Skin And Beauty Center (Sbc)

Summary Statement of Deficiencies 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 the surveyor's examination of laboratory reagents and interview with the laboratory's manager (LM) and the laboratory operation director (LOD); the laboratory failed in not using reagents when they have exceeded their expiration date. The findings include: 1. Based on the surveyor's examination, the laboratory stored the following expired reagents: a. Red Dye, Lot # 1155867, Expiration Date: 02/28 /2023 and b. Light Green for AFB, Lot #176389 Expiration Date:08/31/2024 No other Red Dye or Light Green for AFB was available for replacement. 2. The LM and LOD affirmed on June 26, 2025, at approximately 1:30 p.m., that the laboratory only had at the time of the survey, expired Red Dye and Light Green reagents used for sample staining for microscopic examination. 3. Based on the laboratory's submitted testing declaration test volume, the laboratory stained and tested and reported approximately 18,000 samples for Histopathology microscopic examination for some of which they might have used expired staining reagents. D5815 TEST REPORT CFR(s): 493.1291(h) (h) When the laboratory cannot report patient test results within its established time frames, the laboratory must determine, based on the urgency of the patient test(s) requested, the need to notify the appropriate individual(s) of the delayed testing. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory's policies and procedures, patient test records review from 6/14/2024 to 05/14/2025, and interview with laboratory manager (LM); the laboratory failed to have a policy for turn-around time (TAT) for all histopathology tests performed in the laboratory. 1. The laboratory failed to provide TAT of testing for six (6) out of six (6) randomly selected patients at the time of the survey (June 26, 2025). The laboratory did not provide a TAT policy which may adversely impact patient management. 2. The laboratory manages on June 26, 2025, at approximately 1: 15 p.m. affirmed that the laboratory did not have a TAT policy to notify any delay on testing to the submitters. 3. The laboratory's testing declaration form, signed by the laboratory director on 5/30/25025, stated that the laboratory performs 18,000 histopathology tests annually. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy/procedure, randomly selected patient test records, preventive maintenance documentation, direct observation during the laboratory tour, and interviews with the laboratory's manager and the laboratory director of operation on June 26, 2025, the laboratory director is herein cited due to failure to ensure that several aspects of the preanalytic, analytic, and postanalytic phases of the laboratory testing were monitored. The findings include: 1. Using expired reagents. See D5417. 2. Fail to establish a turn-around-trine TAT policy. See D5815. -- 2 of 2 --

Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 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 Surveyor review of laboratory's personnel qualifications and interview with the laboratory testing person on May 10, 2023, at 11:45 am, and the severity of deficiencies found and cited herein, it was determined that the laboratory director failed to provide effective direction over the operation of the laboratory, hence the Condition: Laboratories performing high complexity testing; laboratory director was not met. The laboratory director's failure to provide direction over the laboratory operation has a consequence of potential erroneous test result reporting and patient harm. The findings include: 1. The laboratory director failed to be responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. See D6079. 2. The laboratory director failed to ensure all personnel testing personnel have the appropriate education and experience. See D6102. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical 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 -- consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's personnel qualifications and interview with the laboratory testing person on May 10, 2023, at 11:45 am, the laboratory director failed to assure laboratory's compliance with the applicable regulations and potentially harmed patients. The findings include: See D6168. 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 Surveyor review of laboratory's personnel qualifications and interview with the laboratory testing person on May 10, 2023, at 11:45 am, the laboratory director failed to ensure that all the testing personnel have the appropriate education and experience. The findings include: See D6168. 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 Surveyor review of laboratory's personnel qualifications and interview with the laboratory testing person on May 10, 2023, at 11:45 am, it was determined that the laboratory failed to have sufficient number of individuals who meet the qualification requirements of 493.1489, hence the Condition: Laboratories performing high complexity testing; testing personnel was not met. The laboratory's failure to have qualified testing personnel has a consequence of potential erroneous test result reporting and patient harm. The findings include: The laboratory had one testing person for grossing, however the person was not qualified as testing person to perform the test. See 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, -- 2 of 4 -- 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) (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 Surveyor review of laboratory's testing personnel qualifications and -- 3 of 4 -- interview with the laboratory testing person on May 10, 2023, at 11:45 am, the laboratory testing personnel failed to meet the required qualification. The findings include: 1. The laboratory performed histopathology tests that include gross examination (macro) and microscopic slide evaluation and interpretation with diagnostic reporting. Gross examination includes weighing, measuring, describing color, specific orientation for diagnostic interpretation, and other characteristics of the tissue, or performing other mechanical procedures including dissection, inking, and marking is a high complexity test. The laboratory had only one testing person who performed the grossing. However, the testing person #1 did not meet the required qualifications. The testing person must be qualified to perform the high complexity test as required by the outlined regulations. Therefore, the quality and accuracy of the patients' test results rendered by the laboratory cannot be assured and might have harmed patients. 2. The laboratory testing person on May 10, 2023, at 11:45 am, affirmed that the testing person #1 is not qualified by the regulations. 3. The laboratory's testing declaration form, signed by the laboratory director on 5/1/2023 stated that the laboratory performs approximately 15,000 tests, annually. -- 4 of 4 --