Acacia Dermatology

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 observation of the laboratory, review of patient accessioning logs, and interview with testing personnel number two, the laboratory failed to ensure reagents were not used past their expiration date in 2021 with patient testing performed. The finding include: 1. Observation of the laboratory on August 2, 2021 at 11:30 am revealed expired reagents that were in use for processing and staining of patient tissue (histopathology) specimens as follows: Gill 3 Hematoxylin, Lot number 084041, expiration date of 2021-01-31 Alcohol, Lot number AE013, expiration date 03/21 2. Review of patient accessioning logs revealed the following: Approximately 771 patient specimens were processed/stained using the expired alcohol reagent. Approximately 536 patient specimens were processed/stained using the expired Gill 3 Hematoxylin reagent. 3. Interview with testing personnel number two on August 2, 2021 at 3pm confirmed the laboratory performed processing and staining of patient tissue samples using expired reagents in 2021. 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. 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 CONDITION is not met as evidenced by: Laboratory personnel performing high complexity testing did not meet the regulatory educational requirements (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 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) -- 2 of 3 -- (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 observation of the laboratory, interview with testing personnel number two, review of testing personnel education documents, and subsequent interview with testing personnel number two, testing personnel number two failed to meet the high complexity regulatory education requirement for performing inking of tissue removed during MOHS procedures in 2021. The findings include: 1. Observation of the laboratory on August 2, 2021 at 11:30 am revealed a microscope, reagents, stains and dyes in use for histopathology testing procedures. 2. Interview with testing personnel number two on August 2, 2021 at 11:45 am revealed that testing personnel number two performs inking of tissue removed during MOHS procedures. 2. Review of education documents for testing personnel number two revealed that testing personnel number two did not meet the minimum education requirements for performing high complexity testing (inking of tissue removed during MOHS procedures). 3. Subsequent interview on August 2, 2021 at 3:00 pm with testing personnel number two confirmed that testing personnel number two performs high complexity, inking of tissue removed during MOHS procedure, without the having the minimum required education. -- 3 of 3 --

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on review of patient number eight test report, slide retention for patient number eight, and interview with testing personnel number one, the laboratory failed to retain histopathology slides for at least 10 years in 2018. The findings include: 1. Review of patient number eight test report revealed patient testing for dermatopathology with a test report date of 08.14.2018. 2. Review of patient number eight slide retention revealed no slides could be located. 3. Interview with testing personnel number one on August 16, 2018 at 2:00 pm confirmed the laboratory failed to retain histopathology slides for at least 10 years in 2018 when the slides for patient number eight could not be located. 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: Review of the laboratory's policy titled "Proficiency Testing," the laboratory form 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 -- titled "QA Report-Proficiency Testing for Histopathology," and interview with the laboratory director, the laboratory failed to verify the accuracy of histopathology procedures twice a year in 2017. The findings include: 1. Review of the laboratory's policy titled "Proficiency Testing" revealed the following statement: Once every year, the technician will randomly select one histopathology case and subject it to microscopic examination by a qualified dermatologist or pathologist. 2. Review of the laboratory's form titled "QA Report-Proficiency Testing for Histopathology 2017" revealed verification of accuracy of histopathology procedures was performed once in 2017. 3. Interview with the laboratory director on August 16, 2018 at 12:30 pm confirmed the laboratory failed to verify the accuracy of histopathology procedures twice a year in 2017. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory failed to have a procedure for the use of special stains (Refer to D5401), failed to ensure reagents were not used past their expiration date (Refer to D5417), and failed to document quality control procedures (D5601). 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: Based on observation of the laboratory, review of the laboratory's procedure manual, and interview with the laboratory director, the laboratory failed to have a procedure for the use of special stains in 2018. The findings include: 1. Observation of the laboratory on August 16, 2018 at 1:00 pm revealed the following special stains in use for patient testing: HMB45 Mart-1 Biocare Sox10 PAS Alcian Blue S100 2. Review of the laboratory's procedure manual revealed there were no procedures for the use of the special stains. 3. Interview with the laboratory director on August 16, 2018 at 2:15 pm confirmed the laboratory uses the special stains for patient testing and failed to have a written procedure for the use of the special stains. 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 -- 2 of 4 -- deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with testing personnel number one, the laboratory failed to ensure reagents and stains were not used past their expiration date in 2018. The findings include: 1. Observation of the laboratory on August 16, 2018 at 1:00 pm revealed the following reagents and stains that were in use for patient testing: KOH Lot #K16C81, expiration date = 2016-12-08 HMB45 Lot #3900215A, expiration date = 01/2017 Mart-1 Lot #5565714AP, expiration date = 05 /2017 Biocare Sox10 Lot# 021016, expiration date = 2018/02 Alcohol 70% Lot # A140.07.29.15, expiration date =07/2018 PAS expiration date=01.05.2018 Alcian Blue expiration date=11.28.17 2. Interview with testing personnel number one on August 16, 2018 at 12:30 pm confirmed that the laboratory uses the reagents and special stains to perform patient testing and failed to ensure reagents and stains were not used past their expiration date in 2018. 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 observation of the laboratory, review of laboratory records and interviews with testing personnel number one and the laboratory director, the laboratory failed to document control procedures in 2018. The findings include: 1. Observation of the laboratory on August 16, 2018 at 1:00 pm revealed the following vials of special stains: SOX-10, Mart-1, HMB-45, S100, PAS, Alcian Blue. 2. Review of the laboratory's records revealed no documentation of quality control for the special stains. 3. Interview with testing personnel number one on August 16, 2018 at 1:00 pm confirmed the observed stains were in use for patient testing. 4. Interview with the laboratory director on August 16, 2018 at 2:15pm confirmed the laboratory uses the special stains for patient testing and failed to document control procedures in 2018. D6101 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(11) The laboratory director must employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart. This STANDARD is not met as evidenced by: Based on review of the education documents for testing personnel number one and interview with testing personnel number one, the laboratory director failed to ensure testing personnel have the appropriate education for the complexity level of testing -- 3 of 4 -- performed. The findings include: 1. Review of the education documents for testing personnel number one revealed testing personnel number one does not have the minimum required educational degree for performing grossing of histopathology specimens. 2. Interview with testing personnel number one on August 16, 2018 at 1 pm confirmed that testing personnel number one performs grossing of histopathology specimens, and the laboratory director failed to ensure testing personnel had the appropriate level of education for the complexity level of testing performed. -- 4 of 4 --