Pediatric Dermatology - Childrens Specialty Grp

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Dermatology- Children's Speciality Group (Norfolk) on April 6, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is as follows: D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), testing personnel (TP) records, procedure manual, lack of documentation, and an interview, the technical consultant (TC) failed to document performance of annual competency evaluations for three (3) of 3 TP in calendar year 2020. Findings include: 1. Review of the CMS 209 form revealed that the laboratory director also performs the duties of TC and that personnel A, B, and C were identified as responsible for performing patient Dermatophyte Test Medium (DTM) fungal culture and Potassium Hydroxide (KOH) Wet Prep microscopy testing (review timeframe of March 2020 to the date of the inspection on 4/6/22). **See Personnel Code Sheet. 2. Review of the laboratory personnel files revealed no 2020 annual competency evaluations for: TP A, B, and C. 3. Review of the laboratory's procedure manual revealed a policy (CSG Division of Dermatology Annual Competency Policy) which stated "Competency will be assessed annually, or more frequently as determined by the laboratory director. The annual competency is to demonstrate continuation in roles of testing personnel". The inspector requested to review 2020 annual competency assessments for the TP outlined above. No records were available for review. The Specialty Procedures Nurse stated on 4/6/22 at 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 -- approximately 11:00 AM: "We utilize a written competency test and the course in Microscopy and DTM for annual competency. We have records for 2019 and 2021 but do not have 2020 documentation." 4. An exit interview with the Specialty Procedures Nurse on 4/6/22 at approximately 12:30 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Dermatology- Children's Speciality Group on February 4, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to evaluate Potassium Hydroxide (KOH) PT scores of zero (0%) received due to results marked as past due for evaluation on two (2) of 2 events in calendar year 2018. Findings include: 1. Review of the laboratory's 2018 and 2019 College of American Pathology (CAP) Clinical Microscopy PT documentation (2018 Events A-B, 2019 Events A-B), a total of 4 events, revealed no evaluation or verification of accuracy for: 2018 CM-A: KOH Score 0% 2018 CM-B: KOH Score 0% The inspector requested to review KOH microscopy accuracy evaluation documentation in calendar year 2018. No additional documentation was available for review. 2. In an exit interview with the Speciality Procedures Nurse at approximately 3:45 PM on 2/4/20, the above findings were confirmed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) 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 -- 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: **REPEAT DEFICIENCY** Based on a review of the policy and procedure manual, Dermatophyte Test Medium (DTM) patient logs, and an interview, the laboratory failed to follow the established procedure for culture incubation timeframe for nineteen (19) of two hundred sixteen (216) DTM cultures in the twenty-four (24) months reviewed. Findings include: 1. Review of the laboratory's policy and procedure manual revealed a DTM procedure (Policy Number Derm-010) that outlined utilization of Accuderm's ACU-DTM culture media to detect dermatophytes from patient cutaneous sources. The procedure stated "Instructions are to incubate patient DTM culture vial at room temperature for up to 14 days and instructions to disregard any color change in the medium after the 14 days of incubation". 2. Review of the laboratory's DTM patient logs (timeframe: February 2018 to 2/4/20) revealed the following 19 DTM patient cultures were read and resulted beyond fourteen (14) days of incubation (listed by chart number identifier): 5109507, 525894, 678238, 5161990, 77091, 5025419, 778310, 520299, 5169632 A and B, 775802, 645232, 606425, 5163109, 5031154, 483022, 5219319, 5181806, and 658956. 3. In an exit interview with the Speciality Procedures Nurse at approximately 3:45 PM on 2/4/20, the above findings were confirmed. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of proficiency testing (PT) records, policy/procedure manual, quality assurance (QA) protocols, Dermatophyte Test Medium (DTM) patient logs, lack of documentation, and interviews, the laboratory director (LD) failed to: 1. ensure the Potassium Hydroxide (KOH) Microscopy PT results for two (2) of 2 events in calendar year 2018 were submitted on time as required by the College of American Pathologists (CAP) program. (See D6017); and 2. ensure that testing personnel reported patient DTM culture results promptly and per established QA protocols in calendar years 2018 and 2019. (See D6030.) D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records and interviews, the laboratory director failed to ensure the Potassium Hydroxide (KOH) PT results for two (2) of 2 events were submitted on time as required by the College of American Pathologists (CAP) program in calendar year 2018. Findings include: 1. Review of the laboratory's CAP Clinical Microscopy PT documentation (2018 Events A-B, 2019 Events A-B), a total of four (4) events, revealed scores of zero percent (0%) due to results received past the due date for: 2018 CM-A: KOH Score 0% 2018 CM-B: KOH Score 0% 2. In an exit interview with the Speciality Procedures Nurse at approximately 3:45 PM on 2 /4/20, the above finding was confirmed. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on a review of the policy and procedure manual, quality assurance (QA) protocols, Dermatophyte Test Medium (DTM) patient logs, lack of documentation, and interviews, the laboratory director (LD) failed to ensure that testing personnel reported patient DTM culture results promptly per the established QA protocols in calendar years 2018 and 2019. (See D5401.) Findings include: 1. Review of the laboratory's policy and procedure manual revealed a DTM procedure (Policy Number Derm-010) that outlined utilization of Accuderm's ACU-DTM culture media to detect dermatophytes from patient cutaneous sources. The procedure stated: "Instructions are to incubate patient DTM culture vial at room temperature for up to 14 days and instructions to disregard any color change in the medium after the 14 days of incubation". 2.. Review of the laboratory's QA protocols revealed a DTM QA protocol (dated/approved on 3/15/18) that stated "all staff are educated on DTM incubation periods and DTM policy and reading procedures. A new procedure is in place to add inspections of all DTM cultures on a daily basis. The LD will oversee and monitor and provide more strict monitoring on a weekly basis to determine compliance. Education needs will be assessed and documented to be sure all staff are aware and adhere to the DTM policy." 3. Review of the laboratory's DTM patient logs (timeframe February 2018 to 2/4/20) revealed the following nineteen (19) DTM patient cultures were read and resulted beyond 14 incubation days (listed by chart number identifier): 5109507, 525894, 678238, 5161990, 77091, 5025419, 778310, 520299, 5169632 A and B, 775802, 645232, 606425, 5163109, 5031154, 483022, 5219319, 5181806, 658956. The inspector inquired regarding QA education assessment documentation after the 19 reporting events outlined above (per the reviewed DTM QA protocol). No records were available for review. The Speciality Procedures Nurse stated, at approximately 2:30 PM on 2/4/20, "This site has shown -- 3 of 4 -- improvements in adhering to the DTM cultures read/report within 14 days but turnover of staff remains an issue". 4. In an exit interview with the Speciality Procedures Nurse at approximately 3:45 PM on 2/4/20, the above finding was confirmed. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Pediatric Dermatology- Childrens Speciality Group on February 28, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of the laboratory's policy and procedure manual, 2016 and 2017 Patient Dermatophyte Test Medium (DTM) patient logs, and an interview, the laboratory failed to follow the established procedure for incubation timeframe for one hundred twenty-eight (128) of eight hundred twenty-two (822) DTM culture results reviewed. Findings include: 1. Review of the laboratory's policy and procedure manual revealed a DTM procedure (Policy Number Derm-010). The procedure outlined that the laboratory utilizes Accuderm's ACU-DTM culture media to detect dermatophytes from patient cutaneous sources. The procedure stated "Incubation instructions are to incubate patient DTM culture vial at room temperature for up to fourteen (14) days". 2. Review of the laboratory's 2016 and 2017 DTM patient logs revealed: DTM patient cultures read and resulted beyond fourteen (14) incubation days in 2016: (Listed by chart number identifier) 627141, 5037933, 5069905, 5242762, 728509, 5066841, 687675, 721806, 680435, 734152, 5194528, 5209953, 596820, 620493, 5188897, 772950, 701775, 5091093, 5009861, 5190342, 5094243, 5069905, 735852, 667280, 633389, 5048736, 581278, 5223962, 5188497, 5091832, 5161864, 5182379, 5085406, 5154047, 664910, 676262, 510755, 771484, 747834, 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 -- 520541, 5262164, 762386, 5263583, 635668, 651343, 5211865, 5263079, 525994; a total of forty-eight (48), out of three hundred six (306) DTM results reviewed. DTM patient cultures read and resulted beyond fourteen (14) incubation days in 2017: (Listed by chart number identifier) 5160473, 5186171, 5263376, 735354, 5024746, 651343, 663589, 694352, 623786, 5100197, 762645, 609803, 5174858, 5268753, 553099, 5266371, 654534, 5109173, 5143807, 631165, 676844, 5155171, 5252722, 5252681, 640039, 5240821, 5270317, 5087706, 762207, 675564, 521543, 5010706, 5112469, 5176987, 5256713, 5240451, 570767, 426627, 489792, 5243278, 654534, 5276997, 5202565, 5079453, 5162383, 548903, 587640, 5275753, 525003, 671604, 559121, 5176987, 661390, 5156042, 5193042, 5283629, 5194379, 698917, 5180326, 653406, 5145943, 560828, 5245769, 5189729, 5118186, 5055390, 5272869, 594889, 5041604, 669805, 5245641, 5218175, 675314, 568206, 775938, 5026135, 5152693, 5197491, 443347, 5191544; a total of eighty (80), out of five hundred sixteen (516) DTM results reviewed. 3. In an interview with the laboratory's speciality procedure nurse at approximately 2:45 PM on 2/28/18, it was confirmed that the laboratory failed to follow the established procedure for DTM culture incubation time limit in calendar years 2016 and 2017 for the one hundred twenty-eight (128) patient charts identified and listed above. -- 2 of 2 --