Corry Memorial Hospital

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Corry Memorial Hospital on 06/11/2024 - 06/12/2024 by the PA Department of Health. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5405, D5423, and D5559. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures and interview with the techical supervisor (TS #1), the laboratory failed to have a complete written procedure for the analyte Creatinine on the Siemens Dimension EXL from 10/19/2022 to the day of survey. Findings include: 1. On the day of the survey, 06/11/2024 at 09:30 am, review of the procedure manuals for Chemistry revealed the operators manual were used to perform testing on the following from 10/19/2022 to day of survey: - Creatinine on the Siemens Dimension EXL. 2. Review of the operators manual revealed that the test system instructions used failed to include the following requirements: - Step by step performance of the procedure including test calculations and interpretation of results. - Control procedures. -

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's competency assessment records and interview with technical supervisor #1(TS), the laboratory failed to establish a competency assessment procedure to assess the competency of 1 of 2 technical supervisors, and 6 of 7 general supervisors (GS) for their supervisory roles from 08/12/2020 to the date of survey. Findings include: 1. On the day of survey, 10/19/2022 at 09:01 am, the laboratory could not provide a competency assessment policy to assess the competency of the following personnel for their supervisory skills from 08/12/2020 to 10/19/2022: - 1 of 2 TS (CMS 209, personnel #2) - 6 of 7 GS (CMS 209, personnel #3, #4, #5, #6, #7, #8) 2. The laboratory could not provide documentation for delegation of duties for TS #1 (CMS 209, personnel #2). 3. The laboratory could not provide competency assessment documents for 6 of 7 GS (CMS 209, personnel #3, #4, #5, #6, #7, #8). 4. TS #1 confirmed the findings above on 10/19/2022 around 04: 30 pm. *This is a repeat deficiency. 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: 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 -- Based on lack of documentation and interview with technical supervisor #2 (TS), the laboratory failed to verify twice annually the accuracy of acetone examinations performed from 08/12/2020 through the date of survey. Findings include: 1. On the day of survey, 10/19/2022 at 11:31 am., the laboratory could not provide documentation of verification of accuracy for acetone examinations performed from 08/12/2020 to 10/19/2022. 2. TS #2 confirmed the findings above on 10/19/2022 around 04:30 pm. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with technical consultant #2 (TC), the laboratory failed to perform calibration verification at least once every six months for the Siemens Dimension Chemistry Analyzer from 08/12/2020 to the date of survey. Findings include: 1. On the date of survey, 10/19/2022 at 02:17 pm, the laboratory could not provide calibration verification records for the required analytes tested on the Siemens Dimension chemistry analyzer from 08/12/2020 to 10/19/2022. 2. TC #2 confirmed the findings above on 10/19/2022 around 04:30 pm. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: A. Based on review of competency assessment records and interview with the technical supervisor (TS) #1 and #2, the laboratory failed to assess the competency for 1 of 9 testing personnel (TP) for their 1st year of semiannual competency in 2019 and 2020. Findings Include: 1. The Orientation and competency policy states, "Competency assessment must be performed at the following frequency: At least semi annually during the first year an employee tests patient specimen and at least annually thereafter". 2. On the day of survey, 08/12/2020, review of TP competency assessment recorded reviewed, the laboratory did not document the competency assessment for 1 of 9 TP (TP #6) hired 01/23/2019 for their semi annual competency in 2019 and 2020 for testing performed in the laboratory departments of microbiology, clinical chemistry, hematology. immunohematology, serology, toxicology, and urinalysis. 3. The TS #1 and #2 confirmed the above findings on 08/12 /2020 around 10:25 am. B. Based on review of the laboratory policies and interview with the technical supervisor #1 and #2, the laboratory failed to establish a competency assessment policy to assess the competency for 2 of 3 laboratory personnel for their regulatory responsibilities in 2018, 2019 and 2020. Findings Include: 1. On the day of survey, 08/12/2020, the laboratory could not provide a competency assessment policy or documentation of competency assessment performed for 2 of 3 laboratory personnel (On the CMS 2019 Testing Personnel form, listed as a technical consultants, technical supervisors and general supervisors) in 2018, 2019 and 2020. 2. The TS #1 and #2 confirmed the above finding on 08/12 /2020 around 10:30 am. 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 -- D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory quality control (QC) records and interview with the technical supervisor (TS) #1 and #2, the laboratory failed to perform quality control each day of patient testing for the one step oxycodone test cards from 05/10/2018 to 08 /13/2020. Findings Include: 1. On the day of survey, 08/12/2020, review of the one step oxycodone test card kit QC records revealed, the laboratory did not perform QC each day of patient testing from 05/10/2018 to 08/13/2020. 2. In 2018 (05/10/2018 to 12/31/2018), 133 oxycodone test cards were analyzed. 3. In 2019 (01/01/2019 to 12/31 /2019), 206 oxycodone test cards were analyzed. 4. In 2020 (01/01/2020 to 08/13 /2020), 118 oxycodone test cards were analyzed. 5. The TS #1 and #2 confirmed the above finding on 08/13/2020 around 10:15 am. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with the technical supervisor (TS) #1 and #2, the LD failed to ensure a quality assessment (QA) policy was established to assess the quality of laboratory services provided from 2018, 2019 and 2020. Findings Include: 1. On the date of survey, 08/12/2020, the TS could not provide a QA policy that assessed the laboratory's pre-analytical, analytical, and post- analytical processes from 05/10/2018 to 08/13/2020. 2. The TS #1 and #2 confirmed on 08/13/2020 around 08:45 am. -- 2 of 2 --

Summary Statement of Deficiencies 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 observation, review of Siemens Complete pH/Blood Gas, ISE, Co-oximeter and Metabolite Quality Control package insert, and interview Technical Consultant (TC) #1, the laboratory failed to monitor and document the condition for storage of Siemens Complete pH/Blood Gas, ISE, Co-oximeter and Metabolite Quality Control, Levels #1, #2 and #3 from 2016 to the date of survey. Findings Include: 1. According to Siemens Complete pH/Blood Gas, ISE, Co-oximeter and Metabolite Quality Control Package insert, Storage and Handling state, "Store complete solution at room temperature (18 - 25 degrees Celsius) away from sunlight. You may also store Complete at 2 - 25 degrees Celsius without out verse effects". 2. On the day of survey, 05/09/2018, it was discovered that one box each level (1-3) of Siemens Complete pH /Blood Gas, ISE, Co-oximeter and Metabolite Quality Controls were stored in a wall cabinet by the instrument, but room temperature was not recorded and documented. 3. 2016 Annual volume (May 2016 to April 2017), 126 patient Blood Gas tests were analyzed. 4. 2017 Annual volume (May 2017 to April 2018), 139 patient Blood Gas tests were analyzed. 5. TC #1 confirmed the findings above on 05/09/2018 around 02: 45 pm D5449 CONTROL PROCEDURES 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 -- CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of Urine Microscopic Analysis, Post Vasectomy Semen Analysis and Osom hcg Combo Test Serum Quality Control (QC) logs and interview with the Technical Consultant (TC) #2, the laboratory failed to document QC for Urine Microscopic Analysis, Post Vasectomy Semen Analysis and perform hcg serum patient testing each day of patient testing in 2016 to the date of survey. Findings Include: A). 1. On the date of survey 05/09/2018, review of Urine Microscopic QC records, revealed the laboratory has reference material available for Urine Microscopic analysis QC but QC was not documented in 2016 and 2017. 2. 2016 Annual volume (May 2016 to April 2017), 2828 Urine Microscopic Analysis tests were analyzed. 3. 2017 Annual volume (May 2017 to April 2018), 2122 Urine Microscopic Analysis tests were analyzed. 4. The TC#2 confirmed the findings above on 05/09/2018 around 09:15 am. B). 1. On the date of survey 05/09/2018, review of Osom hcg Combo Test Serum QC frequency, revealed the laboratory was performing QC on a weekly bases instead of each day of patient testing in 2016 and 2017. 2. No IQCP was developed to support the laboratory weekly frequency for performing Osom hcg Combo Test for Serum QC. 3. Annual volume (May 2016 to April 2017), 198 Serum hcg tests were analyzed. 4. Annual volume (May 2017 to April 2018), 161 Serum hcg tests were analyzed. 5. The TC #2 confirmed the findings above on 05/09 /2018 around 12:00 pm. C). 1. On the date of survey 05/10/2018, review of Semen QC records, revealed the laboratory has reference material available for Semen analysis QC but QC was not documented in 2016 and 2017. 2. 2016 Annual volume (May 2016 to April 2017), 5 Post Vasectomy Semen Analysis tests were analyzed. 3. 2017 Annual volume (May 2017 to April 2018), 5 Post Vasectomy Semen Analysis tests were analyzed. 4. The TC#2 confirmed the findings above on 05/10/2018 around 09:30 am. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Manual Differential Stain Quality control (QC) and interview with the Technical Consultant (TC) #1 and #2, the laboratory failed to test the manual differential stain (Quick III Stain) for reactivity each day of patient use from 2016 to the date of survey. Finding Include: 1. On the day of survey, 05/09/2018, while on the initial tour of the laboratory, surveyor #2 asked "if the laboratory documents wright stain QC?", TC#1 and #2 replied that the stain check is performed but not documented -- 2 of 4 -- in 2016 and 2017. 2. 2016 Annual volume (May 2016 to April 2017), 13433 Manual Differential tests were analyzed. 3. 2017 Annual volume (May 2017 to April 2018), 12474 Manual Differential tests were analyzed. 4. The TC #1 and #2 confirmed the findings above on 05/09/2018 around 9:45 am. D5523 PARASITOLOGY CFR(s): 493.1264(a)(d) The laboratory must have available a reference collection of slides or photographs and, if available, gross specimens for identification of parasites and use these references in the laboratory for appropriate comparison with diagnostic specimens. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's Scabies Wet Mount Quality Control (QC) references material and interview with Technical Consultant (TC) #1, the laboratory failed to document Trichomonas vaginalis Wet Mount QC from 2016 to the date of survey. Findings Include: 1. At the time of the survey 05/09/2018, the laboratory did have Trichomonas vaginalis reference material available for laboratory personnel to review, but QC was not documented in 2016 and 2017. 2. 2016 Annual volume (May 2016 to April 2017), 11 Trichomonas vaginalis Wet Mount tests were analyzed. 3. 2017 Annual volume (May 2017 to April 2018), 14 Trichomonas vaginalis Wet Mount tests were analyzed. 4. TC #1 confirmed the findings above on 05/08/2018 around 10:45 am. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must 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 Blood Gas Procedure Manual and interview with Technical Consultant #1 and #2, the laboratory director (LD) failed to ensure that all the procedure manuals have been signed and approved from 2016 to the date of survey. Findings Include: 1. On the day of survey, 05/09/2018, review of the Blood Gas procedure Manual, revealed that the current LD did not sign and approve the current Blood gases manual in use for patient testing since their start date of 10/11/2016. 2. TC #1 and #2 confirmed the findings above on 05/09/2018 around 02:15 pm. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on, the review of records and interview with the Technical Consultant (TC) #1 and #2, the Technical Supervisor failed to evaluate the competency of 2 of 9 Testing Personnel (TP) who perform, Bacteriology, Chemistry, Hematology, Immunohematology, Parasitology, Virology, and Urinalysis testing in 2017. Findings Include: 1. On the date of survey 05/09/2018, review of personnel's annual competency assessments, revealed that 2 of 9 TP who perform Bacteriology, Chemistry, Hematology, Immunohematology, Parasitology, Virology, and Urinalysis patient tests, were not assessed for competency in 2017. 2. The Laboratories Annual Volume (May 2016 to April 2017), 355,381 patient tests were performed. 3. The Laboratories Annual Volume (May 2017 to April 2018), 331,927 patient tests were performed. 4. The TC #1 and #2 confirmed the findings above on 05/09/2018 around 10:15 am D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on, the review of testing personnel competency assessment records, American Proficiency Institute (API) proficiency records and interview with Technical Consultant #1 and #2 (TC), the Technical Supervisor failed to evaluate the assessment of all testing personnel (TP) for the assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples from 2016 to the date of survey. Findings Include: A. 1. On the day of survey, 05/09/2018, review of the laboratory's API attestation statements from Event 1-3 in 2016 and 2017, revealed that each year, 3 of 7 Laboratory TP perform PT for the categories of Microbiology, Clinical Chemistry, Hematology, Immunohematology and Urinalysis. 2. 4 of 7 Laboratory TP were not evaluated through external proficiency testing samples or internal blind testing samples on non-waived tests in 2016 and 2017. 3. TC#1 and TC#2 confirmed the findings above on 05/09/2018 around 10:00 am. B. 1. On the day of survey, 05/09/2018, review of Blood Gases PT records revealed that 2 of 2 Respiratory therapy TP perform in PT testing for blood gases in 2016 and 2017. 2. 7 of 7 laboratory TP who also periodically run Blood Gases patients samples have not been evaluated through external proficiency testing samples or internal blind testing samples for Blood Gases in 2016 and 2017. 3. TC#1 and TC#2 confirmed the findings above on 05/09/2018 around 02:30 pm. -- 4 of 4 --