 08/18 /2020 showed two patient slides were prepared with the FITE Acid Fast-Stain: 1. GTW204631 on 07/20/2020, and 2. GTW47999 on 07/08/2020. D. Interview with testing personnel #6 listed on the CMS form 209, on October 13, 2021 at 1525 hours in the grossing laboratory confirmed testing was performed using the expired bottle, and explained the Finish Date on the log was when the last pour over from the original bottle occurred. KEY: LIS = Laboratory Information System -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 493.1487 Condition: Laboratories performing high complexity testing; testing personnel 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 review of the laboratory's quality assurance records from 2018 through 2020 and staff interview, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessment for KOH preparations in 2018 and 2019 . Findings included: 1. A review of the laboratory's Parasitology and KOH Competency Exams from 2018 through 2020 found documentation of verification of the accuracy of results for KOH preparations done once each year in 2018 and 2019. The laboratory was not enrolled in a CMS approved proficiency testing program for Clinical Microscopy. Dates of competency exams performed were February 15, 2018 and August 14, 2019. 2. An interview with the clinic manager conducted on January 3, 2020 at 2:47 PM confirmed the laboratory was neither enrolled in a proficiency testing program nor did the laboratory verify the accuracy of the test results for KOH at least twice a year in 2018 or 2019. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a review of laboratory quality control records, policies and procedures, surveyor observation, patient records, and interview of facility personnel it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6102, D6103, and D6120. 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: Review of personnel Records and interview of facility personnel found that the laboratory director failed to ensure that testing personnel had the appropriate education prior to performing gross analysis of patient specimens for Histopathology. (See D 6171) D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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: The laboratory director failed to ensure there was a procedure in place to assess the competency all testing personnel involved in preanalytic, analytic and postanalytic testing of histopathology specimens. (See D6120) D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records and interview, the Technical supervisor failed to evaluate the competency of all testing personnel performing histopathology procedures, using the six required components for competency. The findings included: 1. Review of the laboratory's personnel records found no documentation of Competency assessments for physicians performing histopathology testing in 2018 and 2019 that included the six required elements: Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; Monitoring the recording and reporting of test results; Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; Direct observation of performance of instrument maintenance and function checks; Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; Assessment of problem solving skills; The laboratory offered Peer reviews performed in 2018 and 2019 as competency assessment for six of nine testing personnel 2. Interview of the office manager conducted on February 3, 2020 at 2:39 PM confirmed that peer review evaluations was all that was available to assess the competency of physicians performing Histopathology. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on a review of the Laboratory Personnel Report, personnel records and staff interview, it was revealed that three of three testing personnel performing high complexity testing (gross analysis of tissue specimens) did not have the appropriate documented training required to perform high complexity testing. (refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or -- 3 of 4 -- other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on review of the CMS report 209 laboratory personnel report, personnel records and interview of facility personnel the laboratory failed to have documented training for three of three testing personnel performing gross analysis of patient tissue specimens . The findings included: 1. Review the CMS report 209 laboratory personnel report found seven testing personnel listed for high complexity testing. 2. Review of personnel files found no documented training for testing personnel performing gross examinations including the inking, scoring and dissection of tissue specimens. Testing person 7 (hire date May 24, 2017) Testing person 8 (hire date December 10, 2018) Testing person 9 (hire date July 23, 2018) 3. Interview of testing person seven on the CMS report 209 Laboratory Personnel Report conducted on February 3, 2020 at 3:52 PM confirmed that there was no documentation of training available for review. Interview of the office manager confirmed that the laboratory added the technical component of histopathology to its certificate through a 2018 change in ownership. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the conditions of the CLIA regulations found at 42 CFR 493.and recertification is recommended. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observations, review of laboratory policy, and interview with facility personnel, the laboratory failed to label an aliquot of xylene with the preparation dates, expiration dates, and storage requirements for 1 of 1 aliquot of xylene. The findings included: 1. At 10:35 hours on 01/18/2018, the surveyor observed an aliquot labeled "xylene" in the laboratory's flame proof cabinet. 2. Review of the laboratory's policy "Histopathology - Mohs Surgery" stated the following: "4.2 Preparation and labeling 4.2.3. All reagents are to be labeled with the following information: Reagent Dilution Date prepared Technician Temperature for storage (if not room temperature)." 3. In an interview at 10:35 hours on 01/18/2018 in the laboratory, the Office Manager confirmed the aliquot of xylene was missing preparation dates, expiration dates, and storage requirements. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other 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 -- 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 observations, review of laboratory policy, and interview with facility personnel, the laboratory failed to ensure 2 of 6 margin marker ink containers had not been used when they exceeded their expiration dates. The findings included: 1. At 10:35 hours on 01/18/2018, the surveyor observed 2 of 6 margin marker ink containers that had expired and were available for testing: 1) Stat Lab Red margin Marker -Lot 34371 - Expiration: 11/2016 2) Stat Lab Blue margin marker - Lot: 34949, Expiration: 12/ 2016 2. Review of the laboratory's policy "Histopathology - Mohs Surgery" stated the following: "4.3 Storage Use and Handling 4.3.3 - Do not use reagent after expiration date" 3. In an interview at 10:35 hours on 01/18/2018 in the laboratory, the Office Manager confirmed the 2 margin marker ink containers had exceeded their expiration date and had been used in patient testing. The laboratory reported performing an estimated 573 Mohs cases per year. -- 2 of 2 --