Podiatry Assoc Of Englewood Pc

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on an in-office review of the laboratory's requirements for a New Jersey State Clinical Laboratory License (NJCLL) under New Jersey Statutes Annotated: N.J.S.A. 45:9-42.28. License; necessity; categories, the laboratory failed to maintain NJCLL for 2023. A Surveyor for the Clinical Laboratory Improvement Services (CLIS) confirmed on 6/28/23 that the laboratory did not have a NJCLL license for 2023. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor observation of Acuderm ACU-DTM Dermatrophyte Test Medium (DTM), review of Acuderm ACU-DTM Manufacturers Package Insert (MPI), Room Temperature (RT) Logs and interview with the Laboratory Director (LD), the laboratory failed to follow the MPI for Storage at the time of survey. The findings include: 1. The IFU stated under Storage "For maximum shelf life, Acu-DTM should 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 -- be stored at 2-8 degrees Celsius (36-46 degrees Fahrenheit). 2. The above mentioned media was being stored at RT of 70 degrees Fahrenheit. 3. The LD confirmed on at 1: 50 pm that the laboratory failed to follow the Acuderm Acu-DTM MPI. 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: Based on surveyor review of the Daily Room Temperature Log (DRTL) and interview with the Laboratory Director (LD) and Procedure Manual (PM), the laboratory failed to monitor and document the room temperature where mycology tests were performed on 7/25/22, 7/26/22, 7/27/22, 7/28/22, 7/29/22. The findings include; 1. No documented evidence for the room temperatures not being documented on the above mentioned dates. 2. The LD confirmed on 6/27/23 at 1:35 pm that the laboratory failed to document the room temperature on the above mentioned dates. 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 surveyor review of the Procedure Manual and interview with the Laboratory Director (LD), the LD failed to establish a Competency Assessment (CA) procedure with the required elements from 6/27/18 to the date of the survey. The LD confirmed on 6/27/23 at 2:00 pm that a CA procedure was not established. Note: This is a repeat deficiency which was cited on 6/27/18. -- 2 of 2 --

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 surveyor review of the Biannual Assessment (BA) records and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of Mycology testing twice annually in the calendar year 2020. The LD confirmed on 4/13 /21 at 10:30 am that the laboratory did not verify the accuracy of the Mycology testing twice annually. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of the Manufacturer Package Inserts (MPI), Patient Results (PR) and interview with Laboratory Director (LD), the laboratory failed to follow the MPI for the ACU-(Dermatophyte Test Medium) used for Mycology testing from 6/27 /18 to the date of the survey. The findings include: 1. The MPI stated "Color interpretation of test is questionable after 14 days due to the possibility of false positives" 2. A review of PR revealed that 22 out of 41 PR were read past 14 days 3. The LD confirmed on 4/13/21 at 10:20 am that the laboratory did not follow the MPI. 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 -- D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), and Office Manager (OM) the laboratory failed to check QC on each batch of Dermatophyte Test Media (DTM) used for Mycology testing from 4 /13/19 to the date of the survey. The findings include: 1. The laboratory did not check DTM for: a. Ability to support growth. b. Ability to select or inhibit specific organisms c. Sterility 2. The TP # 1 listed on the CMS form 209 on 4/13/21 at 11:00 am that the laboratory did not perform the above-mentioned QC checks. Note: This was cited on the last survey 6/26/18 D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on the surveyor review of the Final Reports (FR), Test Results (TR) and interview with the Testing Personel (TP), and Office Manager (OM) the laboratory failed to have TR on one out of ten FR reviewed from 1/31/20 to the date of the survey. The OM confirmed on 4/13/21 at 11:01 am that the TR was not on all the FR. -- 2 of 2 --

Summary Statement of Deficiencies D5006 MYCOLOGY CFR(s): 493.1203 If the laboratory provides services in the subspecialty of Mycology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on lack of the Laboratory Records and interview with the Testing Personnel (TP) the laboratory failed to meet the general laboratory and analytic system requirements for Mycology testing from 6/28/16 to the date of survey. The findings include: 1. The laboratory did not have the manufacturer's Package Insert for DTM. Cross refer to D 5411 2. The laboratory did not monitor and document the temperature where Dermatophyte Test Media (DTM) were stored. Cross Refer to D 5413. 3. The laboratory used expired DTM for fungal testing. Cross Refer 5417 4. The laboratory failed to check each batch of DTM for sterility and its ability to support and inhibit growth . Cross Refer to D 5477. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records, Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to retain the 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 -- Manufacturer's Package Inserts (MPI) for Troy Biologicals Dermatophyte Test Media used for fungal cultures from 6/28/16 to the date of survey. The LD confirmed on 6/26 /18 at 10:00 am that the MPI were not retained. 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: Based on surveyor review of Temperature Records (TR) and interview with the Testing Personnel (TP), the laboratory failed to monitor and record the temperature of the room where Dermatophyte Test Media was stored from 6/28/16 to the date of the survey. The TP # 2 listed on the CMS form 209 confirmed on 6/26/18 at 11:00 am that room temperature was not monitored and recorded in the storage area. 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 surveyor observation of Dermatophyte Test Medium (DTM) with active cultures, and interview with the Testing Personnel (TP), the laboratory used expired DTM for Mycology testing from 6/11/18 to the date of survey. The findings include: 1. Troy Biologicals DTM lot # 1715020 expired 5/30/18. 2. Seven patients were cultured with DTM lot # 1715020 two on 6/11/18, one on 6/12/18, two on 6/18/18, one on 6/22/18 and one on 6/26/18 3. The TP # 2 listed on the CMS form 209 confirmed on 6/26/18 at 11:01 am that the laboratory used expired DTM. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: -- 2 of 4 -- Based on surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check QC on each batch of Dermatophyte Test Media (DTM) used for Mycology testing from 7/24/17 to the date of the survey. The findings include: 1. The laboratory did not check SSA for: a. Ability to support growth. b. Ability to select or inhibit specific organisms c. Sterility 2. The TP # 2 listed on the CMS form 209 on 6/26/18 at 11:00 am that the laboratory did not perform the above-mentioned QC checks. 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 surveyor review of the Laboratory Work Records and interview with the Testing Personnel (TP), the Laboratory Director failed to provide overall management and direction to the laboratory for performing Mycology tests from 6/28/16 to the date of survey.The findings include: 1. The LD failed to ensure that Quality Control programs were maintained. Cross refer to D 6020. 2. The LD failed to establish a competency assessment procedure. Cross refer to D 6030. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the Laboratory Director failed to ensure that the established QC program was maintained for laboratory services provided from 7/24/17 to the date of the survey. The TP #2 listed on CMS form 209 confirmed confirmed 6/26/18 at 10: 50 am the LD did not ensure the QC plan was maintained. 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 -- 3 of 4 -- 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 surveyor review of the Procedure Manual and interview with the Testing Personnel (TP), the Laboratory Director failed to establish a Competency Assessment (CA) procedure with the required elements from 6/28/16 to the date of the survey. The TP # 2 listed on the CMS form 209 confirmed on 5/23/18 at 2:00 pm that a CA procedure was not established. -- 4 of 4 --