Pediatrics At Chartley Pa

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with the laboratory director (LD), the laboratory failed to attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. Findings: 1. Records for three PT events were reviewed. 2. Records for PT events D1-C 2022 and D1-B 2023 included the attestation form with the names of the testing personnel (TP) typed into the form, but not signed by the TP who performed the PT. 3. Event D1-A 2023 was performed and evaluated after the PT provider's deadline. A signed attestation form was not included in the PT records. 4. During the survey on 12/15/2023 at 11:15 AM, the LD confirmed that the attestation forms were not signed by the TP performing the PT. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of temperature logs and interview with the laboratory director (LD), the laboratory failed to ensure refrigerator temperature logs were maintained for 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 3 -- least 2 years. Findings: 1. The laboratory stored culture plates and Taxo A discs in the refrigerator designated "Private." 2. Temperature logs for the "Private" refrigerator were reviewed from 05/2022 through 11/2023. 3. Temperature logs for the "Private" refrigerator were missing from 10/2023 and 05/2022-09/2022. 4. During the survey on 12/15/2023 at 11:15 AM, the LD confirmed that at the time of the survey, temperature logs for the "Private" refrigerator could not be located for 10/2023 and 05/2022-09 /2022. 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 review of the procedure, review of the group A Streptococcus (GAS) patient log, and interview with the laboratory director (LD), the laboratory failed to consistently record test results in the patient testing log. Findings; 1. The laboratory performed rapid and culture testing to screen throat specimens for GAS. 2. The testing procedure stated to "Perform Rapid Strep test per package insert. If the Rapid Strep Test is negative, inoculate a blood agar plate for culture" and to "Record the information in the lab log and in the patient's chart." 3. The log included columns for the "Date", "Patient Name", "D. O. B. [date of birth]", "Rapid Result", "MA [medical assistant] Initials", "Throat Culture Y/N", "24 / HR Culture" (culture result after 24 hours), and "Documented in chart". 4. When a throat culture was performed, a result of "+" was entered for positive and "-" was entered for negative. 5. Log entries for 219 patients from 02/03/2023-04/19/2023 and 06/15/2023-11/02/2023 were reviewed. 6. For 9 patients, the log recorded "N" in the "Throat Culture Y/N" column indicating that a throat culture was not performed and a "-" in the "24 / HR Culture" column. 7. For 2 patients, the log recorded a "-" in the "Throat Culture Y/N' column and a "-" in the "24 / HR Culture" column. 8. For 11 patients, the log recorded a "Y" in the "Throat Culture Y/N" column indicating that a throat culture was performed and the "24 / HR Culture" column was left blank with no culture result recorded. 9. During the survey on 12/15/2023 at 11:15 AM, the LD confirmed that the patient testing log was not completed in a consistent manner. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the microbiology proficiency testing (PT) records and interview with the laboratory director (LD), the laboratory failed to ensure that the all PT records were being saved; the testing person who performed the test documented the results in the same manner as the patients; the attestation worksheets were being printed and saved; and the records were maintained for two years as required. Findings: 1. The PT records from the 2021 through the first event of 2022 (7 events) were reviewed. 2. The PT records showed that six of the seven events did not include a copy of the completed PT worksheet showing the results submitted to the PT agency. 3. The PT records showed that the attestation worksheets for six of the seven events were not signed by the laboratory director or the designee. 4. The patient logs showed that the PT samples were recorded along with the patients on one of seven events. 5. During the survey on 05/12/2022 at 2:15 PM, the LD confirmed that the PT records were not available and maintained for required two years. D6021 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: A. Based on review of the Individualized Quality Control Plan (IQCP) and interview with the laboratory director (LD), the LD did not ensure that the IQCP included supporting data and quality control (QC) frequency and remedial actions to be taken for failures as part of the risk assessment. Findings: 1. The IQCP did not include the supporting data for making the assessment, e.g., package insert, documentation of successful proficiency testing results and documentation of successful quality control results. The IQCP did not include policies and procedures for QC frequency and remedial actions to be taken when there is a QC failure. 2. During the survey on 05/12 /2022 at 2:15 PM, the LD confirmed that the IQCP did not have supporting documentation and QC requirements. B. Based on review on the quality assurance (QA) procedure, monthly QA logs and interview with the LD, the LD did not ensure that the monthly QA reviews were performed as required. Findings: 1. The QA procedure requires monthly reviews to be performed and documented. 2. Review of the monthly QA worksheets from January 2020 through April 2022 showed that the monthly QA review was performed and documented 7 of 28 months. The monthly QA reviews that were performed showed that one of seven were signed and dated by the LD. 3. During the survey on 05/12/2022 at 2:15 PM, the LD confirmed that the monthly QA procedure had not been performed as required and the monthly QA reviews had not been signed and dated by the LD. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on review of the standard operating procedure manual (SOPM) and interview with the laboratory director (LD), the LD failed to provide approved policies and procedures for handling, performing, recording and maintaining all required records proficiency testing (PT) records. Findings: 1. The PT records from the 2021 through the first event of 2022 (7 events) were reviewed. The PT records were not being maintained as required. Cross refer to Tag D2015. 2. Review of the SOPM showed that there were no written policies and procedures handling, performing, recording and maintaining all required records PT records. 3. During the survey on 05/12/2022 -- 2 of 3 -- at 2:15 PM, the LD confirmed that there were not written instructions for maintaining the required PT records to ensure that they were available for review at the time of the recertification survey. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of the written procedure manual and interview with the laboratory director (LD), the laboratory did not follow the manufacturer ' s package insert for performing throat cultures with the Taxo A Disc. Findings: 1. The laboratory did not follow the Taxo A Disc package insert for performing throat cultures. 2. The laboratory was incubating patient throat cultures inoculated with the Taxo A Disc between 35-37 degrees Celsius for 24 to 48 hours. 3. The Taxo A Disc package insert states to incubate plates with the Taxo A Disc in ambient air at 35 to 37C for 18 to 24 hours. 4. The LD confirmed that the laboratory did not follow the Taxo A Disc package insert for performing throat cultures. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures 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 STANDARD is not met as evidenced by: Based on review of the written procedure and interview with the laboratory director (LD), the laboratory did not establish an Individualized Quality Control Plan (IQCP) for performing throat culture testing. Findings: 1. The laboratory did not perform two levels quality control procedures with a positive and negative control organisms each day of patient testing. 2. The laboratory performs throat culture testing for Beta Hemolytic Strep A. 3. The laboratory performs QC once a week with the Taxo A Disc and the Strep Select Agar plate. 3. The laboratory did not perform an IQCP that included a risk assessment, quality control plan, and a quality assessment plan. 4. The LD confirmed that an IQCP was not performed. D6021 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with the laboratory director (LD), the LD did not establish and maintain quality assessment (QA) programs for the overall quality of the laboratory. Findings: 1. The laboratory director did not establish programs for the preanalytic, analytic, and postanalytic phases of patient testing to ensure the overall quality of patient testing 2. The laboratory director did not perform QA procedures for "laboratory safety, personnel policies, proficiency testing, patient test management, and quality control". 3. Quality assessment procedures are needed for the preanalytic, analytic, and postanalytic phases of patient testing to ensure the overall quality of patient testing and laboratory services provided. 4. The LD confirmed that QA procedures were not performed. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the written procedure manual and interview with the testing -- 2 of 3 -- person, the laboratory director did not specify in writing the duties and responsibilities of all persons involved in laboratory testing. Findings: The laboratory director did not have written duties and responsibilities for all personnel involved in the preanalytic, analytic, and postanalytic phases when performing bacteriology patient testing. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of training and competency procedures and interview with the laboratory director (LD) , the LD acting as the technical consultant (TC) did not perform competency procedures that included, direct observations, problem solving skills, proficiency testing, maintenance and function checks, preventative maintenance, and reporting patient test results. Findings: 1. The LD acting as the TC did not have training and competency procedures for testing personal performing bacteriology testing. 2. The LD stated that competency procedures that included direct observations, problem solving skills, proficiency testing, maintenance and function checks, preventative maintenance, and reporting patient test results was not performed. -- 3 of 3 --