Ironwood Dermatology

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 review of test procedures on 7/24/25 at 11:07 AM for testing performed in the subspecialty of Histopathology and interview with the facility personnel, the laboratory failed to establish a written test procedure for Frozen Section Biopsy testing. Findings include: 1. The laboratory performs testing in the subspecialty of Histopathology with a reported annual test volume of 12,292. 2. No documentation was presented for review during the survey conducted on 7/24/2025 to indicate the laboratory established a written test procedure for Frozen Section Biopsy testing. 3. The facility personnel interviewed on 7/24/25 at 11:07 AM confirmed the laboratory failed to establish a written test procedure for Frozen Biopsy testing. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on review of temperature records, review of the manufacturer's specifications for laboratory equipment and interview with the facility personnel, the laboratory failed to define an operating humidity range for the laboratory that is consistent with the manufacturer's requirements for one tissue processor, one automatic slide stainer and one immunohistochemical (IHC) stainer, and the laboratory failed to monitor and document the ambient humidity of the laboratory from 6/06/24 through 7/24/25. Findings include: 1. The laboratory utilizes one Tissue-Tek VIP 5 tissue processor, one Leica Autostainer XL and one StatLab Quantum HDX IHC stainer to process and stain tissue specimens. The laboratory reports an annual test volume of 12,292 in the subspecialty of Histopathology. 2. The manufacturer's ambient humidity requirements for operating each piece of equipment are as follows: - Leica Autostainer XL - 20% - 80% - Tissue-Tek VIP 5 Tissue Processor - 30% - 85% - StatLab Quantum HDX IHC Stainer - 0% - 80% 3. The laboratory failed to define an ambient humidity range consistent with the manufacturer's requirements for the area of the laboratory where the equipment indicated above is utilized. 4. The laboratory failed to monitor and document the ambient humidity of the laboratory on each day of patient testing from 6 /06/24 through 7/24/25. 5. The facility personnel interviewed on 7/24/25 at 11:41 AM confirmed the laboratory failed to define an acceptable humidity range for the area of the laboratory where the tissue processor and tissue stainers are operated, and confirmed the lab failed to monitor and document the ambient humidity of the laboratory during the timeframe indicated above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 direct observation of Gram stain reagents for staining histopathology slides and interview with the facility personnel on 7/24/25 at 11:50 AM, the laboratory tested 34 patient specimens with expired Gram stain reagents between 7/01/24 through 7/24/25. Findings include: 1. The laboratory processes dermatopathology tissues and performs the microscopic interpretation of slides in the subspecialty of Histopathology with a reported annual test volume of 12,292. 2. Direct observation of the Gram Stain reagents on 7/24/25 at 11:50 AM revealed each of the 4 stain components included in the Gram Stain kit utilized by the laboratory was expired as follows: - Optimized Tartrazine Counterstain, lot# 181604, expiration date 9/30/24 - Gentian Violet, lot# 182228, expiration date 1/31/25 - Universal Iodine Solution, lot# 182375, expiration date 3/31/25 - Carbol Fuchsin, lot# 182316, expiration date 6/30 /24 3. The laboratory performed and reported Gram Stain test results using the expired stain reagents on 34 patients between 7/01/24 and 7/24/25. 4. The facility personnel interviewed on 7/24/25 at 11:50 AM confirmed the expired Gram Stain kit indicated above was used for patient testing past the manufacturer's expiration date and was in use at the time of the survey. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) -- 2 of 4 -- (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on lack of established IHC control procedure documentation and interview with the facility personnel on 7/24/25 at 11:25 AM, the laboratory failed to establish control procedures for the immunohistochemical (IHC) stains, MART-1, SOX-10-2x, Ki-67 and Pan-Cytokeratin. Findings include: 1. The laboratory performs testing in the sub-specialty of Histopathology, with a reported annual test volume of 12,292. 2. The laboratory began using IHC stains in June 2024 and performs the IHC stains, MART-1, SOX-10-2x, Ki-67 and Pan-Cytokeratin on dermatopathology specimens, as determined by the diagnosing physician. 3. No evidence was presented for review during the survey conducted on 7/24/25 to indicate the laboratory established positive and negative control procedures for the IHC stains indicated above, including but not limited to, the number, type and frequency of testing control materials and the laboratory's practice of using previously known patient specimens as positive and negative control material. 4. The facility personnel interviewed on 7/24/25 at 11:25 AM confirmed the laboratory failed to provide documentation of established, approved QC procedures for the IHC stains listed above and stated that the laboratory uses previously known patient specimens for positive control tissue and utilizes non- reactive areas of the same tissue for negative controls. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on lack of quality assessment (QA) policies and procedures for review on 7/24 /25, lack of documented QA activities and interview with the facility personnel, the laboratory failed to establish QA policies and procedures to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1256 and 493.1281 through 493.1289, and failed to document QA activities for the analytic systems from June 2024 through July 2025. Findings include: 1. The laboratory failed to provide evidence of established QA policies and procedures specific to the analytic systems specified in 493.1251 through 493.1256 and 493.1281 through 493.1289. 2. The laboratory failed to provide evidence of QA documentation from June 2024 through July 2025 to indicate the laboratory monitored, identified and corrected problems found in regards to missing Frozen Section test procedures. Refer to D5401 3. The laboratory failed to provide evidence of QA documentation from June 2024 through July 2025 to indicate the laboratory -- 3 of 4 -- monitored, identified and corrected problems found in regards to a lack of humidity records for the laboratory. Refer to D5413 4. The laboratory failed to provide evidence of QA documentation from June 2024 through July 2025 to indicate the laboratory monitored, identified and corrected problems in regards to using Gram Stain reagents past the expiration date. Refer to D5417 5. The laboratory failed to provide evidence of QA documentation from June 2024 through July 2025 to indicate the laboratory monitored, identified and corrected problems in regards to establishing a Quality Control procedure for IHC stains. Refer to D5441 6. The facility personnel interviewed on 7/24/25 at 12:00 PM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified in the analytic systems, and failed to document QA activities from June 2024 through July 2025. 7. The laboratory performs testing in the subspecialty of Histopathology with a reported annual test volume of 12,292. D5805 TEST REPORT CFR(s): 493.1291(c) (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 pathology test reports for biopsy interpretations and frozen biopsy interpretations and interview with the facility personnel, the laboratory failed to include the gross description on 3 out of 3 pathology reports and failed to include the microscopic description on 1 out of 1 frozen biopsy test report reviewed during the survey. Findings include: 1. The laboratory performs the diagnostic interpretation of dermatopathology specimens in the subspecialty of Histopathology, with a reported annual test volume of 12,292. It is the practice of the laboratory to maintain histopathology test reports in the patient's Electronic Medical Record (EMR). 2. Three out of three dermatopathology test reports (ID24-8684, ID25-3143 and ID25-3037) failed to include the gross description. The gross description (including weighing, measuring, describing color, specific orientation for diagnostic interpretation, and other characteristics of the tissue) must be included on the pathology test report. 3. One out of one frozen biopsy test reports (FS25-02) maintained in the patient's EMR failed to include the microscopic description. 4. The facility personnel interviewed on 7/24/2025 at 10:40 AM acknowledged that the gross description was missing for the 4 biopsy test reports, and the frozen biopsy test report was missing the microscopic description, as referenced above. -- 4 of 4 --

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 lack of competency policies and procedures for review and interview with the facility personnel, the laboratory failed to establish policies and procedures to assess employee competency. Findings include: 1. The laboratory performs the gross evaluation on patient specimens in the sub-specialty of Histopathology. 2. No documentation was presented for review to indicate the laboratory established policies and procedures to assess the competency of individuals who perform the gross evaluation on histopathology specimens. 3. The facility personnel confirmed that the laboratory did not have a policy established to assess the competency of testing personnel who perform the gross evaluation on histopathology specimens. 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 lack of accuracy verification documentation for review and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the sub-specialty of Histopathology at least twice annually during 2021. Findings include: 1. The laboratory performs Mohs and Biopsy interpretation under Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- the sub-specialty of Histopathology, with an approximate annual test volume of 9,380. 2. No documentation was presented for review during the survey conducted on January 26, 2022 to indicate the laboratory verified the accuracy of the microscopic interpretation (reading) of Mohs specimens at least twice annually during 2021. 3. No documentation was presented for review during the survey conducted on January 26, 2022 to indicate the laboratory verified the accuracy of the microscopic interpretation (reading) of Biopsy specimens at least twice annually during 2021. 4. The facility personnel confirmed that the laboratory failed to verify the accuracy of Mohs and biopsy testing at least twice annually during 2021. 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 review of quality assessment (QA) policies and interview with the facility personnel, the laboratory (A) failed to perform and document quality assessment activities as indicated in laboratory policy and (B) failed to perform and document accuracy verification activities as indicated in laboratory policy. Findings include: 1. The laboratory performs patient testing in the sub-specialty of Histopathology with an approximate annual test volume of 9,380. A1. The laboratory's established policy titled, "Method Accuracy Verification For Routine Pathology (Procedure #6)" states, "Every quarter the laboratory staff will pick 2 random cases to review all aspects of grossing, processing, staining and microtomy." A2. No quarterly QA documentation was presented for review from January 2019 through the date of the survey conducted on January 26, 2022. A3. The facility personnel confirmed that the laboratory failed to perform and document the quarterly QA review as stated in policy. B1. The laboratory's established policy titled, "Mohs Slide Review - Procedure #5" states, "Two Mohs cases will be randomly pulled every six months for review by a certified Dermatopathologist (4 cases per year)..." B2. No documentation was presented for review from 2021 to indicate the laboratory followed their established policy indicated above to verify the accuracy of the Mohs testing. See D5217 for findings. B3. The facility personnel acknowledged that the laboratory failed to follow their established policy and provide documentation of accuracy verification procedures as indicated above. 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: -- 2 of 5 -- Based on review of pathology test records and interview with the facility personnel, the laboratory failed to maintain a record system that includes the identity of the individual who performs the gross description on histopathology specimens. Findings include: 1. The laboratory performs the gross description on skin biopsies under the sub-specialty of Histopathology, with an approximate annual test volume of 8,804. The laboratory utilizes an EMR (Electronic Medical Record) to maintain patient test records and test reports. 2. One test report reviewed during the survey (ID21-7495) failed to include the identity of the testing personnel who performed the gross description. The laboratory failed to indicate the identity of the testing personnel who performed the gross description on any other laboratory records. 3. The facility personnel confirmed that the laboratory failed to maintain a record system at the time of the survey conducted on January 26, 2022 that includes the identity of the testing personnel who performed the gross description on patient specimens. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of patient test results maintained in the electronic medical record (EMR), review of the laboratory log used to record patient test results, review of the Mohs map and interview with the facility personnel, the laboratory failed to accurately report the Mohs test result for one patient. Findings include: 1. The laboratory performs Mohs testing under the sub-specialty of Histopathology, with an approximate annual test volume of 576. It is the practice of the laboratory to manually document the Mohs test information onto the laboratory log titled "Mohs Accession Log", as well as documenting the test information on each individual Mohs map, and then to manually enter the test result into the EMR for each patient tested. The EMR is the final test report destination. 2. Review of the Mohs Operative Note (final test report) maintained in the EMR for patient, M21-619 performed on 9/13/21, indicated the Mohs site as "Right inferior medial malar cheek". 3. Review of the Mohs Accession Log listed the site for the Mohs case referenced above as "Right NLF". 4. Review of the Mohs map for the case referenced above listed the site as "Right nasal labial fold". 5. The facility personnel interviewed during the survey confirmed that the site terminology was not accurately entered in the EMR for the patient indicated above. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) documentation, review of electronic test records and interview with the facility personnel, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified with electronic test reports. Findings include: 1. The laboratory performs Mohs testing and Biopsy interpretations in the sub-specialty of Histopathology, with an approximate annual test volume of 9,380. The laboratory utilizes an electronic medical record (EMR) system to document the test procedure and test results. The information is manually transcribed by laboratory personnel into the EMR. 2. No QA documentation was provided for review during the survey to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified with dermatopathology test results manually entered into the EMR. 3. The laboratory failed to enter the correct Mohs test site in the EMR for one patient record reviewed during the survey. See D5801 for findings. 4. The facility personnel confirmed that the laboratory failed to establish QA policies and procedures to monitor, assess and correct problems identified with the postanalytic systems, specifically test report information manually entered into the EMR. 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 the deficient practices identified during the survey, the laboratory director failed to ensure that a quality assessment program is established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. See D5291 and D5891 for findings. 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: Based on lack of education credentials and training documentation for one testing personnel who performs testing in the sub-specialty of Histopathology and interview with the facility personnel, the laboratory director failed to ensure that all testing personnel have the appropriate education and experience, receive the appropriate training and demonstrate that they can perform all testing operations reliably and accurately prior to testing patients' specimens. Findings include: 1. The laboratory performs testing under the sub-specialty of Histopathology, with an approximate annual test volume of 9,380. 2. During the survey conducted on January 26, 2022, no -- 4 of 5 -- education credentials were presented for review for one testing personnel who performs the gross evaluation on patient specimens. The testing personnel began patient testing in July 2020. 3. No initial training documentation was presented for review for one testing personnel hired in July 2020, who performs the gross evaluation on patient specimens in the sub-specialty of Histopathology. 4. The facility personnel confirmed that the laboratory failed to have documentation of the appropriate education and initial training for the testing personnel indicated above. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on lack of documentation of a semi-annual competency evaluation for one testing personnel and interview with the facility personnel, the technical supervisor failed to evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individuals tested patient specimens. Findings include: 1. No semi-annual competency evaluation documentation was presented for review for one testing personnel who began grossing patient specimens in July 2020. 2. The facility personnel confirmed that the technical supervisor failed to document a semi-annual competency evaluation for the testing personnel indicated above. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on lack of testing personnel competency evaluation documentation and interview with the facility personnel, it was determined that the technical supervisor failed to evaluate and document the performance of two out of two testing personnel at least annually. Findings include: 1. During the survey conducted on January 26, 2022, no documentation of an annual competency assessment for was presented for review for two out of two testing personnel who perform the gross description on patient specimens. The testing personnel began testing patient specimens in May 2019 and July 2020.. 2. The facility personnel confirmed that no annual competency evaluation was performed for the testing personnel indicated above. -- 5 of 5 --

Summary Statement of Deficiencies 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 lack of accuracy verification documentation for review and interview with the facility personnel, the laboratory failed to verify the accuracy of histopathology testing at least twice annually during 2017 and 2018. Findings include: 1. The laboratory performs patient testing under the sub-specialty of Histopathology, with an approximate annual test volume of 6,065. 2. No documentation was presented for review during the survey conducted on March 27, 2019 to indicate the laboratory verified the accuracy of Mohs testing at least twice annually during 2017. 3. No documentation was presented for review during the survey conducted on March 27, 2019 to indicate the laboratory verified the accuracy of Biopsy interpretation at least twice annually during 2018. 4. The facility personnel stated that it is the practice of the laboratory to send 4 Mohs cases every 2 months, and 6 Biopsy cases annually to another qualified physician for accuracy verification, however the laboratory failed to send the cases for verification in 2017 and 2018 as indicated. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of quality assessment (QA) policies and interview with the facility personnel, the laboratory failed to perform and document quality assessment activities as indicated in laboratory policy. Findings include: 1. The laboratory presented a monthly Quality Assessment checklist for review during the survey which monitored patient test management, quality control, safety policies, proficiency testing, personnel and QA reviews. The form was retired by the laboratory on July 27, 2017. 2. No other QA documentation was presented for review to indicate the laboratory performed and documented QA activities as indicated above from the time the form was retired in July 2017 through the date of the survey conducted on March 27, 2019. 3. The facility personnel confirmed that the laboratory did not have documentation of QA activities stated above. 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 patient logs, direct observation of stain reagents and interview with the facility personnel, the laboratory used Gram Stain reagents and Colloidal Iron stain reagents past the expiration date. Findings include: 1. The laboratory performs a Gram stain, if warranted, on patient slides in conjunction with biopsy slide interpretation. 2. During the survey conducted on March 27, 2019, direct inspection of the reagents that make up the Gram Stain revealed the laboratory used the reagents past the expiration date. The Gram Stain reagents observed during the survey include: Gentian Violet, lot #15050518, expiration date 9/05/16; Gram's Decolorizer, lot# 14070745, expiration date 7/2016; Universal Iodine Solution, lot# 16110838, expiration date 5/08/16; Optimized Tartrazine Counterstain, lot# 17011062, expiration date 1/10/18; and Carbol Fuchsin Solution, lot# 40523, expiration date 03/2018. 3. Direct observation of Glacial Acetic Acid used for the Colloidal Iron stain indicated the reagent was expired on 09/02/18 (lot# 6245). 4. The facility personnel confirmed that the expired reagents indicated above were still in use on the day of the survey. The number of patients tested using the expired reagents could not be determined at the time of the survey. 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: -- 2 of 3 -- Based on review of the laboratory's test reports and interview with the facility personnel, the Mohs test reports failed to include the address of the laboratory where the reading of the dermatopathology slides was performed . Findings include: 1. The Mohs test reports reviewed during the survey were missing the address of the laboratory where the reading of the dermatopathology slides was performed. 2. The facility personnel confirmed that the laboratory address was missing from the Mohs test reports indicated above. -- 3 of 3 --